Women's Health

SAN FRANCISCO — More than a quarter of pregnant or postpartum patients who screened positive for cardiovascular disease ended up with a cardiovascular disease diagnosis when providers used a risk screening tool built into the electronic medical records system for all patients, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. “Timely diagnosis of cardiovascular disease is critical, though challenging, since pregnancy is a state of hemodynamic stress with symptoms that are like those of cardiovascular disease, and healthcare providers may not suspect cardiovascular disease in pregnant patients with symptoms of it,” Kevin Flatley, MD, a resident ob.gyn. at Montefiore Health System and the Albert Einstein College of Medicine in New York City, told attendees at the conference. “The cardiovascular risk assessment tool proved valuable for identifying and providing individualized care for cardio-obstetric patients.”

The study senior author, Diana S. Wolfe, MD, MPH, associate division director of Maternal Fetal Medicine at Montefiore Health System and associate professor of medicine in cardiology at Albert Einstein College of Medicine, said in an interview that cardiovascular risk in Montefiore’s urban population is significant.

“Cardiovascular disease risk screening identifies true cardiac disease in this population and can change the medical management and outcome of pregnant and postpartum patients,” Dr. Wolfe said. Screening has the potential to decrease maternal morbidity and mortality in our country, she said.

Dawnette Lewis, MD, MPH, director of the Center for Maternal Health at Northwell Health and an ob.gyn. and maternal fetal medicine specialist who was not involved in the study, was impressed with the research.

“We know that cardiovascular disease is one of the leading causes of maternal mortality,” Dr. Lewis said in an interview. “It is important to have an accurate risk assessment score, so I think what is being presented in this abstract is great.” She said she’s aware that other cardio-obstetric programs across the country are also implementing cardiovascular risk assessment tools during pregnancy.

The researchers built into their electronic health records a screening algorithm developed by the California Maternal Quality Care Initiative that had been based on a retrospective review of cardiovascular maternal deaths in California from 2002 to 2006. Their study aimed to identify the true positives — those who actually had cardiovascular disease — of those determined to be at risk by the screening toolkit.

The institution’s goal was for all patients to undergo a screening risk assessment at least once during prenatal and/or postpartum visits. Patients were considered to screen positive if they had at least one symptom, at least one vital sign abnormality, and at least one risk factor, or any combination of these that added up to 4.

Symptoms in the screening tool included shortness of breath, shortness of breath while lying flat, a rapid heart rate, asthma that was unresponsive to therapy, palpitations, fainting or other loss of consciousness, and chest pain. Abnormal vital signs included a resting heart rate of 110 bpm or greater, systolic blood pressure of 140 mm Hg or higher, a respiratory rate of 24 or higher, and an oxygen saturation of 96% or lower.

Risk factors included being 40 or older, being Black, having a pre-pregnancy BMI of 35 or greater, preexisting diabetes, hypertension, substance use, and a history of cancer, chemotherapy, or chest radiation. “Current practice acknowledges that the risk factor currently included in the algorithm of self-identified as Black actually represents racism, bias, and social determinants of health, known risk factors for CVD,” Wolfe said.

Patients who screened positive underwent an echocardiogram, a cardio-obstetric consultation, and an additional work-up.

During the June 2022–September 2023 study period, 148 out of 1877 screened patients (7.9%) had a positive screen. Of these, 108 were false positives and 40 (27%) were true positives. The number of true false positives is not known because many women did not come for their workups.* The true positives mostly included patients with mild valvular disease, but about a quarter had mild, moderate, or severe ventricular dilation or hypertrophy and a little less than a quarter were positive for systolic or diastolic dysfunction.

Most (72.5%) of the 40 true-positive cases needed a multidisciplinary cardio-obstetrics team plan, and 11 patients (27.5%) needed follow-up and had multiple visits with the cardio-obstetrics team. Six of the true-positive cases (15%) “were deemed to be of higher risk for decompensation during labor and required detailed plans for intrapartum and postpartum management,” the researchers reported. Nine patients (22.5%) began new cardiovascular medications.

This research is a validation study of the current algorithm, Wolfe said, and the algorithm will be revised based on the results of the completed validation study.

“The objective is universal cardiovascular risk screening for all pregnant and postpartum persons in the US,” Wolfe said. “Once the data collection from this validation study is concluded, our goal is to disseminate a revised CVD risk screening tool that can be implemented into the electronic medical records of all institutions in our country.”

*The study partially funded by the National Institute of Child Health and Human Development award #5R21HD101783. All the authors and Dr. Lewis had no disclosures. Dr. Afshan B. Hameed of the University of California at Irvine was a partner in the study.

*This study was updated on May 30, 2024.

SAN FRANCISCO — More than a quarter of pregnant or postpartum patients who screened positive for cardiovascular disease ended up with a cardiovascular disease diagnosis when providers used a risk screening tool built into the electronic medical records system for all patients, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. “Timely diagnosis of cardiovascular disease is critical, though challenging, since pregnancy is a state of hemodynamic stress with symptoms that are like those of cardiovascular disease, and healthcare providers may not suspect cardiovascular disease in pregnant patients with symptoms of it,” Kevin Flatley, MD, a resident ob.gyn. at Montefiore Health System and the Albert Einstein College of Medicine in New York City, told attendees at the conference. “The cardiovascular risk assessment tool proved valuable for identifying and providing individualized care for cardio-obstetric patients.”

The study senior author, Diana S. Wolfe, MD, MPH, associate division director of Maternal Fetal Medicine at Montefiore Health System and associate professor of medicine in cardiology at Albert Einstein College of Medicine, said in an interview that cardiovascular risk in Montefiore’s urban population is significant.

“Cardiovascular disease risk screening identifies true cardiac disease in this population and can change the medical management and outcome of pregnant and postpartum patients,” Dr. Wolfe said. Screening has the potential to decrease maternal morbidity and mortality in our country, she said.

Dawnette Lewis, MD, MPH, director of the Center for Maternal Health at Northwell Health and an ob.gyn. and maternal fetal medicine specialist who was not involved in the study, was impressed with the research.

“We know that cardiovascular disease is one of the leading causes of maternal mortality,” Dr. Lewis said in an interview. “It is important to have an accurate risk assessment score, so I think what is being presented in this abstract is great.” She said she’s aware that other cardio-obstetric programs across the country are also implementing cardiovascular risk assessment tools during pregnancy.

The researchers built into their electronic health records a screening algorithm developed by the California Maternal Quality Care Initiative that had been based on a retrospective review of cardiovascular maternal deaths in California from 2002 to 2006. Their study aimed to identify the true positives — those who actually had cardiovascular disease — of those determined to be at risk by the screening toolkit.

The institution’s goal was for all patients to undergo a screening risk assessment at least once during prenatal and/or postpartum visits. Patients were considered to screen positive if they had at least one symptom, at least one vital sign abnormality, and at least one risk factor, or any combination of these that added up to 4.

Symptoms in the screening tool included shortness of breath, shortness of breath while lying flat, a rapid heart rate, asthma that was unresponsive to therapy, palpitations, fainting or other loss of consciousness, and chest pain. Abnormal vital signs included a resting heart rate of 110 bpm or greater, systolic blood pressure of 140 mm Hg or higher, a respiratory rate of 24 or higher, and an oxygen saturation of 96% or lower.

Risk factors included being 40 or older, being Black, having a pre-pregnancy BMI of 35 or greater, preexisting diabetes, hypertension, substance use, and a history of cancer, chemotherapy, or chest radiation. “Current practice acknowledges that the risk factor currently included in the algorithm of self-identified as Black actually represents racism, bias, and social determinants of health, known risk factors for CVD,” Wolfe said.

Patients who screened positive underwent an echocardiogram, a cardio-obstetric consultation, and an additional work-up.

During the June 2022–September 2023 study period, 148 out of 1877 screened patients (7.9%) had a positive screen. Of these, 108 were false positives and 40 (27%) were true positives. The number of true false positives is not known because many women did not come for their workups.* The true positives mostly included patients with mild valvular disease, but about a quarter had mild, moderate, or severe ventricular dilation or hypertrophy and a little less than a quarter were positive for systolic or diastolic dysfunction.

Most (72.5%) of the 40 true-positive cases needed a multidisciplinary cardio-obstetrics team plan, and 11 patients (27.5%) needed follow-up and had multiple visits with the cardio-obstetrics team. Six of the true-positive cases (15%) “were deemed to be of higher risk for decompensation during labor and required detailed plans for intrapartum and postpartum management,” the researchers reported. Nine patients (22.5%) began new cardiovascular medications.

This research is a validation study of the current algorithm, Wolfe said, and the algorithm will be revised based on the results of the completed validation study.

“The objective is universal cardiovascular risk screening for all pregnant and postpartum persons in the US,” Wolfe said. “Once the data collection from this validation study is concluded, our goal is to disseminate a revised CVD risk screening tool that can be implemented into the electronic medical records of all institutions in our country.”

*The study partially funded by the National Institute of Child Health and Human Development award #5R21HD101783. All the authors and Dr. Lewis had no disclosures. Dr. Afshan B. Hameed of the University of California at Irvine was a partner in the study.

*This study was updated on May 30, 2024.

SAN FRANCISCO — More than a quarter of pregnant or postpartum patients who screened positive for cardiovascular disease ended up with a cardiovascular disease diagnosis when providers used a risk screening tool built into the electronic medical records system for all patients, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. “Timely diagnosis of cardiovascular disease is critical, though challenging, since pregnancy is a state of hemodynamic stress with symptoms that are like those of cardiovascular disease, and healthcare providers may not suspect cardiovascular disease in pregnant patients with symptoms of it,” Kevin Flatley, MD, a resident ob.gyn. at Montefiore Health System and the Albert Einstein College of Medicine in New York City, told attendees at the conference. “The cardiovascular risk assessment tool proved valuable for identifying and providing individualized care for cardio-obstetric patients.”

The study senior author, Diana S. Wolfe, MD, MPH, associate division director of Maternal Fetal Medicine at Montefiore Health System and associate professor of medicine in cardiology at Albert Einstein College of Medicine, said in an interview that cardiovascular risk in Montefiore’s urban population is significant.

“Cardiovascular disease risk screening identifies true cardiac disease in this population and can change the medical management and outcome of pregnant and postpartum patients,” Dr. Wolfe said. Screening has the potential to decrease maternal morbidity and mortality in our country, she said.

Dawnette Lewis, MD, MPH, director of the Center for Maternal Health at Northwell Health and an ob.gyn. and maternal fetal medicine specialist who was not involved in the study, was impressed with the research.

“We know that cardiovascular disease is one of the leading causes of maternal mortality,” Dr. Lewis said in an interview. “It is important to have an accurate risk assessment score, so I think what is being presented in this abstract is great.” She said she’s aware that other cardio-obstetric programs across the country are also implementing cardiovascular risk assessment tools during pregnancy.

The researchers built into their electronic health records a screening algorithm developed by the California Maternal Quality Care Initiative that had been based on a retrospective review of cardiovascular maternal deaths in California from 2002 to 2006. Their study aimed to identify the true positives — those who actually had cardiovascular disease — of those determined to be at risk by the screening toolkit.

The institution’s goal was for all patients to undergo a screening risk assessment at least once during prenatal and/or postpartum visits. Patients were considered to screen positive if they had at least one symptom, at least one vital sign abnormality, and at least one risk factor, or any combination of these that added up to 4.

Symptoms in the screening tool included shortness of breath, shortness of breath while lying flat, a rapid heart rate, asthma that was unresponsive to therapy, palpitations, fainting or other loss of consciousness, and chest pain. Abnormal vital signs included a resting heart rate of 110 bpm or greater, systolic blood pressure of 140 mm Hg or higher, a respiratory rate of 24 or higher, and an oxygen saturation of 96% or lower.

Risk factors included being 40 or older, being Black, having a pre-pregnancy BMI of 35 or greater, preexisting diabetes, hypertension, substance use, and a history of cancer, chemotherapy, or chest radiation. “Current practice acknowledges that the risk factor currently included in the algorithm of self-identified as Black actually represents racism, bias, and social determinants of health, known risk factors for CVD,” Wolfe said.

Patients who screened positive underwent an echocardiogram, a cardio-obstetric consultation, and an additional work-up.

During the June 2022–September 2023 study period, 148 out of 1877 screened patients (7.9%) had a positive screen. Of these, 108 were false positives and 40 (27%) were true positives. The number of true false positives is not known because many women did not come for their workups.* The true positives mostly included patients with mild valvular disease, but about a quarter had mild, moderate, or severe ventricular dilation or hypertrophy and a little less than a quarter were positive for systolic or diastolic dysfunction.

Most (72.5%) of the 40 true-positive cases needed a multidisciplinary cardio-obstetrics team plan, and 11 patients (27.5%) needed follow-up and had multiple visits with the cardio-obstetrics team. Six of the true-positive cases (15%) “were deemed to be of higher risk for decompensation during labor and required detailed plans for intrapartum and postpartum management,” the researchers reported. Nine patients (22.5%) began new cardiovascular medications.

This research is a validation study of the current algorithm, Wolfe said, and the algorithm will be revised based on the results of the completed validation study.

“The objective is universal cardiovascular risk screening for all pregnant and postpartum persons in the US,” Wolfe said. “Once the data collection from this validation study is concluded, our goal is to disseminate a revised CVD risk screening tool that can be implemented into the electronic medical records of all institutions in our country.”

*The study partially funded by the National Institute of Child Health and Human Development award #5R21HD101783. All the authors and Dr. Lewis had no disclosures. Dr. Afshan B. Hameed of the University of California at Irvine was a partner in the study.

*This study was updated on May 30, 2024.

TOPLINE:

In women with gestational diabetes (GD), continuous glucose monitoring (CGM) shows elevated glycemic metrics earlier in pregnancy compared with the standard oral glucose tolerance test (OGTT).

METHODOLOGY:

• Earlier diagnosis and treatment of GDM may mitigate some perinatal risks, but the traditional OGTT at 24-28 weeks’ gestation delivers inconsistent results in early pregnancy, potentially leading to missed cases or overdiagnosis.
• This prospective noninterventional observational study conducted at two US academic-based clinical sites from June 2020 to December 2021 assessed CGM-derived glycemic patterns in 768 participants (mean age, 33 years; 77% White) enrolled prior to 17 weeks’ gestation with singleton pregnancy and an initial A1c level < 6.5%.
• Participants were encouraged to wear a blinded Dexcom G6 Pro CGM System sensor continuously until the day of delivery, with a median CGM wear duration of 67 days prior to OGTT.
• GDM was diagnosed using an OGTT conducted between 24 and 34 weeks’ gestation, which sorted women into those with GDM (n = 58) or without GDM (n = 710).
• CGM-derived glycemic patterns were compared between the participants with and without GDM.

TAKEAWAY:

• Women with GDM had a higher mean glucose (109 ± 13 vs 100 ± 8 mg/dL; P < .001) and greater glucose SD (23 ± 4 vs 19 ± 3; P < .001) than those without GDM throughout the gestational period prior to OGTT.
• Women with GDM spent lesser time in glycemic ranges of 63-140 mg/dL (87% ± 11% vs 94% ± 4%; P < .001) and 63-120 mg/dL (70% ± 17% vs 84% ± 8%; P < .001) throughout gestation than those without GDM prior to OGTT.
• The daytime and overnight mean glucose levels were higher in those with vs without GDM and attributed to increased hyperglycemia rather than decreased hypoglycemia, with those with GDM spending more time > 120 mg/dL and > 140 mg/dL and less time < 63 mg/dL and < 54 mg/dL.
• Mean glucose and percent time in the > 120 mg/dL and > 140 mg/dL ranges were higher in those with GDM as early as 13-14 weeks of gestation, which persisted at each 2-week period prior to OGTT.

IN PRACTICE:

“CGM could be used in addition to or instead of OGTT to screen individuals at risk for hyperglycemia during pregnancy, even as early as the first trimester,” the authors wrote, adding that “CGM could potentially play a pivotal role in providing timely identification of distinct glycemic patterns indicative of early dysglycemia.”

SOURCE:

The study, led by Celeste Durnwald, MD, Maternal-Fetal Medicine Research Program, Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, was published online in Diabetes Care.

LIMITATIONS:

To include participants with possible early GDM, the study allowed the inclusion of up to 14 days of CGM data after OGTT in the overall gestational period and up to 10 days in the first and second trimesters. A detailed analysis of glycemia at the earliest timepoint of pregnancy could not be conducted as the first trimester data were limited. The findings may not be generalizable to a population with gestational hyperglycemia, as only 58 participants were identified with GDM using OGTT.

DISCLOSURES:

The study was supported by the Leona M. and Harry B. Helmsley Charitable Trust and UnitedHealth Group. Some authors reported performing advisory work, receiving research support and consultancy fees, and being on scientific advisory boards through their employer, while several authors reported that their institution received funds on their behalf from various pharmaceutical, healthcare, and medical device companies.

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

TOPLINE:

In women with gestational diabetes (GD), continuous glucose monitoring (CGM) shows elevated glycemic metrics earlier in pregnancy compared with the standard oral glucose tolerance test (OGTT).

METHODOLOGY:

• Earlier diagnosis and treatment of GDM may mitigate some perinatal risks, but the traditional OGTT at 24-28 weeks’ gestation delivers inconsistent results in early pregnancy, potentially leading to missed cases or overdiagnosis.
• This prospective noninterventional observational study conducted at two US academic-based clinical sites from June 2020 to December 2021 assessed CGM-derived glycemic patterns in 768 participants (mean age, 33 years; 77% White) enrolled prior to 17 weeks’ gestation with singleton pregnancy and an initial A1c level < 6.5%.
• Participants were encouraged to wear a blinded Dexcom G6 Pro CGM System sensor continuously until the day of delivery, with a median CGM wear duration of 67 days prior to OGTT.
• GDM was diagnosed using an OGTT conducted between 24 and 34 weeks’ gestation, which sorted women into those with GDM (n = 58) or without GDM (n = 710).
• CGM-derived glycemic patterns were compared between the participants with and without GDM.

