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Half of Family Physicians Feel Their Payment Matches Their Workload
More than half of family physicians think that physicians in general are underpaid, but 50% said that in their own situations, they felt fairly paid given their work demands, based on data from Medscape’s annual Family Physician Compensation Report.
The report, based on data from 7,000 physicians across the United States, showed similarly that 50% of family physicians were happy with their pay, which put them about midway on a list of 29 specialties ranking happiness with pay, above some of the higher paid specialties including orthopedics and plastic surgery.
The report cited data from the Mercer consulting firm showing an increase of 3% in 2023 over 2022 earnings among physicians in the United States overall. The average annual earnings for family medicine physicians were near the bottom of a list of 29 specialties included in the report, but 90% said that potential pay was not a factor or a minor factor in choosing the specialty.
According to the report, 61% of family physicians reported taking no additional work to boost income, but 20% reported taking on additional medical-related work, and 6% reported non-medical-related work.
For most family physicians compensation for patient care remained approximately the same as previous years, and a majority said that neither competing physician practices nor other medical businesses (such as retail clinics or nonphysician practitioners) had an effect on their incomes (70% and 62%, respectively).
Although 54% of family practice physicians reported opportunities for incentive bonuses, these bonuses are generally based on a combination of clinical, economic, and experience factors, and are lower for primary care physicians than for specialists. The average bonus for a primary care physician in 2023 was $27,000 compared with an average bonus of $51,000 for a specialist, according to the report.
Overall, 32% of the family physicians reported gratitude from and relationships with patients as the most satisfying part of their jobs, followed by being good at their jobs by finding answers to medical questions and making diagnoses (24%), and making the world a better place (19%).
Why Money Still Matters
The relatively minor increase in earnings is “the minimum necessary to continue to attract talented individuals into family medicine,” Susan Kuchera, MD, associate director of the Family Medicine Residency Program at Jefferson Health, Abington, Pennsylvania, said in an interview.
The current report referenced a 2023 report of interviews with medical residents, and approximately half of residents overall said that potential earnings were influential in their decisions.
However, the current Medscape report does not reflect the debt burden held by most new physicians, said Dr. Kuchera, who was not involved in the report. “The educational debt and long years of training can be a deterrent for some to choose a lower paying specialty like primary care; if we want to continue to provide our communities with primary care specialists, we need to keep pace with other areas of medicine,” she said.
“It takes a minimum of 7 years to train a primary care physician, we can’t lose sight over time of the factors that impact a person’s choice to pursue primary care,” Dr. Kuchera said.
More Support Needed for Community-Based Care
The data from the report were not surprising, given that the work of primary care physicians is hard, but “historically undervalued” compared with procedural medicine, Dr. Kuchera said. With more emphasis on the value of healthy communities, “we will realize that the relationship family physicians have with their communities is paramount to creating a healthy society,” she added.
The fact that patient care accounts for more than 75% of what family doctors feel to be most rewarding in their profession reflects that most do this work because longitudinal care of patients and communities is rewarding, Dr. Kuchera said in an interview.
“Employers need to value the special training of family doctors to take care of communities,” Dr. Kuchera said. This includes finding ways to incentivize value-based care and to provide the necessary resources to care for communities with poor social determinants of health, she added.
Dr. Kuchera had no financial conflicts to disclose.
More than half of family physicians think that physicians in general are underpaid, but 50% said that in their own situations, they felt fairly paid given their work demands, based on data from Medscape’s annual Family Physician Compensation Report.
The report, based on data from 7,000 physicians across the United States, showed similarly that 50% of family physicians were happy with their pay, which put them about midway on a list of 29 specialties ranking happiness with pay, above some of the higher paid specialties including orthopedics and plastic surgery.
The report cited data from the Mercer consulting firm showing an increase of 3% in 2023 over 2022 earnings among physicians in the United States overall. The average annual earnings for family medicine physicians were near the bottom of a list of 29 specialties included in the report, but 90% said that potential pay was not a factor or a minor factor in choosing the specialty.
According to the report, 61% of family physicians reported taking no additional work to boost income, but 20% reported taking on additional medical-related work, and 6% reported non-medical-related work.
For most family physicians compensation for patient care remained approximately the same as previous years, and a majority said that neither competing physician practices nor other medical businesses (such as retail clinics or nonphysician practitioners) had an effect on their incomes (70% and 62%, respectively).
Although 54% of family practice physicians reported opportunities for incentive bonuses, these bonuses are generally based on a combination of clinical, economic, and experience factors, and are lower for primary care physicians than for specialists. The average bonus for a primary care physician in 2023 was $27,000 compared with an average bonus of $51,000 for a specialist, according to the report.
Overall, 32% of the family physicians reported gratitude from and relationships with patients as the most satisfying part of their jobs, followed by being good at their jobs by finding answers to medical questions and making diagnoses (24%), and making the world a better place (19%).
Why Money Still Matters
The relatively minor increase in earnings is “the minimum necessary to continue to attract talented individuals into family medicine,” Susan Kuchera, MD, associate director of the Family Medicine Residency Program at Jefferson Health, Abington, Pennsylvania, said in an interview.
The current report referenced a 2023 report of interviews with medical residents, and approximately half of residents overall said that potential earnings were influential in their decisions.
However, the current Medscape report does not reflect the debt burden held by most new physicians, said Dr. Kuchera, who was not involved in the report. “The educational debt and long years of training can be a deterrent for some to choose a lower paying specialty like primary care; if we want to continue to provide our communities with primary care specialists, we need to keep pace with other areas of medicine,” she said.
“It takes a minimum of 7 years to train a primary care physician, we can’t lose sight over time of the factors that impact a person’s choice to pursue primary care,” Dr. Kuchera said.
More Support Needed for Community-Based Care
The data from the report were not surprising, given that the work of primary care physicians is hard, but “historically undervalued” compared with procedural medicine, Dr. Kuchera said. With more emphasis on the value of healthy communities, “we will realize that the relationship family physicians have with their communities is paramount to creating a healthy society,” she added.
The fact that patient care accounts for more than 75% of what family doctors feel to be most rewarding in their profession reflects that most do this work because longitudinal care of patients and communities is rewarding, Dr. Kuchera said in an interview.
“Employers need to value the special training of family doctors to take care of communities,” Dr. Kuchera said. This includes finding ways to incentivize value-based care and to provide the necessary resources to care for communities with poor social determinants of health, she added.
Dr. Kuchera had no financial conflicts to disclose.
More than half of family physicians think that physicians in general are underpaid, but 50% said that in their own situations, they felt fairly paid given their work demands, based on data from Medscape’s annual Family Physician Compensation Report.
The report, based on data from 7,000 physicians across the United States, showed similarly that 50% of family physicians were happy with their pay, which put them about midway on a list of 29 specialties ranking happiness with pay, above some of the higher paid specialties including orthopedics and plastic surgery.
The report cited data from the Mercer consulting firm showing an increase of 3% in 2023 over 2022 earnings among physicians in the United States overall. The average annual earnings for family medicine physicians were near the bottom of a list of 29 specialties included in the report, but 90% said that potential pay was not a factor or a minor factor in choosing the specialty.
According to the report, 61% of family physicians reported taking no additional work to boost income, but 20% reported taking on additional medical-related work, and 6% reported non-medical-related work.
For most family physicians compensation for patient care remained approximately the same as previous years, and a majority said that neither competing physician practices nor other medical businesses (such as retail clinics or nonphysician practitioners) had an effect on their incomes (70% and 62%, respectively).
Although 54% of family practice physicians reported opportunities for incentive bonuses, these bonuses are generally based on a combination of clinical, economic, and experience factors, and are lower for primary care physicians than for specialists. The average bonus for a primary care physician in 2023 was $27,000 compared with an average bonus of $51,000 for a specialist, according to the report.
Overall, 32% of the family physicians reported gratitude from and relationships with patients as the most satisfying part of their jobs, followed by being good at their jobs by finding answers to medical questions and making diagnoses (24%), and making the world a better place (19%).
Why Money Still Matters
The relatively minor increase in earnings is “the minimum necessary to continue to attract talented individuals into family medicine,” Susan Kuchera, MD, associate director of the Family Medicine Residency Program at Jefferson Health, Abington, Pennsylvania, said in an interview.
The current report referenced a 2023 report of interviews with medical residents, and approximately half of residents overall said that potential earnings were influential in their decisions.
However, the current Medscape report does not reflect the debt burden held by most new physicians, said Dr. Kuchera, who was not involved in the report. “The educational debt and long years of training can be a deterrent for some to choose a lower paying specialty like primary care; if we want to continue to provide our communities with primary care specialists, we need to keep pace with other areas of medicine,” she said.
“It takes a minimum of 7 years to train a primary care physician, we can’t lose sight over time of the factors that impact a person’s choice to pursue primary care,” Dr. Kuchera said.
More Support Needed for Community-Based Care
The data from the report were not surprising, given that the work of primary care physicians is hard, but “historically undervalued” compared with procedural medicine, Dr. Kuchera said. With more emphasis on the value of healthy communities, “we will realize that the relationship family physicians have with their communities is paramount to creating a healthy society,” she added.
The fact that patient care accounts for more than 75% of what family doctors feel to be most rewarding in their profession reflects that most do this work because longitudinal care of patients and communities is rewarding, Dr. Kuchera said in an interview.
“Employers need to value the special training of family doctors to take care of communities,” Dr. Kuchera said. This includes finding ways to incentivize value-based care and to provide the necessary resources to care for communities with poor social determinants of health, she added.
Dr. Kuchera had no financial conflicts to disclose.
Failed IOL Promotes Poor Maternal and Fetal Outcomes for Mothers With Diabetes
Approximately one-quarter of mothers with diabetes failed induction of labor, and this failure was associated with a range of adverse outcomes for mothers and infants, based on data from more than 2,000 individuals.
Uncontrolled diabetes remains a risk factor for cesarean delivery, Ali Alhousseini, MD, of Corewell Health East, Dearborn, Michigan, and colleagues wrote in a study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
“Identifying and stratifying associated risk factors for failed induction of labor [IOL] may improve counseling and intrapartum care,” the researchers wrote in their abstract.
The researchers reviewed data from 2,172 mothers with diabetes who underwent IOL at a single university medical center between January 2013 and December 2021. They examined a range of maternal characteristics including age, ethnicity, gestational age, medical comorbidities, insulin administration, parity, and health insurance.
A total of 567 mothers with diabetes (26.1%) failed IOL and underwent cesarean delivery.
Overall, failed IOL was significantly associated with nulliparity (P = .0001), as well as preexisting diabetes compared with gestational diabetes, diabetes control with insulin, maternal essential hypertension, preeclampsia, and polyhydramnios (P = .001 for all). Other factors significantly associated with failed IOL included prenatal diagnosis of fetal growth restriction (P = .008), and placental abnormalities (P = .027).
Neonatal factors of weight, large for gestational age, head circumference, and height were not significantly associated with failed IOL (P > .05 for all).
As for neonatal outcomes, failed IOL was significantly associated with admission to neonatal intensive care unit, hyperbilirubinemia, and longer hospital stay (P = .001 for all). Failed IOL was significantly associated with lower 1-minute APGAR scores, but not with lower 5-minute APGAR scores, the researchers noted (P = .033 for 1-minute score). No association was noted between failed IOL and neonatal readmission, lower umbilical cord pH value, or maternal ethnicity.
The findings were limited by the retrospective design, but data analysis is ongoing, Dr. Alhousseini said. The researchers are continuing to assess the roles not only of optimal glucose control, but other maternal factors in improving maternal and neonatal outcomes, he said.
Data Add to Awareness of Risk Factors
The current study is important because of the increasing incidence of diabetes and the need to examine associated risk factors in pregnancy, Michael Richley, MD, a maternal fetal medicine physician at the University of Washington, Seattle, said in an interview. “The average age of onset of diabetes is becoming younger and type 2 diabetes in pregnancy is an increasingly common diagnosis,” said Dr. Richley, who was not involved in the study.
The increase in both maternal and neonatal adverse outcomes is expected given the risk factors identified in the study, said Dr. Richley. “The patients with diabetes also were sicker at baseline, with hypertensive disorders, growth restriction, and pregestational diabetes,” he noted.
The study findings support data from previous research, Dr. Richley said. The message to clinicians is that patients with diabetes not only have an increased risk of needing a cesarean delivery but also have an increased risk of poor outcomes if a cesarean delivery is needed, he said.
Although a prospective study would be useful to show causality as opposed to just an association, such a study is challenging in this patient population given the limitations of conducting research on labor and delivery, he said.
The study received no outside funding. The researchers and Dr. Richley had no financial conflicts to disclose.
Approximately one-quarter of mothers with diabetes failed induction of labor, and this failure was associated with a range of adverse outcomes for mothers and infants, based on data from more than 2,000 individuals.
Uncontrolled diabetes remains a risk factor for cesarean delivery, Ali Alhousseini, MD, of Corewell Health East, Dearborn, Michigan, and colleagues wrote in a study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
“Identifying and stratifying associated risk factors for failed induction of labor [IOL] may improve counseling and intrapartum care,” the researchers wrote in their abstract.
The researchers reviewed data from 2,172 mothers with diabetes who underwent IOL at a single university medical center between January 2013 and December 2021. They examined a range of maternal characteristics including age, ethnicity, gestational age, medical comorbidities, insulin administration, parity, and health insurance.
A total of 567 mothers with diabetes (26.1%) failed IOL and underwent cesarean delivery.
Overall, failed IOL was significantly associated with nulliparity (P = .0001), as well as preexisting diabetes compared with gestational diabetes, diabetes control with insulin, maternal essential hypertension, preeclampsia, and polyhydramnios (P = .001 for all). Other factors significantly associated with failed IOL included prenatal diagnosis of fetal growth restriction (P = .008), and placental abnormalities (P = .027).
Neonatal factors of weight, large for gestational age, head circumference, and height were not significantly associated with failed IOL (P > .05 for all).
As for neonatal outcomes, failed IOL was significantly associated with admission to neonatal intensive care unit, hyperbilirubinemia, and longer hospital stay (P = .001 for all). Failed IOL was significantly associated with lower 1-minute APGAR scores, but not with lower 5-minute APGAR scores, the researchers noted (P = .033 for 1-minute score). No association was noted between failed IOL and neonatal readmission, lower umbilical cord pH value, or maternal ethnicity.
The findings were limited by the retrospective design, but data analysis is ongoing, Dr. Alhousseini said. The researchers are continuing to assess the roles not only of optimal glucose control, but other maternal factors in improving maternal and neonatal outcomes, he said.
Data Add to Awareness of Risk Factors
The current study is important because of the increasing incidence of diabetes and the need to examine associated risk factors in pregnancy, Michael Richley, MD, a maternal fetal medicine physician at the University of Washington, Seattle, said in an interview. “The average age of onset of diabetes is becoming younger and type 2 diabetes in pregnancy is an increasingly common diagnosis,” said Dr. Richley, who was not involved in the study.
The increase in both maternal and neonatal adverse outcomes is expected given the risk factors identified in the study, said Dr. Richley. “The patients with diabetes also were sicker at baseline, with hypertensive disorders, growth restriction, and pregestational diabetes,” he noted.
The study findings support data from previous research, Dr. Richley said. The message to clinicians is that patients with diabetes not only have an increased risk of needing a cesarean delivery but also have an increased risk of poor outcomes if a cesarean delivery is needed, he said.
Although a prospective study would be useful to show causality as opposed to just an association, such a study is challenging in this patient population given the limitations of conducting research on labor and delivery, he said.
The study received no outside funding. The researchers and Dr. Richley had no financial conflicts to disclose.
Approximately one-quarter of mothers with diabetes failed induction of labor, and this failure was associated with a range of adverse outcomes for mothers and infants, based on data from more than 2,000 individuals.
Uncontrolled diabetes remains a risk factor for cesarean delivery, Ali Alhousseini, MD, of Corewell Health East, Dearborn, Michigan, and colleagues wrote in a study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
“Identifying and stratifying associated risk factors for failed induction of labor [IOL] may improve counseling and intrapartum care,” the researchers wrote in their abstract.
The researchers reviewed data from 2,172 mothers with diabetes who underwent IOL at a single university medical center between January 2013 and December 2021. They examined a range of maternal characteristics including age, ethnicity, gestational age, medical comorbidities, insulin administration, parity, and health insurance.
A total of 567 mothers with diabetes (26.1%) failed IOL and underwent cesarean delivery.
Overall, failed IOL was significantly associated with nulliparity (P = .0001), as well as preexisting diabetes compared with gestational diabetes, diabetes control with insulin, maternal essential hypertension, preeclampsia, and polyhydramnios (P = .001 for all). Other factors significantly associated with failed IOL included prenatal diagnosis of fetal growth restriction (P = .008), and placental abnormalities (P = .027).
Neonatal factors of weight, large for gestational age, head circumference, and height were not significantly associated with failed IOL (P > .05 for all).
As for neonatal outcomes, failed IOL was significantly associated with admission to neonatal intensive care unit, hyperbilirubinemia, and longer hospital stay (P = .001 for all). Failed IOL was significantly associated with lower 1-minute APGAR scores, but not with lower 5-minute APGAR scores, the researchers noted (P = .033 for 1-minute score). No association was noted between failed IOL and neonatal readmission, lower umbilical cord pH value, or maternal ethnicity.
The findings were limited by the retrospective design, but data analysis is ongoing, Dr. Alhousseini said. The researchers are continuing to assess the roles not only of optimal glucose control, but other maternal factors in improving maternal and neonatal outcomes, he said.
Data Add to Awareness of Risk Factors
The current study is important because of the increasing incidence of diabetes and the need to examine associated risk factors in pregnancy, Michael Richley, MD, a maternal fetal medicine physician at the University of Washington, Seattle, said in an interview. “The average age of onset of diabetes is becoming younger and type 2 diabetes in pregnancy is an increasingly common diagnosis,” said Dr. Richley, who was not involved in the study.
The increase in both maternal and neonatal adverse outcomes is expected given the risk factors identified in the study, said Dr. Richley. “The patients with diabetes also were sicker at baseline, with hypertensive disorders, growth restriction, and pregestational diabetes,” he noted.
