Ob.Gyn. News

As doctors and researchers learn more about long COVID, an interesting fact has emerged: Women experiencing menopause and perimenopause appear to be more likely to experience serious complications from the virus.
 

British researchers have noted that women at midlife who have long COVID seem to get specific, and severe, symptoms, including brain fog, fatigue, new-onset dizziness, and difficulty sleeping through the night. 

Doctors also think it’s possible that long COVID worsens the symptoms of perimenopause and menopause. Lower levels of estrogen and testosterone appear to be the reason.

“A long COVID theory is that there is a temporary disruption to physiological ovarian steroid hormone production, which could [worsen] symptoms of perimenopause and menopause,” said JoAnn V. Pinkerton, MD, professor of obstetrics at the University of Virginia, Charlottesville, and executive director of the North American Menopause Society.

Long COVID symptoms and menopause symptoms can also be very hard to tell apart. 

Another U.K. study cautions that because of this kind of symptom overlap, women at midlife may be misdiagnosed. Research from the North American Menopause Society shows that many women may have trouble recovering from long COVID unless their hormone deficiency is treated. 
 

What are the symptoms of long COVID?

There are over 200 symptoms that have been associated with long COVID, according to the American Medical Association. Some common symptoms are currently defined as the following: feeling extremely tired, feeling depleted after exertion, cognitive issues such as brain fog, heart beating over 100 times a minute, and a loss of sense of smell and taste. 

Long COVID symptoms begin a few weeks to a few months after a COVID infection. They can last an indefinite amount of time, but “the hope is that long COVID will not be lifelong,” said Clare Flannery, MD, an endocrinologist and associate professor in the departments of obstetrics, gynecology and reproductive sciences and internal medicine at Yale University, New Haven, Conn. 
 

What are the symptoms of menopause?

Some symptoms of menopause include vaginal infections, irregular bleeding, urinary problems, and sexual problems.

Women in their middle years have other symptoms that can be the same as perimenopause/menopause symptoms. 

“Common symptoms of perimenopause and menopause which may also be symptoms ascribed to long COVID include hot flashes, night sweats, disrupted sleep, low mood, depression or anxiety, decreased concentration, memory problems, joint and muscle pains, and headaches,” Dr. Pinkerton said. 
 

Can long COVID actually bring on menopause? 

In short: Possibly.

A new study from the Massachusetts Institute of Technology/Patient-Led Research Collaborative/University of California, San Francisco, found that long COVID can cause disruptions to a woman’s menstrual cycle, ovaries, fertility, and menopause itself. 

This could be caused by chronic inflammation caused by long COVID on hormones as well. This kind of inflammatory response could explain irregularities in a woman’s menstrual cycle, according to the Newson Health Research and Education study. For instance, “when the body has inflammation, ovulation can happen,” Dr. Flannery said. 

The mechanism for how long COVID could spur menopause can also involve a woman’s ovaries. 

“Since the theory is that COVID affects the ovary with declines in ovarian reserve and ovarian function, it makes sense that long COVID could bring on symptoms of perimenopause or menopause more acutely or more severely and lengthen the symptoms of the perimenopause and menopausal transition,” Dr. Pinkerton said. 
 

How can hormone replacement therapy benefit women dealing with long COVID during menopause?

Estradiol, the strongest estrogen hormone in a woman’s body, has already been shown to have a positive effect against COVID.

“Estradiol therapy treats symptoms more aggressively in the setting of long COVID,” said Dr. Flannery.

Estradiol is also a form of hormone therapy for menopause symptoms. 

“Estradiol has been shown to help hot flashes, night sweats, and sleep and improve mood during perimenopause,” said Dr. Pinkerton. “So it’s likely that perimenopausal or menopausal women with long COVID would see improvements both due to the action of estradiol on the ovary seen during COVID and the improvements in symptoms.”

Estrogen-based hormone therapy has been linked to an increased risk for endometrial, breast, and ovarian cancer, according to the American Cancer Society. This means you should carefully consider how comfortable you are with those additional risks before starting this kind of therapy.

“Which of your symptoms are the most difficult to manage? You may see if you can navigate one to three of them. What are you willing to do for your symptoms? If a woman is willing to favor her sleep for the next 6 months to a year, she may be willing to change how she perceives her risk for cancer,” Dr. Flannery said. “What risk is a woman willing to take? I think if someone has a very low concern about a risk of cancer, and she’s suffering a disrupted life, then taking estradiol in a 1- to 2-year trial period could be critical to help.” 
 

What else can help ease long COVID during menopause? 

Getting the COVID vaccine, as well as getting a booster, could help. Not only will this help prevent people from being reinfected with COVID, which can worsen symptoms, but a new Swedish study says there is no evidence that it will cause postmenopausal problems like irregular bleeding.

“Weak and inconsistent associations were observed between SARS-CoV-2 vaccination and healthcare contacts for bleeding in women who are postmenopausal, and even less evidence was recorded of an association for menstrual disturbance or bleeding in women who were premenopausal,” said study coauthor Rickard Ljung, MD, PhD, MPH, professor and acting head of the pharmacoepidemiology and analysis department in the division of use and information of the Swedish Medical Products Agency in Uppsala.

A version of this article first appeared on WebMD.com.

As doctors and researchers learn more about long COVID, an interesting fact has emerged: Women experiencing menopause and perimenopause appear to be more likely to experience serious complications from the virus.
 

British researchers have noted that women at midlife who have long COVID seem to get specific, and severe, symptoms, including brain fog, fatigue, new-onset dizziness, and difficulty sleeping through the night. 

Doctors also think it’s possible that long COVID worsens the symptoms of perimenopause and menopause. Lower levels of estrogen and testosterone appear to be the reason.

“A long COVID theory is that there is a temporary disruption to physiological ovarian steroid hormone production, which could [worsen] symptoms of perimenopause and menopause,” said JoAnn V. Pinkerton, MD, professor of obstetrics at the University of Virginia, Charlottesville, and executive director of the North American Menopause Society.

Long COVID symptoms and menopause symptoms can also be very hard to tell apart. 

Another U.K. study cautions that because of this kind of symptom overlap, women at midlife may be misdiagnosed. Research from the North American Menopause Society shows that many women may have trouble recovering from long COVID unless their hormone deficiency is treated. 
 

What are the symptoms of long COVID?

There are over 200 symptoms that have been associated with long COVID, according to the American Medical Association. Some common symptoms are currently defined as the following: feeling extremely tired, feeling depleted after exertion, cognitive issues such as brain fog, heart beating over 100 times a minute, and a loss of sense of smell and taste. 

Long COVID symptoms begin a few weeks to a few months after a COVID infection. They can last an indefinite amount of time, but “the hope is that long COVID will not be lifelong,” said Clare Flannery, MD, an endocrinologist and associate professor in the departments of obstetrics, gynecology and reproductive sciences and internal medicine at Yale University, New Haven, Conn. 
 

What are the symptoms of menopause?

Some symptoms of menopause include vaginal infections, irregular bleeding, urinary problems, and sexual problems.

Women in their middle years have other symptoms that can be the same as perimenopause/menopause symptoms. 

“Common symptoms of perimenopause and menopause which may also be symptoms ascribed to long COVID include hot flashes, night sweats, disrupted sleep, low mood, depression or anxiety, decreased concentration, memory problems, joint and muscle pains, and headaches,” Dr. Pinkerton said. 
 

Can long COVID actually bring on menopause? 

In short: Possibly.

A new study from the Massachusetts Institute of Technology/Patient-Led Research Collaborative/University of California, San Francisco, found that long COVID can cause disruptions to a woman’s menstrual cycle, ovaries, fertility, and menopause itself. 

This could be caused by chronic inflammation caused by long COVID on hormones as well. This kind of inflammatory response could explain irregularities in a woman’s menstrual cycle, according to the Newson Health Research and Education study. For instance, “when the body has inflammation, ovulation can happen,” Dr. Flannery said. 

The mechanism for how long COVID could spur menopause can also involve a woman’s ovaries. 

“Since the theory is that COVID affects the ovary with declines in ovarian reserve and ovarian function, it makes sense that long COVID could bring on symptoms of perimenopause or menopause more acutely or more severely and lengthen the symptoms of the perimenopause and menopausal transition,” Dr. Pinkerton said. 
 

How can hormone replacement therapy benefit women dealing with long COVID during menopause?

Estradiol, the strongest estrogen hormone in a woman’s body, has already been shown to have a positive effect against COVID.

“Estradiol therapy treats symptoms more aggressively in the setting of long COVID,” said Dr. Flannery.

Estradiol is also a form of hormone therapy for menopause symptoms. 

“Estradiol has been shown to help hot flashes, night sweats, and sleep and improve mood during perimenopause,” said Dr. Pinkerton. “So it’s likely that perimenopausal or menopausal women with long COVID would see improvements both due to the action of estradiol on the ovary seen during COVID and the improvements in symptoms.”

Estrogen-based hormone therapy has been linked to an increased risk for endometrial, breast, and ovarian cancer, according to the American Cancer Society. This means you should carefully consider how comfortable you are with those additional risks before starting this kind of therapy.

“Which of your symptoms are the most difficult to manage? You may see if you can navigate one to three of them. What are you willing to do for your symptoms? If a woman is willing to favor her sleep for the next 6 months to a year, she may be willing to change how she perceives her risk for cancer,” Dr. Flannery said. “What risk is a woman willing to take? I think if someone has a very low concern about a risk of cancer, and she’s suffering a disrupted life, then taking estradiol in a 1- to 2-year trial period could be critical to help.” 
 

What else can help ease long COVID during menopause? 

Getting the COVID vaccine, as well as getting a booster, could help. Not only will this help prevent people from being reinfected with COVID, which can worsen symptoms, but a new Swedish study says there is no evidence that it will cause postmenopausal problems like irregular bleeding.

“Weak and inconsistent associations were observed between SARS-CoV-2 vaccination and healthcare contacts for bleeding in women who are postmenopausal, and even less evidence was recorded of an association for menstrual disturbance or bleeding in women who were premenopausal,” said study coauthor Rickard Ljung, MD, PhD, MPH, professor and acting head of the pharmacoepidemiology and analysis department in the division of use and information of the Swedish Medical Products Agency in Uppsala.

A version of this article first appeared on WebMD.com.

As doctors and researchers learn more about long COVID, an interesting fact has emerged: Women experiencing menopause and perimenopause appear to be more likely to experience serious complications from the virus.
 

British researchers have noted that women at midlife who have long COVID seem to get specific, and severe, symptoms, including brain fog, fatigue, new-onset dizziness, and difficulty sleeping through the night. 

Doctors also think it’s possible that long COVID worsens the symptoms of perimenopause and menopause. Lower levels of estrogen and testosterone appear to be the reason.

“A long COVID theory is that there is a temporary disruption to physiological ovarian steroid hormone production, which could [worsen] symptoms of perimenopause and menopause,” said JoAnn V. Pinkerton, MD, professor of obstetrics at the University of Virginia, Charlottesville, and executive director of the North American Menopause Society.

Long COVID symptoms and menopause symptoms can also be very hard to tell apart. 

Another U.K. study cautions that because of this kind of symptom overlap, women at midlife may be misdiagnosed. Research from the North American Menopause Society shows that many women may have trouble recovering from long COVID unless their hormone deficiency is treated. 
 

What are the symptoms of long COVID?

There are over 200 symptoms that have been associated with long COVID, according to the American Medical Association. Some common symptoms are currently defined as the following: feeling extremely tired, feeling depleted after exertion, cognitive issues such as brain fog, heart beating over 100 times a minute, and a loss of sense of smell and taste. 

Long COVID symptoms begin a few weeks to a few months after a COVID infection. They can last an indefinite amount of time, but “the hope is that long COVID will not be lifelong,” said Clare Flannery, MD, an endocrinologist and associate professor in the departments of obstetrics, gynecology and reproductive sciences and internal medicine at Yale University, New Haven, Conn. 
 

What are the symptoms of menopause?

Some symptoms of menopause include vaginal infections, irregular bleeding, urinary problems, and sexual problems.

Women in their middle years have other symptoms that can be the same as perimenopause/menopause symptoms. 

“Common symptoms of perimenopause and menopause which may also be symptoms ascribed to long COVID include hot flashes, night sweats, disrupted sleep, low mood, depression or anxiety, decreased concentration, memory problems, joint and muscle pains, and headaches,” Dr. Pinkerton said. 
 

Can long COVID actually bring on menopause? 

In short: Possibly.

A new study from the Massachusetts Institute of Technology/Patient-Led Research Collaborative/University of California, San Francisco, found that long COVID can cause disruptions to a woman’s menstrual cycle, ovaries, fertility, and menopause itself. 

This could be caused by chronic inflammation caused by long COVID on hormones as well. This kind of inflammatory response could explain irregularities in a woman’s menstrual cycle, according to the Newson Health Research and Education study. For instance, “when the body has inflammation, ovulation can happen,” Dr. Flannery said. 

The mechanism for how long COVID could spur menopause can also involve a woman’s ovaries. 

“Since the theory is that COVID affects the ovary with declines in ovarian reserve and ovarian function, it makes sense that long COVID could bring on symptoms of perimenopause or menopause more acutely or more severely and lengthen the symptoms of the perimenopause and menopausal transition,” Dr. Pinkerton said. 
 

How can hormone replacement therapy benefit women dealing with long COVID during menopause?

Estradiol, the strongest estrogen hormone in a woman’s body, has already been shown to have a positive effect against COVID.

“Estradiol therapy treats symptoms more aggressively in the setting of long COVID,” said Dr. Flannery.

Estradiol is also a form of hormone therapy for menopause symptoms. 

“Estradiol has been shown to help hot flashes, night sweats, and sleep and improve mood during perimenopause,” said Dr. Pinkerton. “So it’s likely that perimenopausal or menopausal women with long COVID would see improvements both due to the action of estradiol on the ovary seen during COVID and the improvements in symptoms.”

Estrogen-based hormone therapy has been linked to an increased risk for endometrial, breast, and ovarian cancer, according to the American Cancer Society. This means you should carefully consider how comfortable you are with those additional risks before starting this kind of therapy.

“Which of your symptoms are the most difficult to manage? You may see if you can navigate one to three of them. What are you willing to do for your symptoms? If a woman is willing to favor her sleep for the next 6 months to a year, she may be willing to change how she perceives her risk for cancer,” Dr. Flannery said. “What risk is a woman willing to take? I think if someone has a very low concern about a risk of cancer, and she’s suffering a disrupted life, then taking estradiol in a 1- to 2-year trial period could be critical to help.” 
 

What else can help ease long COVID during menopause? 

Getting the COVID vaccine, as well as getting a booster, could help. Not only will this help prevent people from being reinfected with COVID, which can worsen symptoms, but a new Swedish study says there is no evidence that it will cause postmenopausal problems like irregular bleeding.

“Weak and inconsistent associations were observed between SARS-CoV-2 vaccination and healthcare contacts for bleeding in women who are postmenopausal, and even less evidence was recorded of an association for menstrual disturbance or bleeding in women who were premenopausal,” said study coauthor Rickard Ljung, MD, PhD, MPH, professor and acting head of the pharmacoepidemiology and analysis department in the division of use and information of the Swedish Medical Products Agency in Uppsala.

A version of this article first appeared on WebMD.com.

Fibroids, or leiomyomas, are noncancerous monoclonal tumors of the smooth muscle layer of the uterus. Fibroids occur more frequently in Black patients and their prevalence increases with age. The hormonally responsive nature of fibroids, frequently leading to growth with estrogen and progesterone exposure, makes them of particular concern during pregnancy.

Although most patients with fibroids do not have pregnancy complications directly attributable to their fibroids, prior studies have reported several associations, including painful degeneration, early pregnancy loss, preterm birth, placental abruption, malpresentation, and postpartum hemorrhage. Fibroids may predispose to uterine atony and hemorrhage by disrupting or impairing the synchronization and coordination of uterine contractions. Within the current body of literature, it remains less certain whether certain fibroid characteristics are associated with increased hemorrhage risk.

Prior studies evaluating the association between specific fibroid characteristics and postpartum hemorrhage have yielded inconsistent findings. In our study, we evaluated whether certain fibroid characteristics are associated with hemorrhage requiring blood transfusion. Specifically, our goal was to determine whether larger or more numerous fibroids increase the risk of transfusion.

This was a retrospective cohort study spanning 2019-2022. A total of 4,421 patients were included in this study. Fibroid characteristics were collected, including size, number, and location. Fibroid size was classified as small (< 5 cm), medium (5-10 cm), and large (> 10 cm).

In terms of number of fibroids, there was no significant increase in transfusions when comparing one fibroid to multiple fibroids. When assessing fibroid size, however, we did observe a significant incremental increase in rate of transfusions with increasing fibroid size. Compared to patients with small fibroids (< 5 cm), those with medium fibroids (5-10 cm) were 1.7 times and those with large fibroids (> 10 cm) 2.4 times more likely to experience hemorrhage requiring blood transfusion. In terms of fibroid location, patients with fibroids in the lower uterine segment or cervix were about 1.5 times more likely to have hemorrhage requiring transfusion, compared with those without a fibroid in that location.

This study allows practitioners to better risk-stratify patients from the practical perspective of postpartum hemorrhage requiring transfusions. In pregnant patients with fibroids, the specific fibroid characteristics can help us better anticipate clinically significant postpartum hemorrhage. In such patients, it is important to document specific fibroid characteristics, especially the largest fibroid diameter and fibroid location in the lower uterine segment or cervix. This emphasizes the importance of careful sonographic evaluation and consistent documentation of fibroids in pregnant patients.

Our study helps guide more informed counseling and risk stratification in this population, with increasing risk according to fibroid size and location. Patients with high-risk features, that is, medium or large fibroids and those with fibroids located in the lower uterine segment or cervix, should thus receive counseling about their increased risk of hemorrhage. As providers, we can help ameliorate this risk by optimizing hemoglobin levels of those at increased risk prior to delivery, and by ensuring availability of appropriate resources at the time of delivery.

Dr. Yaghoubian is a maternal-fetal medicine fellow at North Shore University Hospital/Long Island Jewish Medical Center in Manhasset, N.Y., and will be joining the faculty at the same institution. Email Dr. Yaghoubian at yyaghoubian@northwell.edu.

Fibroids, or leiomyomas, are noncancerous monoclonal tumors of the smooth muscle layer of the uterus. Fibroids occur more frequently in Black patients and their prevalence increases with age. The hormonally responsive nature of fibroids, frequently leading to growth with estrogen and progesterone exposure, makes them of particular concern during pregnancy.

Although most patients with fibroids do not have pregnancy complications directly attributable to their fibroids, prior studies have reported several associations, including painful degeneration, early pregnancy loss, preterm birth, placental abruption, malpresentation, and postpartum hemorrhage. Fibroids may predispose to uterine atony and hemorrhage by disrupting or impairing the synchronization and coordination of uterine contractions. Within the current body of literature, it remains less certain whether certain fibroid characteristics are associated with increased hemorrhage risk.

Prior studies evaluating the association between specific fibroid characteristics and postpartum hemorrhage have yielded inconsistent findings. In our study, we evaluated whether certain fibroid characteristics are associated with hemorrhage requiring blood transfusion. Specifically, our goal was to determine whether larger or more numerous fibroids increase the risk of transfusion.

This was a retrospective cohort study spanning 2019-2022. A total of 4,421 patients were included in this study. Fibroid characteristics were collected, including size, number, and location. Fibroid size was classified as small (< 5 cm), medium (5-10 cm), and large (> 10 cm).