TAKEAWAY:

• Women with GDM had a higher mean glucose (109 ± 13 vs 100 ± 8 mg/dL; P < .001) and greater glucose SD (23 ± 4 vs 19 ± 3; P < .001) than those without GDM throughout the gestational period prior to OGTT.
• Women with GDM spent lesser time in glycemic ranges of 63-140 mg/dL (87% ± 11% vs 94% ± 4%; P < .001) and 63-120 mg/dL (70% ± 17% vs 84% ± 8%; P < .001) throughout gestation than those without GDM prior to OGTT.
• The daytime and overnight mean glucose levels were higher in those with vs without GDM and attributed to increased hyperglycemia rather than decreased hypoglycemia, with those with GDM spending more time > 120 mg/dL and > 140 mg/dL and less time < 63 mg/dL and < 54 mg/dL.
• Mean glucose and percent time in the > 120 mg/dL and > 140 mg/dL ranges were higher in those with GDM as early as 13-14 weeks of gestation, which persisted at each 2-week period prior to OGTT.

IN PRACTICE:

“CGM could be used in addition to or instead of OGTT to screen individuals at risk for hyperglycemia during pregnancy, even as early as the first trimester,” the authors wrote, adding that “CGM could potentially play a pivotal role in providing timely identification of distinct glycemic patterns indicative of early dysglycemia.”

SOURCE:

The study, led by Celeste Durnwald, MD, Maternal-Fetal Medicine Research Program, Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, was published online in Diabetes Care.

LIMITATIONS:

To include participants with possible early GDM, the study allowed the inclusion of up to 14 days of CGM data after OGTT in the overall gestational period and up to 10 days in the first and second trimesters. A detailed analysis of glycemia at the earliest timepoint of pregnancy could not be conducted as the first trimester data were limited. The findings may not be generalizable to a population with gestational hyperglycemia, as only 58 participants were identified with GDM using OGTT.

DISCLOSURES:

The study was supported by the Leona M. and Harry B. Helmsley Charitable Trust and UnitedHealth Group. Some authors reported performing advisory work, receiving research support and consultancy fees, and being on scientific advisory boards through their employer, while several authors reported that their institution received funds on their behalf from various pharmaceutical, healthcare, and medical device companies.

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

TOPLINE:

In women with gestational diabetes (GD), continuous glucose monitoring (CGM) shows elevated glycemic metrics earlier in pregnancy compared with the standard oral glucose tolerance test (OGTT).

METHODOLOGY:

• Earlier diagnosis and treatment of GDM may mitigate some perinatal risks, but the traditional OGTT at 24-28 weeks’ gestation delivers inconsistent results in early pregnancy, potentially leading to missed cases or overdiagnosis.
• This prospective noninterventional observational study conducted at two US academic-based clinical sites from June 2020 to December 2021 assessed CGM-derived glycemic patterns in 768 participants (mean age, 33 years; 77% White) enrolled prior to 17 weeks’ gestation with singleton pregnancy and an initial A1c level < 6.5%.
• Participants were encouraged to wear a blinded Dexcom G6 Pro CGM System sensor continuously until the day of delivery, with a median CGM wear duration of 67 days prior to OGTT.
• GDM was diagnosed using an OGTT conducted between 24 and 34 weeks’ gestation, which sorted women into those with GDM (n = 58) or without GDM (n = 710).
• CGM-derived glycemic patterns were compared between the participants with and without GDM.

TAKEAWAY:

• Women with GDM had a higher mean glucose (109 ± 13 vs 100 ± 8 mg/dL; P < .001) and greater glucose SD (23 ± 4 vs 19 ± 3; P < .001) than those without GDM throughout the gestational period prior to OGTT.
• Women with GDM spent lesser time in glycemic ranges of 63-140 mg/dL (87% ± 11% vs 94% ± 4%; P < .001) and 63-120 mg/dL (70% ± 17% vs 84% ± 8%; P < .001) throughout gestation than those without GDM prior to OGTT.
• The daytime and overnight mean glucose levels were higher in those with vs without GDM and attributed to increased hyperglycemia rather than decreased hypoglycemia, with those with GDM spending more time > 120 mg/dL and > 140 mg/dL and less time < 63 mg/dL and < 54 mg/dL.
• Mean glucose and percent time in the > 120 mg/dL and > 140 mg/dL ranges were higher in those with GDM as early as 13-14 weeks of gestation, which persisted at each 2-week period prior to OGTT.

IN PRACTICE:

“CGM could be used in addition to or instead of OGTT to screen individuals at risk for hyperglycemia during pregnancy, even as early as the first trimester,” the authors wrote, adding that “CGM could potentially play a pivotal role in providing timely identification of distinct glycemic patterns indicative of early dysglycemia.”

SOURCE:

The study, led by Celeste Durnwald, MD, Maternal-Fetal Medicine Research Program, Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, was published online in Diabetes Care.

LIMITATIONS:

To include participants with possible early GDM, the study allowed the inclusion of up to 14 days of CGM data after OGTT in the overall gestational period and up to 10 days in the first and second trimesters. A detailed analysis of glycemia at the earliest timepoint of pregnancy could not be conducted as the first trimester data were limited. The findings may not be generalizable to a population with gestational hyperglycemia, as only 58 participants were identified with GDM using OGTT.

DISCLOSURES:

The study was supported by the Leona M. and Harry B. Helmsley Charitable Trust and UnitedHealth Group. Some authors reported performing advisory work, receiving research support and consultancy fees, and being on scientific advisory boards through their employer, while several authors reported that their institution received funds on their behalf from various pharmaceutical, healthcare, and medical device companies.

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

Approximately one-quarter of mothers with diabetes failed induction of labor, and this failure was associated with a range of adverse outcomes for mothers and infants, based on data from more than 2,000 individuals.

Uncontrolled diabetes remains a risk factor for cesarean delivery, Ali Alhousseini, MD, of Corewell Health East, Dearborn, Michigan, and colleagues wrote in a study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

“Identifying and stratifying associated risk factors for failed induction of labor [IOL] may improve counseling and intrapartum care,” the researchers wrote in their abstract.

The researchers reviewed data from 2,172 mothers with diabetes who underwent IOL at a single university medical center between January 2013 and December 2021. They examined a range of maternal characteristics including age, ethnicity, gestational age, medical comorbidities, insulin administration, parity, and health insurance.

A total of 567 mothers with diabetes (26.1%) failed IOL and underwent cesarean delivery.

Overall, failed IOL was significantly associated with nulliparity (P = .0001), as well as preexisting diabetes compared with gestational diabetes, diabetes control with insulin, maternal essential hypertension, preeclampsia, and polyhydramnios (P = .001 for all). Other factors significantly associated with failed IOL included prenatal diagnosis of fetal growth restriction (P = .008), and placental abnormalities (P = .027).

Neonatal factors of weight, large for gestational age, head circumference, and height were not significantly associated with failed IOL (P > .05 for all).

As for neonatal outcomes, failed IOL was significantly associated with admission to neonatal intensive care unit, hyperbilirubinemia, and longer hospital stay (P = .001 for all). Failed IOL was significantly associated with lower 1-minute APGAR scores, but not with lower 5-minute APGAR scores, the researchers noted (P = .033 for 1-minute score). No association was noted between failed IOL and neonatal readmission, lower umbilical cord pH value, or maternal ethnicity.

The findings were limited by the retrospective design, but data analysis is ongoing, Dr. Alhousseini said. The researchers are continuing to assess the roles not only of optimal glucose control, but other maternal factors in improving maternal and neonatal outcomes, he said.
 

Data Add to Awareness of Risk Factors

The current study is important because of the increasing incidence of diabetes and the need to examine associated risk factors in pregnancy, Michael Richley, MD, a maternal fetal medicine physician at the University of Washington, Seattle, said in an interview. “The average age of onset of diabetes is becoming younger and type 2 diabetes in pregnancy is an increasingly common diagnosis,” said Dr. Richley, who was not involved in the study.  

The increase in both maternal and neonatal adverse outcomes is expected given the risk factors identified in the study, said Dr. Richley. “The patients with diabetes also were sicker at baseline, with hypertensive disorders, growth restriction, and pregestational diabetes,” he noted.

The study findings support data from previous research, Dr. Richley said. The message to clinicians is that patients with diabetes not only have an increased risk of needing a cesarean delivery but also have an increased risk of poor outcomes if a cesarean delivery is needed, he said.

Although a prospective study would be useful to show causality as opposed to just an association, such a study is challenging in this patient population given the limitations of conducting research on labor and delivery, he said.

The study received no outside funding. The researchers and Dr. Richley had no financial conflicts to disclose.

Approximately one-quarter of mothers with diabetes failed induction of labor, and this failure was associated with a range of adverse outcomes for mothers and infants, based on data from more than 2,000 individuals.

Uncontrolled diabetes remains a risk factor for cesarean delivery, Ali Alhousseini, MD, of Corewell Health East, Dearborn, Michigan, and colleagues wrote in a study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

“Identifying and stratifying associated risk factors for failed induction of labor [IOL] may improve counseling and intrapartum care,” the researchers wrote in their abstract.

The researchers reviewed data from 2,172 mothers with diabetes who underwent IOL at a single university medical center between January 2013 and December 2021. They examined a range of maternal characteristics including age, ethnicity, gestational age, medical comorbidities, insulin administration, parity, and health insurance.

A total of 567 mothers with diabetes (26.1%) failed IOL and underwent cesarean delivery.

Overall, failed IOL was significantly associated with nulliparity (P = .0001), as well as preexisting diabetes compared with gestational diabetes, diabetes control with insulin, maternal essential hypertension, preeclampsia, and polyhydramnios (P = .001 for all). Other factors significantly associated with failed IOL included prenatal diagnosis of fetal growth restriction (P = .008), and placental abnormalities (P = .027).

Neonatal factors of weight, large for gestational age, head circumference, and height were not significantly associated with failed IOL (P > .05 for all).

As for neonatal outcomes, failed IOL was significantly associated with admission to neonatal intensive care unit, hyperbilirubinemia, and longer hospital stay (P = .001 for all). Failed IOL was significantly associated with lower 1-minute APGAR scores, but not with lower 5-minute APGAR scores, the researchers noted (P = .033 for 1-minute score). No association was noted between failed IOL and neonatal readmission, lower umbilical cord pH value, or maternal ethnicity.

The findings were limited by the retrospective design, but data analysis is ongoing, Dr. Alhousseini said. The researchers are continuing to assess the roles not only of optimal glucose control, but other maternal factors in improving maternal and neonatal outcomes, he said.
 

Data Add to Awareness of Risk Factors

The current study is important because of the increasing incidence of diabetes and the need to examine associated risk factors in pregnancy, Michael Richley, MD, a maternal fetal medicine physician at the University of Washington, Seattle, said in an interview. “The average age of onset of diabetes is becoming younger and type 2 diabetes in pregnancy is an increasingly common diagnosis,” said Dr. Richley, who was not involved in the study.  

The increase in both maternal and neonatal adverse outcomes is expected given the risk factors identified in the study, said Dr. Richley. “The patients with diabetes also were sicker at baseline, with hypertensive disorders, growth restriction, and pregestational diabetes,” he noted.

The study findings support data from previous research, Dr. Richley said. The message to clinicians is that patients with diabetes not only have an increased risk of needing a cesarean delivery but also have an increased risk of poor outcomes if a cesarean delivery is needed, he said.

Although a prospective study would be useful to show causality as opposed to just an association, such a study is challenging in this patient population given the limitations of conducting research on labor and delivery, he said.

The study received no outside funding. The researchers and Dr. Richley had no financial conflicts to disclose.

Approximately one-quarter of mothers with diabetes failed induction of labor, and this failure was associated with a range of adverse outcomes for mothers and infants, based on data from more than 2,000 individuals.

Uncontrolled diabetes remains a risk factor for cesarean delivery, Ali Alhousseini, MD, of Corewell Health East, Dearborn, Michigan, and colleagues wrote in a study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

“Identifying and stratifying associated risk factors for failed induction of labor [IOL] may improve counseling and intrapartum care,” the researchers wrote in their abstract.

The researchers reviewed data from 2,172 mothers with diabetes who underwent IOL at a single university medical center between January 2013 and December 2021. They examined a range of maternal characteristics including age, ethnicity, gestational age, medical comorbidities, insulin administration, parity, and health insurance.

A total of 567 mothers with diabetes (26.1%) failed IOL and underwent cesarean delivery.

Overall, failed IOL was significantly associated with nulliparity (P = .0001), as well as preexisting diabetes compared with gestational diabetes, diabetes control with insulin, maternal essential hypertension, preeclampsia, and polyhydramnios (P = .001 for all). Other factors significantly associated with failed IOL included prenatal diagnosis of fetal growth restriction (P = .008), and placental abnormalities (P = .027).

Neonatal factors of weight, large for gestational age, head circumference, and height were not significantly associated with failed IOL (P > .05 for all).

As for neonatal outcomes, failed IOL was significantly associated with admission to neonatal intensive care unit, hyperbilirubinemia, and longer hospital stay (P = .001 for all). Failed IOL was significantly associated with lower 1-minute APGAR scores, but not with lower 5-minute APGAR scores, the researchers noted (P = .033 for 1-minute score). No association was noted between failed IOL and neonatal readmission, lower umbilical cord pH value, or maternal ethnicity.

The findings were limited by the retrospective design, but data analysis is ongoing, Dr. Alhousseini said. The researchers are continuing to assess the roles not only of optimal glucose control, but other maternal factors in improving maternal and neonatal outcomes, he said.
 

Data Add to Awareness of Risk Factors

The current study is important because of the increasing incidence of diabetes and the need to examine associated risk factors in pregnancy, Michael Richley, MD, a maternal fetal medicine physician at the University of Washington, Seattle, said in an interview. “The average age of onset of diabetes is becoming younger and type 2 diabetes in pregnancy is an increasingly common diagnosis,” said Dr. Richley, who was not involved in the study.  

The increase in both maternal and neonatal adverse outcomes is expected given the risk factors identified in the study, said Dr. Richley. “The patients with diabetes also were sicker at baseline, with hypertensive disorders, growth restriction, and pregestational diabetes,” he noted.

The study findings support data from previous research, Dr. Richley said. The message to clinicians is that patients with diabetes not only have an increased risk of needing a cesarean delivery but also have an increased risk of poor outcomes if a cesarean delivery is needed, he said.

Although a prospective study would be useful to show causality as opposed to just an association, such a study is challenging in this patient population given the limitations of conducting research on labor and delivery, he said.

The study received no outside funding. The researchers and Dr. Richley had no financial conflicts to disclose.

Measures of fetal breathing movement were lower in fetuses of pregnant patients who received buprenorphine, compared with controls, based on data from 177 individuals.

The findings were presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists by Caroline Bulger, MD, of East Tennessee State University, Johnson City.

Pregnant patients with opioid-use disorder in the community surrounding Johnson City receive medication-assisted therapy with buprenorphine during the prenatal period, Dr. Bulger and colleagues wrote in their abstract. The current prenatal program for substance use disorder was established in 2016 based on patient requests for assistance in lowering their buprenorphine dosages during pregnancy, said senior author Martin E. Olsen, MD, also of East Tennessee State University, in an interview.

“Buprenorphine medication–assisted treatment in pregnancy is associated with long-term effects on childhood development such as smaller neonatal brains, decreased school performance, and low birth weight;” however, data on the fetal effects of buprenorphine are limited, said Dr. Olsen.

The current study was conducted to evaluate a short-term finding of the fetal effects of buprenorphine, Dr. Olsen said.

“This study was performed after obstetric sonographers at our institution noted that biophysical profile [BPP] ultrasound assessments of the fetuses of mothers on buprenorphine took longer than for other patients,” said Dr. Olsen.

The researchers conducted a retrospective chart review of 131 patients who received buprenorphine and 46 who were followed for chronic hypertension and served as high-risk controls. Patients were seen at a single institution between July 1, 2016, and June 30, 2020.

The researchers hypothesized that BPP of fetuses in patients receiving buprenorphine might be different from controls because of the effects of buprenorphine.

Overall, patients who received buprenorphine were more likely to have a fetal breathing score of zero than those who underwent a BPP for hypertension. A significant relationship emerged between buprenorphine dosage and breathing motion assessment; patients on high-dose buprenorphine were more likely than patients on low doses to have values of zero on fetal breathing motion assessment, and a chi-squared test yielded a P value of .04269.

The takeaway for clinical practice is that clinicians performing BPP ultrasounds on buprenorphine-exposed fetuses can expect that these assessments may take longer on average than assessments of other high-risk patients, said Dr. Olsen. “Additional assessment after a low BPP score is still indicated for these fetuses just as in other high-risk pregnancies,” he said.

The study was limited primarily by the retrospective design, Dr. Olsen said.

Although current treatment guidelines do not emphasize the effects of maternal buprenorphine use on fetal development, these findings support previous research showing effects of buprenorphine on fetal brain structure, the researchers wrote in their abstract. Looking ahead, “We recommend additional study on the maternal buprenorphine medication–assisted treatment dose effects for fetal and neonatal development with attention to such factors as head circumference, birth weight, achievement of developmental milestones, and school performance,” Dr. Olsen said.

“We and others have shown that the lowest effective dose of buprenorphine can lower neonatal abstinence syndrome/neonatal opioid withdrawal syndrome rates,” but data showing an impact of lowest effective dose management on long-term complications of fetal buprenorphine exposure are lacking, he noted.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Measures of fetal breathing movement were lower in fetuses of pregnant patients who received buprenorphine, compared with controls, based on data from 177 individuals.

The findings were presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists by Caroline Bulger, MD, of East Tennessee State University, Johnson City.

Pregnant patients with opioid-use disorder in the community surrounding Johnson City receive medication-assisted therapy with buprenorphine during the prenatal period, Dr. Bulger and colleagues wrote in their abstract. The current prenatal program for substance use disorder was established in 2016 based on patient requests for assistance in lowering their buprenorphine dosages during pregnancy, said senior author Martin E. Olsen, MD, also of East Tennessee State University, in an interview.

“Buprenorphine medication–assisted treatment in pregnancy is associated with long-term effects on childhood development such as smaller neonatal brains, decreased school performance, and low birth weight;” however, data on the fetal effects of buprenorphine are limited, said Dr. Olsen.

The current study was conducted to evaluate a short-term finding of the fetal effects of buprenorphine, Dr. Olsen said.

“This study was performed after obstetric sonographers at our institution noted that biophysical profile [BPP] ultrasound assessments of the fetuses of mothers on buprenorphine took longer than for other patients,” said Dr. Olsen.

The researchers conducted a retrospective chart review of 131 patients who received buprenorphine and 46 who were followed for chronic hypertension and served as high-risk controls. Patients were seen at a single institution between July 1, 2016, and June 30, 2020.

The researchers hypothesized that BPP of fetuses in patients receiving buprenorphine might be different from controls because of the effects of buprenorphine.