The study findings support data from previous research, Dr. Richley said. The message to clinicians is that patients with diabetes not only have an increased risk of needing a cesarean delivery but also have an increased risk of poor outcomes if a cesarean delivery is needed, he said.
Although a prospective study would be useful to show causality as opposed to just an association, such a study is challenging in this patient population given the limitations of conducting research on labor and delivery, he said.
The study received no outside funding. The researchers and Dr. Richley had no financial conflicts to disclose.
FROM ACOG 2024
Maternal Buprenorphine Affects Fetal Breathing
Measures of fetal breathing movement were lower in fetuses of pregnant patients who received buprenorphine, compared with controls, based on data from 177 individuals.
The findings were presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists by Caroline Bulger, MD, of East Tennessee State University, Johnson City.
Pregnant patients with opioid-use disorder in the community surrounding Johnson City receive medication-assisted therapy with buprenorphine during the prenatal period, Dr. Bulger and colleagues wrote in their abstract. The current prenatal program for substance use disorder was established in 2016 based on patient requests for assistance in lowering their buprenorphine dosages during pregnancy, said senior author Martin E. Olsen, MD, also of East Tennessee State University, in an interview.
“Buprenorphine medication–assisted treatment in pregnancy is associated with long-term effects on childhood development such as smaller neonatal brains, decreased school performance, and low birth weight;” however, data on the fetal effects of buprenorphine are limited, said Dr. Olsen.
The current study was conducted to evaluate a short-term finding of the fetal effects of buprenorphine, Dr. Olsen said.
“This study was performed after obstetric sonographers at our institution noted that biophysical profile [BPP] ultrasound assessments of the fetuses of mothers on buprenorphine took longer than for other patients,” said Dr. Olsen.
The researchers conducted a retrospective chart review of 131 patients who received buprenorphine and 46 who were followed for chronic hypertension and served as high-risk controls. Patients were seen at a single institution between July 1, 2016, and June 30, 2020.
The researchers hypothesized that BPP of fetuses in patients receiving buprenorphine might be different from controls because of the effects of buprenorphine.
Overall, patients who received buprenorphine were more likely to have a fetal breathing score of zero than those who underwent a BPP for hypertension. A significant relationship emerged between buprenorphine dosage and breathing motion assessment; patients on high-dose buprenorphine were more likely than patients on low doses to have values of zero on fetal breathing motion assessment, and a chi-squared test yielded a P value of .04269.
The takeaway for clinical practice is that clinicians performing BPP ultrasounds on buprenorphine-exposed fetuses can expect that these assessments may take longer on average than assessments of other high-risk patients, said Dr. Olsen. “Additional assessment after a low BPP score is still indicated for these fetuses just as in other high-risk pregnancies,” he said.
The study was limited primarily by the retrospective design, Dr. Olsen said.
Although current treatment guidelines do not emphasize the effects of maternal buprenorphine use on fetal development, these findings support previous research showing effects of buprenorphine on fetal brain structure, the researchers wrote in their abstract. Looking ahead, “We recommend additional study on the maternal buprenorphine medication–assisted treatment dose effects for fetal and neonatal development with attention to such factors as head circumference, birth weight, achievement of developmental milestones, and school performance,” Dr. Olsen said.
“We and others have shown that the lowest effective dose of buprenorphine can lower neonatal abstinence syndrome/neonatal opioid withdrawal syndrome rates,” but data showing an impact of lowest effective dose management on long-term complications of fetal buprenorphine exposure are lacking, he noted.
The study received no outside funding. The researchers had no financial conflicts to disclose.
Measures of fetal breathing movement were lower in fetuses of pregnant patients who received buprenorphine, compared with controls, based on data from 177 individuals.
The findings were presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists by Caroline Bulger, MD, of East Tennessee State University, Johnson City.
Pregnant patients with opioid-use disorder in the community surrounding Johnson City receive medication-assisted therapy with buprenorphine during the prenatal period, Dr. Bulger and colleagues wrote in their abstract. The current prenatal program for substance use disorder was established in 2016 based on patient requests for assistance in lowering their buprenorphine dosages during pregnancy, said senior author Martin E. Olsen, MD, also of East Tennessee State University, in an interview.
“Buprenorphine medication–assisted treatment in pregnancy is associated with long-term effects on childhood development such as smaller neonatal brains, decreased school performance, and low birth weight;” however, data on the fetal effects of buprenorphine are limited, said Dr. Olsen.
The current study was conducted to evaluate a short-term finding of the fetal effects of buprenorphine, Dr. Olsen said.
“This study was performed after obstetric sonographers at our institution noted that biophysical profile [BPP] ultrasound assessments of the fetuses of mothers on buprenorphine took longer than for other patients,” said Dr. Olsen.
The researchers conducted a retrospective chart review of 131 patients who received buprenorphine and 46 who were followed for chronic hypertension and served as high-risk controls. Patients were seen at a single institution between July 1, 2016, and June 30, 2020.
The researchers hypothesized that BPP of fetuses in patients receiving buprenorphine might be different from controls because of the effects of buprenorphine.
Overall, patients who received buprenorphine were more likely to have a fetal breathing score of zero than those who underwent a BPP for hypertension. A significant relationship emerged between buprenorphine dosage and breathing motion assessment; patients on high-dose buprenorphine were more likely than patients on low doses to have values of zero on fetal breathing motion assessment, and a chi-squared test yielded a P value of .04269.
The takeaway for clinical practice is that clinicians performing BPP ultrasounds on buprenorphine-exposed fetuses can expect that these assessments may take longer on average than assessments of other high-risk patients, said Dr. Olsen. “Additional assessment after a low BPP score is still indicated for these fetuses just as in other high-risk pregnancies,” he said.
The study was limited primarily by the retrospective design, Dr. Olsen said.
Although current treatment guidelines do not emphasize the effects of maternal buprenorphine use on fetal development, these findings support previous research showing effects of buprenorphine on fetal brain structure, the researchers wrote in their abstract. Looking ahead, “We recommend additional study on the maternal buprenorphine medication–assisted treatment dose effects for fetal and neonatal development with attention to such factors as head circumference, birth weight, achievement of developmental milestones, and school performance,” Dr. Olsen said.
“We and others have shown that the lowest effective dose of buprenorphine can lower neonatal abstinence syndrome/neonatal opioid withdrawal syndrome rates,” but data showing an impact of lowest effective dose management on long-term complications of fetal buprenorphine exposure are lacking, he noted.
The study received no outside funding. The researchers had no financial conflicts to disclose.
Measures of fetal breathing movement were lower in fetuses of pregnant patients who received buprenorphine, compared with controls, based on data from 177 individuals.
The findings were presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists by Caroline Bulger, MD, of East Tennessee State University, Johnson City.
Pregnant patients with opioid-use disorder in the community surrounding Johnson City receive medication-assisted therapy with buprenorphine during the prenatal period, Dr. Bulger and colleagues wrote in their abstract. The current prenatal program for substance use disorder was established in 2016 based on patient requests for assistance in lowering their buprenorphine dosages during pregnancy, said senior author Martin E. Olsen, MD, also of East Tennessee State University, in an interview.
“Buprenorphine medication–assisted treatment in pregnancy is associated with long-term effects on childhood development such as smaller neonatal brains, decreased school performance, and low birth weight;” however, data on the fetal effects of buprenorphine are limited, said Dr. Olsen.
The current study was conducted to evaluate a short-term finding of the fetal effects of buprenorphine, Dr. Olsen said.
“This study was performed after obstetric sonographers at our institution noted that biophysical profile [BPP] ultrasound assessments of the fetuses of mothers on buprenorphine took longer than for other patients,” said Dr. Olsen.
The researchers conducted a retrospective chart review of 131 patients who received buprenorphine and 46 who were followed for chronic hypertension and served as high-risk controls. Patients were seen at a single institution between July 1, 2016, and June 30, 2020.
The researchers hypothesized that BPP of fetuses in patients receiving buprenorphine might be different from controls because of the effects of buprenorphine.
Overall, patients who received buprenorphine were more likely to have a fetal breathing score of zero than those who underwent a BPP for hypertension. A significant relationship emerged between buprenorphine dosage and breathing motion assessment; patients on high-dose buprenorphine were more likely than patients on low doses to have values of zero on fetal breathing motion assessment, and a chi-squared test yielded a P value of .04269.
The takeaway for clinical practice is that clinicians performing BPP ultrasounds on buprenorphine-exposed fetuses can expect that these assessments may take longer on average than assessments of other high-risk patients, said Dr. Olsen. “Additional assessment after a low BPP score is still indicated for these fetuses just as in other high-risk pregnancies,” he said.
The study was limited primarily by the retrospective design, Dr. Olsen said.
Although current treatment guidelines do not emphasize the effects of maternal buprenorphine use on fetal development, these findings support previous research showing effects of buprenorphine on fetal brain structure, the researchers wrote in their abstract. Looking ahead, “We recommend additional study on the maternal buprenorphine medication–assisted treatment dose effects for fetal and neonatal development with attention to such factors as head circumference, birth weight, achievement of developmental milestones, and school performance,” Dr. Olsen said.
“We and others have shown that the lowest effective dose of buprenorphine can lower neonatal abstinence syndrome/neonatal opioid withdrawal syndrome rates,” but data showing an impact of lowest effective dose management on long-term complications of fetal buprenorphine exposure are lacking, he noted.
The study received no outside funding. The researchers had no financial conflicts to disclose.
ACOG 2024
LDCT Lung Cancer Screening Finds Undiagnosed Pulmonary Comorbidities in High-Risk Population
Lung cancer screening with low-dose CT (LDCT) can effectively evaluate a high-risk population for undiagnosed chronic obstructive pulmonary disease (COPD) and airflow obstruction, based on data from a new study of approximately 2000 individuals.
Previous research suggests that approximately 70%-90% of individuals with COPD are undiagnosed, especially low-income and minority populations who may be less likely to undergo screening, said Michaela A. Seigo, DO, of Temple University Hospital, Philadelphia, in a study presented at the American Thoracic Society (ATS) 2024 International Conference.
The researchers reviewed data from 2083 adults enrolled in the Temple Healthy Chest Initiative, an urban health system-wide lung cancer screening program, combined with the detection of symptoms and comorbidities.
Baseline LDCT for Identification of Comorbidities
Study participants underwent baseline LDCT between October 2021 and October 2022. The images were reviewed by radiologists for pulmonary comorbidities including emphysema, airway disease, bronchiectasis, and interstitial lung disease. In addition, 604 participants (29%) completed a symptom survey, and 624 (30%) underwent spirometry. The mean age of the participants was 65.8 years and 63.9 years for those with and without a history of COPD, respectively.
Approximately half of the participants in both groups were female.
Overall, 66 of 181 (36.5%) individuals previously undiagnosed with COPD had spirometry consistent with airflow obstruction (forced expiratory volume in 1 second/forced vital capacity, < 70%). Individuals with previously undiagnosed COPD were more likely to be younger, male, current smokers, and identified as Hispanic or other race (not Black, White, Hispanic, or Asian/Native American/Pacific Islander).
Individuals without a reported history of COPD had fewer pulmonary comorbidities on LDCT and lower rates of respiratory symptoms than those with COPD. However, nearly 25% of individuals with no reported history of COPD said that breathing issues affected their “ability to do things,” Ms. Seigo said, and a majority of those with no COPD diagnosis exhibited airway disease (76.2% compared with 84% of diagnosed patients with COPD). In addition, 88.1% reported ever experiencing dyspnea and 72.6% reported experiencing cough; both symptoms are compatible with a clinical diagnosis of COPD, the researchers noted.
“We detected pulmonary comorbidities at higher rates than previously published,” Ms. Seigo said in an interview. The increase likely reflects the patient population at Temple, which includes a relatively high percentage of city-dwelling, lower-income individuals, as well as more racial-ethnic minorities and persons of color, she said.
However, “these findings will help clinicians target the most at-risk populations for previously undiagnosed COPD,” Ms. Seigo said.
Looking ahead, Ms. Seigo said she sees a dominant role for artificial intelligence (AI) in COPD screening. “At-risk populations will get LDCT scans, and AI will identify pulmonary and extra-pulmonary comorbidities that may need to be addressed,” she said.
A combination of symptom detection plus strategic and more widely available access to screening offers “a huge opportunity to intervene earlier and potentially save lives,” she told this news organization.
Lung Cancer Screening May Promote Earlier COPD Intervention
The current study examines the prevalence of undiagnosed COPD, especially among low-income and minority populations, in an asymptomatic high-risk group. “By integrating lung cancer CT screening with the detection of pulmonary comorbidities on LDCT and respiratory symptoms, the current study aimed to identify individuals with undiagnosed COPD,” said Dharani K. Narendra, MD, of Baylor College of Medicine, Houston, in an interview.
“The study highlighted the feasibility and potential benefits of coupling lung cancer screening tests with COPD detection, which is noteworthy, and hits two targets with one arrow — early detection of lung cancer and COPD — in high-risk groups, Dr. Narendra said.
“Although the USPSTF recommends against screening for COPD in asymptomatic patients, abnormal pulmonary comorbidities observed on CT chest scans could serve as a gateway for clinicians to screen for COPD,” said Dr. Narendra. “This approach allows for early diagnosis, education on smoking cessation, and timely treatment of COPD, potentially preventing lung function deterioration and reducing the risk of exacerbations,” she noted.
The finding that one third of previously undiagnosed and asymptomatic patients with COPD showed significant rates of airflow obstruction on spirometry is consistent with previous research, Dr. Narendra told this news organization.
“Interestingly, in questions about specific symptoms, undiagnosed COPD patients reported higher rates of dyspnea, more cough, and breathing difficulties affecting their daily activities, at 16.1%, 27.4%, and 24.5%, respectively, highlighting a lower perception of symptoms,” she said.
“Barriers to lung cancer screening in urban, high-risk communities include limited healthcare facility access, insufficient awareness of screening programs, financial constraints, and cultural or language barriers,” said Dr. Narendra.
Potential strategies to overcome these barriers include improving access through additional screening centers and providing transportation, implementing community-based education and outreach programs to increase awareness about the benefits of lung cancer screening and early COPD detection, and providing financial assistance in the form of free screening options and collaboration with insurers to cover screening expenses, she said.
“Healthcare providers must recognize the dual benefits of lung cancer screening programs, including the opportunity to screen for undiagnosed COPD,” Dr. Narendra emphasized. “This integrated approach is crucial in identifying high-risk individuals who could benefit from early intervention and effective management of COPD. Clinicians should actively support implementing comprehensive screening programs incorporating assessments for pulmonary comorbidities through LDCT and screening questionnaires for COPD symptoms,” she said.
“Further research is needed to evaluate long-term mortality outcomes and identify best practices to determine the most effective methods and cost-effectiveness for implementing and sustaining combined screening programs in various urban settings,” Dr. Narendra told this news organization.
Other areas to address in future studies include investigating specific barriers to screening among different high-risk groups and tailoring interventions to improve screening uptake and adherence, Narendra said. “By addressing these research gaps, health care providers can optimize screening programs and enhance the overall health of urban, high-risk populations,” she added.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Narendra serves on the editorial board of CHEST Physician.
A version of this article first appeared on Medscape.com.
Lung cancer screening with low-dose CT (LDCT) can effectively evaluate a high-risk population for undiagnosed chronic obstructive pulmonary disease (COPD) and airflow obstruction, based on data from a new study of approximately 2000 individuals.
Previous research suggests that approximately 70%-90% of individuals with COPD are undiagnosed, especially low-income and minority populations who may be less likely to undergo screening, said Michaela A. Seigo, DO, of Temple University Hospital, Philadelphia, in a study presented at the American Thoracic Society (ATS) 2024 International Conference.
The researchers reviewed data from 2083 adults enrolled in the Temple Healthy Chest Initiative, an urban health system-wide lung cancer screening program, combined with the detection of symptoms and comorbidities.
Baseline LDCT for Identification of Comorbidities
Study participants underwent baseline LDCT between October 2021 and October 2022. The images were reviewed by radiologists for pulmonary comorbidities including emphysema, airway disease, bronchiectasis, and interstitial lung disease. In addition, 604 participants (29%) completed a symptom survey, and 624 (30%) underwent spirometry. The mean age of the participants was 65.8 years and 63.9 years for those with and without a history of COPD, respectively.
Approximately half of the participants in both groups were female.
Overall, 66 of 181 (36.5%) individuals previously undiagnosed with COPD had spirometry consistent with airflow obstruction (forced expiratory volume in 1 second/forced vital capacity, < 70%). Individuals with previously undiagnosed COPD were more likely to be younger, male, current smokers, and identified as Hispanic or other race (not Black, White, Hispanic, or Asian/Native American/Pacific Islander).
Individuals without a reported history of COPD had fewer pulmonary comorbidities on LDCT and lower rates of respiratory symptoms than those with COPD. However, nearly 25% of individuals with no reported history of COPD said that breathing issues affected their “ability to do things,” Ms. Seigo said, and a majority of those with no COPD diagnosis exhibited airway disease (76.2% compared with 84% of diagnosed patients with COPD). In addition, 88.1% reported ever experiencing dyspnea and 72.6% reported experiencing cough; both symptoms are compatible with a clinical diagnosis of COPD, the researchers noted.
“We detected pulmonary comorbidities at higher rates than previously published,” Ms. Seigo said in an interview. The increase likely reflects the patient population at Temple, which includes a relatively high percentage of city-dwelling, lower-income individuals, as well as more racial-ethnic minorities and persons of color, she said.
However, “these findings will help clinicians target the most at-risk populations for previously undiagnosed COPD,” Ms. Seigo said.
Looking ahead, Ms. Seigo said she sees a dominant role for artificial intelligence (AI) in COPD screening. “At-risk populations will get LDCT scans, and AI will identify pulmonary and extra-pulmonary comorbidities that may need to be addressed,” she said.
A combination of symptom detection plus strategic and more widely available access to screening offers “a huge opportunity to intervene earlier and potentially save lives,” she told this news organization.