In terms of number of fibroids, there was no significant increase in transfusions when comparing one fibroid to multiple fibroids. When assessing fibroid size, however, we did observe a significant incremental increase in rate of transfusions with increasing fibroid size. Compared to patients with small fibroids (< 5 cm), those with medium fibroids (5-10 cm) were 1.7 times and those with large fibroids (> 10 cm) 2.4 times more likely to experience hemorrhage requiring blood transfusion. In terms of fibroid location, patients with fibroids in the lower uterine segment or cervix were about 1.5 times more likely to have hemorrhage requiring transfusion, compared with those without a fibroid in that location.

This study allows practitioners to better risk-stratify patients from the practical perspective of postpartum hemorrhage requiring transfusions. In pregnant patients with fibroids, the specific fibroid characteristics can help us better anticipate clinically significant postpartum hemorrhage. In such patients, it is important to document specific fibroid characteristics, especially the largest fibroid diameter and fibroid location in the lower uterine segment or cervix. This emphasizes the importance of careful sonographic evaluation and consistent documentation of fibroids in pregnant patients.

Our study helps guide more informed counseling and risk stratification in this population, with increasing risk according to fibroid size and location. Patients with high-risk features, that is, medium or large fibroids and those with fibroids located in the lower uterine segment or cervix, should thus receive counseling about their increased risk of hemorrhage. As providers, we can help ameliorate this risk by optimizing hemoglobin levels of those at increased risk prior to delivery, and by ensuring availability of appropriate resources at the time of delivery.

Dr. Yaghoubian is a maternal-fetal medicine fellow at North Shore University Hospital/Long Island Jewish Medical Center in Manhasset, N.Y., and will be joining the faculty at the same institution. Email Dr. Yaghoubian at yyaghoubian@northwell.edu.

Fibroids, or leiomyomas, are noncancerous monoclonal tumors of the smooth muscle layer of the uterus. Fibroids occur more frequently in Black patients and their prevalence increases with age. The hormonally responsive nature of fibroids, frequently leading to growth with estrogen and progesterone exposure, makes them of particular concern during pregnancy.

Although most patients with fibroids do not have pregnancy complications directly attributable to their fibroids, prior studies have reported several associations, including painful degeneration, early pregnancy loss, preterm birth, placental abruption, malpresentation, and postpartum hemorrhage. Fibroids may predispose to uterine atony and hemorrhage by disrupting or impairing the synchronization and coordination of uterine contractions. Within the current body of literature, it remains less certain whether certain fibroid characteristics are associated with increased hemorrhage risk.

Prior studies evaluating the association between specific fibroid characteristics and postpartum hemorrhage have yielded inconsistent findings. In our study, we evaluated whether certain fibroid characteristics are associated with hemorrhage requiring blood transfusion. Specifically, our goal was to determine whether larger or more numerous fibroids increase the risk of transfusion.

This was a retrospective cohort study spanning 2019-2022. A total of 4,421 patients were included in this study. Fibroid characteristics were collected, including size, number, and location. Fibroid size was classified as small (< 5 cm), medium (5-10 cm), and large (> 10 cm).

In terms of number of fibroids, there was no significant increase in transfusions when comparing one fibroid to multiple fibroids. When assessing fibroid size, however, we did observe a significant incremental increase in rate of transfusions with increasing fibroid size. Compared to patients with small fibroids (< 5 cm), those with medium fibroids (5-10 cm) were 1.7 times and those with large fibroids (> 10 cm) 2.4 times more likely to experience hemorrhage requiring blood transfusion. In terms of fibroid location, patients with fibroids in the lower uterine segment or cervix were about 1.5 times more likely to have hemorrhage requiring transfusion, compared with those without a fibroid in that location.

This study allows practitioners to better risk-stratify patients from the practical perspective of postpartum hemorrhage requiring transfusions. In pregnant patients with fibroids, the specific fibroid characteristics can help us better anticipate clinically significant postpartum hemorrhage. In such patients, it is important to document specific fibroid characteristics, especially the largest fibroid diameter and fibroid location in the lower uterine segment or cervix. This emphasizes the importance of careful sonographic evaluation and consistent documentation of fibroids in pregnant patients.

Our study helps guide more informed counseling and risk stratification in this population, with increasing risk according to fibroid size and location. Patients with high-risk features, that is, medium or large fibroids and those with fibroids located in the lower uterine segment or cervix, should thus receive counseling about their increased risk of hemorrhage. As providers, we can help ameliorate this risk by optimizing hemoglobin levels of those at increased risk prior to delivery, and by ensuring availability of appropriate resources at the time of delivery.

Dr. Yaghoubian is a maternal-fetal medicine fellow at North Shore University Hospital/Long Island Jewish Medical Center in Manhasset, N.Y., and will be joining the faculty at the same institution. Email Dr. Yaghoubian at yyaghoubian@northwell.edu.

Postpartum hemorrhage (PPH) is the leading cause of maternal deaths worldwide, particularly in the least developed and developing countries. Of the 14 million female patients affected each year, approximately 70,000 cases result in death. However, according to a new study conducted by the World Health Organization and the University of Birmingham (England), a simple and affordable strategy may reduce the occurrence of severe cases during vaginal delivery.

Using the E-MOTIVE intervention reduced severe cases of PPH by 60%. These cases are defined as entailing blood loss greater than or equal to 1,000 mL in the 24 hours following delivery. This intervention also substantially reduced the need for blood transfusions, which are often costly and difficult to obtain.

In this trial, 80 secondary-level hospitals in Kenya, Nigeria, South Africa, and Tanzania, in which 210,132 patients underwent vaginal delivery, were randomly assigned to the intervention group or the usual-care group. Researchers identified that, among hospitals and patients with data, a primary outcome event occurred in 1.6% of the patients in the intervention group, compared with 4.3% of those in the usual-care group. In addition, PPH was detected in 93.1% of the patients in the intervention group and in 51.1% of those in the usual-care group. The treatment bundle was used in 91.2% and 19.4%, respectively.

The E-MOTIVE intervention, which is intended for use by health care professionals, consists of three elements:

• A strategy for early detection of PPH, which allows triggering of the “first response” treatment bundle
• A first response bundle called MOTIVE, which is based on WHO guidelines and consists of uterine massage, oxytocic drugs, tranexamic acid, IV fluids, and examination of the genital tract and escalation
• An implementation strategy that focuses on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley or carry case

During a WHO press conference, study author Arri Coomarasamy, MD, said, “This new approach to treating postpartum hemorrhage could radically improve women’s chances of surviving childbirth globally, helping them get the treatment they need when they need it.”

Dr. Coomarasamy, who is also co-director of the WHO Collaborating Centre on Global Women’s Health at the University of Birmingham, added, “Time is of the essence when responding to postpartum bleeding, so interventions that eliminate delays in diagnosis or treatment should be game-changers for maternal health.”
 

PPH a ‘preventable’ problem

In Brazil, maternal mortality is still one of the most significant challenges in public health. In recent years, the COVID-19 pandemic exacerbated the difficulties and weaknesses in the health care system for pregnant women and new mothers.

The maternal mortality ratio (MMR) is the number of maternal deaths per 100,000 live births from any cause related to or aggravated by pregnancy or its management (excluding accidental or incidental causes) during pregnancy and childbirth or within 42 days of termination of pregnancy. In 2021, the MMR was 113. This figure was almost double the 55.3 maternal deaths per 100,000 live births reported in 2019, which was before the pandemic. Preliminary data from the Brazilian Ministry of Health collected by the Brazilian Obstetric Observatory (OOBr) indicate that the MMR in 2022 decreased to 50.6 maternal deaths per 100,000 live births. However, these numbers could increase, because the maternal mortality committees are still reviewing cases.

Rossana Pulcineli Vieira Francisco, MD, PhD, a professor of obstetrics and gynecology at the University of São Paulo School of Medicine and obstetrics coordinator of the OOBr, affirmed that although these numbers have dropped, they are still much higher than the targets set by health authorities. Brazil is a participant of the UN agreement that aims to reduce MMR to a maximum of 30 maternal deaths per 100,000 live births per year by 2030. “We still have a long way to go to reach this goal within the next 7 years,” Dr. Francisco warned.

She compared rates in Brazil with those of more developed regions. According to the data, the mean MMR in Europe is 13 maternal deaths per 100,000 live births. “Portugal was shocked when maternal deaths surpassed 20 [maternal deaths per 100,000 live births in 2020] amidst the COVID-19 pandemic. The ratio in Brazil, even before the pandemic, was 55,” she said.

“Maternal mortality and infant mortality ratios are powerful indicators of the quality of the health care system,” added the OOBr coordinator, who asserted that investing in primary and prenatal care is essential. Dr. Francisco also pointed out the preventable nature of maternal mortality in Brazil. “The three main causes of direct maternal mortality in Brazil are high blood pressure, postpartum hemorrhage, and infection, particularly in the postpartum period. These issues are all considered preventable.”

Although it is difficult to prevent preeclampsia, hospital care and maternity care measures can significantly reduce the number of deaths caused by this condition. “For high blood pressure, what we most miss is having specialized prenatal care for at-risk women when the problem is diagnosed during pregnancy.”

Regarding PPH, Dr. Francisco calls attention to the importance of training teams to treat the problem. “In Brazil, the lack of training [for professionals] is still a serious problem.”

According to her, investments in rapid response systems are also needed. “As the baby needs nutrients and oxygen, the uterus becomes full of blood vessels at the end of pregnancy. As a result, a PPH leads to significant blood loss. In Brazil, some hospitals don’t even have blood bags. And in some cases, there may not be enough time to get a blood bag from somewhere else.”

Dr. Francisco also points out that, although it may not be feasible for all of Brazil’s health care units to have blood banks, integrated structures could be created to facilitate access to blood in case of emergency.

A grant from the Bill & Melinda Gates Foundation supported the E-MOTIVE project.

A version of this article first appeared on Medscape.com.

Postpartum hemorrhage (PPH) is the leading cause of maternal deaths worldwide, particularly in the least developed and developing countries. Of the 14 million female patients affected each year, approximately 70,000 cases result in death. However, according to a new study conducted by the World Health Organization and the University of Birmingham (England), a simple and affordable strategy may reduce the occurrence of severe cases during vaginal delivery.

Using the E-MOTIVE intervention reduced severe cases of PPH by 60%. These cases are defined as entailing blood loss greater than or equal to 1,000 mL in the 24 hours following delivery. This intervention also substantially reduced the need for blood transfusions, which are often costly and difficult to obtain.

In this trial, 80 secondary-level hospitals in Kenya, Nigeria, South Africa, and Tanzania, in which 210,132 patients underwent vaginal delivery, were randomly assigned to the intervention group or the usual-care group. Researchers identified that, among hospitals and patients with data, a primary outcome event occurred in 1.6% of the patients in the intervention group, compared with 4.3% of those in the usual-care group. In addition, PPH was detected in 93.1% of the patients in the intervention group and in 51.1% of those in the usual-care group. The treatment bundle was used in 91.2% and 19.4%, respectively.

The E-MOTIVE intervention, which is intended for use by health care professionals, consists of three elements:

• A strategy for early detection of PPH, which allows triggering of the “first response” treatment bundle
• A first response bundle called MOTIVE, which is based on WHO guidelines and consists of uterine massage, oxytocic drugs, tranexamic acid, IV fluids, and examination of the genital tract and escalation
• An implementation strategy that focuses on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley or carry case

During a WHO press conference, study author Arri Coomarasamy, MD, said, “This new approach to treating postpartum hemorrhage could radically improve women’s chances of surviving childbirth globally, helping them get the treatment they need when they need it.”

Dr. Coomarasamy, who is also co-director of the WHO Collaborating Centre on Global Women’s Health at the University of Birmingham, added, “Time is of the essence when responding to postpartum bleeding, so interventions that eliminate delays in diagnosis or treatment should be game-changers for maternal health.”
 

PPH a ‘preventable’ problem

In Brazil, maternal mortality is still one of the most significant challenges in public health. In recent years, the COVID-19 pandemic exacerbated the difficulties and weaknesses in the health care system for pregnant women and new mothers.

The maternal mortality ratio (MMR) is the number of maternal deaths per 100,000 live births from any cause related to or aggravated by pregnancy or its management (excluding accidental or incidental causes) during pregnancy and childbirth or within 42 days of termination of pregnancy. In 2021, the MMR was 113. This figure was almost double the 55.3 maternal deaths per 100,000 live births reported in 2019, which was before the pandemic. Preliminary data from the Brazilian Ministry of Health collected by the Brazilian Obstetric Observatory (OOBr) indicate that the MMR in 2022 decreased to 50.6 maternal deaths per 100,000 live births. However, these numbers could increase, because the maternal mortality committees are still reviewing cases.

Rossana Pulcineli Vieira Francisco, MD, PhD, a professor of obstetrics and gynecology at the University of São Paulo School of Medicine and obstetrics coordinator of the OOBr, affirmed that although these numbers have dropped, they are still much higher than the targets set by health authorities. Brazil is a participant of the UN agreement that aims to reduce MMR to a maximum of 30 maternal deaths per 100,000 live births per year by 2030. “We still have a long way to go to reach this goal within the next 7 years,” Dr. Francisco warned.

She compared rates in Brazil with those of more developed regions. According to the data, the mean MMR in Europe is 13 maternal deaths per 100,000 live births. “Portugal was shocked when maternal deaths surpassed 20 [maternal deaths per 100,000 live births in 2020] amidst the COVID-19 pandemic. The ratio in Brazil, even before the pandemic, was 55,” she said.

“Maternal mortality and infant mortality ratios are powerful indicators of the quality of the health care system,” added the OOBr coordinator, who asserted that investing in primary and prenatal care is essential. Dr. Francisco also pointed out the preventable nature of maternal mortality in Brazil. “The three main causes of direct maternal mortality in Brazil are high blood pressure, postpartum hemorrhage, and infection, particularly in the postpartum period. These issues are all considered preventable.”

Although it is difficult to prevent preeclampsia, hospital care and maternity care measures can significantly reduce the number of deaths caused by this condition. “For high blood pressure, what we most miss is having specialized prenatal care for at-risk women when the problem is diagnosed during pregnancy.”

Regarding PPH, Dr. Francisco calls attention to the importance of training teams to treat the problem. “In Brazil, the lack of training [for professionals] is still a serious problem.”

According to her, investments in rapid response systems are also needed. “As the baby needs nutrients and oxygen, the uterus becomes full of blood vessels at the end of pregnancy. As a result, a PPH leads to significant blood loss. In Brazil, some hospitals don’t even have blood bags. And in some cases, there may not be enough time to get a blood bag from somewhere else.”

Dr. Francisco also points out that, although it may not be feasible for all of Brazil’s health care units to have blood banks, integrated structures could be created to facilitate access to blood in case of emergency.

A grant from the Bill & Melinda Gates Foundation supported the E-MOTIVE project.

A version of this article first appeared on Medscape.com.

Postpartum hemorrhage (PPH) is the leading cause of maternal deaths worldwide, particularly in the least developed and developing countries. Of the 14 million female patients affected each year, approximately 70,000 cases result in death. However, according to a new study conducted by the World Health Organization and the University of Birmingham (England), a simple and affordable strategy may reduce the occurrence of severe cases during vaginal delivery.

Using the E-MOTIVE intervention reduced severe cases of PPH by 60%. These cases are defined as entailing blood loss greater than or equal to 1,000 mL in the 24 hours following delivery. This intervention also substantially reduced the need for blood transfusions, which are often costly and difficult to obtain.

In this trial, 80 secondary-level hospitals in Kenya, Nigeria, South Africa, and Tanzania, in which 210,132 patients underwent vaginal delivery, were randomly assigned to the intervention group or the usual-care group. Researchers identified that, among hospitals and patients with data, a primary outcome event occurred in 1.6% of the patients in the intervention group, compared with 4.3% of those in the usual-care group. In addition, PPH was detected in 93.1% of the patients in the intervention group and in 51.1% of those in the usual-care group. The treatment bundle was used in 91.2% and 19.4%, respectively.

The E-MOTIVE intervention, which is intended for use by health care professionals, consists of three elements:

• A strategy for early detection of PPH, which allows triggering of the “first response” treatment bundle
• A first response bundle called MOTIVE, which is based on WHO guidelines and consists of uterine massage, oxytocic drugs, tranexamic acid, IV fluids, and examination of the genital tract and escalation
• An implementation strategy that focuses on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley or carry case

During a WHO press conference, study author Arri Coomarasamy, MD, said, “This new approach to treating postpartum hemorrhage could radically improve women’s chances of surviving childbirth globally, helping them get the treatment they need when they need it.”

Dr. Coomarasamy, who is also co-director of the WHO Collaborating Centre on Global Women’s Health at the University of Birmingham, added, “Time is of the essence when responding to postpartum bleeding, so interventions that eliminate delays in diagnosis or treatment should be game-changers for maternal health.”
 

PPH a ‘preventable’ problem

In Brazil, maternal mortality is still one of the most significant challenges in public health. In recent years, the COVID-19 pandemic exacerbated the difficulties and weaknesses in the health care system for pregnant women and new mothers.

The maternal mortality ratio (MMR) is the number of maternal deaths per 100,000 live births from any cause related to or aggravated by pregnancy or its management (excluding accidental or incidental causes) during pregnancy and childbirth or within 42 days of termination of pregnancy. In 2021, the MMR was 113. This figure was almost double the 55.3 maternal deaths per 100,000 live births reported in 2019, which was before the pandemic. Preliminary data from the Brazilian Ministry of Health collected by the Brazilian Obstetric Observatory (OOBr) indicate that the MMR in 2022 decreased to 50.6 maternal deaths per 100,000 live births. However, these numbers could increase, because the maternal mortality committees are still reviewing cases.

Rossana Pulcineli Vieira Francisco, MD, PhD, a professor of obstetrics and gynecology at the University of São Paulo School of Medicine and obstetrics coordinator of the OOBr, affirmed that although these numbers have dropped, they are still much higher than the targets set by health authorities. Brazil is a participant of the UN agreement that aims to reduce MMR to a maximum of 30 maternal deaths per 100,000 live births per year by 2030. “We still have a long way to go to reach this goal within the next 7 years,” Dr. Francisco warned.

She compared rates in Brazil with those of more developed regions. According to the data, the mean MMR in Europe is 13 maternal deaths per 100,000 live births. “Portugal was shocked when maternal deaths surpassed 20 [maternal deaths per 100,000 live births in 2020] amidst the COVID-19 pandemic. The ratio in Brazil, even before the pandemic, was 55,” she said.

“Maternal mortality and infant mortality ratios are powerful indicators of the quality of the health care system,” added the OOBr coordinator, who asserted that investing in primary and prenatal care is essential. Dr. Francisco also pointed out the preventable nature of maternal mortality in Brazil. “The three main causes of direct maternal mortality in Brazil are high blood pressure, postpartum hemorrhage, and infection, particularly in the postpartum period. These issues are all considered preventable.”

Although it is difficult to prevent preeclampsia, hospital care and maternity care measures can significantly reduce the number of deaths caused by this condition. “For high blood pressure, what we most miss is having specialized prenatal care for at-risk women when the problem is diagnosed during pregnancy.”

Regarding PPH, Dr. Francisco calls attention to the importance of training teams to treat the problem. “In Brazil, the lack of training [for professionals] is still a serious problem.”