Overall, patients who received buprenorphine were more likely to have a fetal breathing score of zero than those who underwent a BPP for hypertension. A significant relationship emerged between buprenorphine dosage and breathing motion assessment; patients on high-dose buprenorphine were more likely than patients on low doses to have values of zero on fetal breathing motion assessment, and a chi-squared test yielded a P value of .04269.

The takeaway for clinical practice is that clinicians performing BPP ultrasounds on buprenorphine-exposed fetuses can expect that these assessments may take longer on average than assessments of other high-risk patients, said Dr. Olsen. “Additional assessment after a low BPP score is still indicated for these fetuses just as in other high-risk pregnancies,” he said.

The study was limited primarily by the retrospective design, Dr. Olsen said.

Although current treatment guidelines do not emphasize the effects of maternal buprenorphine use on fetal development, these findings support previous research showing effects of buprenorphine on fetal brain structure, the researchers wrote in their abstract. Looking ahead, “We recommend additional study on the maternal buprenorphine medication–assisted treatment dose effects for fetal and neonatal development with attention to such factors as head circumference, birth weight, achievement of developmental milestones, and school performance,” Dr. Olsen said.

“We and others have shown that the lowest effective dose of buprenorphine can lower neonatal abstinence syndrome/neonatal opioid withdrawal syndrome rates,” but data showing an impact of lowest effective dose management on long-term complications of fetal buprenorphine exposure are lacking, he noted.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Measures of fetal breathing movement were lower in fetuses of pregnant patients who received buprenorphine, compared with controls, based on data from 177 individuals.

The findings were presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists by Caroline Bulger, MD, of East Tennessee State University, Johnson City.

Pregnant patients with opioid-use disorder in the community surrounding Johnson City receive medication-assisted therapy with buprenorphine during the prenatal period, Dr. Bulger and colleagues wrote in their abstract. The current prenatal program for substance use disorder was established in 2016 based on patient requests for assistance in lowering their buprenorphine dosages during pregnancy, said senior author Martin E. Olsen, MD, also of East Tennessee State University, in an interview.

“Buprenorphine medication–assisted treatment in pregnancy is associated with long-term effects on childhood development such as smaller neonatal brains, decreased school performance, and low birth weight;” however, data on the fetal effects of buprenorphine are limited, said Dr. Olsen.

The current study was conducted to evaluate a short-term finding of the fetal effects of buprenorphine, Dr. Olsen said.

“This study was performed after obstetric sonographers at our institution noted that biophysical profile [BPP] ultrasound assessments of the fetuses of mothers on buprenorphine took longer than for other patients,” said Dr. Olsen.

The researchers conducted a retrospective chart review of 131 patients who received buprenorphine and 46 who were followed for chronic hypertension and served as high-risk controls. Patients were seen at a single institution between July 1, 2016, and June 30, 2020.

The researchers hypothesized that BPP of fetuses in patients receiving buprenorphine might be different from controls because of the effects of buprenorphine.

Overall, patients who received buprenorphine were more likely to have a fetal breathing score of zero than those who underwent a BPP for hypertension. A significant relationship emerged between buprenorphine dosage and breathing motion assessment; patients on high-dose buprenorphine were more likely than patients on low doses to have values of zero on fetal breathing motion assessment, and a chi-squared test yielded a P value of .04269.

The takeaway for clinical practice is that clinicians performing BPP ultrasounds on buprenorphine-exposed fetuses can expect that these assessments may take longer on average than assessments of other high-risk patients, said Dr. Olsen. “Additional assessment after a low BPP score is still indicated for these fetuses just as in other high-risk pregnancies,” he said.

The study was limited primarily by the retrospective design, Dr. Olsen said.

Although current treatment guidelines do not emphasize the effects of maternal buprenorphine use on fetal development, these findings support previous research showing effects of buprenorphine on fetal brain structure, the researchers wrote in their abstract. Looking ahead, “We recommend additional study on the maternal buprenorphine medication–assisted treatment dose effects for fetal and neonatal development with attention to such factors as head circumference, birth weight, achievement of developmental milestones, and school performance,” Dr. Olsen said.

“We and others have shown that the lowest effective dose of buprenorphine can lower neonatal abstinence syndrome/neonatal opioid withdrawal syndrome rates,” but data showing an impact of lowest effective dose management on long-term complications of fetal buprenorphine exposure are lacking, he noted.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Most younger women diagnosed with nonmetastatic breast cancer will succeed if they attempt to become pregnant after treatment, according to new research.

The findings, presented May 23 in advance of the annual meeting of the American Society of Clinical Oncology (ASCO) represent the most comprehensive look to date at fertility outcomes following treatment for women diagnosed with breast cancer before age 40 (Abstract 1518).

Kimia Sorouri, MD, a research fellow at the Dana-Farber Cancer Center in Boston, Massachusetts, and her colleagues, looked at data from the Young Women’s Breast Cancer study, a multicenter longitudinal cohort study, for 1213 U.S. and Canadian women (74% non-Hispanic white) who were diagnosed with stages 0-III breast cancer between 2006 and 2016. None of the included patients had metastatic disease, prior hysterectomy, or prior oophorectomy at diagnosis.

During a median 11 years of follow up, 197 of the women reported attempting pregnancy. Of these, 73% reported becoming pregnant, and 65% delivered a live infant a median 4 years after cancer diagnosis. The median age at diagnosis was 32 years, and 28% opted for egg or embryo freezing to preserve fertility. Importantly, 68% received chemotherapy, which can impair fertility, with only a small percentage undergoing ovarian suppression during chemotherapy treatment.

Key predictors of pregnancy or live birth in this study were “financial comfort,” a self-reported measure defined as having money left over to spend after bills are paid (odds ratio [OR], 2.04; 95% CI 1.01-4.12; P = .047); younger age at the time of diagnosis; and undergoing fertility preservation interventions at diagnosis (OR, 2.78; 95% CI 1.29-6.00; P = .009). Chemotherapy and other treatment factors were not seen to be associated with pregnancy or birth outcomes.

“Current research that informs our understanding of the impact of breast cancer treatment on pregnancy and live birth rates is fairly limited,” Dr. Sorouri said during an online press conference announcing the findings. Quality data on fertility outcomes has been limited to studies in certain subgroups, such as women with estrogen receptor–positive breast cancers, she noted, while other studies “have short-term follow-up and critically lack prospective assessment of attempt at conception.”

The new findings show, Dr. Sorouri said, “that in this modern cohort with a heightened awareness of fertility, access to fertility preservation can help to mitigate a portion of the damage from chemotherapy and other agents. Importantly, this highlights the need for increased accessibility of fertility preservation services for women newly diagnosed with breast cancer who are interested in a future pregnancy.”

Commenting on Dr. Sorouri and colleagues’ findings, Julie Gralow, MD, a breast cancer researcher and ASCO’s chief medical officer, stressed that, while younger age at diagnosis and financial comfort were two factors outside the scope of clinical oncology practice, “we can impact fertility preservation prior to treatment.”

She called it “critical” that every patient be informed of the impact of a breast cancer diagnosis and treatment on future fertility, and that all young patients interested in future fertility be offered fertility preservation prior to beginning treatment.

Ann Partridge, MD, of Dana-Farber, said in an interview that the findings reflected a decades’ long change in approach. “Twenty years ago when we first started this cohort, people would tell women ‘you can’t get pregnant. It’s too dangerous. You won’t be able to.’ And some indeed aren’t able to, but the majority who are attempting are succeeding, especially if they preserve their eggs or embryos. So even if chemo puts you into menopause or made you subfertile, if you’ve preserved eggs or embryos, we now can mitigate that distressing effect that many cancer patients have suffered from historically. That’s the good news here.”

Nonetheless, Dr. Partridge, an oncologist and the last author of the study, noted, the results reflected success only for women actively attempting pregnancy. “Remember, we’re not including the people who didn’t attempt. There may be some who went into menopause who never banked eggs or embryos, and may never have tried because they went to a doctor who told them they’re not fertile.” Further, she said, not all insurances cover in vitro fertilization for women who have had breast cancer.

The fact that financial comfort was correlated with reproductive success, Dr. Partridge said, speaks to broader issues about access. “It may not be all about insurers. It may be to have the ability, to have the time, the education and the wherewithal to do this right — and about being with doctors who talk about it.”

Dr. Sorouri and colleagues’ study was sponsored by the Breast Cancer Research Foundation and Susan G. Komen. Several co-authors disclosed receiving speaking and/or consulting fees from pharmaceutical companies, and one reported being an employee of GlaxoSmithKline. Dr. Sorouri reported no industry funding, while Dr. Partridge reported research funding from Novartis.

Most younger women diagnosed with nonmetastatic breast cancer will succeed if they attempt to become pregnant after treatment, according to new research.

The findings, presented May 23 in advance of the annual meeting of the American Society of Clinical Oncology (ASCO) represent the most comprehensive look to date at fertility outcomes following treatment for women diagnosed with breast cancer before age 40 (Abstract 1518).

Kimia Sorouri, MD, a research fellow at the Dana-Farber Cancer Center in Boston, Massachusetts, and her colleagues, looked at data from the Young Women’s Breast Cancer study, a multicenter longitudinal cohort study, for 1213 U.S. and Canadian women (74% non-Hispanic white) who were diagnosed with stages 0-III breast cancer between 2006 and 2016. None of the included patients had metastatic disease, prior hysterectomy, or prior oophorectomy at diagnosis.

During a median 11 years of follow up, 197 of the women reported attempting pregnancy. Of these, 73% reported becoming pregnant, and 65% delivered a live infant a median 4 years after cancer diagnosis. The median age at diagnosis was 32 years, and 28% opted for egg or embryo freezing to preserve fertility. Importantly, 68% received chemotherapy, which can impair fertility, with only a small percentage undergoing ovarian suppression during chemotherapy treatment.

Key predictors of pregnancy or live birth in this study were “financial comfort,” a self-reported measure defined as having money left over to spend after bills are paid (odds ratio [OR], 2.04; 95% CI 1.01-4.12; P = .047); younger age at the time of diagnosis; and undergoing fertility preservation interventions at diagnosis (OR, 2.78; 95% CI 1.29-6.00; P = .009). Chemotherapy and other treatment factors were not seen to be associated with pregnancy or birth outcomes.

“Current research that informs our understanding of the impact of breast cancer treatment on pregnancy and live birth rates is fairly limited,” Dr. Sorouri said during an online press conference announcing the findings. Quality data on fertility outcomes has been limited to studies in certain subgroups, such as women with estrogen receptor–positive breast cancers, she noted, while other studies “have short-term follow-up and critically lack prospective assessment of attempt at conception.”

The new findings show, Dr. Sorouri said, “that in this modern cohort with a heightened awareness of fertility, access to fertility preservation can help to mitigate a portion of the damage from chemotherapy and other agents. Importantly, this highlights the need for increased accessibility of fertility preservation services for women newly diagnosed with breast cancer who are interested in a future pregnancy.”

Commenting on Dr. Sorouri and colleagues’ findings, Julie Gralow, MD, a breast cancer researcher and ASCO’s chief medical officer, stressed that, while younger age at diagnosis and financial comfort were two factors outside the scope of clinical oncology practice, “we can impact fertility preservation prior to treatment.”

She called it “critical” that every patient be informed of the impact of a breast cancer diagnosis and treatment on future fertility, and that all young patients interested in future fertility be offered fertility preservation prior to beginning treatment.

Ann Partridge, MD, of Dana-Farber, said in an interview that the findings reflected a decades’ long change in approach. “Twenty years ago when we first started this cohort, people would tell women ‘you can’t get pregnant. It’s too dangerous. You won’t be able to.’ And some indeed aren’t able to, but the majority who are attempting are succeeding, especially if they preserve their eggs or embryos. So even if chemo puts you into menopause or made you subfertile, if you’ve preserved eggs or embryos, we now can mitigate that distressing effect that many cancer patients have suffered from historically. That’s the good news here.”

Nonetheless, Dr. Partridge, an oncologist and the last author of the study, noted, the results reflected success only for women actively attempting pregnancy. “Remember, we’re not including the people who didn’t attempt. There may be some who went into menopause who never banked eggs or embryos, and may never have tried because they went to a doctor who told them they’re not fertile.” Further, she said, not all insurances cover in vitro fertilization for women who have had breast cancer.

The fact that financial comfort was correlated with reproductive success, Dr. Partridge said, speaks to broader issues about access. “It may not be all about insurers. It may be to have the ability, to have the time, the education and the wherewithal to do this right — and about being with doctors who talk about it.”

Dr. Sorouri and colleagues’ study was sponsored by the Breast Cancer Research Foundation and Susan G. Komen. Several co-authors disclosed receiving speaking and/or consulting fees from pharmaceutical companies, and one reported being an employee of GlaxoSmithKline. Dr. Sorouri reported no industry funding, while Dr. Partridge reported research funding from Novartis.

Most younger women diagnosed with nonmetastatic breast cancer will succeed if they attempt to become pregnant after treatment, according to new research.

The findings, presented May 23 in advance of the annual meeting of the American Society of Clinical Oncology (ASCO) represent the most comprehensive look to date at fertility outcomes following treatment for women diagnosed with breast cancer before age 40 (Abstract 1518).

Kimia Sorouri, MD, a research fellow at the Dana-Farber Cancer Center in Boston, Massachusetts, and her colleagues, looked at data from the Young Women’s Breast Cancer study, a multicenter longitudinal cohort study, for 1213 U.S. and Canadian women (74% non-Hispanic white) who were diagnosed with stages 0-III breast cancer between 2006 and 2016. None of the included patients had metastatic disease, prior hysterectomy, or prior oophorectomy at diagnosis.

During a median 11 years of follow up, 197 of the women reported attempting pregnancy. Of these, 73% reported becoming pregnant, and 65% delivered a live infant a median 4 years after cancer diagnosis. The median age at diagnosis was 32 years, and 28% opted for egg or embryo freezing to preserve fertility. Importantly, 68% received chemotherapy, which can impair fertility, with only a small percentage undergoing ovarian suppression during chemotherapy treatment.

Key predictors of pregnancy or live birth in this study were “financial comfort,” a self-reported measure defined as having money left over to spend after bills are paid (odds ratio [OR], 2.04; 95% CI 1.01-4.12; P = .047); younger age at the time of diagnosis; and undergoing fertility preservation interventions at diagnosis (OR, 2.78; 95% CI 1.29-6.00; P = .009). Chemotherapy and other treatment factors were not seen to be associated with pregnancy or birth outcomes.

“Current research that informs our understanding of the impact of breast cancer treatment on pregnancy and live birth rates is fairly limited,” Dr. Sorouri said during an online press conference announcing the findings. Quality data on fertility outcomes has been limited to studies in certain subgroups, such as women with estrogen receptor–positive breast cancers, she noted, while other studies “have short-term follow-up and critically lack prospective assessment of attempt at conception.”

The new findings show, Dr. Sorouri said, “that in this modern cohort with a heightened awareness of fertility, access to fertility preservation can help to mitigate a portion of the damage from chemotherapy and other agents. Importantly, this highlights the need for increased accessibility of fertility preservation services for women newly diagnosed with breast cancer who are interested in a future pregnancy.”

Commenting on Dr. Sorouri and colleagues’ findings, Julie Gralow, MD, a breast cancer researcher and ASCO’s chief medical officer, stressed that, while younger age at diagnosis and financial comfort were two factors outside the scope of clinical oncology practice, “we can impact fertility preservation prior to treatment.”

She called it “critical” that every patient be informed of the impact of a breast cancer diagnosis and treatment on future fertility, and that all young patients interested in future fertility be offered fertility preservation prior to beginning treatment.

Ann Partridge, MD, of Dana-Farber, said in an interview that the findings reflected a decades’ long change in approach. “Twenty years ago when we first started this cohort, people would tell women ‘you can’t get pregnant. It’s too dangerous. You won’t be able to.’ And some indeed aren’t able to, but the majority who are attempting are succeeding, especially if they preserve their eggs or embryos. So even if chemo puts you into menopause or made you subfertile, if you’ve preserved eggs or embryos, we now can mitigate that distressing effect that many cancer patients have suffered from historically. That’s the good news here.”

Nonetheless, Dr. Partridge, an oncologist and the last author of the study, noted, the results reflected success only for women actively attempting pregnancy. “Remember, we’re not including the people who didn’t attempt. There may be some who went into menopause who never banked eggs or embryos, and may never have tried because they went to a doctor who told them they’re not fertile.” Further, she said, not all insurances cover in vitro fertilization for women who have had breast cancer.

The fact that financial comfort was correlated with reproductive success, Dr. Partridge said, speaks to broader issues about access. “It may not be all about insurers. It may be to have the ability, to have the time, the education and the wherewithal to do this right — and about being with doctors who talk about it.”

Dr. Sorouri and colleagues’ study was sponsored by the Breast Cancer Research Foundation and Susan G. Komen. Several co-authors disclosed receiving speaking and/or consulting fees from pharmaceutical companies, and one reported being an employee of GlaxoSmithKline. Dr. Sorouri reported no industry funding, while Dr. Partridge reported research funding from Novartis.

TOPLINE:

Vaginal estrogen therapy does not increase the risk for recurrence in women with hormone receptor (HR)–negative breast cancer or in those with HR–positive tumors concurrently treated with tamoxifen but should be avoided in aromatase inhibitor users, a French study suggested.

METHODOLOGY:

• Survivors of breast cancer often experience genitourinary symptoms due to declining estrogen levels. Vaginal estrogen therapies, including estriol and promestriene (3-propyl ethyl, 17B-methyl estradiol), can prevent these symptoms, but the effect on breast cancer outcomes remains uncertain.
• Researchers used French insurance claims data to emulate a target trial assessing the effect of initiating vaginal estrogen therapy — any molecule, promestriene, or estriol — on disease-free survival in survivors of breast cancer.
• Patients included in the study had a median age of 54 years; 85% were HR-positive, and 15% were HR–negative. The researchers conducted subgroup analyses based on HR status and endocrine therapy regimen.

TAKEAWAY:

• Among 134,942 unique patients, 1739 started vaginal estrogen therapy — 56%, promestriene; 34%, estriol; and 10%, both. 
• Initiation of vaginal estrogen therapy led to a modest decrease in disease-free survival in patients with HR–positive tumors (−2.1 percentage point at 5 years), particularly in those concurrently treated with an aromatase inhibitor (−3.0 percentage points).
• No decrease in disease-free survival was observed in patients with HR–negative tumors or in those treated with tamoxifen.
• In aromatase inhibitor users, starting estriol led to a “more severe and premature” decrease in disease-free survival (−4.2 percentage point after 3 years) compared with initiating promestriene (1.0 percentage point difference at 3 years).

