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Specialized care may curb suicide risk in veterans with disabilities
TOPLINE:
Investigators speculate that veteran status may mitigate suicide risk given increased provision of disability-related care through the Department of Veterans Affairs, but they acknowledge that more research is needed to confirm this theory.
METHODOLOGY:
- The study includes analysis of self-reported data collected from 2015 to 2020 from 231,000 NSDUH respondents, 9% of whom were veterans; 20% reported at least one disability.
- Respondents were asked questions about suicide, veteran status, and the number and type of disability they had, if applicable.
- Disabilities included those related to hearing, sight, and concentration, memory, decision-making, ambulation, or functional status (at home or outside the home).
TAKEAWAY:
- Overall, 4.4% of the sample reported suicide ideation, planning, or attempt.
- Among participants with one disability, being a veteran was associated with a 43% lower risk of suicide planning (adjusted odds ratio, 0.57; P = .03).
- Among those with two disabilities, veterans had a 54% lower likelihood of having a history of suicide attempt, compared with nonveterans (aOR, 0.46; P = .02).
- Compared with U.S. veterans reporting 1, 2, and ≥ 3 disabilities, U.S. veterans with no disabilities were 50%, 160%, and 127% more likely, respectively, to report suicidal ideation.
IN PRACTICE:
“The observed buffering effect of veteran status among people with a disability may be reflective of characteristics of disability-related care offered through the Department of Veterans Affairs,” the authors write. “It is possible that VA services could act as a protective factor for suicide-related outcomes for veterans with disabilities by improving access, quality of care, and understanding of their disability context.”
SOURCE:
Rebecca K. Blais, PhD, of Arizona State University, Tempe, led the study, which was published online in JAMA Network Open.
LIMITATIONS:
Assessments were based on self-reported information and there was no information about disability severity, which may have influenced suicide risk among veterans and nonveterans.
DISCLOSURES:
Coauthor Anne Kirby, PhD, received grants from the National Institute of Mental Health during the conduct of the study as well as grants from the U.S. Centers for Disease Control and Prevention and personal fees from University of Pittsburgh outside the submitted work. No other disclosures were reported.
A version of this article first appeared on Medscape.com.
TOPLINE:
Investigators speculate that veteran status may mitigate suicide risk given increased provision of disability-related care through the Department of Veterans Affairs, but they acknowledge that more research is needed to confirm this theory.
METHODOLOGY:
- The study includes analysis of self-reported data collected from 2015 to 2020 from 231,000 NSDUH respondents, 9% of whom were veterans; 20% reported at least one disability.
- Respondents were asked questions about suicide, veteran status, and the number and type of disability they had, if applicable.
- Disabilities included those related to hearing, sight, and concentration, memory, decision-making, ambulation, or functional status (at home or outside the home).
TAKEAWAY:
- Overall, 4.4% of the sample reported suicide ideation, planning, or attempt.
- Among participants with one disability, being a veteran was associated with a 43% lower risk of suicide planning (adjusted odds ratio, 0.57; P = .03).
- Among those with two disabilities, veterans had a 54% lower likelihood of having a history of suicide attempt, compared with nonveterans (aOR, 0.46; P = .02).
- Compared with U.S. veterans reporting 1, 2, and ≥ 3 disabilities, U.S. veterans with no disabilities were 50%, 160%, and 127% more likely, respectively, to report suicidal ideation.
IN PRACTICE:
“The observed buffering effect of veteran status among people with a disability may be reflective of characteristics of disability-related care offered through the Department of Veterans Affairs,” the authors write. “It is possible that VA services could act as a protective factor for suicide-related outcomes for veterans with disabilities by improving access, quality of care, and understanding of their disability context.”
SOURCE:
Rebecca K. Blais, PhD, of Arizona State University, Tempe, led the study, which was published online in JAMA Network Open.
LIMITATIONS:
Assessments were based on self-reported information and there was no information about disability severity, which may have influenced suicide risk among veterans and nonveterans.
DISCLOSURES:
Coauthor Anne Kirby, PhD, received grants from the National Institute of Mental Health during the conduct of the study as well as grants from the U.S. Centers for Disease Control and Prevention and personal fees from University of Pittsburgh outside the submitted work. No other disclosures were reported.
A version of this article first appeared on Medscape.com.
TOPLINE:
Investigators speculate that veteran status may mitigate suicide risk given increased provision of disability-related care through the Department of Veterans Affairs, but they acknowledge that more research is needed to confirm this theory.
METHODOLOGY:
- The study includes analysis of self-reported data collected from 2015 to 2020 from 231,000 NSDUH respondents, 9% of whom were veterans; 20% reported at least one disability.
- Respondents were asked questions about suicide, veteran status, and the number and type of disability they had, if applicable.
- Disabilities included those related to hearing, sight, and concentration, memory, decision-making, ambulation, or functional status (at home or outside the home).
TAKEAWAY:
- Overall, 4.4% of the sample reported suicide ideation, planning, or attempt.
- Among participants with one disability, being a veteran was associated with a 43% lower risk of suicide planning (adjusted odds ratio, 0.57; P = .03).
- Among those with two disabilities, veterans had a 54% lower likelihood of having a history of suicide attempt, compared with nonveterans (aOR, 0.46; P = .02).
- Compared with U.S. veterans reporting 1, 2, and ≥ 3 disabilities, U.S. veterans with no disabilities were 50%, 160%, and 127% more likely, respectively, to report suicidal ideation.
IN PRACTICE:
“The observed buffering effect of veteran status among people with a disability may be reflective of characteristics of disability-related care offered through the Department of Veterans Affairs,” the authors write. “It is possible that VA services could act as a protective factor for suicide-related outcomes for veterans with disabilities by improving access, quality of care, and understanding of their disability context.”
SOURCE:
Rebecca K. Blais, PhD, of Arizona State University, Tempe, led the study, which was published online in JAMA Network Open.
LIMITATIONS:
Assessments were based on self-reported information and there was no information about disability severity, which may have influenced suicide risk among veterans and nonveterans.
DISCLOSURES:
Coauthor Anne Kirby, PhD, received grants from the National Institute of Mental Health during the conduct of the study as well as grants from the U.S. Centers for Disease Control and Prevention and personal fees from University of Pittsburgh outside the submitted work. No other disclosures were reported.
A version of this article first appeared on Medscape.com.
How Does Military Service Impact Cancer Risk? It’s Complicated
CHICAGO—While it’s extremely difficult to link cancer rates to military service, researchers are starting to get some initial inklings of possible connections, a US Department of Veterans Affairs (VA) oncologist told an audience at the 2023 annual meeting of the Association of VA Hematology/Oncology.
One study found surprising levels of abnormal proteins and cancer in the blood of service members, said Christin DeStefano, MD, of David Grant US Air Force Medical Center at Travis Air Force Base in California. Another may have uncovered a link between military trauma and lymphoma. And an analysis of pilots found they have higher rates of certain kinds of cancer— but lower levels of other cancer types.
“It is hard to tell if service-related exposures heighten the risk of cancer. Some aspects of military service might increase cancer risk,” DeStefano said. “But other aspects of military service might decrease cancer risk.”
The VA has been especially focused on the possible link between military service and cancer since the passage of the PACT Act in 2022. The legislation prioritizes claims for cancer, terminal illnesses, and homelessness, and it’s sparked more than 4.1 million free toxic-exposure screenings for veterans.
VA Under Secretary for Health Shereef Elnahal, MD, MBA, noted in the keynote address at the 2023 AVAHO annual meeting that “Every type of solid tumor is now considered a presumptive condition associated with burden of exposure to veterans deployed anywhere in Central Command, either in the Persian Gulf War or the post-9/11 conflicts.”
DeStefano noted that there are a variety of challenges to analyzing data regarding connections between military exposure and cancer. For one, “it’s hard to include people from the time they enter the military to postmilitary service. Some are getting their health care in the civilian health care systems.” In addition, “There are a lot of problems with ICD-9 and ICD-10 codes, which can be very erroneous. Maybe somebody came in with a mass, the doctor or the nurse practitioner was busy and they put down ‘suspected cancer,’ and now they have that ICD code in their chart where they never actually had cancer.” This is why more reliable cancer registries are so important, she said.
Another challenge is figuring out when exposures occurred and whether they actually occurred in the military at all. “There are multiple studies suggesting that a first driver event is often acquired 20 to 40 years before a cancer diagnosis, often in one’s 20s and 30s,” she said. “It's hard to quantify an exposure, since there can be exposures before military service and exposures after military service. The amount of exposure and duration of exposure might differ, and individuals might metabolize the exposures differently from each other.”
To make matters more complicated, research is pointing in surprising directions. DeStefano highlighted her not-yet-published study of monoclonal gammopathy (MG), a condition in which abnormal proteins are found in the blood, in 534 service members. MG can be a cancer precursor. Those exposed to burn pits in Iraq had similar risks of MG (6.7%) vs an unexposed, matched control group (5.4%; P = .22), Dr. DeStefano said. Over a mean follow-up of 14 years and 10 years, respectively, 7% of participants in each group developed cancer.
“You might think, ‘this is a negative study. There's no difference.’ However, it is very notable that the prevalence of monoclonal gammopathy was 6.1%. That is 3 times as high as we would expect in somebody in their 40s,” she said. “Also, 7% having a cancer diagnosis is not insignificant.” She added: “It is very possible that many of these service members already have full-blown multiple myeloma or something associated with monoclonal gammopathy that just has not been diagnosed yet.”
In another study, this one published in 2021, Dr. DeStefano and colleagues tracked 8834 injured Iraq/Afghanistan veterans and compared them with matched controls to see if there was a link between severe trauma and cancer. There wasn’t except for lymphoma (22 vs 7 cases, respectively; odds ratio = 3.1; 95% CI, 1.34-7.37; P = .008). The connection remained after adjustment for confounders.
What’s going on? “It’s possible that blast injury might induce some alterations to the immune system that might set the stage for lymphoma genesis,” she said. “Or maybe that blast injury is a surrogate for a toxic exposure: Maybe carcinogens are released during a blast injury.”
Dr. DeStefano also highlighted a 2022 study that tracked 386,190 Air Force officers. The study found that combat pilots (9.1% of the total) had greater adjusted odds of testicular and prostate cancers and melanoma than the other officers. Why? “Military pilots have exposure to cosmic ionizing radiation as well as ultraviolet radiation,” she said.
But while “these are scary, sobering things,” she noted that combat pilots were less likely to develop several cancers than the general population, including kidney, testicular, colorectal, bladder and thyroid cancer, and they were less likely to die from colorectal cancer.
CHICAGO—While it’s extremely difficult to link cancer rates to military service, researchers are starting to get some initial inklings of possible connections, a US Department of Veterans Affairs (VA) oncologist told an audience at the 2023 annual meeting of the Association of VA Hematology/Oncology.
One study found surprising levels of abnormal proteins and cancer in the blood of service members, said Christin DeStefano, MD, of David Grant US Air Force Medical Center at Travis Air Force Base in California. Another may have uncovered a link between military trauma and lymphoma. And an analysis of pilots found they have higher rates of certain kinds of cancer— but lower levels of other cancer types.
“It is hard to tell if service-related exposures heighten the risk of cancer. Some aspects of military service might increase cancer risk,” DeStefano said. “But other aspects of military service might decrease cancer risk.”
The VA has been especially focused on the possible link between military service and cancer since the passage of the PACT Act in 2022. The legislation prioritizes claims for cancer, terminal illnesses, and homelessness, and it’s sparked more than 4.1 million free toxic-exposure screenings for veterans.
VA Under Secretary for Health Shereef Elnahal, MD, MBA, noted in the keynote address at the 2023 AVAHO annual meeting that “Every type of solid tumor is now considered a presumptive condition associated with burden of exposure to veterans deployed anywhere in Central Command, either in the Persian Gulf War or the post-9/11 conflicts.”
DeStefano noted that there are a variety of challenges to analyzing data regarding connections between military exposure and cancer. For one, “it’s hard to include people from the time they enter the military to postmilitary service. Some are getting their health care in the civilian health care systems.” In addition, “There are a lot of problems with ICD-9 and ICD-10 codes, which can be very erroneous. Maybe somebody came in with a mass, the doctor or the nurse practitioner was busy and they put down ‘suspected cancer,’ and now they have that ICD code in their chart where they never actually had cancer.” This is why more reliable cancer registries are so important, she said.
Another challenge is figuring out when exposures occurred and whether they actually occurred in the military at all. “There are multiple studies suggesting that a first driver event is often acquired 20 to 40 years before a cancer diagnosis, often in one’s 20s and 30s,” she said. “It's hard to quantify an exposure, since there can be exposures before military service and exposures after military service. The amount of exposure and duration of exposure might differ, and individuals might metabolize the exposures differently from each other.”
To make matters more complicated, research is pointing in surprising directions. DeStefano highlighted her not-yet-published study of monoclonal gammopathy (MG), a condition in which abnormal proteins are found in the blood, in 534 service members. MG can be a cancer precursor. Those exposed to burn pits in Iraq had similar risks of MG (6.7%) vs an unexposed, matched control group (5.4%; P = .22), Dr. DeStefano said. Over a mean follow-up of 14 years and 10 years, respectively, 7% of participants in each group developed cancer.
“You might think, ‘this is a negative study. There's no difference.’ However, it is very notable that the prevalence of monoclonal gammopathy was 6.1%. That is 3 times as high as we would expect in somebody in their 40s,” she said. “Also, 7% having a cancer diagnosis is not insignificant.” She added: “It is very possible that many of these service members already have full-blown multiple myeloma or something associated with monoclonal gammopathy that just has not been diagnosed yet.”
In another study, this one published in 2021, Dr. DeStefano and colleagues tracked 8834 injured Iraq/Afghanistan veterans and compared them with matched controls to see if there was a link between severe trauma and cancer. There wasn’t except for lymphoma (22 vs 7 cases, respectively; odds ratio = 3.1; 95% CI, 1.34-7.37; P = .008). The connection remained after adjustment for confounders.
What’s going on? “It’s possible that blast injury might induce some alterations to the immune system that might set the stage for lymphoma genesis,” she said. “Or maybe that blast injury is a surrogate for a toxic exposure: Maybe carcinogens are released during a blast injury.”
Dr. DeStefano also highlighted a 2022 study that tracked 386,190 Air Force officers. The study found that combat pilots (9.1% of the total) had greater adjusted odds of testicular and prostate cancers and melanoma than the other officers. Why? “Military pilots have exposure to cosmic ionizing radiation as well as ultraviolet radiation,” she said.
But while “these are scary, sobering things,” she noted that combat pilots were less likely to develop several cancers than the general population, including kidney, testicular, colorectal, bladder and thyroid cancer, and they were less likely to die from colorectal cancer.
CHICAGO—While it’s extremely difficult to link cancer rates to military service, researchers are starting to get some initial inklings of possible connections, a US Department of Veterans Affairs (VA) oncologist told an audience at the 2023 annual meeting of the Association of VA Hematology/Oncology.