According to her, investments in rapid response systems are also needed. “As the baby needs nutrients and oxygen, the uterus becomes full of blood vessels at the end of pregnancy. As a result, a PPH leads to significant blood loss. In Brazil, some hospitals don’t even have blood bags. And in some cases, there may not be enough time to get a blood bag from somewhere else.”

Dr. Francisco also points out that, although it may not be feasible for all of Brazil’s health care units to have blood banks, integrated structures could be created to facilitate access to blood in case of emergency.

A grant from the Bill & Melinda Gates Foundation supported the E-MOTIVE project.

A version of this article first appeared on Medscape.com.

Vulvodynia is a little-known condition that, according to some U.S. studies, affects 3%-14% of the female population. It is defined as chronic pain, present for at least 3 months, that generally involves the vulva or some of its specific areas such as the clitoris or vestibule and is not attributable to causes of an infectious, inflammatory, oncologic, or endocrine nature; skin trauma; or damage to nerve fibers.
 

“There are probably many more women who suffer from it who don’t talk about it out of shame, because they feel ‘wrong,’ ” said gynecologist Pina Belfiore, MD, chair of the Italian Interdisciplinary Society of Vulvology, at the annual conference of the Italian Society of Gender Medicine in Neurosciences. “It is a treatable condition, or at the very least, a patient’s quality of life can be significantly improved with a personalized therapeutic approach.”
 

The correct diagnosis

The first step for setting the patient on the right course toward recovery is to offer welcome and empathy, recognizing that the suffering, which can have psychological causes, is not imaginary. “We need to explain to patients that their condition has a name, that they are not alone in this situation, and, above all, that there is hope for solving the problem. They can get through it,” said Dr. Belfiore.

First, an accurate history of the pain is needed to correctly diagnose vulvodynia. How long has the pain been going on? Is it continuous or is it triggered by an environmental factor, for example by sexual intercourse or contact with underwear? Is it a burning or stinging sensation? Did it first occur after an infection or after a physical or psychological trauma? Does the patient suffer from other forms of chronic pain such as recurring headaches or fibromyalgia?

“It is then necessary to inspect the vulva to exclude other systematic conditions or injuries that may be responsible for the pain, as well as to locate hypersensitive areas and evaluate the intensity of the symptoms,” said Dr. Belfiore.” A swab test is performed for this purpose, which is carried out by applying light pressure on different points of the vulva with a cotton swab.”
 

CNS dysfunction

Vulvodynia is not a direct condition of the vulva. Instead, it involves the dysfunction of the central nervous system (CNS), which confuses signals coming from the peripheral area, interpreting signals of a different nature as painful stimuli.

“The origin of this dysfunction is an individual predisposition. In fact, often the women who suffer from it are also affected by other forms of chronic pain,” said Dr. Belfiore. “Triggers for vulvodynia can be bacterial infections, candidiasis, or traumatic events such as surgically assisted birth or psychological trauma.”

Because inflammatory mechanisms are not involved, anti-inflammatory drugs are not helpful in treating the problem. “Instead, it is necessary to reduce the sensitivity of the CNS. For this purpose, low-dose antidepressant or antiepileptic drugs are used,” said Dr. Belfiore. “Pelvic floor rehabilitation is another treatment that can be beneficial when combined with pharmacologic treatment. This should be conducted by a professional with specific experience in vulvodynia, because an excessive increase in the tone of the levator ani muscle can make the situation worse. Psychotherapy and the adoption of certain hygienic and behavioral measures can also help, such as using lubricant during sexual intercourse, wearing pure cotton underwear, and using gentle intimate body washes.”

“It is important that family doctors who see women with this problem refer them to an experienced specialist,” said Dr. Belfiore.

A version of this article first appeared on Medscape.com.

This article was translated from Univadis Italy, which is part of the Medscape Professional Network.

Vulvodynia is a little-known condition that, according to some U.S. studies, affects 3%-14% of the female population. It is defined as chronic pain, present for at least 3 months, that generally involves the vulva or some of its specific areas such as the clitoris or vestibule and is not attributable to causes of an infectious, inflammatory, oncologic, or endocrine nature; skin trauma; or damage to nerve fibers.
 

“There are probably many more women who suffer from it who don’t talk about it out of shame, because they feel ‘wrong,’ ” said gynecologist Pina Belfiore, MD, chair of the Italian Interdisciplinary Society of Vulvology, at the annual conference of the Italian Society of Gender Medicine in Neurosciences. “It is a treatable condition, or at the very least, a patient’s quality of life can be significantly improved with a personalized therapeutic approach.”
 

The correct diagnosis

The first step for setting the patient on the right course toward recovery is to offer welcome and empathy, recognizing that the suffering, which can have psychological causes, is not imaginary. “We need to explain to patients that their condition has a name, that they are not alone in this situation, and, above all, that there is hope for solving the problem. They can get through it,” said Dr. Belfiore.

First, an accurate history of the pain is needed to correctly diagnose vulvodynia. How long has the pain been going on? Is it continuous or is it triggered by an environmental factor, for example by sexual intercourse or contact with underwear? Is it a burning or stinging sensation? Did it first occur after an infection or after a physical or psychological trauma? Does the patient suffer from other forms of chronic pain such as recurring headaches or fibromyalgia?

“It is then necessary to inspect the vulva to exclude other systematic conditions or injuries that may be responsible for the pain, as well as to locate hypersensitive areas and evaluate the intensity of the symptoms,” said Dr. Belfiore.” A swab test is performed for this purpose, which is carried out by applying light pressure on different points of the vulva with a cotton swab.”
 

CNS dysfunction

Vulvodynia is not a direct condition of the vulva. Instead, it involves the dysfunction of the central nervous system (CNS), which confuses signals coming from the peripheral area, interpreting signals of a different nature as painful stimuli.

“The origin of this dysfunction is an individual predisposition. In fact, often the women who suffer from it are also affected by other forms of chronic pain,” said Dr. Belfiore. “Triggers for vulvodynia can be bacterial infections, candidiasis, or traumatic events such as surgically assisted birth or psychological trauma.”

Because inflammatory mechanisms are not involved, anti-inflammatory drugs are not helpful in treating the problem. “Instead, it is necessary to reduce the sensitivity of the CNS. For this purpose, low-dose antidepressant or antiepileptic drugs are used,” said Dr. Belfiore. “Pelvic floor rehabilitation is another treatment that can be beneficial when combined with pharmacologic treatment. This should be conducted by a professional with specific experience in vulvodynia, because an excessive increase in the tone of the levator ani muscle can make the situation worse. Psychotherapy and the adoption of certain hygienic and behavioral measures can also help, such as using lubricant during sexual intercourse, wearing pure cotton underwear, and using gentle intimate body washes.”

“It is important that family doctors who see women with this problem refer them to an experienced specialist,” said Dr. Belfiore.

A version of this article first appeared on Medscape.com.

This article was translated from Univadis Italy, which is part of the Medscape Professional Network.

Vulvodynia is a little-known condition that, according to some U.S. studies, affects 3%-14% of the female population. It is defined as chronic pain, present for at least 3 months, that generally involves the vulva or some of its specific areas such as the clitoris or vestibule and is not attributable to causes of an infectious, inflammatory, oncologic, or endocrine nature; skin trauma; or damage to nerve fibers.
 

“There are probably many more women who suffer from it who don’t talk about it out of shame, because they feel ‘wrong,’ ” said gynecologist Pina Belfiore, MD, chair of the Italian Interdisciplinary Society of Vulvology, at the annual conference of the Italian Society of Gender Medicine in Neurosciences. “It is a treatable condition, or at the very least, a patient’s quality of life can be significantly improved with a personalized therapeutic approach.”
 

The correct diagnosis

The first step for setting the patient on the right course toward recovery is to offer welcome and empathy, recognizing that the suffering, which can have psychological causes, is not imaginary. “We need to explain to patients that their condition has a name, that they are not alone in this situation, and, above all, that there is hope for solving the problem. They can get through it,” said Dr. Belfiore.

First, an accurate history of the pain is needed to correctly diagnose vulvodynia. How long has the pain been going on? Is it continuous or is it triggered by an environmental factor, for example by sexual intercourse or contact with underwear? Is it a burning or stinging sensation? Did it first occur after an infection or after a physical or psychological trauma? Does the patient suffer from other forms of chronic pain such as recurring headaches or fibromyalgia?

“It is then necessary to inspect the vulva to exclude other systematic conditions or injuries that may be responsible for the pain, as well as to locate hypersensitive areas and evaluate the intensity of the symptoms,” said Dr. Belfiore.” A swab test is performed for this purpose, which is carried out by applying light pressure on different points of the vulva with a cotton swab.”
 

CNS dysfunction

Vulvodynia is not a direct condition of the vulva. Instead, it involves the dysfunction of the central nervous system (CNS), which confuses signals coming from the peripheral area, interpreting signals of a different nature as painful stimuli.

“The origin of this dysfunction is an individual predisposition. In fact, often the women who suffer from it are also affected by other forms of chronic pain,” said Dr. Belfiore. “Triggers for vulvodynia can be bacterial infections, candidiasis, or traumatic events such as surgically assisted birth or psychological trauma.”

Because inflammatory mechanisms are not involved, anti-inflammatory drugs are not helpful in treating the problem. “Instead, it is necessary to reduce the sensitivity of the CNS. For this purpose, low-dose antidepressant or antiepileptic drugs are used,” said Dr. Belfiore. “Pelvic floor rehabilitation is another treatment that can be beneficial when combined with pharmacologic treatment. This should be conducted by a professional with specific experience in vulvodynia, because an excessive increase in the tone of the levator ani muscle can make the situation worse. Psychotherapy and the adoption of certain hygienic and behavioral measures can also help, such as using lubricant during sexual intercourse, wearing pure cotton underwear, and using gentle intimate body washes.”

“It is important that family doctors who see women with this problem refer them to an experienced specialist,” said Dr. Belfiore.

A version of this article first appeared on Medscape.com.

This article was translated from Univadis Italy, which is part of the Medscape Professional Network.

A targeted genetic sequencing strategy effectively identified homologous recombination DNA repair deficiency in ovarian cancer patients, and may eventually help predict treatment response, a study suggests.

Previous research has identified homologous recombination DNA repair deficiency (HRD) as a biomarker for sensitivity to poly( ADP-ribose) polymerase inhibitors (PARPi) and platinum-based therapies in patients with ovarian and breast cancers, wrote Niklas Krumm, MD, of the University of Washington, Seattle, and colleagues.

Currently, direct genetic testing is the most widely used method to identify mutations in HRD-associated genes, but not all genes underlying HDD have been identified, therefore current HRD assays that don’t rely on gene-specific information have been considered more diagnostically useful, the researchers noted. Two genetic tests are approved by the Food and Drug Administration, which are the FoundationFocus CDX BRCA and myChoice CDx, the researchers wrote. The Foundation Focus CDX BRCA was approved in 2016, and myChoice CDx was approved in 2019.

“However, transparent, well-defined methods and criteria for diagnosing HRD by genomic scarring that are practical for smaller, academic, or private laboratories have not yet been established or widely implemented,” they said.

In the paper published in JCO Precision Oncology, the researchers said they developed a molecular testing strategy involving the use of common, polymorphic single-nucleotide polymorphisms (SNPs).

They used a panel of approximately 3,000 SNPs distributed across the genome to create a loss of heterozygosity (LOH) score that could identify HRD.

To determine the ability of LOH to diagnose HRD in ovarian cancers, the researchers examined 99 ovarian neoplasm–normal pairs using the LOH method, and compared results with patient mutational genotypes and HRD predictors. LOH scores of 11% or higher showed greater than 86% sensitivity for identifying tumors with HRD-causing mutations in an independent validation set, and a sensitivity of 90.9% across training and validation sets.

When LOH scores were compared to a validated genome-wide mutational signature assay (HRDetect) the sensitivity and specificity of an LOH score of 11% or higher were estimated at 96.7% and 50%, respectively, for determining HRD-positive tumors.

However, the researchers found poor concordance (statistically insignificant correlation) using their LOH capture design to diagnose HRD based on mutational signatures only from targeted regions. “We conclude that mutational signatures inferred from our diagnostic tumor panel are unable to accurately ascertain HRD status, likely because the absolute number of somatic variants that it is able to identify is insufficient,” they said.

LOH scores were not significantly correlated with treatment outcomes, which suggests that LOH score can be used to infer HRD status, rather than serving as a direct predictor of patient response to primary platinum therapy, the researchers said. The average LOH score was higher in patients whose cancers responded to platinum therapy than in those with no treatment response (17% vs. 15%) but this difference was not significant.


 

Study limitations

The research was limited by several factors, including the validation only for high-grade non–clear cell ovarian carcinomas, and LOH scores likely vary across cancer types, therefore more studies will be needed to optimize the strategy for different cancers, the researchers noted. Other potential limitations include the high level of tumor cellularity needed (30%), which will eliminate some specimens, they said.

Finally, the poor predictive value of LOH itself for treatment outcomes suggests a limitation of the HRD biomarker in this respect, the researchers concluded.
 

Potential advantages of using LOH method

However, the potential advantages of the LOH method include the minimal sequence reads and the ability to integrate the LOH into current targeted gene capture workflows, the researchers wrote, and the LOH score appears to be a reliable predictor of HRD positivity.

“Although we have found that the regions targeted by our assay are insufficient to identify HRD-associated mutational signatures, future refinements to this approach could integrate minimal additional sequencing targets designed to robustly identify such signatures in concert with LOH events,” they concluded.
 

Study shares the details of detection methodology

“Tumors with HRD are sensitive to certain cancer chemotherapeutic agents [PARP inhibitors],” said Dr. Krumm, in an interview. “Until recently, HR-deficient tumors were primarily identified via inactivating BRCA1 or BRCA2 mutations, but now it is understood that an entire repair pathway can be affected and can result in HRD. Therefore, we sought to implement an NGS-based approach that could detect the ‘HRD phenotype’ in the DNA of tumors,” he said.

The approach developed by Dr. Krumm and colleagues and presented in the current study “is not the first in the field, as some commercial tests have similar approaches,” he said. However, the current study is important, “because it openly publishes the methodology and detailed results of our validation work in bringing HRD detection online in our clinical lab,” he said.

“One of the advantages of a genome-wide approach is that we can identify HR-deficient tumors, even when BRCA1 and BRCA2 do not have any detectable loss-of-function mutations,” said Dr. Krumm. “HRD detection is a relatively young test in the field of next-generation sequencing (NGS)–based cancer diagnostics. One of the challenges currently is the lack of large, standardized reference data sets or reference materials that can be used to compare tests and methodology in a clinical setting. We hope that by publishing our methods, more data sets can be generated and published,” he said.

Some specific challenges to using the test clinically today include the need for a paired tumor plus blood sample, and the need for a relatively high fraction of tumor content in the sample, Dr. Krumm noted.

“This test is currently being used in a clinical setting at the University of Washington, as it is a laboratory-developed test (LDT) and part of our clinically validated NGS platform,” said Dr. Krumm. “This test highlights how LDTs can advance clinical testing capabilities and improve the care of our patients and illustrates the UW Medicine position that LDTs are a necessary and important part of the clinical care. That said, we anticipate that additional validation studies, including long-term clinical effectiveness and outcome studies, will be required to bring HRD testing into a commercial platform that undergoes FDA review,” he explained.

The study was supported by the Brotman Baty Institute for Precision Medicine, the National Institutes of Health, and the Department of Defense, Ovarian Cancer Research Program Clinical Development Award. Dr. Krumm disclosed stock and ownership interests in Reference Genomics.

A targeted genetic sequencing strategy effectively identified homologous recombination DNA repair deficiency in ovarian cancer patients, and may eventually help predict treatment response, a study suggests.

Previous research has identified homologous recombination DNA repair deficiency (HRD) as a biomarker for sensitivity to poly( ADP-ribose) polymerase inhibitors (PARPi) and platinum-based therapies in patients with ovarian and breast cancers, wrote Niklas Krumm, MD, of the University of Washington, Seattle, and colleagues.

Currently, direct genetic testing is the most widely used method to identify mutations in HRD-associated genes, but not all genes underlying HDD have been identified, therefore current HRD assays that don’t rely on gene-specific information have been considered more diagnostically useful, the researchers noted. Two genetic tests are approved by the Food and Drug Administration, which are the FoundationFocus CDX BRCA and myChoice CDx, the researchers wrote. The Foundation Focus CDX BRCA was approved in 2016, and myChoice CDx was approved in 2019.

“However, transparent, well-defined methods and criteria for diagnosing HRD by genomic scarring that are practical for smaller, academic, or private laboratories have not yet been established or widely implemented,” they said.

In the paper published in JCO Precision Oncology, the researchers said they developed a molecular testing strategy involving the use of common, polymorphic single-nucleotide polymorphisms (SNPs).

They used a panel of approximately 3,000 SNPs distributed across the genome to create a loss of heterozygosity (LOH) score that could identify HRD.

To determine the ability of LOH to diagnose HRD in ovarian cancers, the researchers examined 99 ovarian neoplasm–normal pairs using the LOH method, and compared results with patient mutational genotypes and HRD predictors. LOH scores of 11% or higher showed greater than 86% sensitivity for identifying tumors with HRD-causing mutations in an independent validation set, and a sensitivity of 90.9% across training and validation sets.

When LOH scores were compared to a validated genome-wide mutational signature assay (HRDetect) the sensitivity and specificity of an LOH score of 11% or higher were estimated at 96.7% and 50%, respectively, for determining HRD-positive tumors.

However, the researchers found poor concordance (statistically insignificant correlation) using their LOH capture design to diagnose HRD based on mutational signatures only from targeted regions. “We conclude that mutational signatures inferred from our diagnostic tumor panel are unable to accurately ascertain HRD status, likely because the absolute number of somatic variants that it is able to identify is insufficient,” they said.

LOH scores were not significantly correlated with treatment outcomes, which suggests that LOH score can be used to infer HRD status, rather than serving as a direct predictor of patient response to primary platinum therapy, the researchers said. The average LOH score was higher in patients whose cancers responded to platinum therapy than in those with no treatment response (17% vs. 15%) but this difference was not significant.


 

Study limitations

The research was limited by several factors, including the validation only for high-grade non–clear cell ovarian carcinomas, and LOH scores likely vary across cancer types, therefore more studies will be needed to optimize the strategy for different cancers, the researchers noted. Other potential limitations include the high level of tumor cellularity needed (30%), which will eliminate some specimens, they said.

Finally, the poor predictive value of LOH itself for treatment outcomes suggests a limitation of the HRD biomarker in this respect, the researchers concluded.
 

Potential advantages of using LOH method

However, the potential advantages of the LOH method include the minimal sequence reads and the ability to integrate the LOH into current targeted gene capture workflows, the researchers wrote, and the LOH score appears to be a reliable predictor of HRD positivity.

“Although we have found that the regions targeted by our assay are insufficient to identify HRD-associated mutational signatures, future refinements to this approach could integrate minimal additional sequencing targets designed to robustly identify such signatures in concert with LOH events,” they concluded.
 

Study shares the details of detection methodology

“Tumors with HRD are sensitive to certain cancer chemotherapeutic agents [PARP inhibitors],” said Dr. Krumm, in an interview. “Until recently, HR-deficient tumors were primarily identified via inactivating BRCA1 or BRCA2 mutations, but now it is understood that an entire repair pathway can be affected and can result in HRD. Therefore, we sought to implement an NGS-based approach that could detect the ‘HRD phenotype’ in the DNA of tumors,” he said.