Lung Cancer Screening May Promote Earlier COPD Intervention
The current study examines the prevalence of undiagnosed COPD, especially among low-income and minority populations, in an asymptomatic high-risk group. “By integrating lung cancer CT screening with the detection of pulmonary comorbidities on LDCT and respiratory symptoms, the current study aimed to identify individuals with undiagnosed COPD,” said Dharani K. Narendra, MD, of Baylor College of Medicine, Houston, in an interview.
“The study highlighted the feasibility and potential benefits of coupling lung cancer screening tests with COPD detection, which is noteworthy, and hits two targets with one arrow — early detection of lung cancer and COPD — in high-risk groups, Dr. Narendra said.
“Although the USPSTF recommends against screening for COPD in asymptomatic patients, abnormal pulmonary comorbidities observed on CT chest scans could serve as a gateway for clinicians to screen for COPD,” said Dr. Narendra. “This approach allows for early diagnosis, education on smoking cessation, and timely treatment of COPD, potentially preventing lung function deterioration and reducing the risk of exacerbations,” she noted.
The finding that one third of previously undiagnosed and asymptomatic patients with COPD showed significant rates of airflow obstruction on spirometry is consistent with previous research, Dr. Narendra told this news organization.
“Interestingly, in questions about specific symptoms, undiagnosed COPD patients reported higher rates of dyspnea, more cough, and breathing difficulties affecting their daily activities, at 16.1%, 27.4%, and 24.5%, respectively, highlighting a lower perception of symptoms,” she said.
“Barriers to lung cancer screening in urban, high-risk communities include limited healthcare facility access, insufficient awareness of screening programs, financial constraints, and cultural or language barriers,” said Dr. Narendra.
Potential strategies to overcome these barriers include improving access through additional screening centers and providing transportation, implementing community-based education and outreach programs to increase awareness about the benefits of lung cancer screening and early COPD detection, and providing financial assistance in the form of free screening options and collaboration with insurers to cover screening expenses, she said.
“Healthcare providers must recognize the dual benefits of lung cancer screening programs, including the opportunity to screen for undiagnosed COPD,” Dr. Narendra emphasized. “This integrated approach is crucial in identifying high-risk individuals who could benefit from early intervention and effective management of COPD. Clinicians should actively support implementing comprehensive screening programs incorporating assessments for pulmonary comorbidities through LDCT and screening questionnaires for COPD symptoms,” she said.
“Further research is needed to evaluate long-term mortality outcomes and identify best practices to determine the most effective methods and cost-effectiveness for implementing and sustaining combined screening programs in various urban settings,” Dr. Narendra told this news organization.
Other areas to address in future studies include investigating specific barriers to screening among different high-risk groups and tailoring interventions to improve screening uptake and adherence, Narendra said. “By addressing these research gaps, health care providers can optimize screening programs and enhance the overall health of urban, high-risk populations,” she added.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Narendra serves on the editorial board of CHEST Physician.
A version of this article first appeared on Medscape.com.
Lung cancer screening with low-dose CT (LDCT) can effectively evaluate a high-risk population for undiagnosed chronic obstructive pulmonary disease (COPD) and airflow obstruction, based on data from a new study of approximately 2000 individuals.
Previous research suggests that approximately 70%-90% of individuals with COPD are undiagnosed, especially low-income and minority populations who may be less likely to undergo screening, said Michaela A. Seigo, DO, of Temple University Hospital, Philadelphia, in a study presented at the American Thoracic Society (ATS) 2024 International Conference.
The researchers reviewed data from 2083 adults enrolled in the Temple Healthy Chest Initiative, an urban health system-wide lung cancer screening program, combined with the detection of symptoms and comorbidities.
Baseline LDCT for Identification of Comorbidities
Study participants underwent baseline LDCT between October 2021 and October 2022. The images were reviewed by radiologists for pulmonary comorbidities including emphysema, airway disease, bronchiectasis, and interstitial lung disease. In addition, 604 participants (29%) completed a symptom survey, and 624 (30%) underwent spirometry. The mean age of the participants was 65.8 years and 63.9 years for those with and without a history of COPD, respectively.
Approximately half of the participants in both groups were female.
Overall, 66 of 181 (36.5%) individuals previously undiagnosed with COPD had spirometry consistent with airflow obstruction (forced expiratory volume in 1 second/forced vital capacity, < 70%). Individuals with previously undiagnosed COPD were more likely to be younger, male, current smokers, and identified as Hispanic or other race (not Black, White, Hispanic, or Asian/Native American/Pacific Islander).
Individuals without a reported history of COPD had fewer pulmonary comorbidities on LDCT and lower rates of respiratory symptoms than those with COPD. However, nearly 25% of individuals with no reported history of COPD said that breathing issues affected their “ability to do things,” Ms. Seigo said, and a majority of those with no COPD diagnosis exhibited airway disease (76.2% compared with 84% of diagnosed patients with COPD). In addition, 88.1% reported ever experiencing dyspnea and 72.6% reported experiencing cough; both symptoms are compatible with a clinical diagnosis of COPD, the researchers noted.
“We detected pulmonary comorbidities at higher rates than previously published,” Ms. Seigo said in an interview. The increase likely reflects the patient population at Temple, which includes a relatively high percentage of city-dwelling, lower-income individuals, as well as more racial-ethnic minorities and persons of color, she said.
However, “these findings will help clinicians target the most at-risk populations for previously undiagnosed COPD,” Ms. Seigo said.
Looking ahead, Ms. Seigo said she sees a dominant role for artificial intelligence (AI) in COPD screening. “At-risk populations will get LDCT scans, and AI will identify pulmonary and extra-pulmonary comorbidities that may need to be addressed,” she said.
A combination of symptom detection plus strategic and more widely available access to screening offers “a huge opportunity to intervene earlier and potentially save lives,” she told this news organization.
Lung Cancer Screening May Promote Earlier COPD Intervention
The current study examines the prevalence of undiagnosed COPD, especially among low-income and minority populations, in an asymptomatic high-risk group. “By integrating lung cancer CT screening with the detection of pulmonary comorbidities on LDCT and respiratory symptoms, the current study aimed to identify individuals with undiagnosed COPD,” said Dharani K. Narendra, MD, of Baylor College of Medicine, Houston, in an interview.
“The study highlighted the feasibility and potential benefits of coupling lung cancer screening tests with COPD detection, which is noteworthy, and hits two targets with one arrow — early detection of lung cancer and COPD — in high-risk groups, Dr. Narendra said.
“Although the USPSTF recommends against screening for COPD in asymptomatic patients, abnormal pulmonary comorbidities observed on CT chest scans could serve as a gateway for clinicians to screen for COPD,” said Dr. Narendra. “This approach allows for early diagnosis, education on smoking cessation, and timely treatment of COPD, potentially preventing lung function deterioration and reducing the risk of exacerbations,” she noted.
The finding that one third of previously undiagnosed and asymptomatic patients with COPD showed significant rates of airflow obstruction on spirometry is consistent with previous research, Dr. Narendra told this news organization.
“Interestingly, in questions about specific symptoms, undiagnosed COPD patients reported higher rates of dyspnea, more cough, and breathing difficulties affecting their daily activities, at 16.1%, 27.4%, and 24.5%, respectively, highlighting a lower perception of symptoms,” she said.
“Barriers to lung cancer screening in urban, high-risk communities include limited healthcare facility access, insufficient awareness of screening programs, financial constraints, and cultural or language barriers,” said Dr. Narendra.
Potential strategies to overcome these barriers include improving access through additional screening centers and providing transportation, implementing community-based education and outreach programs to increase awareness about the benefits of lung cancer screening and early COPD detection, and providing financial assistance in the form of free screening options and collaboration with insurers to cover screening expenses, she said.
“Healthcare providers must recognize the dual benefits of lung cancer screening programs, including the opportunity to screen for undiagnosed COPD,” Dr. Narendra emphasized. “This integrated approach is crucial in identifying high-risk individuals who could benefit from early intervention and effective management of COPD. Clinicians should actively support implementing comprehensive screening programs incorporating assessments for pulmonary comorbidities through LDCT and screening questionnaires for COPD symptoms,” she said.
“Further research is needed to evaluate long-term mortality outcomes and identify best practices to determine the most effective methods and cost-effectiveness for implementing and sustaining combined screening programs in various urban settings,” Dr. Narendra told this news organization.
Other areas to address in future studies include investigating specific barriers to screening among different high-risk groups and tailoring interventions to improve screening uptake and adherence, Narendra said. “By addressing these research gaps, health care providers can optimize screening programs and enhance the overall health of urban, high-risk populations,” she added.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Narendra serves on the editorial board of CHEST Physician.
A version of this article first appeared on Medscape.com.
Research Highlights From ESMO Breast Cancer
Among the topics the speakers addressed were breast cancer prevention, early breast cancer, advanced breast cancer, and supportive care.
In recent years, the way clinicians look at carcinogenesis in breast cancer has changed, and many new targets for potential early detection and prevention have emerged, said Suzette Delaloge, MD, of Gustave Roussy, Paris, France, in her presentation at the meeting.
Instant risk assessment at different time points could potentially intercept cancer among high-risk individuals, she said.
A study by Mikael Eriksson, PhD, and colleagues focused on external validation of the Profound AI tool to identify breast cancer risk in the general population. The researchers showed an area under the curve of 0.72 in their AI risk model, which has the potential to be clinically meaningful, although it must be prospectively validated, Dr. Delaloge said in her presentation.
She also reviewed two studies on the use of genes to further refine breast cancer risk among carriers. One of these, a prospective study presented in a session by Kelly-Anne Phillips, MD, of Peter MacCallum Cancer Center, Melbourne, Australia, used the CANRISK online risk assessment tool and validated increased breast cancer risk in BRCA1 and BRCA2 carriers, with AUCs of 0.79 and 0.78, respectively. The other study, which was by Maria Rezqallah Aron, MD, and colleagues examined polygenic scores as a way to refine breast cancer risk stratification among carriers of the ALM and PALB2 genes as well. These genes might be useful in identifying individuals who could benefit from early intervention, including surgery, Dr. Delaloge said.
Translational Research
“Preparing my talk, I felt like a kid in a candy store,” because of the amount of new translational research presented, including several studies of endocrine treatment–based approaches to therapy, said Marleen Kok, MD, of the Netherlands Cancer Institute, Amsterdam.
In her presentation, Dr. Kok highlighted findings from an analysis of patients in the monarchE study (a trial of high-risk patients) showing a consistent improvement in invasive disease-free survival for the subset of patients with germline BRCA1 and BRCA2 mutations who received abemaciclib plus endocrine therapy.
The value of tumor-infiltrating lymphocytes (TILs) on patients who are not receiving chemotherapy is important because of the focus on prognosis, and prospective trials are underway, she said.
A poster on the impact of chemotherapy and stromal tumor-infiltrating lymphocytes (sTILs) in stage I triple-negative breast cancer showed no association between chemotherapy and better outcomes regardless of sTILs in patients who did and did not receive chemotherapy, which has implications for potential treatment sparing in this population, Dr. Kok noted.
Artificial Intelligence (AI) was the subject of several posters at the meeting, and Dr. Kok identified a multisite European study of an automated HER2 scoring system as notable for its size and accuracy. In the study, the accuracy among pathologists was much higher with the assistance of AI, she said. Using AI for more complex analysis has shown success, she said.
Dr. Kok ended her talk with a poster that surveyed breast cancer patients about their understanding of their disease. The results showed that less than half (44%) of patients reported that their healthcare providers had given them enough information to learn about their breast cancer type, and less than one third could recall terminology about biomarkers; the study is important because it shows that clinicians need to do better in explaining these terms to patients, Dr. Kok said.
Early Breast Cancer
Right-sizing therapy, meaning identifying the right treatment for every patient, is a key element of new research in early breast cancer, said Erika Hamilton, MD, of the Sarah Cannon Research Institute, Nashville, Tenn.
She highlighted safety and treatment duration updates from the NATALEE study, which compared adjuvant ribociclib plus nonsteroidal aromatase inhibitor (NSAI) to NSAI alone for ER+/HER2- breast cancer. The current analysis presented at the meeting showed significant benefits with the addition of ribociclib and no evidence of new safety signals or adverse event exacerbations at 3 years, she said. Dose modifications had no significant impact on efficacy, she added.
The findings of no impact of dose reduction on efficacy in both the NATALEE and monarchE studies provide important information on whether dosage can be reduced in patients, which will increase the odds that patients will tolerate extended therapy with good outcomes and stay on their prescribed therapies, Dr. Hamilton emphasized.
The CARABELA study, a phase 2 trial of neoadjuvant letrozole plus abemaciclib vs adriamycin and cyclophosphamide (AC), showed clinically similar response rates but did not meet its endpoint for residual cancer burden (RCB) scores. These data add to results from other studies and show that it is too soon to universally replace neoadjuvant chemotherapy as first-line treatment for highly proliferative ER+ breast cancer, Dr. Hamilton said in her presentation.
Advanced Breast Cancer
Take-home messages about advanced breast cancer include growing evidence for the potential benefits of antibody drug conjugates (ADCs), said Eva Ciruelos, MD, of University Hospital, Madrid, Spain. The TROPION-BREAST01 study, a phase 3 randomized trial, showed significant and clinically meaningful improvement in progression-free survival in patients with previously treated, inoperable, or metastatic HR+/HER2- breast cancer who received datopotamab deruxtecan (Dato-DXd) compared with those who received chemotherapy.
Data from an additional safety analysis were presented at the meeting; although Dato-DXd, a trophoblast cell-surface antigen 2 (TROP2)–directed antibody-drug conjugate, was well-tolerated, it is important to remain aware of toxicities, notably oral mucositis, which occurred in 55.6% of the patients in the study across all grades, and ocular surface toxicity, which occurred in 40% of patients across all grades, Dr. Ciruelos emphasized.
Key research in the area of advanced triple-negative breast cancer included data from the IMPASSION 132 study. This study is “specifically centered on early relapsers,” a population often excluded from other trials, Dr. Ciruelos said. In this study, patients with advanced triple-negative breast cancer were randomized to chemotherapy with or without atezolizumab, and the study showed no benefits with atezolizumab for overall survival, progression-free survival, or overall response rate, she said. “This is something to work with, because this is a very refractory population,” Dr. Ciruelos noted.
New immunotherapy combinations are needed to improve survival in advanced breast cancer patients, Dr. Ciruelos said. At the meeting, researchers presented interim data from a subset of patients in the MORPHEUS-pan breast cancer trial, a phase 1B/2 study involving multiple treatment combinations in locally advanced/metastatic breast cancer patients.
The interim analysis included 18-week data from triple-negative breast cancer patients and compared outcomes for patients randomized to atezolizumab with or without sacituzumab govitecan (SG).
The study was small, with only 31 patients in the combination arm and 11 controls, but the results were promising, with an overall response rate of 76.7% in the combination arm vs 66.7% in the control arm, Dr. Ciruelos said.
Supportive Care
Key supportive care takeaways included data on pregnancy in young breast cancer survivors and the safety of vaginal estrogen therapy in breast cancer patients with genitourinary symptoms, said Anne May, MD, of the University Medical Center Utrecht, Utrecht, Netherlands.
A study previously published in JAMA including nearly 5000 BRCA carriers who were diagnosed with invasive breast cancer at age 40 years or younger showed no association between pregnancy after breast cancer and adverse maternal or fetal outcomes, and pregnancy had no significant impact on overall survival. The authors presented new data on the safety of assisted reproductive techniques (ART) based on the 543 pregnancies in the original study, at the meeting. Of these, 436 conceived naturally, and 107 used ART. After a median of 9.1 years, ART had no effect on disease-free survival compared to natural conception (hazard ratio [HR], 0.64). Based on these findings, fertility preservation should be offered to all women who receive a breast cancer diagnosis and are interested in future fertility, Dr. May said.
Conceiving after breast cancer treatment and follow-up should not be contraindicated for young BRCA carriers, she added.No trial data are available for the effects of vaginal estrogen therapy (VET) on disease-free survival in breast cancer survivors with genitourinary symptoms caused by declining estrogen levels, Dr. May said. However, researchers in France and Switzerland conducted an emulation of a hypothetical target trial using data from the French National social security system for more than 130,000 individuals. Although VET therapy had no impact on disease-free survival in most breast cancer survivors overall, it did have a negative impact in a subset of patients with HR-positive and HR-negative tumors who were treated with aromatase inhibitors. The study was hypothetical, but important because the results suggest that clinicians can safely propose VTE to patients who report genitourinary symptoms after treatment for early-stage breast cancer with tamoxifen, but VTE should be avoided in patients treated with aromatase inhibitors, Dr. May said.
Dr. Delaloge disclosed research support to her institution from AstraZeneca, MSD, Bristol Myers Squibb, Sanofi, Taiho, Novartis, European Commission, INCa, Banque des Territoires, and Fondation Philanthropia. She also disclosed honoraria to her institution from AstraZeneca, Gilead, Novartis, Elsan, Besins, Sanofi, Exact Sciences, and Lilly, as well as travel support from Novartis.
Dr. Kok disclosed research funding from AstraZeneca, Bristol Myers Squibb, Daichi, and Roche, and advisory board membership/speaker’s fees from Alderaan Biotechnology, BIONTECH, Domain Therapeutics, AstraZeneca, Daichi, Bristol Myers Squibb, Gilead, Medscape, MSD, and Roche.
Dr. Hamilton disclosed a consulting advisory role (to her institution) for Accutar Biotechology, AstraZeneca, Daiichi Sankyo, Ellipses Pharma, Entos, Forsum Pharma, Gilead Sciences, Greenwich LifeSciences, Jazz Pharmaceuticals, Lilly, Medical Pharma Services, Mersana, Novartis, Olema Pharmaceuticals, Orum Therapeutics, Roche/Genentech, Stemline Therapeutics, ands others. She also disclosed contracted research/grant support to her institution only from Abbvie, Acerta Pharma, Accutar Biotechnology , ADC Therapeutics, AKESOBIO Australia , Amgen, Aravive, ArQule, Artios, Arvinas, AstraZeneca, AtlasMedx, BeiGene, Black Diamond and others.