One study found surprising levels of abnormal proteins and cancer in the blood of service members, said Christin DeStefano, MD, of David Grant US Air Force Medical Center at Travis Air Force Base in California. Another may have uncovered a link between military trauma and lymphoma. And an analysis of pilots found they have higher rates of certain kinds of cancer— but lower levels of other cancer types.
“It is hard to tell if service-related exposures heighten the risk of cancer. Some aspects of military service might increase cancer risk,” DeStefano said. “But other aspects of military service might decrease cancer risk.”
The VA has been especially focused on the possible link between military service and cancer since the passage of the PACT Act in 2022. The legislation prioritizes claims for cancer, terminal illnesses, and homelessness, and it’s sparked more than 4.1 million free toxic-exposure screenings for veterans.
VA Under Secretary for Health Shereef Elnahal, MD, MBA, noted in the keynote address at the 2023 AVAHO annual meeting that “Every type of solid tumor is now considered a presumptive condition associated with burden of exposure to veterans deployed anywhere in Central Command, either in the Persian Gulf War or the post-9/11 conflicts.”
DeStefano noted that there are a variety of challenges to analyzing data regarding connections between military exposure and cancer. For one, “it’s hard to include people from the time they enter the military to postmilitary service. Some are getting their health care in the civilian health care systems.” In addition, “There are a lot of problems with ICD-9 and ICD-10 codes, which can be very erroneous. Maybe somebody came in with a mass, the doctor or the nurse practitioner was busy and they put down ‘suspected cancer,’ and now they have that ICD code in their chart where they never actually had cancer.” This is why more reliable cancer registries are so important, she said.
Another challenge is figuring out when exposures occurred and whether they actually occurred in the military at all. “There are multiple studies suggesting that a first driver event is often acquired 20 to 40 years before a cancer diagnosis, often in one’s 20s and 30s,” she said. “It's hard to quantify an exposure, since there can be exposures before military service and exposures after military service. The amount of exposure and duration of exposure might differ, and individuals might metabolize the exposures differently from each other.”
To make matters more complicated, research is pointing in surprising directions. DeStefano highlighted her not-yet-published study of monoclonal gammopathy (MG), a condition in which abnormal proteins are found in the blood, in 534 service members. MG can be a cancer precursor. Those exposed to burn pits in Iraq had similar risks of MG (6.7%) vs an unexposed, matched control group (5.4%; P = .22), Dr. DeStefano said. Over a mean follow-up of 14 years and 10 years, respectively, 7% of participants in each group developed cancer.
“You might think, ‘this is a negative study. There's no difference.’ However, it is very notable that the prevalence of monoclonal gammopathy was 6.1%. That is 3 times as high as we would expect in somebody in their 40s,” she said. “Also, 7% having a cancer diagnosis is not insignificant.” She added: “It is very possible that many of these service members already have full-blown multiple myeloma or something associated with monoclonal gammopathy that just has not been diagnosed yet.”
In another study, this one published in 2021, Dr. DeStefano and colleagues tracked 8834 injured Iraq/Afghanistan veterans and compared them with matched controls to see if there was a link between severe trauma and cancer. There wasn’t except for lymphoma (22 vs 7 cases, respectively; odds ratio = 3.1; 95% CI, 1.34-7.37; P = .008). The connection remained after adjustment for confounders.
What’s going on? “It’s possible that blast injury might induce some alterations to the immune system that might set the stage for lymphoma genesis,” she said. “Or maybe that blast injury is a surrogate for a toxic exposure: Maybe carcinogens are released during a blast injury.”
Dr. DeStefano also highlighted a 2022 study that tracked 386,190 Air Force officers. The study found that combat pilots (9.1% of the total) had greater adjusted odds of testicular and prostate cancers and melanoma than the other officers. Why? “Military pilots have exposure to cosmic ionizing radiation as well as ultraviolet radiation,” she said.
But while “these are scary, sobering things,” she noted that combat pilots were less likely to develop several cancers than the general population, including kidney, testicular, colorectal, bladder and thyroid cancer, and they were less likely to die from colorectal cancer.
Study reveals potentially unnecessary CRC screening in older adults
TOPLINE:
Older adults with limited life expectancy are just as likely to undergo colorectal cancer (CRC) screening as those with longer life expectancy, a new study shows.
METHODOLOGY:
- Researchers used national survey data to estimate the prevalence and factors associated with CRC screening in 25,888 community-dwelling adults aged 65-84 according to their predicted 10-year mortality risk.
- They estimated 10-year mortality risk using a validated index. From the lowest to highest quintiles, mortality risk was 12%, 24%, 39%, 58%, and 79%, respectively.
- Investigators determined the proportion of screening performed in adults with life expectancy less than 10 years, defined as 10-year mortality risk ≥ 50% (that is, quintiles 4 and 5).
TAKEAWAY:
- In this cohort of older adults previously not up to date with CRC screening, the overall prevalence of past-year screening was 38.5%.
- The prevalence of past-year CRC screening decreased with advancing age but did not differ significantly by 10-year mortality risk. From lowest to highest quintile, prevalence was 39.5%, 40.6%, 38.7%, 36.4%, and 35.4%, respectively.
- The likelihood of CRC screening did not differ between adults in the lowest vs. highest quintile of 10-year mortality risk (adjusted odds ratio, 1.05).
- More than one-quarter (27.9%) of past-year screening occurred in adults with life expectancy less than 10 years, and 50.7% of adults aged 75-84 years had life expectancy less than 10 years at the time of screening.
- Paradoxically, the prevalence of invasive screening increased with lowered life expectancy among adults aged 70-79 years.
IN PRACTICE:
“Our results suggest that health status and life expectancy may be overlooked in current CRC screening programs, and personalized screening incorporating individual life expectancy may improve the value of screening,” the authors write.
SOURCE:
The study, with first author Po-Hong Liu, MD, MPH, division of digestive and liver diseases, University of Texas Southwestern Medical Center, Dallas, was published online in the American Journal of Gastroenterology.
LIMITATIONS:
The survey data were self-reported and were not validated by medical records. The data did not include information to identify individuals who were at higher risk for CRC or to trace prior CRC screening history. It was not possible to reliably classify test indication (screening vs. surveillance vs. diagnostic).
DISCLOSURES:
The study was supported by the National Institutes of Health. One author disclosed serving as a consultant or on advisory boards for Exact Sciences, Universal Dx, Roche, and Freenome. Another disclosed consulting for Freenome.
A version of this article first appeared on Medscape.com.
TOPLINE:
Older adults with limited life expectancy are just as likely to undergo colorectal cancer (CRC) screening as those with longer life expectancy, a new study shows.
METHODOLOGY:
- Researchers used national survey data to estimate the prevalence and factors associated with CRC screening in 25,888 community-dwelling adults aged 65-84 according to their predicted 10-year mortality risk.
- They estimated 10-year mortality risk using a validated index. From the lowest to highest quintiles, mortality risk was 12%, 24%, 39%, 58%, and 79%, respectively.
- Investigators determined the proportion of screening performed in adults with life expectancy less than 10 years, defined as 10-year mortality risk ≥ 50% (that is, quintiles 4 and 5).
TAKEAWAY:
- In this cohort of older adults previously not up to date with CRC screening, the overall prevalence of past-year screening was 38.5%.
- The prevalence of past-year CRC screening decreased with advancing age but did not differ significantly by 10-year mortality risk. From lowest to highest quintile, prevalence was 39.5%, 40.6%, 38.7%, 36.4%, and 35.4%, respectively.
- The likelihood of CRC screening did not differ between adults in the lowest vs. highest quintile of 10-year mortality risk (adjusted odds ratio, 1.05).
- More than one-quarter (27.9%) of past-year screening occurred in adults with life expectancy less than 10 years, and 50.7% of adults aged 75-84 years had life expectancy less than 10 years at the time of screening.
- Paradoxically, the prevalence of invasive screening increased with lowered life expectancy among adults aged 70-79 years.
IN PRACTICE:
“Our results suggest that health status and life expectancy may be overlooked in current CRC screening programs, and personalized screening incorporating individual life expectancy may improve the value of screening,” the authors write.
SOURCE:
The study, with first author Po-Hong Liu, MD, MPH, division of digestive and liver diseases, University of Texas Southwestern Medical Center, Dallas, was published online in the American Journal of Gastroenterology.
LIMITATIONS:
The survey data were self-reported and were not validated by medical records. The data did not include information to identify individuals who were at higher risk for CRC or to trace prior CRC screening history. It was not possible to reliably classify test indication (screening vs. surveillance vs. diagnostic).
DISCLOSURES:
The study was supported by the National Institutes of Health. One author disclosed serving as a consultant or on advisory boards for Exact Sciences, Universal Dx, Roche, and Freenome. Another disclosed consulting for Freenome.
A version of this article first appeared on Medscape.com.
TOPLINE:
Older adults with limited life expectancy are just as likely to undergo colorectal cancer (CRC) screening as those with longer life expectancy, a new study shows.
METHODOLOGY:
- Researchers used national survey data to estimate the prevalence and factors associated with CRC screening in 25,888 community-dwelling adults aged 65-84 according to their predicted 10-year mortality risk.
- They estimated 10-year mortality risk using a validated index. From the lowest to highest quintiles, mortality risk was 12%, 24%, 39%, 58%, and 79%, respectively.
- Investigators determined the proportion of screening performed in adults with life expectancy less than 10 years, defined as 10-year mortality risk ≥ 50% (that is, quintiles 4 and 5).
TAKEAWAY:
- In this cohort of older adults previously not up to date with CRC screening, the overall prevalence of past-year screening was 38.5%.
- The prevalence of past-year CRC screening decreased with advancing age but did not differ significantly by 10-year mortality risk. From lowest to highest quintile, prevalence was 39.5%, 40.6%, 38.7%, 36.4%, and 35.4%, respectively.
- The likelihood of CRC screening did not differ between adults in the lowest vs. highest quintile of 10-year mortality risk (adjusted odds ratio, 1.05).
- More than one-quarter (27.9%) of past-year screening occurred in adults with life expectancy less than 10 years, and 50.7% of adults aged 75-84 years had life expectancy less than 10 years at the time of screening.
- Paradoxically, the prevalence of invasive screening increased with lowered life expectancy among adults aged 70-79 years.
IN PRACTICE:
“Our results suggest that health status and life expectancy may be overlooked in current CRC screening programs, and personalized screening incorporating individual life expectancy may improve the value of screening,” the authors write.
SOURCE:
The study, with first author Po-Hong Liu, MD, MPH, division of digestive and liver diseases, University of Texas Southwestern Medical Center, Dallas, was published online in the American Journal of Gastroenterology.
LIMITATIONS:
The survey data were self-reported and were not validated by medical records. The data did not include information to identify individuals who were at higher risk for CRC or to trace prior CRC screening history. It was not possible to reliably classify test indication (screening vs. surveillance vs. diagnostic).
DISCLOSURES:
The study was supported by the National Institutes of Health. One author disclosed serving as a consultant or on advisory boards for Exact Sciences, Universal Dx, Roche, and Freenome. Another disclosed consulting for Freenome.
A version of this article first appeared on Medscape.com.
Common meds link to sudden cardiac arrest in type 2 diabetes
HAMBURG, Germany – , shows the first such analysis of real-world, primary care data.
People with type 2 diabetes who do not have a history of CVD have almost three times the risk of SCA if they take antipsychotic medications and nearly double the risk if they take certain antibiotics that prolong the QT interval, notably, macrolides and fluoroquinolones.
“These data show that commonly prescribed drugs - antipsychotic medications, used by about 3% of people with type 2 diabetes, and antibiotics, taken by 5% to 10%, convey an increased risk of sudden cardiac arrest in those without a history of cardiovascular disease,” said Peter Harms, MSc, who presented the study at the annual meeting of the European Association for the Study of Diabetes. Another drug associated with an increase in SCA among patients with diabetes was domperidone, an antinausea medication.
“Perhaps these drugs could be avoided in some cases, and GPs should be more aware of the possible consequences of their use,” he added. “If the patient has type 2 diabetes, then maybe it’s better to avoid some of these medications and try and cope without them, or at least find an alternative antibiotic.”
Mr. Harms, an epidemiologist from Amsterdam University Medical Centers, highlighted that their study was unique because the investigators drew upon primary care data. “These data are extensive, and we find a lot of associations which are very real.”
SCA is associated with 50% of all cardiac deaths and accounts for 20% of all mortality in high-income countries. Of those people who experience SCA, 80% of cases prove fatal.
“As the name suggests, it is difficult to predict because it is sudden, especially in people without a cardiovascular disease history,” Mr. Harms pointed out in an interview with this news organization. He highlighted that “around half of those who experience SCA, often between the ages of 40 and 60 years, have never seen a cardiologist, but many do have type 2 diabetes.
“We need to better understand how to recognize people at risk of SCA, know who to watch and how to prevent these events,” he emphasized.
Vladimira Fejfarova, MD, comoderated the session and commented on the study. “From the clinical point of view, it’s necessary to evaluate risk factors that can contribute to sudden cardiac arrest.”
Overall, the researchers found that, among people with type 2 diabetes who do not have a history of CVD, hypoglycemia, severe hypertension, dyslipidemia, and use of QTc-prolonging medications are associated with SCA risk. Among people with type 2 diabetes and CVD, albuminuria and heart failure are associated with SCA risk.
Dr. Fejfarova added: “With type 2 diabetes and also type 1, we need to look more at adverse events, especially when treating infections with macrolides, but also mycotic infections, because antimycotic drugs are known to influence QT intervals that could contribute to sudden cardiac arrest.
“We need to be more cautious with prescribing certain antibiotics that have these side effects in our patients with diabetes,” asserted Dr. Fejfarova, from the Diabetes Centre, Institute for Clinical and Experimental Medicine, Prague.
Type 2 diabetes doubles the risk of SCA
The researcher decided to investigate the population of people with type 2 diabetes because their risk of SCD is around twice that of those without type 2 diabetes. Because these patients have relatively frequent checkups with general practitioners, Mr. Harms turned to primary care databases that contained comprehensive and relatively routine information on risk indicators.
Longitudinal associations between clinical characteristics of 3,919 patients with type 2 diabetes – both those with and those without a history of CVD – and SCA (a total of 689 patients) were determined.
Cases were found in the AmsteRdam REsuscitation STtudies (ARREST) registry of out-of-hospital resuscitation attempts by emergency medical services in the Dutch region of Noord-Holland from 2010 to 2019. Case patients were matched with up to five control patients. The control group comprised people with type 2 diabetes who had not experienced an SCA. Control patients were sourced from the same primary care practices who were of similar age and sex. Clinical measurements, including blood pressure and blood glucose readings, medication use, and medical history for the 5 years leading up to an SCA, were obtained from general practice records. A multivariable analysis was performed, and results were stratified for people with and for those without a history of CVD.