The approach developed by Dr. Krumm and colleagues and presented in the current study “is not the first in the field, as some commercial tests have similar approaches,” he said. However, the current study is important, “because it openly publishes the methodology and detailed results of our validation work in bringing HRD detection online in our clinical lab,” he said.

“One of the advantages of a genome-wide approach is that we can identify HR-deficient tumors, even when BRCA1 and BRCA2 do not have any detectable loss-of-function mutations,” said Dr. Krumm. “HRD detection is a relatively young test in the field of next-generation sequencing (NGS)–based cancer diagnostics. One of the challenges currently is the lack of large, standardized reference data sets or reference materials that can be used to compare tests and methodology in a clinical setting. We hope that by publishing our methods, more data sets can be generated and published,” he said.

Some specific challenges to using the test clinically today include the need for a paired tumor plus blood sample, and the need for a relatively high fraction of tumor content in the sample, Dr. Krumm noted.

“This test is currently being used in a clinical setting at the University of Washington, as it is a laboratory-developed test (LDT) and part of our clinically validated NGS platform,” said Dr. Krumm. “This test highlights how LDTs can advance clinical testing capabilities and improve the care of our patients and illustrates the UW Medicine position that LDTs are a necessary and important part of the clinical care. That said, we anticipate that additional validation studies, including long-term clinical effectiveness and outcome studies, will be required to bring HRD testing into a commercial platform that undergoes FDA review,” he explained.

The study was supported by the Brotman Baty Institute for Precision Medicine, the National Institutes of Health, and the Department of Defense, Ovarian Cancer Research Program Clinical Development Award. Dr. Krumm disclosed stock and ownership interests in Reference Genomics.

A targeted genetic sequencing strategy effectively identified homologous recombination DNA repair deficiency in ovarian cancer patients, and may eventually help predict treatment response, a study suggests.

Previous research has identified homologous recombination DNA repair deficiency (HRD) as a biomarker for sensitivity to poly( ADP-ribose) polymerase inhibitors (PARPi) and platinum-based therapies in patients with ovarian and breast cancers, wrote Niklas Krumm, MD, of the University of Washington, Seattle, and colleagues.

Currently, direct genetic testing is the most widely used method to identify mutations in HRD-associated genes, but not all genes underlying HDD have been identified, therefore current HRD assays that don’t rely on gene-specific information have been considered more diagnostically useful, the researchers noted. Two genetic tests are approved by the Food and Drug Administration, which are the FoundationFocus CDX BRCA and myChoice CDx, the researchers wrote. The Foundation Focus CDX BRCA was approved in 2016, and myChoice CDx was approved in 2019.

“However, transparent, well-defined methods and criteria for diagnosing HRD by genomic scarring that are practical for smaller, academic, or private laboratories have not yet been established or widely implemented,” they said.

In the paper published in JCO Precision Oncology, the researchers said they developed a molecular testing strategy involving the use of common, polymorphic single-nucleotide polymorphisms (SNPs).

They used a panel of approximately 3,000 SNPs distributed across the genome to create a loss of heterozygosity (LOH) score that could identify HRD.

To determine the ability of LOH to diagnose HRD in ovarian cancers, the researchers examined 99 ovarian neoplasm–normal pairs using the LOH method, and compared results with patient mutational genotypes and HRD predictors. LOH scores of 11% or higher showed greater than 86% sensitivity for identifying tumors with HRD-causing mutations in an independent validation set, and a sensitivity of 90.9% across training and validation sets.

When LOH scores were compared to a validated genome-wide mutational signature assay (HRDetect) the sensitivity and specificity of an LOH score of 11% or higher were estimated at 96.7% and 50%, respectively, for determining HRD-positive tumors.

However, the researchers found poor concordance (statistically insignificant correlation) using their LOH capture design to diagnose HRD based on mutational signatures only from targeted regions. “We conclude that mutational signatures inferred from our diagnostic tumor panel are unable to accurately ascertain HRD status, likely because the absolute number of somatic variants that it is able to identify is insufficient,” they said.

LOH scores were not significantly correlated with treatment outcomes, which suggests that LOH score can be used to infer HRD status, rather than serving as a direct predictor of patient response to primary platinum therapy, the researchers said. The average LOH score was higher in patients whose cancers responded to platinum therapy than in those with no treatment response (17% vs. 15%) but this difference was not significant.


 

Study limitations

The research was limited by several factors, including the validation only for high-grade non–clear cell ovarian carcinomas, and LOH scores likely vary across cancer types, therefore more studies will be needed to optimize the strategy for different cancers, the researchers noted. Other potential limitations include the high level of tumor cellularity needed (30%), which will eliminate some specimens, they said.

Finally, the poor predictive value of LOH itself for treatment outcomes suggests a limitation of the HRD biomarker in this respect, the researchers concluded.
 

Potential advantages of using LOH method

However, the potential advantages of the LOH method include the minimal sequence reads and the ability to integrate the LOH into current targeted gene capture workflows, the researchers wrote, and the LOH score appears to be a reliable predictor of HRD positivity.

“Although we have found that the regions targeted by our assay are insufficient to identify HRD-associated mutational signatures, future refinements to this approach could integrate minimal additional sequencing targets designed to robustly identify such signatures in concert with LOH events,” they concluded.
 

Study shares the details of detection methodology

“Tumors with HRD are sensitive to certain cancer chemotherapeutic agents [PARP inhibitors],” said Dr. Krumm, in an interview. “Until recently, HR-deficient tumors were primarily identified via inactivating BRCA1 or BRCA2 mutations, but now it is understood that an entire repair pathway can be affected and can result in HRD. Therefore, we sought to implement an NGS-based approach that could detect the ‘HRD phenotype’ in the DNA of tumors,” he said.

The approach developed by Dr. Krumm and colleagues and presented in the current study “is not the first in the field, as some commercial tests have similar approaches,” he said. However, the current study is important, “because it openly publishes the methodology and detailed results of our validation work in bringing HRD detection online in our clinical lab,” he said.

“One of the advantages of a genome-wide approach is that we can identify HR-deficient tumors, even when BRCA1 and BRCA2 do not have any detectable loss-of-function mutations,” said Dr. Krumm. “HRD detection is a relatively young test in the field of next-generation sequencing (NGS)–based cancer diagnostics. One of the challenges currently is the lack of large, standardized reference data sets or reference materials that can be used to compare tests and methodology in a clinical setting. We hope that by publishing our methods, more data sets can be generated and published,” he said.

Some specific challenges to using the test clinically today include the need for a paired tumor plus blood sample, and the need for a relatively high fraction of tumor content in the sample, Dr. Krumm noted.

“This test is currently being used in a clinical setting at the University of Washington, as it is a laboratory-developed test (LDT) and part of our clinically validated NGS platform,” said Dr. Krumm. “This test highlights how LDTs can advance clinical testing capabilities and improve the care of our patients and illustrates the UW Medicine position that LDTs are a necessary and important part of the clinical care. That said, we anticipate that additional validation studies, including long-term clinical effectiveness and outcome studies, will be required to bring HRD testing into a commercial platform that undergoes FDA review,” he explained.

The study was supported by the Brotman Baty Institute for Precision Medicine, the National Institutes of Health, and the Department of Defense, Ovarian Cancer Research Program Clinical Development Award. Dr. Krumm disclosed stock and ownership interests in Reference Genomics.

CHICAGO – In the phase 3 MIRASOL study, the antibody-drug conjugate (ADC) mirvetuximab soravtansine-gynx (MIRV, Elahere, ImmunoGen) produced an overall survival benefit in women with platinum-resistant ovarian cancer.

The conclusion of this study marks the first time that a novel therapy has demonstrated an overall survival (OS) improvement in any phase 3 trial in this population, according to lead investigator Kathleen Moore, MD.

“We believe these data are practice changing and position mirvetuximab [soravtansine] as the new standard of care for patients with folate receptor–alpha positive, platinum-resistant ovarian cancer,” said Dr. Moore during a presentation of the study at a special session of the annual meeting of the American Society of Clinical Oncology devoted solely to the MIRASOL study.
 

New standard of care

Following Dr. Moore’s presentation, Roisin Eilish O’Cearbhaill, MD, served as a discussant, and she confirmed the trial’s importance.

“It has firmly established the role of mirvetuximab [soravtansine] in folate receptor–alpha high-expression, platinum-resistant ovarian cancer,” said Dr. O’Cearbhaill, who is Research director of the gynecologic medical oncology service and clinical director of the solid tumor, cellular therapy service at Memorial Sloan Kettering Cancer Center, New York.

Mirvetuximab soravtansine received accelerated FDA approval in November based on the results of the single-arm SORAYA trial, which demonstrated a progression-free survival (PFS) benefit in platinum-resistant patients who had been previously treated with one to three treatment regimens, at least one of which having included bevacizumab.

The new study compared MIRV with physician choice chemotherapy and found both a PFS and OS benefit in the MIRV arm. The results garnered significant enthusiasm from the audience, and others reacted positively as well.

“The results that she presented are just astounding, with a significant improvement in both progression-free and overall survival. I think certainly the overall survival needs to be highlighted here, because this is a patient population that’s notoriously difficult to treat,” said Ana Valente, MD, a gynecologic oncologist at the Ochsner Health System in New Orleans. Dr. Valente, who did not attend the presentation but was asked to comment on the study, is also a member of the Society of Gynecological Oncologist communications committee.

Unlike SORAYA, MIRASOL was open to patients who had not received bevacizumab, and Dr. Moore and colleagues found similar survival benefits in patients who had not received bevacizumab as in those who had, said Dr. Moore, who is the associate director of clinical research at Stephenson Cancer Center and director of the Oklahoma TSET Phase 1 Program, both in Oklahoma City. This opens the possibility of using MIRV instead of bevacizumab combined with chemotherapy in platinum-resistant patients.

“I think this data really shows you can move right to mirvetuximab [soravtansine] and feel pretty solid about the decision in a biomarker selected [population],” Dr. Moore said, during an interview.
 

Not just for high expression levels

MIRASOL was restricted to patients with high levels of expression of folate receptor–alpha, which is MIRV’s target on the surface of tumor cells. High expression is defined as at least 75% of viable tumor cells exhibiting a minimum of 2+ level membrane staining intensity by immunohistochemistry. That represents about 35% of patients, according to Dr. Moore, but she said that the drug also shows promise in patients with medium levels of folate receptor–alpha expression.

“I think it’s just going to be now starting to get those label extension studies launched to branch it out. Then you account for 60% of your population which [have] medium to high [expression levels], and that’s really where you see benefit,” said Dr. Moore. Medium expression levels of folate receptor–alpha are defined as 50% to greater than 75% of tumor cells with 2+ level membrane staining intensity.

She also noted that the FORWARD II trial combining mirvetuximab soravtansine with bevacizumab in platinum-resistant ovarian cancer is showing good results.

“We have really beautiful data [from FORWARD II]. If I have a medium expresser, I’m using the doublet [of MIRV and bevacizumab], and it works,” said Dr. Moore, while also pointing out that this remains an off-label use.

It’s possible that the drug could be extended even to low expression levels, defined as 25% to less than 50% of tumor cells with 2+ level membrane staining intensity. “[We are] currently working on that strategy with already available data,” said Dr. Moore.

She speculated that the improved OS may be attributed to the reduced toxicity of MIRV, compared with chemotherapy agents, which leaves patients feeling better and more able to pursue other treatments, which in turn may increase survival odds.

Dr. O’Cearbhaill touted the benefits of ADCs and their ability to target powerful cytotoxic agents while limiting side effects, and she is looking forward to more new therapies on the horizon.

“There are four [ADCs] in late stages of development [for platinum-resistant ovarian cancer], so hopefully there will be other ones coming online as well,” Dr. O’Cearbhaill said in an interview. “Then we’ll have to figure out how to sequence them, which drug will be best in class. Will we be just giving one or will be giving ADC followed by ADC?”
 

Study methods and results

The study enrolled 453 patients and randomized them to treatment with MIRV or investigator’s choice of chemotherapy, which could be paclitaxel, pegylated liposomal doxorubicin, or topotecan. The MIRV dose was 6 mg/kg adjusted ideal body weight every 3 weeks. The median age was 62 in the chemotherapy arm and 63 years in the MIRV arm. About 63% of the chemotherapy arm had prior bevacizumab exposure, as did 61% of the MIRV arm.

Median PFS was 5.62 months in the MIRV arm and 3.98 months in the chemotherapy arm (hazard ratio, 0.65; P less than .0001). The overall response rate was 42% in the MIRV arm and 16% in the chemotherapy arm (P < .0001).

The safety outcomes also favored MIRV: 42% experienced grade 3 or higher treatment-emergent adverse events (TEAEs) versus 54% in the chemotherapy group. Severe adverse events were also lower in MIRV, 24% versus 33%. Just 9% of patients in the MIRV discontinued because of TEAEs, compared with 16% in the chemotherapy arm.

MIRV was associated with blurred vision (41%), keratopathy (32%), and dry eye (28%), but these issues were generally manageable through collaboration with optometrists or ophthalmologists.

Dr. Moore and Dr. O’Cearbhaill reported receiving honoraria, research funding, and travel expenses from numerous pharmaceutical companies. Dr. O’Cearbhaill has consulted for or advised Aptitude Health, Bayer, Carina Biotech, Fresenius Kabi, GlaxoSmithKline, GOG Foundation, Immunogen, R-Pharm, Regeneron, and Seagen.

CHICAGO – In the phase 3 MIRASOL study, the antibody-drug conjugate (ADC) mirvetuximab soravtansine-gynx (MIRV, Elahere, ImmunoGen) produced an overall survival benefit in women with platinum-resistant ovarian cancer.

The conclusion of this study marks the first time that a novel therapy has demonstrated an overall survival (OS) improvement in any phase 3 trial in this population, according to lead investigator Kathleen Moore, MD.

“We believe these data are practice changing and position mirvetuximab [soravtansine] as the new standard of care for patients with folate receptor–alpha positive, platinum-resistant ovarian cancer,” said Dr. Moore during a presentation of the study at a special session of the annual meeting of the American Society of Clinical Oncology devoted solely to the MIRASOL study.
 

New standard of care

Following Dr. Moore’s presentation, Roisin Eilish O’Cearbhaill, MD, served as a discussant, and she confirmed the trial’s importance.

“It has firmly established the role of mirvetuximab [soravtansine] in folate receptor–alpha high-expression, platinum-resistant ovarian cancer,” said Dr. O’Cearbhaill, who is Research director of the gynecologic medical oncology service and clinical director of the solid tumor, cellular therapy service at Memorial Sloan Kettering Cancer Center, New York.

Mirvetuximab soravtansine received accelerated FDA approval in November based on the results of the single-arm SORAYA trial, which demonstrated a progression-free survival (PFS) benefit in platinum-resistant patients who had been previously treated with one to three treatment regimens, at least one of which having included bevacizumab.

The new study compared MIRV with physician choice chemotherapy and found both a PFS and OS benefit in the MIRV arm. The results garnered significant enthusiasm from the audience, and others reacted positively as well.

“The results that she presented are just astounding, with a significant improvement in both progression-free and overall survival. I think certainly the overall survival needs to be highlighted here, because this is a patient population that’s notoriously difficult to treat,” said Ana Valente, MD, a gynecologic oncologist at the Ochsner Health System in New Orleans. Dr. Valente, who did not attend the presentation but was asked to comment on the study, is also a member of the Society of Gynecological Oncologist communications committee.

Unlike SORAYA, MIRASOL was open to patients who had not received bevacizumab, and Dr. Moore and colleagues found similar survival benefits in patients who had not received bevacizumab as in those who had, said Dr. Moore, who is the associate director of clinical research at Stephenson Cancer Center and director of the Oklahoma TSET Phase 1 Program, both in Oklahoma City. This opens the possibility of using MIRV instead of bevacizumab combined with chemotherapy in platinum-resistant patients.

“I think this data really shows you can move right to mirvetuximab [soravtansine] and feel pretty solid about the decision in a biomarker selected [population],” Dr. Moore said, during an interview.
 

Not just for high expression levels

MIRASOL was restricted to patients with high levels of expression of folate receptor–alpha, which is MIRV’s target on the surface of tumor cells. High expression is defined as at least 75% of viable tumor cells exhibiting a minimum of 2+ level membrane staining intensity by immunohistochemistry. That represents about 35% of patients, according to Dr. Moore, but she said that the drug also shows promise in patients with medium levels of folate receptor–alpha expression.

“I think it’s just going to be now starting to get those label extension studies launched to branch it out. Then you account for 60% of your population which [have] medium to high [expression levels], and that’s really where you see benefit,” said Dr. Moore. Medium expression levels of folate receptor–alpha are defined as 50% to greater than 75% of tumor cells with 2+ level membrane staining intensity.

She also noted that the FORWARD II trial combining mirvetuximab soravtansine with bevacizumab in platinum-resistant ovarian cancer is showing good results.

“We have really beautiful data [from FORWARD II]. If I have a medium expresser, I’m using the doublet [of MIRV and bevacizumab], and it works,” said Dr. Moore, while also pointing out that this remains an off-label use.

It’s possible that the drug could be extended even to low expression levels, defined as 25% to less than 50% of tumor cells with 2+ level membrane staining intensity. “[We are] currently working on that strategy with already available data,” said Dr. Moore.

She speculated that the improved OS may be attributed to the reduced toxicity of MIRV, compared with chemotherapy agents, which leaves patients feeling better and more able to pursue other treatments, which in turn may increase survival odds.

Dr. O’Cearbhaill touted the benefits of ADCs and their ability to target powerful cytotoxic agents while limiting side effects, and she is looking forward to more new therapies on the horizon.

“There are four [ADCs] in late stages of development [for platinum-resistant ovarian cancer], so hopefully there will be other ones coming online as well,” Dr. O’Cearbhaill said in an interview. “Then we’ll have to figure out how to sequence them, which drug will be best in class. Will we be just giving one or will be giving ADC followed by ADC?”
 

Study methods and results

The study enrolled 453 patients and randomized them to treatment with MIRV or investigator’s choice of chemotherapy, which could be paclitaxel, pegylated liposomal doxorubicin, or topotecan. The MIRV dose was 6 mg/kg adjusted ideal body weight every 3 weeks. The median age was 62 in the chemotherapy arm and 63 years in the MIRV arm. About 63% of the chemotherapy arm had prior bevacizumab exposure, as did 61% of the MIRV arm.

Median PFS was 5.62 months in the MIRV arm and 3.98 months in the chemotherapy arm (hazard ratio, 0.65; P less than .0001). The overall response rate was 42% in the MIRV arm and 16% in the chemotherapy arm (P < .0001).

The safety outcomes also favored MIRV: 42% experienced grade 3 or higher treatment-emergent adverse events (TEAEs) versus 54% in the chemotherapy group. Severe adverse events were also lower in MIRV, 24% versus 33%. Just 9% of patients in the MIRV discontinued because of TEAEs, compared with 16% in the chemotherapy arm.

MIRV was associated with blurred vision (41%), keratopathy (32%), and dry eye (28%), but these issues were generally manageable through collaboration with optometrists or ophthalmologists.