IN PRACTICE:

“This study addresses a very important survivorship issue — sexual dysfunction in cancer patients — which is associated with anxiety and depression and should be considered a crucial component of survivorship care,” said study discussant Matteo Lambertini, MD, PhD, with University of Genova, Genova, Italy.

Our results suggest that using vaginal estrogen therapy “is safe in individuals with HR-negative tumors and in those concurrently treated with tamoxifen,” said study presenter Elise Dumas, PhD, with Institut Curie, Paris, France. For breast cancer survivors treated with aromatase inhibitors, vaginal estrogen therapy should be avoided as much as possible, but promestriene is preferred over estriol in this subgroup of patients.

SOURCE:

The research (Abstract 268MO) was presented at the European Society for Medical Oncology Breast Cancer 2024 Annual Congress on May 17, 2024.

LIMITATIONS:

No limitations were discussed in the presentation.

DISCLOSURES:

Funding was provided by Monoprix and the French National Cancer Institute. Dumas declared no conflicts of interest. Lambertini has financial relationships with various pharmaceutical companies including Roche, Novartis, AstraZeneca, Lilly, Exact Sciences, Pfizer, and others.

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

TOPLINE:

Vaginal estrogen therapy does not increase the risk for recurrence in women with hormone receptor (HR)–negative breast cancer or in those with HR–positive tumors concurrently treated with tamoxifen but should be avoided in aromatase inhibitor users, a French study suggested.

METHODOLOGY:

• Survivors of breast cancer often experience genitourinary symptoms due to declining estrogen levels. Vaginal estrogen therapies, including estriol and promestriene (3-propyl ethyl, 17B-methyl estradiol), can prevent these symptoms, but the effect on breast cancer outcomes remains uncertain.
• Researchers used French insurance claims data to emulate a target trial assessing the effect of initiating vaginal estrogen therapy — any molecule, promestriene, or estriol — on disease-free survival in survivors of breast cancer.
• Patients included in the study had a median age of 54 years; 85% were HR-positive, and 15% were HR–negative. The researchers conducted subgroup analyses based on HR status and endocrine therapy regimen.

TAKEAWAY:

• Among 134,942 unique patients, 1739 started vaginal estrogen therapy — 56%, promestriene; 34%, estriol; and 10%, both. 
• Initiation of vaginal estrogen therapy led to a modest decrease in disease-free survival in patients with HR–positive tumors (−2.1 percentage point at 5 years), particularly in those concurrently treated with an aromatase inhibitor (−3.0 percentage points).
• No decrease in disease-free survival was observed in patients with HR–negative tumors or in those treated with tamoxifen.
• In aromatase inhibitor users, starting estriol led to a “more severe and premature” decrease in disease-free survival (−4.2 percentage point after 3 years) compared with initiating promestriene (1.0 percentage point difference at 3 years).

IN PRACTICE:

“This study addresses a very important survivorship issue — sexual dysfunction in cancer patients — which is associated with anxiety and depression and should be considered a crucial component of survivorship care,” said study discussant Matteo Lambertini, MD, PhD, with University of Genova, Genova, Italy.

Our results suggest that using vaginal estrogen therapy “is safe in individuals with HR-negative tumors and in those concurrently treated with tamoxifen,” said study presenter Elise Dumas, PhD, with Institut Curie, Paris, France. For breast cancer survivors treated with aromatase inhibitors, vaginal estrogen therapy should be avoided as much as possible, but promestriene is preferred over estriol in this subgroup of patients.

SOURCE:

The research (Abstract 268MO) was presented at the European Society for Medical Oncology Breast Cancer 2024 Annual Congress on May 17, 2024.

LIMITATIONS:

No limitations were discussed in the presentation.

DISCLOSURES:

Funding was provided by Monoprix and the French National Cancer Institute. Dumas declared no conflicts of interest. Lambertini has financial relationships with various pharmaceutical companies including Roche, Novartis, AstraZeneca, Lilly, Exact Sciences, Pfizer, and others.

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

TOPLINE:

Vaginal estrogen therapy does not increase the risk for recurrence in women with hormone receptor (HR)–negative breast cancer or in those with HR–positive tumors concurrently treated with tamoxifen but should be avoided in aromatase inhibitor users, a French study suggested.

METHODOLOGY:

• Survivors of breast cancer often experience genitourinary symptoms due to declining estrogen levels. Vaginal estrogen therapies, including estriol and promestriene (3-propyl ethyl, 17B-methyl estradiol), can prevent these symptoms, but the effect on breast cancer outcomes remains uncertain.
• Researchers used French insurance claims data to emulate a target trial assessing the effect of initiating vaginal estrogen therapy — any molecule, promestriene, or estriol — on disease-free survival in survivors of breast cancer.
• Patients included in the study had a median age of 54 years; 85% were HR-positive, and 15% were HR–negative. The researchers conducted subgroup analyses based on HR status and endocrine therapy regimen.

TAKEAWAY:

• Among 134,942 unique patients, 1739 started vaginal estrogen therapy — 56%, promestriene; 34%, estriol; and 10%, both. 
• Initiation of vaginal estrogen therapy led to a modest decrease in disease-free survival in patients with HR–positive tumors (−2.1 percentage point at 5 years), particularly in those concurrently treated with an aromatase inhibitor (−3.0 percentage points).
• No decrease in disease-free survival was observed in patients with HR–negative tumors or in those treated with tamoxifen.
• In aromatase inhibitor users, starting estriol led to a “more severe and premature” decrease in disease-free survival (−4.2 percentage point after 3 years) compared with initiating promestriene (1.0 percentage point difference at 3 years).

IN PRACTICE:

“This study addresses a very important survivorship issue — sexual dysfunction in cancer patients — which is associated with anxiety and depression and should be considered a crucial component of survivorship care,” said study discussant Matteo Lambertini, MD, PhD, with University of Genova, Genova, Italy.

Our results suggest that using vaginal estrogen therapy “is safe in individuals with HR-negative tumors and in those concurrently treated with tamoxifen,” said study presenter Elise Dumas, PhD, with Institut Curie, Paris, France. For breast cancer survivors treated with aromatase inhibitors, vaginal estrogen therapy should be avoided as much as possible, but promestriene is preferred over estriol in this subgroup of patients.

SOURCE:

The research (Abstract 268MO) was presented at the European Society for Medical Oncology Breast Cancer 2024 Annual Congress on May 17, 2024.

LIMITATIONS:

No limitations were discussed in the presentation.

DISCLOSURES:

Funding was provided by Monoprix and the French National Cancer Institute. Dumas declared no conflicts of interest. Lambertini has financial relationships with various pharmaceutical companies including Roche, Novartis, AstraZeneca, Lilly, Exact Sciences, Pfizer, and others.

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

SAN FRANCISCO — Primary care providers placed contraceptive intrauterine devices (IUDs) incorrectly nearly twice as often as ob.gyn. providers at a single institution, according to data presented at the annual meeting of the American College of Obstetricians and Gynecologists.

“Adequate training for providers regarding proper techniques for IUD insertion is imperative for good clinical practice, patient satisfaction, and effectiveness of the LARC [long-acting reversible contraceptive],” Kerrilyn Hewell, MD, a fourth-year resident ob.gyn. at Southern Illinois University in Springfield, reported. “Primary care providers are often seen for contraception management. Therefore, the significantly higher malpositioned rate indicates the need to implement an enhanced simulation/education curriculum for IUD insertion.”

Kevin Ault, MD, a professor and chair of the Department of Obstetrics and Gynecology at Western Michigan University Homer Stryker M.D. School of Medicine, was not involved in the study but said it was not surprising.

“The reasons for obtaining an ultrasound are not discussed in the abstract, so the primary care physicians may have found more problems by ordering more ultrasounds,” Dr. Ault told this news organization. “The takeaway would be to order an ultrasound if you are unsure of placement of the IUD. Malpositioned IUDs may be at risk for expulsion and women may be at risk for unplanned pregnancy.”

The researchers conducted a retrospective review of all adult women’s ultrasounds from the ob.gyn. department of the Southern Illinois University School of Medicine between 2017 and 2020 in which an IUD was documented. Two physicians certified by the American Institute of Ultrasound in Medicine interpreted the images to determine whether the IUD was positioned correctly.

Among 602 ultrasounds included, 562 of the IUDs were placed by an ob.gyn., and 40 were placed by a primary care provider. Most of the IUDs were properly positioned (82%) while 18% were malpositioned. When the researchers compared positioning by specialty, they found that 30% of the malpositioned IUDs had been placed by primary care providers, compared to 17% of malpositioned IUDs placed by an ob.gyn. (P = .043).

The most common type of malpositioning was placement low in the cervix (40.4%) or low but not in the cervix (25.7%). Other types of malpositioning included a deviated axis, the device being inverted or transverse, the IUD arms being folded, the device being embedded, or the device placed outside the uterus.

Of the 136 IUDs placed by an ob.gyn. resident, 17% were malpositioned. Only 6 IUDs had been placed by a primary care resident, and one was malpositioned. Among midlevel providers, 17% of 78 IUDs placed by an ob.gyn. and 33% (5) of 15 IUDs placed by a primary care provider were malpositioned. Among attending physicians, 18% of the 348 IUDs placed by an ob.gyn. and 30% of the 40 IUDs placed by a primary care provider were malpositioned.

No external funding was noted, and the authors and Dr. Ault had no disclosures.

SAN FRANCISCO — Primary care providers placed contraceptive intrauterine devices (IUDs) incorrectly nearly twice as often as ob.gyn. providers at a single institution, according to data presented at the annual meeting of the American College of Obstetricians and Gynecologists.

“Adequate training for providers regarding proper techniques for IUD insertion is imperative for good clinical practice, patient satisfaction, and effectiveness of the LARC [long-acting reversible contraceptive],” Kerrilyn Hewell, MD, a fourth-year resident ob.gyn. at Southern Illinois University in Springfield, reported. “Primary care providers are often seen for contraception management. Therefore, the significantly higher malpositioned rate indicates the need to implement an enhanced simulation/education curriculum for IUD insertion.”

Kevin Ault, MD, a professor and chair of the Department of Obstetrics and Gynecology at Western Michigan University Homer Stryker M.D. School of Medicine, was not involved in the study but said it was not surprising.

“The reasons for obtaining an ultrasound are not discussed in the abstract, so the primary care physicians may have found more problems by ordering more ultrasounds,” Dr. Ault told this news organization. “The takeaway would be to order an ultrasound if you are unsure of placement of the IUD. Malpositioned IUDs may be at risk for expulsion and women may be at risk for unplanned pregnancy.”

The researchers conducted a retrospective review of all adult women’s ultrasounds from the ob.gyn. department of the Southern Illinois University School of Medicine between 2017 and 2020 in which an IUD was documented. Two physicians certified by the American Institute of Ultrasound in Medicine interpreted the images to determine whether the IUD was positioned correctly.

Among 602 ultrasounds included, 562 of the IUDs were placed by an ob.gyn., and 40 were placed by a primary care provider. Most of the IUDs were properly positioned (82%) while 18% were malpositioned. When the researchers compared positioning by specialty, they found that 30% of the malpositioned IUDs had been placed by primary care providers, compared to 17% of malpositioned IUDs placed by an ob.gyn. (P = .043).

The most common type of malpositioning was placement low in the cervix (40.4%) or low but not in the cervix (25.7%). Other types of malpositioning included a deviated axis, the device being inverted or transverse, the IUD arms being folded, the device being embedded, or the device placed outside the uterus.

Of the 136 IUDs placed by an ob.gyn. resident, 17% were malpositioned. Only 6 IUDs had been placed by a primary care resident, and one was malpositioned. Among midlevel providers, 17% of 78 IUDs placed by an ob.gyn. and 33% (5) of 15 IUDs placed by a primary care provider were malpositioned. Among attending physicians, 18% of the 348 IUDs placed by an ob.gyn. and 30% of the 40 IUDs placed by a primary care provider were malpositioned.

No external funding was noted, and the authors and Dr. Ault had no disclosures.

SAN FRANCISCO — Primary care providers placed contraceptive intrauterine devices (IUDs) incorrectly nearly twice as often as ob.gyn. providers at a single institution, according to data presented at the annual meeting of the American College of Obstetricians and Gynecologists.

“Adequate training for providers regarding proper techniques for IUD insertion is imperative for good clinical practice, patient satisfaction, and effectiveness of the LARC [long-acting reversible contraceptive],” Kerrilyn Hewell, MD, a fourth-year resident ob.gyn. at Southern Illinois University in Springfield, reported. “Primary care providers are often seen for contraception management. Therefore, the significantly higher malpositioned rate indicates the need to implement an enhanced simulation/education curriculum for IUD insertion.”

Kevin Ault, MD, a professor and chair of the Department of Obstetrics and Gynecology at Western Michigan University Homer Stryker M.D. School of Medicine, was not involved in the study but said it was not surprising.

“The reasons for obtaining an ultrasound are not discussed in the abstract, so the primary care physicians may have found more problems by ordering more ultrasounds,” Dr. Ault told this news organization. “The takeaway would be to order an ultrasound if you are unsure of placement of the IUD. Malpositioned IUDs may be at risk for expulsion and women may be at risk for unplanned pregnancy.”

The researchers conducted a retrospective review of all adult women’s ultrasounds from the ob.gyn. department of the Southern Illinois University School of Medicine between 2017 and 2020 in which an IUD was documented. Two physicians certified by the American Institute of Ultrasound in Medicine interpreted the images to determine whether the IUD was positioned correctly.

Among 602 ultrasounds included, 562 of the IUDs were placed by an ob.gyn., and 40 were placed by a primary care provider. Most of the IUDs were properly positioned (82%) while 18% were malpositioned. When the researchers compared positioning by specialty, they found that 30% of the malpositioned IUDs had been placed by primary care providers, compared to 17% of malpositioned IUDs placed by an ob.gyn. (P = .043).

The most common type of malpositioning was placement low in the cervix (40.4%) or low but not in the cervix (25.7%). Other types of malpositioning included a deviated axis, the device being inverted or transverse, the IUD arms being folded, the device being embedded, or the device placed outside the uterus.

Of the 136 IUDs placed by an ob.gyn. resident, 17% were malpositioned. Only 6 IUDs had been placed by a primary care resident, and one was malpositioned. Among midlevel providers, 17% of 78 IUDs placed by an ob.gyn. and 33% (5) of 15 IUDs placed by a primary care provider were malpositioned. Among attending physicians, 18% of the 348 IUDs placed by an ob.gyn. and 30% of the 40 IUDs placed by a primary care provider were malpositioned.

No external funding was noted, and the authors and Dr. Ault had no disclosures.

SAN FRANCISCO — An estimated two out of five adult women in the United States have obesity, and given the potential challenges of losing pregnancy weight postpartum or staving off the weight gain associated with menopause, women are likely to be receptive toward weight management help from their ob.gyns. A whole new armamentarium of anti-obesity medications has become available in the past decade, providing physicians and patients with more treatment options.

Ob.gyns. are therefore well-poised to offer counseling and treatment for obesity management for their patients, Johanna G. Finkle, MD, clinical assistant professor of obstetrics and gynecology and a weight management specialist at the University of Kansas Heath System, told attendees at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. Dr. Finkle provided an extensive overview of what ob.gyns. need to know if they are interested in prescribing anti-obesity medications or simply providing their patients with information about the available drugs.

Kitila S. Heyward, MD, an ob.gyn. at Atrium Health in Monroe, North Carolina, who attended the talk, tries to prescribe anti-obesity medications but has run into roadblocks that Dr. Finkle’s talk helped her understand how to overcome.

“I thought it was very helpful because [I] and one of my midwives, in practice, have been trying to get things prescribed, and we can’t figure out the loopholes,” Dr. Heyward said. “Also, the failure rates are really helpful to us so that we know how to counsel people.”

Even for clinicians who aren’t prescribing these medications, Dr. Heyward said the talk was illuminating. “It offered a better understanding of the medications that your patients are on and how it can affect things like birth control, management of surgery, pregnancy, and things along those lines from a clinical day-by-day standpoint,” she said.
 

Starting With the Basics

Dr. Finkle began by emphasizing the importance of using patient-first language in discussing obesity, which means using terms such as “weight, excess weight, overweight, body mass index,” and “affected by obesity” instead of “obese, morbidly obese, heaviness, or large.” She also cited the Obesity Medicine Association’s definition of obesity: “a chronic, relapsing and treatable multifactorial, neurobehavioral disease, wherein an increase in body fat promotes adipose tissue dysfunction and abnormal fat mass physical forces, resulting in adverse metabolic, biomechanical, and psychosocial health consequences.”

Though Dr. Finkle acknowledged the limitations of relying on BMI for defining obesity, it remains the standard tool in current practice, with a BMI of 25-29.9 defining overweight and a BMI of 30 or greater defining obesity. Other diagnostic criteria for obesity in women, however, include a percentage body fat over 32% or a waist circumference of more than 35 inches.

“Women are at risk for weight gain through their entire lifespan” Dr. Finkle said, and in women with polycystic ovarian syndrome, 60%-80% have pre-obesity or obesity. In menopause, the triple threat of decreased estrogen, decreased activity, and changes in diet all contribute to obesity risk and no evidence suggests that hormone therapy can prevent weight gain.

Healthy nutrition, physical activity, and behavioral modification remain key pillars of weight management, but interventions such as surgery or medications are also important tools, she said.

“One size does not fit all in terms of treatment,” Dr. Finkle said. ”When I talk to a patient, I think about other medical complications that I can treat with these medications.”

Women for whom anti-obesity medications may be indicated are those with a BMI of 30 or greater, and those with a BMI of at least 27 along with at least one obesity-related comorbidity, such as hypertension, high cholesterol, diabetes, or sleep apnea. The goal of treating obesity with medication is at least a 5%-10% reduction of body weight.
 

Three Pharmacotherapy Categories

Dr. Finkle reviewed three basic categories of anti-obesity medications: Food and Drug Administration–approved short-term and long-term medications and then off-label drugs that can also aid in healthy weight loss. Short-term options include phentermine, diethylpropion, phendimetrazine, and benzphetamine. Long-term options include orlistat, phentermine/topiramate ER, naltrexone HCl/bupropion HCl ER, and the three GLP-1 receptor agonist drugs, liraglutide, semaglutide, and tirzepatide.

The short-term medications are stimulants that increase satiety, but adverse effects can include tachycardia, hypertension, insomnia, dry mouth, constipation, and diarrhea.