Of particular interest were drugs that interfere with cardiac function, including some prokinetic, antibiotic, and antipsychotic medications. All of the drugs are known to be associated with a change in QTc prolongation. Examples include domperidone (QTc-prolonging prokinetic), macrolides and fluoroquinolones (QTc-prolonging antibiotics), and haloperidol (a QTc-prolonging antipsychotic).
Antibiotic and antipsychotic use might contribute to SCA in T2D
Case patients and control patients were similar in age, hemoglobin A1c level, and other characteristics with the exception that more patients with SCA had a history of CVD (40.0% vs. 29.4%).
“Looking at the associations in the overall population, insulin use was strongly associated with SCA risk [hazard ratio, 2.38] and perhaps this was an indicator of severity of type 2 diabetes,” remarked Mr. Harms. “Also, unsurprisingly, a history of arrhythmia [HR, 1.68] and, more surprisingly, prokinetic drug use [HR, 1.66; 95% confidence interval, 1.20-2.31], specifically those known for QTc-prolongation, were associated with SCA.”
Among people who had experienced an SCA and who did not have a history of CVD (337 case patients/2,023 control patients), QTc-prolonging antipsychotic medication use was associated with SCA at an HR of 2.87, and antibiotic medication use was associated with SCA at an HR of 1.66. A low fasting glucose level (< 4.5 mmol/mol) was associated with SCA at an HR of 2.5; severely high systolic blood pressure (> 180 mm Hg) was associated with SCA at an HR of 2.21; low HDL cholesterol level, with an HR of 1.35; and high LDL cholesterol level (> 2.6 mmol/L), with an HR of 1.64.
Among people with a history of CVD (352 case patients/1,207 control patients), associations between albuminuria and SCA were moderate (HR, 1.54) and severe (HR, 1.55); heart failure was associated with SCA at an HR of 1.85 (95% CI, 1.50-2.29).
Comoderator Dr. Fejfarova added that, in addition to the findings from Dr. Harms’ study, other research presented in the same session highlighted the importance of checking patients for the presence of arrhythmias that could lead to the development of atrioventricular blocks, sinus node diseases, and SCA.
Mr. Harms and Dr. Fejfarova have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
HAMBURG, Germany – , shows the first such analysis of real-world, primary care data.
People with type 2 diabetes who do not have a history of CVD have almost three times the risk of SCA if they take antipsychotic medications and nearly double the risk if they take certain antibiotics that prolong the QT interval, notably, macrolides and fluoroquinolones.
“These data show that commonly prescribed drugs - antipsychotic medications, used by about 3% of people with type 2 diabetes, and antibiotics, taken by 5% to 10%, convey an increased risk of sudden cardiac arrest in those without a history of cardiovascular disease,” said Peter Harms, MSc, who presented the study at the annual meeting of the European Association for the Study of Diabetes. Another drug associated with an increase in SCA among patients with diabetes was domperidone, an antinausea medication.
“Perhaps these drugs could be avoided in some cases, and GPs should be more aware of the possible consequences of their use,” he added. “If the patient has type 2 diabetes, then maybe it’s better to avoid some of these medications and try and cope without them, or at least find an alternative antibiotic.”
Mr. Harms, an epidemiologist from Amsterdam University Medical Centers, highlighted that their study was unique because the investigators drew upon primary care data. “These data are extensive, and we find a lot of associations which are very real.”
SCA is associated with 50% of all cardiac deaths and accounts for 20% of all mortality in high-income countries. Of those people who experience SCA, 80% of cases prove fatal.
“As the name suggests, it is difficult to predict because it is sudden, especially in people without a cardiovascular disease history,” Mr. Harms pointed out in an interview with this news organization. He highlighted that “around half of those who experience SCA, often between the ages of 40 and 60 years, have never seen a cardiologist, but many do have type 2 diabetes.
“We need to better understand how to recognize people at risk of SCA, know who to watch and how to prevent these events,” he emphasized.
Vladimira Fejfarova, MD, comoderated the session and commented on the study. “From the clinical point of view, it’s necessary to evaluate risk factors that can contribute to sudden cardiac arrest.”
Overall, the researchers found that, among people with type 2 diabetes who do not have a history of CVD, hypoglycemia, severe hypertension, dyslipidemia, and use of QTc-prolonging medications are associated with SCA risk. Among people with type 2 diabetes and CVD, albuminuria and heart failure are associated with SCA risk.
Dr. Fejfarova added: “With type 2 diabetes and also type 1, we need to look more at adverse events, especially when treating infections with macrolides, but also mycotic infections, because antimycotic drugs are known to influence QT intervals that could contribute to sudden cardiac arrest.
“We need to be more cautious with prescribing certain antibiotics that have these side effects in our patients with diabetes,” asserted Dr. Fejfarova, from the Diabetes Centre, Institute for Clinical and Experimental Medicine, Prague.
Type 2 diabetes doubles the risk of SCA
The researcher decided to investigate the population of people with type 2 diabetes because their risk of SCD is around twice that of those without type 2 diabetes. Because these patients have relatively frequent checkups with general practitioners, Mr. Harms turned to primary care databases that contained comprehensive and relatively routine information on risk indicators.
Longitudinal associations between clinical characteristics of 3,919 patients with type 2 diabetes – both those with and those without a history of CVD – and SCA (a total of 689 patients) were determined.
Cases were found in the AmsteRdam REsuscitation STtudies (ARREST) registry of out-of-hospital resuscitation attempts by emergency medical services in the Dutch region of Noord-Holland from 2010 to 2019. Case patients were matched with up to five control patients. The control group comprised people with type 2 diabetes who had not experienced an SCA. Control patients were sourced from the same primary care practices who were of similar age and sex. Clinical measurements, including blood pressure and blood glucose readings, medication use, and medical history for the 5 years leading up to an SCA, were obtained from general practice records. A multivariable analysis was performed, and results were stratified for people with and for those without a history of CVD.
Of particular interest were drugs that interfere with cardiac function, including some prokinetic, antibiotic, and antipsychotic medications. All of the drugs are known to be associated with a change in QTc prolongation. Examples include domperidone (QTc-prolonging prokinetic), macrolides and fluoroquinolones (QTc-prolonging antibiotics), and haloperidol (a QTc-prolonging antipsychotic).
Antibiotic and antipsychotic use might contribute to SCA in T2D
Case patients and control patients were similar in age, hemoglobin A1c level, and other characteristics with the exception that more patients with SCA had a history of CVD (40.0% vs. 29.4%).
“Looking at the associations in the overall population, insulin use was strongly associated with SCA risk [hazard ratio, 2.38] and perhaps this was an indicator of severity of type 2 diabetes,” remarked Mr. Harms. “Also, unsurprisingly, a history of arrhythmia [HR, 1.68] and, more surprisingly, prokinetic drug use [HR, 1.66; 95% confidence interval, 1.20-2.31], specifically those known for QTc-prolongation, were associated with SCA.”
Among people who had experienced an SCA and who did not have a history of CVD (337 case patients/2,023 control patients), QTc-prolonging antipsychotic medication use was associated with SCA at an HR of 2.87, and antibiotic medication use was associated with SCA at an HR of 1.66. A low fasting glucose level (< 4.5 mmol/mol) was associated with SCA at an HR of 2.5; severely high systolic blood pressure (> 180 mm Hg) was associated with SCA at an HR of 2.21; low HDL cholesterol level, with an HR of 1.35; and high LDL cholesterol level (> 2.6 mmol/L), with an HR of 1.64.
Among people with a history of CVD (352 case patients/1,207 control patients), associations between albuminuria and SCA were moderate (HR, 1.54) and severe (HR, 1.55); heart failure was associated with SCA at an HR of 1.85 (95% CI, 1.50-2.29).
Comoderator Dr. Fejfarova added that, in addition to the findings from Dr. Harms’ study, other research presented in the same session highlighted the importance of checking patients for the presence of arrhythmias that could lead to the development of atrioventricular blocks, sinus node diseases, and SCA.
Mr. Harms and Dr. Fejfarova have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
HAMBURG, Germany – , shows the first such analysis of real-world, primary care data.
People with type 2 diabetes who do not have a history of CVD have almost three times the risk of SCA if they take antipsychotic medications and nearly double the risk if they take certain antibiotics that prolong the QT interval, notably, macrolides and fluoroquinolones.
“These data show that commonly prescribed drugs - antipsychotic medications, used by about 3% of people with type 2 diabetes, and antibiotics, taken by 5% to 10%, convey an increased risk of sudden cardiac arrest in those without a history of cardiovascular disease,” said Peter Harms, MSc, who presented the study at the annual meeting of the European Association for the Study of Diabetes. Another drug associated with an increase in SCA among patients with diabetes was domperidone, an antinausea medication.
“Perhaps these drugs could be avoided in some cases, and GPs should be more aware of the possible consequences of their use,” he added. “If the patient has type 2 diabetes, then maybe it’s better to avoid some of these medications and try and cope without them, or at least find an alternative antibiotic.”
Mr. Harms, an epidemiologist from Amsterdam University Medical Centers, highlighted that their study was unique because the investigators drew upon primary care data. “These data are extensive, and we find a lot of associations which are very real.”
SCA is associated with 50% of all cardiac deaths and accounts for 20% of all mortality in high-income countries. Of those people who experience SCA, 80% of cases prove fatal.
“As the name suggests, it is difficult to predict because it is sudden, especially in people without a cardiovascular disease history,” Mr. Harms pointed out in an interview with this news organization. He highlighted that “around half of those who experience SCA, often between the ages of 40 and 60 years, have never seen a cardiologist, but many do have type 2 diabetes.
“We need to better understand how to recognize people at risk of SCA, know who to watch and how to prevent these events,” he emphasized.
Vladimira Fejfarova, MD, comoderated the session and commented on the study. “From the clinical point of view, it’s necessary to evaluate risk factors that can contribute to sudden cardiac arrest.”
Overall, the researchers found that, among people with type 2 diabetes who do not have a history of CVD, hypoglycemia, severe hypertension, dyslipidemia, and use of QTc-prolonging medications are associated with SCA risk. Among people with type 2 diabetes and CVD, albuminuria and heart failure are associated with SCA risk.
Dr. Fejfarova added: “With type 2 diabetes and also type 1, we need to look more at adverse events, especially when treating infections with macrolides, but also mycotic infections, because antimycotic drugs are known to influence QT intervals that could contribute to sudden cardiac arrest.
“We need to be more cautious with prescribing certain antibiotics that have these side effects in our patients with diabetes,” asserted Dr. Fejfarova, from the Diabetes Centre, Institute for Clinical and Experimental Medicine, Prague.
Type 2 diabetes doubles the risk of SCA
The researcher decided to investigate the population of people with type 2 diabetes because their risk of SCD is around twice that of those without type 2 diabetes. Because these patients have relatively frequent checkups with general practitioners, Mr. Harms turned to primary care databases that contained comprehensive and relatively routine information on risk indicators.
Longitudinal associations between clinical characteristics of 3,919 patients with type 2 diabetes – both those with and those without a history of CVD – and SCA (a total of 689 patients) were determined.
Cases were found in the AmsteRdam REsuscitation STtudies (ARREST) registry of out-of-hospital resuscitation attempts by emergency medical services in the Dutch region of Noord-Holland from 2010 to 2019. Case patients were matched with up to five control patients. The control group comprised people with type 2 diabetes who had not experienced an SCA. Control patients were sourced from the same primary care practices who were of similar age and sex. Clinical measurements, including blood pressure and blood glucose readings, medication use, and medical history for the 5 years leading up to an SCA, were obtained from general practice records. A multivariable analysis was performed, and results were stratified for people with and for those without a history of CVD.
Of particular interest were drugs that interfere with cardiac function, including some prokinetic, antibiotic, and antipsychotic medications. All of the drugs are known to be associated with a change in QTc prolongation. Examples include domperidone (QTc-prolonging prokinetic), macrolides and fluoroquinolones (QTc-prolonging antibiotics), and haloperidol (a QTc-prolonging antipsychotic).
Antibiotic and antipsychotic use might contribute to SCA in T2D
Case patients and control patients were similar in age, hemoglobin A1c level, and other characteristics with the exception that more patients with SCA had a history of CVD (40.0% vs. 29.4%).
“Looking at the associations in the overall population, insulin use was strongly associated with SCA risk [hazard ratio, 2.38] and perhaps this was an indicator of severity of type 2 diabetes,” remarked Mr. Harms. “Also, unsurprisingly, a history of arrhythmia [HR, 1.68] and, more surprisingly, prokinetic drug use [HR, 1.66; 95% confidence interval, 1.20-2.31], specifically those known for QTc-prolongation, were associated with SCA.”
Among people who had experienced an SCA and who did not have a history of CVD (337 case patients/2,023 control patients), QTc-prolonging antipsychotic medication use was associated with SCA at an HR of 2.87, and antibiotic medication use was associated with SCA at an HR of 1.66. A low fasting glucose level (< 4.5 mmol/mol) was associated with SCA at an HR of 2.5; severely high systolic blood pressure (> 180 mm Hg) was associated with SCA at an HR of 2.21; low HDL cholesterol level, with an HR of 1.35; and high LDL cholesterol level (> 2.6 mmol/L), with an HR of 1.64.
Among people with a history of CVD (352 case patients/1,207 control patients), associations between albuminuria and SCA were moderate (HR, 1.54) and severe (HR, 1.55); heart failure was associated with SCA at an HR of 1.85 (95% CI, 1.50-2.29).
Comoderator Dr. Fejfarova added that, in addition to the findings from Dr. Harms’ study, other research presented in the same session highlighted the importance of checking patients for the presence of arrhythmias that could lead to the development of atrioventricular blocks, sinus node diseases, and SCA.
Mr. Harms and Dr. Fejfarova have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT EASD 2023
Exercise as good as Viagra for ED: Study
, according to a new analysis of the best research to date on aerobic exercise and erectile function.
The study, published in The Journal of Sexual Medicine, found that aerobic activities – such as walking or cycling – improved erectile function in all men with erectile dysfunction, regardless of body weight, overall health, or medication use. Men with the most severe erectile dysfunction saw the greatest benefit.
“This study provides physicians and patients the proof needed to definitively recommend aerobic activity as part of ED management,” said study author Larry E. Miller, PhD, president, Miller Scientific Consulting, Johnson City, Tenn.
Doctors have long known that erectile function is linked to cardiovascular health, but there is limited high-quality evidence on the impact of exercise on the disorder.
The researchers scoured the scientific literature and found 11 randomized, controlled trials – a preferred study design where participants are randomly assigned to receive an intervention or not. Of the 1,100 men involved in the studies, 600 were assigned to “experimental” groups that typically exercised for 30 to 60 minutes, three to five times a week, while 500 were assigned to “control” groups with no exercise plan.