Dr. Moore and Dr. O’Cearbhaill reported receiving honoraria, research funding, and travel expenses from numerous pharmaceutical companies. Dr. O’Cearbhaill has consulted for or advised Aptitude Health, Bayer, Carina Biotech, Fresenius Kabi, GlaxoSmithKline, GOG Foundation, Immunogen, R-Pharm, Regeneron, and Seagen.

CHICAGO – In the phase 3 MIRASOL study, the antibody-drug conjugate (ADC) mirvetuximab soravtansine-gynx (MIRV, Elahere, ImmunoGen) produced an overall survival benefit in women with platinum-resistant ovarian cancer.

The conclusion of this study marks the first time that a novel therapy has demonstrated an overall survival (OS) improvement in any phase 3 trial in this population, according to lead investigator Kathleen Moore, MD.

“We believe these data are practice changing and position mirvetuximab [soravtansine] as the new standard of care for patients with folate receptor–alpha positive, platinum-resistant ovarian cancer,” said Dr. Moore during a presentation of the study at a special session of the annual meeting of the American Society of Clinical Oncology devoted solely to the MIRASOL study.
 

New standard of care

Following Dr. Moore’s presentation, Roisin Eilish O’Cearbhaill, MD, served as a discussant, and she confirmed the trial’s importance.

“It has firmly established the role of mirvetuximab [soravtansine] in folate receptor–alpha high-expression, platinum-resistant ovarian cancer,” said Dr. O’Cearbhaill, who is Research director of the gynecologic medical oncology service and clinical director of the solid tumor, cellular therapy service at Memorial Sloan Kettering Cancer Center, New York.

Mirvetuximab soravtansine received accelerated FDA approval in November based on the results of the single-arm SORAYA trial, which demonstrated a progression-free survival (PFS) benefit in platinum-resistant patients who had been previously treated with one to three treatment regimens, at least one of which having included bevacizumab.

The new study compared MIRV with physician choice chemotherapy and found both a PFS and OS benefit in the MIRV arm. The results garnered significant enthusiasm from the audience, and others reacted positively as well.

“The results that she presented are just astounding, with a significant improvement in both progression-free and overall survival. I think certainly the overall survival needs to be highlighted here, because this is a patient population that’s notoriously difficult to treat,” said Ana Valente, MD, a gynecologic oncologist at the Ochsner Health System in New Orleans. Dr. Valente, who did not attend the presentation but was asked to comment on the study, is also a member of the Society of Gynecological Oncologist communications committee.

Unlike SORAYA, MIRASOL was open to patients who had not received bevacizumab, and Dr. Moore and colleagues found similar survival benefits in patients who had not received bevacizumab as in those who had, said Dr. Moore, who is the associate director of clinical research at Stephenson Cancer Center and director of the Oklahoma TSET Phase 1 Program, both in Oklahoma City. This opens the possibility of using MIRV instead of bevacizumab combined with chemotherapy in platinum-resistant patients.

“I think this data really shows you can move right to mirvetuximab [soravtansine] and feel pretty solid about the decision in a biomarker selected [population],” Dr. Moore said, during an interview.
 

Not just for high expression levels

MIRASOL was restricted to patients with high levels of expression of folate receptor–alpha, which is MIRV’s target on the surface of tumor cells. High expression is defined as at least 75% of viable tumor cells exhibiting a minimum of 2+ level membrane staining intensity by immunohistochemistry. That represents about 35% of patients, according to Dr. Moore, but she said that the drug also shows promise in patients with medium levels of folate receptor–alpha expression.

“I think it’s just going to be now starting to get those label extension studies launched to branch it out. Then you account for 60% of your population which [have] medium to high [expression levels], and that’s really where you see benefit,” said Dr. Moore. Medium expression levels of folate receptor–alpha are defined as 50% to greater than 75% of tumor cells with 2+ level membrane staining intensity.

She also noted that the FORWARD II trial combining mirvetuximab soravtansine with bevacizumab in platinum-resistant ovarian cancer is showing good results.

“We have really beautiful data [from FORWARD II]. If I have a medium expresser, I’m using the doublet [of MIRV and bevacizumab], and it works,” said Dr. Moore, while also pointing out that this remains an off-label use.

It’s possible that the drug could be extended even to low expression levels, defined as 25% to less than 50% of tumor cells with 2+ level membrane staining intensity. “[We are] currently working on that strategy with already available data,” said Dr. Moore.

She speculated that the improved OS may be attributed to the reduced toxicity of MIRV, compared with chemotherapy agents, which leaves patients feeling better and more able to pursue other treatments, which in turn may increase survival odds.

Dr. O’Cearbhaill touted the benefits of ADCs and their ability to target powerful cytotoxic agents while limiting side effects, and she is looking forward to more new therapies on the horizon.

“There are four [ADCs] in late stages of development [for platinum-resistant ovarian cancer], so hopefully there will be other ones coming online as well,” Dr. O’Cearbhaill said in an interview. “Then we’ll have to figure out how to sequence them, which drug will be best in class. Will we be just giving one or will be giving ADC followed by ADC?”
 

Study methods and results

The study enrolled 453 patients and randomized them to treatment with MIRV or investigator’s choice of chemotherapy, which could be paclitaxel, pegylated liposomal doxorubicin, or topotecan. The MIRV dose was 6 mg/kg adjusted ideal body weight every 3 weeks. The median age was 62 in the chemotherapy arm and 63 years in the MIRV arm. About 63% of the chemotherapy arm had prior bevacizumab exposure, as did 61% of the MIRV arm.

Median PFS was 5.62 months in the MIRV arm and 3.98 months in the chemotherapy arm (hazard ratio, 0.65; P less than .0001). The overall response rate was 42% in the MIRV arm and 16% in the chemotherapy arm (P < .0001).

The safety outcomes also favored MIRV: 42% experienced grade 3 or higher treatment-emergent adverse events (TEAEs) versus 54% in the chemotherapy group. Severe adverse events were also lower in MIRV, 24% versus 33%. Just 9% of patients in the MIRV discontinued because of TEAEs, compared with 16% in the chemotherapy arm.

MIRV was associated with blurred vision (41%), keratopathy (32%), and dry eye (28%), but these issues were generally manageable through collaboration with optometrists or ophthalmologists.

Dr. Moore and Dr. O’Cearbhaill reported receiving honoraria, research funding, and travel expenses from numerous pharmaceutical companies. Dr. O’Cearbhaill has consulted for or advised Aptitude Health, Bayer, Carina Biotech, Fresenius Kabi, GlaxoSmithKline, GOG Foundation, Immunogen, R-Pharm, Regeneron, and Seagen.

BALTIMORE – Poor prenatal sleep may increase the risk of postpartum depression, and prenatal depression may reduce the likelihood of mothers coming to their prenatal appointments, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Together, the two studies suggest that commonly overlooked experiences in the prenatal period can have negative effects down the line if clinicians aren’t asking patients about them and addressing the issue.

”I think the national conversation around mental health in general will hopefully carry us forward to better supporting the patients who are coming in with preexisting conditions,” lead author Minnie Jang, a 4th-year medical student at Johns Hopkins University, Baltimore, said in an interview.

Most of the attention on mood disorders of pregnancy focus on the postpartum period, but preexisting or new-onset depression during pregnancy deserves more attention, Ms. Jang told attendees. ACOG recommends that clinicians screen all patients at least once during the perinatal period, but that could be anywhere from early pregnancy to the postpartum period. Ms. Jang would like to see recommendations addressing both early pregnancy and the postpartum period.

“I think there’s this framing that postpartum depression is a distinct entity from other mental health conditions whereas it’s really part of a continuum,” Ms. Jang said in an interview.

She retrospectively analyzed the medical records of all pregnant women who completed the Edinburgh Postnatal Depression Scale (EPDS) during their first or second trimesters between 2002 and 2021 at Johns Hopkins Hospital. Among the 718 women who were screened in early pregnancy, 44.6% were Black or African American, 39.7% were white, and 15.7% were of a different race. Nearly all (94%) were not Hispanic/Latino.

Most (59%) were partnered, employed (68%), and had private insurance (58%). Only 7% used tobacco while 11% used alcohol and 6% used illicit drugs.

Twelve percent of the patients scored positive for depression, with a score of at least 10 or an affirmative answer to question 10 regarding self-harm. These women tended to be younger (P = .034), with an median age of 28 at their first visit versus 31 for those who screened negative, and were more likely to be publicly insured (P = .013) and without a partner (P = .005).

Patients who screened positive were more likely to have a history of substance use or history of a previous psychiatric diagnosis (P < .0001 for both). In addition, more patients who screened positive (49%) than those who screened negative (26%) had fetal complications (P < .001).

”There are some interesting subgroups of patients who are screening positive for depressive symptoms early on in pregnancy,” Ms. Jang said. Some come into pregnancy with preexisting mental health conditions while others have situational depressive symptoms, such as the subgroup referred to social work who had diagnosed fetal complications, she said. “Then there’s a whole other group of patients who are developing new symptoms during pregnancy.”

Patients who screened positive tended to start prenatal care later, at a median 12.3 weeks gestational age, than patients who screened negative, at a median 10.7 weeks gestational age (P = .002), the analysis found.

The number of routine prenatal care visits did not significantly differ between those who screened positive and those who screened negative, but patients with positive depression screens were almost half as likely to complete glucose tolerance testing (odds ratio, 0.6) or group B streptococcus testing (OR, 0.56) after adjusting for insurance status, gravidity, and gestational age at the patient’s first visit.

The researchers also identified a significant positive association between higher EPDS scores and the number of labor and delivery triage visits (P = .006). There were no significant differences in the rates of Tdap vaccination or screening for sexually transmitted infections between the two groups.
 

Poor sleep linked to later depression

The other study was prospective, using data from the PATCH Prenatal Care and Maternal and Child Health Outcomes study, which initially “compared health outcomes and satisfaction with prenatal care between patients receiving Centering Pregnancy group prenatal care and patients receiving traditional prenatal care,” the authors explained. This secondary analysis looked at sleep problems and postpartum depression.

“We don’t routinely ask patients about sleep or screen patients for sleeping issues,” lead author Carolyn Sinow, MD, a 4th-year resident at Kaiser Permanente Santa Clara (Calif.) Medical Center, said in an interview. “I think that we need to take sleep complaints more seriously overall, especially in early pregnancy.” While sleep problems in the third trimester often have more to do with discomforts from pregnancy itself, better sleep “in the first and second trimester is something we can really target with good sleep hygiene,” she added.

The 336 pregnant participants were recruited from Health Connect as long as they had a singleton pregnancy, were receiving prenatal care from Kaiser Permanente Northern California, and completed baseline questionnaires about their sleep and depression and anxiety symptoms during their first trimester between August 2020 and April 2021. Those with clinical depression or a high-risk pregnancy were excluded. The participants then completed the questionnaires again between 4 and 8 weeks post partum.

After adjusting for baseline depression and potential confounders, patients with poor sleep quality, indicated by a score greater than 5 on the Pittsburgh Sleep Quality Index (PSQI), were 12% more likely to develop postpartum depression, indicated by a score on the Patient Health Questionnaire depression scale (PHQ-8) of 10 or greater (relative risk, 1.12; 95% confidence interval, 1.01-1.25).

The two aspects of sleep that specifically correlated with postpartum depression were sleep quality and sleep latency, or taking a long time to fall asleep. Those reporting poor sleep quality were twice as likely to develop postpartum depression (relative risk, 2.18; 95% CI, 1.22-3.91), and those who took a while to fall asleep were 52% more likely to develop postpartum depression (RR, 1.52; 95% CI, 1.06-2.17).

Though the study also found prenatal sleep problems correlated with higher postpartum anxiety scores on the General Anxiety Disorder scale (GAD-7), the results were not statistically significant.

Kathleen Morrell, MD, MPH, an ob.gyn. in New York, was not involved in the study and said she was surprised it wasn’t something that had been studied much before because it makes sense.

“I always like it when studies confirm what we think should make sense, so it’s nice to see it,” Dr. Morrell said in an interview. “I think anytime you put something out, research it, and define it with numbers for doctors, that sometimes allows us to [realize], ‘Oh, that’s probably something we should be paying more attention to, especially if we have available treatments for it,’” she added.

“The clinical takeaway is that we really need to be screening for sleep pattern disruptions early in pregnancy, because even though it makes logical sense, it might not be something on our radar to think about,” Dr. Morrell said. “If people aren’t sleeping, well, their mental health is negatively affected.”

The most promising therapy for sleep issues currently is cognitive-behavioral therapy, which can accessed through various apps, Dr. Sinow said in an interview. “There are also safe interventions, such as melatonin and Unisom, that are totally safe in pregnancy that we can use to target sleep in early pregnancy.”

Dr. Morrell added that vitamin B6, often taken for nausea and vomiting during pregnancy, can also sometimes help people sleep and is safe during pregnancy.

“We know that postpartum depression does not necessarily only have a negative effect on the mother, but also has a negative effect on the infant and the family dynamic as well,” Dr. Morrell said. “So, we should be looking and screening for it so that we can offer people potential treatment because we know it can have long-term effects.”

Ms. Jang and Dr. Sinow did not have any disclosures. Dr. Morrell has done training for Nexplanon. Neither study noted external funding.

BALTIMORE – Poor prenatal sleep may increase the risk of postpartum depression, and prenatal depression may reduce the likelihood of mothers coming to their prenatal appointments, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Together, the two studies suggest that commonly overlooked experiences in the prenatal period can have negative effects down the line if clinicians aren’t asking patients about them and addressing the issue.

”I think the national conversation around mental health in general will hopefully carry us forward to better supporting the patients who are coming in with preexisting conditions,” lead author Minnie Jang, a 4th-year medical student at Johns Hopkins University, Baltimore, said in an interview.

Most of the attention on mood disorders of pregnancy focus on the postpartum period, but preexisting or new-onset depression during pregnancy deserves more attention, Ms. Jang told attendees. ACOG recommends that clinicians screen all patients at least once during the perinatal period, but that could be anywhere from early pregnancy to the postpartum period. Ms. Jang would like to see recommendations addressing both early pregnancy and the postpartum period.

“I think there’s this framing that postpartum depression is a distinct entity from other mental health conditions whereas it’s really part of a continuum,” Ms. Jang said in an interview.

She retrospectively analyzed the medical records of all pregnant women who completed the Edinburgh Postnatal Depression Scale (EPDS) during their first or second trimesters between 2002 and 2021 at Johns Hopkins Hospital. Among the 718 women who were screened in early pregnancy, 44.6% were Black or African American, 39.7% were white, and 15.7% were of a different race. Nearly all (94%) were not Hispanic/Latino.

Most (59%) were partnered, employed (68%), and had private insurance (58%). Only 7% used tobacco while 11% used alcohol and 6% used illicit drugs.

Twelve percent of the patients scored positive for depression, with a score of at least 10 or an affirmative answer to question 10 regarding self-harm. These women tended to be younger (P = .034), with an median age of 28 at their first visit versus 31 for those who screened negative, and were more likely to be publicly insured (P = .013) and without a partner (P = .005).

Patients who screened positive were more likely to have a history of substance use or history of a previous psychiatric diagnosis (P < .0001 for both). In addition, more patients who screened positive (49%) than those who screened negative (26%) had fetal complications (P < .001).

”There are some interesting subgroups of patients who are screening positive for depressive symptoms early on in pregnancy,” Ms. Jang said. Some come into pregnancy with preexisting mental health conditions while others have situational depressive symptoms, such as the subgroup referred to social work who had diagnosed fetal complications, she said. “Then there’s a whole other group of patients who are developing new symptoms during pregnancy.”

Patients who screened positive tended to start prenatal care later, at a median 12.3 weeks gestational age, than patients who screened negative, at a median 10.7 weeks gestational age (P = .002), the analysis found.

The number of routine prenatal care visits did not significantly differ between those who screened positive and those who screened negative, but patients with positive depression screens were almost half as likely to complete glucose tolerance testing (odds ratio, 0.6) or group B streptococcus testing (OR, 0.56) after adjusting for insurance status, gravidity, and gestational age at the patient’s first visit.

The researchers also identified a significant positive association between higher EPDS scores and the number of labor and delivery triage visits (P = .006). There were no significant differences in the rates of Tdap vaccination or screening for sexually transmitted infections between the two groups.
 

Poor sleep linked to later depression

The other study was prospective, using data from the PATCH Prenatal Care and Maternal and Child Health Outcomes study, which initially “compared health outcomes and satisfaction with prenatal care between patients receiving Centering Pregnancy group prenatal care and patients receiving traditional prenatal care,” the authors explained. This secondary analysis looked at sleep problems and postpartum depression.

“We don’t routinely ask patients about sleep or screen patients for sleeping issues,” lead author Carolyn Sinow, MD, a 4th-year resident at Kaiser Permanente Santa Clara (Calif.) Medical Center, said in an interview. “I think that we need to take sleep complaints more seriously overall, especially in early pregnancy.” While sleep problems in the third trimester often have more to do with discomforts from pregnancy itself, better sleep “in the first and second trimester is something we can really target with good sleep hygiene,” she added.

The 336 pregnant participants were recruited from Health Connect as long as they had a singleton pregnancy, were receiving prenatal care from Kaiser Permanente Northern California, and completed baseline questionnaires about their sleep and depression and anxiety symptoms during their first trimester between August 2020 and April 2021. Those with clinical depression or a high-risk pregnancy were excluded. The participants then completed the questionnaires again between 4 and 8 weeks post partum.

After adjusting for baseline depression and potential confounders, patients with poor sleep quality, indicated by a score greater than 5 on the Pittsburgh Sleep Quality Index (PSQI), were 12% more likely to develop postpartum depression, indicated by a score on the Patient Health Questionnaire depression scale (PHQ-8) of 10 or greater (relative risk, 1.12; 95% confidence interval, 1.01-1.25).

The two aspects of sleep that specifically correlated with postpartum depression were sleep quality and sleep latency, or taking a long time to fall asleep. Those reporting poor sleep quality were twice as likely to develop postpartum depression (relative risk, 2.18; 95% CI, 1.22-3.91), and those who took a while to fall asleep were 52% more likely to develop postpartum depression (RR, 1.52; 95% CI, 1.06-2.17).

Though the study also found prenatal sleep problems correlated with higher postpartum anxiety scores on the General Anxiety Disorder scale (GAD-7), the results were not statistically significant.

Kathleen Morrell, MD, MPH, an ob.gyn. in New York, was not involved in the study and said she was surprised it wasn’t something that had been studied much before because it makes sense.

“I always like it when studies confirm what we think should make sense, so it’s nice to see it,” Dr. Morrell said in an interview. “I think anytime you put something out, research it, and define it with numbers for doctors, that sometimes allows us to [realize], ‘Oh, that’s probably something we should be paying more attention to, especially if we have available treatments for it,’” she added.

“The clinical takeaway is that we really need to be screening for sleep pattern disruptions early in pregnancy, because even though it makes logical sense, it might not be something on our radar to think about,” Dr. Morrell said. “If people aren’t sleeping, well, their mental health is negatively affected.”

The most promising therapy for sleep issues currently is cognitive-behavioral therapy, which can accessed through various apps, Dr. Sinow said in an interview. “There are also safe interventions, such as melatonin and Unisom, that are totally safe in pregnancy that we can use to target sleep in early pregnancy.”

Dr. Morrell added that vitamin B6, often taken for nausea and vomiting during pregnancy, can also sometimes help people sleep and is safe during pregnancy.

