Women's Health

Women who are considered to be at average risk for breast cancer should have mammograms every other year starting at age 40 years until age 74, according to the latest recommendations from the US Preventive Services Task Force (USPSTF).

In its updated recommendations published April 30 in JAMA, the USPSTF also made an urgent call to address reasons why Black women are more likely to die from breast cancer than are White women and pressed for more research to address persisting questions about how best to screen for cancer in dense breasts, which about 40% of women have. The USPSTF highlighted evidence gaps on the benefits and harms of continuing mammography after age 75 years as well.

The updated USPSTF recommendations were first unveiled last year in a draft version. 

In 2016, the task force recommended biennial mammograms for women starting 10 years later, at age 50 years, while stressing a need for clinicians and patients to weigh the risks and benefits of screening for those in their 40s. 

The shift to a general recommendation to start at age 40 years is based on a broad review of available data on mammography, including modeling from Cancer Intervention and Surveillance Modeling Network (CISNET).

Alongside the USPSTF report, JAMA published three separate editorials — a reflection of the controversy that these breast cancer screening recommendations often generate. 

In one editorial, published in JAMA Network Open, Lydia E. Pace, MD, MPH, and Nancy L. Keating, MD, MPH, highlighted that though screening earlier will prevent more deaths from breast cancer, it will also lead to more false positive findings and increase rates of overdiagnosis. 

Dr. Pace and Dr. Keating explained that the modeling study commissioned by the USPSTF estimated that screening every 2 years starting at age 40 years would avoid an additional 1.3 breast cancer deaths compared with screening at age 50 years. Among Black women, screening every 2 years starting at age 40 years would avert an extra 1.8 breast cancer deaths per 1000 people screened. 

However, the model also found that screening every 2 years starting at age 40 years would lead to more false positive tests — a rate of about 8.5% vs 7.8% for those starting at age 50.

“Given mammography screening’s modest benefits, we feel that all women — and particularly those aged 40 to 49 years —should be counseled about the benefits and harms of mammography and supported in deciding whether the balance of benefits to harms fits with their priorities and values,” wrote Dr. Pace and Dr. Keating, who specialize in internal medicine.

In a second editorial, in JAMA, Joann G. Elmore, MD, MPH, of UCLA, and Christoph I. Lee, MD, MS, of the University of Washington, Seattle, noted that the revised recommendations “shed light on 2 major issues that demand greater attention: addressing health inequities related to breast cancer outcomes and ensuring benefits for all women amid rapid screening technological advancements.” 

The USPSTF’s decision to recommend an earlier start age for routine mammography was partly intended to begin to address the fact that Black women are about 40% more likely to die from breast cancer than are White women.

“Despite greater absolute benefits of screening for Black women, the modeling study and systematic review underscore that mammography’s benefits (ie, breast cancer deaths averted) are modest for both Black women and the general population,” wrote Dr. Elmore and Dr. Lee.

The editorialists also cautioned against adopting artificial intelligence (AI) support tools too rapidly, criticizing the USPSTF for overlooking this “pressing issue.” 

“While AI algorithms show promise for enhancing cancer detection, their impact on patient outcomes and the balance between benefit and harms remain uncertain,” the editorialists wrote.

In a third editorial, in JAMA Oncology, Wendie A. Berg, MD, PhD, a radiologist at the University of Pittsburgh, argued that though the updated recommendations are “an important step forward,” they don’t go far enough.

Dr. Berg, for instance, noted her surprise “ to see the USPSTF recommendation only for biennial, rather than annual, screening among women aged 40 to 74 years.”

Compared with no screening, annual screening would reduce rates of breast cancer mortality (35.2%) more than biennial (28.4%) screening does among women aged 40-74 years, according to the CISNET modeling that informed the USPSTF’s decision.

Plus, Dr. Berg noted, regular risk assessments should begin at age 25 years “to identify women at high risk who should start annual MRI screenings.”

The American College of Radiology (ACR) offered similar views in a statement, saying the recommendations “do not go far enough to save more women’s lives.” It urged a more aggressive screening schedule, which starts at age 40 years but occurs annually vs biennially and continues past age 74 years. Like Dr. Berg, the ACR advocated for breast cancer risk assessments to begin at age 25 years.

The American Cancer Society also recommended annual mammography screening, starting as early as age 40 years in average-risk women, with high-risk women receiving a breast MRI and a mammogram every year starting at age 30 years. 
 

Ongoing Uncertainties 

The USPSTF’s 2024 update highlighted persistent evidence gaps in several key areas. 

The USPSTF, for instance, highlighted insufficient evidence on the benefits and harms of continuing to screen women who are 75 years or older as well as the benefits and harms of supplemental screening with breast ultrasonography or MRI in women with dense breasts who had a negative screening mammogram.

In the update, USPSTF noted that it’s still clear what proportion of ductal carcinoma in situ involves lesions detected by screening would not have ultimately caused harm. 

For women with dense breasts, the USPSTF said that “research is needed to help clinicians and patients understand the best strategy for breast cancer screening in women found to have dense breasts,” which includes supplemental screening.

Women with dense breasts should still get mammograms, but there is not enough evidence for a blanket statement about which benefit they might get from additional screening, Carol Mangione, MD, past chair of USPSTF, told this news organization. 

“We don’t want to send a message that the mammogram doesn’t have value in that group, because it does have high value,” said Dr. Mangione, chief of the division of general internal medicine and health services research at UCLA Health. 

Women with dense breasts should work with primary care clinicians who can take a holistic view of their preferences and needs, allowing them to make an informed choice about additional screening, she said.

“But we can’t make a global population choice because we don’t have the studies to do that,” Dr. Mangione said.
 

A version of this article appeared on Medscape.com.

Women who are considered to be at average risk for breast cancer should have mammograms every other year starting at age 40 years until age 74, according to the latest recommendations from the US Preventive Services Task Force (USPSTF).

In its updated recommendations published April 30 in JAMA, the USPSTF also made an urgent call to address reasons why Black women are more likely to die from breast cancer than are White women and pressed for more research to address persisting questions about how best to screen for cancer in dense breasts, which about 40% of women have. The USPSTF highlighted evidence gaps on the benefits and harms of continuing mammography after age 75 years as well.

The updated USPSTF recommendations were first unveiled last year in a draft version. 

In 2016, the task force recommended biennial mammograms for women starting 10 years later, at age 50 years, while stressing a need for clinicians and patients to weigh the risks and benefits of screening for those in their 40s. 

The shift to a general recommendation to start at age 40 years is based on a broad review of available data on mammography, including modeling from Cancer Intervention and Surveillance Modeling Network (CISNET).