The worse the ED was, the more exercise helped, the researchers found. On a standardized scale of 6 to 30, men with severe ED who exercised reported a 5-point improvement in erectile function. Those with mild and moderate ED saw improvements of 2 and 3 points, respectively.
By comparison, phosphodiesterase-5 inhibitors – like sildenafil (Viagra) or tadalafil (Cialis) – can lead to improvements of 4 to 8 points, the study authors note. And testosterone replacement therapy can lead to an improvement of 2 points.
“We were particularly impressed by the finding that men with more severe erectile dysfunction saw greater improvements with exercise, and these improvements were similar to those seen in men taking” drugs like Viagra, Dr. Miller said.
ED and heart health
Erectile dysfunction can often be traced to the same causes as cardiovascular disease, including inflammation, a narrowing of the arteries (endothelial dysfunction), or a hardening of the arteries (atherosclerosis).
“It’s important to recognize that erectile dysfunction can often serve as an indicator or barometer of underlying cardiovascular health,” said Amy Pearlman, MD, a urologist specializing in male sexual health at Prime Institute in Miami.
Dr. Pearlman was not involved in the study but thinks the results make sense. “It stands to reason that any intervention aimed at enhancing cardiovascular health may also have a positive impact on erectile health.”
But what was surprising was that aerobic exercise reduced symptoms on par with medications like Viagra, said urologist Rahul Mehan, MD, founder of East Valley Urology Center, in Mesa, Ariz. (Dr. Mehan was also not involved in the study.)
While erectile dysfunction medications are generally affordable and accessible, some patients don’t want to take them or can’t tolerate the side effects. These can include “headache, heartburn, nausea, flushing, and pain in muscles, back, arms, or legs,” said Dr. Mehan. He adds, “Everyone can exercise.”
Some doctors, including Dr. Mehan, already recommend exercise to their patients with ED.
Now they can tell patients that it’s “a proven approach backed by high-quality data from randomized studies,” Dr. Miller said. “Exercise is low risk and affordable, making it an ideal first-line treatment option for erectile difficulties, especially for patients unwilling or unable to use medications.”
A version of this article first appeared on Medscape.com.
, according to a new analysis of the best research to date on aerobic exercise and erectile function.
The study, published in The Journal of Sexual Medicine, found that aerobic activities – such as walking or cycling – improved erectile function in all men with erectile dysfunction, regardless of body weight, overall health, or medication use. Men with the most severe erectile dysfunction saw the greatest benefit.
“This study provides physicians and patients the proof needed to definitively recommend aerobic activity as part of ED management,” said study author Larry E. Miller, PhD, president, Miller Scientific Consulting, Johnson City, Tenn.
Doctors have long known that erectile function is linked to cardiovascular health, but there is limited high-quality evidence on the impact of exercise on the disorder.
The researchers scoured the scientific literature and found 11 randomized, controlled trials – a preferred study design where participants are randomly assigned to receive an intervention or not. Of the 1,100 men involved in the studies, 600 were assigned to “experimental” groups that typically exercised for 30 to 60 minutes, three to five times a week, while 500 were assigned to “control” groups with no exercise plan.
The worse the ED was, the more exercise helped, the researchers found. On a standardized scale of 6 to 30, men with severe ED who exercised reported a 5-point improvement in erectile function. Those with mild and moderate ED saw improvements of 2 and 3 points, respectively.
By comparison, phosphodiesterase-5 inhibitors – like sildenafil (Viagra) or tadalafil (Cialis) – can lead to improvements of 4 to 8 points, the study authors note. And testosterone replacement therapy can lead to an improvement of 2 points.
“We were particularly impressed by the finding that men with more severe erectile dysfunction saw greater improvements with exercise, and these improvements were similar to those seen in men taking” drugs like Viagra, Dr. Miller said.
ED and heart health
Erectile dysfunction can often be traced to the same causes as cardiovascular disease, including inflammation, a narrowing of the arteries (endothelial dysfunction), or a hardening of the arteries (atherosclerosis).
“It’s important to recognize that erectile dysfunction can often serve as an indicator or barometer of underlying cardiovascular health,” said Amy Pearlman, MD, a urologist specializing in male sexual health at Prime Institute in Miami.
Dr. Pearlman was not involved in the study but thinks the results make sense. “It stands to reason that any intervention aimed at enhancing cardiovascular health may also have a positive impact on erectile health.”
But what was surprising was that aerobic exercise reduced symptoms on par with medications like Viagra, said urologist Rahul Mehan, MD, founder of East Valley Urology Center, in Mesa, Ariz. (Dr. Mehan was also not involved in the study.)
While erectile dysfunction medications are generally affordable and accessible, some patients don’t want to take them or can’t tolerate the side effects. These can include “headache, heartburn, nausea, flushing, and pain in muscles, back, arms, or legs,” said Dr. Mehan. He adds, “Everyone can exercise.”
Some doctors, including Dr. Mehan, already recommend exercise to their patients with ED.
Now they can tell patients that it’s “a proven approach backed by high-quality data from randomized studies,” Dr. Miller said. “Exercise is low risk and affordable, making it an ideal first-line treatment option for erectile difficulties, especially for patients unwilling or unable to use medications.”
A version of this article first appeared on Medscape.com.
, according to a new analysis of the best research to date on aerobic exercise and erectile function.
The study, published in The Journal of Sexual Medicine, found that aerobic activities – such as walking or cycling – improved erectile function in all men with erectile dysfunction, regardless of body weight, overall health, or medication use. Men with the most severe erectile dysfunction saw the greatest benefit.
“This study provides physicians and patients the proof needed to definitively recommend aerobic activity as part of ED management,” said study author Larry E. Miller, PhD, president, Miller Scientific Consulting, Johnson City, Tenn.
Doctors have long known that erectile function is linked to cardiovascular health, but there is limited high-quality evidence on the impact of exercise on the disorder.
The researchers scoured the scientific literature and found 11 randomized, controlled trials – a preferred study design where participants are randomly assigned to receive an intervention or not. Of the 1,100 men involved in the studies, 600 were assigned to “experimental” groups that typically exercised for 30 to 60 minutes, three to five times a week, while 500 were assigned to “control” groups with no exercise plan.
The worse the ED was, the more exercise helped, the researchers found. On a standardized scale of 6 to 30, men with severe ED who exercised reported a 5-point improvement in erectile function. Those with mild and moderate ED saw improvements of 2 and 3 points, respectively.
By comparison, phosphodiesterase-5 inhibitors – like sildenafil (Viagra) or tadalafil (Cialis) – can lead to improvements of 4 to 8 points, the study authors note. And testosterone replacement therapy can lead to an improvement of 2 points.
“We were particularly impressed by the finding that men with more severe erectile dysfunction saw greater improvements with exercise, and these improvements were similar to those seen in men taking” drugs like Viagra, Dr. Miller said.
ED and heart health
Erectile dysfunction can often be traced to the same causes as cardiovascular disease, including inflammation, a narrowing of the arteries (endothelial dysfunction), or a hardening of the arteries (atherosclerosis).
“It’s important to recognize that erectile dysfunction can often serve as an indicator or barometer of underlying cardiovascular health,” said Amy Pearlman, MD, a urologist specializing in male sexual health at Prime Institute in Miami.
Dr. Pearlman was not involved in the study but thinks the results make sense. “It stands to reason that any intervention aimed at enhancing cardiovascular health may also have a positive impact on erectile health.”
But what was surprising was that aerobic exercise reduced symptoms on par with medications like Viagra, said urologist Rahul Mehan, MD, founder of East Valley Urology Center, in Mesa, Ariz. (Dr. Mehan was also not involved in the study.)
While erectile dysfunction medications are generally affordable and accessible, some patients don’t want to take them or can’t tolerate the side effects. These can include “headache, heartburn, nausea, flushing, and pain in muscles, back, arms, or legs,” said Dr. Mehan. He adds, “Everyone can exercise.”
Some doctors, including Dr. Mehan, already recommend exercise to their patients with ED.
Now they can tell patients that it’s “a proven approach backed by high-quality data from randomized studies,” Dr. Miller said. “Exercise is low risk and affordable, making it an ideal first-line treatment option for erectile difficulties, especially for patients unwilling or unable to use medications.”
A version of this article first appeared on Medscape.com.
Asthma with EoE linked to earlier hospitalization
, according to a new analysis of data from HCA Healthcare.
Not much work has been done on the overlap between the two conditions, both of which are believed to be driven by the action of both eosinophils and helper T cells, according to Linda Pham, DO, who presented the research at the annual meeting of the American College of Chest Physicians (CHEST).
“I have a colleague who is interested in GI and he’s really interested in EOE. We thought it would be nice to look at those populations of patients to see if there’s a correlation between them aside from just the atopic disease,” said Dr. Pham, who is an internal medicine resident at Riverside (Calif.) Community Hospital.
The findings underscore the need for assessing individual patient risk. “Having another concomitant disease like EoE, or maybe like atopic dermatitis, might cause you to have more severe [asthma] exacerbations causing you to go into the hospital more. I think if patients have more of these diseases, doctors can be more cognizant that they need to really be on top of treatment and make sure that [their patients] are aware of themselves so that if their symptoms exacerbate, they can go to the hospital and seek care,” said Dr. Pham.
The study was a retrospective analysis of 3,678,812 patients with asthma and 5,823 patients with both EoE and asthma. The data was drawn from 185 HCA hospitals, with records between 2016 and 2021.
The incidence of both asthma and asthma with EoE remained stable between 2016 and 2021. Dr. Pham pointed out that there are good methods to diagnose both conditions, which suggests that existing treatments are effective enough to be limiting the need for emergency treatment, according to Dr. Pham.
Among patients hospitalized with asthma alone, 72.55% were female, while 27.45% were male (P < .001). The numbers were much more evenly split among those with asthma and EoE, at 51.78% and 48.22%, respectively. The differing gender statistics aren’t easy to explain. “It’s not quite clear whether it’s because they just have more severe symptoms, or if it is other factors causing women to seek care more than their male counterparts. It could be personal biases, or it could be the asthma itself that is more severe in women,” said Dr. Pham.
When they broke down the analysis by sex, the researchers found that male EoE patients without asthma were a mean value of 5.517 years older than male EoE patients with asthma, and the mean difference was 5.480 years in female patients (P < .001 for both).
Although the direct cause of earlier hospitalization among patients with concomitant EoE and asthma is unclear, Dr. Pham speculated that the combination of atopic diseases may be leading to a stronger inflammatory response.
It remains to be seen if a similar relationship occurs with other atopic diseases, and future research could examine other factors. “I think it’d be good to look at not just age and gender, but BMI and occupation, things like that,” said Dr. Pham.
The study was of particular interest to Michelle Robertson, MD, who was in the audience. She is the director for clinical services at the Airborne Hazards and Burn Pits Center of Excellence at the New Jersey War-Related Illness and Injury Study Center. “We see a significant number of [veterans] who have been diagnosed with both asthma and eosinophilic esophagitis, and our thinking is that that is likely related to some of the military exposures: In particular, [what the] deployed veterans encountered in the Gulf War, [such as] the smoke from burn pits, sand and dust storms, and smoke from oil well fires. Our thinking is that the particulate matter, the PM 2.5, the very, very tiny particles, may be either sensitizing the lung area and/or esophagus and predisposing them to having those symptoms when they return home,” said Dr. Robertson, in an interview.
Particles in this size range may be able to bypass the protected areas of the nose and the lungs to reach the alveoli, where they could potentially interfere with the transfer of air between the lungs and the rest of the body, which could in turn lead to a variety of inflammatory conditions, according to Dr. Robertson.
She noted that particle exposure varies with a soldier’s wartime occupation, with higher exposures among mechanics and burn pit managers, for example. However, the highest levels of exposure do not predict later illness, which is a natural prompt for future research. “The second part of this whole pathophysiology is susceptibility. Is there something about those people that do get sick that makes them more susceptible than folks that don’t, even though they both have the same jobs?”
Dr. Pham and Dr. Robertson have no relevant financial disclosures.
, according to a new analysis of data from HCA Healthcare.
Not much work has been done on the overlap between the two conditions, both of which are believed to be driven by the action of both eosinophils and helper T cells, according to Linda Pham, DO, who presented the research at the annual meeting of the American College of Chest Physicians (CHEST).
“I have a colleague who is interested in GI and he’s really interested in EOE. We thought it would be nice to look at those populations of patients to see if there’s a correlation between them aside from just the atopic disease,” said Dr. Pham, who is an internal medicine resident at Riverside (Calif.) Community Hospital.
The findings underscore the need for assessing individual patient risk. “Having another concomitant disease like EoE, or maybe like atopic dermatitis, might cause you to have more severe [asthma] exacerbations causing you to go into the hospital more. I think if patients have more of these diseases, doctors can be more cognizant that they need to really be on top of treatment and make sure that [their patients] are aware of themselves so that if their symptoms exacerbate, they can go to the hospital and seek care,” said Dr. Pham.
The study was a retrospective analysis of 3,678,812 patients with asthma and 5,823 patients with both EoE and asthma. The data was drawn from 185 HCA hospitals, with records between 2016 and 2021.
The incidence of both asthma and asthma with EoE remained stable between 2016 and 2021. Dr. Pham pointed out that there are good methods to diagnose both conditions, which suggests that existing treatments are effective enough to be limiting the need for emergency treatment, according to Dr. Pham.
Among patients hospitalized with asthma alone, 72.55% were female, while 27.45% were male (P < .001). The numbers were much more evenly split among those with asthma and EoE, at 51.78% and 48.22%, respectively. The differing gender statistics aren’t easy to explain. “It’s not quite clear whether it’s because they just have more severe symptoms, or if it is other factors causing women to seek care more than their male counterparts. It could be personal biases, or it could be the asthma itself that is more severe in women,” said Dr. Pham.
When they broke down the analysis by sex, the researchers found that male EoE patients without asthma were a mean value of 5.517 years older than male EoE patients with asthma, and the mean difference was 5.480 years in female patients (P < .001 for both).
Although the direct cause of earlier hospitalization among patients with concomitant EoE and asthma is unclear, Dr. Pham speculated that the combination of atopic diseases may be leading to a stronger inflammatory response.
It remains to be seen if a similar relationship occurs with other atopic diseases, and future research could examine other factors. “I think it’d be good to look at not just age and gender, but BMI and occupation, things like that,” said Dr. Pham.
The study was of particular interest to Michelle Robertson, MD, who was in the audience. She is the director for clinical services at the Airborne Hazards and Burn Pits Center of Excellence at the New Jersey War-Related Illness and Injury Study Center. “We see a significant number of [veterans] who have been diagnosed with both asthma and eosinophilic esophagitis, and our thinking is that that is likely related to some of the military exposures: In particular, [what the] deployed veterans encountered in the Gulf War, [such as] the smoke from burn pits, sand and dust storms, and smoke from oil well fires. Our thinking is that the particulate matter, the PM 2.5, the very, very tiny particles, may be either sensitizing the lung area and/or esophagus and predisposing them to having those symptoms when they return home,” said Dr. Robertson, in an interview.