Dr. Ciruelos disclosed serving as an external advisor for Roche, MSD, Gilead, AstraZeneca, Daichii Sankyo, Reveal Genomics, Pfizer, Novartis, and Lilly, as well as serving as a speaker for Roche, MSD, Gilead, AstraZeneca, Daichii Sankyo, Reveal Genomics, Pfizer, Novartis, Lilly, and Pierre Fabre. She also disclosed travel grants from Roche, Pfizer, and AstraZeneca, and research grants from Seagen and Roche.
Dr. May had no financial conflicts to disclose.
Among the topics the speakers addressed were breast cancer prevention, early breast cancer, advanced breast cancer, and supportive care.
In recent years, the way clinicians look at carcinogenesis in breast cancer has changed, and many new targets for potential early detection and prevention have emerged, said Suzette Delaloge, MD, of Gustave Roussy, Paris, France, in her presentation at the meeting.
Instant risk assessment at different time points could potentially intercept cancer among high-risk individuals, she said.
A study by Mikael Eriksson, PhD, and colleagues focused on external validation of the Profound AI tool to identify breast cancer risk in the general population. The researchers showed an area under the curve of 0.72 in their AI risk model, which has the potential to be clinically meaningful, although it must be prospectively validated, Dr. Delaloge said in her presentation.
She also reviewed two studies on the use of genes to further refine breast cancer risk among carriers. One of these, a prospective study presented in a session by Kelly-Anne Phillips, MD, of Peter MacCallum Cancer Center, Melbourne, Australia, used the CANRISK online risk assessment tool and validated increased breast cancer risk in BRCA1 and BRCA2 carriers, with AUCs of 0.79 and 0.78, respectively. The other study, which was by Maria Rezqallah Aron, MD, and colleagues examined polygenic scores as a way to refine breast cancer risk stratification among carriers of the ALM and PALB2 genes as well. These genes might be useful in identifying individuals who could benefit from early intervention, including surgery, Dr. Delaloge said.
Translational Research
“Preparing my talk, I felt like a kid in a candy store,” because of the amount of new translational research presented, including several studies of endocrine treatment–based approaches to therapy, said Marleen Kok, MD, of the Netherlands Cancer Institute, Amsterdam.
In her presentation, Dr. Kok highlighted findings from an analysis of patients in the monarchE study (a trial of high-risk patients) showing a consistent improvement in invasive disease-free survival for the subset of patients with germline BRCA1 and BRCA2 mutations who received abemaciclib plus endocrine therapy.
The value of tumor-infiltrating lymphocytes (TILs) on patients who are not receiving chemotherapy is important because of the focus on prognosis, and prospective trials are underway, she said.
A poster on the impact of chemotherapy and stromal tumor-infiltrating lymphocytes (sTILs) in stage I triple-negative breast cancer showed no association between chemotherapy and better outcomes regardless of sTILs in patients who did and did not receive chemotherapy, which has implications for potential treatment sparing in this population, Dr. Kok noted.
Artificial Intelligence (AI) was the subject of several posters at the meeting, and Dr. Kok identified a multisite European study of an automated HER2 scoring system as notable for its size and accuracy. In the study, the accuracy among pathologists was much higher with the assistance of AI, she said. Using AI for more complex analysis has shown success, she said.
Dr. Kok ended her talk with a poster that surveyed breast cancer patients about their understanding of their disease. The results showed that less than half (44%) of patients reported that their healthcare providers had given them enough information to learn about their breast cancer type, and less than one third could recall terminology about biomarkers; the study is important because it shows that clinicians need to do better in explaining these terms to patients, Dr. Kok said.
Early Breast Cancer
Right-sizing therapy, meaning identifying the right treatment for every patient, is a key element of new research in early breast cancer, said Erika Hamilton, MD, of the Sarah Cannon Research Institute, Nashville, Tenn.
She highlighted safety and treatment duration updates from the NATALEE study, which compared adjuvant ribociclib plus nonsteroidal aromatase inhibitor (NSAI) to NSAI alone for ER+/HER2- breast cancer. The current analysis presented at the meeting showed significant benefits with the addition of ribociclib and no evidence of new safety signals or adverse event exacerbations at 3 years, she said. Dose modifications had no significant impact on efficacy, she added.
The findings of no impact of dose reduction on efficacy in both the NATALEE and monarchE studies provide important information on whether dosage can be reduced in patients, which will increase the odds that patients will tolerate extended therapy with good outcomes and stay on their prescribed therapies, Dr. Hamilton emphasized.
The CARABELA study, a phase 2 trial of neoadjuvant letrozole plus abemaciclib vs adriamycin and cyclophosphamide (AC), showed clinically similar response rates but did not meet its endpoint for residual cancer burden (RCB) scores. These data add to results from other studies and show that it is too soon to universally replace neoadjuvant chemotherapy as first-line treatment for highly proliferative ER+ breast cancer, Dr. Hamilton said in her presentation.
Advanced Breast Cancer
Take-home messages about advanced breast cancer include growing evidence for the potential benefits of antibody drug conjugates (ADCs), said Eva Ciruelos, MD, of University Hospital, Madrid, Spain. The TROPION-BREAST01 study, a phase 3 randomized trial, showed significant and clinically meaningful improvement in progression-free survival in patients with previously treated, inoperable, or metastatic HR+/HER2- breast cancer who received datopotamab deruxtecan (Dato-DXd) compared with those who received chemotherapy.
Data from an additional safety analysis were presented at the meeting; although Dato-DXd, a trophoblast cell-surface antigen 2 (TROP2)–directed antibody-drug conjugate, was well-tolerated, it is important to remain aware of toxicities, notably oral mucositis, which occurred in 55.6% of the patients in the study across all grades, and ocular surface toxicity, which occurred in 40% of patients across all grades, Dr. Ciruelos emphasized.
Key research in the area of advanced triple-negative breast cancer included data from the IMPASSION 132 study. This study is “specifically centered on early relapsers,” a population often excluded from other trials, Dr. Ciruelos said. In this study, patients with advanced triple-negative breast cancer were randomized to chemotherapy with or without atezolizumab, and the study showed no benefits with atezolizumab for overall survival, progression-free survival, or overall response rate, she said. “This is something to work with, because this is a very refractory population,” Dr. Ciruelos noted.
New immunotherapy combinations are needed to improve survival in advanced breast cancer patients, Dr. Ciruelos said. At the meeting, researchers presented interim data from a subset of patients in the MORPHEUS-pan breast cancer trial, a phase 1B/2 study involving multiple treatment combinations in locally advanced/metastatic breast cancer patients.
The interim analysis included 18-week data from triple-negative breast cancer patients and compared outcomes for patients randomized to atezolizumab with or without sacituzumab govitecan (SG).
The study was small, with only 31 patients in the combination arm and 11 controls, but the results were promising, with an overall response rate of 76.7% in the combination arm vs 66.7% in the control arm, Dr. Ciruelos said.
Supportive Care
Key supportive care takeaways included data on pregnancy in young breast cancer survivors and the safety of vaginal estrogen therapy in breast cancer patients with genitourinary symptoms, said Anne May, MD, of the University Medical Center Utrecht, Utrecht, Netherlands.
A study previously published in JAMA including nearly 5000 BRCA carriers who were diagnosed with invasive breast cancer at age 40 years or younger showed no association between pregnancy after breast cancer and adverse maternal or fetal outcomes, and pregnancy had no significant impact on overall survival. The authors presented new data on the safety of assisted reproductive techniques (ART) based on the 543 pregnancies in the original study, at the meeting. Of these, 436 conceived naturally, and 107 used ART. After a median of 9.1 years, ART had no effect on disease-free survival compared to natural conception (hazard ratio [HR], 0.64). Based on these findings, fertility preservation should be offered to all women who receive a breast cancer diagnosis and are interested in future fertility, Dr. May said.
Conceiving after breast cancer treatment and follow-up should not be contraindicated for young BRCA carriers, she added.No trial data are available for the effects of vaginal estrogen therapy (VET) on disease-free survival in breast cancer survivors with genitourinary symptoms caused by declining estrogen levels, Dr. May said. However, researchers in France and Switzerland conducted an emulation of a hypothetical target trial using data from the French National social security system for more than 130,000 individuals. Although VET therapy had no impact on disease-free survival in most breast cancer survivors overall, it did have a negative impact in a subset of patients with HR-positive and HR-negative tumors who were treated with aromatase inhibitors. The study was hypothetical, but important because the results suggest that clinicians can safely propose VTE to patients who report genitourinary symptoms after treatment for early-stage breast cancer with tamoxifen, but VTE should be avoided in patients treated with aromatase inhibitors, Dr. May said.
Dr. Delaloge disclosed research support to her institution from AstraZeneca, MSD, Bristol Myers Squibb, Sanofi, Taiho, Novartis, European Commission, INCa, Banque des Territoires, and Fondation Philanthropia. She also disclosed honoraria to her institution from AstraZeneca, Gilead, Novartis, Elsan, Besins, Sanofi, Exact Sciences, and Lilly, as well as travel support from Novartis.
Dr. Kok disclosed research funding from AstraZeneca, Bristol Myers Squibb, Daichi, and Roche, and advisory board membership/speaker’s fees from Alderaan Biotechnology, BIONTECH, Domain Therapeutics, AstraZeneca, Daichi, Bristol Myers Squibb, Gilead, Medscape, MSD, and Roche.
Dr. Hamilton disclosed a consulting advisory role (to her institution) for Accutar Biotechology, AstraZeneca, Daiichi Sankyo, Ellipses Pharma, Entos, Forsum Pharma, Gilead Sciences, Greenwich LifeSciences, Jazz Pharmaceuticals, Lilly, Medical Pharma Services, Mersana, Novartis, Olema Pharmaceuticals, Orum Therapeutics, Roche/Genentech, Stemline Therapeutics, ands others. She also disclosed contracted research/grant support to her institution only from Abbvie, Acerta Pharma, Accutar Biotechnology , ADC Therapeutics, AKESOBIO Australia , Amgen, Aravive, ArQule, Artios, Arvinas, AstraZeneca, AtlasMedx, BeiGene, Black Diamond and others.
Dr. Ciruelos disclosed serving as an external advisor for Roche, MSD, Gilead, AstraZeneca, Daichii Sankyo, Reveal Genomics, Pfizer, Novartis, and Lilly, as well as serving as a speaker for Roche, MSD, Gilead, AstraZeneca, Daichii Sankyo, Reveal Genomics, Pfizer, Novartis, Lilly, and Pierre Fabre. She also disclosed travel grants from Roche, Pfizer, and AstraZeneca, and research grants from Seagen and Roche.
Dr. May had no financial conflicts to disclose.
Among the topics the speakers addressed were breast cancer prevention, early breast cancer, advanced breast cancer, and supportive care.
In recent years, the way clinicians look at carcinogenesis in breast cancer has changed, and many new targets for potential early detection and prevention have emerged, said Suzette Delaloge, MD, of Gustave Roussy, Paris, France, in her presentation at the meeting.
Instant risk assessment at different time points could potentially intercept cancer among high-risk individuals, she said.
A study by Mikael Eriksson, PhD, and colleagues focused on external validation of the Profound AI tool to identify breast cancer risk in the general population. The researchers showed an area under the curve of 0.72 in their AI risk model, which has the potential to be clinically meaningful, although it must be prospectively validated, Dr. Delaloge said in her presentation.
She also reviewed two studies on the use of genes to further refine breast cancer risk among carriers. One of these, a prospective study presented in a session by Kelly-Anne Phillips, MD, of Peter MacCallum Cancer Center, Melbourne, Australia, used the CANRISK online risk assessment tool and validated increased breast cancer risk in BRCA1 and BRCA2 carriers, with AUCs of 0.79 and 0.78, respectively. The other study, which was by Maria Rezqallah Aron, MD, and colleagues examined polygenic scores as a way to refine breast cancer risk stratification among carriers of the ALM and PALB2 genes as well. These genes might be useful in identifying individuals who could benefit from early intervention, including surgery, Dr. Delaloge said.
Translational Research
“Preparing my talk, I felt like a kid in a candy store,” because of the amount of new translational research presented, including several studies of endocrine treatment–based approaches to therapy, said Marleen Kok, MD, of the Netherlands Cancer Institute, Amsterdam.
In her presentation, Dr. Kok highlighted findings from an analysis of patients in the monarchE study (a trial of high-risk patients) showing a consistent improvement in invasive disease-free survival for the subset of patients with germline BRCA1 and BRCA2 mutations who received abemaciclib plus endocrine therapy.
The value of tumor-infiltrating lymphocytes (TILs) on patients who are not receiving chemotherapy is important because of the focus on prognosis, and prospective trials are underway, she said.
A poster on the impact of chemotherapy and stromal tumor-infiltrating lymphocytes (sTILs) in stage I triple-negative breast cancer showed no association between chemotherapy and better outcomes regardless of sTILs in patients who did and did not receive chemotherapy, which has implications for potential treatment sparing in this population, Dr. Kok noted.
Artificial Intelligence (AI) was the subject of several posters at the meeting, and Dr. Kok identified a multisite European study of an automated HER2 scoring system as notable for its size and accuracy. In the study, the accuracy among pathologists was much higher with the assistance of AI, she said. Using AI for more complex analysis has shown success, she said.
Dr. Kok ended her talk with a poster that surveyed breast cancer patients about their understanding of their disease. The results showed that less than half (44%) of patients reported that their healthcare providers had given them enough information to learn about their breast cancer type, and less than one third could recall terminology about biomarkers; the study is important because it shows that clinicians need to do better in explaining these terms to patients, Dr. Kok said.
Early Breast Cancer
Right-sizing therapy, meaning identifying the right treatment for every patient, is a key element of new research in early breast cancer, said Erika Hamilton, MD, of the Sarah Cannon Research Institute, Nashville, Tenn.
She highlighted safety and treatment duration updates from the NATALEE study, which compared adjuvant ribociclib plus nonsteroidal aromatase inhibitor (NSAI) to NSAI alone for ER+/HER2- breast cancer. The current analysis presented at the meeting showed significant benefits with the addition of ribociclib and no evidence of new safety signals or adverse event exacerbations at 3 years, she said. Dose modifications had no significant impact on efficacy, she added.
The findings of no impact of dose reduction on efficacy in both the NATALEE and monarchE studies provide important information on whether dosage can be reduced in patients, which will increase the odds that patients will tolerate extended therapy with good outcomes and stay on their prescribed therapies, Dr. Hamilton emphasized.
The CARABELA study, a phase 2 trial of neoadjuvant letrozole plus abemaciclib vs adriamycin and cyclophosphamide (AC), showed clinically similar response rates but did not meet its endpoint for residual cancer burden (RCB) scores. These data add to results from other studies and show that it is too soon to universally replace neoadjuvant chemotherapy as first-line treatment for highly proliferative ER+ breast cancer, Dr. Hamilton said in her presentation.
Advanced Breast Cancer
Take-home messages about advanced breast cancer include growing evidence for the potential benefits of antibody drug conjugates (ADCs), said Eva Ciruelos, MD, of University Hospital, Madrid, Spain. The TROPION-BREAST01 study, a phase 3 randomized trial, showed significant and clinically meaningful improvement in progression-free survival in patients with previously treated, inoperable, or metastatic HR+/HER2- breast cancer who received datopotamab deruxtecan (Dato-DXd) compared with those who received chemotherapy.
Data from an additional safety analysis were presented at the meeting; although Dato-DXd, a trophoblast cell-surface antigen 2 (TROP2)–directed antibody-drug conjugate, was well-tolerated, it is important to remain aware of toxicities, notably oral mucositis, which occurred in 55.6% of the patients in the study across all grades, and ocular surface toxicity, which occurred in 40% of patients across all grades, Dr. Ciruelos emphasized.
Key research in the area of advanced triple-negative breast cancer included data from the IMPASSION 132 study. This study is “specifically centered on early relapsers,” a population often excluded from other trials, Dr. Ciruelos said. In this study, patients with advanced triple-negative breast cancer were randomized to chemotherapy with or without atezolizumab, and the study showed no benefits with atezolizumab for overall survival, progression-free survival, or overall response rate, she said. “This is something to work with, because this is a very refractory population,” Dr. Ciruelos noted.
New immunotherapy combinations are needed to improve survival in advanced breast cancer patients, Dr. Ciruelos said. At the meeting, researchers presented interim data from a subset of patients in the MORPHEUS-pan breast cancer trial, a phase 1B/2 study involving multiple treatment combinations in locally advanced/metastatic breast cancer patients.
The interim analysis included 18-week data from triple-negative breast cancer patients and compared outcomes for patients randomized to atezolizumab with or without sacituzumab govitecan (SG).
The study was small, with only 31 patients in the combination arm and 11 controls, but the results were promising, with an overall response rate of 76.7% in the combination arm vs 66.7% in the control arm, Dr. Ciruelos said.
Supportive Care
Key supportive care takeaways included data on pregnancy in young breast cancer survivors and the safety of vaginal estrogen therapy in breast cancer patients with genitourinary symptoms, said Anne May, MD, of the University Medical Center Utrecht, Utrecht, Netherlands.
A study previously published in JAMA including nearly 5000 BRCA carriers who were diagnosed with invasive breast cancer at age 40 years or younger showed no association between pregnancy after breast cancer and adverse maternal or fetal outcomes, and pregnancy had no significant impact on overall survival. The authors presented new data on the safety of assisted reproductive techniques (ART) based on the 543 pregnancies in the original study, at the meeting. Of these, 436 conceived naturally, and 107 used ART. After a median of 9.1 years, ART had no effect on disease-free survival compared to natural conception (hazard ratio [HR], 0.64). Based on these findings, fertility preservation should be offered to all women who receive a breast cancer diagnosis and are interested in future fertility, Dr. May said.
Conceiving after breast cancer treatment and follow-up should not be contraindicated for young BRCA carriers, she added.No trial data are available for the effects of vaginal estrogen therapy (VET) on disease-free survival in breast cancer survivors with genitourinary symptoms caused by declining estrogen levels, Dr. May said. However, researchers in France and Switzerland conducted an emulation of a hypothetical target trial using data from the French National social security system for more than 130,000 individuals. Although VET therapy had no impact on disease-free survival in most breast cancer survivors overall, it did have a negative impact in a subset of patients with HR-positive and HR-negative tumors who were treated with aromatase inhibitors. The study was hypothetical, but important because the results suggest that clinicians can safely propose VTE to patients who report genitourinary symptoms after treatment for early-stage breast cancer with tamoxifen, but VTE should be avoided in patients treated with aromatase inhibitors, Dr. May said.