Alongside the USPSTF report, JAMA published three separate editorials — a reflection of the controversy that these breast cancer screening recommendations often generate. 

In one editorial, published in JAMA Network Open, Lydia E. Pace, MD, MPH, and Nancy L. Keating, MD, MPH, highlighted that though screening earlier will prevent more deaths from breast cancer, it will also lead to more false positive findings and increase rates of overdiagnosis. 

Dr. Pace and Dr. Keating explained that the modeling study commissioned by the USPSTF estimated that screening every 2 years starting at age 40 years would avoid an additional 1.3 breast cancer deaths compared with screening at age 50 years. Among Black women, screening every 2 years starting at age 40 years would avert an extra 1.8 breast cancer deaths per 1000 people screened. 

However, the model also found that screening every 2 years starting at age 40 years would lead to more false positive tests — a rate of about 8.5% vs 7.8% for those starting at age 50.

“Given mammography screening’s modest benefits, we feel that all women — and particularly those aged 40 to 49 years —should be counseled about the benefits and harms of mammography and supported in deciding whether the balance of benefits to harms fits with their priorities and values,” wrote Dr. Pace and Dr. Keating, who specialize in internal medicine.

In a second editorial, in JAMA, Joann G. Elmore, MD, MPH, of UCLA, and Christoph I. Lee, MD, MS, of the University of Washington, Seattle, noted that the revised recommendations “shed light on 2 major issues that demand greater attention: addressing health inequities related to breast cancer outcomes and ensuring benefits for all women amid rapid screening technological advancements.” 

The USPSTF’s decision to recommend an earlier start age for routine mammography was partly intended to begin to address the fact that Black women are about 40% more likely to die from breast cancer than are White women.

“Despite greater absolute benefits of screening for Black women, the modeling study and systematic review underscore that mammography’s benefits (ie, breast cancer deaths averted) are modest for both Black women and the general population,” wrote Dr. Elmore and Dr. Lee.

The editorialists also cautioned against adopting artificial intelligence (AI) support tools too rapidly, criticizing the USPSTF for overlooking this “pressing issue.” 

“While AI algorithms show promise for enhancing cancer detection, their impact on patient outcomes and the balance between benefit and harms remain uncertain,” the editorialists wrote.

In a third editorial, in JAMA Oncology, Wendie A. Berg, MD, PhD, a radiologist at the University of Pittsburgh, argued that though the updated recommendations are “an important step forward,” they don’t go far enough.

Dr. Berg, for instance, noted her surprise “ to see the USPSTF recommendation only for biennial, rather than annual, screening among women aged 40 to 74 years.”

Compared with no screening, annual screening would reduce rates of breast cancer mortality (35.2%) more than biennial (28.4%) screening does among women aged 40-74 years, according to the CISNET modeling that informed the USPSTF’s decision.

Plus, Dr. Berg noted, regular risk assessments should begin at age 25 years “to identify women at high risk who should start annual MRI screenings.”

The American College of Radiology (ACR) offered similar views in a statement, saying the recommendations “do not go far enough to save more women’s lives.” It urged a more aggressive screening schedule, which starts at age 40 years but occurs annually vs biennially and continues past age 74 years. Like Dr. Berg, the ACR advocated for breast cancer risk assessments to begin at age 25 years.

The American Cancer Society also recommended annual mammography screening, starting as early as age 40 years in average-risk women, with high-risk women receiving a breast MRI and a mammogram every year starting at age 30 years. 
 

Ongoing Uncertainties 

The USPSTF’s 2024 update highlighted persistent evidence gaps in several key areas. 

The USPSTF, for instance, highlighted insufficient evidence on the benefits and harms of continuing to screen women who are 75 years or older as well as the benefits and harms of supplemental screening with breast ultrasonography or MRI in women with dense breasts who had a negative screening mammogram.

In the update, USPSTF noted that it’s still clear what proportion of ductal carcinoma in situ involves lesions detected by screening would not have ultimately caused harm. 

For women with dense breasts, the USPSTF said that “research is needed to help clinicians and patients understand the best strategy for breast cancer screening in women found to have dense breasts,” which includes supplemental screening.

Women with dense breasts should still get mammograms, but there is not enough evidence for a blanket statement about which benefit they might get from additional screening, Carol Mangione, MD, past chair of USPSTF, told this news organization. 

“We don’t want to send a message that the mammogram doesn’t have value in that group, because it does have high value,” said Dr. Mangione, chief of the division of general internal medicine and health services research at UCLA Health. 

Women with dense breasts should work with primary care clinicians who can take a holistic view of their preferences and needs, allowing them to make an informed choice about additional screening, she said.

“But we can’t make a global population choice because we don’t have the studies to do that,” Dr. Mangione said.
 

A version of this article appeared on Medscape.com.

Women who are considered to be at average risk for breast cancer should have mammograms every other year starting at age 40 years until age 74, according to the latest recommendations from the US Preventive Services Task Force (USPSTF).

In its updated recommendations published April 30 in JAMA, the USPSTF also made an urgent call to address reasons why Black women are more likely to die from breast cancer than are White women and pressed for more research to address persisting questions about how best to screen for cancer in dense breasts, which about 40% of women have. The USPSTF highlighted evidence gaps on the benefits and harms of continuing mammography after age 75 years as well.

The updated USPSTF recommendations were first unveiled last year in a draft version. 

In 2016, the task force recommended biennial mammograms for women starting 10 years later, at age 50 years, while stressing a need for clinicians and patients to weigh the risks and benefits of screening for those in their 40s. 

The shift to a general recommendation to start at age 40 years is based on a broad review of available data on mammography, including modeling from Cancer Intervention and Surveillance Modeling Network (CISNET).

Alongside the USPSTF report, JAMA published three separate editorials — a reflection of the controversy that these breast cancer screening recommendations often generate. 

In one editorial, published in JAMA Network Open, Lydia E. Pace, MD, MPH, and Nancy L. Keating, MD, MPH, highlighted that though screening earlier will prevent more deaths from breast cancer, it will also lead to more false positive findings and increase rates of overdiagnosis. 

Dr. Pace and Dr. Keating explained that the modeling study commissioned by the USPSTF estimated that screening every 2 years starting at age 40 years would avoid an additional 1.3 breast cancer deaths compared with screening at age 50 years. Among Black women, screening every 2 years starting at age 40 years would avert an extra 1.8 breast cancer deaths per 1000 people screened. 

However, the model also found that screening every 2 years starting at age 40 years would lead to more false positive tests — a rate of about 8.5% vs 7.8% for those starting at age 50.