Particles in this size range may be able to bypass the protected areas of the nose and the lungs to reach the alveoli, where they could potentially interfere with the transfer of air between the lungs and the rest of the body, which could in turn lead to a variety of inflammatory conditions, according to Dr. Robertson.
She noted that particle exposure varies with a soldier’s wartime occupation, with higher exposures among mechanics and burn pit managers, for example. However, the highest levels of exposure do not predict later illness, which is a natural prompt for future research. “The second part of this whole pathophysiology is susceptibility. Is there something about those people that do get sick that makes them more susceptible than folks that don’t, even though they both have the same jobs?”
Dr. Pham and Dr. Robertson have no relevant financial disclosures.
, according to a new analysis of data from HCA Healthcare.
Not much work has been done on the overlap between the two conditions, both of which are believed to be driven by the action of both eosinophils and helper T cells, according to Linda Pham, DO, who presented the research at the annual meeting of the American College of Chest Physicians (CHEST).
“I have a colleague who is interested in GI and he’s really interested in EOE. We thought it would be nice to look at those populations of patients to see if there’s a correlation between them aside from just the atopic disease,” said Dr. Pham, who is an internal medicine resident at Riverside (Calif.) Community Hospital.
The findings underscore the need for assessing individual patient risk. “Having another concomitant disease like EoE, or maybe like atopic dermatitis, might cause you to have more severe [asthma] exacerbations causing you to go into the hospital more. I think if patients have more of these diseases, doctors can be more cognizant that they need to really be on top of treatment and make sure that [their patients] are aware of themselves so that if their symptoms exacerbate, they can go to the hospital and seek care,” said Dr. Pham.
The study was a retrospective analysis of 3,678,812 patients with asthma and 5,823 patients with both EoE and asthma. The data was drawn from 185 HCA hospitals, with records between 2016 and 2021.
The incidence of both asthma and asthma with EoE remained stable between 2016 and 2021. Dr. Pham pointed out that there are good methods to diagnose both conditions, which suggests that existing treatments are effective enough to be limiting the need for emergency treatment, according to Dr. Pham.
Among patients hospitalized with asthma alone, 72.55% were female, while 27.45% were male (P < .001). The numbers were much more evenly split among those with asthma and EoE, at 51.78% and 48.22%, respectively. The differing gender statistics aren’t easy to explain. “It’s not quite clear whether it’s because they just have more severe symptoms, or if it is other factors causing women to seek care more than their male counterparts. It could be personal biases, or it could be the asthma itself that is more severe in women,” said Dr. Pham.
When they broke down the analysis by sex, the researchers found that male EoE patients without asthma were a mean value of 5.517 years older than male EoE patients with asthma, and the mean difference was 5.480 years in female patients (P < .001 for both).
Although the direct cause of earlier hospitalization among patients with concomitant EoE and asthma is unclear, Dr. Pham speculated that the combination of atopic diseases may be leading to a stronger inflammatory response.
It remains to be seen if a similar relationship occurs with other atopic diseases, and future research could examine other factors. “I think it’d be good to look at not just age and gender, but BMI and occupation, things like that,” said Dr. Pham.
The study was of particular interest to Michelle Robertson, MD, who was in the audience. She is the director for clinical services at the Airborne Hazards and Burn Pits Center of Excellence at the New Jersey War-Related Illness and Injury Study Center. “We see a significant number of [veterans] who have been diagnosed with both asthma and eosinophilic esophagitis, and our thinking is that that is likely related to some of the military exposures: In particular, [what the] deployed veterans encountered in the Gulf War, [such as] the smoke from burn pits, sand and dust storms, and smoke from oil well fires. Our thinking is that the particulate matter, the PM 2.5, the very, very tiny particles, may be either sensitizing the lung area and/or esophagus and predisposing them to having those symptoms when they return home,” said Dr. Robertson, in an interview.
Particles in this size range may be able to bypass the protected areas of the nose and the lungs to reach the alveoli, where they could potentially interfere with the transfer of air between the lungs and the rest of the body, which could in turn lead to a variety of inflammatory conditions, according to Dr. Robertson.
She noted that particle exposure varies with a soldier’s wartime occupation, with higher exposures among mechanics and burn pit managers, for example. However, the highest levels of exposure do not predict later illness, which is a natural prompt for future research. “The second part of this whole pathophysiology is susceptibility. Is there something about those people that do get sick that makes them more susceptible than folks that don’t, even though they both have the same jobs?”
Dr. Pham and Dr. Robertson have no relevant financial disclosures.
FROM CHEST 2023
Chemo-immunotherapy good, adding a PARP inhibitor better in endometrial cancer?
MADRID – Research presented at the European Society for Medical Oncology (ESMO) Annual Meeting 2023 underline the benefit of adding immunotherapy to chemotherapy in advanced or recurrent endometrial cancer, and question whether adding the PARP inhibitor olaparib to the chemo-immunotherapy combination could provide further benefit.
In the AtTEnd trial, presented on Oct. 21, more than 550 patients with advanced newly diagnosed or recurrent disease were randomized to the antiprogrammed death–ligand 1 (PD-L1) antibody atezolizumab (Tecentriq) or placebo plus chemotherapy followed by maintenance atezolizumab or placebo.
– 28.1% vs. 17% at 2 years. The PFS benefit was much more pronounced among patients with mismatch repair-deficient (dMMR) disease – 50.4% vs. 16% at 2 years. Mismatch repair-deficient disease patients receiving atezolizumab also demonstrated an early overall survival benefit, according to findings from the interim analysis.
In the DUO-E trial, presented during the same Oct. 21 session, nearly 720 patients with newly diagnosed advanced or recurrent endometrial cancer were randomized to one of three groups: Chemotherapy alone with maintenance placebo, chemotherapy plus durvalumab (Imfinzi) with maintenance durvalumab, or chemotherapy plus durvalumab with maintenance durvalumab and the PARP inhibitor olaparib.
The results, published simultaneously in the Journal of Clinical Oncology, showed that adding durvalumab to chemotherapy followed by maintenance durvalumab with or without olaparib led to a significant improvement in PFS, compared with chemotherapy alone. As in the AtTEnd trial, this PFS was also more pronounced in dMMR patients.
Overall, Andrés Cervantes, MD, PhD, from the University of Valencia, Spain, and president of ESMO, explained that this research marks “very positive data for women with gynecological cancers,” with immunotherapy now incorporated into the standard of care.
However, an expert questioned whether the DUO-E trial clearly demonstrated the benefit of adding olaparib to immuno- and chemotherapy and whether certain subsets of patients may be more likely to benefit from the PARP inhibitor.
Inside AtTEnd
A growing body of research has shown that single agent immunotherapy is effective in treating endometrial cancer, particularly in tumors with dMMR, and that immunotherapy and chemotherapy may have a synergistic effect.
David S. P. Tan, MD, PhD, National University Cancer Institute, Singapore, who was not involved in the studies, commented that “the molecular classification of endometrial cancer is now leading us to areas that we didn’t think before [were] possible.”
The rationale for combining immunotherapy with chemotherapy, Dr. Tan explained, is that “the cytotoxicity you get from chemotherapy is partly dependent on immune activity within the tumor, and so it makes sense” to combine them.
This approach was borne out by recent positive PFS results from the NRG-GY018 trial of pembrolizumab plus chemotherapy in advanced endometrial cancer as well as from the RUBY trial of dostarlimab in primary advanced or recurrent disease.
To further investigate this chemo-immunotherapy strategy, the AtTEnd team enrolled patients with newly diagnosed or recurrent stage III-IV disease who had received no prior systemic chemotherapy for recurrence within the previous 6 months.
Overall, 551 patients from 89 sites across 10 countries were randomized to standard first-line chemotherapy – carboplatin plus paclitaxel – with either atezolizumab or placebo, followed by maintenance atezolizumab or placebo, which continued until confirmed disease progression.
The median age in the intention-to-treat population was 64-67 years. Nearly 23% of patients had dMMR tumors, and 67.2% had recurrent disease.
The baseline characteristics were well balanced and distributed between arms in the dMMR and all-comers population, said Nicoletta Colombo, MD, University of Milan–Bicocca, European Institute of Oncology Istituto di Ricovero e Cura a Carattere Scientifico, Italy, who presented the findings at ESMO.
Over a median follow up of 26.2 months, Dr. Colombo and colleagues observed a statistically significant improvement in PFS in the dMMR arm in favor of atezolizumab (hazard ratio, 0.36; P = .0005). At 2 years, 50.4% of patients receiving the immunotherapy were progression-free, compared with 16.0% in the placebo arm.
In all-comers, the PFS improvement with atezolizumab was less pronounced but remained significant (HR, 0.74; P = .0219).
A secondary analysis revealed, among dMMR patients, atezolizumab was associated with an overall survival advantage over placebo (HR, 0.41), with 75% of patients still alive at 2 years vs. 54.2% in the placebo arm. Dr. Colombo also noted a “clear trend” for improved overall survival with atezolizumab as well (HR, 0.82; P = .0483), but no PFS or overall survival benefit was seen with atezolizumab in MMR proficient (pMMR) patients.
Dr. Colombo said the safety profile of atezolizumab plus chemotherapy was “manageable,” with no differences in the rates of “major side effects,” although there was an increase in the rate of treatment-related grade ≥ 3 adverse events in the atezolizumab group (25.8% vs. 14.1%).
Dr. Tan noted that the AtTEnd trial revealed comparable results to earlier trials in this space but underlined that the survival curves in the interim analysis revealed a “red zone” of dMMR patients who do not respond to the combination and in whom immunotherapy is “not sufficient.”
Alongside this, Dr. Tan flagged a “blue zone” of dMMR patients who plateaued in both PFS and overall survival after 2 years. The question for these patients at this point is whether they need to continue immunotherapy beyond 24 months, he said.
But overall, Dr. Tan noted, the AtTEnd data “continue to validate practice-changing therapy for dMMR endometrial cancer patients” with immunotherapy plus chemotherapy, with the lack of benefit in pMMR disease underscoring an “unmet medical need.”
Inside DUO-E
The burning question, however, was whether adding a PARP inhibitor to immunotherapy and chemotherapy would boost the survival outcomes further.
The DUO-E trial involved patients with newly diagnosed stage III/IV or recurrent endometrial cancer who had not received systematic therapy for advanced disease and were naive to both PARP inhibitors and immune-mediated therapy.
Overall, 718 patients were randomized to one of three arms: Chemotherapy alone followed by maintenance placebo, chemotherapy plus durvalumab with maintenance durvalumab, or chemotherapy plus durvalumab with maintenance durvalumab plus olaparib.
Maintenance was continued until disease progression or unacceptable toxicity, or the patients met another discontinuation criteria.
About half of patients were newly diagnosed, half had recurrent disease, and approximately one-fifth had dMMR disease, said Shannon Westin, MD, from the University of Texas MD Anderson Cancer Center, Houston, who presented the findings.
Compared with placebo plus chemotherapy, patients in both the durvalumab alone and durvalumab plus olaparib arms experienced a significant improvement in PFS (HR, 0.71; P = .003; and HR, 0.55; P < .0001, respectively).
This effect was amplified in dMMR patients with durvalumab (HR, 0.42) as well as with durvalumab plus olaparib (HR, 0.41).
In pMMR patients, PFS benefit was stronger in the durvalumab-olaparib arm vs. durvalumab (HR, 0.57 vs. 0.77).
Although the overall survival analysis remains exploratory, Dr. Westin noted a trend toward better overall survival in the two treatment arms vs. placebo (HR, 0.77 with durvalumab, and HR, 0.59 with durvalumab plus olaparib).
However, adding olaparib to the equation increased the rate of grade ≥ 3 adverse events – 67.2% vs. 54.9% with durvalumab and 56.4% with chemotherapy alone in the overall analysis. The addition of olaparib also led to treatment discontinuation in 24.4% of patients vs. 20.9% in the durvalumab arm and 18.6% in the chemotherapy alone arm.
Domenica Lorusso, MD, PhD, who was not involved in the study, commented that the marginal PFS benefit of adding olaparib in DUO-E is “not surprising” because the bar set by immunotherapy is “so high in this population that it’s very difficult” to go any higher.
But the results in pMMR patients reveal “a clear additional benefit” to olaparib, said Dr. Lorusso, from Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.
“The main limitation of the trial,” she continued, “is that it was not powered to make a formal comparison between the two experimental arms.”
So, what then is the added benefit of olaparib? “Unfortunately, that remains an unanswered question,” Dr. Lorusso said.
AtTEnd was sponsored by the Mario Negri Institute for Pharmacological Research.
DUO-E was funded by AstraZeneca.
Dr. Colombo declares relationships with AstraZeneca, Clovis Oncology, Esai, GSK, Immunogen, Mersana, MSD/Merck, Nuvation Bio, OncXerna, Pieris, Roche, and Novocure.
Dr. Tan declares relationships with AstraZeneca, Karyopharm Therapeutics, Bayer, Roche, MSD, Genmab, Esai, PMV, BioNTech, Ellipses Pharma, Boehringer Ingelheim, Merck Serono, Takeda, and Clovis.
Dr. Westin declares relationships with AstraZeneca, Avenge Bio, Bayer, Bio-Path, Clovis, Genentech/Roche, GSK, Jazz Pharmaceuticals, Mereo, Novartis, Nuvectis, and Zentalis; and consulting and advisory roles for AstraZeneca, Caris, Clovis, Eisai, EQRx, Genentech/Roche, Gilead, GSK, Immunocore, ImmunoGen, Lilly, Merck, Mersana, Mereo, NGM Bio, Nuvectis, Seagen, Verastem, Vincerx, Zentalis, and ZielBio.
Dr. Lorusso declares relationships with PharmaMar, Merck Serono, Novartis, AstraZeneca, Clovis, Tesaro/GSK, Genmab, Immunogen, and Roche.
A version of this article first appeared on Medscape.com.
MADRID – Research presented at the European Society for Medical Oncology (ESMO) Annual Meeting 2023 underline the benefit of adding immunotherapy to chemotherapy in advanced or recurrent endometrial cancer, and question whether adding the PARP inhibitor olaparib to the chemo-immunotherapy combination could provide further benefit.
In the AtTEnd trial, presented on Oct. 21, more than 550 patients with advanced newly diagnosed or recurrent disease were randomized to the antiprogrammed death–ligand 1 (PD-L1) antibody atezolizumab (Tecentriq) or placebo plus chemotherapy followed by maintenance atezolizumab or placebo.
– 28.1% vs. 17% at 2 years. The PFS benefit was much more pronounced among patients with mismatch repair-deficient (dMMR) disease – 50.4% vs. 16% at 2 years. Mismatch repair-deficient disease patients receiving atezolizumab also demonstrated an early overall survival benefit, according to findings from the interim analysis.