Dr. Delaloge disclosed research support to her institution from AstraZeneca, MSD, Bristol Myers Squibb, Sanofi, Taiho, Novartis, European Commission, INCa, Banque des Territoires, and Fondation Philanthropia. She also disclosed honoraria to her institution from AstraZeneca, Gilead, Novartis, Elsan, Besins, Sanofi, Exact Sciences, and Lilly, as well as travel support from Novartis.
Dr. Kok disclosed research funding from AstraZeneca, Bristol Myers Squibb, Daichi, and Roche, and advisory board membership/speaker’s fees from Alderaan Biotechnology, BIONTECH, Domain Therapeutics, AstraZeneca, Daichi, Bristol Myers Squibb, Gilead, Medscape, MSD, and Roche.
Dr. Hamilton disclosed a consulting advisory role (to her institution) for Accutar Biotechology, AstraZeneca, Daiichi Sankyo, Ellipses Pharma, Entos, Forsum Pharma, Gilead Sciences, Greenwich LifeSciences, Jazz Pharmaceuticals, Lilly, Medical Pharma Services, Mersana, Novartis, Olema Pharmaceuticals, Orum Therapeutics, Roche/Genentech, Stemline Therapeutics, ands others. She also disclosed contracted research/grant support to her institution only from Abbvie, Acerta Pharma, Accutar Biotechnology , ADC Therapeutics, AKESOBIO Australia , Amgen, Aravive, ArQule, Artios, Arvinas, AstraZeneca, AtlasMedx, BeiGene, Black Diamond and others.
Dr. Ciruelos disclosed serving as an external advisor for Roche, MSD, Gilead, AstraZeneca, Daichii Sankyo, Reveal Genomics, Pfizer, Novartis, and Lilly, as well as serving as a speaker for Roche, MSD, Gilead, AstraZeneca, Daichii Sankyo, Reveal Genomics, Pfizer, Novartis, Lilly, and Pierre Fabre. She also disclosed travel grants from Roche, Pfizer, and AstraZeneca, and research grants from Seagen and Roche.
Dr. May had no financial conflicts to disclose.
FROM ESMO BREAST CANCER 2024
Statin Use May Extend Life for Early Breast Cancer Patients
Previous research examining the association between cholesterol and breast cancer metabolism suggests that cholesterol-lowering medications such as statins may improve outcomes in breast cancer patients, Sixten Harborg, a medical student and PhD student at Aarhus University, Denmark, said in a presentation at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress.
In addition, cardiovascular-related death is the second most common cause of death for breast cancer survivors, and given the survival rates in early breast cancer, there is a demand for cardioprotective initiatives and maintenance of cardioprotective drugs after diagnosis, he said in an interview.
What Is Known About Statins and Breast Cancer?
Statins are the most common drugs used to lower cholesterol and may deprive tumor cells of the cholesterol needed for cell membrane synthesis, Mr. Harborg said in his presentation.
Data from a randomized trial published in the Journal of Clinical Oncology in 2017 showed significantly improved disease-free survival, breast cancer–free interval, and distant recurrence–free interval in early stage breast cancer patients randomized to cholesterol-lowering medication vs. those who did not receive cholesterol-lowering medication.
The 2017 study prompted the creation of the MASTER study, a randomized, multicenter, double-blind, placebo-controlled trial comparing standard adjuvant therapy plus placebo to standard adjuvant therapy plus atorvastatin in patients with early breast cancer (NCT04601116), Mr. Harborg said. The MASTER trial is currently recruiting patients in Denmark.
How Was the Current Study Designed?
To provide preliminary analysis, Mr. Harborg and colleagues used an emulation trial design based on electronic health care data from 110,160 females with a diagnosis of stage I, II, or III breast cancer who were part of the Danish Breast Cancer Group, a national clinical registry in Denmark, between 2000 and 2020.
As defined in the European Journal of Epidemiology in 2017, target trial emulation involves application of randomized trial designs to observational data with the goal of improving the quality of observational epidemiology when a comparator trial is not yet available.
The researchers created a cohort of patients based on electronic health care data to simulate a target trial of the use of atorvastatin after breast cancer diagnosis. Patients were randomized to one of two treatment strategies: starting to use statins within 36 months of diagnosis, or not using statins. The primary outcome was death from breast cancer. The follow-up for the MASTER study starts with inclusion and ends with death, emigration from Denmark, end of clinical follow-up, or 10 years of follow-up (whichever comes first); the follow-up was the same in the current study.
The researchers calculated hazard ratios (HR) of breast cancer mortality in statin users vs. non–statin users and used a technique known as inverse-probability of censoring-weighting (IPCW) to estimate the effects of statin use based on prognostic factors.
What Did the Results Show?
The results favored statin use for improved survival in early breast cancer patients, Mr. Harborg said. Overall, the hazard ratio for breast cancer mortality was 0.96 in statin users compared with non–statin users, and was similar in both a Cox regression analysis (HR 0.81), and in a 10-year landmark analysis (HR 0.86).
The difference in mortality between statin and non–statin users was even stronger in patients who were receiving adjuvant chemotherapy (HR 0.94, 0.64, and 0.76 on the IPCW, Cox, and landmark analyses, respectively).
The results were in line with previous reports of statins’ effect on breast cancer survival, Mr. Harborg said in an interview.
“We believe the results encourage the continuous effort of the currently enrolling MASTER trial,” he said.
The results also suggest that deprescribing statins at the time of breast cancer diagnosis is not recommended, and that statin treatment can safely be prescribed to breast cancer patients with increased cardiovascular disease risk and/or dyslipidemia, Mr. Harborg said in the interview.
What Is the Takeaway Message for Clinical Practice?
“The clinical takeaway from our study is that statin use is associated with reduced risk of dying from breast cancer, but that it is not possible to determine the true effect of statins on breast cancer survival without a randomized, placebo-controlled trial,” Mr. Harborg told this publication. “Statins are inexpensive and well-tolerated drugs and may have a beneficial effect in terms of survival for breast cancer patients. However, with the current level of evidence [because the MASTER study is ongoing], we still cannot recommend that oncologists prescribe statins to prevent mortality from breast cancer,” he said.
What Are the Next Steps for Research?
The findings were limited by the study design, and real-world data are needed, Dr. Harborg said. Other limitations include the presence of residual bias, and the use of data based on prescription codes, but these were not considered to have an effect on the main conclusion of the study, Mr. Harborg said in the interview.
However, the results suggest that the addition of statins may improve outcomes for early breast cancer patients, especially when used with chemotherapy, and support the value of the ongoing MASTER study, he concluded.
Ultimately, the MASTER study will provide a more definitive answer to the question of whether statins should be added to the adjuvant treatment regimen of breast cancer to improve breast cancer outcomes, he said.
What Do Clinicians Think of the Study?
The current study is timely and highlights the need for phase 3 trials to examine the potential of statin use for breast cancer outcomes, Malinda T. West, MD, a medical oncologist and breast oncologist at the University of Wisconsin Carbone Cancer Center, Madison, said in an interview.
Questions for future research include whether statins can be used in combination with adjuvant abemaciclib if indicated, or how to best sequence these agents, said Dr. West, who was not involved in the study. Other questions raised by the current study include whether other cholesterol-lowering agents have a potential adjuvant benefit in reducing breast cancer recurrent and/or mortality, and whether the addition of statins would benefit subgroups such as HER2+ and triple negative breast cancer, she said.
“I was not surprised to see another study reporting benefit with statins and reduced risk of breast cancer recurrence and/or mortality, but I think the larger question is defining the subgroups who benefit the most, and identifying predictors for benefit or resistance,” Dr. West said in an interview.
Previous studies have shown that cholesterol elevation, specifically LDL levels, can be linked to increased tumor growth in breast cancer, so the lower mortality risk associated with lipid-lowering therapies in the current study was consistent, Peyton L. Reves, MD, a hematology/oncology fellow, also at the University of Wisconsin, said in an interview. In practice, data from the current study and previous research could be especially useful for patients with elevated LDL levels, said Dr. Reves, who was not involved in the study.
“These results could impact clinical practice in many ways, including leading to routine cholesterol monitoring in breast cancer patients on adjuvant therapy as well as the addition of lipid-lowering therapy with statins in these patients,” Dr. Reves said.
The findings showing particular benefit for patients on adjuvant chemotherapy highlight the need for more research on this specific population and the effect of statins on overall breast cancer mortality, to explore the extent to which the results of the current study were driven by the benefit seen in patients receiving adjuvant chemotherapy, Dr. Reves said.
The study was supported by Director Michael Hermann Nielsen’s Memorial Grant, Manufacturer Einar Willumsen’s Memorial Grant, Astrid Thaysen’s Grant for Medical Basic Research, Eva and Henry Fraenkel’s Memorial Fund, and the Novo Nordisk Foundation.
The researchers had no financial conflicts to disclose. Dr. West and Dr. Reves had no financial conflicts to disclose.
Previous research examining the association between cholesterol and breast cancer metabolism suggests that cholesterol-lowering medications such as statins may improve outcomes in breast cancer patients, Sixten Harborg, a medical student and PhD student at Aarhus University, Denmark, said in a presentation at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress.
In addition, cardiovascular-related death is the second most common cause of death for breast cancer survivors, and given the survival rates in early breast cancer, there is a demand for cardioprotective initiatives and maintenance of cardioprotective drugs after diagnosis, he said in an interview.
What Is Known About Statins and Breast Cancer?
Statins are the most common drugs used to lower cholesterol and may deprive tumor cells of the cholesterol needed for cell membrane synthesis, Mr. Harborg said in his presentation.
Data from a randomized trial published in the Journal of Clinical Oncology in 2017 showed significantly improved disease-free survival, breast cancer–free interval, and distant recurrence–free interval in early stage breast cancer patients randomized to cholesterol-lowering medication vs. those who did not receive cholesterol-lowering medication.
The 2017 study prompted the creation of the MASTER study, a randomized, multicenter, double-blind, placebo-controlled trial comparing standard adjuvant therapy plus placebo to standard adjuvant therapy plus atorvastatin in patients with early breast cancer (NCT04601116), Mr. Harborg said. The MASTER trial is currently recruiting patients in Denmark.
How Was the Current Study Designed?
To provide preliminary analysis, Mr. Harborg and colleagues used an emulation trial design based on electronic health care data from 110,160 females with a diagnosis of stage I, II, or III breast cancer who were part of the Danish Breast Cancer Group, a national clinical registry in Denmark, between 2000 and 2020.
As defined in the European Journal of Epidemiology in 2017, target trial emulation involves application of randomized trial designs to observational data with the goal of improving the quality of observational epidemiology when a comparator trial is not yet available.
The researchers created a cohort of patients based on electronic health care data to simulate a target trial of the use of atorvastatin after breast cancer diagnosis. Patients were randomized to one of two treatment strategies: starting to use statins within 36 months of diagnosis, or not using statins. The primary outcome was death from breast cancer. The follow-up for the MASTER study starts with inclusion and ends with death, emigration from Denmark, end of clinical follow-up, or 10 years of follow-up (whichever comes first); the follow-up was the same in the current study.
The researchers calculated hazard ratios (HR) of breast cancer mortality in statin users vs. non–statin users and used a technique known as inverse-probability of censoring-weighting (IPCW) to estimate the effects of statin use based on prognostic factors.
What Did the Results Show?
The results favored statin use for improved survival in early breast cancer patients, Mr. Harborg said. Overall, the hazard ratio for breast cancer mortality was 0.96 in statin users compared with non–statin users, and was similar in both a Cox regression analysis (HR 0.81), and in a 10-year landmark analysis (HR 0.86).
The difference in mortality between statin and non–statin users was even stronger in patients who were receiving adjuvant chemotherapy (HR 0.94, 0.64, and 0.76 on the IPCW, Cox, and landmark analyses, respectively).
The results were in line with previous reports of statins’ effect on breast cancer survival, Mr. Harborg said in an interview.
“We believe the results encourage the continuous effort of the currently enrolling MASTER trial,” he said.
The results also suggest that deprescribing statins at the time of breast cancer diagnosis is not recommended, and that statin treatment can safely be prescribed to breast cancer patients with increased cardiovascular disease risk and/or dyslipidemia, Mr. Harborg said in the interview.
What Is the Takeaway Message for Clinical Practice?
“The clinical takeaway from our study is that statin use is associated with reduced risk of dying from breast cancer, but that it is not possible to determine the true effect of statins on breast cancer survival without a randomized, placebo-controlled trial,” Mr. Harborg told this publication. “Statins are inexpensive and well-tolerated drugs and may have a beneficial effect in terms of survival for breast cancer patients. However, with the current level of evidence [because the MASTER study is ongoing], we still cannot recommend that oncologists prescribe statins to prevent mortality from breast cancer,” he said.
What Are the Next Steps for Research?
The findings were limited by the study design, and real-world data are needed, Dr. Harborg said. Other limitations include the presence of residual bias, and the use of data based on prescription codes, but these were not considered to have an effect on the main conclusion of the study, Mr. Harborg said in the interview.
However, the results suggest that the addition of statins may improve outcomes for early breast cancer patients, especially when used with chemotherapy, and support the value of the ongoing MASTER study, he concluded.
Ultimately, the MASTER study will provide a more definitive answer to the question of whether statins should be added to the adjuvant treatment regimen of breast cancer to improve breast cancer outcomes, he said.
What Do Clinicians Think of the Study?
The current study is timely and highlights the need for phase 3 trials to examine the potential of statin use for breast cancer outcomes, Malinda T. West, MD, a medical oncologist and breast oncologist at the University of Wisconsin Carbone Cancer Center, Madison, said in an interview.
Questions for future research include whether statins can be used in combination with adjuvant abemaciclib if indicated, or how to best sequence these agents, said Dr. West, who was not involved in the study. Other questions raised by the current study include whether other cholesterol-lowering agents have a potential adjuvant benefit in reducing breast cancer recurrent and/or mortality, and whether the addition of statins would benefit subgroups such as HER2+ and triple negative breast cancer, she said.
“I was not surprised to see another study reporting benefit with statins and reduced risk of breast cancer recurrence and/or mortality, but I think the larger question is defining the subgroups who benefit the most, and identifying predictors for benefit or resistance,” Dr. West said in an interview.
Previous studies have shown that cholesterol elevation, specifically LDL levels, can be linked to increased tumor growth in breast cancer, so the lower mortality risk associated with lipid-lowering therapies in the current study was consistent, Peyton L. Reves, MD, a hematology/oncology fellow, also at the University of Wisconsin, said in an interview. In practice, data from the current study and previous research could be especially useful for patients with elevated LDL levels, said Dr. Reves, who was not involved in the study.
“These results could impact clinical practice in many ways, including leading to routine cholesterol monitoring in breast cancer patients on adjuvant therapy as well as the addition of lipid-lowering therapy with statins in these patients,” Dr. Reves said.
The findings showing particular benefit for patients on adjuvant chemotherapy highlight the need for more research on this specific population and the effect of statins on overall breast cancer mortality, to explore the extent to which the results of the current study were driven by the benefit seen in patients receiving adjuvant chemotherapy, Dr. Reves said.
The study was supported by Director Michael Hermann Nielsen’s Memorial Grant, Manufacturer Einar Willumsen’s Memorial Grant, Astrid Thaysen’s Grant for Medical Basic Research, Eva and Henry Fraenkel’s Memorial Fund, and the Novo Nordisk Foundation.
The researchers had no financial conflicts to disclose. Dr. West and Dr. Reves had no financial conflicts to disclose.
Previous research examining the association between cholesterol and breast cancer metabolism suggests that cholesterol-lowering medications such as statins may improve outcomes in breast cancer patients, Sixten Harborg, a medical student and PhD student at Aarhus University, Denmark, said in a presentation at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress.
In addition, cardiovascular-related death is the second most common cause of death for breast cancer survivors, and given the survival rates in early breast cancer, there is a demand for cardioprotective initiatives and maintenance of cardioprotective drugs after diagnosis, he said in an interview.
What Is Known About Statins and Breast Cancer?
Statins are the most common drugs used to lower cholesterol and may deprive tumor cells of the cholesterol needed for cell membrane synthesis, Mr. Harborg said in his presentation.
Data from a randomized trial published in the Journal of Clinical Oncology in 2017 showed significantly improved disease-free survival, breast cancer–free interval, and distant recurrence–free interval in early stage breast cancer patients randomized to cholesterol-lowering medication vs. those who did not receive cholesterol-lowering medication.
The 2017 study prompted the creation of the MASTER study, a randomized, multicenter, double-blind, placebo-controlled trial comparing standard adjuvant therapy plus placebo to standard adjuvant therapy plus atorvastatin in patients with early breast cancer (NCT04601116), Mr. Harborg said. The MASTER trial is currently recruiting patients in Denmark.
How Was the Current Study Designed?
To provide preliminary analysis, Mr. Harborg and colleagues used an emulation trial design based on electronic health care data from 110,160 females with a diagnosis of stage I, II, or III breast cancer who were part of the Danish Breast Cancer Group, a national clinical registry in Denmark, between 2000 and 2020.
As defined in the European Journal of Epidemiology in 2017, target trial emulation involves application of randomized trial designs to observational data with the goal of improving the quality of observational epidemiology when a comparator trial is not yet available.
The researchers created a cohort of patients based on electronic health care data to simulate a target trial of the use of atorvastatin after breast cancer diagnosis. Patients were randomized to one of two treatment strategies: starting to use statins within 36 months of diagnosis, or not using statins. The primary outcome was death from breast cancer. The follow-up for the MASTER study starts with inclusion and ends with death, emigration from Denmark, end of clinical follow-up, or 10 years of follow-up (whichever comes first); the follow-up was the same in the current study.