“Given mammography screening’s modest benefits, we feel that all women — and particularly those aged 40 to 49 years —should be counseled about the benefits and harms of mammography and supported in deciding whether the balance of benefits to harms fits with their priorities and values,” wrote Dr. Pace and Dr. Keating, who specialize in internal medicine.

In a second editorial, in JAMA, Joann G. Elmore, MD, MPH, of UCLA, and Christoph I. Lee, MD, MS, of the University of Washington, Seattle, noted that the revised recommendations “shed light on 2 major issues that demand greater attention: addressing health inequities related to breast cancer outcomes and ensuring benefits for all women amid rapid screening technological advancements.” 

The USPSTF’s decision to recommend an earlier start age for routine mammography was partly intended to begin to address the fact that Black women are about 40% more likely to die from breast cancer than are White women.

“Despite greater absolute benefits of screening for Black women, the modeling study and systematic review underscore that mammography’s benefits (ie, breast cancer deaths averted) are modest for both Black women and the general population,” wrote Dr. Elmore and Dr. Lee.

The editorialists also cautioned against adopting artificial intelligence (AI) support tools too rapidly, criticizing the USPSTF for overlooking this “pressing issue.” 

“While AI algorithms show promise for enhancing cancer detection, their impact on patient outcomes and the balance between benefit and harms remain uncertain,” the editorialists wrote.

In a third editorial, in JAMA Oncology, Wendie A. Berg, MD, PhD, a radiologist at the University of Pittsburgh, argued that though the updated recommendations are “an important step forward,” they don’t go far enough.

Dr. Berg, for instance, noted her surprise “ to see the USPSTF recommendation only for biennial, rather than annual, screening among women aged 40 to 74 years.”

Compared with no screening, annual screening would reduce rates of breast cancer mortality (35.2%) more than biennial (28.4%) screening does among women aged 40-74 years, according to the CISNET modeling that informed the USPSTF’s decision.

Plus, Dr. Berg noted, regular risk assessments should begin at age 25 years “to identify women at high risk who should start annual MRI screenings.”

The American College of Radiology (ACR) offered similar views in a statement, saying the recommendations “do not go far enough to save more women’s lives.” It urged a more aggressive screening schedule, which starts at age 40 years but occurs annually vs biennially and continues past age 74 years. Like Dr. Berg, the ACR advocated for breast cancer risk assessments to begin at age 25 years.

The American Cancer Society also recommended annual mammography screening, starting as early as age 40 years in average-risk women, with high-risk women receiving a breast MRI and a mammogram every year starting at age 30 years. 
 

Ongoing Uncertainties 

The USPSTF’s 2024 update highlighted persistent evidence gaps in several key areas. 

The USPSTF, for instance, highlighted insufficient evidence on the benefits and harms of continuing to screen women who are 75 years or older as well as the benefits and harms of supplemental screening with breast ultrasonography or MRI in women with dense breasts who had a negative screening mammogram.

In the update, USPSTF noted that it’s still clear what proportion of ductal carcinoma in situ involves lesions detected by screening would not have ultimately caused harm. 

For women with dense breasts, the USPSTF said that “research is needed to help clinicians and patients understand the best strategy for breast cancer screening in women found to have dense breasts,” which includes supplemental screening.

Women with dense breasts should still get mammograms, but there is not enough evidence for a blanket statement about which benefit they might get from additional screening, Carol Mangione, MD, past chair of USPSTF, told this news organization. 

“We don’t want to send a message that the mammogram doesn’t have value in that group, because it does have high value,” said Dr. Mangione, chief of the division of general internal medicine and health services research at UCLA Health. 

Women with dense breasts should work with primary care clinicians who can take a holistic view of their preferences and needs, allowing them to make an informed choice about additional screening, she said.

“But we can’t make a global population choice because we don’t have the studies to do that,” Dr. Mangione said.
 

A version of this article appeared on Medscape.com.

Approximately one third of pregnant individuals with syphilis were inadequately treated or not treated for syphilis despite receiving timely prenatal care, based on data from nearly 1500 patients.

Although congenital syphilis is preventable with treatment before or early in pregnancy, data from the Centers for Disease Control and Prevention (CDC) show a doubling of syphilis rates in the United States between 2018 and 2021 wrote Ayzsa Tannis, MPH, of the Centers for Disease Control and Prevention, Atlanta, and colleagues.

To better understand factors contributing to inadequate syphilis treatment during pregnancy, the researchers examined data from 1476 individuals with syphilis during pregnancy. The study population came from six jurisdictions that participated in the Surveillance for Emerging Threats to Pregnant People and Infants Network, and sources included case investigations, medical records, and links between laboratory data and vital records.

The researchers characterized the status of syphilis during pregnancy as adequate, inadequate, or not treated based on the CDC’s Sexually Transmitted Infections Treatment Guidelines, 2021. Prenatal care was defined as timely (at least 30 days prior to pregnancy outcome), nontimely (less than 30 days before pregnancy outcome), and no prenatal care. The findings were published in Obstetrics & Gynecology.

Of the 1476 individuals studied, 855 (57.9%) were adequately treated for syphilis and 621 (42.1%) were inadequately or not treated.

Overall, 82% of the study population received timely prenatal care. However, 32.1% of those who received timely prenatal care were inadequately treated, including 14.8% who received no syphilis treatment. Individuals with nontimely or no prenatal care were significantly more likely to receive inadequate or no treatment for syphilis than those who received timely care (risk ratio, 2.50 and 2.73, respectively).

The findings were consistent with previous studies of missed opportunities for prevention and treatment, the researchers noted. Factors behind nontimely treatment (less than 30 days before pregnancy outcome) may include intermittent shortages of benzathine penicillin G, the standard treatment for syphilis, as well as the lack of time and administrative support for clinicians to communicate with patients and health departments, and to expedite treatment, the researchers wrote.

The results were limited by several factors including the use of data from six US jurisdictions that may not generalize to other areas, the variations in reporting years for the different jurisdictions, and variation in mandates for syphilis screening during pregnancy, the researchers noted.

More research is needed to improve syphilis testing itself, and to develop more treatment options, the researchers concluded. Partnerships among public health, patient advocacy groups, prenatal care clinicians, and other clinicians outside the prenatal care setting also are needed for effective intervention in pregnant individuals with syphilis, they said.

The study was carried out as part of the regular work of the CDC, supported by the Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases Cooperative Agreement and through contractual mechanisms including the Local Health Department Initiative to Chickasaw Health Consulting. The researchers had no financial conflicts to disclose.

Approximately one third of pregnant individuals with syphilis were inadequately treated or not treated for syphilis despite receiving timely prenatal care, based on data from nearly 1500 patients.