“We know that postpartum depression does not necessarily only have a negative effect on the mother, but also has a negative effect on the infant and the family dynamic as well,” Dr. Morrell said. “So, we should be looking and screening for it so that we can offer people potential treatment because we know it can have long-term effects.”

Ms. Jang and Dr. Sinow did not have any disclosures. Dr. Morrell has done training for Nexplanon. Neither study noted external funding.

BALTIMORE – Poor prenatal sleep may increase the risk of postpartum depression, and prenatal depression may reduce the likelihood of mothers coming to their prenatal appointments, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Together, the two studies suggest that commonly overlooked experiences in the prenatal period can have negative effects down the line if clinicians aren’t asking patients about them and addressing the issue.

”I think the national conversation around mental health in general will hopefully carry us forward to better supporting the patients who are coming in with preexisting conditions,” lead author Minnie Jang, a 4th-year medical student at Johns Hopkins University, Baltimore, said in an interview.

Most of the attention on mood disorders of pregnancy focus on the postpartum period, but preexisting or new-onset depression during pregnancy deserves more attention, Ms. Jang told attendees. ACOG recommends that clinicians screen all patients at least once during the perinatal period, but that could be anywhere from early pregnancy to the postpartum period. Ms. Jang would like to see recommendations addressing both early pregnancy and the postpartum period.

“I think there’s this framing that postpartum depression is a distinct entity from other mental health conditions whereas it’s really part of a continuum,” Ms. Jang said in an interview.

She retrospectively analyzed the medical records of all pregnant women who completed the Edinburgh Postnatal Depression Scale (EPDS) during their first or second trimesters between 2002 and 2021 at Johns Hopkins Hospital. Among the 718 women who were screened in early pregnancy, 44.6% were Black or African American, 39.7% were white, and 15.7% were of a different race. Nearly all (94%) were not Hispanic/Latino.

Most (59%) were partnered, employed (68%), and had private insurance (58%). Only 7% used tobacco while 11% used alcohol and 6% used illicit drugs.

Twelve percent of the patients scored positive for depression, with a score of at least 10 or an affirmative answer to question 10 regarding self-harm. These women tended to be younger (P = .034), with an median age of 28 at their first visit versus 31 for those who screened negative, and were more likely to be publicly insured (P = .013) and without a partner (P = .005).

Patients who screened positive were more likely to have a history of substance use or history of a previous psychiatric diagnosis (P < .0001 for both). In addition, more patients who screened positive (49%) than those who screened negative (26%) had fetal complications (P < .001).

”There are some interesting subgroups of patients who are screening positive for depressive symptoms early on in pregnancy,” Ms. Jang said. Some come into pregnancy with preexisting mental health conditions while others have situational depressive symptoms, such as the subgroup referred to social work who had diagnosed fetal complications, she said. “Then there’s a whole other group of patients who are developing new symptoms during pregnancy.”

Patients who screened positive tended to start prenatal care later, at a median 12.3 weeks gestational age, than patients who screened negative, at a median 10.7 weeks gestational age (P = .002), the analysis found.

The number of routine prenatal care visits did not significantly differ between those who screened positive and those who screened negative, but patients with positive depression screens were almost half as likely to complete glucose tolerance testing (odds ratio, 0.6) or group B streptococcus testing (OR, 0.56) after adjusting for insurance status, gravidity, and gestational age at the patient’s first visit.

The researchers also identified a significant positive association between higher EPDS scores and the number of labor and delivery triage visits (P = .006). There were no significant differences in the rates of Tdap vaccination or screening for sexually transmitted infections between the two groups.
 

Poor sleep linked to later depression

The other study was prospective, using data from the PATCH Prenatal Care and Maternal and Child Health Outcomes study, which initially “compared health outcomes and satisfaction with prenatal care between patients receiving Centering Pregnancy group prenatal care and patients receiving traditional prenatal care,” the authors explained. This secondary analysis looked at sleep problems and postpartum depression.

“We don’t routinely ask patients about sleep or screen patients for sleeping issues,” lead author Carolyn Sinow, MD, a 4th-year resident at Kaiser Permanente Santa Clara (Calif.) Medical Center, said in an interview. “I think that we need to take sleep complaints more seriously overall, especially in early pregnancy.” While sleep problems in the third trimester often have more to do with discomforts from pregnancy itself, better sleep “in the first and second trimester is something we can really target with good sleep hygiene,” she added.

The 336 pregnant participants were recruited from Health Connect as long as they had a singleton pregnancy, were receiving prenatal care from Kaiser Permanente Northern California, and completed baseline questionnaires about their sleep and depression and anxiety symptoms during their first trimester between August 2020 and April 2021. Those with clinical depression or a high-risk pregnancy were excluded. The participants then completed the questionnaires again between 4 and 8 weeks post partum.

After adjusting for baseline depression and potential confounders, patients with poor sleep quality, indicated by a score greater than 5 on the Pittsburgh Sleep Quality Index (PSQI), were 12% more likely to develop postpartum depression, indicated by a score on the Patient Health Questionnaire depression scale (PHQ-8) of 10 or greater (relative risk, 1.12; 95% confidence interval, 1.01-1.25).

The two aspects of sleep that specifically correlated with postpartum depression were sleep quality and sleep latency, or taking a long time to fall asleep. Those reporting poor sleep quality were twice as likely to develop postpartum depression (relative risk, 2.18; 95% CI, 1.22-3.91), and those who took a while to fall asleep were 52% more likely to develop postpartum depression (RR, 1.52; 95% CI, 1.06-2.17).

Though the study also found prenatal sleep problems correlated with higher postpartum anxiety scores on the General Anxiety Disorder scale (GAD-7), the results were not statistically significant.

Kathleen Morrell, MD, MPH, an ob.gyn. in New York, was not involved in the study and said she was surprised it wasn’t something that had been studied much before because it makes sense.

“I always like it when studies confirm what we think should make sense, so it’s nice to see it,” Dr. Morrell said in an interview. “I think anytime you put something out, research it, and define it with numbers for doctors, that sometimes allows us to [realize], ‘Oh, that’s probably something we should be paying more attention to, especially if we have available treatments for it,’” she added.

“The clinical takeaway is that we really need to be screening for sleep pattern disruptions early in pregnancy, because even though it makes logical sense, it might not be something on our radar to think about,” Dr. Morrell said. “If people aren’t sleeping, well, their mental health is negatively affected.”

The most promising therapy for sleep issues currently is cognitive-behavioral therapy, which can accessed through various apps, Dr. Sinow said in an interview. “There are also safe interventions, such as melatonin and Unisom, that are totally safe in pregnancy that we can use to target sleep in early pregnancy.”

Dr. Morrell added that vitamin B6, often taken for nausea and vomiting during pregnancy, can also sometimes help people sleep and is safe during pregnancy.

“We know that postpartum depression does not necessarily only have a negative effect on the mother, but also has a negative effect on the infant and the family dynamic as well,” Dr. Morrell said. “So, we should be looking and screening for it so that we can offer people potential treatment because we know it can have long-term effects.”

Ms. Jang and Dr. Sinow did not have any disclosures. Dr. Morrell has done training for Nexplanon. Neither study noted external funding.

A new standard of care for patients with chemotherapy-naive persistent, recurrent, or metastatic cervical cancer is first-line therapy with the combination of the immune checkpoint inhibitor pembrolizumab (Keytruda) with platinum-based chemotherapy and paclitaxel – with or without bevacizumab.

This is based on final overall survival results from the phase 3, randomized KEYNOTE-826 study, which showed that adding immunotherapy resulted in a 40% reduction in risk of death, compared with chemotherapy alone, for women with advanced cervical cancers expressing programmed death–ligand 1 (PD-L1).

“At this protocol-specified final analysis of KEYNOTE-826, the addition of immune therapy to chemotherapy with or without the antiangiogenic bevacizumab showed substantial and clinically meaningful improvement in survival,” said lead author Bradley J. Monk, MD, from HonorHealth Research Institute, Phoenix.

He was speaking at a media briefing held prior to the annual meeting of the American Society of Clinical Oncology, where the results were presented.

“The results of this study solidify the addition of pembrolizumab to chemotherapy with or without bevacizumab in people with persistent, recurrent, or metastatic cervical cancer as the frontline standard of care for this disease. Survival significantly improved with this approach, regardless of PD-L1 expression, further supporting its use for all patients in this population,” commented ASCO expert Merry Jennifer Markham, MD, from the University of Florida, Gainesville.

At the briefing, Dr. Monk raised the possibility that adding immunotherapy to the standard of care could offer a chance for cure for some patients with advanced or recurrent cervical cancer.

“Is it possible to cure a widely metastatic cancer, a solid tumor? And I think it probably is,” he said. “There’s a tail to this [survival] curve, and I can’t believe that in my lifetime we as a group, as a team, have sort of figured out – and it’s not enough – that we can actually cure some patients, and if not maybe cure, have them at least live a long time, so it’s exciting.”

Briefing comoderater Julie R. Gralow, MD, chief medical officer and executive vice president of ASCO, agreed that the survival benefit “is exciting to see, and in my long career as a breast medical oncologist, I’m pretty sure we cure some metastatic breast cancer. We definitely had patients who lived out their normal life span and died of something else after decades.

“But the definition of cure, sadly, in these situations is that you die of something else without evidence of disease, so we certainly need to do better here and be better able to use the word ‘cure’ in the metastatic setting,” she added.
 

Promising start

Since 2014, the standard of care for treating patients with recurrent, persistent, or metastatic cervical cancer has been chemotherapy with a platinum compound, paclitaxel, and bevacizumab, based on the results of the GOG 240 study.

Immunotherapy with PD-1 inhibitors had previously shown efficacy as monotherapy in second- or later-line therapy for women with cervical cancer, but KEYNOTE 826 was the first study to show a benefit to promoting immunotherapy to the front ranks.

In the first interim analysis of the trial, reported at the 2021 annual meeting of the European Society for Medical Oncology, after a median follow-up of 22 months, the combination of pembrolizumab and chemotherapy demonstrated significant improvement in progression-free survival (PFS) and overall survival (OS), compared with chemotherapy plus placebo in a biomarker-selected population, which consisted of patients with a combined positive score (CPS) for PD-L1 of 1 or greater.

Pembrolizumab had no apparent efficacy in patients whose tumors did not have detectable PD-L1, however.
 

Latest results

Now the investigators are reporting the final analysis, conducted after a median follow-up of 39.1 months. The results are those for all comers (308 randomly assigned to receive pembrolizumab plus chemotherapy, and 309 assigned to receive chemotherapy plus placebo), as well as for the biomarker-selected population (consisting of all patients with PD-L1 CPS of 1 or greater) and for the subpopulation of patients with PD-L1 CPS of 10 or greater.

In the all-comers population, the median OS was 26.4 months for patients who received pembrolizumab, compared with 16.8 months for those who received placebo. The 24-month OS rates were 52.1% and 38.7%, respectively. The difference translated into a hazard ratio for death with pembrolizumab of 0.63 (P < .0001).

In the biomarker-selected population (273 assigned to pembrolizumab and 275 assigned to placebo), the respective median OS was 28.6 months versus 16.6 months, with 24-month OS rates of 53.5% versus 39.4%, which translates into an HR for death with pembrolizumab of 0.60 (P < .0001).

Not surprisingly, the best responses to the addition of the PD-1 inhibitor were seen among patients with a PD-L1 CPS of 10 or greater (158 assigned to pembrolizumab and 159 assigned to placebo). In this subgroup, the median OS was 29.6 months with the immune checkpoint inhibitor added to chemotherapy versus 17.4 months for chemotherapy plus placebo. The respective 24-month OS rates were 54.4% and 42.5%, and the HR for overall survival favoring pembrolizumab was 0.58 (P < .0001).

Median PFS 12-month PFS rates also favored pembrolizumab in both the total patient population and the biomarker-selected groups, with median PFS of approximately 10.4 months with pembrolizumab versus approximately 8.2 months with placebo.

The safety profile was manageable, with adverse events as expected from the safety profiles of the individual drugs in the combined regimen. No new safety signals have been seen since the interim analysis, Dr. Monk said.
 

Regimen details

Patients were randomly assigned in a 1:1 ratio to receive pembrolizumab 200 mg or placebo every 3 weeks for up to 35 cycles plus platinum-based chemotherapy, with bevacizumab added at the investigator’s discretion. Approximately two-thirds of patients in each study arm received bevacizumab.

The dual primary endpoints of PFS and OS were each tested sequentially in patients with a PD-L1 CPS of 1 or greater in both the intention-to-treat or “all-comers” population and in patients with a PD-L1 CPS of 10 or greater.

Patient characteristics were generally well balanced between the treatment groups, except that a slightly higher proportion of patients in the pembrolizumab had tumors of squamous cell histology, compared with the placebo group (76.3% vs. 68.3%).

KEYNOTE-826 was funded by Merck. Dr. Monk has received honoraria and has participated in consulting/advising and speaker’s bureau activity with Merck and other companies. Dr. Gralow has had a consulting or advisory role with Genentech and Roche. Dr. Markham has had a consulting/advisory role for GlaxoSmithKline and has received institutional research funding from Merck and other companies.

A version of this article first appeared on Medscape.com.

A new standard of care for patients with chemotherapy-naive persistent, recurrent, or metastatic cervical cancer is first-line therapy with the combination of the immune checkpoint inhibitor pembrolizumab (Keytruda) with platinum-based chemotherapy and paclitaxel – with or without bevacizumab.

This is based on final overall survival results from the phase 3, randomized KEYNOTE-826 study, which showed that adding immunotherapy resulted in a 40% reduction in risk of death, compared with chemotherapy alone, for women with advanced cervical cancers expressing programmed death–ligand 1 (PD-L1).

“At this protocol-specified final analysis of KEYNOTE-826, the addition of immune therapy to chemotherapy with or without the antiangiogenic bevacizumab showed substantial and clinically meaningful improvement in survival,” said lead author Bradley J. Monk, MD, from HonorHealth Research Institute, Phoenix.

He was speaking at a media briefing held prior to the annual meeting of the American Society of Clinical Oncology, where the results were presented.

“The results of this study solidify the addition of pembrolizumab to chemotherapy with or without bevacizumab in people with persistent, recurrent, or metastatic cervical cancer as the frontline standard of care for this disease. Survival significantly improved with this approach, regardless of PD-L1 expression, further supporting its use for all patients in this population,” commented ASCO expert Merry Jennifer Markham, MD, from the University of Florida, Gainesville.

At the briefing, Dr. Monk raised the possibility that adding immunotherapy to the standard of care could offer a chance for cure for some patients with advanced or recurrent cervical cancer.

“Is it possible to cure a widely metastatic cancer, a solid tumor? And I think it probably is,” he said. “There’s a tail to this [survival] curve, and I can’t believe that in my lifetime we as a group, as a team, have sort of figured out – and it’s not enough – that we can actually cure some patients, and if not maybe cure, have them at least live a long time, so it’s exciting.”

Briefing comoderater Julie R. Gralow, MD, chief medical officer and executive vice president of ASCO, agreed that the survival benefit “is exciting to see, and in my long career as a breast medical oncologist, I’m pretty sure we cure some metastatic breast cancer. We definitely had patients who lived out their normal life span and died of something else after decades.

“But the definition of cure, sadly, in these situations is that you die of something else without evidence of disease, so we certainly need to do better here and be better able to use the word ‘cure’ in the metastatic setting,” she added.
 

Promising start

Since 2014, the standard of care for treating patients with recurrent, persistent, or metastatic cervical cancer has been chemotherapy with a platinum compound, paclitaxel, and bevacizumab, based on the results of the GOG 240 study.

Immunotherapy with PD-1 inhibitors had previously shown efficacy as monotherapy in second- or later-line therapy for women with cervical cancer, but KEYNOTE 826 was the first study to show a benefit to promoting immunotherapy to the front ranks.

In the first interim analysis of the trial, reported at the 2021 annual meeting of the European Society for Medical Oncology, after a median follow-up of 22 months, the combination of pembrolizumab and chemotherapy demonstrated significant improvement in progression-free survival (PFS) and overall survival (OS), compared with chemotherapy plus placebo in a biomarker-selected population, which consisted of patients with a combined positive score (CPS) for PD-L1 of 1 or greater.

Pembrolizumab had no apparent efficacy in patients whose tumors did not have detectable PD-L1, however.
 

Latest results

Now the investigators are reporting the final analysis, conducted after a median follow-up of 39.1 months. The results are those for all comers (308 randomly assigned to receive pembrolizumab plus chemotherapy, and 309 assigned to receive chemotherapy plus placebo), as well as for the biomarker-selected population (consisting of all patients with PD-L1 CPS of 1 or greater) and for the subpopulation of patients with PD-L1 CPS of 10 or greater.

In the all-comers population, the median OS was 26.4 months for patients who received pembrolizumab, compared with 16.8 months for those who received placebo. The 24-month OS rates were 52.1% and 38.7%, respectively. The difference translated into a hazard ratio for death with pembrolizumab of 0.63 (P < .0001).

In the biomarker-selected population (273 assigned to pembrolizumab and 275 assigned to placebo), the respective median OS was 28.6 months versus 16.6 months, with 24-month OS rates of 53.5% versus 39.4%, which translates into an HR for death with pembrolizumab of 0.60 (P < .0001).

Not surprisingly, the best responses to the addition of the PD-1 inhibitor were seen among patients with a PD-L1 CPS of 10 or greater (158 assigned to pembrolizumab and 159 assigned to placebo). In this subgroup, the median OS was 29.6 months with the immune checkpoint inhibitor added to chemotherapy versus 17.4 months for chemotherapy plus placebo. The respective 24-month OS rates were 54.4% and 42.5%, and the HR for overall survival favoring pembrolizumab was 0.58 (P < .0001).

Median PFS 12-month PFS rates also favored pembrolizumab in both the total patient population and the biomarker-selected groups, with median PFS of approximately 10.4 months with pembrolizumab versus approximately 8.2 months with placebo.

The safety profile was manageable, with adverse events as expected from the safety profiles of the individual drugs in the combined regimen. No new safety signals have been seen since the interim analysis, Dr. Monk said.
 

Regimen details

Patients were randomly assigned in a 1:1 ratio to receive pembrolizumab 200 mg or placebo every 3 weeks for up to 35 cycles plus platinum-based chemotherapy, with bevacizumab added at the investigator’s discretion. Approximately two-thirds of patients in each study arm received bevacizumab.

The dual primary endpoints of PFS and OS were each tested sequentially in patients with a PD-L1 CPS of 1 or greater in both the intention-to-treat or “all-comers” population and in patients with a PD-L1 CPS of 10 or greater.

Patient characteristics were generally well balanced between the treatment groups, except that a slightly higher proportion of patients in the pembrolizumab had tumors of squamous cell histology, compared with the placebo group (76.3% vs. 68.3%).

KEYNOTE-826 was funded by Merck. Dr. Monk has received honoraria and has participated in consulting/advising and speaker’s bureau activity with Merck and other companies. Dr. Gralow has had a consulting or advisory role with Genentech and Roche. Dr. Markham has had a consulting/advisory role for GlaxoSmithKline and has received institutional research funding from Merck and other companies.

A version of this article first appeared on Medscape.com.

A new standard of care for patients with chemotherapy-naive persistent, recurrent, or metastatic cervical cancer is first-line therapy with the combination of the immune checkpoint inhibitor pembrolizumab (Keytruda) with platinum-based chemotherapy and paclitaxel – with or without bevacizumab.