These medications are contraindicated for anyone with uncontrolled hypertension, hyperthyroidism, cardiovascular disease, MAOI use, glaucoma, or history of substance use. The goal is a 5% weight loss in 3 months, and 3 months is the maximum prescribing term.

Then Dr. Finkle reviewed the side effects and contraindications for the oral long-term medications. Orlistat, which can aid in up to 5% weight loss, can result in oily stools and fecal incontinence and is contraindicated for people with chronic malabsorption or cholestasis.

Phentermine/topiramate ER, which can aid in up to 10% weight loss, can result in hypertension, paresthesia, or constipation, and is contraindicated for those with glaucoma, hyperthyroidism, and kidney stones. After the starting dose of 3.75 mg/23 mg, Dr. Finkle increases patients’ dose every 2 weeks, ”but if they’re not tolerating it, if they’re having significant side effects, or they’re losing weight, you do not increase the medication.”

Side effects of naltrexone HCl/bupropion HCl ER, which can lead to 5%-6% weight loss, can include hypertension, suicidal ideation, and glaucoma, and it’s contraindicated in those taking opioids or with a history of seizures or anorexia.
 

The GLP-1 Receptor Agonists

Next Dr. Finkle discussed the newest but most effective medications, the GLP-1 agonists liraglutide, semaglutide, and tirzepatide. The main contraindications for these drugs are a personal or family history of medullary thyroid cancer, multiple endocrine neoplasia type II syndrome, or any hypersensitivity to this drug class. The two main serious risks are pancreatitis — a 1% risk — and gallstones. Though Dr. Finkle included suicidal ideation as a potential risk of these drugs, the most recent evidence suggests there is no link between suicidal ideation and GLP-1 agonists. The most common side effects are nausea, vomiting, diarrhea, constipation, dyspepsia, and an increased heart rate, though these eventually resolve.

“We always start low with these medications,” Dr. Finkle said, and then titrate the dose up each week, “but if they are having awful side effects, just stay on that dose longer.”

The mechanisms of all three drugs for treating obesity are similar; they work to curb central satiety and slow gastric emptying, though they also have additional mechanisms with benefits for blood glucose levels and for the liver and heart.

• Liraglutide, the first of these drugs approved, is a daily subcutaneous injection that starts at a dose of 0.6 mg and goes up to 3 mg. Patients should lose 4% of weight in 16 weeks or else they are non-responders, Dr. Finkle said.
• Semaglutide, a GLP-1 agonist given as a weekly subcutaneous injection, starts at a dose of 0.25 mg and goes up to 2.4 mg; patients should expect a 5% weight loss in 16 weeks if they are responders. Long term, however, patients lose up to an average 15% of body weight with semaglutide; a third of patients lost more than 20% of body weight in clinical trials, compared with 7%-8% body weight loss with liraglutide. An additional benefit of semaglutide is a 20% reduction in risk of cardiovascular disease.
• Tirzepatide is a combined GLP-1 and GIP agonist, also delivered as a weekly subcutaneous injection, that should result in an estimated 5% weight loss in 16 weeks for responders. But tirzepatide is the most effective of the three, with 91% of patients losing at least 5% body weight and more than half of patients (56%) losing at least 20%.

The big drawbacks to the GLP-1 agonists, however, are their high cost, common lack of insurance coverage, and continued shortages. Dr. Finkle recommended using manufacturer coupons, comparison shopping on Good Rx, and appealing prior authorization requirements to help patients pay for the GLP-1 agonists.

“Drug availability is my second problem. There’s not enough drug,” she said, and her patients often have to call around to different pharmacies to find out which ones are carrying the drug and at what doses. She will sometimes switch their doses as needed based on availability.

It’s also important for physicians to be aware of guidance from the American Society of Anesthesiologists regarding GLP-1 agonist use prior to surgery because of their slowed gastric-emptying mechanism. To reduce the risk of aspiration, patients undergoing general anesthesia should not take liraglutide on the day of surgery, and semaglutide and tirzepatide should be held for 1 week prior to the procedure. New research in JAMA Surgery, however, suggests holding these medications for longer than a week may be wiser.
 

Getting Patients Started

All the short-term and long-term medications are contraindicated during pregnancy and breastfeeding, Dr. Finkle said. Animal studies with GLP-1 agonists suggest adverse fetal effects when used during pregnancy, but the limited data in human studies so far have not shown a risk of major malformations. Dr. Finkle said the recommendations for now are to stop all GLP-1 receptor agonist drugs 2 months before patients attempt to become pregnant and not to begin them again until after they are no longer breastfeeding.

Finally, Dr. Finkle reviewed off-label medications that can result in modest weight loss, including topiramate, phentermine (not to be used for longer than 12 weeks), bupropion, naltrexone, and metformin. Metformin is likely to result in only 2% weight loss, but it may enhance the effects of GLP-1s, she said.

For ob.gyns. who want to get their patients started on one of these medications, Dr. Finkle first recommends asking patients if it’s okay to discuss their weight. ”Studies show that if you just ask permission to discuss someone’s weight, they go on to lose weight and lose more than someone who has never been asked,” Dr. Finkle said. Then she takes a history.

”When I see a patient, I ask, ‘Tell me why you’re here today,’ ” Dr. Finkle said.

This gives me a lot of insight as to why they’re coming in and it helps me understand where they’re at in terms of other things, such as depression or anxiety with weight, and it helps me to tailor my treatment.”

A full medical history is important for learning about potential contraindications or picking medications that might help with other conditions, such as topiramate for migraines. Finally, Dr. Finkle advises a lab screening with a comprehensive metabolic panel, lipid panel, HbA1c, and vitamin D.

“The [comprehensive metabolic panel] allows me to know about creatinine and liver function,” she said. If these are elevated, she will still prescribe GLP-1s but will monitor the values more closely. “Then I discuss options with the patient. They may be eligible for bariatric surgery or medications. We talk about lifestyle behavioral management, and then I go through the medications and we set goals.”

Goals include nutrition and exercise; start modest and have them work their way up by doing activities they enjoy. In addition, patients taking GLP-1s need to eat enough protein — 80 to 100 grams a day, though she starts them at 60 grams — and do regular muscle strengthening since they can lose muscle mass.

Indications for referral to an obesity medicine specialist are a history of gastric bypass/sleeve surgery, having type 2 diabetes, having an eating disorder, or having failed one of these anti-obesity medications.

Finally, Dr. Finkle reviewed medications that can cause weight gain: medroxyprogesterone acetate for birth control; beta blockers for hypertension or migraine; the antidepressants amitriptyline, paroxetine, venlafaxine, and trazodone; the mood stabilizers gabapentin, lithium, valproate, and carbamazepine; and diphenhydramine and zolpidem for sleep.

No external funding was used for the talk. Dr. Finkle and Dr. Heyward had no disclosures.

SAN FRANCISCO — An estimated two out of five adult women in the United States have obesity, and given the potential challenges of losing pregnancy weight postpartum or staving off the weight gain associated with menopause, women are likely to be receptive toward weight management help from their ob.gyns. A whole new armamentarium of anti-obesity medications has become available in the past decade, providing physicians and patients with more treatment options.

Ob.gyns. are therefore well-poised to offer counseling and treatment for obesity management for their patients, Johanna G. Finkle, MD, clinical assistant professor of obstetrics and gynecology and a weight management specialist at the University of Kansas Heath System, told attendees at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. Dr. Finkle provided an extensive overview of what ob.gyns. need to know if they are interested in prescribing anti-obesity medications or simply providing their patients with information about the available drugs.

Kitila S. Heyward, MD, an ob.gyn. at Atrium Health in Monroe, North Carolina, who attended the talk, tries to prescribe anti-obesity medications but has run into roadblocks that Dr. Finkle’s talk helped her understand how to overcome.

“I thought it was very helpful because [I] and one of my midwives, in practice, have been trying to get things prescribed, and we can’t figure out the loopholes,” Dr. Heyward said. “Also, the failure rates are really helpful to us so that we know how to counsel people.”

Even for clinicians who aren’t prescribing these medications, Dr. Heyward said the talk was illuminating. “It offered a better understanding of the medications that your patients are on and how it can affect things like birth control, management of surgery, pregnancy, and things along those lines from a clinical day-by-day standpoint,” she said.
 

Starting With the Basics

Dr. Finkle began by emphasizing the importance of using patient-first language in discussing obesity, which means using terms such as “weight, excess weight, overweight, body mass index,” and “affected by obesity” instead of “obese, morbidly obese, heaviness, or large.” She also cited the Obesity Medicine Association’s definition of obesity: “a chronic, relapsing and treatable multifactorial, neurobehavioral disease, wherein an increase in body fat promotes adipose tissue dysfunction and abnormal fat mass physical forces, resulting in adverse metabolic, biomechanical, and psychosocial health consequences.”

Though Dr. Finkle acknowledged the limitations of relying on BMI for defining obesity, it remains the standard tool in current practice, with a BMI of 25-29.9 defining overweight and a BMI of 30 or greater defining obesity. Other diagnostic criteria for obesity in women, however, include a percentage body fat over 32% or a waist circumference of more than 35 inches.

“Women are at risk for weight gain through their entire lifespan” Dr. Finkle said, and in women with polycystic ovarian syndrome, 60%-80% have pre-obesity or obesity. In menopause, the triple threat of decreased estrogen, decreased activity, and changes in diet all contribute to obesity risk and no evidence suggests that hormone therapy can prevent weight gain.

Healthy nutrition, physical activity, and behavioral modification remain key pillars of weight management, but interventions such as surgery or medications are also important tools, she said.

“One size does not fit all in terms of treatment,” Dr. Finkle said. ”When I talk to a patient, I think about other medical complications that I can treat with these medications.”

Women for whom anti-obesity medications may be indicated are those with a BMI of 30 or greater, and those with a BMI of at least 27 along with at least one obesity-related comorbidity, such as hypertension, high cholesterol, diabetes, or sleep apnea. The goal of treating obesity with medication is at least a 5%-10% reduction of body weight.
 

Three Pharmacotherapy Categories

Dr. Finkle reviewed three basic categories of anti-obesity medications: Food and Drug Administration–approved short-term and long-term medications and then off-label drugs that can also aid in healthy weight loss. Short-term options include phentermine, diethylpropion, phendimetrazine, and benzphetamine. Long-term options include orlistat, phentermine/topiramate ER, naltrexone HCl/bupropion HCl ER, and the three GLP-1 receptor agonist drugs, liraglutide, semaglutide, and tirzepatide.

The short-term medications are stimulants that increase satiety, but adverse effects can include tachycardia, hypertension, insomnia, dry mouth, constipation, and diarrhea.

These medications are contraindicated for anyone with uncontrolled hypertension, hyperthyroidism, cardiovascular disease, MAOI use, glaucoma, or history of substance use. The goal is a 5% weight loss in 3 months, and 3 months is the maximum prescribing term.

Then Dr. Finkle reviewed the side effects and contraindications for the oral long-term medications. Orlistat, which can aid in up to 5% weight loss, can result in oily stools and fecal incontinence and is contraindicated for people with chronic malabsorption or cholestasis.

Phentermine/topiramate ER, which can aid in up to 10% weight loss, can result in hypertension, paresthesia, or constipation, and is contraindicated for those with glaucoma, hyperthyroidism, and kidney stones. After the starting dose of 3.75 mg/23 mg, Dr. Finkle increases patients’ dose every 2 weeks, ”but if they’re not tolerating it, if they’re having significant side effects, or they’re losing weight, you do not increase the medication.”

Side effects of naltrexone HCl/bupropion HCl ER, which can lead to 5%-6% weight loss, can include hypertension, suicidal ideation, and glaucoma, and it’s contraindicated in those taking opioids or with a history of seizures or anorexia.
 

The GLP-1 Receptor Agonists

Next Dr. Finkle discussed the newest but most effective medications, the GLP-1 agonists liraglutide, semaglutide, and tirzepatide. The main contraindications for these drugs are a personal or family history of medullary thyroid cancer, multiple endocrine neoplasia type II syndrome, or any hypersensitivity to this drug class. The two main serious risks are pancreatitis — a 1% risk — and gallstones. Though Dr. Finkle included suicidal ideation as a potential risk of these drugs, the most recent evidence suggests there is no link between suicidal ideation and GLP-1 agonists. The most common side effects are nausea, vomiting, diarrhea, constipation, dyspepsia, and an increased heart rate, though these eventually resolve.

“We always start low with these medications,” Dr. Finkle said, and then titrate the dose up each week, “but if they are having awful side effects, just stay on that dose longer.”

The mechanisms of all three drugs for treating obesity are similar; they work to curb central satiety and slow gastric emptying, though they also have additional mechanisms with benefits for blood glucose levels and for the liver and heart.

• Liraglutide, the first of these drugs approved, is a daily subcutaneous injection that starts at a dose of 0.6 mg and goes up to 3 mg. Patients should lose 4% of weight in 16 weeks or else they are non-responders, Dr. Finkle said.
• Semaglutide, a GLP-1 agonist given as a weekly subcutaneous injection, starts at a dose of 0.25 mg and goes up to 2.4 mg; patients should expect a 5% weight loss in 16 weeks if they are responders. Long term, however, patients lose up to an average 15% of body weight with semaglutide; a third of patients lost more than 20% of body weight in clinical trials, compared with 7%-8% body weight loss with liraglutide. An additional benefit of semaglutide is a 20% reduction in risk of cardiovascular disease.
• Tirzepatide is a combined GLP-1 and GIP agonist, also delivered as a weekly subcutaneous injection, that should result in an estimated 5% weight loss in 16 weeks for responders. But tirzepatide is the most effective of the three, with 91% of patients losing at least 5% body weight and more than half of patients (56%) losing at least 20%.

The big drawbacks to the GLP-1 agonists, however, are their high cost, common lack of insurance coverage, and continued shortages. Dr. Finkle recommended using manufacturer coupons, comparison shopping on Good Rx, and appealing prior authorization requirements to help patients pay for the GLP-1 agonists.

“Drug availability is my second problem. There’s not enough drug,” she said, and her patients often have to call around to different pharmacies to find out which ones are carrying the drug and at what doses. She will sometimes switch their doses as needed based on availability.

It’s also important for physicians to be aware of guidance from the American Society of Anesthesiologists regarding GLP-1 agonist use prior to surgery because of their slowed gastric-emptying mechanism. To reduce the risk of aspiration, patients undergoing general anesthesia should not take liraglutide on the day of surgery, and semaglutide and tirzepatide should be held for 1 week prior to the procedure. New research in JAMA Surgery, however, suggests holding these medications for longer than a week may be wiser.
 

Getting Patients Started

All the short-term and long-term medications are contraindicated during pregnancy and breastfeeding, Dr. Finkle said. Animal studies with GLP-1 agonists suggest adverse fetal effects when used during pregnancy, but the limited data in human studies so far have not shown a risk of major malformations. Dr. Finkle said the recommendations for now are to stop all GLP-1 receptor agonist drugs 2 months before patients attempt to become pregnant and not to begin them again until after they are no longer breastfeeding.

Finally, Dr. Finkle reviewed off-label medications that can result in modest weight loss, including topiramate, phentermine (not to be used for longer than 12 weeks), bupropion, naltrexone, and metformin. Metformin is likely to result in only 2% weight loss, but it may enhance the effects of GLP-1s, she said.

For ob.gyns. who want to get their patients started on one of these medications, Dr. Finkle first recommends asking patients if it’s okay to discuss their weight. ”Studies show that if you just ask permission to discuss someone’s weight, they go on to lose weight and lose more than someone who has never been asked,” Dr. Finkle said. Then she takes a history.

”When I see a patient, I ask, ‘Tell me why you’re here today,’ ” Dr. Finkle said.

This gives me a lot of insight as to why they’re coming in and it helps me understand where they’re at in terms of other things, such as depression or anxiety with weight, and it helps me to tailor my treatment.”

A full medical history is important for learning about potential contraindications or picking medications that might help with other conditions, such as topiramate for migraines. Finally, Dr. Finkle advises a lab screening with a comprehensive metabolic panel, lipid panel, HbA1c, and vitamin D.

“The [comprehensive metabolic panel] allows me to know about creatinine and liver function,” she said. If these are elevated, she will still prescribe GLP-1s but will monitor the values more closely. “Then I discuss options with the patient. They may be eligible for bariatric surgery or medications. We talk about lifestyle behavioral management, and then I go through the medications and we set goals.”

Goals include nutrition and exercise; start modest and have them work their way up by doing activities they enjoy. In addition, patients taking GLP-1s need to eat enough protein — 80 to 100 grams a day, though she starts them at 60 grams — and do regular muscle strengthening since they can lose muscle mass.

Indications for referral to an obesity medicine specialist are a history of gastric bypass/sleeve surgery, having type 2 diabetes, having an eating disorder, or having failed one of these anti-obesity medications.

Finally, Dr. Finkle reviewed medications that can cause weight gain: medroxyprogesterone acetate for birth control; beta blockers for hypertension or migraine; the antidepressants amitriptyline, paroxetine, venlafaxine, and trazodone; the mood stabilizers gabapentin, lithium, valproate, and carbamazepine; and diphenhydramine and zolpidem for sleep.

No external funding was used for the talk. Dr. Finkle and Dr. Heyward had no disclosures.

SAN FRANCISCO — An estimated two out of five adult women in the United States have obesity, and given the potential challenges of losing pregnancy weight postpartum or staving off the weight gain associated with menopause, women are likely to be receptive toward weight management help from their ob.gyns. A whole new armamentarium of anti-obesity medications has become available in the past decade, providing physicians and patients with more treatment options.

Ob.gyns. are therefore well-poised to offer counseling and treatment for obesity management for their patients, Johanna G. Finkle, MD, clinical assistant professor of obstetrics and gynecology and a weight management specialist at the University of Kansas Heath System, told attendees at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. Dr. Finkle provided an extensive overview of what ob.gyns. need to know if they are interested in prescribing anti-obesity medications or simply providing their patients with information about the available drugs.

Kitila S. Heyward, MD, an ob.gyn. at Atrium Health in Monroe, North Carolina, who attended the talk, tries to prescribe anti-obesity medications but has run into roadblocks that Dr. Finkle’s talk helped her understand how to overcome.

“I thought it was very helpful because [I] and one of my midwives, in practice, have been trying to get things prescribed, and we can’t figure out the loopholes,” Dr. Heyward said. “Also, the failure rates are really helpful to us so that we know how to counsel people.”