The researchers calculated hazard ratios (HR) of breast cancer mortality in statin users vs. non–statin users and used a technique known as inverse-probability of censoring-weighting (IPCW) to estimate the effects of statin use based on prognostic factors.
What Did the Results Show?
The results favored statin use for improved survival in early breast cancer patients, Mr. Harborg said. Overall, the hazard ratio for breast cancer mortality was 0.96 in statin users compared with non–statin users, and was similar in both a Cox regression analysis (HR 0.81), and in a 10-year landmark analysis (HR 0.86).
The difference in mortality between statin and non–statin users was even stronger in patients who were receiving adjuvant chemotherapy (HR 0.94, 0.64, and 0.76 on the IPCW, Cox, and landmark analyses, respectively).
The results were in line with previous reports of statins’ effect on breast cancer survival, Mr. Harborg said in an interview.
“We believe the results encourage the continuous effort of the currently enrolling MASTER trial,” he said.
The results also suggest that deprescribing statins at the time of breast cancer diagnosis is not recommended, and that statin treatment can safely be prescribed to breast cancer patients with increased cardiovascular disease risk and/or dyslipidemia, Mr. Harborg said in the interview.
What Is the Takeaway Message for Clinical Practice?
“The clinical takeaway from our study is that statin use is associated with reduced risk of dying from breast cancer, but that it is not possible to determine the true effect of statins on breast cancer survival without a randomized, placebo-controlled trial,” Mr. Harborg told this publication. “Statins are inexpensive and well-tolerated drugs and may have a beneficial effect in terms of survival for breast cancer patients. However, with the current level of evidence [because the MASTER study is ongoing], we still cannot recommend that oncologists prescribe statins to prevent mortality from breast cancer,” he said.
What Are the Next Steps for Research?
The findings were limited by the study design, and real-world data are needed, Dr. Harborg said. Other limitations include the presence of residual bias, and the use of data based on prescription codes, but these were not considered to have an effect on the main conclusion of the study, Mr. Harborg said in the interview.
However, the results suggest that the addition of statins may improve outcomes for early breast cancer patients, especially when used with chemotherapy, and support the value of the ongoing MASTER study, he concluded.
Ultimately, the MASTER study will provide a more definitive answer to the question of whether statins should be added to the adjuvant treatment regimen of breast cancer to improve breast cancer outcomes, he said.
What Do Clinicians Think of the Study?
The current study is timely and highlights the need for phase 3 trials to examine the potential of statin use for breast cancer outcomes, Malinda T. West, MD, a medical oncologist and breast oncologist at the University of Wisconsin Carbone Cancer Center, Madison, said in an interview.
Questions for future research include whether statins can be used in combination with adjuvant abemaciclib if indicated, or how to best sequence these agents, said Dr. West, who was not involved in the study. Other questions raised by the current study include whether other cholesterol-lowering agents have a potential adjuvant benefit in reducing breast cancer recurrent and/or mortality, and whether the addition of statins would benefit subgroups such as HER2+ and triple negative breast cancer, she said.
“I was not surprised to see another study reporting benefit with statins and reduced risk of breast cancer recurrence and/or mortality, but I think the larger question is defining the subgroups who benefit the most, and identifying predictors for benefit or resistance,” Dr. West said in an interview.
Previous studies have shown that cholesterol elevation, specifically LDL levels, can be linked to increased tumor growth in breast cancer, so the lower mortality risk associated with lipid-lowering therapies in the current study was consistent, Peyton L. Reves, MD, a hematology/oncology fellow, also at the University of Wisconsin, said in an interview. In practice, data from the current study and previous research could be especially useful for patients with elevated LDL levels, said Dr. Reves, who was not involved in the study.
“These results could impact clinical practice in many ways, including leading to routine cholesterol monitoring in breast cancer patients on adjuvant therapy as well as the addition of lipid-lowering therapy with statins in these patients,” Dr. Reves said.
The findings showing particular benefit for patients on adjuvant chemotherapy highlight the need for more research on this specific population and the effect of statins on overall breast cancer mortality, to explore the extent to which the results of the current study were driven by the benefit seen in patients receiving adjuvant chemotherapy, Dr. Reves said.
The study was supported by Director Michael Hermann Nielsen’s Memorial Grant, Manufacturer Einar Willumsen’s Memorial Grant, Astrid Thaysen’s Grant for Medical Basic Research, Eva and Henry Fraenkel’s Memorial Fund, and the Novo Nordisk Foundation.
The researchers had no financial conflicts to disclose. Dr. West and Dr. Reves had no financial conflicts to disclose.
FROM ESMO BREAST CANCER 2024
Lower Urinary Tract Symptoms Associated With Poorer Cognition in Older Adults
Lower urinary tract symptoms were significantly associated with lower scores on measures of cognitive impairment in older adults, based on data from approximately 10,000 individuals.
“We know that lower urinary tract symptoms are very common in aging men and women;” however, older adults often underreport symptoms and avoid seeking treatment, Belinda Williams, MD, of the University of Alabama, Birmingham, said in a presentation at the annual meeting of the American Geriatrics Society.
“Evidence also shows us that the incidence of lower urinary tract symptoms (LUTS) is higher in patients with dementia,” she said. However, the association between cognitive impairment and LUTS has not been well studied, she said.
To address this knowledge gap, Dr. Williams and colleagues reviewed data from older adults with and without LUTS who were enrolled in the REasons for Geographic and Racial Differences in Stroke (REGARDS) study, a cohort study including 30,239 Black or White adults aged 45 years and older who completed telephone or in-home assessments in 2003-2007 and in 2013-2017.
The study population included 6062 women and 4438 men who responded to questionnaires about LUTS and completed several cognitive tests via telephone in 2019-2010. The tests evaluated verbal fluency, executive function, and memory, and included the Six-Item Screener, Animal Naming, Letter F naming, and word list learning; lower scores indicated poorer cognitive performance.
Participants who met the criteria for LUTS were categorized as having mild, moderate, or severe symptoms.
The researchers controlled for age, race, education, income, and urban/rural setting in a multivariate analysis. The mean ages of the women and men were 69 years and 63 years, respectively; 41% and 32% were Black, 59% and 68% were White.
Overall, 70% of women and 62% of men reported LUTS; 6.2% and 8.2%, respectively, met criteria for cognitive impairment. The association between cognitive impairment and LUTS was statistically significant for all specific tests (P < .01), but not for the global cognitive domain tests.
Black men were more likely to report LUTS than White men, but LUTS reports were similar between Black and White women.
Moderate LUTS was the most common degree of severity for men and women (54% and 64%, respectively).
The most common symptom overall was pre-toilet leakage (urge urinary incontinence), reported by 94% of women and 91% of men. The next most common symptoms for men and women were nocturia and urgency.
“We found that, across the board, in all the cognitive tests, LUTS were associated with lower cognitive test scores,” Dr. Williams said in her presentation. Little differences were seen on the Six-Item Screener, she noted, but when they further analyzed the data using scores lower than 4 to indicate cognitive impairment, they found significant association with LUTS, she said.
The results showing that the presence of LUTS was consistently associated with lower cognitive test scores of verbal fluency, executive function, and memory, are applicable in clinical practice, Dr. Williams said in her presentation.
“Recognizing the subtle changes in cognition among older adults with LUTS may impact treatment decisions,” she said. “For example, we can encourage and advise our patients to be physically and cognitively active and to avoid anticholinergic medications.”
Next steps for research include analyzing longitudinal changes in cognition among participants with and without LUTS, said Dr. Williams.
During a question-and-answer session, Dr. Williams agreed with a comment that incorporating cognitive screening strategies in to LUTS clinical pathways might be helpful, such as conducting a baseline Montreal Cognitive Assessment Test (MoCA) in patients with LUTS. “Periodic repeat MoCAs thereafter can help assess decline in cognition,” she said.
The study was supported by the National Institutes of Neurological Disorders and Stroke and the National Institute on Aging. The researchers had no financial conflicts to disclose.
Lower urinary tract symptoms were significantly associated with lower scores on measures of cognitive impairment in older adults, based on data from approximately 10,000 individuals.
“We know that lower urinary tract symptoms are very common in aging men and women;” however, older adults often underreport symptoms and avoid seeking treatment, Belinda Williams, MD, of the University of Alabama, Birmingham, said in a presentation at the annual meeting of the American Geriatrics Society.
“Evidence also shows us that the incidence of lower urinary tract symptoms (LUTS) is higher in patients with dementia,” she said. However, the association between cognitive impairment and LUTS has not been well studied, she said.
To address this knowledge gap, Dr. Williams and colleagues reviewed data from older adults with and without LUTS who were enrolled in the REasons for Geographic and Racial Differences in Stroke (REGARDS) study, a cohort study including 30,239 Black or White adults aged 45 years and older who completed telephone or in-home assessments in 2003-2007 and in 2013-2017.
The study population included 6062 women and 4438 men who responded to questionnaires about LUTS and completed several cognitive tests via telephone in 2019-2010. The tests evaluated verbal fluency, executive function, and memory, and included the Six-Item Screener, Animal Naming, Letter F naming, and word list learning; lower scores indicated poorer cognitive performance.
Participants who met the criteria for LUTS were categorized as having mild, moderate, or severe symptoms.
The researchers controlled for age, race, education, income, and urban/rural setting in a multivariate analysis. The mean ages of the women and men were 69 years and 63 years, respectively; 41% and 32% were Black, 59% and 68% were White.
Overall, 70% of women and 62% of men reported LUTS; 6.2% and 8.2%, respectively, met criteria for cognitive impairment. The association between cognitive impairment and LUTS was statistically significant for all specific tests (P < .01), but not for the global cognitive domain tests.
Black men were more likely to report LUTS than White men, but LUTS reports were similar between Black and White women.
Moderate LUTS was the most common degree of severity for men and women (54% and 64%, respectively).
The most common symptom overall was pre-toilet leakage (urge urinary incontinence), reported by 94% of women and 91% of men. The next most common symptoms for men and women were nocturia and urgency.
“We found that, across the board, in all the cognitive tests, LUTS were associated with lower cognitive test scores,” Dr. Williams said in her presentation. Little differences were seen on the Six-Item Screener, she noted, but when they further analyzed the data using scores lower than 4 to indicate cognitive impairment, they found significant association with LUTS, she said.
The results showing that the presence of LUTS was consistently associated with lower cognitive test scores of verbal fluency, executive function, and memory, are applicable in clinical practice, Dr. Williams said in her presentation.
“Recognizing the subtle changes in cognition among older adults with LUTS may impact treatment decisions,” she said. “For example, we can encourage and advise our patients to be physically and cognitively active and to avoid anticholinergic medications.”
Next steps for research include analyzing longitudinal changes in cognition among participants with and without LUTS, said Dr. Williams.
During a question-and-answer session, Dr. Williams agreed with a comment that incorporating cognitive screening strategies in to LUTS clinical pathways might be helpful, such as conducting a baseline Montreal Cognitive Assessment Test (MoCA) in patients with LUTS. “Periodic repeat MoCAs thereafter can help assess decline in cognition,” she said.
The study was supported by the National Institutes of Neurological Disorders and Stroke and the National Institute on Aging. The researchers had no financial conflicts to disclose.
Lower urinary tract symptoms were significantly associated with lower scores on measures of cognitive impairment in older adults, based on data from approximately 10,000 individuals.
“We know that lower urinary tract symptoms are very common in aging men and women;” however, older adults often underreport symptoms and avoid seeking treatment, Belinda Williams, MD, of the University of Alabama, Birmingham, said in a presentation at the annual meeting of the American Geriatrics Society.
“Evidence also shows us that the incidence of lower urinary tract symptoms (LUTS) is higher in patients with dementia,” she said. However, the association between cognitive impairment and LUTS has not been well studied, she said.
To address this knowledge gap, Dr. Williams and colleagues reviewed data from older adults with and without LUTS who were enrolled in the REasons for Geographic and Racial Differences in Stroke (REGARDS) study, a cohort study including 30,239 Black or White adults aged 45 years and older who completed telephone or in-home assessments in 2003-2007 and in 2013-2017.
The study population included 6062 women and 4438 men who responded to questionnaires about LUTS and completed several cognitive tests via telephone in 2019-2010. The tests evaluated verbal fluency, executive function, and memory, and included the Six-Item Screener, Animal Naming, Letter F naming, and word list learning; lower scores indicated poorer cognitive performance.
Participants who met the criteria for LUTS were categorized as having mild, moderate, or severe symptoms.
The researchers controlled for age, race, education, income, and urban/rural setting in a multivariate analysis. The mean ages of the women and men were 69 years and 63 years, respectively; 41% and 32% were Black, 59% and 68% were White.
Overall, 70% of women and 62% of men reported LUTS; 6.2% and 8.2%, respectively, met criteria for cognitive impairment. The association between cognitive impairment and LUTS was statistically significant for all specific tests (P < .01), but not for the global cognitive domain tests.
Black men were more likely to report LUTS than White men, but LUTS reports were similar between Black and White women.
Moderate LUTS was the most common degree of severity for men and women (54% and 64%, respectively).
The most common symptom overall was pre-toilet leakage (urge urinary incontinence), reported by 94% of women and 91% of men. The next most common symptoms for men and women were nocturia and urgency.
“We found that, across the board, in all the cognitive tests, LUTS were associated with lower cognitive test scores,” Dr. Williams said in her presentation. Little differences were seen on the Six-Item Screener, she noted, but when they further analyzed the data using scores lower than 4 to indicate cognitive impairment, they found significant association with LUTS, she said.
The results showing that the presence of LUTS was consistently associated with lower cognitive test scores of verbal fluency, executive function, and memory, are applicable in clinical practice, Dr. Williams said in her presentation.
“Recognizing the subtle changes in cognition among older adults with LUTS may impact treatment decisions,” she said. “For example, we can encourage and advise our patients to be physically and cognitively active and to avoid anticholinergic medications.”
Next steps for research include analyzing longitudinal changes in cognition among participants with and without LUTS, said Dr. Williams.
During a question-and-answer session, Dr. Williams agreed with a comment that incorporating cognitive screening strategies in to LUTS clinical pathways might be helpful, such as conducting a baseline Montreal Cognitive Assessment Test (MoCA) in patients with LUTS. “Periodic repeat MoCAs thereafter can help assess decline in cognition,” she said.
The study was supported by the National Institutes of Neurological Disorders and Stroke and the National Institute on Aging. The researchers had no financial conflicts to disclose.
FROM AGS 2024
Lower Protein Intake In Midlife May Increase Mortality Risk
Lower intake of dietary protein in midlife was a significant independent predictor of all-cause mortality in later life, based on data from a cohort study of more than 8000 men.
The Recommended Dietary Allowance of dietary protein intake is 0.8 g/kg body weight, but previous studies of the effect of dietary protein on all-cause mortality have yielded inconsistent results, Pedro Joaquin Ayau Aguilar, MD, of the University of Hawaii, Honolulu, said in a presentation at the annual meeting of the American Geriatrics Society.
To better examine these effects, Dr. Aguilar and colleagues reviewed data from 7486 participants in the Kuakini Honolulu Heart Program (HHP), a prospective cohort study of Japanese-American men in Hawaii.
Participants underwent a baseline exam in 1965-1968 at ages 45-68 years and were followed for mortality until December 31, 2022. The researchers created quintiles of dietary protein/kg categorized as plant or animal source, trained dietitians worked with participants to complete a 24-hour diet recall, and the primary outcome was all-cause mortality.
Overall, the mean protein intake in the study population was 1.5 g/kg body weight; the mean animal protein and plant protein intakes were 1.1 g/kg and 0.4 g/kg, respectively.
In an age-adjusted analysis, mortality rates per 1,000 person-years were significantly higher with lower total protein intake, with rates of 39.7 per 1,000 person-years and 36.8 per 1,000 person-years in the first and fifth quintiles, respectively (P < .0001).
Data Show Consistency Across Protein Types
Trends were similar for animal protein and plant protein intake, with mortality rates of 39.6 and 36.5 per 1000 person-years for the first and fifth quintiles, respectively.
“All of these categories had a significant trend, with the lowest quintile showing the highest mortality rate,” Dr. Aguilar said in his presentation.
The study was limited by several factors including the homogeneous population of Japanese men, and the inability to make conclusions about cause and effect, Dr. Aguilar said. However, the results were strengthened by the large cohort, long follow-up, and complete mortality surveillance, he added.
As for the study’s clinical implications, “I believe it adds to the body of evidence on how nutrition impacts health and [the data] can help us better advise our patients on their macronutrient intake to better optimize their health,” Dr. Aguilar said in a question-and-answer session following the presentation.
Looking ahead, “More research is needed to more accurately define which type of protein and in which amounts are optimal for health,” as well as how other macronutrients in different stages of life affect health span and life span, he said.
Although a minimum Recommended Daily Allowance of dietary protein is 0.8 g/kg body weight, the relationship between dietary protein intake and all-cause mortality remains unclear, said Shelly Gray, PharmD, professor of pharmacy at the University of Washington School of Pharmacy, said in an interview.
Dr. Gray, who served as a moderator for the session in which the study was presented, agreed that more research is needed before clinical implications can be discussed.
The study was supported by the Department of Geriatric Medicine, John A. Burns School of Medicine, University of Hawaii; Kuakini Medical Center, Honolulu, Hawaii; and the National Institutes of Health. The researchers had no financial conflicts to disclose. Dr. Gray had no financial conflicts to disclose.
Lower intake of dietary protein in midlife was a significant independent predictor of all-cause mortality in later life, based on data from a cohort study of more than 8000 men.
The Recommended Dietary Allowance of dietary protein intake is 0.8 g/kg body weight, but previous studies of the effect of dietary protein on all-cause mortality have yielded inconsistent results, Pedro Joaquin Ayau Aguilar, MD, of the University of Hawaii, Honolulu, said in a presentation at the annual meeting of the American Geriatrics Society.
To better examine these effects, Dr. Aguilar and colleagues reviewed data from 7486 participants in the Kuakini Honolulu Heart Program (HHP), a prospective cohort study of Japanese-American men in Hawaii.