Although congenital syphilis is preventable with treatment before or early in pregnancy, data from the Centers for Disease Control and Prevention (CDC) show a doubling of syphilis rates in the United States between 2018 and 2021 wrote Ayzsa Tannis, MPH, of the Centers for Disease Control and Prevention, Atlanta, and colleagues.

To better understand factors contributing to inadequate syphilis treatment during pregnancy, the researchers examined data from 1476 individuals with syphilis during pregnancy. The study population came from six jurisdictions that participated in the Surveillance for Emerging Threats to Pregnant People and Infants Network, and sources included case investigations, medical records, and links between laboratory data and vital records.

The researchers characterized the status of syphilis during pregnancy as adequate, inadequate, or not treated based on the CDC’s Sexually Transmitted Infections Treatment Guidelines, 2021. Prenatal care was defined as timely (at least 30 days prior to pregnancy outcome), nontimely (less than 30 days before pregnancy outcome), and no prenatal care. The findings were published in Obstetrics & Gynecology.

Of the 1476 individuals studied, 855 (57.9%) were adequately treated for syphilis and 621 (42.1%) were inadequately or not treated.

Overall, 82% of the study population received timely prenatal care. However, 32.1% of those who received timely prenatal care were inadequately treated, including 14.8% who received no syphilis treatment. Individuals with nontimely or no prenatal care were significantly more likely to receive inadequate or no treatment for syphilis than those who received timely care (risk ratio, 2.50 and 2.73, respectively).

The findings were consistent with previous studies of missed opportunities for prevention and treatment, the researchers noted. Factors behind nontimely treatment (less than 30 days before pregnancy outcome) may include intermittent shortages of benzathine penicillin G, the standard treatment for syphilis, as well as the lack of time and administrative support for clinicians to communicate with patients and health departments, and to expedite treatment, the researchers wrote.

The results were limited by several factors including the use of data from six US jurisdictions that may not generalize to other areas, the variations in reporting years for the different jurisdictions, and variation in mandates for syphilis screening during pregnancy, the researchers noted.

More research is needed to improve syphilis testing itself, and to develop more treatment options, the researchers concluded. Partnerships among public health, patient advocacy groups, prenatal care clinicians, and other clinicians outside the prenatal care setting also are needed for effective intervention in pregnant individuals with syphilis, they said.

The study was carried out as part of the regular work of the CDC, supported by the Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases Cooperative Agreement and through contractual mechanisms including the Local Health Department Initiative to Chickasaw Health Consulting. The researchers had no financial conflicts to disclose.

Approximately one third of pregnant individuals with syphilis were inadequately treated or not treated for syphilis despite receiving timely prenatal care, based on data from nearly 1500 patients.

Although congenital syphilis is preventable with treatment before or early in pregnancy, data from the Centers for Disease Control and Prevention (CDC) show a doubling of syphilis rates in the United States between 2018 and 2021 wrote Ayzsa Tannis, MPH, of the Centers for Disease Control and Prevention, Atlanta, and colleagues.

To better understand factors contributing to inadequate syphilis treatment during pregnancy, the researchers examined data from 1476 individuals with syphilis during pregnancy. The study population came from six jurisdictions that participated in the Surveillance for Emerging Threats to Pregnant People and Infants Network, and sources included case investigations, medical records, and links between laboratory data and vital records.

The researchers characterized the status of syphilis during pregnancy as adequate, inadequate, or not treated based on the CDC’s Sexually Transmitted Infections Treatment Guidelines, 2021. Prenatal care was defined as timely (at least 30 days prior to pregnancy outcome), nontimely (less than 30 days before pregnancy outcome), and no prenatal care. The findings were published in Obstetrics & Gynecology.

Of the 1476 individuals studied, 855 (57.9%) were adequately treated for syphilis and 621 (42.1%) were inadequately or not treated.

Overall, 82% of the study population received timely prenatal care. However, 32.1% of those who received timely prenatal care were inadequately treated, including 14.8% who received no syphilis treatment. Individuals with nontimely or no prenatal care were significantly more likely to receive inadequate or no treatment for syphilis than those who received timely care (risk ratio, 2.50 and 2.73, respectively).

The findings were consistent with previous studies of missed opportunities for prevention and treatment, the researchers noted. Factors behind nontimely treatment (less than 30 days before pregnancy outcome) may include intermittent shortages of benzathine penicillin G, the standard treatment for syphilis, as well as the lack of time and administrative support for clinicians to communicate with patients and health departments, and to expedite treatment, the researchers wrote.

The results were limited by several factors including the use of data from six US jurisdictions that may not generalize to other areas, the variations in reporting years for the different jurisdictions, and variation in mandates for syphilis screening during pregnancy, the researchers noted.

More research is needed to improve syphilis testing itself, and to develop more treatment options, the researchers concluded. Partnerships among public health, patient advocacy groups, prenatal care clinicians, and other clinicians outside the prenatal care setting also are needed for effective intervention in pregnant individuals with syphilis, they said.

The study was carried out as part of the regular work of the CDC, supported by the Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases Cooperative Agreement and through contractual mechanisms including the Local Health Department Initiative to Chickasaw Health Consulting. The researchers had no financial conflicts to disclose.

BOSTON — The US Food and Drug Administration (FDA) approved 55 new medications in 2023 and 11 more in 2024 to date. During a presentation on April 18 at the annual American College of Physicians Internal Medicine Meeting, Gerald Smetana, MD, professor of medicine in the Division of General Medicine at Beth Israel Deaconess Medical Center in Boston, reviewed four of these new therapies that are likely to be particularly important for primary care clinicians. 

A New First-Line for GERD?

Vonoprazan, an oral potassium-competitive acid blocker — which received FDA approval in November 2023 — may be a good alternative for patients whose symptoms continue to linger despite taking medications designated to treat gastroesophageal reflux disease (GERD). 

GERD is the most common gastrointestinal symptom encountered by primary care physicians. Proton-pump inhibitors (PPIs) are the first-line treatment for the condition but can have long-term side effects such as Clostridioides difficile infection and kidney lesions.

“We know that not all patients are going to have symptom relief with H2 blockers and PPIs, so there’s an opportunity for patients who don’t get full symptom relief,” Dr. Smetana told attendees. 

Vonoprazan blocks potassium binding to ATPase proton pumps and inhibits the secretion of gastric acid.

The approval of vonoprazan for erosive GERD was based on results from the phase 3 PHALCON-EE study, a randomized, double-blind, multicenter study that found the drug to be more effective than lansoprazole in treating erosive esophagitis.

Vonoprazan “has more rapid absorption than PPIs [and a] longer half-life and is more potent than PPIs, so theoretically it could be more effective in certain settings,” Dr. Smetana said.