Even for clinicians who aren’t prescribing these medications, Dr. Heyward said the talk was illuminating. “It offered a better understanding of the medications that your patients are on and how it can affect things like birth control, management of surgery, pregnancy, and things along those lines from a clinical day-by-day standpoint,” she said.
 

Starting With the Basics

Dr. Finkle began by emphasizing the importance of using patient-first language in discussing obesity, which means using terms such as “weight, excess weight, overweight, body mass index,” and “affected by obesity” instead of “obese, morbidly obese, heaviness, or large.” She also cited the Obesity Medicine Association’s definition of obesity: “a chronic, relapsing and treatable multifactorial, neurobehavioral disease, wherein an increase in body fat promotes adipose tissue dysfunction and abnormal fat mass physical forces, resulting in adverse metabolic, biomechanical, and psychosocial health consequences.”

Though Dr. Finkle acknowledged the limitations of relying on BMI for defining obesity, it remains the standard tool in current practice, with a BMI of 25-29.9 defining overweight and a BMI of 30 or greater defining obesity. Other diagnostic criteria for obesity in women, however, include a percentage body fat over 32% or a waist circumference of more than 35 inches.

“Women are at risk for weight gain through their entire lifespan” Dr. Finkle said, and in women with polycystic ovarian syndrome, 60%-80% have pre-obesity or obesity. In menopause, the triple threat of decreased estrogen, decreased activity, and changes in diet all contribute to obesity risk and no evidence suggests that hormone therapy can prevent weight gain.

Healthy nutrition, physical activity, and behavioral modification remain key pillars of weight management, but interventions such as surgery or medications are also important tools, she said.

“One size does not fit all in terms of treatment,” Dr. Finkle said. ”When I talk to a patient, I think about other medical complications that I can treat with these medications.”

Women for whom anti-obesity medications may be indicated are those with a BMI of 30 or greater, and those with a BMI of at least 27 along with at least one obesity-related comorbidity, such as hypertension, high cholesterol, diabetes, or sleep apnea. The goal of treating obesity with medication is at least a 5%-10% reduction of body weight.
 

Three Pharmacotherapy Categories

Dr. Finkle reviewed three basic categories of anti-obesity medications: Food and Drug Administration–approved short-term and long-term medications and then off-label drugs that can also aid in healthy weight loss. Short-term options include phentermine, diethylpropion, phendimetrazine, and benzphetamine. Long-term options include orlistat, phentermine/topiramate ER, naltrexone HCl/bupropion HCl ER, and the three GLP-1 receptor agonist drugs, liraglutide, semaglutide, and tirzepatide.

The short-term medications are stimulants that increase satiety, but adverse effects can include tachycardia, hypertension, insomnia, dry mouth, constipation, and diarrhea.

These medications are contraindicated for anyone with uncontrolled hypertension, hyperthyroidism, cardiovascular disease, MAOI use, glaucoma, or history of substance use. The goal is a 5% weight loss in 3 months, and 3 months is the maximum prescribing term.

Then Dr. Finkle reviewed the side effects and contraindications for the oral long-term medications. Orlistat, which can aid in up to 5% weight loss, can result in oily stools and fecal incontinence and is contraindicated for people with chronic malabsorption or cholestasis.

Phentermine/topiramate ER, which can aid in up to 10% weight loss, can result in hypertension, paresthesia, or constipation, and is contraindicated for those with glaucoma, hyperthyroidism, and kidney stones. After the starting dose of 3.75 mg/23 mg, Dr. Finkle increases patients’ dose every 2 weeks, ”but if they’re not tolerating it, if they’re having significant side effects, or they’re losing weight, you do not increase the medication.”

Side effects of naltrexone HCl/bupropion HCl ER, which can lead to 5%-6% weight loss, can include hypertension, suicidal ideation, and glaucoma, and it’s contraindicated in those taking opioids or with a history of seizures or anorexia.
 

The GLP-1 Receptor Agonists

Next Dr. Finkle discussed the newest but most effective medications, the GLP-1 agonists liraglutide, semaglutide, and tirzepatide. The main contraindications for these drugs are a personal or family history of medullary thyroid cancer, multiple endocrine neoplasia type II syndrome, or any hypersensitivity to this drug class. The two main serious risks are pancreatitis — a 1% risk — and gallstones. Though Dr. Finkle included suicidal ideation as a potential risk of these drugs, the most recent evidence suggests there is no link between suicidal ideation and GLP-1 agonists. The most common side effects are nausea, vomiting, diarrhea, constipation, dyspepsia, and an increased heart rate, though these eventually resolve.

“We always start low with these medications,” Dr. Finkle said, and then titrate the dose up each week, “but if they are having awful side effects, just stay on that dose longer.”

The mechanisms of all three drugs for treating obesity are similar; they work to curb central satiety and slow gastric emptying, though they also have additional mechanisms with benefits for blood glucose levels and for the liver and heart.

• Liraglutide, the first of these drugs approved, is a daily subcutaneous injection that starts at a dose of 0.6 mg and goes up to 3 mg. Patients should lose 4% of weight in 16 weeks or else they are non-responders, Dr. Finkle said.
• Semaglutide, a GLP-1 agonist given as a weekly subcutaneous injection, starts at a dose of 0.25 mg and goes up to 2.4 mg; patients should expect a 5% weight loss in 16 weeks if they are responders. Long term, however, patients lose up to an average 15% of body weight with semaglutide; a third of patients lost more than 20% of body weight in clinical trials, compared with 7%-8% body weight loss with liraglutide. An additional benefit of semaglutide is a 20% reduction in risk of cardiovascular disease.
• Tirzepatide is a combined GLP-1 and GIP agonist, also delivered as a weekly subcutaneous injection, that should result in an estimated 5% weight loss in 16 weeks for responders. But tirzepatide is the most effective of the three, with 91% of patients losing at least 5% body weight and more than half of patients (56%) losing at least 20%.

The big drawbacks to the GLP-1 agonists, however, are their high cost, common lack of insurance coverage, and continued shortages. Dr. Finkle recommended using manufacturer coupons, comparison shopping on Good Rx, and appealing prior authorization requirements to help patients pay for the GLP-1 agonists.

“Drug availability is my second problem. There’s not enough drug,” she said, and her patients often have to call around to different pharmacies to find out which ones are carrying the drug and at what doses. She will sometimes switch their doses as needed based on availability.

It’s also important for physicians to be aware of guidance from the American Society of Anesthesiologists regarding GLP-1 agonist use prior to surgery because of their slowed gastric-emptying mechanism. To reduce the risk of aspiration, patients undergoing general anesthesia should not take liraglutide on the day of surgery, and semaglutide and tirzepatide should be held for 1 week prior to the procedure. New research in JAMA Surgery, however, suggests holding these medications for longer than a week may be wiser.
 

Getting Patients Started

All the short-term and long-term medications are contraindicated during pregnancy and breastfeeding, Dr. Finkle said. Animal studies with GLP-1 agonists suggest adverse fetal effects when used during pregnancy, but the limited data in human studies so far have not shown a risk of major malformations. Dr. Finkle said the recommendations for now are to stop all GLP-1 receptor agonist drugs 2 months before patients attempt to become pregnant and not to begin them again until after they are no longer breastfeeding.

Finally, Dr. Finkle reviewed off-label medications that can result in modest weight loss, including topiramate, phentermine (not to be used for longer than 12 weeks), bupropion, naltrexone, and metformin. Metformin is likely to result in only 2% weight loss, but it may enhance the effects of GLP-1s, she said.

For ob.gyns. who want to get their patients started on one of these medications, Dr. Finkle first recommends asking patients if it’s okay to discuss their weight. ”Studies show that if you just ask permission to discuss someone’s weight, they go on to lose weight and lose more than someone who has never been asked,” Dr. Finkle said. Then she takes a history.

”When I see a patient, I ask, ‘Tell me why you’re here today,’ ” Dr. Finkle said.

This gives me a lot of insight as to why they’re coming in and it helps me understand where they’re at in terms of other things, such as depression or anxiety with weight, and it helps me to tailor my treatment.”

A full medical history is important for learning about potential contraindications or picking medications that might help with other conditions, such as topiramate for migraines. Finally, Dr. Finkle advises a lab screening with a comprehensive metabolic panel, lipid panel, HbA1c, and vitamin D.

“The [comprehensive metabolic panel] allows me to know about creatinine and liver function,” she said. If these are elevated, she will still prescribe GLP-1s but will monitor the values more closely. “Then I discuss options with the patient. They may be eligible for bariatric surgery or medications. We talk about lifestyle behavioral management, and then I go through the medications and we set goals.”

Goals include nutrition and exercise; start modest and have them work their way up by doing activities they enjoy. In addition, patients taking GLP-1s need to eat enough protein — 80 to 100 grams a day, though she starts them at 60 grams — and do regular muscle strengthening since they can lose muscle mass.

Indications for referral to an obesity medicine specialist are a history of gastric bypass/sleeve surgery, having type 2 diabetes, having an eating disorder, or having failed one of these anti-obesity medications.

Finally, Dr. Finkle reviewed medications that can cause weight gain: medroxyprogesterone acetate for birth control; beta blockers for hypertension or migraine; the antidepressants amitriptyline, paroxetine, venlafaxine, and trazodone; the mood stabilizers gabapentin, lithium, valproate, and carbamazepine; and diphenhydramine and zolpidem for sleep.

No external funding was used for the talk. Dr. Finkle and Dr. Heyward had no disclosures.

NEW ORLEANS — Postmenopausal women with osteoporosis may not be receiving all the recommended tests to rule out secondary causes of bone loss prior to treatment initiation, new research found.

In a single-center chart review of 150 postmenopausal women who had been diagnosed and treated for osteoporosis, most had received a complete blood cell count, basic metabolic panel, thyroid screening, and vitamin D testing. However, one in four had not been tested for a parathyroid hormone (PTH) level, and in nearly two thirds, a 24-hour urine calcium collection had not been ordered.

Overall, less than a third had received the complete workup for secondary osteoporosis causes as recommended by the American Association of Clinical Endocrinologists (AACE) and the Endocrine Society.

“An appropriate evaluation for secondary causes of osteoporosis is essential because it impacts different treatment options and modalities. We discovered low rates of complete testing for secondary causes of osteoporosis in our patient population prior to treatment initiation,” said Kajol Manglani, MD, an internal medicine resident at Georgetown University/MedStar Washington Hospital Center, Washington, DC, and colleagues, in a poster at the American Association of Clinical Endocrinology (AACE) annual meeting held on May 9-12, 2024.

First author Sheetal Bulchandani, MD, said in an interview, “It depends a lot on clinical judgment, but there are certain things that everybody with osteoporosis should be evaluated for. We looked for the things that all the guidelines recommend.”

Studies have suggested that up to 30% of postmenopausal women with osteoporosis have secondary causes, noted Dr. Bulchandani, who conducted the study as a postdoctoral fellow with colleagues at Georgetown University/MedStar Washington Hospital and is now in private endocrine practice in Petersburg, Virginia.

“It’s important not to assume that every woman who walks in with osteoporosis has postmenopausal osteoporosis. I think it would be appropriate to at least discuss with the patients what would warrant certain kinds of clinical workup. … If you don’t figure out if there is an underlying cause, you may end up using an unnecessary medication,” Dr. Bulchandani said.
 

Are You Missing Something Treatable?

For example, she said, if the patient has underlying hyperparathyroidism and is treated with osteoporosis medications, “you might not see the desired or expected outcome in their bone density.”

Asked to comment, Rachel Pessah-Pollack, MD, clinical associate professor at the Holman Division of Endocrinology, Diabetes, and Metabolism at New York University School of Medicine, New York City, told this news organization, “Certainly, if you have patients who have osteoporosis, it’s important to take a good history and consider secondary causes of bone loss because you may find a treatable etiology that actually can improve their bone density without even starting on a medication.”

Dr. Pessah-Pollack, who was an author of the 2020 AACE/American College of Endocrinology 2020 Clinical Practice Guidelines for the Diagnosis and Treatment of Osteoporosis, said a 24-hour urine calcium collection, not a spot calcium check, is “super important because you’re looking to see if there’s any evidence of hypercalciuria or malabsorption that may be associated with higher rates of bone loss. … These may be a little more cumbersome and harder to get patients to do and more logistics to arrange. But clearly, if you pick up hypercalciuria, that is a potentially treatable etiology and can improve bone density as well.”

Another example, Dr. Pessah-Pollack said, is “if they have a low serum calcium level and high PTH, that would be a real reason to look for celiac disease. By not getting that PTH level, you may be missing that potential diagnosis. There is a wide range of additional causes of osteoporosis ranging from common conditions such as hyperthyroidism to rare conditions such as Cushing disease.”
 

Differences in Ordering Found Across Specialties

The 150 postmenopausal women were all receiving treatment with either alendronate, denosumab, or zoledronic acid. Their average age was 64.7 years, and 63% were seeing an endocrinologist.

Complete workups as per AACE and Endocrine Society guidelines had been performed in just 28% of those who saw an endocrinologist and 12.5% of patients seen by a rheumatologist, in contrast to 84% of those who saw the head of the hospital’s fracture prevention program.

Overall, across all specialties, just 28.67% had the complete recommended workup for secondary osteoporosis causes.

The most missed test was a 24-hour urine calcium collection, ordered for just 38% of the patients, while PTH was ordered for 73% and phosphorus for 80%. The rest were more commonly ordered: Thyroid-stimulating hormone level for 92.7%, complete blood cell count for 91.3%, basic metabolic panel for 100%, and vitamin D level for 96%.

The high rate of vitamin D testing is noteworthy, Dr. Pessah-Pollack said. “The fact that 96% of women are having vitamin D levels checked as part of an osteoporosis evaluation means that everybody’s aware about vitamin D deficiency, and people want to know what their vitamin D levels are. … That’s good because we want to identify vitamin D deficiency in our osteoporosis patients.”

But the low rate of complete secondary screening even by endocrinologists is concerning. “I look at this study as an opportunity for education that we can reinforce the importance of a secondary evaluation for our osteoporosis patients and really tailor which additional tests should be ordered for the individual patient,” Dr. Pessah-Pollack said.

In the poster, Dr. Bulchandani and colleagues wrote, “Further intervention will be aimed to ensure physicians undertake adequate evaluation before considering further treatment directions.” Possibilities that have been discussed include electronic health record alerts and educational materials for primary care providers, she told this news organization.

Dr. Manglani and Dr. Bulchandani had no disclosures. Dr. Pessah-Pollack is an advisor for Boehringer Ingelheim and Eli Lilly.

A version of this article appeared on Medscape.com.

NEW ORLEANS — Postmenopausal women with osteoporosis may not be receiving all the recommended tests to rule out secondary causes of bone loss prior to treatment initiation, new research found.

In a single-center chart review of 150 postmenopausal women who had been diagnosed and treated for osteoporosis, most had received a complete blood cell count, basic metabolic panel, thyroid screening, and vitamin D testing. However, one in four had not been tested for a parathyroid hormone (PTH) level, and in nearly two thirds, a 24-hour urine calcium collection had not been ordered.

Overall, less than a third had received the complete workup for secondary osteoporosis causes as recommended by the American Association of Clinical Endocrinologists (AACE) and the Endocrine Society.

“An appropriate evaluation for secondary causes of osteoporosis is essential because it impacts different treatment options and modalities. We discovered low rates of complete testing for secondary causes of osteoporosis in our patient population prior to treatment initiation,” said Kajol Manglani, MD, an internal medicine resident at Georgetown University/MedStar Washington Hospital Center, Washington, DC, and colleagues, in a poster at the American Association of Clinical Endocrinology (AACE) annual meeting held on May 9-12, 2024.

First author Sheetal Bulchandani, MD, said in an interview, “It depends a lot on clinical judgment, but there are certain things that everybody with osteoporosis should be evaluated for. We looked for the things that all the guidelines recommend.”

Studies have suggested that up to 30% of postmenopausal women with osteoporosis have secondary causes, noted Dr. Bulchandani, who conducted the study as a postdoctoral fellow with colleagues at Georgetown University/MedStar Washington Hospital and is now in private endocrine practice in Petersburg, Virginia.

“It’s important not to assume that every woman who walks in with osteoporosis has postmenopausal osteoporosis. I think it would be appropriate to at least discuss with the patients what would warrant certain kinds of clinical workup. … If you don’t figure out if there is an underlying cause, you may end up using an unnecessary medication,” Dr. Bulchandani said.
 

Are You Missing Something Treatable?

For example, she said, if the patient has underlying hyperparathyroidism and is treated with osteoporosis medications, “you might not see the desired or expected outcome in their bone density.”

Asked to comment, Rachel Pessah-Pollack, MD, clinical associate professor at the Holman Division of Endocrinology, Diabetes, and Metabolism at New York University School of Medicine, New York City, told this news organization, “Certainly, if you have patients who have osteoporosis, it’s important to take a good history and consider secondary causes of bone loss because you may find a treatable etiology that actually can improve their bone density without even starting on a medication.”

Dr. Pessah-Pollack, who was an author of the 2020 AACE/American College of Endocrinology 2020 Clinical Practice Guidelines for the Diagnosis and Treatment of Osteoporosis, said a 24-hour urine calcium collection, not a spot calcium check, is “super important because you’re looking to see if there’s any evidence of hypercalciuria or malabsorption that may be associated with higher rates of bone loss. … These may be a little more cumbersome and harder to get patients to do and more logistics to arrange. But clearly, if you pick up hypercalciuria, that is a potentially treatable etiology and can improve bone density as well.”

Another example, Dr. Pessah-Pollack said, is “if they have a low serum calcium level and high PTH, that would be a real reason to look for celiac disease. By not getting that PTH level, you may be missing that potential diagnosis. There is a wide range of additional causes of osteoporosis ranging from common conditions such as hyperthyroidism to rare conditions such as Cushing disease.”
 

Differences in Ordering Found Across Specialties

The 150 postmenopausal women were all receiving treatment with either alendronate, denosumab, or zoledronic acid. Their average age was 64.7 years, and 63% were seeing an endocrinologist.

Complete workups as per AACE and Endocrine Society guidelines had been performed in just 28% of those who saw an endocrinologist and 12.5% of patients seen by a rheumatologist, in contrast to 84% of those who saw the head of the hospital’s fracture prevention program.

Overall, across all specialties, just 28.67% had the complete recommended workup for secondary osteoporosis causes.

The most missed test was a 24-hour urine calcium collection, ordered for just 38% of the patients, while PTH was ordered for 73% and phosphorus for 80%. The rest were more commonly ordered: Thyroid-stimulating hormone level for 92.7%, complete blood cell count for 91.3%, basic metabolic panel for 100%, and vitamin D level for 96%.