In the DUO-E trial, presented during the same Oct. 21 session, nearly 720 patients with newly diagnosed advanced or recurrent endometrial cancer were randomized to one of three groups: Chemotherapy alone with maintenance placebo, chemotherapy plus durvalumab (Imfinzi) with maintenance durvalumab, or chemotherapy plus durvalumab with maintenance durvalumab and the PARP inhibitor olaparib.
The results, published simultaneously in the Journal of Clinical Oncology, showed that adding durvalumab to chemotherapy followed by maintenance durvalumab with or without olaparib led to a significant improvement in PFS, compared with chemotherapy alone. As in the AtTEnd trial, this PFS was also more pronounced in dMMR patients.
Overall, Andrés Cervantes, MD, PhD, from the University of Valencia, Spain, and president of ESMO, explained that this research marks “very positive data for women with gynecological cancers,” with immunotherapy now incorporated into the standard of care.
However, an expert questioned whether the DUO-E trial clearly demonstrated the benefit of adding olaparib to immuno- and chemotherapy and whether certain subsets of patients may be more likely to benefit from the PARP inhibitor.
Inside AtTEnd
A growing body of research has shown that single agent immunotherapy is effective in treating endometrial cancer, particularly in tumors with dMMR, and that immunotherapy and chemotherapy may have a synergistic effect.
David S. P. Tan, MD, PhD, National University Cancer Institute, Singapore, who was not involved in the studies, commented that “the molecular classification of endometrial cancer is now leading us to areas that we didn’t think before [were] possible.”
The rationale for combining immunotherapy with chemotherapy, Dr. Tan explained, is that “the cytotoxicity you get from chemotherapy is partly dependent on immune activity within the tumor, and so it makes sense” to combine them.
This approach was borne out by recent positive PFS results from the NRG-GY018 trial of pembrolizumab plus chemotherapy in advanced endometrial cancer as well as from the RUBY trial of dostarlimab in primary advanced or recurrent disease.
To further investigate this chemo-immunotherapy strategy, the AtTEnd team enrolled patients with newly diagnosed or recurrent stage III-IV disease who had received no prior systemic chemotherapy for recurrence within the previous 6 months.
Overall, 551 patients from 89 sites across 10 countries were randomized to standard first-line chemotherapy – carboplatin plus paclitaxel – with either atezolizumab or placebo, followed by maintenance atezolizumab or placebo, which continued until confirmed disease progression.
The median age in the intention-to-treat population was 64-67 years. Nearly 23% of patients had dMMR tumors, and 67.2% had recurrent disease.
The baseline characteristics were well balanced and distributed between arms in the dMMR and all-comers population, said Nicoletta Colombo, MD, University of Milan–Bicocca, European Institute of Oncology Istituto di Ricovero e Cura a Carattere Scientifico, Italy, who presented the findings at ESMO.
Over a median follow up of 26.2 months, Dr. Colombo and colleagues observed a statistically significant improvement in PFS in the dMMR arm in favor of atezolizumab (hazard ratio, 0.36; P = .0005). At 2 years, 50.4% of patients receiving the immunotherapy were progression-free, compared with 16.0% in the placebo arm.
In all-comers, the PFS improvement with atezolizumab was less pronounced but remained significant (HR, 0.74; P = .0219).
A secondary analysis revealed, among dMMR patients, atezolizumab was associated with an overall survival advantage over placebo (HR, 0.41), with 75% of patients still alive at 2 years vs. 54.2% in the placebo arm. Dr. Colombo also noted a “clear trend” for improved overall survival with atezolizumab as well (HR, 0.82; P = .0483), but no PFS or overall survival benefit was seen with atezolizumab in MMR proficient (pMMR) patients.
Dr. Colombo said the safety profile of atezolizumab plus chemotherapy was “manageable,” with no differences in the rates of “major side effects,” although there was an increase in the rate of treatment-related grade ≥ 3 adverse events in the atezolizumab group (25.8% vs. 14.1%).
Dr. Tan noted that the AtTEnd trial revealed comparable results to earlier trials in this space but underlined that the survival curves in the interim analysis revealed a “red zone” of dMMR patients who do not respond to the combination and in whom immunotherapy is “not sufficient.”
Alongside this, Dr. Tan flagged a “blue zone” of dMMR patients who plateaued in both PFS and overall survival after 2 years. The question for these patients at this point is whether they need to continue immunotherapy beyond 24 months, he said.
But overall, Dr. Tan noted, the AtTEnd data “continue to validate practice-changing therapy for dMMR endometrial cancer patients” with immunotherapy plus chemotherapy, with the lack of benefit in pMMR disease underscoring an “unmet medical need.”
Inside DUO-E
The burning question, however, was whether adding a PARP inhibitor to immunotherapy and chemotherapy would boost the survival outcomes further.
The DUO-E trial involved patients with newly diagnosed stage III/IV or recurrent endometrial cancer who had not received systematic therapy for advanced disease and were naive to both PARP inhibitors and immune-mediated therapy.
Overall, 718 patients were randomized to one of three arms: Chemotherapy alone followed by maintenance placebo, chemotherapy plus durvalumab with maintenance durvalumab, or chemotherapy plus durvalumab with maintenance durvalumab plus olaparib.
Maintenance was continued until disease progression or unacceptable toxicity, or the patients met another discontinuation criteria.
About half of patients were newly diagnosed, half had recurrent disease, and approximately one-fifth had dMMR disease, said Shannon Westin, MD, from the University of Texas MD Anderson Cancer Center, Houston, who presented the findings.
Compared with placebo plus chemotherapy, patients in both the durvalumab alone and durvalumab plus olaparib arms experienced a significant improvement in PFS (HR, 0.71; P = .003; and HR, 0.55; P < .0001, respectively).
This effect was amplified in dMMR patients with durvalumab (HR, 0.42) as well as with durvalumab plus olaparib (HR, 0.41).
In pMMR patients, PFS benefit was stronger in the durvalumab-olaparib arm vs. durvalumab (HR, 0.57 vs. 0.77).
Although the overall survival analysis remains exploratory, Dr. Westin noted a trend toward better overall survival in the two treatment arms vs. placebo (HR, 0.77 with durvalumab, and HR, 0.59 with durvalumab plus olaparib).
However, adding olaparib to the equation increased the rate of grade ≥ 3 adverse events – 67.2% vs. 54.9% with durvalumab and 56.4% with chemotherapy alone in the overall analysis. The addition of olaparib also led to treatment discontinuation in 24.4% of patients vs. 20.9% in the durvalumab arm and 18.6% in the chemotherapy alone arm.
Domenica Lorusso, MD, PhD, who was not involved in the study, commented that the marginal PFS benefit of adding olaparib in DUO-E is “not surprising” because the bar set by immunotherapy is “so high in this population that it’s very difficult” to go any higher.
But the results in pMMR patients reveal “a clear additional benefit” to olaparib, said Dr. Lorusso, from Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.
“The main limitation of the trial,” she continued, “is that it was not powered to make a formal comparison between the two experimental arms.”
So, what then is the added benefit of olaparib? “Unfortunately, that remains an unanswered question,” Dr. Lorusso said.
AtTEnd was sponsored by the Mario Negri Institute for Pharmacological Research.
DUO-E was funded by AstraZeneca.
Dr. Colombo declares relationships with AstraZeneca, Clovis Oncology, Esai, GSK, Immunogen, Mersana, MSD/Merck, Nuvation Bio, OncXerna, Pieris, Roche, and Novocure.
Dr. Tan declares relationships with AstraZeneca, Karyopharm Therapeutics, Bayer, Roche, MSD, Genmab, Esai, PMV, BioNTech, Ellipses Pharma, Boehringer Ingelheim, Merck Serono, Takeda, and Clovis.
Dr. Westin declares relationships with AstraZeneca, Avenge Bio, Bayer, Bio-Path, Clovis, Genentech/Roche, GSK, Jazz Pharmaceuticals, Mereo, Novartis, Nuvectis, and Zentalis; and consulting and advisory roles for AstraZeneca, Caris, Clovis, Eisai, EQRx, Genentech/Roche, Gilead, GSK, Immunocore, ImmunoGen, Lilly, Merck, Mersana, Mereo, NGM Bio, Nuvectis, Seagen, Verastem, Vincerx, Zentalis, and ZielBio.
Dr. Lorusso declares relationships with PharmaMar, Merck Serono, Novartis, AstraZeneca, Clovis, Tesaro/GSK, Genmab, Immunogen, and Roche.
A version of this article first appeared on Medscape.com.
MADRID – Research presented at the European Society for Medical Oncology (ESMO) Annual Meeting 2023 underline the benefit of adding immunotherapy to chemotherapy in advanced or recurrent endometrial cancer, and question whether adding the PARP inhibitor olaparib to the chemo-immunotherapy combination could provide further benefit.
In the AtTEnd trial, presented on Oct. 21, more than 550 patients with advanced newly diagnosed or recurrent disease were randomized to the antiprogrammed death–ligand 1 (PD-L1) antibody atezolizumab (Tecentriq) or placebo plus chemotherapy followed by maintenance atezolizumab or placebo.
– 28.1% vs. 17% at 2 years. The PFS benefit was much more pronounced among patients with mismatch repair-deficient (dMMR) disease – 50.4% vs. 16% at 2 years. Mismatch repair-deficient disease patients receiving atezolizumab also demonstrated an early overall survival benefit, according to findings from the interim analysis.
In the DUO-E trial, presented during the same Oct. 21 session, nearly 720 patients with newly diagnosed advanced or recurrent endometrial cancer were randomized to one of three groups: Chemotherapy alone with maintenance placebo, chemotherapy plus durvalumab (Imfinzi) with maintenance durvalumab, or chemotherapy plus durvalumab with maintenance durvalumab and the PARP inhibitor olaparib.
The results, published simultaneously in the Journal of Clinical Oncology, showed that adding durvalumab to chemotherapy followed by maintenance durvalumab with or without olaparib led to a significant improvement in PFS, compared with chemotherapy alone. As in the AtTEnd trial, this PFS was also more pronounced in dMMR patients.
Overall, Andrés Cervantes, MD, PhD, from the University of Valencia, Spain, and president of ESMO, explained that this research marks “very positive data for women with gynecological cancers,” with immunotherapy now incorporated into the standard of care.
However, an expert questioned whether the DUO-E trial clearly demonstrated the benefit of adding olaparib to immuno- and chemotherapy and whether certain subsets of patients may be more likely to benefit from the PARP inhibitor.
Inside AtTEnd
A growing body of research has shown that single agent immunotherapy is effective in treating endometrial cancer, particularly in tumors with dMMR, and that immunotherapy and chemotherapy may have a synergistic effect.
David S. P. Tan, MD, PhD, National University Cancer Institute, Singapore, who was not involved in the studies, commented that “the molecular classification of endometrial cancer is now leading us to areas that we didn’t think before [were] possible.”
The rationale for combining immunotherapy with chemotherapy, Dr. Tan explained, is that “the cytotoxicity you get from chemotherapy is partly dependent on immune activity within the tumor, and so it makes sense” to combine them.
This approach was borne out by recent positive PFS results from the NRG-GY018 trial of pembrolizumab plus chemotherapy in advanced endometrial cancer as well as from the RUBY trial of dostarlimab in primary advanced or recurrent disease.
To further investigate this chemo-immunotherapy strategy, the AtTEnd team enrolled patients with newly diagnosed or recurrent stage III-IV disease who had received no prior systemic chemotherapy for recurrence within the previous 6 months.
Overall, 551 patients from 89 sites across 10 countries were randomized to standard first-line chemotherapy – carboplatin plus paclitaxel – with either atezolizumab or placebo, followed by maintenance atezolizumab or placebo, which continued until confirmed disease progression.
The median age in the intention-to-treat population was 64-67 years. Nearly 23% of patients had dMMR tumors, and 67.2% had recurrent disease.
The baseline characteristics were well balanced and distributed between arms in the dMMR and all-comers population, said Nicoletta Colombo, MD, University of Milan–Bicocca, European Institute of Oncology Istituto di Ricovero e Cura a Carattere Scientifico, Italy, who presented the findings at ESMO.
Over a median follow up of 26.2 months, Dr. Colombo and colleagues observed a statistically significant improvement in PFS in the dMMR arm in favor of atezolizumab (hazard ratio, 0.36; P = .0005). At 2 years, 50.4% of patients receiving the immunotherapy were progression-free, compared with 16.0% in the placebo arm.
In all-comers, the PFS improvement with atezolizumab was less pronounced but remained significant (HR, 0.74; P = .0219).
A secondary analysis revealed, among dMMR patients, atezolizumab was associated with an overall survival advantage over placebo (HR, 0.41), with 75% of patients still alive at 2 years vs. 54.2% in the placebo arm. Dr. Colombo also noted a “clear trend” for improved overall survival with atezolizumab as well (HR, 0.82; P = .0483), but no PFS or overall survival benefit was seen with atezolizumab in MMR proficient (pMMR) patients.
Dr. Colombo said the safety profile of atezolizumab plus chemotherapy was “manageable,” with no differences in the rates of “major side effects,” although there was an increase in the rate of treatment-related grade ≥ 3 adverse events in the atezolizumab group (25.8% vs. 14.1%).
Dr. Tan noted that the AtTEnd trial revealed comparable results to earlier trials in this space but underlined that the survival curves in the interim analysis revealed a “red zone” of dMMR patients who do not respond to the combination and in whom immunotherapy is “not sufficient.”
Alongside this, Dr. Tan flagged a “blue zone” of dMMR patients who plateaued in both PFS and overall survival after 2 years. The question for these patients at this point is whether they need to continue immunotherapy beyond 24 months, he said.
But overall, Dr. Tan noted, the AtTEnd data “continue to validate practice-changing therapy for dMMR endometrial cancer patients” with immunotherapy plus chemotherapy, with the lack of benefit in pMMR disease underscoring an “unmet medical need.”
Inside DUO-E
The burning question, however, was whether adding a PARP inhibitor to immunotherapy and chemotherapy would boost the survival outcomes further.
The DUO-E trial involved patients with newly diagnosed stage III/IV or recurrent endometrial cancer who had not received systematic therapy for advanced disease and were naive to both PARP inhibitors and immune-mediated therapy.
Overall, 718 patients were randomized to one of three arms: Chemotherapy alone followed by maintenance placebo, chemotherapy plus durvalumab with maintenance durvalumab, or chemotherapy plus durvalumab with maintenance durvalumab plus olaparib.
Maintenance was continued until disease progression or unacceptable toxicity, or the patients met another discontinuation criteria.
About half of patients were newly diagnosed, half had recurrent disease, and approximately one-fifth had dMMR disease, said Shannon Westin, MD, from the University of Texas MD Anderson Cancer Center, Houston, who presented the findings.