Vonoprazan is FDA approved for only 6 months of use. Despite its efficacy, cost may be a barrier to many patients. H2 blockers generally cost patients less than $10 for 1 month’s supply, whereas vonoprazan can cost up to $650.
 

Nonhormonal Drug for Menopause

Fezolinetant, the first neurokinin receptor antagonist to receive approval from the FDA to treat vasomotor symptoms, may be an option for women concerned about hormone-based therapy for menopausal hot flashes.

“[Fezolinetant] specifically works in the area of the brain that’s involved in body temperature regulation and sweating,” Dr. Smetana said.

Results from the SKYLIGHT 1 randomized controlled trial of fezolinetant found the medication reduced the frequency and severity of hot flashes. Some of the side effects include abdominal pain, diarrhea, and insomnia. 

Other nonestrogen treatments, including selective serotonin reuptake inhibitors (SSRIs), gabapentin, cognitive-behavioral therapy, and hypnosis, are modestly effective, according to the North American Menopause Society.

“[Fezolinetant] offers a different option that physicians may be more comfortable prescribing,” Dr. Smetana said. “And I think this will be an important addition to nonhormonal therapy.”
 

RSV Vaccine for Everyone 

Once considered an illness that is more prevalent in young children, respiratory syncytial virus (RSV) has become more prevalent and severe among older adults. Between 60,000 and 120,000 older adults are hospitalized and 6000-10,000 die of RSV infection each year, according to the US Centers for Disease Control and Prevention. 

The FDA has approved two RSV vaccines approved for older adults, but clinicians may find it challenging to get older patients vaccinated for this and other preventable illnesses.

Patients who received the RSV vaccine had an 83% relative risk reduction for the illness, according to a recent study, and an overall lower risk for hospitalization.

Moderna is developing an mRNA vaccine for RSV that is similar to many COVID-19 vaccines. A study published in 2023 in The New England Journal of Medicine found no cases of neuroinflammatory disorders among patients who received the mRNA RSV vaccine, with a median follow-up of 112 days.

“This is important given ongoing concerns of neurological safety,” among older adults who receive the RSV vaccine, Dr. Smetana said.

As of March 2024, the CDC recommends shared decision-making for adults older than 60 years and for healthcare providers to “consider” rather than “recommend” the vaccine for their patients. The agency’s Adult RSV Work Group plans to meet at June 2024 to reconsider whether shared clinical decision-making remains the preferred policy option.
 

New Antidepressants

A medication thrice rejected by the FDA is now heading a new class of drugs to treat major depressive disorder.

Gepirone, a 5-HT1A receptor agonist, has a different mechanism of action from that of SSRIs, which are currently considered the first-line treatment for depression. 

Gepirone was rejected by the FDA in 2002, 2004, and 2007, with concerns that the efficacy studies were too small. In 2015, an FDA advisory committee agreed that the evidence to date did not support approval of an extended-release form of the drug. But the agency decided to approve the medication in September 2023.

“So why is this medication worth discussing now?” Dr. Smetana said. “It’s because the side effect profile is different from existing antidepressants.” 

Many patients may stop using SSRIs because of side effects such as insomnia and loss of libido, Dr. Smetana said. Gepirone has the potential to avoid activation of other 5-HT receptors that mediate side effects, he said. 

Studies suggest that gepirone reduces both anxiety and depression scores on the Hamilton Depression Rating Scale in patients who have both conditions and decreases rates of depression relapse compared with placebo through at least 48 weeks. The drug also may be less likely than SSRIs to cause sexual dysfunction in men, Dr. Smetana said. 

Gepirone will be available to prescribe to patients in fall 2024.

Dr. Smetana reported no relevant financial conflicts of interest. 
 

A version of this article appeared on Medscape.com.

BOSTON — The US Food and Drug Administration (FDA) approved 55 new medications in 2023 and 11 more in 2024 to date. During a presentation on April 18 at the annual American College of Physicians Internal Medicine Meeting, Gerald Smetana, MD, professor of medicine in the Division of General Medicine at Beth Israel Deaconess Medical Center in Boston, reviewed four of these new therapies that are likely to be particularly important for primary care clinicians. 

A New First-Line for GERD?

Vonoprazan, an oral potassium-competitive acid blocker — which received FDA approval in November 2023 — may be a good alternative for patients whose symptoms continue to linger despite taking medications designated to treat gastroesophageal reflux disease (GERD). 

GERD is the most common gastrointestinal symptom encountered by primary care physicians. Proton-pump inhibitors (PPIs) are the first-line treatment for the condition but can have long-term side effects such as Clostridioides difficile infection and kidney lesions.

“We know that not all patients are going to have symptom relief with H2 blockers and PPIs, so there’s an opportunity for patients who don’t get full symptom relief,” Dr. Smetana told attendees. 

Vonoprazan blocks potassium binding to ATPase proton pumps and inhibits the secretion of gastric acid.

The approval of vonoprazan for erosive GERD was based on results from the phase 3 PHALCON-EE study, a randomized, double-blind, multicenter study that found the drug to be more effective than lansoprazole in treating erosive esophagitis.

Vonoprazan “has more rapid absorption than PPIs [and a] longer half-life and is more potent than PPIs, so theoretically it could be more effective in certain settings,” Dr. Smetana said.

Vonoprazan is FDA approved for only 6 months of use. Despite its efficacy, cost may be a barrier to many patients. H2 blockers generally cost patients less than $10 for 1 month’s supply, whereas vonoprazan can cost up to $650.
 

Nonhormonal Drug for Menopause

Fezolinetant, the first neurokinin receptor antagonist to receive approval from the FDA to treat vasomotor symptoms, may be an option for women concerned about hormone-based therapy for menopausal hot flashes.

“[Fezolinetant] specifically works in the area of the brain that’s involved in body temperature regulation and sweating,” Dr. Smetana said.

Results from the SKYLIGHT 1 randomized controlled trial of fezolinetant found the medication reduced the frequency and severity of hot flashes. Some of the side effects include abdominal pain, diarrhea, and insomnia. 

Other nonestrogen treatments, including selective serotonin reuptake inhibitors (SSRIs), gabapentin, cognitive-behavioral therapy, and hypnosis, are modestly effective, according to the North American Menopause Society.

“[Fezolinetant] offers a different option that physicians may be more comfortable prescribing,” Dr. Smetana said. “And I think this will be an important addition to nonhormonal therapy.”
 

RSV Vaccine for Everyone 

Once considered an illness that is more prevalent in young children, respiratory syncytial virus (RSV) has become more prevalent and severe among older adults. Between 60,000 and 120,000 older adults are hospitalized and 6000-10,000 die of RSV infection each year, according to the US Centers for Disease Control and Prevention. 