The high rate of vitamin D testing is noteworthy, Dr. Pessah-Pollack said. “The fact that 96% of women are having vitamin D levels checked as part of an osteoporosis evaluation means that everybody’s aware about vitamin D deficiency, and people want to know what their vitamin D levels are. … That’s good because we want to identify vitamin D deficiency in our osteoporosis patients.”

But the low rate of complete secondary screening even by endocrinologists is concerning. “I look at this study as an opportunity for education that we can reinforce the importance of a secondary evaluation for our osteoporosis patients and really tailor which additional tests should be ordered for the individual patient,” Dr. Pessah-Pollack said.

In the poster, Dr. Bulchandani and colleagues wrote, “Further intervention will be aimed to ensure physicians undertake adequate evaluation before considering further treatment directions.” Possibilities that have been discussed include electronic health record alerts and educational materials for primary care providers, she told this news organization.

Dr. Manglani and Dr. Bulchandani had no disclosures. Dr. Pessah-Pollack is an advisor for Boehringer Ingelheim and Eli Lilly.

A version of this article appeared on Medscape.com.

NEW ORLEANS — Postmenopausal women with osteoporosis may not be receiving all the recommended tests to rule out secondary causes of bone loss prior to treatment initiation, new research found.

In a single-center chart review of 150 postmenopausal women who had been diagnosed and treated for osteoporosis, most had received a complete blood cell count, basic metabolic panel, thyroid screening, and vitamin D testing. However, one in four had not been tested for a parathyroid hormone (PTH) level, and in nearly two thirds, a 24-hour urine calcium collection had not been ordered.

Overall, less than a third had received the complete workup for secondary osteoporosis causes as recommended by the American Association of Clinical Endocrinologists (AACE) and the Endocrine Society.

“An appropriate evaluation for secondary causes of osteoporosis is essential because it impacts different treatment options and modalities. We discovered low rates of complete testing for secondary causes of osteoporosis in our patient population prior to treatment initiation,” said Kajol Manglani, MD, an internal medicine resident at Georgetown University/MedStar Washington Hospital Center, Washington, DC, and colleagues, in a poster at the American Association of Clinical Endocrinology (AACE) annual meeting held on May 9-12, 2024.

First author Sheetal Bulchandani, MD, said in an interview, “It depends a lot on clinical judgment, but there are certain things that everybody with osteoporosis should be evaluated for. We looked for the things that all the guidelines recommend.”

Studies have suggested that up to 30% of postmenopausal women with osteoporosis have secondary causes, noted Dr. Bulchandani, who conducted the study as a postdoctoral fellow with colleagues at Georgetown University/MedStar Washington Hospital and is now in private endocrine practice in Petersburg, Virginia.

“It’s important not to assume that every woman who walks in with osteoporosis has postmenopausal osteoporosis. I think it would be appropriate to at least discuss with the patients what would warrant certain kinds of clinical workup. … If you don’t figure out if there is an underlying cause, you may end up using an unnecessary medication,” Dr. Bulchandani said.
 

Are You Missing Something Treatable?

For example, she said, if the patient has underlying hyperparathyroidism and is treated with osteoporosis medications, “you might not see the desired or expected outcome in their bone density.”

Asked to comment, Rachel Pessah-Pollack, MD, clinical associate professor at the Holman Division of Endocrinology, Diabetes, and Metabolism at New York University School of Medicine, New York City, told this news organization, “Certainly, if you have patients who have osteoporosis, it’s important to take a good history and consider secondary causes of bone loss because you may find a treatable etiology that actually can improve their bone density without even starting on a medication.”

Dr. Pessah-Pollack, who was an author of the 2020 AACE/American College of Endocrinology 2020 Clinical Practice Guidelines for the Diagnosis and Treatment of Osteoporosis, said a 24-hour urine calcium collection, not a spot calcium check, is “super important because you’re looking to see if there’s any evidence of hypercalciuria or malabsorption that may be associated with higher rates of bone loss. … These may be a little more cumbersome and harder to get patients to do and more logistics to arrange. But clearly, if you pick up hypercalciuria, that is a potentially treatable etiology and can improve bone density as well.”

Another example, Dr. Pessah-Pollack said, is “if they have a low serum calcium level and high PTH, that would be a real reason to look for celiac disease. By not getting that PTH level, you may be missing that potential diagnosis. There is a wide range of additional causes of osteoporosis ranging from common conditions such as hyperthyroidism to rare conditions such as Cushing disease.”
 

Differences in Ordering Found Across Specialties

The 150 postmenopausal women were all receiving treatment with either alendronate, denosumab, or zoledronic acid. Their average age was 64.7 years, and 63% were seeing an endocrinologist.

Complete workups as per AACE and Endocrine Society guidelines had been performed in just 28% of those who saw an endocrinologist and 12.5% of patients seen by a rheumatologist, in contrast to 84% of those who saw the head of the hospital’s fracture prevention program.

Overall, across all specialties, just 28.67% had the complete recommended workup for secondary osteoporosis causes.

The most missed test was a 24-hour urine calcium collection, ordered for just 38% of the patients, while PTH was ordered for 73% and phosphorus for 80%. The rest were more commonly ordered: Thyroid-stimulating hormone level for 92.7%, complete blood cell count for 91.3%, basic metabolic panel for 100%, and vitamin D level for 96%.

The high rate of vitamin D testing is noteworthy, Dr. Pessah-Pollack said. “The fact that 96% of women are having vitamin D levels checked as part of an osteoporosis evaluation means that everybody’s aware about vitamin D deficiency, and people want to know what their vitamin D levels are. … That’s good because we want to identify vitamin D deficiency in our osteoporosis patients.”

But the low rate of complete secondary screening even by endocrinologists is concerning. “I look at this study as an opportunity for education that we can reinforce the importance of a secondary evaluation for our osteoporosis patients and really tailor which additional tests should be ordered for the individual patient,” Dr. Pessah-Pollack said.

In the poster, Dr. Bulchandani and colleagues wrote, “Further intervention will be aimed to ensure physicians undertake adequate evaluation before considering further treatment directions.” Possibilities that have been discussed include electronic health record alerts and educational materials for primary care providers, she told this news organization.

Dr. Manglani and Dr. Bulchandani had no disclosures. Dr. Pessah-Pollack is an advisor for Boehringer Ingelheim and Eli Lilly.

A version of this article appeared on Medscape.com.

Five experts discussed research that they considered to be highlights of the European Society of Medical Oncology (ESMO) Breast Cancer annual congress during a “Key Takeaways” session at the meeting.

Among the topics the speakers addressed were breast cancer prevention, early breast cancer, advanced breast cancer, and supportive care.

In recent years, the way clinicians look at carcinogenesis in breast cancer has changed, and many new targets for potential early detection and prevention have emerged, said Suzette Delaloge, MD, of Gustave Roussy, Paris, France, in her presentation at the meeting.

Instant risk assessment at different time points could potentially intercept cancer among high-risk individuals, she said.

A study by Mikael Eriksson, PhD, and colleagues focused on external validation of the Profound AI tool to identify breast cancer risk in the general population. The researchers showed an area under the curve of 0.72 in their AI risk model, which has the potential to be clinically meaningful, although it must be prospectively validated, Dr. Delaloge said in her presentation.

She also reviewed two studies on the use of genes to further refine breast cancer risk among carriers. One of these, a prospective study presented in a session by Kelly-Anne Phillips, MD, of Peter MacCallum Cancer Center, Melbourne, Australia, used the CANRISK online risk assessment tool and validated increased breast cancer risk in BRCA1 and BRCA2 carriers, with AUCs of 0.79 and 0.78, respectively. The other study, which was by Maria Rezqallah Aron, MD, and colleagues examined polygenic scores as a way to refine breast cancer risk stratification among carriers of the ALM and PALB2 genes as well. These genes might be useful in identifying individuals who could benefit from early intervention, including surgery, Dr. Delaloge said.
 

Translational Research

“Preparing my talk, I felt like a kid in a candy store,” because of the amount of new translational research presented, including several studies of endocrine treatment–based approaches to therapy, said Marleen Kok, MD, of the Netherlands Cancer Institute, Amsterdam.

In her presentation, Dr. Kok highlighted findings from an analysis of patients in the monarchE study (a trial of high-risk patients) showing a consistent improvement in invasive disease-free survival for the subset of patients with germline BRCA1 and BRCA2 mutations who received abemaciclib plus endocrine therapy.

The value of tumor-infiltrating lymphocytes (TILs) on patients who are not receiving chemotherapy is important because of the focus on prognosis, and prospective trials are underway, she said.

A poster on the impact of chemotherapy and stromal tumor-infiltrating lymphocytes (sTILs) in stage I triple-negative breast cancer showed no association between chemotherapy and better outcomes regardless of sTILs in patients who did and did not receive chemotherapy, which has implications for potential treatment sparing in this population, Dr. Kok noted.

Artificial Intelligence (AI) was the subject of several posters at the meeting, and Dr. Kok identified a multisite European study of an automated HER2 scoring system as notable for its size and accuracy. In the study, the accuracy among pathologists was much higher with the assistance of AI, she said. Using AI for more complex analysis has shown success, she said.

Dr. Kok ended her talk with a poster that surveyed breast cancer patients about their understanding of their disease. The results showed that less than half (44%) of patients reported that their healthcare providers had given them enough information to learn about their breast cancer type, and less than one third could recall terminology about biomarkers; the study is important because it shows that clinicians need to do better in explaining these terms to patients, Dr. Kok said.
 

Early Breast Cancer

Right-sizing therapy, meaning identifying the right treatment for every patient, is a key element of new research in early breast cancer, said Erika Hamilton, MD, of the Sarah Cannon Research Institute, Nashville, Tenn.

She highlighted safety and treatment duration updates from the NATALEE study, which compared adjuvant ribociclib plus nonsteroidal aromatase inhibitor (NSAI) to NSAI alone for ER+/HER2- breast cancer. The current analysis presented at the meeting showed significant benefits with the addition of ribociclib and no evidence of new safety signals or adverse event exacerbations at 3 years, she said. Dose modifications had no significant impact on efficacy, she added.

The findings of no impact of dose reduction on efficacy in both the NATALEE and monarchE studies provide important information on whether dosage can be reduced in patients, which will increase the odds that patients will tolerate extended therapy with good outcomes and stay on their prescribed therapies, Dr. Hamilton emphasized.

The CARABELA study, a phase 2 trial of neoadjuvant letrozole plus abemaciclib vs adriamycin and cyclophosphamide (AC), showed clinically similar response rates but did not meet its endpoint for residual cancer burden (RCB) scores. These data add to results from other studies and show that it is too soon to universally replace neoadjuvant chemotherapy as first-line treatment for highly proliferative ER+ breast cancer, Dr. Hamilton said in her presentation.
 

Advanced Breast Cancer

Take-home messages about advanced breast cancer include growing evidence for the potential benefits of antibody drug conjugates (ADCs), said Eva Ciruelos, MD, of University Hospital, Madrid, Spain. The TROPION-BREAST01 study, a phase 3 randomized trial, showed significant and clinically meaningful improvement in progression-free survival in patients with previously treated, inoperable, or metastatic HR+/HER2- breast cancer who received datopotamab deruxtecan (Dato-DXd) compared with those who received chemotherapy.

Data from an additional safety analysis were presented at the meeting; although Dato-DXd, a trophoblast cell-surface antigen 2 (TROP2)–directed antibody-drug conjugate, was well-tolerated, it is important to remain aware of toxicities, notably oral mucositis, which occurred in 55.6% of the patients in the study across all grades, and ocular surface toxicity, which occurred in 40% of patients across all grades, Dr. Ciruelos emphasized.

Key research in the area of advanced triple-negative breast cancer included data from the IMPASSION 132 study. This study is “specifically centered on early relapsers,” a population often excluded from other trials, Dr. Ciruelos said. In this study, patients with advanced triple-negative breast cancer were randomized to chemotherapy with or without atezolizumab, and the study showed no benefits with atezolizumab for overall survival, progression-free survival, or overall response rate, she said. “This is something to work with, because this is a very refractory population,” Dr. Ciruelos noted.

New immunotherapy combinations are needed to improve survival in advanced breast cancer patients, Dr. Ciruelos said. At the meeting, researchers presented interim data from a subset of patients in the MORPHEUS-pan breast cancer trial, a phase 1B/2 study involving multiple treatment combinations in locally advanced/metastatic breast cancer patients.

The interim analysis included 18-week data from triple-negative breast cancer patients and compared outcomes for patients randomized to atezolizumab with or without sacituzumab govitecan (SG).

The study was small, with only 31 patients in the combination arm and 11 controls, but the results were promising, with an overall response rate of 76.7% in the combination arm vs 66.7% in the control arm, Dr. Ciruelos said.

Supportive Care

Key supportive care takeaways included data on pregnancy in young breast cancer survivors and the safety of vaginal estrogen therapy in breast cancer patients with genitourinary symptoms, said Anne May, MD, of the University Medical Center Utrecht, Utrecht, Netherlands.

A study previously published in JAMA including nearly 5000 BRCA carriers who were diagnosed with invasive breast cancer at age 40 years or younger showed no association between pregnancy after breast cancer and adverse maternal or fetal outcomes, and pregnancy had no significant impact on overall survival. The authors presented new data on the safety of assisted reproductive techniques (ART) based on the 543 pregnancies in the original study, at the meeting. Of these, 436 conceived naturally, and 107 used ART. After a median of 9.1 years, ART had no effect on disease-free survival compared to natural conception (hazard ratio [HR], 0.64). Based on these findings, fertility preservation should be offered to all women who receive a breast cancer diagnosis and are interested in future fertility, Dr. May said.

Conceiving after breast cancer treatment and follow-up should not be contraindicated for young BRCA carriers, she added.No trial data are available for the effects of vaginal estrogen therapy (VET) on disease-free survival in breast cancer survivors with genitourinary symptoms caused by declining estrogen levels, Dr. May said. However, researchers in France and Switzerland conducted an emulation of a hypothetical target trial using data from the French National social security system for more than 130,000 individuals. Although VET therapy had no impact on disease-free survival in most breast cancer survivors overall, it did have a negative impact in a subset of patients with HR-positive and HR-negative tumors who were treated with aromatase inhibitors. The study was hypothetical, but important because the results suggest that clinicians can safely propose VTE to patients who report genitourinary symptoms after treatment for early-stage breast cancer with tamoxifen, but VTE should be avoided in patients treated with aromatase inhibitors, Dr. May said.

Dr. Delaloge disclosed research support to her institution from AstraZeneca, MSD, Bristol Myers Squibb, Sanofi, Taiho, Novartis, European Commission, INCa, Banque des Territoires, and Fondation Philanthropia. She also disclosed honoraria to her institution from AstraZeneca, Gilead, Novartis, Elsan, Besins, Sanofi, Exact Sciences, and Lilly, as well as travel support from Novartis.

Dr. Kok disclosed research funding from AstraZeneca, Bristol Myers Squibb, Daichi, and Roche, and advisory board membership/speaker’s fees from Alderaan Biotechnology, BIONTECH, Domain Therapeutics, AstraZeneca, Daichi, Bristol Myers Squibb, Gilead, Medscape, MSD, and Roche.

Dr. Hamilton disclosed a consulting advisory role (to her institution) for Accutar Biotechology, AstraZeneca, Daiichi Sankyo, Ellipses Pharma, Entos, Forsum Pharma, Gilead Sciences, Greenwich LifeSciences, Jazz Pharmaceuticals, Lilly, Medical Pharma Services, Mersana, Novartis, Olema Pharmaceuticals, Orum Therapeutics, Roche/Genentech, Stemline Therapeutics, ands others. She also disclosed contracted research/grant support to her institution only from Abbvie, Acerta Pharma, Accutar Biotechnology , ADC Therapeutics, AKESOBIO Australia , Amgen, Aravive, ArQule, Artios, Arvinas, AstraZeneca, AtlasMedx, BeiGene, Black Diamond and others.

Dr. Ciruelos disclosed serving as an external advisor for Roche, MSD, Gilead, AstraZeneca, Daichii Sankyo, Reveal Genomics, Pfizer, Novartis, and Lilly, as well as serving as a speaker for Roche, MSD, Gilead, AstraZeneca, Daichii Sankyo, Reveal Genomics, Pfizer, Novartis, Lilly, and Pierre Fabre. She also disclosed travel grants from Roche, Pfizer, and AstraZeneca, and research grants from Seagen and Roche.

Dr. May had no financial conflicts to disclose.

Five experts discussed research that they considered to be highlights of the European Society of Medical Oncology (ESMO) Breast Cancer annual congress during a “Key Takeaways” session at the meeting.

Among the topics the speakers addressed were breast cancer prevention, early breast cancer, advanced breast cancer, and supportive care.

In recent years, the way clinicians look at carcinogenesis in breast cancer has changed, and many new targets for potential early detection and prevention have emerged, said Suzette Delaloge, MD, of Gustave Roussy, Paris, France, in her presentation at the meeting.

Instant risk assessment at different time points could potentially intercept cancer among high-risk individuals, she said.

A study by Mikael Eriksson, PhD, and colleagues focused on external validation of the Profound AI tool to identify breast cancer risk in the general population. The researchers showed an area under the curve of 0.72 in their AI risk model, which has the potential to be clinically meaningful, although it must be prospectively validated, Dr. Delaloge said in her presentation.

She also reviewed two studies on the use of genes to further refine breast cancer risk among carriers. One of these, a prospective study presented in a session by Kelly-Anne Phillips, MD, of Peter MacCallum Cancer Center, Melbourne, Australia, used the CANRISK online risk assessment tool and validated increased breast cancer risk in BRCA1 and BRCA2 carriers, with AUCs of 0.79 and 0.78, respectively. The other study, which was by Maria Rezqallah Aron, MD, and colleagues examined polygenic scores as a way to refine breast cancer risk stratification among carriers of the ALM and PALB2 genes as well. These genes might be useful in identifying individuals who could benefit from early intervention, including surgery, Dr. Delaloge said.
 

Translational Research

“Preparing my talk, I felt like a kid in a candy store,” because of the amount of new translational research presented, including several studies of endocrine treatment–based approaches to therapy, said Marleen Kok, MD, of the Netherlands Cancer Institute, Amsterdam.