Compared with placebo plus chemotherapy, patients in both the durvalumab alone and durvalumab plus olaparib arms experienced a significant improvement in PFS (HR, 0.71; P = .003; and HR, 0.55; P < .0001, respectively).
This effect was amplified in dMMR patients with durvalumab (HR, 0.42) as well as with durvalumab plus olaparib (HR, 0.41).
In pMMR patients, PFS benefit was stronger in the durvalumab-olaparib arm vs. durvalumab (HR, 0.57 vs. 0.77).
Although the overall survival analysis remains exploratory, Dr. Westin noted a trend toward better overall survival in the two treatment arms vs. placebo (HR, 0.77 with durvalumab, and HR, 0.59 with durvalumab plus olaparib).
However, adding olaparib to the equation increased the rate of grade ≥ 3 adverse events – 67.2% vs. 54.9% with durvalumab and 56.4% with chemotherapy alone in the overall analysis. The addition of olaparib also led to treatment discontinuation in 24.4% of patients vs. 20.9% in the durvalumab arm and 18.6% in the chemotherapy alone arm.
Domenica Lorusso, MD, PhD, who was not involved in the study, commented that the marginal PFS benefit of adding olaparib in DUO-E is “not surprising” because the bar set by immunotherapy is “so high in this population that it’s very difficult” to go any higher.
But the results in pMMR patients reveal “a clear additional benefit” to olaparib, said Dr. Lorusso, from Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.
“The main limitation of the trial,” she continued, “is that it was not powered to make a formal comparison between the two experimental arms.”
So, what then is the added benefit of olaparib? “Unfortunately, that remains an unanswered question,” Dr. Lorusso said.
AtTEnd was sponsored by the Mario Negri Institute for Pharmacological Research.
DUO-E was funded by AstraZeneca.
Dr. Colombo declares relationships with AstraZeneca, Clovis Oncology, Esai, GSK, Immunogen, Mersana, MSD/Merck, Nuvation Bio, OncXerna, Pieris, Roche, and Novocure.
Dr. Tan declares relationships with AstraZeneca, Karyopharm Therapeutics, Bayer, Roche, MSD, Genmab, Esai, PMV, BioNTech, Ellipses Pharma, Boehringer Ingelheim, Merck Serono, Takeda, and Clovis.
Dr. Westin declares relationships with AstraZeneca, Avenge Bio, Bayer, Bio-Path, Clovis, Genentech/Roche, GSK, Jazz Pharmaceuticals, Mereo, Novartis, Nuvectis, and Zentalis; and consulting and advisory roles for AstraZeneca, Caris, Clovis, Eisai, EQRx, Genentech/Roche, Gilead, GSK, Immunocore, ImmunoGen, Lilly, Merck, Mersana, Mereo, NGM Bio, Nuvectis, Seagen, Verastem, Vincerx, Zentalis, and ZielBio.
Dr. Lorusso declares relationships with PharmaMar, Merck Serono, Novartis, AstraZeneca, Clovis, Tesaro/GSK, Genmab, Immunogen, and Roche.
A version of this article first appeared on Medscape.com.
FROM ESMO 2023
VA and Non-VA Partners Improving Care by Sharing Data
The US Department of Veterans Affairs (VA) and 13 health care systems have signed a pledge for interoperability—to securely share data on veteran health care, regardless of whether it is provided inside the VA or not.
“This pledge will improve veteran health care by giving us seamless, immediate access to a patient’s medical history, which will help us make timely and accurate treatment decisions,” said VA Under Secretary for Health Shereef Elnahal, MD, MBA. “It will also empower VA to send helpful information to our partner health systems that they can then offer to veterans in their care—including information about new benefits we are offering under the PACT Act, no-cost emergency suicide care, and more.”
The pledge will allow the health systems to access local, state, and federal health resources and will provide the VA access to health system clinical and administrative data for quality assessment and care coordination. The pledge signers are committed to developing and providing capabilities that: (1) Accurately identify veterans when they seek care from clinicians in [the signers’] communities; (2) Connect veterans with VA and community resources that promote health and health care—especially VA services that lower veterans’ out-of-pocket expenses; and (3) Responsively and reliably coordinate care for shared patients—including exchanging care information requested and provided.
In addition to helping reduce the financial burden for veterans, the VA says, the information sharing could help clinicians outside the VA system to provide more targeted care: “[I]t will also allow us to send helpful information to our partner health systems that they can then offer to veterans in their care,” Elnahal said, “to include information about new benefits we are offering under the PACT Act and other resources that assist with suicide prevention and identifying social risk factors."
The first pledge partners are Emory Healthcare, Inova, Jefferson Health, Sanford Health, University of California Davis Health, Intermountain Health, Mass General Brigham, Rush Health, Tufts Medicine, Marshfield Clinic, Kaiser Permanente Health Plan and Hospitals, University of Pittsburg Medical Center, and Atrium Health. Any health system or clinician that supports the pledge’s objectives is encouraged to participate, the VA says. Signers have begun work, and aim to provide proof-of-concept in early 2024.
The US Department of Veterans Affairs (VA) and 13 health care systems have signed a pledge for interoperability—to securely share data on veteran health care, regardless of whether it is provided inside the VA or not.
“This pledge will improve veteran health care by giving us seamless, immediate access to a patient’s medical history, which will help us make timely and accurate treatment decisions,” said VA Under Secretary for Health Shereef Elnahal, MD, MBA. “It will also empower VA to send helpful information to our partner health systems that they can then offer to veterans in their care—including information about new benefits we are offering under the PACT Act, no-cost emergency suicide care, and more.”
The pledge will allow the health systems to access local, state, and federal health resources and will provide the VA access to health system clinical and administrative data for quality assessment and care coordination. The pledge signers are committed to developing and providing capabilities that: (1) Accurately identify veterans when they seek care from clinicians in [the signers’] communities; (2) Connect veterans with VA and community resources that promote health and health care—especially VA services that lower veterans’ out-of-pocket expenses; and (3) Responsively and reliably coordinate care for shared patients—including exchanging care information requested and provided.
In addition to helping reduce the financial burden for veterans, the VA says, the information sharing could help clinicians outside the VA system to provide more targeted care: “[I]t will also allow us to send helpful information to our partner health systems that they can then offer to veterans in their care,” Elnahal said, “to include information about new benefits we are offering under the PACT Act and other resources that assist with suicide prevention and identifying social risk factors."
The first pledge partners are Emory Healthcare, Inova, Jefferson Health, Sanford Health, University of California Davis Health, Intermountain Health, Mass General Brigham, Rush Health, Tufts Medicine, Marshfield Clinic, Kaiser Permanente Health Plan and Hospitals, University of Pittsburg Medical Center, and Atrium Health. Any health system or clinician that supports the pledge’s objectives is encouraged to participate, the VA says. Signers have begun work, and aim to provide proof-of-concept in early 2024.
The US Department of Veterans Affairs (VA) and 13 health care systems have signed a pledge for interoperability—to securely share data on veteran health care, regardless of whether it is provided inside the VA or not.
“This pledge will improve veteran health care by giving us seamless, immediate access to a patient’s medical history, which will help us make timely and accurate treatment decisions,” said VA Under Secretary for Health Shereef Elnahal, MD, MBA. “It will also empower VA to send helpful information to our partner health systems that they can then offer to veterans in their care—including information about new benefits we are offering under the PACT Act, no-cost emergency suicide care, and more.”
The pledge will allow the health systems to access local, state, and federal health resources and will provide the VA access to health system clinical and administrative data for quality assessment and care coordination. The pledge signers are committed to developing and providing capabilities that: (1) Accurately identify veterans when they seek care from clinicians in [the signers’] communities; (2) Connect veterans with VA and community resources that promote health and health care—especially VA services that lower veterans’ out-of-pocket expenses; and (3) Responsively and reliably coordinate care for shared patients—including exchanging care information requested and provided.
In addition to helping reduce the financial burden for veterans, the VA says, the information sharing could help clinicians outside the VA system to provide more targeted care: “[I]t will also allow us to send helpful information to our partner health systems that they can then offer to veterans in their care,” Elnahal said, “to include information about new benefits we are offering under the PACT Act and other resources that assist with suicide prevention and identifying social risk factors."
The first pledge partners are Emory Healthcare, Inova, Jefferson Health, Sanford Health, University of California Davis Health, Intermountain Health, Mass General Brigham, Rush Health, Tufts Medicine, Marshfield Clinic, Kaiser Permanente Health Plan and Hospitals, University of Pittsburg Medical Center, and Atrium Health. Any health system or clinician that supports the pledge’s objectives is encouraged to participate, the VA says. Signers have begun work, and aim to provide proof-of-concept in early 2024.
Playing board games may slow cognitive decline, improve QoL
“For patients who are elderly and suffer from social isolation and mild cognitive issues, I would definitely recommend board games,” study investigator Frederico Emanuele Pozzi, MD, a neurology resident at Fondazione IRCCS San Gerardo dei Tintori in Monza, Italy, told this news organization.
The findings were presented at the virtual XXVI World Congress of Neurology (WCN).
After searching the published literature, Dr. Pozzi and his colleagues selected 15 studies for the review. The studies assessed the impact of board games on older individuals at risk of or with cognitive impairment, or those with mild cognitive impairment (MCI) at any age.
The studies included different board games including chess, Mah-jongg, and Go, a two-player game popular in China, Japan, and Korea that involves moving board pieces to surround and capture as much territory as possible.
Most interventions lasted about an hour and were held once or twice per week for 3-4 months.
Which games are best?
Researchers found that board games improved cognitive function, as measured by improved scores on the Montreal Cognitive Assessment (P = .003) and Mini-Mental State Examination (P = .02).
Playing Go was linked with improved working memory, as measured by the Trail Making Test-A. Those who played Mah-jongg reported improved executive functioning and a temporary decrease in depressive symptoms. And chess players reported improved quality of life on the World Health Organization Quality of Life scale from playing chess (P < .00001).
In general, cognition improved across different populations. For example, some studies looked at unimpaired elderly while others looked at MCI, said Dr. Pozzi.
Playing board games in a social context appeared to be especially good at boosting brain power. One Japanese study included a control group that just did tai chi, a group that did Go alone on tablets, and another group that did Go in groups. Both Go groups improved cognitively, but participants who played together improved the most.
The results also seemed to suggest that Go and chess have different biological effects. “For example, Go increased [brain-derived neurotrophic factor] (BDNF) levels and metabolism in areas key for cognition like the middle temporal gyrus,” Dr. Pozzi said.
He noted that the methodology of the studies was generally “not bad,” although in some cases the analyses were per protocol and in others intention-to-treat. Outcomes varied across studies, there were a lot of dropouts, and some were not randomized, meaning reverse causality can’t be ruled out.
Dr. Pozzi has started a randomized controlled trial at a Go and chess club in Italy. He’s enrolling patients aged 60 and over with subjective cognitive decline or MCI and separating participants into a control group, a group that plays chess, another that plays Go, and another that plays both Go and chess.
In addition to the standard cognitive tests, and measures of depression and quality of life, Dr. Pozzi aims to assess cognitive reserve and is in the process of validating a questionnaire that will look at leisure activities and lifestyle.
Social and cognitive value
Commenting on the research for this news organization, Vladimir Hachinski, MD, a professor of clinical neurological sciences at Western University in London, Ont., said the results make sense.
Playing a board game involves concentration, strategy, and intermittent rewards – all of which are good for the brain and may involve the prefrontal cortex, he noted. Board games are also typically timed, which involves brain speed processing, and they have a winner and loser so emotions can run high, which also affects the brain, Dr. Hachinski added.
There may also be social value in playing a board game with someone else, added Dr. Hachinski.
“It’s encouraging that people can improve what they’re doing, and the longer they’re at it, the more of the brain they use,” he said. “There might be a long-term effect because players are building up networks.”
But Dr. Hachinski cautioned that playing a lot of chess does not necessarily make you a better thinker, just as learning to play one instrument doesn’t mean you can automatically play others.
“Learning one skill will translate only partially to another, and only if it’s related,” he said. “It increases cognition in the area you’re practicing in, but it doesn’t spread to other areas.”
Dr. Pozzi and Dr. Hachinski report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“For patients who are elderly and suffer from social isolation and mild cognitive issues, I would definitely recommend board games,” study investigator Frederico Emanuele Pozzi, MD, a neurology resident at Fondazione IRCCS San Gerardo dei Tintori in Monza, Italy, told this news organization.
The findings were presented at the virtual XXVI World Congress of Neurology (WCN).
After searching the published literature, Dr. Pozzi and his colleagues selected 15 studies for the review. The studies assessed the impact of board games on older individuals at risk of or with cognitive impairment, or those with mild cognitive impairment (MCI) at any age.
The studies included different board games including chess, Mah-jongg, and Go, a two-player game popular in China, Japan, and Korea that involves moving board pieces to surround and capture as much territory as possible.
Most interventions lasted about an hour and were held once or twice per week for 3-4 months.
Which games are best?
Researchers found that board games improved cognitive function, as measured by improved scores on the Montreal Cognitive Assessment (P = .003) and Mini-Mental State Examination (P = .02).
Playing Go was linked with improved working memory, as measured by the Trail Making Test-A. Those who played Mah-jongg reported improved executive functioning and a temporary decrease in depressive symptoms. And chess players reported improved quality of life on the World Health Organization Quality of Life scale from playing chess (P < .00001).
In general, cognition improved across different populations. For example, some studies looked at unimpaired elderly while others looked at MCI, said Dr. Pozzi.
Playing board games in a social context appeared to be especially good at boosting brain power. One Japanese study included a control group that just did tai chi, a group that did Go alone on tablets, and another group that did Go in groups. Both Go groups improved cognitively, but participants who played together improved the most.
The results also seemed to suggest that Go and chess have different biological effects. “For example, Go increased [brain-derived neurotrophic factor] (BDNF) levels and metabolism in areas key for cognition like the middle temporal gyrus,” Dr. Pozzi said.
He noted that the methodology of the studies was generally “not bad,” although in some cases the analyses were per protocol and in others intention-to-treat. Outcomes varied across studies, there were a lot of dropouts, and some were not randomized, meaning reverse causality can’t be ruled out.
Dr. Pozzi has started a randomized controlled trial at a Go and chess club in Italy. He’s enrolling patients aged 60 and over with subjective cognitive decline or MCI and separating participants into a control group, a group that plays chess, another that plays Go, and another that plays both Go and chess.
In addition to the standard cognitive tests, and measures of depression and quality of life, Dr. Pozzi aims to assess cognitive reserve and is in the process of validating a questionnaire that will look at leisure activities and lifestyle.
Social and cognitive value
Commenting on the research for this news organization, Vladimir Hachinski, MD, a professor of clinical neurological sciences at Western University in London, Ont., said the results make sense.