Participants underwent a baseline exam in 1965-1968 at ages 45-68 years and were followed for mortality until December 31, 2022. The researchers created quintiles of dietary protein/kg categorized as plant or animal source, trained dietitians worked with participants to complete a 24-hour diet recall, and the primary outcome was all-cause mortality.
Overall, the mean protein intake in the study population was 1.5 g/kg body weight; the mean animal protein and plant protein intakes were 1.1 g/kg and 0.4 g/kg, respectively.
In an age-adjusted analysis, mortality rates per 1,000 person-years were significantly higher with lower total protein intake, with rates of 39.7 per 1,000 person-years and 36.8 per 1,000 person-years in the first and fifth quintiles, respectively (P < .0001).
Data Show Consistency Across Protein Types
Trends were similar for animal protein and plant protein intake, with mortality rates of 39.6 and 36.5 per 1000 person-years for the first and fifth quintiles, respectively.
“All of these categories had a significant trend, with the lowest quintile showing the highest mortality rate,” Dr. Aguilar said in his presentation.
The study was limited by several factors including the homogeneous population of Japanese men, and the inability to make conclusions about cause and effect, Dr. Aguilar said. However, the results were strengthened by the large cohort, long follow-up, and complete mortality surveillance, he added.
As for the study’s clinical implications, “I believe it adds to the body of evidence on how nutrition impacts health and [the data] can help us better advise our patients on their macronutrient intake to better optimize their health,” Dr. Aguilar said in a question-and-answer session following the presentation.
Looking ahead, “More research is needed to more accurately define which type of protein and in which amounts are optimal for health,” as well as how other macronutrients in different stages of life affect health span and life span, he said.
Although a minimum Recommended Daily Allowance of dietary protein is 0.8 g/kg body weight, the relationship between dietary protein intake and all-cause mortality remains unclear, said Shelly Gray, PharmD, professor of pharmacy at the University of Washington School of Pharmacy, said in an interview.
Dr. Gray, who served as a moderator for the session in which the study was presented, agreed that more research is needed before clinical implications can be discussed.
The study was supported by the Department of Geriatric Medicine, John A. Burns School of Medicine, University of Hawaii; Kuakini Medical Center, Honolulu, Hawaii; and the National Institutes of Health. The researchers had no financial conflicts to disclose. Dr. Gray had no financial conflicts to disclose.
Lower intake of dietary protein in midlife was a significant independent predictor of all-cause mortality in later life, based on data from a cohort study of more than 8000 men.
The Recommended Dietary Allowance of dietary protein intake is 0.8 g/kg body weight, but previous studies of the effect of dietary protein on all-cause mortality have yielded inconsistent results, Pedro Joaquin Ayau Aguilar, MD, of the University of Hawaii, Honolulu, said in a presentation at the annual meeting of the American Geriatrics Society.
To better examine these effects, Dr. Aguilar and colleagues reviewed data from 7486 participants in the Kuakini Honolulu Heart Program (HHP), a prospective cohort study of Japanese-American men in Hawaii.
Participants underwent a baseline exam in 1965-1968 at ages 45-68 years and were followed for mortality until December 31, 2022. The researchers created quintiles of dietary protein/kg categorized as plant or animal source, trained dietitians worked with participants to complete a 24-hour diet recall, and the primary outcome was all-cause mortality.
Overall, the mean protein intake in the study population was 1.5 g/kg body weight; the mean animal protein and plant protein intakes were 1.1 g/kg and 0.4 g/kg, respectively.
In an age-adjusted analysis, mortality rates per 1,000 person-years were significantly higher with lower total protein intake, with rates of 39.7 per 1,000 person-years and 36.8 per 1,000 person-years in the first and fifth quintiles, respectively (P < .0001).
Data Show Consistency Across Protein Types
Trends were similar for animal protein and plant protein intake, with mortality rates of 39.6 and 36.5 per 1000 person-years for the first and fifth quintiles, respectively.
“All of these categories had a significant trend, with the lowest quintile showing the highest mortality rate,” Dr. Aguilar said in his presentation.
The study was limited by several factors including the homogeneous population of Japanese men, and the inability to make conclusions about cause and effect, Dr. Aguilar said. However, the results were strengthened by the large cohort, long follow-up, and complete mortality surveillance, he added.
As for the study’s clinical implications, “I believe it adds to the body of evidence on how nutrition impacts health and [the data] can help us better advise our patients on their macronutrient intake to better optimize their health,” Dr. Aguilar said in a question-and-answer session following the presentation.
Looking ahead, “More research is needed to more accurately define which type of protein and in which amounts are optimal for health,” as well as how other macronutrients in different stages of life affect health span and life span, he said.
Although a minimum Recommended Daily Allowance of dietary protein is 0.8 g/kg body weight, the relationship between dietary protein intake and all-cause mortality remains unclear, said Shelly Gray, PharmD, professor of pharmacy at the University of Washington School of Pharmacy, said in an interview.
Dr. Gray, who served as a moderator for the session in which the study was presented, agreed that more research is needed before clinical implications can be discussed.
The study was supported by the Department of Geriatric Medicine, John A. Burns School of Medicine, University of Hawaii; Kuakini Medical Center, Honolulu, Hawaii; and the National Institutes of Health. The researchers had no financial conflicts to disclose. Dr. Gray had no financial conflicts to disclose.
FROM AGS 2024
Inappropriate Medication Use Persists in Older Adults With Dementia
Medications that could have a negative effect on cognition are often used by older adults with dementia, according to data from approximately 13 million individuals presented at the annual meeting of the American Geriatrics Society.
Classes of medications including anticholinergics, antipsychotics, benzodiazepines, and non-benzodiazepine sedatives (Z drugs) have been identified as potentially inappropriate medications (PIMs) in patients with dementia, according to The American Geriatrics Society Beers Criteria for Potentially Inappropriate Medication Use in Older Adults.
The medications that could worsen dementia or cognition are known as CogPIMs, said presenting author Caroline M. Mak, a doctor of pharmacy candidate at the University at Buffalo School of Pharmacy and Pharmaceutical Sciences, New York.
Previous research has characterized the prevalence of use of CogPIMs, but data connecting use of CogPIMs and healthcare use are lacking, Ms. Mak said.
Ms. Mak and colleagues conducted a cross-sectional analysis of data from 2011 to 2015 from the Medical Expenditure Panel Survey (MEPS), a national survey with data on medication and healthcare use. The researchers included approximately 13 million survey respondents older than 65 years with dementia.
Exposure to CogPIMs was defined as filling a prescription for one or more of the CogPIMs during the study period. Population estimates of the prevalence of use of the CogPIMs were created using survey-weighted procedures, and prevalence trends were assessed using the Cochran-Armitage test.
Overall, the prevalence was 15.9%, 11.5%, 7.5%, and 3.8% for use of benzodiazepines, anticholinergics, antipsychotics, and Z drugs, respectively, during the study period.
Of these, benzodiazepines showed a significant trend with an increase in prevalence from 8.9% in 2011 to 16.4% in 2015 (P = .02).
The odds of hospitalization were more than twice as likely in individuals who reported using Z drugs (odds ratio, 2.57; P = .02) based on logistic regression. In addition, exposure to antipsychotics was significantly associated with an increased rate of hospitalization based on a binomial model for incidence rate ratio (IRR, 1.51; P = .02).
The findings were limited by several factors including the cross-sectional design, reliance on self-reports, and the lack of more recent data.
However, the results show that CogPIMs are often used by older adults with dementia, and antipsychotics and Z drugs could be targets for interventions to prevent harm from medication interactions and side effects, the researchers concluded.
Findings Highlight Need for Drug Awareness
The current study is important because of the expansion in the aging population and an increase in the number of patients with dementia, Ms. Mak said in an interview. “In both our older population and dementia patients, there are certain medication considerations that we need to take into account, and certain drugs that should be avoided if possible,” she said. Clinicians have been trying to use the Beers criteria to reduce potential medication harm, she noted. “One group of investigators (Hilmer et al.), has proposed a narrower focus on anticholinergic and sedative/hypnotic medication in the Drug Burden Index (DBI); the CogPIMs are a subset of both approaches (Beers and DBI) and represent a collection of medications that pose potential risks to our patients,” said Ms. Mak.
Continued reassessment is needed on appropriateness of anticholinergics, Z drugs, benzodiazepines, and antipsychotics in older patients with dementia, she added.
“Even though the only group to have a significant increase in prevalence [of use] was the benzodiazepine group, we didn’t see a decrease in any of the other groups,” said Ms. Mak. The current research provides a benchmark for CogPIMs use that can be monitored in the future for increases or, ideally, decreases, she said.
Part of a Bigger Picture
The current study is part of the work of Team Alice, a national deprescribing group affiliated with the University at Buffalo that was inspired by the tragic death of Alice Brennan, triggered by preventable medication harm, Ms. Mak said in an interview. “Team Alice consists of an array of academic, primary care, health plan, and regional health information partners that have designed patient-driven interventions to reduce medication harm, especially within primary care settings,” she said. “Their mission is to save people like Alice by pursuing multiple strategies to deprescribe unsafe medication, reduce harm, and foster successful aging. By characterizing the use of CogPIMs, we can design better intervention strategies,” she said.
Although Ms. Mak was not surprised by the emergence of benzodiazepines as the most commonly used drug groups, she was surprised by the increase during the study period.
“Unfortunately, our dataset was not rich enough to include reasons for this increase,” she said. In practice, “I have seen patients getting short-term, as needed, prescriptions for a benzodiazepine to address the anxiety and/or insomnia after the loss of a loved one; this may account for a small proportion of benzodiazepine use that appears to be inappropriate because of a lack of associated appropriate diagnosis,” she noted.
Also, the findings of increased hospitalization associated with Z drugs raises concerns, Ms. Mak said. Although the findings are consistent with other research, they illustrate the need for further investigation to identify strategies to prevent this harm, she said. “Not finding associations with hospitalization related to benzodiazepine or anticholinergics was a mild surprise,” Ms. Mak said in an interview. “However, while we know that these drugs can have a negative effect on older people, the effects may not have been severe enough to result in hospitalizations,” she said.
Looking ahead, Ms. Mak said she would like to see the study rerun with a more current data set, especially with regard to benzodiazepines and antipsychotics.
Seek Strategies to Reduce Medication Use
The current study was notable for its community-based population and attention to hospitalizations, Shelly Gray, PharmD, a professor of pharmacy at the University of Washington School of Pharmacy, said in an interview.
“Most studies examining potentially inappropriate medications that may impair cognition have been conducted in nursing homes, while this study focuses on community dwelling older adults where most people with dementia live,” said Dr. Gray, who served as a moderator for the session in which the study was presented.
In addition, “A unique aspect of this study was to examine how these medications are related to hospitalizations,” she said.
Given recent efforts to reduce use of potentially inappropriate medications in people with dementia, the increase in prevalence of use over the study period was surprising, especially for benzodiazepines, said Dr. Gray.
In clinical practice, “health care providers should continue to look for opportunities to deprescribe medications that may worsen cognition in people with dementia,” she said. However, more research is needed to examine trends in the years beyond 2015 for a more contemporary picture of medication use in this population, she noted.
The study received no outside funding. The researchers and Dr. Gray had no financial conflicts to disclose.
Medications that could have a negative effect on cognition are often used by older adults with dementia, according to data from approximately 13 million individuals presented at the annual meeting of the American Geriatrics Society.
Classes of medications including anticholinergics, antipsychotics, benzodiazepines, and non-benzodiazepine sedatives (Z drugs) have been identified as potentially inappropriate medications (PIMs) in patients with dementia, according to The American Geriatrics Society Beers Criteria for Potentially Inappropriate Medication Use in Older Adults.
The medications that could worsen dementia or cognition are known as CogPIMs, said presenting author Caroline M. Mak, a doctor of pharmacy candidate at the University at Buffalo School of Pharmacy and Pharmaceutical Sciences, New York.
Previous research has characterized the prevalence of use of CogPIMs, but data connecting use of CogPIMs and healthcare use are lacking, Ms. Mak said.
Ms. Mak and colleagues conducted a cross-sectional analysis of data from 2011 to 2015 from the Medical Expenditure Panel Survey (MEPS), a national survey with data on medication and healthcare use. The researchers included approximately 13 million survey respondents older than 65 years with dementia.
Exposure to CogPIMs was defined as filling a prescription for one or more of the CogPIMs during the study period. Population estimates of the prevalence of use of the CogPIMs were created using survey-weighted procedures, and prevalence trends were assessed using the Cochran-Armitage test.
Overall, the prevalence was 15.9%, 11.5%, 7.5%, and 3.8% for use of benzodiazepines, anticholinergics, antipsychotics, and Z drugs, respectively, during the study period.
Of these, benzodiazepines showed a significant trend with an increase in prevalence from 8.9% in 2011 to 16.4% in 2015 (P = .02).
The odds of hospitalization were more than twice as likely in individuals who reported using Z drugs (odds ratio, 2.57; P = .02) based on logistic regression. In addition, exposure to antipsychotics was significantly associated with an increased rate of hospitalization based on a binomial model for incidence rate ratio (IRR, 1.51; P = .02).
The findings were limited by several factors including the cross-sectional design, reliance on self-reports, and the lack of more recent data.
However, the results show that CogPIMs are often used by older adults with dementia, and antipsychotics and Z drugs could be targets for interventions to prevent harm from medication interactions and side effects, the researchers concluded.
Findings Highlight Need for Drug Awareness
The current study is important because of the expansion in the aging population and an increase in the number of patients with dementia, Ms. Mak said in an interview. “In both our older population and dementia patients, there are certain medication considerations that we need to take into account, and certain drugs that should be avoided if possible,” she said. Clinicians have been trying to use the Beers criteria to reduce potential medication harm, she noted. “One group of investigators (Hilmer et al.), has proposed a narrower focus on anticholinergic and sedative/hypnotic medication in the Drug Burden Index (DBI); the CogPIMs are a subset of both approaches (Beers and DBI) and represent a collection of medications that pose potential risks to our patients,” said Ms. Mak.
Continued reassessment is needed on appropriateness of anticholinergics, Z drugs, benzodiazepines, and antipsychotics in older patients with dementia, she added.
“Even though the only group to have a significant increase in prevalence [of use] was the benzodiazepine group, we didn’t see a decrease in any of the other groups,” said Ms. Mak. The current research provides a benchmark for CogPIMs use that can be monitored in the future for increases or, ideally, decreases, she said.
Part of a Bigger Picture
The current study is part of the work of Team Alice, a national deprescribing group affiliated with the University at Buffalo that was inspired by the tragic death of Alice Brennan, triggered by preventable medication harm, Ms. Mak said in an interview. “Team Alice consists of an array of academic, primary care, health plan, and regional health information partners that have designed patient-driven interventions to reduce medication harm, especially within primary care settings,” she said. “Their mission is to save people like Alice by pursuing multiple strategies to deprescribe unsafe medication, reduce harm, and foster successful aging. By characterizing the use of CogPIMs, we can design better intervention strategies,” she said.
Although Ms. Mak was not surprised by the emergence of benzodiazepines as the most commonly used drug groups, she was surprised by the increase during the study period.
“Unfortunately, our dataset was not rich enough to include reasons for this increase,” she said. In practice, “I have seen patients getting short-term, as needed, prescriptions for a benzodiazepine to address the anxiety and/or insomnia after the loss of a loved one; this may account for a small proportion of benzodiazepine use that appears to be inappropriate because of a lack of associated appropriate diagnosis,” she noted.
Also, the findings of increased hospitalization associated with Z drugs raises concerns, Ms. Mak said. Although the findings are consistent with other research, they illustrate the need for further investigation to identify strategies to prevent this harm, she said. “Not finding associations with hospitalization related to benzodiazepine or anticholinergics was a mild surprise,” Ms. Mak said in an interview. “However, while we know that these drugs can have a negative effect on older people, the effects may not have been severe enough to result in hospitalizations,” she said.
Looking ahead, Ms. Mak said she would like to see the study rerun with a more current data set, especially with regard to benzodiazepines and antipsychotics.
Seek Strategies to Reduce Medication Use
The current study was notable for its community-based population and attention to hospitalizations, Shelly Gray, PharmD, a professor of pharmacy at the University of Washington School of Pharmacy, said in an interview.
“Most studies examining potentially inappropriate medications that may impair cognition have been conducted in nursing homes, while this study focuses on community dwelling older adults where most people with dementia live,” said Dr. Gray, who served as a moderator for the session in which the study was presented.
In addition, “A unique aspect of this study was to examine how these medications are related to hospitalizations,” she said.
Given recent efforts to reduce use of potentially inappropriate medications in people with dementia, the increase in prevalence of use over the study period was surprising, especially for benzodiazepines, said Dr. Gray.
In clinical practice, “health care providers should continue to look for opportunities to deprescribe medications that may worsen cognition in people with dementia,” she said. However, more research is needed to examine trends in the years beyond 2015 for a more contemporary picture of medication use in this population, she noted.
The study received no outside funding. The researchers and Dr. Gray had no financial conflicts to disclose.
Medications that could have a negative effect on cognition are often used by older adults with dementia, according to data from approximately 13 million individuals presented at the annual meeting of the American Geriatrics Society.
Classes of medications including anticholinergics, antipsychotics, benzodiazepines, and non-benzodiazepine sedatives (Z drugs) have been identified as potentially inappropriate medications (PIMs) in patients with dementia, according to The American Geriatrics Society Beers Criteria for Potentially Inappropriate Medication Use in Older Adults.
The medications that could worsen dementia or cognition are known as CogPIMs, said presenting author Caroline M. Mak, a doctor of pharmacy candidate at the University at Buffalo School of Pharmacy and Pharmaceutical Sciences, New York.
Previous research has characterized the prevalence of use of CogPIMs, but data connecting use of CogPIMs and healthcare use are lacking, Ms. Mak said.
Ms. Mak and colleagues conducted a cross-sectional analysis of data from 2011 to 2015 from the Medical Expenditure Panel Survey (MEPS), a national survey with data on medication and healthcare use. The researchers included approximately 13 million survey respondents older than 65 years with dementia.
Exposure to CogPIMs was defined as filling a prescription for one or more of the CogPIMs during the study period. Population estimates of the prevalence of use of the CogPIMs were created using survey-weighted procedures, and prevalence trends were assessed using the Cochran-Armitage test.