The FDA has approved two RSV vaccines approved for older adults, but clinicians may find it challenging to get older patients vaccinated for this and other preventable illnesses.

Patients who received the RSV vaccine had an 83% relative risk reduction for the illness, according to a recent study, and an overall lower risk for hospitalization.

Moderna is developing an mRNA vaccine for RSV that is similar to many COVID-19 vaccines. A study published in 2023 in The New England Journal of Medicine found no cases of neuroinflammatory disorders among patients who received the mRNA RSV vaccine, with a median follow-up of 112 days.

“This is important given ongoing concerns of neurological safety,” among older adults who receive the RSV vaccine, Dr. Smetana said.

As of March 2024, the CDC recommends shared decision-making for adults older than 60 years and for healthcare providers to “consider” rather than “recommend” the vaccine for their patients. The agency’s Adult RSV Work Group plans to meet at June 2024 to reconsider whether shared clinical decision-making remains the preferred policy option.
 

New Antidepressants

A medication thrice rejected by the FDA is now heading a new class of drugs to treat major depressive disorder.

Gepirone, a 5-HT1A receptor agonist, has a different mechanism of action from that of SSRIs, which are currently considered the first-line treatment for depression. 

Gepirone was rejected by the FDA in 2002, 2004, and 2007, with concerns that the efficacy studies were too small. In 2015, an FDA advisory committee agreed that the evidence to date did not support approval of an extended-release form of the drug. But the agency decided to approve the medication in September 2023.

“So why is this medication worth discussing now?” Dr. Smetana said. “It’s because the side effect profile is different from existing antidepressants.” 

Many patients may stop using SSRIs because of side effects such as insomnia and loss of libido, Dr. Smetana said. Gepirone has the potential to avoid activation of other 5-HT receptors that mediate side effects, he said. 

Studies suggest that gepirone reduces both anxiety and depression scores on the Hamilton Depression Rating Scale in patients who have both conditions and decreases rates of depression relapse compared with placebo through at least 48 weeks. The drug also may be less likely than SSRIs to cause sexual dysfunction in men, Dr. Smetana said. 

Gepirone will be available to prescribe to patients in fall 2024.

Dr. Smetana reported no relevant financial conflicts of interest. 
 

A version of this article appeared on Medscape.com.

BOSTON — The US Food and Drug Administration (FDA) approved 55 new medications in 2023 and 11 more in 2024 to date. During a presentation on April 18 at the annual American College of Physicians Internal Medicine Meeting, Gerald Smetana, MD, professor of medicine in the Division of General Medicine at Beth Israel Deaconess Medical Center in Boston, reviewed four of these new therapies that are likely to be particularly important for primary care clinicians. 

A New First-Line for GERD?

Vonoprazan, an oral potassium-competitive acid blocker — which received FDA approval in November 2023 — may be a good alternative for patients whose symptoms continue to linger despite taking medications designated to treat gastroesophageal reflux disease (GERD). 

GERD is the most common gastrointestinal symptom encountered by primary care physicians. Proton-pump inhibitors (PPIs) are the first-line treatment for the condition but can have long-term side effects such as Clostridioides difficile infection and kidney lesions.

“We know that not all patients are going to have symptom relief with H2 blockers and PPIs, so there’s an opportunity for patients who don’t get full symptom relief,” Dr. Smetana told attendees. 

Vonoprazan blocks potassium binding to ATPase proton pumps and inhibits the secretion of gastric acid.

The approval of vonoprazan for erosive GERD was based on results from the phase 3 PHALCON-EE study, a randomized, double-blind, multicenter study that found the drug to be more effective than lansoprazole in treating erosive esophagitis.

Vonoprazan “has more rapid absorption than PPIs [and a] longer half-life and is more potent than PPIs, so theoretically it could be more effective in certain settings,” Dr. Smetana said.

Vonoprazan is FDA approved for only 6 months of use. Despite its efficacy, cost may be a barrier to many patients. H2 blockers generally cost patients less than $10 for 1 month’s supply, whereas vonoprazan can cost up to $650.
 

Nonhormonal Drug for Menopause

Fezolinetant, the first neurokinin receptor antagonist to receive approval from the FDA to treat vasomotor symptoms, may be an option for women concerned about hormone-based therapy for menopausal hot flashes.

“[Fezolinetant] specifically works in the area of the brain that’s involved in body temperature regulation and sweating,” Dr. Smetana said.

Results from the SKYLIGHT 1 randomized controlled trial of fezolinetant found the medication reduced the frequency and severity of hot flashes. Some of the side effects include abdominal pain, diarrhea, and insomnia. 

Other nonestrogen treatments, including selective serotonin reuptake inhibitors (SSRIs), gabapentin, cognitive-behavioral therapy, and hypnosis, are modestly effective, according to the North American Menopause Society.

“[Fezolinetant] offers a different option that physicians may be more comfortable prescribing,” Dr. Smetana said. “And I think this will be an important addition to nonhormonal therapy.”
 

RSV Vaccine for Everyone 

Once considered an illness that is more prevalent in young children, respiratory syncytial virus (RSV) has become more prevalent and severe among older adults. Between 60,000 and 120,000 older adults are hospitalized and 6000-10,000 die of RSV infection each year, according to the US Centers for Disease Control and Prevention. 

The FDA has approved two RSV vaccines approved for older adults, but clinicians may find it challenging to get older patients vaccinated for this and other preventable illnesses.

Patients who received the RSV vaccine had an 83% relative risk reduction for the illness, according to a recent study, and an overall lower risk for hospitalization.

Moderna is developing an mRNA vaccine for RSV that is similar to many COVID-19 vaccines. A study published in 2023 in The New England Journal of Medicine found no cases of neuroinflammatory disorders among patients who received the mRNA RSV vaccine, with a median follow-up of 112 days.

“This is important given ongoing concerns of neurological safety,” among older adults who receive the RSV vaccine, Dr. Smetana said.

As of March 2024, the CDC recommends shared decision-making for adults older than 60 years and for healthcare providers to “consider” rather than “recommend” the vaccine for their patients. The agency’s Adult RSV Work Group plans to meet at June 2024 to reconsider whether shared clinical decision-making remains the preferred policy option.
 

New Antidepressants

A medication thrice rejected by the FDA is now heading a new class of drugs to treat major depressive disorder.

Gepirone, a 5-HT1A receptor agonist, has a different mechanism of action from that of SSRIs, which are currently considered the first-line treatment for depression. 

Gepirone was rejected by the FDA in 2002, 2004, and 2007, with concerns that the efficacy studies were too small. In 2015, an FDA advisory committee agreed that the evidence to date did not support approval of an extended-release form of the drug. But the agency decided to approve the medication in September 2023.