Playing a board game involves concentration, strategy, and intermittent rewards – all of which are good for the brain and may involve the prefrontal cortex, he noted. Board games are also typically timed, which involves brain speed processing, and they have a winner and loser so emotions can run high, which also affects the brain, Dr. Hachinski added.
There may also be social value in playing a board game with someone else, added Dr. Hachinski.
“It’s encouraging that people can improve what they’re doing, and the longer they’re at it, the more of the brain they use,” he said. “There might be a long-term effect because players are building up networks.”
But Dr. Hachinski cautioned that playing a lot of chess does not necessarily make you a better thinker, just as learning to play one instrument doesn’t mean you can automatically play others.
“Learning one skill will translate only partially to another, and only if it’s related,” he said. “It increases cognition in the area you’re practicing in, but it doesn’t spread to other areas.”
Dr. Pozzi and Dr. Hachinski report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“For patients who are elderly and suffer from social isolation and mild cognitive issues, I would definitely recommend board games,” study investigator Frederico Emanuele Pozzi, MD, a neurology resident at Fondazione IRCCS San Gerardo dei Tintori in Monza, Italy, told this news organization.
The findings were presented at the virtual XXVI World Congress of Neurology (WCN).
After searching the published literature, Dr. Pozzi and his colleagues selected 15 studies for the review. The studies assessed the impact of board games on older individuals at risk of or with cognitive impairment, or those with mild cognitive impairment (MCI) at any age.
The studies included different board games including chess, Mah-jongg, and Go, a two-player game popular in China, Japan, and Korea that involves moving board pieces to surround and capture as much territory as possible.
Most interventions lasted about an hour and were held once or twice per week for 3-4 months.
Which games are best?
Researchers found that board games improved cognitive function, as measured by improved scores on the Montreal Cognitive Assessment (P = .003) and Mini-Mental State Examination (P = .02).
Playing Go was linked with improved working memory, as measured by the Trail Making Test-A. Those who played Mah-jongg reported improved executive functioning and a temporary decrease in depressive symptoms. And chess players reported improved quality of life on the World Health Organization Quality of Life scale from playing chess (P < .00001).
In general, cognition improved across different populations. For example, some studies looked at unimpaired elderly while others looked at MCI, said Dr. Pozzi.
Playing board games in a social context appeared to be especially good at boosting brain power. One Japanese study included a control group that just did tai chi, a group that did Go alone on tablets, and another group that did Go in groups. Both Go groups improved cognitively, but participants who played together improved the most.
The results also seemed to suggest that Go and chess have different biological effects. “For example, Go increased [brain-derived neurotrophic factor] (BDNF) levels and metabolism in areas key for cognition like the middle temporal gyrus,” Dr. Pozzi said.
He noted that the methodology of the studies was generally “not bad,” although in some cases the analyses were per protocol and in others intention-to-treat. Outcomes varied across studies, there were a lot of dropouts, and some were not randomized, meaning reverse causality can’t be ruled out.
Dr. Pozzi has started a randomized controlled trial at a Go and chess club in Italy. He’s enrolling patients aged 60 and over with subjective cognitive decline or MCI and separating participants into a control group, a group that plays chess, another that plays Go, and another that plays both Go and chess.
In addition to the standard cognitive tests, and measures of depression and quality of life, Dr. Pozzi aims to assess cognitive reserve and is in the process of validating a questionnaire that will look at leisure activities and lifestyle.
Social and cognitive value
Commenting on the research for this news organization, Vladimir Hachinski, MD, a professor of clinical neurological sciences at Western University in London, Ont., said the results make sense.
Playing a board game involves concentration, strategy, and intermittent rewards – all of which are good for the brain and may involve the prefrontal cortex, he noted. Board games are also typically timed, which involves brain speed processing, and they have a winner and loser so emotions can run high, which also affects the brain, Dr. Hachinski added.
There may also be social value in playing a board game with someone else, added Dr. Hachinski.
“It’s encouraging that people can improve what they’re doing, and the longer they’re at it, the more of the brain they use,” he said. “There might be a long-term effect because players are building up networks.”
But Dr. Hachinski cautioned that playing a lot of chess does not necessarily make you a better thinker, just as learning to play one instrument doesn’t mean you can automatically play others.
“Learning one skill will translate only partially to another, and only if it’s related,” he said. “It increases cognition in the area you’re practicing in, but it doesn’t spread to other areas.”
Dr. Pozzi and Dr. Hachinski report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
ALK inhibitor alectinib shows DFS benefit in early NSCLC
Alectinib, a potent anaplastic lymphoma kinase (ALK) inhibitor, significantly improved disease-free survival (DFS) at 2 years, compared with chemotherapy, in patients with completely resected ALK+ non–small cell lung cancer (NSCLC), according to interim findings from the open-label phase 3 ALINA trial.
The , said Ben Solomon, MBBS, PhD, who presented late-breaking data from the trial at the annual meeting of the European Society for Medical Oncology.
ALINA is the first phase 3 trial of an ALK inhibitor to show a DFS benefit in completely resected stage IB-IIIA disease, said Dr. Solomon, professor and medical oncologist at Peter MacCallum Cancer Centre, Melbourne.
The current treatment recommendation for after surgery in this patient population is platinum-based chemotherapy, which is associated with modest improvements in overall survival. But multiple trials looking at alectinib in stage I-III NSCLC are underway given the unmet need for treatment in the 4%-5% of NSCLC patients with ALK rearrangements, Dr. Solomon explained.
The ALINA trial enrolled adults with good performance status and completely resected stage IB-IIIA ALK+ NSCLC. Patients were randomized 1:1 to 600 mg of oral alectinib twice daily for up to 24 months or until disease recurrence, or up to four 21-day cycles of intravenous platinum-based chemotherapy.
At median follow-up of 27.8 months, Dr. Solomon and colleagues observed an overall DFS benefit in 130 patients with stage II-IIIA disease randomized to receive alectinib, compared with the 127 patients who received chemotherapy (median DFS not reached vs. 44.4 months; hazard ratio, 0.24). The benefit was observed in the overall intention-to-treat (ITT) population of patients with stage IB-IIIA disease (median DFS not reached vs. 41.3 months; HR, 0.24).
Two-year DFS was also improved with alectinib vs. chemotherapy for stage IB (HR, 0.21), stage II (HR, 0.24), and stage IIIA disease (HR, 0.25).
The investigators observed a clinically meaningful central nervous system DFS benefit in the ITT population as well (HR, 0.22). This finding is important, given that patients with ALK+ disease have a high risk of brain metastases, which occurs in 50%-60% of patients over the course of disease, Dr. Solomon noted.
Over the treatment duration in each arm, 23.4% of patients in the alectinib arm and 25.8% in the chemotherapy arm experienced grade 3 or 4 adverse events; 5 patients in the alectinib arm and 13 in the chemotherapy arm had adverse events that led to treatment discontinuation.
“Adjuvant alectinib was tolerable and in line with the known safety profile of alectinib,” Dr. Solomon concluded, but noted that the overall survival data were not yet mature.
Invited discussant Marina Garassino, MBBS, however, cautioned against rushing to judgment, calling the DFS findings “interesting, but early.”
“Are 2 years of alectinib enough to impact overall survival? We don’t know yet,” said Dr. Garassino, professor of medicine and director of the thoracic oncology program at the University of Chicago.
Chemotherapy, conversely, has been shown to improve overall survival, she noted.
Toxicity of alectinib in the adjuvant setting may be a concern as well, she said, explaining that patients have reported numerous side effects that can affect quality of life, such as sun sensitivity, difficulty focusing, neuropathy, lower back muscle soreness, and constipation.
“So, I think we should still wait for more results from this trial,” she said.
In the meantime, she said she will ask patients “if they want this kind of toxicity in the absence of a clear overall survival benefit.”
The ALINA trial is funded by F. Hoffmann-La Roche. Dr. Solomon and Dr. Garassino each reported numerous relationships with pharmaceutical companies and other entities.
A version of this article first appeared on Medscape.com.
Alectinib, a potent anaplastic lymphoma kinase (ALK) inhibitor, significantly improved disease-free survival (DFS) at 2 years, compared with chemotherapy, in patients with completely resected ALK+ non–small cell lung cancer (NSCLC), according to interim findings from the open-label phase 3 ALINA trial.
The , said Ben Solomon, MBBS, PhD, who presented late-breaking data from the trial at the annual meeting of the European Society for Medical Oncology.
ALINA is the first phase 3 trial of an ALK inhibitor to show a DFS benefit in completely resected stage IB-IIIA disease, said Dr. Solomon, professor and medical oncologist at Peter MacCallum Cancer Centre, Melbourne.
The current treatment recommendation for after surgery in this patient population is platinum-based chemotherapy, which is associated with modest improvements in overall survival. But multiple trials looking at alectinib in stage I-III NSCLC are underway given the unmet need for treatment in the 4%-5% of NSCLC patients with ALK rearrangements, Dr. Solomon explained.
The ALINA trial enrolled adults with good performance status and completely resected stage IB-IIIA ALK+ NSCLC. Patients were randomized 1:1 to 600 mg of oral alectinib twice daily for up to 24 months or until disease recurrence, or up to four 21-day cycles of intravenous platinum-based chemotherapy.
At median follow-up of 27.8 months, Dr. Solomon and colleagues observed an overall DFS benefit in 130 patients with stage II-IIIA disease randomized to receive alectinib, compared with the 127 patients who received chemotherapy (median DFS not reached vs. 44.4 months; hazard ratio, 0.24). The benefit was observed in the overall intention-to-treat (ITT) population of patients with stage IB-IIIA disease (median DFS not reached vs. 41.3 months; HR, 0.24).
Two-year DFS was also improved with alectinib vs. chemotherapy for stage IB (HR, 0.21), stage II (HR, 0.24), and stage IIIA disease (HR, 0.25).
The investigators observed a clinically meaningful central nervous system DFS benefit in the ITT population as well (HR, 0.22). This finding is important, given that patients with ALK+ disease have a high risk of brain metastases, which occurs in 50%-60% of patients over the course of disease, Dr. Solomon noted.
Over the treatment duration in each arm, 23.4% of patients in the alectinib arm and 25.8% in the chemotherapy arm experienced grade 3 or 4 adverse events; 5 patients in the alectinib arm and 13 in the chemotherapy arm had adverse events that led to treatment discontinuation.
“Adjuvant alectinib was tolerable and in line with the known safety profile of alectinib,” Dr. Solomon concluded, but noted that the overall survival data were not yet mature.
Invited discussant Marina Garassino, MBBS, however, cautioned against rushing to judgment, calling the DFS findings “interesting, but early.”
“Are 2 years of alectinib enough to impact overall survival? We don’t know yet,” said Dr. Garassino, professor of medicine and director of the thoracic oncology program at the University of Chicago.
Chemotherapy, conversely, has been shown to improve overall survival, she noted.
Toxicity of alectinib in the adjuvant setting may be a concern as well, she said, explaining that patients have reported numerous side effects that can affect quality of life, such as sun sensitivity, difficulty focusing, neuropathy, lower back muscle soreness, and constipation.
“So, I think we should still wait for more results from this trial,” she said.
In the meantime, she said she will ask patients “if they want this kind of toxicity in the absence of a clear overall survival benefit.”
The ALINA trial is funded by F. Hoffmann-La Roche. Dr. Solomon and Dr. Garassino each reported numerous relationships with pharmaceutical companies and other entities.
A version of this article first appeared on Medscape.com.
Alectinib, a potent anaplastic lymphoma kinase (ALK) inhibitor, significantly improved disease-free survival (DFS) at 2 years, compared with chemotherapy, in patients with completely resected ALK+ non–small cell lung cancer (NSCLC), according to interim findings from the open-label phase 3 ALINA trial.
The , said Ben Solomon, MBBS, PhD, who presented late-breaking data from the trial at the annual meeting of the European Society for Medical Oncology.
ALINA is the first phase 3 trial of an ALK inhibitor to show a DFS benefit in completely resected stage IB-IIIA disease, said Dr. Solomon, professor and medical oncologist at Peter MacCallum Cancer Centre, Melbourne.
The current treatment recommendation for after surgery in this patient population is platinum-based chemotherapy, which is associated with modest improvements in overall survival. But multiple trials looking at alectinib in stage I-III NSCLC are underway given the unmet need for treatment in the 4%-5% of NSCLC patients with ALK rearrangements, Dr. Solomon explained.
The ALINA trial enrolled adults with good performance status and completely resected stage IB-IIIA ALK+ NSCLC. Patients were randomized 1:1 to 600 mg of oral alectinib twice daily for up to 24 months or until disease recurrence, or up to four 21-day cycles of intravenous platinum-based chemotherapy.
At median follow-up of 27.8 months, Dr. Solomon and colleagues observed an overall DFS benefit in 130 patients with stage II-IIIA disease randomized to receive alectinib, compared with the 127 patients who received chemotherapy (median DFS not reached vs. 44.4 months; hazard ratio, 0.24). The benefit was observed in the overall intention-to-treat (ITT) population of patients with stage IB-IIIA disease (median DFS not reached vs. 41.3 months; HR, 0.24).
Two-year DFS was also improved with alectinib vs. chemotherapy for stage IB (HR, 0.21), stage II (HR, 0.24), and stage IIIA disease (HR, 0.25).
The investigators observed a clinically meaningful central nervous system DFS benefit in the ITT population as well (HR, 0.22). This finding is important, given that patients with ALK+ disease have a high risk of brain metastases, which occurs in 50%-60% of patients over the course of disease, Dr. Solomon noted.
Over the treatment duration in each arm, 23.4% of patients in the alectinib arm and 25.8% in the chemotherapy arm experienced grade 3 or 4 adverse events; 5 patients in the alectinib arm and 13 in the chemotherapy arm had adverse events that led to treatment discontinuation.
“Adjuvant alectinib was tolerable and in line with the known safety profile of alectinib,” Dr. Solomon concluded, but noted that the overall survival data were not yet mature.
Invited discussant Marina Garassino, MBBS, however, cautioned against rushing to judgment, calling the DFS findings “interesting, but early.”
“Are 2 years of alectinib enough to impact overall survival? We don’t know yet,” said Dr. Garassino, professor of medicine and director of the thoracic oncology program at the University of Chicago.
Chemotherapy, conversely, has been shown to improve overall survival, she noted.
Toxicity of alectinib in the adjuvant setting may be a concern as well, she said, explaining that patients have reported numerous side effects that can affect quality of life, such as sun sensitivity, difficulty focusing, neuropathy, lower back muscle soreness, and constipation.
“So, I think we should still wait for more results from this trial,” she said.
In the meantime, she said she will ask patients “if they want this kind of toxicity in the absence of a clear overall survival benefit.”
The ALINA trial is funded by F. Hoffmann-La Roche. Dr. Solomon and Dr. Garassino each reported numerous relationships with pharmaceutical companies and other entities.
A version of this article first appeared on Medscape.com.
FROM ESMO CONGRESS 2023