Overall, the prevalence was 15.9%, 11.5%, 7.5%, and 3.8% for use of benzodiazepines, anticholinergics, antipsychotics, and Z drugs, respectively, during the study period.
Of these, benzodiazepines showed a significant trend with an increase in prevalence from 8.9% in 2011 to 16.4% in 2015 (P = .02).
The odds of hospitalization were more than twice as likely in individuals who reported using Z drugs (odds ratio, 2.57; P = .02) based on logistic regression. In addition, exposure to antipsychotics was significantly associated with an increased rate of hospitalization based on a binomial model for incidence rate ratio (IRR, 1.51; P = .02).
The findings were limited by several factors including the cross-sectional design, reliance on self-reports, and the lack of more recent data.
However, the results show that CogPIMs are often used by older adults with dementia, and antipsychotics and Z drugs could be targets for interventions to prevent harm from medication interactions and side effects, the researchers concluded.
Findings Highlight Need for Drug Awareness
The current study is important because of the expansion in the aging population and an increase in the number of patients with dementia, Ms. Mak said in an interview. “In both our older population and dementia patients, there are certain medication considerations that we need to take into account, and certain drugs that should be avoided if possible,” she said. Clinicians have been trying to use the Beers criteria to reduce potential medication harm, she noted. “One group of investigators (Hilmer et al.), has proposed a narrower focus on anticholinergic and sedative/hypnotic medication in the Drug Burden Index (DBI); the CogPIMs are a subset of both approaches (Beers and DBI) and represent a collection of medications that pose potential risks to our patients,” said Ms. Mak.
Continued reassessment is needed on appropriateness of anticholinergics, Z drugs, benzodiazepines, and antipsychotics in older patients with dementia, she added.
“Even though the only group to have a significant increase in prevalence [of use] was the benzodiazepine group, we didn’t see a decrease in any of the other groups,” said Ms. Mak. The current research provides a benchmark for CogPIMs use that can be monitored in the future for increases or, ideally, decreases, she said.
Part of a Bigger Picture
The current study is part of the work of Team Alice, a national deprescribing group affiliated with the University at Buffalo that was inspired by the tragic death of Alice Brennan, triggered by preventable medication harm, Ms. Mak said in an interview. “Team Alice consists of an array of academic, primary care, health plan, and regional health information partners that have designed patient-driven interventions to reduce medication harm, especially within primary care settings,” she said. “Their mission is to save people like Alice by pursuing multiple strategies to deprescribe unsafe medication, reduce harm, and foster successful aging. By characterizing the use of CogPIMs, we can design better intervention strategies,” she said.
Although Ms. Mak was not surprised by the emergence of benzodiazepines as the most commonly used drug groups, she was surprised by the increase during the study period.
“Unfortunately, our dataset was not rich enough to include reasons for this increase,” she said. In practice, “I have seen patients getting short-term, as needed, prescriptions for a benzodiazepine to address the anxiety and/or insomnia after the loss of a loved one; this may account for a small proportion of benzodiazepine use that appears to be inappropriate because of a lack of associated appropriate diagnosis,” she noted.
Also, the findings of increased hospitalization associated with Z drugs raises concerns, Ms. Mak said. Although the findings are consistent with other research, they illustrate the need for further investigation to identify strategies to prevent this harm, she said. “Not finding associations with hospitalization related to benzodiazepine or anticholinergics was a mild surprise,” Ms. Mak said in an interview. “However, while we know that these drugs can have a negative effect on older people, the effects may not have been severe enough to result in hospitalizations,” she said.
Looking ahead, Ms. Mak said she would like to see the study rerun with a more current data set, especially with regard to benzodiazepines and antipsychotics.
Seek Strategies to Reduce Medication Use
The current study was notable for its community-based population and attention to hospitalizations, Shelly Gray, PharmD, a professor of pharmacy at the University of Washington School of Pharmacy, said in an interview.
“Most studies examining potentially inappropriate medications that may impair cognition have been conducted in nursing homes, while this study focuses on community dwelling older adults where most people with dementia live,” said Dr. Gray, who served as a moderator for the session in which the study was presented.
In addition, “A unique aspect of this study was to examine how these medications are related to hospitalizations,” she said.
Given recent efforts to reduce use of potentially inappropriate medications in people with dementia, the increase in prevalence of use over the study period was surprising, especially for benzodiazepines, said Dr. Gray.
In clinical practice, “health care providers should continue to look for opportunities to deprescribe medications that may worsen cognition in people with dementia,” she said. However, more research is needed to examine trends in the years beyond 2015 for a more contemporary picture of medication use in this population, she noted.
The study received no outside funding. The researchers and Dr. Gray had no financial conflicts to disclose.
FROM AGS 2024
Climate Change’s Impact on Respiratory Care to Increase
Extreme heat, wildfires, and particulate matter not from wildfires were the most studied climate issues in conjunction with increased respiratory care, based on data from more than 60 studies.
Recent local events prompted Dr. Lewy and colleagues to examine the current landscape of climate change studies and respiratory healthcare.
“Last summer, when Canadian wildfire smoke enveloped the Midwest and the East Coast, patients presented with exacerbations of asthma and COPD to our clinics,” corresponding author Alexander S. Rabin, MD, of the University of Michigan, said in an interview.
“The event was a reminder of the increasing health threats that our most vulnerable patients face from climate change,” he said. “The smoke events also got us thinking about how health systems around the world are preparing, and we wanted to better understand what is known about the impacts of climate change on healthcare delivery to patients with lung disease and look for blind spots in the research,” he explained.
In the review, published in The Journal of Climate Change and Health, the researchers identified 67 studies related to climate and respiratory care; 50 of these were published between 2020 and 2023.
The most frequently studied climate and weather topics were extreme heat (31 studies), particulate matter not from wildfires (22 studies), and wildfires (19 studies).
The most common respiratory-related outcomes were respiratory-related hospital admissions (33 studies) and respiratory-related emergency department (ED) visits (24 studies).
Few studies addressed the potential impact of climate on telehealth, facility energy distribution, and pharmaceutical supplies, the researchers wrote. Notably, only one study in the review showed an association between power outages in New York City and higher chronic obstructive pulmonary disease (COPD)-related hospital admission rates, and no primary research emerged on the effects of climate change on respiratory medicine supply or distribution, they said.
Findings from studies with demographic breakdowns included evidence of greater effects of extreme weather on elderly populations compared with younger groups, and data from the seven studies focused on children showed a particular risk for climate-related respiratory exacerbations among those younger than 5 years.
The findings of the review were limited by several factors including the targeted article selection and potential misclassification bias, as respiratory outcomes often overlapped with cardiac or other outcomes, the researchers noted.
However, the results highlighted three key areas for future research. First, more studies are needed on the impact of climate on understudied populations in areas such as Africa, South America, Asia, and the Caribbean. Second, studies are needed on the impact of climate on respiratory care beyond acute care, with attention to primary and specialty respiratory care use, supply chain impacts, and effects on long-term pulmonary care and rehabilitation. Finally, more research is needed to explore solutions to the increased demands on pulmonary care in the context of climate change, including the use of telehealth, the authors wrote.
Limitations and Research Gaps
“While we found extensive published research chronicling the acute respiratory health impacts of climate change and extreme weather, such as heat waves and wildfires, we were surprised to find few studies on health system adaptation,” Dr. Rabin told this news organization.
“Although we know that prevention and long-term disease management are critical, studies looking at primary care impacts on respiratory care, healthcare infrastructure hardening, and medication supply chain resilience were largely absent from the literature,” he said. “We were further struck by the limited amount of research originating from the most climate-affected areas such as in the Global South, where outdoor air pollution already results in over 4 million deaths per year,” he noted.
Although clinicians increasingly recognize that climate change and extreme weather threaten lung health, solutions are needed to make health systems resilient, accessible, and adaptable, especially with the likely increase in demand for respiratory care, Dr. Rabin emphasized.
More research is needed on preventive measures that could mitigate the risk for bad air quality, heat, and other extreme climate change events on vulnerable populations, said Dr. Rabin. “Every domain of healthcare delivery, from pharmaceutical procurement to hospital heating and cooling system design, must account for these environmental changes,” he said. “More collaboration is needed with researchers and clinicians in areas of the world that are underrepresented and underresourced to help share knowledge and tools to build health system resilience.”
Takeaways and Next Steps
“I was struck by how many studies used healthcare metrics as a way to measure health outcomes but not to measure resilience and efficiency of healthcare systems themselves,” Dr. Lewy said in an interview. “For example, many studies used ED visits or hospital admissions as ways to measure severity of disease associated with a climate event, but the strain that increased visits or admissions have on healthcare systems was barely mentioned,” she noted.
Looking ahead, more studies that focus specifically on infrastructure as it relates to healthcare would be valuable, said Dr. Lewy. Recent research has explored virtual care as a way to mitigate climate change-associated COPD exacerbations, but virtual care may not be reliably accessible in cases of the widespread power and network outages that often accompany storms, heat waves, and other catastrophic weather events, she noted. “More research into these types of logistical factors affecting healthcare systems would be helpful,” she added.
Dr. Rabin disclosed support for the study from the US Department of Veterans Affairs but had no other financial conflicts to disclose. Dr. Lewy had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Extreme heat, wildfires, and particulate matter not from wildfires were the most studied climate issues in conjunction with increased respiratory care, based on data from more than 60 studies.
Recent local events prompted Dr. Lewy and colleagues to examine the current landscape of climate change studies and respiratory healthcare.
“Last summer, when Canadian wildfire smoke enveloped the Midwest and the East Coast, patients presented with exacerbations of asthma and COPD to our clinics,” corresponding author Alexander S. Rabin, MD, of the University of Michigan, said in an interview.
“The event was a reminder of the increasing health threats that our most vulnerable patients face from climate change,” he said. “The smoke events also got us thinking about how health systems around the world are preparing, and we wanted to better understand what is known about the impacts of climate change on healthcare delivery to patients with lung disease and look for blind spots in the research,” he explained.
In the review, published in The Journal of Climate Change and Health, the researchers identified 67 studies related to climate and respiratory care; 50 of these were published between 2020 and 2023.
The most frequently studied climate and weather topics were extreme heat (31 studies), particulate matter not from wildfires (22 studies), and wildfires (19 studies).
The most common respiratory-related outcomes were respiratory-related hospital admissions (33 studies) and respiratory-related emergency department (ED) visits (24 studies).
Few studies addressed the potential impact of climate on telehealth, facility energy distribution, and pharmaceutical supplies, the researchers wrote. Notably, only one study in the review showed an association between power outages in New York City and higher chronic obstructive pulmonary disease (COPD)-related hospital admission rates, and no primary research emerged on the effects of climate change on respiratory medicine supply or distribution, they said.
Findings from studies with demographic breakdowns included evidence of greater effects of extreme weather on elderly populations compared with younger groups, and data from the seven studies focused on children showed a particular risk for climate-related respiratory exacerbations among those younger than 5 years.
The findings of the review were limited by several factors including the targeted article selection and potential misclassification bias, as respiratory outcomes often overlapped with cardiac or other outcomes, the researchers noted.
However, the results highlighted three key areas for future research. First, more studies are needed on the impact of climate on understudied populations in areas such as Africa, South America, Asia, and the Caribbean. Second, studies are needed on the impact of climate on respiratory care beyond acute care, with attention to primary and specialty respiratory care use, supply chain impacts, and effects on long-term pulmonary care and rehabilitation. Finally, more research is needed to explore solutions to the increased demands on pulmonary care in the context of climate change, including the use of telehealth, the authors wrote.
Limitations and Research Gaps
“While we found extensive published research chronicling the acute respiratory health impacts of climate change and extreme weather, such as heat waves and wildfires, we were surprised to find few studies on health system adaptation,” Dr. Rabin told this news organization.
“Although we know that prevention and long-term disease management are critical, studies looking at primary care impacts on respiratory care, healthcare infrastructure hardening, and medication supply chain resilience were largely absent from the literature,” he said. “We were further struck by the limited amount of research originating from the most climate-affected areas such as in the Global South, where outdoor air pollution already results in over 4 million deaths per year,” he noted.
Although clinicians increasingly recognize that climate change and extreme weather threaten lung health, solutions are needed to make health systems resilient, accessible, and adaptable, especially with the likely increase in demand for respiratory care, Dr. Rabin emphasized.
More research is needed on preventive measures that could mitigate the risk for bad air quality, heat, and other extreme climate change events on vulnerable populations, said Dr. Rabin. “Every domain of healthcare delivery, from pharmaceutical procurement to hospital heating and cooling system design, must account for these environmental changes,” he said. “More collaboration is needed with researchers and clinicians in areas of the world that are underrepresented and underresourced to help share knowledge and tools to build health system resilience.”
Takeaways and Next Steps
“I was struck by how many studies used healthcare metrics as a way to measure health outcomes but not to measure resilience and efficiency of healthcare systems themselves,” Dr. Lewy said in an interview. “For example, many studies used ED visits or hospital admissions as ways to measure severity of disease associated with a climate event, but the strain that increased visits or admissions have on healthcare systems was barely mentioned,” she noted.
Looking ahead, more studies that focus specifically on infrastructure as it relates to healthcare would be valuable, said Dr. Lewy. Recent research has explored virtual care as a way to mitigate climate change-associated COPD exacerbations, but virtual care may not be reliably accessible in cases of the widespread power and network outages that often accompany storms, heat waves, and other catastrophic weather events, she noted. “More research into these types of logistical factors affecting healthcare systems would be helpful,” she added.
Dr. Rabin disclosed support for the study from the US Department of Veterans Affairs but had no other financial conflicts to disclose. Dr. Lewy had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Extreme heat, wildfires, and particulate matter not from wildfires were the most studied climate issues in conjunction with increased respiratory care, based on data from more than 60 studies.
Recent local events prompted Dr. Lewy and colleagues to examine the current landscape of climate change studies and respiratory healthcare.
“Last summer, when Canadian wildfire smoke enveloped the Midwest and the East Coast, patients presented with exacerbations of asthma and COPD to our clinics,” corresponding author Alexander S. Rabin, MD, of the University of Michigan, said in an interview.
“The event was a reminder of the increasing health threats that our most vulnerable patients face from climate change,” he said. “The smoke events also got us thinking about how health systems around the world are preparing, and we wanted to better understand what is known about the impacts of climate change on healthcare delivery to patients with lung disease and look for blind spots in the research,” he explained.
In the review, published in The Journal of Climate Change and Health, the researchers identified 67 studies related to climate and respiratory care; 50 of these were published between 2020 and 2023.
The most frequently studied climate and weather topics were extreme heat (31 studies), particulate matter not from wildfires (22 studies), and wildfires (19 studies).
The most common respiratory-related outcomes were respiratory-related hospital admissions (33 studies) and respiratory-related emergency department (ED) visits (24 studies).
Few studies addressed the potential impact of climate on telehealth, facility energy distribution, and pharmaceutical supplies, the researchers wrote. Notably, only one study in the review showed an association between power outages in New York City and higher chronic obstructive pulmonary disease (COPD)-related hospital admission rates, and no primary research emerged on the effects of climate change on respiratory medicine supply or distribution, they said.
Findings from studies with demographic breakdowns included evidence of greater effects of extreme weather on elderly populations compared with younger groups, and data from the seven studies focused on children showed a particular risk for climate-related respiratory exacerbations among those younger than 5 years.
The findings of the review were limited by several factors including the targeted article selection and potential misclassification bias, as respiratory outcomes often overlapped with cardiac or other outcomes, the researchers noted.
However, the results highlighted three key areas for future research. First, more studies are needed on the impact of climate on understudied populations in areas such as Africa, South America, Asia, and the Caribbean. Second, studies are needed on the impact of climate on respiratory care beyond acute care, with attention to primary and specialty respiratory care use, supply chain impacts, and effects on long-term pulmonary care and rehabilitation. Finally, more research is needed to explore solutions to the increased demands on pulmonary care in the context of climate change, including the use of telehealth, the authors wrote.
Limitations and Research Gaps
“While we found extensive published research chronicling the acute respiratory health impacts of climate change and extreme weather, such as heat waves and wildfires, we were surprised to find few studies on health system adaptation,” Dr. Rabin told this news organization.
“Although we know that prevention and long-term disease management are critical, studies looking at primary care impacts on respiratory care, healthcare infrastructure hardening, and medication supply chain resilience were largely absent from the literature,” he said. “We were further struck by the limited amount of research originating from the most climate-affected areas such as in the Global South, where outdoor air pollution already results in over 4 million deaths per year,” he noted.
Although clinicians increasingly recognize that climate change and extreme weather threaten lung health, solutions are needed to make health systems resilient, accessible, and adaptable, especially with the likely increase in demand for respiratory care, Dr. Rabin emphasized.
More research is needed on preventive measures that could mitigate the risk for bad air quality, heat, and other extreme climate change events on vulnerable populations, said Dr. Rabin. “Every domain of healthcare delivery, from pharmaceutical procurement to hospital heating and cooling system design, must account for these environmental changes,” he said. “More collaboration is needed with researchers and clinicians in areas of the world that are underrepresented and underresourced to help share knowledge and tools to build health system resilience.”
Takeaways and Next Steps
“I was struck by how many studies used healthcare metrics as a way to measure health outcomes but not to measure resilience and efficiency of healthcare systems themselves,” Dr. Lewy said in an interview. “For example, many studies used ED visits or hospital admissions as ways to measure severity of disease associated with a climate event, but the strain that increased visits or admissions have on healthcare systems was barely mentioned,” she noted.
Looking ahead, more studies that focus specifically on infrastructure as it relates to healthcare would be valuable, said Dr. Lewy. Recent research has explored virtual care as a way to mitigate climate change-associated COPD exacerbations, but virtual care may not be reliably accessible in cases of the widespread power and network outages that often accompany storms, heat waves, and other catastrophic weather events, she noted. “More research into these types of logistical factors affecting healthcare systems would be helpful,” she added.
Dr. Rabin disclosed support for the study from the US Department of Veterans Affairs but had no other financial conflicts to disclose. Dr. Lewy had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.