“So why is this medication worth discussing now?” Dr. Smetana said. “It’s because the side effect profile is different from existing antidepressants.” 

Many patients may stop using SSRIs because of side effects such as insomnia and loss of libido, Dr. Smetana said. Gepirone has the potential to avoid activation of other 5-HT receptors that mediate side effects, he said. 

Studies suggest that gepirone reduces both anxiety and depression scores on the Hamilton Depression Rating Scale in patients who have both conditions and decreases rates of depression relapse compared with placebo through at least 48 weeks. The drug also may be less likely than SSRIs to cause sexual dysfunction in men, Dr. Smetana said. 

Gepirone will be available to prescribe to patients in fall 2024.

Dr. Smetana reported no relevant financial conflicts of interest. 
 

A version of this article appeared on Medscape.com.

Pregnant physicians may receive more workplace accommodations and protection against discrimination thanks to an updated rule from the US Equal Employment Opportunity Commission (EEOC). The guidelines could prevent women from losing critical career momentum. 

The Pregnant Workers Fairness Act (PWFA) aims to help workers balance professional demands with healthy pregnancies. It requires employers to provide reasonable accommodations for a “worker’s known limitations,” including physical or mental conditions associated with “pregnancy, childbirth, or related medical conditions.”

Reasonable accommodations vary but may involve time off to attend healthcare appointments or recover from childbirth, extra breaks during a shift, shorter work hours, or the ability to sit instead of stand. Private and public sector employers, including state and local governments, federal agencies, and employment agencies, must abide by the new guidelines unless they can provide evidence that doing so will cause undue hardship. 

Female doctors have historically encountered significant barriers to family planning. Years of training cause them to delay having children, often leading to higher rates of infertility, miscarriage, and pregnancy complications than in the general population. 

Some specialties, like surgeons, are particularly at risk, with 42% reporting at least one pregnancy loss. Most surgeons work their regular schedules until delivery despite desiring workload reductions, commonly citing unsupportive workplaces as a reason for not seeking accommodations. 

Trauma surgeon Qaali Hussein, MD, became pregnant with her first child during her intern year in 2008. She told this news organization that her residency program didn’t even have a maternity policy at the time, and her male supervisor was certain that motherhood would end her surgical career. 

She shared how “women usually waited until the end of their training to get pregnant. No one had ever gotten pregnant during the program and returned from maternity leave. I was the first to do so, so there wasn’t a policy or any program support to say, ‘What can we do to help?’ ”

Dr. Hussein used her vacation and sick time, returning to work 4 weeks after delivery. She had five more children, including twins her chief year and another baby during fellowship training in 2014. 

Each subsequent pregnancy was met with the same response from program leadership, she recalled. “They’d say, ‘This is it. You may have been able to do the first and second child, but this one will be impossible.’ ”

After the PWFA regulations first became enforceable in June, the EEOC accepted public feedback. The guidelines received nearly 100,000 comments, spurred mainly by the inclusion of abortion care as a qualifying condition for which an employee could receive accommodations. About 54,000 comments called for abortion to be excluded from the final rule, and 40,000 supported keeping the clause. 

The EEOC issued the final rule on April 15. It includes abortion care. However, the updated rule “does not require any employee to have — or not to have — an abortion, does not require taxpayers to pay for any abortions, and does not compel health care providers to provide any abortions,” the unpublished version of the final rule said. It is scheduled to take effect 60 days after its publication in the Federal Register on April 19.
 

Increasing Support for Doctor-Moms

The PWFA supplements other EEOC protections, such as pregnancy discrimination under Title VII of the Civil Rights Act of 1964 and access to reasonable accommodations under the Americans with Disabilities Act. In addition, it builds upon Department of Labor regulations, like the PUMP Act for breastfeeding employees and the Family and Medical Leave Act, which provides 12 weeks of unpaid, job-protected leave for the arrival of a child or certain medical conditions.

FMLA applies only to employees who have worked full-time for at least 12 months for an employer with 50 or more employees. Meanwhile, the unpaid, job-protected leave under the PWFA has no waiting period, lowers the required number of employees to 15, and permits accommodations for up to 40 weeks. 

Employers are encouraged to honor “common and simple” requests, like using a closer parking space or pumping or nursing at work, without requiring a doctor’s note, the rule said. 

Efforts to improve family leave policies for physicians and residents have been gaining traction. In 2021, the American Board of Medical Specialties began requiring its member boards with training programs lasting 2 or more years to allow at least 6 weeks off for parental, caregiver, and medical leave. This time can be taken without exhausting vacation or sick leave or requiring an extension in training. Over half of the 24 member boards permit leave beyond 6 weeks, including the American Boards of Allergy and Immunology, Emergency Medicine, Family Medicine, Radiology, and Surgery. 

Estefania Oliveros, MD, MSc, cardiologist and assistant professor at the Lewis Katz School of Medicine at Temple University, Philadelphia, told this news organization that the Accreditation Council for Graduate Medical Education also requires that residents and fellows receive 6 weeks of paid leave. 

“We add to that vacation time, so it gives them at least 8 weeks,” she said. The school has created spaces for nursing mothers — something neither she nor Dr. Hussein had access to when breastfeeding — and encourages the attendings to be proactive in excusing pregnant fellows for appointments. 

This differs significantly from her fellowship training experience 6 years ago at another institution, where she worked without accommodations until the day before her cesarean delivery. Dr. Oliveros had to use all her vacation time for recovery, returning to the program after 4 weeks instead of the recommended 6. 

“And that’s the story you hear all the time. Not because people are ill-intended; I just don’t think the system is designed to accommodate women, so we lose a lot of talent that way,” said Dr. Oliveros, whose 2019 survey in the Journal of the American College of Cardiology called for more support and protections for pregnant doctors. 

Both doctors believe the PWFA will be beneficial but only if leadership in the field takes up the cause. 

“The cultures of these institutions determine whether women feel safe or even confident enough to have children in medical school or residency,” said Dr. Hussein. 
 

A version of this article appeared on Medscape.com.

Pregnant physicians may receive more workplace accommodations and protection against discrimination thanks to an updated rule from the US Equal Employment Opportunity Commission (EEOC). The guidelines could prevent women from losing critical career momentum. 

The Pregnant Workers Fairness Act (PWFA) aims to help workers balance professional demands with healthy pregnancies. It requires employers to provide reasonable accommodations for a “worker’s known limitations,” including physical or mental conditions associated with “pregnancy, childbirth, or related medical conditions.”