In her presentation, Dr. Kok highlighted findings from an analysis of patients in the monarchE study (a trial of high-risk patients) showing a consistent improvement in invasive disease-free survival for the subset of patients with germline BRCA1 and BRCA2 mutations who received abemaciclib plus endocrine therapy.

The value of tumor-infiltrating lymphocytes (TILs) on patients who are not receiving chemotherapy is important because of the focus on prognosis, and prospective trials are underway, she said.

A poster on the impact of chemotherapy and stromal tumor-infiltrating lymphocytes (sTILs) in stage I triple-negative breast cancer showed no association between chemotherapy and better outcomes regardless of sTILs in patients who did and did not receive chemotherapy, which has implications for potential treatment sparing in this population, Dr. Kok noted.

Artificial Intelligence (AI) was the subject of several posters at the meeting, and Dr. Kok identified a multisite European study of an automated HER2 scoring system as notable for its size and accuracy. In the study, the accuracy among pathologists was much higher with the assistance of AI, she said. Using AI for more complex analysis has shown success, she said.

Dr. Kok ended her talk with a poster that surveyed breast cancer patients about their understanding of their disease. The results showed that less than half (44%) of patients reported that their healthcare providers had given them enough information to learn about their breast cancer type, and less than one third could recall terminology about biomarkers; the study is important because it shows that clinicians need to do better in explaining these terms to patients, Dr. Kok said.
 

Early Breast Cancer

Right-sizing therapy, meaning identifying the right treatment for every patient, is a key element of new research in early breast cancer, said Erika Hamilton, MD, of the Sarah Cannon Research Institute, Nashville, Tenn.

She highlighted safety and treatment duration updates from the NATALEE study, which compared adjuvant ribociclib plus nonsteroidal aromatase inhibitor (NSAI) to NSAI alone for ER+/HER2- breast cancer. The current analysis presented at the meeting showed significant benefits with the addition of ribociclib and no evidence of new safety signals or adverse event exacerbations at 3 years, she said. Dose modifications had no significant impact on efficacy, she added.

The findings of no impact of dose reduction on efficacy in both the NATALEE and monarchE studies provide important information on whether dosage can be reduced in patients, which will increase the odds that patients will tolerate extended therapy with good outcomes and stay on their prescribed therapies, Dr. Hamilton emphasized.

The CARABELA study, a phase 2 trial of neoadjuvant letrozole plus abemaciclib vs adriamycin and cyclophosphamide (AC), showed clinically similar response rates but did not meet its endpoint for residual cancer burden (RCB) scores. These data add to results from other studies and show that it is too soon to universally replace neoadjuvant chemotherapy as first-line treatment for highly proliferative ER+ breast cancer, Dr. Hamilton said in her presentation.
 

Advanced Breast Cancer

Take-home messages about advanced breast cancer include growing evidence for the potential benefits of antibody drug conjugates (ADCs), said Eva Ciruelos, MD, of University Hospital, Madrid, Spain. The TROPION-BREAST01 study, a phase 3 randomized trial, showed significant and clinically meaningful improvement in progression-free survival in patients with previously treated, inoperable, or metastatic HR+/HER2- breast cancer who received datopotamab deruxtecan (Dato-DXd) compared with those who received chemotherapy.

Data from an additional safety analysis were presented at the meeting; although Dato-DXd, a trophoblast cell-surface antigen 2 (TROP2)–directed antibody-drug conjugate, was well-tolerated, it is important to remain aware of toxicities, notably oral mucositis, which occurred in 55.6% of the patients in the study across all grades, and ocular surface toxicity, which occurred in 40% of patients across all grades, Dr. Ciruelos emphasized.

Key research in the area of advanced triple-negative breast cancer included data from the IMPASSION 132 study. This study is “specifically centered on early relapsers,” a population often excluded from other trials, Dr. Ciruelos said. In this study, patients with advanced triple-negative breast cancer were randomized to chemotherapy with or without atezolizumab, and the study showed no benefits with atezolizumab for overall survival, progression-free survival, or overall response rate, she said. “This is something to work with, because this is a very refractory population,” Dr. Ciruelos noted.

New immunotherapy combinations are needed to improve survival in advanced breast cancer patients, Dr. Ciruelos said. At the meeting, researchers presented interim data from a subset of patients in the MORPHEUS-pan breast cancer trial, a phase 1B/2 study involving multiple treatment combinations in locally advanced/metastatic breast cancer patients.

The interim analysis included 18-week data from triple-negative breast cancer patients and compared outcomes for patients randomized to atezolizumab with or without sacituzumab govitecan (SG).

The study was small, with only 31 patients in the combination arm and 11 controls, but the results were promising, with an overall response rate of 76.7% in the combination arm vs 66.7% in the control arm, Dr. Ciruelos said.

Supportive Care

Key supportive care takeaways included data on pregnancy in young breast cancer survivors and the safety of vaginal estrogen therapy in breast cancer patients with genitourinary symptoms, said Anne May, MD, of the University Medical Center Utrecht, Utrecht, Netherlands.

A study previously published in JAMA including nearly 5000 BRCA carriers who were diagnosed with invasive breast cancer at age 40 years or younger showed no association between pregnancy after breast cancer and adverse maternal or fetal outcomes, and pregnancy had no significant impact on overall survival. The authors presented new data on the safety of assisted reproductive techniques (ART) based on the 543 pregnancies in the original study, at the meeting. Of these, 436 conceived naturally, and 107 used ART. After a median of 9.1 years, ART had no effect on disease-free survival compared to natural conception (hazard ratio [HR], 0.64). Based on these findings, fertility preservation should be offered to all women who receive a breast cancer diagnosis and are interested in future fertility, Dr. May said.

Conceiving after breast cancer treatment and follow-up should not be contraindicated for young BRCA carriers, she added.No trial data are available for the effects of vaginal estrogen therapy (VET) on disease-free survival in breast cancer survivors with genitourinary symptoms caused by declining estrogen levels, Dr. May said. However, researchers in France and Switzerland conducted an emulation of a hypothetical target trial using data from the French National social security system for more than 130,000 individuals. Although VET therapy had no impact on disease-free survival in most breast cancer survivors overall, it did have a negative impact in a subset of patients with HR-positive and HR-negative tumors who were treated with aromatase inhibitors. The study was hypothetical, but important because the results suggest that clinicians can safely propose VTE to patients who report genitourinary symptoms after treatment for early-stage breast cancer with tamoxifen, but VTE should be avoided in patients treated with aromatase inhibitors, Dr. May said.

Dr. Delaloge disclosed research support to her institution from AstraZeneca, MSD, Bristol Myers Squibb, Sanofi, Taiho, Novartis, European Commission, INCa, Banque des Territoires, and Fondation Philanthropia. She also disclosed honoraria to her institution from AstraZeneca, Gilead, Novartis, Elsan, Besins, Sanofi, Exact Sciences, and Lilly, as well as travel support from Novartis.

Dr. Kok disclosed research funding from AstraZeneca, Bristol Myers Squibb, Daichi, and Roche, and advisory board membership/speaker’s fees from Alderaan Biotechnology, BIONTECH, Domain Therapeutics, AstraZeneca, Daichi, Bristol Myers Squibb, Gilead, Medscape, MSD, and Roche.

Dr. Hamilton disclosed a consulting advisory role (to her institution) for Accutar Biotechology, AstraZeneca, Daiichi Sankyo, Ellipses Pharma, Entos, Forsum Pharma, Gilead Sciences, Greenwich LifeSciences, Jazz Pharmaceuticals, Lilly, Medical Pharma Services, Mersana, Novartis, Olema Pharmaceuticals, Orum Therapeutics, Roche/Genentech, Stemline Therapeutics, ands others. She also disclosed contracted research/grant support to her institution only from Abbvie, Acerta Pharma, Accutar Biotechnology , ADC Therapeutics, AKESOBIO Australia , Amgen, Aravive, ArQule, Artios, Arvinas, AstraZeneca, AtlasMedx, BeiGene, Black Diamond and others.

Dr. Ciruelos disclosed serving as an external advisor for Roche, MSD, Gilead, AstraZeneca, Daichii Sankyo, Reveal Genomics, Pfizer, Novartis, and Lilly, as well as serving as a speaker for Roche, MSD, Gilead, AstraZeneca, Daichii Sankyo, Reveal Genomics, Pfizer, Novartis, Lilly, and Pierre Fabre. She also disclosed travel grants from Roche, Pfizer, and AstraZeneca, and research grants from Seagen and Roche.

Dr. May had no financial conflicts to disclose.

Five experts discussed research that they considered to be highlights of the European Society of Medical Oncology (ESMO) Breast Cancer annual congress during a “Key Takeaways” session at the meeting.

Among the topics the speakers addressed were breast cancer prevention, early breast cancer, advanced breast cancer, and supportive care.

In recent years, the way clinicians look at carcinogenesis in breast cancer has changed, and many new targets for potential early detection and prevention have emerged, said Suzette Delaloge, MD, of Gustave Roussy, Paris, France, in her presentation at the meeting.

Instant risk assessment at different time points could potentially intercept cancer among high-risk individuals, she said.

A study by Mikael Eriksson, PhD, and colleagues focused on external validation of the Profound AI tool to identify breast cancer risk in the general population. The researchers showed an area under the curve of 0.72 in their AI risk model, which has the potential to be clinically meaningful, although it must be prospectively validated, Dr. Delaloge said in her presentation.

She also reviewed two studies on the use of genes to further refine breast cancer risk among carriers. One of these, a prospective study presented in a session by Kelly-Anne Phillips, MD, of Peter MacCallum Cancer Center, Melbourne, Australia, used the CANRISK online risk assessment tool and validated increased breast cancer risk in BRCA1 and BRCA2 carriers, with AUCs of 0.79 and 0.78, respectively. The other study, which was by Maria Rezqallah Aron, MD, and colleagues examined polygenic scores as a way to refine breast cancer risk stratification among carriers of the ALM and PALB2 genes as well. These genes might be useful in identifying individuals who could benefit from early intervention, including surgery, Dr. Delaloge said.
 

Translational Research

“Preparing my talk, I felt like a kid in a candy store,” because of the amount of new translational research presented, including several studies of endocrine treatment–based approaches to therapy, said Marleen Kok, MD, of the Netherlands Cancer Institute, Amsterdam.

In her presentation, Dr. Kok highlighted findings from an analysis of patients in the monarchE study (a trial of high-risk patients) showing a consistent improvement in invasive disease-free survival for the subset of patients with germline BRCA1 and BRCA2 mutations who received abemaciclib plus endocrine therapy.

The value of tumor-infiltrating lymphocytes (TILs) on patients who are not receiving chemotherapy is important because of the focus on prognosis, and prospective trials are underway, she said.

A poster on the impact of chemotherapy and stromal tumor-infiltrating lymphocytes (sTILs) in stage I triple-negative breast cancer showed no association between chemotherapy and better outcomes regardless of sTILs in patients who did and did not receive chemotherapy, which has implications for potential treatment sparing in this population, Dr. Kok noted.

Artificial Intelligence (AI) was the subject of several posters at the meeting, and Dr. Kok identified a multisite European study of an automated HER2 scoring system as notable for its size and accuracy. In the study, the accuracy among pathologists was much higher with the assistance of AI, she said. Using AI for more complex analysis has shown success, she said.

Dr. Kok ended her talk with a poster that surveyed breast cancer patients about their understanding of their disease. The results showed that less than half (44%) of patients reported that their healthcare providers had given them enough information to learn about their breast cancer type, and less than one third could recall terminology about biomarkers; the study is important because it shows that clinicians need to do better in explaining these terms to patients, Dr. Kok said.
 

Early Breast Cancer

Right-sizing therapy, meaning identifying the right treatment for every patient, is a key element of new research in early breast cancer, said Erika Hamilton, MD, of the Sarah Cannon Research Institute, Nashville, Tenn.

She highlighted safety and treatment duration updates from the NATALEE study, which compared adjuvant ribociclib plus nonsteroidal aromatase inhibitor (NSAI) to NSAI alone for ER+/HER2- breast cancer. The current analysis presented at the meeting showed significant benefits with the addition of ribociclib and no evidence of new safety signals or adverse event exacerbations at 3 years, she said. Dose modifications had no significant impact on efficacy, she added.

The findings of no impact of dose reduction on efficacy in both the NATALEE and monarchE studies provide important information on whether dosage can be reduced in patients, which will increase the odds that patients will tolerate extended therapy with good outcomes and stay on their prescribed therapies, Dr. Hamilton emphasized.

The CARABELA study, a phase 2 trial of neoadjuvant letrozole plus abemaciclib vs adriamycin and cyclophosphamide (AC), showed clinically similar response rates but did not meet its endpoint for residual cancer burden (RCB) scores. These data add to results from other studies and show that it is too soon to universally replace neoadjuvant chemotherapy as first-line treatment for highly proliferative ER+ breast cancer, Dr. Hamilton said in her presentation.
 

Advanced Breast Cancer

Take-home messages about advanced breast cancer include growing evidence for the potential benefits of antibody drug conjugates (ADCs), said Eva Ciruelos, MD, of University Hospital, Madrid, Spain. The TROPION-BREAST01 study, a phase 3 randomized trial, showed significant and clinically meaningful improvement in progression-free survival in patients with previously treated, inoperable, or metastatic HR+/HER2- breast cancer who received datopotamab deruxtecan (Dato-DXd) compared with those who received chemotherapy.

Data from an additional safety analysis were presented at the meeting; although Dato-DXd, a trophoblast cell-surface antigen 2 (TROP2)–directed antibody-drug conjugate, was well-tolerated, it is important to remain aware of toxicities, notably oral mucositis, which occurred in 55.6% of the patients in the study across all grades, and ocular surface toxicity, which occurred in 40% of patients across all grades, Dr. Ciruelos emphasized.

Key research in the area of advanced triple-negative breast cancer included data from the IMPASSION 132 study. This study is “specifically centered on early relapsers,” a population often excluded from other trials, Dr. Ciruelos said. In this study, patients with advanced triple-negative breast cancer were randomized to chemotherapy with or without atezolizumab, and the study showed no benefits with atezolizumab for overall survival, progression-free survival, or overall response rate, she said. “This is something to work with, because this is a very refractory population,” Dr. Ciruelos noted.

New immunotherapy combinations are needed to improve survival in advanced breast cancer patients, Dr. Ciruelos said. At the meeting, researchers presented interim data from a subset of patients in the MORPHEUS-pan breast cancer trial, a phase 1B/2 study involving multiple treatment combinations in locally advanced/metastatic breast cancer patients.

The interim analysis included 18-week data from triple-negative breast cancer patients and compared outcomes for patients randomized to atezolizumab with or without sacituzumab govitecan (SG).

The study was small, with only 31 patients in the combination arm and 11 controls, but the results were promising, with an overall response rate of 76.7% in the combination arm vs 66.7% in the control arm, Dr. Ciruelos said.

Supportive Care

Key supportive care takeaways included data on pregnancy in young breast cancer survivors and the safety of vaginal estrogen therapy in breast cancer patients with genitourinary symptoms, said Anne May, MD, of the University Medical Center Utrecht, Utrecht, Netherlands.

A study previously published in JAMA including nearly 5000 BRCA carriers who were diagnosed with invasive breast cancer at age 40 years or younger showed no association between pregnancy after breast cancer and adverse maternal or fetal outcomes, and pregnancy had no significant impact on overall survival. The authors presented new data on the safety of assisted reproductive techniques (ART) based on the 543 pregnancies in the original study, at the meeting. Of these, 436 conceived naturally, and 107 used ART. After a median of 9.1 years, ART had no effect on disease-free survival compared to natural conception (hazard ratio [HR], 0.64). Based on these findings, fertility preservation should be offered to all women who receive a breast cancer diagnosis and are interested in future fertility, Dr. May said.

Conceiving after breast cancer treatment and follow-up should not be contraindicated for young BRCA carriers, she added.No trial data are available for the effects of vaginal estrogen therapy (VET) on disease-free survival in breast cancer survivors with genitourinary symptoms caused by declining estrogen levels, Dr. May said. However, researchers in France and Switzerland conducted an emulation of a hypothetical target trial using data from the French National social security system for more than 130,000 individuals. Although VET therapy had no impact on disease-free survival in most breast cancer survivors overall, it did have a negative impact in a subset of patients with HR-positive and HR-negative tumors who were treated with aromatase inhibitors. The study was hypothetical, but important because the results suggest that clinicians can safely propose VTE to patients who report genitourinary symptoms after treatment for early-stage breast cancer with tamoxifen, but VTE should be avoided in patients treated with aromatase inhibitors, Dr. May said.

Dr. Delaloge disclosed research support to her institution from AstraZeneca, MSD, Bristol Myers Squibb, Sanofi, Taiho, Novartis, European Commission, INCa, Banque des Territoires, and Fondation Philanthropia. She also disclosed honoraria to her institution from AstraZeneca, Gilead, Novartis, Elsan, Besins, Sanofi, Exact Sciences, and Lilly, as well as travel support from Novartis.

Dr. Kok disclosed research funding from AstraZeneca, Bristol Myers Squibb, Daichi, and Roche, and advisory board membership/speaker’s fees from Alderaan Biotechnology, BIONTECH, Domain Therapeutics, AstraZeneca, Daichi, Bristol Myers Squibb, Gilead, Medscape, MSD, and Roche.

Dr. Hamilton disclosed a consulting advisory role (to her institution) for Accutar Biotechology, AstraZeneca, Daiichi Sankyo, Ellipses Pharma, Entos, Forsum Pharma, Gilead Sciences, Greenwich LifeSciences, Jazz Pharmaceuticals, Lilly, Medical Pharma Services, Mersana, Novartis, Olema Pharmaceuticals, Orum Therapeutics, Roche/Genentech, Stemline Therapeutics, ands others. She also disclosed contracted research/grant support to her institution only from Abbvie, Acerta Pharma, Accutar Biotechnology , ADC Therapeutics, AKESOBIO Australia , Amgen, Aravive, ArQule, Artios, Arvinas, AstraZeneca, AtlasMedx, BeiGene, Black Diamond and others.

Dr. Ciruelos disclosed serving as an external advisor for Roche, MSD, Gilead, AstraZeneca, Daichii Sankyo, Reveal Genomics, Pfizer, Novartis, and Lilly, as well as serving as a speaker for Roche, MSD, Gilead, AstraZeneca, Daichii Sankyo, Reveal Genomics, Pfizer, Novartis, Lilly, and Pierre Fabre. She also disclosed travel grants from Roche, Pfizer, and AstraZeneca, and research grants from Seagen and Roche.

Dr. May had no financial conflicts to disclose.