This is based on final overall survival results from the phase 3, randomized KEYNOTE-826 study, which showed that adding immunotherapy resulted in a 40% reduction in risk of death, compared with chemotherapy alone, for women with advanced cervical cancers expressing programmed death–ligand 1 (PD-L1).

“At this protocol-specified final analysis of KEYNOTE-826, the addition of immune therapy to chemotherapy with or without the antiangiogenic bevacizumab showed substantial and clinically meaningful improvement in survival,” said lead author Bradley J. Monk, MD, from HonorHealth Research Institute, Phoenix.

He was speaking at a media briefing held prior to the annual meeting of the American Society of Clinical Oncology, where the results were presented.

“The results of this study solidify the addition of pembrolizumab to chemotherapy with or without bevacizumab in people with persistent, recurrent, or metastatic cervical cancer as the frontline standard of care for this disease. Survival significantly improved with this approach, regardless of PD-L1 expression, further supporting its use for all patients in this population,” commented ASCO expert Merry Jennifer Markham, MD, from the University of Florida, Gainesville.

At the briefing, Dr. Monk raised the possibility that adding immunotherapy to the standard of care could offer a chance for cure for some patients with advanced or recurrent cervical cancer.

“Is it possible to cure a widely metastatic cancer, a solid tumor? And I think it probably is,” he said. “There’s a tail to this [survival] curve, and I can’t believe that in my lifetime we as a group, as a team, have sort of figured out – and it’s not enough – that we can actually cure some patients, and if not maybe cure, have them at least live a long time, so it’s exciting.”

Briefing comoderater Julie R. Gralow, MD, chief medical officer and executive vice president of ASCO, agreed that the survival benefit “is exciting to see, and in my long career as a breast medical oncologist, I’m pretty sure we cure some metastatic breast cancer. We definitely had patients who lived out their normal life span and died of something else after decades.

“But the definition of cure, sadly, in these situations is that you die of something else without evidence of disease, so we certainly need to do better here and be better able to use the word ‘cure’ in the metastatic setting,” she added.
 

Promising start

Since 2014, the standard of care for treating patients with recurrent, persistent, or metastatic cervical cancer has been chemotherapy with a platinum compound, paclitaxel, and bevacizumab, based on the results of the GOG 240 study.

Immunotherapy with PD-1 inhibitors had previously shown efficacy as monotherapy in second- or later-line therapy for women with cervical cancer, but KEYNOTE 826 was the first study to show a benefit to promoting immunotherapy to the front ranks.

In the first interim analysis of the trial, reported at the 2021 annual meeting of the European Society for Medical Oncology, after a median follow-up of 22 months, the combination of pembrolizumab and chemotherapy demonstrated significant improvement in progression-free survival (PFS) and overall survival (OS), compared with chemotherapy plus placebo in a biomarker-selected population, which consisted of patients with a combined positive score (CPS) for PD-L1 of 1 or greater.

Pembrolizumab had no apparent efficacy in patients whose tumors did not have detectable PD-L1, however.
 

Latest results

Now the investigators are reporting the final analysis, conducted after a median follow-up of 39.1 months. The results are those for all comers (308 randomly assigned to receive pembrolizumab plus chemotherapy, and 309 assigned to receive chemotherapy plus placebo), as well as for the biomarker-selected population (consisting of all patients with PD-L1 CPS of 1 or greater) and for the subpopulation of patients with PD-L1 CPS of 10 or greater.

In the all-comers population, the median OS was 26.4 months for patients who received pembrolizumab, compared with 16.8 months for those who received placebo. The 24-month OS rates were 52.1% and 38.7%, respectively. The difference translated into a hazard ratio for death with pembrolizumab of 0.63 (P < .0001).

In the biomarker-selected population (273 assigned to pembrolizumab and 275 assigned to placebo), the respective median OS was 28.6 months versus 16.6 months, with 24-month OS rates of 53.5% versus 39.4%, which translates into an HR for death with pembrolizumab of 0.60 (P < .0001).

Not surprisingly, the best responses to the addition of the PD-1 inhibitor were seen among patients with a PD-L1 CPS of 10 or greater (158 assigned to pembrolizumab and 159 assigned to placebo). In this subgroup, the median OS was 29.6 months with the immune checkpoint inhibitor added to chemotherapy versus 17.4 months for chemotherapy plus placebo. The respective 24-month OS rates were 54.4% and 42.5%, and the HR for overall survival favoring pembrolizumab was 0.58 (P < .0001).

Median PFS 12-month PFS rates also favored pembrolizumab in both the total patient population and the biomarker-selected groups, with median PFS of approximately 10.4 months with pembrolizumab versus approximately 8.2 months with placebo.

The safety profile was manageable, with adverse events as expected from the safety profiles of the individual drugs in the combined regimen. No new safety signals have been seen since the interim analysis, Dr. Monk said.
 

Regimen details

Patients were randomly assigned in a 1:1 ratio to receive pembrolizumab 200 mg or placebo every 3 weeks for up to 35 cycles plus platinum-based chemotherapy, with bevacizumab added at the investigator’s discretion. Approximately two-thirds of patients in each study arm received bevacizumab.

The dual primary endpoints of PFS and OS were each tested sequentially in patients with a PD-L1 CPS of 1 or greater in both the intention-to-treat or “all-comers” population and in patients with a PD-L1 CPS of 10 or greater.

Patient characteristics were generally well balanced between the treatment groups, except that a slightly higher proportion of patients in the pembrolizumab had tumors of squamous cell histology, compared with the placebo group (76.3% vs. 68.3%).

KEYNOTE-826 was funded by Merck. Dr. Monk has received honoraria and has participated in consulting/advising and speaker’s bureau activity with Merck and other companies. Dr. Gralow has had a consulting or advisory role with Genentech and Roche. Dr. Markham has had a consulting/advisory role for GlaxoSmithKline and has received institutional research funding from Merck and other companies.

A version of this article first appeared on Medscape.com.

CHICAGO – New results in the treatment of advanced ovarian cancer have been welcomed by an expert not involved in the trial, even though the study showed only an improvement in progression-free survival (PFS), not yet overall survival.

The results come from the DUO-O trial, in which the poly (ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza) and immunotherapy with the anti–PD-L1 antibody durvalumab (Imfinzi) were added on to standard of care with paclitaxel/carboplatin chemotherapy and bevacizumab (Avastin) in patients with newly diagnosed,non–BRCA-mutated advanced ovarian cancer.

A preplanned interim analysis revealed that the addition of durvalumab and olaparib was associated with a 37% improvement of PFS, compared with the standard of care of chemotherapy plus bevacizumab alone.

This improvement increased to 51% in patients who had tumors positive for homologous recombination deficiency (HRD), which indicates the inability to effectively repair double-stranded DNA breaks, a defect that is present in approximately 70% of ovarian cancers.

Coprincipal investigator Carol Aghajanian, MD, chief of the gynecologic medical oncology service at Memorial Sloan Kettering Cancer Center, New York, described the benefit seen with the novel combination therapy as both “statistically significant and clinically meaningful.”

She was speaking at a press briefing held ahead of the annual meeting of the American Society of Clinical Oncology, where the results were presented.

Commenting for ASCO, Merry Jennifer Markham, MD, professor of medicine and chief of the division of hematology and oncology at University of Florida Health, Gainesville, said the results represents a “huge step forward.”

She added the rate of progress it represents may not be “quick enough for our patients with advanced ovarian cancer but every little integral improvement that we can find in studies that are important, like this one, really means so much to that individual patient in that exam room.”

Dr. Markham underlined that around 80% of women with epithelial ovarian cancer are diagnosed at an advanced stage. “They know what they are facing,” she said. “The vast majority” of them will have a recurrence “at some point.”

“So while progression-free survival may not necessarily mean their overall survival, there will be hope it does. And I’m very excited to see where this study heads in that direction.” Dr. Markham added that PFS is “very important to our patients,” and the study does represent progress. “We are chipping away at improving outcomes for advanced ovarian cancer.”

Moreover, “women are often disappointed when their tumor doesn’t have a BRCA mutation because they know that that may limit some of their treatment options,” and so the current study suggests that there are “options for all-comers” and “there is still hope.”
 

Access to treatment and testing

When asked whether there could be any access issues for patients clinically eligible for the novel combination, Dr. Aghajanian said that all of the drugs have been approved by the Food and Drug Administration for indications that cover this usage.

They are also covered by medical insurance and, for those patients with financial toxicity, “there is access to co-pay assistance programs and the like.”

She said that patients can then “be counseled on their expected benefit,” based on their BRCA and HRD testing.

Dr. Markham, on the other hand, said she is “a little less optimistic” about access, explaining that she practices in the southern United States, and “our populations [and] insurance coverages are a bit different.”

She noted that, at her institution, a “fair number of patients are underinsured,” and they “ran into a lot of issues with people not being able to afford their copays,” which can be “prohibitive.”

“A large portion of my counseling has been and will continue to be around the benefit, but also the financial toxicity, that that individual patient may experience and the need for copay assistance programs or other support mechanisms,” Markham said.

Dr. Aghajanian added that “financial toxicity and the access issue comes even prior to the treatment, in getting those BRCA1/2 tests and the HRD testing done, so patients have the information they need to make informed decisions.”

“We do have disparities with genetic testing and genomic testing that need to be solved,” she said.
 

Study details

Previous studies, including SOLO1 and PAOLA-1, have shown that maintenance therapy with olaparib and bevacizumab improves outcomes in the first-line treatment of advanced ovarian cancer.

“However, there still remains unmet need, especially in some patient subgroups without a BRCA mutation,” Dr. Aghajanian said.

While the addition of immunotherapy to standard of care has yet to show a clinical benefit in this setting in phase 3 trials, the phase 2 MEDIOLA study indicated that the combination of durvalumab, bevacizumab, and olaparib was active in nongermline, BRCA-mutated, platinum-sensitive relapsed cancer.

The phase 3 DUO-O study therefore set out to determine whether this combination would be beneficial as a maintenance therapy in 1130 patients with newly diagnosed stage III or IV high-grade ovarian cancer without a tumor BRCA1/2 mutation.

Patients were required to have had no prior systemic therapy for ovarian cancer, and be naive to both PARP inhibition and immunotherapy. They also had to have completed up-front primary debulking surgery, or be scheduled to undergo the procedure.

After an initial cycle of paclitaxel/carboplatin chemotherapy, the patients were randomly assigned to one of three regimens:

• Standard of care treatment, comprising chemotherapy plus bevacizumab and durvalumab-placebo, followed by maintenance therapy with bevacizumab, durvalumab-placebo, and olaparib-placebo (arm 1)
• Chemotherapy plus bevacizumab and durvalumab, followed by maintenance therapy with bevacizumab, durvalumab, and olaparib-placebo (arm 2)
• Chemotherapy plus bevacizumab and durvalumab, followed by maintenance therapy with bevacizumab, durvalumab, and olaparib (arm 3)

In the maintenance phase, bevacizumab was to be given for a total of 15 months, while durvalumab and olaparib, or their equivalent placebos, were prescribed for 24 months. Treatment was continued until disease progression, study completion, or another discontinuation criteria was met.

Dr. Aghajanian presented results from a preplanned interim analysis, with a date cutoff of Dec. 5, 2022.

Among HRD-positive patients, those in arm 3 had a significantly longer PFS than those in arm 1, at a median of 37.3 months versus 23 months, or a hazard ratio of 0.49 (P < .0001).

In the intention-to-treat analysis, arm 3 was also associated with a significant improvement in median PFS over arm 1, at 24.2 months versus 19.3 months, or an HR of 0.63 (P < .0001), indicating that the trial met both of its primary endpoints.

While there was a numerical difference in median PFS between arm 2 and arm 1, at a median of 20.6 months versus 19.3 months, this was not significant. This means that relative contribution of adding durvalumab alone is not clear, Dr. Aghajanian commented, and said that this comparison “will be reassessed at the time of the final PFS analysis.”

She added that a “PFS effect was observed across all subgroups for the arm 3 versus arm 1 comparison,” including in the HRD-negative subgroup, at a median of 20.9 months versus 17.4 months, or an HR of 0.68.

The safety and tolerability of the regimens were generally consistent with what is known for the individual agents, she commented.

Serious adverse events were reported in 34%, 43%, and 39% of patients in arms 1, 2, and 3, respectively.

The most common grade 3 or higher adverse events were neutropenia (in 26% of arm 1 patients, 28% of those in arm 2, and 31% of those in arm 3) followed by anemia (in 8%, 8%, and 24%, respectively).

Dose modifications were required in 72% of arm 1 patients, 80% of those in arm 2, and 85% of arm 3 patients. Treatment discontinuation was recorded in 20%, 26%, and 35%, respectively.
 

Tackling underserved patient populations

Discussing the results, Christina Fotopoulou, MD, PhD, professor of gynecological cancer surgery in the department of surgery and cancer, Imperial College London, said that, while the regimen may seem new, the treatments involved are “veterans,” and that they are nevertheless tackling previously underserved patient populations.

Dr. Fotopoulou, who was not involved in the study, noted that the results were highly anticipated, and the study has delivered a “breakthrough in ovarian cancer.” She nevertheless questioned the choice of the control arm, and pointed out that the hazard ratio in favor of the combination therapy is “relatively modest” considering that it involves three drugs.

Dr. Fotopoulou highlighted, however, that one of the most important results was in the HRD-negative patients, which she characterized as the equivalent of the clinicians going to “the dark side of the moon.” She said that “for the first time, we have a positive study in this patient population,” although she underlined that the results are from an interim analysis.

The key question that remains, Dr. Fotopoulou asked, is “why? What is making the difference?” She noted that, unfortunately, the trial design does not allow the identification of the relative contribution of olaparib and durvalumab.

The study was sponsored by AstraZeneca, and conducted in collaboration with the European Network of Gynaecological Oncological Trial Groups, GOG Foundation, and Myriad Genetic Laboratories. Dr. Aghajanian declared relationships with AstraZeneca, Merck, Eisai, Repare Therapeutics, AbbVie, Clovis Oncology, and Genentech/Roche. Dr. Markham declared relationships with Pfizer, GlaxoSmithKline, Aduro Biotech, Lilly, Tesaro, Novartis, VBL Therapeutics, AstraZeneca, and Merck.

A version of this article first appeared on Medscape.com.

CHICAGO – New results in the treatment of advanced ovarian cancer have been welcomed by an expert not involved in the trial, even though the study showed only an improvement in progression-free survival (PFS), not yet overall survival.

The results come from the DUO-O trial, in which the poly (ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza) and immunotherapy with the anti–PD-L1 antibody durvalumab (Imfinzi) were added on to standard of care with paclitaxel/carboplatin chemotherapy and bevacizumab (Avastin) in patients with newly diagnosed,non–BRCA-mutated advanced ovarian cancer.

A preplanned interim analysis revealed that the addition of durvalumab and olaparib was associated with a 37% improvement of PFS, compared with the standard of care of chemotherapy plus bevacizumab alone.

This improvement increased to 51% in patients who had tumors positive for homologous recombination deficiency (HRD), which indicates the inability to effectively repair double-stranded DNA breaks, a defect that is present in approximately 70% of ovarian cancers.

Coprincipal investigator Carol Aghajanian, MD, chief of the gynecologic medical oncology service at Memorial Sloan Kettering Cancer Center, New York, described the benefit seen with the novel combination therapy as both “statistically significant and clinically meaningful.”

She was speaking at a press briefing held ahead of the annual meeting of the American Society of Clinical Oncology, where the results were presented.

Commenting for ASCO, Merry Jennifer Markham, MD, professor of medicine and chief of the division of hematology and oncology at University of Florida Health, Gainesville, said the results represents a “huge step forward.”

She added the rate of progress it represents may not be “quick enough for our patients with advanced ovarian cancer but every little integral improvement that we can find in studies that are important, like this one, really means so much to that individual patient in that exam room.”

Dr. Markham underlined that around 80% of women with epithelial ovarian cancer are diagnosed at an advanced stage. “They know what they are facing,” she said. “The vast majority” of them will have a recurrence “at some point.”

“So while progression-free survival may not necessarily mean their overall survival, there will be hope it does. And I’m very excited to see where this study heads in that direction.” Dr. Markham added that PFS is “very important to our patients,” and the study does represent progress. “We are chipping away at improving outcomes for advanced ovarian cancer.”

Moreover, “women are often disappointed when their tumor doesn’t have a BRCA mutation because they know that that may limit some of their treatment options,” and so the current study suggests that there are “options for all-comers” and “there is still hope.”
 

Access to treatment and testing

When asked whether there could be any access issues for patients clinically eligible for the novel combination, Dr. Aghajanian said that all of the drugs have been approved by the Food and Drug Administration for indications that cover this usage.

They are also covered by medical insurance and, for those patients with financial toxicity, “there is access to co-pay assistance programs and the like.”

She said that patients can then “be counseled on their expected benefit,” based on their BRCA and HRD testing.

Dr. Markham, on the other hand, said she is “a little less optimistic” about access, explaining that she practices in the southern United States, and “our populations [and] insurance coverages are a bit different.”

She noted that, at her institution, a “fair number of patients are underinsured,” and they “ran into a lot of issues with people not being able to afford their copays,” which can be “prohibitive.”

“A large portion of my counseling has been and will continue to be around the benefit, but also the financial toxicity, that that individual patient may experience and the need for copay assistance programs or other support mechanisms,” Markham said.

Dr. Aghajanian added that “financial toxicity and the access issue comes even prior to the treatment, in getting those BRCA1/2 tests and the HRD testing done, so patients have the information they need to make informed decisions.”

“We do have disparities with genetic testing and genomic testing that need to be solved,” she said.
 

Study details

Previous studies, including SOLO1 and PAOLA-1, have shown that maintenance therapy with olaparib and bevacizumab improves outcomes in the first-line treatment of advanced ovarian cancer.

“However, there still remains unmet need, especially in some patient subgroups without a BRCA mutation,” Dr. Aghajanian said.

While the addition of immunotherapy to standard of care has yet to show a clinical benefit in this setting in phase 3 trials, the phase 2 MEDIOLA study indicated that the combination of durvalumab, bevacizumab, and olaparib was active in nongermline, BRCA-mutated, platinum-sensitive relapsed cancer.

The phase 3 DUO-O study therefore set out to determine whether this combination would be beneficial as a maintenance therapy in 1130 patients with newly diagnosed stage III or IV high-grade ovarian cancer without a tumor BRCA1/2 mutation.

Patients were required to have had no prior systemic therapy for ovarian cancer, and be naive to both PARP inhibition and immunotherapy. They also had to have completed up-front primary debulking surgery, or be scheduled to undergo the procedure.

After an initial cycle of paclitaxel/carboplatin chemotherapy, the patients were randomly assigned to one of three regimens:

• Standard of care treatment, comprising chemotherapy plus bevacizumab and durvalumab-placebo, followed by maintenance therapy with bevacizumab, durvalumab-placebo, and olaparib-placebo (arm 1)
• Chemotherapy plus bevacizumab and durvalumab, followed by maintenance therapy with bevacizumab, durvalumab, and olaparib-placebo (arm 2)
• Chemotherapy plus bevacizumab and durvalumab, followed by maintenance therapy with bevacizumab, durvalumab, and olaparib (arm 3)

In the maintenance phase, bevacizumab was to be given for a total of 15 months, while durvalumab and olaparib, or their equivalent placebos, were prescribed for 24 months. Treatment was continued until disease progression, study completion, or another discontinuation criteria was met.

Dr. Aghajanian presented results from a preplanned interim analysis, with a date cutoff of Dec. 5, 2022.

Among HRD-positive patients, those in arm 3 had a significantly longer PFS than those in arm 1, at a median of 37.3 months versus 23 months, or a hazard ratio of 0.49 (P < .0001).

In the intention-to-treat analysis, arm 3 was also associated with a significant improvement in median PFS over arm 1, at 24.2 months versus 19.3 months, or an HR of 0.63 (P < .0001), indicating that the trial met both of its primary endpoints.

While there was a numerical difference in median PFS between arm 2 and arm 1, at a median of 20.6 months versus 19.3 months, this was not significant. This means that relative contribution of adding durvalumab alone is not clear, Dr. Aghajanian commented, and said that this comparison “will be reassessed at the time of the final PFS analysis.”

She added that a “PFS effect was observed across all subgroups for the arm 3 versus arm 1 comparison,” including in the HRD-negative subgroup, at a median of 20.9 months versus 17.4 months, or an HR of 0.68.

The safety and tolerability of the regimens were generally consistent with what is known for the individual agents, she commented.

Serious adverse events were reported in 34%, 43%, and 39% of patients in arms 1, 2, and 3, respectively.

The most common grade 3 or higher adverse events were neutropenia (in 26% of arm 1 patients, 28% of those in arm 2, and 31% of those in arm 3) followed by anemia (in 8%, 8%, and 24%, respectively).

Dose modifications were required in 72% of arm 1 patients, 80% of those in arm 2, and 85% of arm 3 patients. Treatment discontinuation was recorded in 20%, 26%, and 35%, respectively.
 

Tackling underserved patient populations

Discussing the results, Christina Fotopoulou, MD, PhD, professor of gynecological cancer surgery in the department of surgery and cancer, Imperial College London, said that, while the regimen may seem new, the treatments involved are “veterans,” and that they are nevertheless tackling previously underserved patient populations.

Dr. Fotopoulou, who was not involved in the study, noted that the results were highly anticipated, and the study has delivered a “breakthrough in ovarian cancer.” She nevertheless questioned the choice of the control arm, and pointed out that the hazard ratio in favor of the combination therapy is “relatively modest” considering that it involves three drugs.

Dr. Fotopoulou highlighted, however, that one of the most important results was in the HRD-negative patients, which she characterized as the equivalent of the clinicians going to “the dark side of the moon.” She said that “for the first time, we have a positive study in this patient population,” although she underlined that the results are from an interim analysis.

The key question that remains, Dr. Fotopoulou asked, is “why? What is making the difference?” She noted that, unfortunately, the trial design does not allow the identification of the relative contribution of olaparib and durvalumab.

The study was sponsored by AstraZeneca, and conducted in collaboration with the European Network of Gynaecological Oncological Trial Groups, GOG Foundation, and Myriad Genetic Laboratories. Dr. Aghajanian declared relationships with AstraZeneca, Merck, Eisai, Repare Therapeutics, AbbVie, Clovis Oncology, and Genentech/Roche. Dr. Markham declared relationships with Pfizer, GlaxoSmithKline, Aduro Biotech, Lilly, Tesaro, Novartis, VBL Therapeutics, AstraZeneca, and Merck.

A version of this article first appeared on Medscape.com.

CHICAGO – New results in the treatment of advanced ovarian cancer have been welcomed by an expert not involved in the trial, even though the study showed only an improvement in progression-free survival (PFS), not yet overall survival.

The results come from the DUO-O trial, in which the poly (ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza) and immunotherapy with the anti–PD-L1 antibody durvalumab (Imfinzi) were added on to standard of care with paclitaxel/carboplatin chemotherapy and bevacizumab (Avastin) in patients with newly diagnosed,non–BRCA-mutated advanced ovarian cancer.

A preplanned interim analysis revealed that the addition of durvalumab and olaparib was associated with a 37% improvement of PFS, compared with the standard of care of chemotherapy plus bevacizumab alone.

This improvement increased to 51% in patients who had tumors positive for homologous recombination deficiency (HRD), which indicates the inability to effectively repair double-stranded DNA breaks, a defect that is present in approximately 70% of ovarian cancers.

Coprincipal investigator Carol Aghajanian, MD, chief of the gynecologic medical oncology service at Memorial Sloan Kettering Cancer Center, New York, described the benefit seen with the novel combination therapy as both “statistically significant and clinically meaningful.”

She was speaking at a press briefing held ahead of the annual meeting of the American Society of Clinical Oncology, where the results were presented.

Commenting for ASCO, Merry Jennifer Markham, MD, professor of medicine and chief of the division of hematology and oncology at University of Florida Health, Gainesville, said the results represents a “huge step forward.”

She added the rate of progress it represents may not be “quick enough for our patients with advanced ovarian cancer but every little integral improvement that we can find in studies that are important, like this one, really means so much to that individual patient in that exam room.”

Dr. Markham underlined that around 80% of women with epithelial ovarian cancer are diagnosed at an advanced stage. “They know what they are facing,” she said. “The vast majority” of them will have a recurrence “at some point.”

“So while progression-free survival may not necessarily mean their overall survival, there will be hope it does. And I’m very excited to see where this study heads in that direction.” Dr. Markham added that PFS is “very important to our patients,” and the study does represent progress. “We are chipping away at improving outcomes for advanced ovarian cancer.”

Moreover, “women are often disappointed when their tumor doesn’t have a BRCA mutation because they know that that may limit some of their treatment options,” and so the current study suggests that there are “options for all-comers” and “there is still hope.”
 

Access to treatment and testing

When asked whether there could be any access issues for patients clinically eligible for the novel combination, Dr. Aghajanian said that all of the drugs have been approved by the Food and Drug Administration for indications that cover this usage.

They are also covered by medical insurance and, for those patients with financial toxicity, “there is access to co-pay assistance programs and the like.”

She said that patients can then “be counseled on their expected benefit,” based on their BRCA and HRD testing.

Dr. Markham, on the other hand, said she is “a little less optimistic” about access, explaining that she practices in the southern United States, and “our populations [and] insurance coverages are a bit different.”

She noted that, at her institution, a “fair number of patients are underinsured,” and they “ran into a lot of issues with people not being able to afford their copays,” which can be “prohibitive.”

“A large portion of my counseling has been and will continue to be around the benefit, but also the financial toxicity, that that individual patient may experience and the need for copay assistance programs or other support mechanisms,” Markham said.

Dr. Aghajanian added that “financial toxicity and the access issue comes even prior to the treatment, in getting those BRCA1/2 tests and the HRD testing done, so patients have the information they need to make informed decisions.”

“We do have disparities with genetic testing and genomic testing that need to be solved,” she said.
 

Study details

Previous studies, including SOLO1 and PAOLA-1, have shown that maintenance therapy with olaparib and bevacizumab improves outcomes in the first-line treatment of advanced ovarian cancer.

“However, there still remains unmet need, especially in some patient subgroups without a BRCA mutation,” Dr. Aghajanian said.

While the addition of immunotherapy to standard of care has yet to show a clinical benefit in this setting in phase 3 trials, the phase 2 MEDIOLA study indicated that the combination of durvalumab, bevacizumab, and olaparib was active in nongermline, BRCA-mutated, platinum-sensitive relapsed cancer.

The phase 3 DUO-O study therefore set out to determine whether this combination would be beneficial as a maintenance therapy in 1130 patients with newly diagnosed stage III or IV high-grade ovarian cancer without a tumor BRCA1/2 mutation.

Patients were required to have had no prior systemic therapy for ovarian cancer, and be naive to both PARP inhibition and immunotherapy. They also had to have completed up-front primary debulking surgery, or be scheduled to undergo the procedure.

After an initial cycle of paclitaxel/carboplatin chemotherapy, the patients were randomly assigned to one of three regimens:

• Standard of care treatment, comprising chemotherapy plus bevacizumab and durvalumab-placebo, followed by maintenance therapy with bevacizumab, durvalumab-placebo, and olaparib-placebo (arm 1)
• Chemotherapy plus bevacizumab and durvalumab, followed by maintenance therapy with bevacizumab, durvalumab, and olaparib-placebo (arm 2)
• Chemotherapy plus bevacizumab and durvalumab, followed by maintenance therapy with bevacizumab, durvalumab, and olaparib (arm 3)

In the maintenance phase, bevacizumab was to be given for a total of 15 months, while durvalumab and olaparib, or their equivalent placebos, were prescribed for 24 months. Treatment was continued until disease progression, study completion, or another discontinuation criteria was met.

Dr. Aghajanian presented results from a preplanned interim analysis, with a date cutoff of Dec. 5, 2022.

Among HRD-positive patients, those in arm 3 had a significantly longer PFS than those in arm 1, at a median of 37.3 months versus 23 months, or a hazard ratio of 0.49 (P < .0001).

In the intention-to-treat analysis, arm 3 was also associated with a significant improvement in median PFS over arm 1, at 24.2 months versus 19.3 months, or an HR of 0.63 (P < .0001), indicating that the trial met both of its primary endpoints.

While there was a numerical difference in median PFS between arm 2 and arm 1, at a median of 20.6 months versus 19.3 months, this was not significant. This means that relative contribution of adding durvalumab alone is not clear, Dr. Aghajanian commented, and said that this comparison “will be reassessed at the time of the final PFS analysis.”

She added that a “PFS effect was observed across all subgroups for the arm 3 versus arm 1 comparison,” including in the HRD-negative subgroup, at a median of 20.9 months versus 17.4 months, or an HR of 0.68.

The safety and tolerability of the regimens were generally consistent with what is known for the individual agents, she commented.

Serious adverse events were reported in 34%, 43%, and 39% of patients in arms 1, 2, and 3, respectively.

The most common grade 3 or higher adverse events were neutropenia (in 26% of arm 1 patients, 28% of those in arm 2, and 31% of those in arm 3) followed by anemia (in 8%, 8%, and 24%, respectively).

Dose modifications were required in 72% of arm 1 patients, 80% of those in arm 2, and 85% of arm 3 patients. Treatment discontinuation was recorded in 20%, 26%, and 35%, respectively.
 

Tackling underserved patient populations

Discussing the results, Christina Fotopoulou, MD, PhD, professor of gynecological cancer surgery in the department of surgery and cancer, Imperial College London, said that, while the regimen may seem new, the treatments involved are “veterans,” and that they are nevertheless tackling previously underserved patient populations.

Dr. Fotopoulou, who was not involved in the study, noted that the results were highly anticipated, and the study has delivered a “breakthrough in ovarian cancer.” She nevertheless questioned the choice of the control arm, and pointed out that the hazard ratio in favor of the combination therapy is “relatively modest” considering that it involves three drugs.

Dr. Fotopoulou highlighted, however, that one of the most important results was in the HRD-negative patients, which she characterized as the equivalent of the clinicians going to “the dark side of the moon.” She said that “for the first time, we have a positive study in this patient population,” although she underlined that the results are from an interim analysis.

The key question that remains, Dr. Fotopoulou asked, is “why? What is making the difference?” She noted that, unfortunately, the trial design does not allow the identification of the relative contribution of olaparib and durvalumab.

The study was sponsored by AstraZeneca, and conducted in collaboration with the European Network of Gynaecological Oncological Trial Groups, GOG Foundation, and Myriad Genetic Laboratories. Dr. Aghajanian declared relationships with AstraZeneca, Merck, Eisai, Repare Therapeutics, AbbVie, Clovis Oncology, and Genentech/Roche. Dr. Markham declared relationships with Pfizer, GlaxoSmithKline, Aduro Biotech, Lilly, Tesaro, Novartis, VBL Therapeutics, AstraZeneca, and Merck.

A version of this article first appeared on Medscape.com.

A telephone-based weight loss intervention resulted in clinically meaningful weight loss in patients with breast cancer who were overweight and obese.

The finding comes from a case-control study of 3,136 women who had been diagnosed with stage II or III breast cancer. The average body mass index of participants was 34.5 kg/m², and mean age was 53.4 years.

After 6 months, patients who received telephone coaching as well as health education lost 4.4 kg (9.7 lb), which was 4.8% of their baseline body weight.

In contrast, patients in the control group, who received only health education, gained 0.2 kg (0.3% of their baseline body weight) over the same period.

At the 1-year mark, the telephone weight loss intervention group had maintained the weight they lost at 6 months, whereas the control group gained even more weight and ended with a 0.9% weight gain.

“This equated to a 5.56% weight differential in the two arms demonstrating significant weight loss, which was also clinically significant given that a 3% weight loss is sufficient to improve diabetes and other chronic diseases,” commented lead author Jennifer Ligibel, MD, associate professor of medicine at the Dana-Farber Cancer Institute in Boston. 

She spoke at a press briefing ahead of the annual meeting of the American Society of Clinical Oncology, where the study was presented.

“Our study provides compelling evidence that weight loss interventions can successfully reduce weight in a diverse population of patients with breast cancer,” she said in a statement. At the time of diagnosis, 57% of patients were postmenopausal, 80.3% were White, 12.8% were Black, and 7.3% were Hispanic. 

Patients in the intervention group received a health education program plus a 2-year telephone-based weight loss program that focused on lowering calorie intake and increasing physical activity.

Those in the control group only received the health education program that included nontailored diet and exercise materials, a quarterly newsletter, twice-yearly webinars, and a subscription to a health magazine of the participant’s choosing

“This study was delivered completely remotely and it was done so purposefully because we wanted to develop a program that could work for somebody who lived in a rural area in the middle of the country, as well as it could for somebody who lived close to a cancer center,” Dr. Ligibel commented.

“The next step will be to determine whether this weight loss translates into lower rates of cancer recurrence and mortality. If our trial is successful in improving cancer outcomes, it will have far-reaching implications, demonstrating that weight loss should be incorporated into the standard of care for survivors of breast cancer,” she added.

Commenting on the new findings, ASCO expert Elizabeth Anne Comen, MD, Memorial Sloan Kettering Cancer Center, New York, said: “This study demonstrates that consistent health coaching by telephone – a more accessible, cost-effective approach compared to in-person programs – can significantly help patients with breast cancer lose weight over 1 year and is effective across diverse groups of patients.

“We anxiously await longer-term follow-up to see whether this weight reduction will ultimately improve outcomes for these patients,” she added.

A version of this article first appeared on Medscape.com.

A telephone-based weight loss intervention resulted in clinically meaningful weight loss in patients with breast cancer who were overweight and obese.

The finding comes from a case-control study of 3,136 women who had been diagnosed with stage II or III breast cancer. The average body mass index of participants was 34.5 kg/m², and mean age was 53.4 years.

After 6 months, patients who received telephone coaching as well as health education lost 4.4 kg (9.7 lb), which was 4.8% of their baseline body weight.

In contrast, patients in the control group, who received only health education, gained 0.2 kg (0.3% of their baseline body weight) over the same period.

At the 1-year mark, the telephone weight loss intervention group had maintained the weight they lost at 6 months, whereas the control group gained even more weight and ended with a 0.9% weight gain.

“This equated to a 5.56% weight differential in the two arms demonstrating significant weight loss, which was also clinically significant given that a 3% weight loss is sufficient to improve diabetes and other chronic diseases,” commented lead author Jennifer Ligibel, MD, associate professor of medicine at the Dana-Farber Cancer Institute in Boston. 

She spoke at a press briefing ahead of the annual meeting of the American Society of Clinical Oncology, where the study was presented.

“Our study provides compelling evidence that weight loss interventions can successfully reduce weight in a diverse population of patients with breast cancer,” she said in a statement. At the time of diagnosis, 57% of patients were postmenopausal, 80.3% were White, 12.8% were Black, and 7.3% were Hispanic. 

Patients in the intervention group received a health education program plus a 2-year telephone-based weight loss program that focused on lowering calorie intake and increasing physical activity.

Those in the control group only received the health education program that included nontailored diet and exercise materials, a quarterly newsletter, twice-yearly webinars, and a subscription to a health magazine of the participant’s choosing

“This study was delivered completely remotely and it was done so purposefully because we wanted to develop a program that could work for somebody who lived in a rural area in the middle of the country, as well as it could for somebody who lived close to a cancer center,” Dr. Ligibel commented.

“The next step will be to determine whether this weight loss translates into lower rates of cancer recurrence and mortality. If our trial is successful in improving cancer outcomes, it will have far-reaching implications, demonstrating that weight loss should be incorporated into the standard of care for survivors of breast cancer,” she added.

Commenting on the new findings, ASCO expert Elizabeth Anne Comen, MD, Memorial Sloan Kettering Cancer Center, New York, said: “This study demonstrates that consistent health coaching by telephone – a more accessible, cost-effective approach compared to in-person programs – can significantly help patients with breast cancer lose weight over 1 year and is effective across diverse groups of patients.

“We anxiously await longer-term follow-up to see whether this weight reduction will ultimately improve outcomes for these patients,” she added.

A version of this article first appeared on Medscape.com.

A telephone-based weight loss intervention resulted in clinically meaningful weight loss in patients with breast cancer who were overweight and obese.

The finding comes from a case-control study of 3,136 women who had been diagnosed with stage II or III breast cancer. The average body mass index of participants was 34.5 kg/m², and mean age was 53.4 years.

After 6 months, patients who received telephone coaching as well as health education lost 4.4 kg (9.7 lb), which was 4.8% of their baseline body weight.

In contrast, patients in the control group, who received only health education, gained 0.2 kg (0.3% of their baseline body weight) over the same period.

At the 1-year mark, the telephone weight loss intervention group had maintained the weight they lost at 6 months, whereas the control group gained even more weight and ended with a 0.9% weight gain.

“This equated to a 5.56% weight differential in the two arms demonstrating significant weight loss, which was also clinically significant given that a 3% weight loss is sufficient to improve diabetes and other chronic diseases,” commented lead author Jennifer Ligibel, MD, associate professor of medicine at the Dana-Farber Cancer Institute in Boston. 

She spoke at a press briefing ahead of the annual meeting of the American Society of Clinical Oncology, where the study was presented.

“Our study provides compelling evidence that weight loss interventions can successfully reduce weight in a diverse population of patients with breast cancer,” she said in a statement. At the time of diagnosis, 57% of patients were postmenopausal, 80.3% were White, 12.8% were Black, and 7.3% were Hispanic. 

Patients in the intervention group received a health education program plus a 2-year telephone-based weight loss program that focused on lowering calorie intake and increasing physical activity.

Those in the control group only received the health education program that included nontailored diet and exercise materials, a quarterly newsletter, twice-yearly webinars, and a subscription to a health magazine of the participant’s choosing

“This study was delivered completely remotely and it was done so purposefully because we wanted to develop a program that could work for somebody who lived in a rural area in the middle of the country, as well as it could for somebody who lived close to a cancer center,” Dr. Ligibel commented.

“The next step will be to determine whether this weight loss translates into lower rates of cancer recurrence and mortality. If our trial is successful in improving cancer outcomes, it will have far-reaching implications, demonstrating that weight loss should be incorporated into the standard of care for survivors of breast cancer,” she added.

Commenting on the new findings, ASCO expert Elizabeth Anne Comen, MD, Memorial Sloan Kettering Cancer Center, New York, said: “This study demonstrates that consistent health coaching by telephone – a more accessible, cost-effective approach compared to in-person programs – can significantly help patients with breast cancer lose weight over 1 year and is effective across diverse groups of patients.

“We anxiously await longer-term follow-up to see whether this weight reduction will ultimately improve outcomes for these patients,” she added.