Reasonable accommodations vary but may involve time off to attend healthcare appointments or recover from childbirth, extra breaks during a shift, shorter work hours, or the ability to sit instead of stand. Private and public sector employers, including state and local governments, federal agencies, and employment agencies, must abide by the new guidelines unless they can provide evidence that doing so will cause undue hardship. 

Female doctors have historically encountered significant barriers to family planning. Years of training cause them to delay having children, often leading to higher rates of infertility, miscarriage, and pregnancy complications than in the general population. 

Some specialties, like surgeons, are particularly at risk, with 42% reporting at least one pregnancy loss. Most surgeons work their regular schedules until delivery despite desiring workload reductions, commonly citing unsupportive workplaces as a reason for not seeking accommodations. 

Trauma surgeon Qaali Hussein, MD, became pregnant with her first child during her intern year in 2008. She told this news organization that her residency program didn’t even have a maternity policy at the time, and her male supervisor was certain that motherhood would end her surgical career. 

She shared how “women usually waited until the end of their training to get pregnant. No one had ever gotten pregnant during the program and returned from maternity leave. I was the first to do so, so there wasn’t a policy or any program support to say, ‘What can we do to help?’ ”

Dr. Hussein used her vacation and sick time, returning to work 4 weeks after delivery. She had five more children, including twins her chief year and another baby during fellowship training in 2014. 

Each subsequent pregnancy was met with the same response from program leadership, she recalled. “They’d say, ‘This is it. You may have been able to do the first and second child, but this one will be impossible.’ ”

After the PWFA regulations first became enforceable in June, the EEOC accepted public feedback. The guidelines received nearly 100,000 comments, spurred mainly by the inclusion of abortion care as a qualifying condition for which an employee could receive accommodations. About 54,000 comments called for abortion to be excluded from the final rule, and 40,000 supported keeping the clause. 

The EEOC issued the final rule on April 15. It includes abortion care. However, the updated rule “does not require any employee to have — or not to have — an abortion, does not require taxpayers to pay for any abortions, and does not compel health care providers to provide any abortions,” the unpublished version of the final rule said. It is scheduled to take effect 60 days after its publication in the Federal Register on April 19.
 

Increasing Support for Doctor-Moms

The PWFA supplements other EEOC protections, such as pregnancy discrimination under Title VII of the Civil Rights Act of 1964 and access to reasonable accommodations under the Americans with Disabilities Act. In addition, it builds upon Department of Labor regulations, like the PUMP Act for breastfeeding employees and the Family and Medical Leave Act, which provides 12 weeks of unpaid, job-protected leave for the arrival of a child or certain medical conditions.

FMLA applies only to employees who have worked full-time for at least 12 months for an employer with 50 or more employees. Meanwhile, the unpaid, job-protected leave under the PWFA has no waiting period, lowers the required number of employees to 15, and permits accommodations for up to 40 weeks. 

Employers are encouraged to honor “common and simple” requests, like using a closer parking space or pumping or nursing at work, without requiring a doctor’s note, the rule said. 

Efforts to improve family leave policies for physicians and residents have been gaining traction. In 2021, the American Board of Medical Specialties began requiring its member boards with training programs lasting 2 or more years to allow at least 6 weeks off for parental, caregiver, and medical leave. This time can be taken without exhausting vacation or sick leave or requiring an extension in training. Over half of the 24 member boards permit leave beyond 6 weeks, including the American Boards of Allergy and Immunology, Emergency Medicine, Family Medicine, Radiology, and Surgery. 

Estefania Oliveros, MD, MSc, cardiologist and assistant professor at the Lewis Katz School of Medicine at Temple University, Philadelphia, told this news organization that the Accreditation Council for Graduate Medical Education also requires that residents and fellows receive 6 weeks of paid leave. 

“We add to that vacation time, so it gives them at least 8 weeks,” she said. The school has created spaces for nursing mothers — something neither she nor Dr. Hussein had access to when breastfeeding — and encourages the attendings to be proactive in excusing pregnant fellows for appointments. 

This differs significantly from her fellowship training experience 6 years ago at another institution, where she worked without accommodations until the day before her cesarean delivery. Dr. Oliveros had to use all her vacation time for recovery, returning to the program after 4 weeks instead of the recommended 6. 

“And that’s the story you hear all the time. Not because people are ill-intended; I just don’t think the system is designed to accommodate women, so we lose a lot of talent that way,” said Dr. Oliveros, whose 2019 survey in the Journal of the American College of Cardiology called for more support and protections for pregnant doctors. 

Both doctors believe the PWFA will be beneficial but only if leadership in the field takes up the cause. 

“The cultures of these institutions determine whether women feel safe or even confident enough to have children in medical school or residency,” said Dr. Hussein. 
 

A version of this article appeared on Medscape.com.

Pregnant physicians may receive more workplace accommodations and protection against discrimination thanks to an updated rule from the US Equal Employment Opportunity Commission (EEOC). The guidelines could prevent women from losing critical career momentum. 

The Pregnant Workers Fairness Act (PWFA) aims to help workers balance professional demands with healthy pregnancies. It requires employers to provide reasonable accommodations for a “worker’s known limitations,” including physical or mental conditions associated with “pregnancy, childbirth, or related medical conditions.”

Reasonable accommodations vary but may involve time off to attend healthcare appointments or recover from childbirth, extra breaks during a shift, shorter work hours, or the ability to sit instead of stand. Private and public sector employers, including state and local governments, federal agencies, and employment agencies, must abide by the new guidelines unless they can provide evidence that doing so will cause undue hardship. 

Female doctors have historically encountered significant barriers to family planning. Years of training cause them to delay having children, often leading to higher rates of infertility, miscarriage, and pregnancy complications than in the general population. 

Some specialties, like surgeons, are particularly at risk, with 42% reporting at least one pregnancy loss. Most surgeons work their regular schedules until delivery despite desiring workload reductions, commonly citing unsupportive workplaces as a reason for not seeking accommodations. 

Trauma surgeon Qaali Hussein, MD, became pregnant with her first child during her intern year in 2008. She told this news organization that her residency program didn’t even have a maternity policy at the time, and her male supervisor was certain that motherhood would end her surgical career. 

She shared how “women usually waited until the end of their training to get pregnant. No one had ever gotten pregnant during the program and returned from maternity leave. I was the first to do so, so there wasn’t a policy or any program support to say, ‘What can we do to help?’ ”

Dr. Hussein used her vacation and sick time, returning to work 4 weeks after delivery. She had five more children, including twins her chief year and another baby during fellowship training in 2014. 

Each subsequent pregnancy was met with the same response from program leadership, she recalled. “They’d say, ‘This is it. You may have been able to do the first and second child, but this one will be impossible.’ ”

After the PWFA regulations first became enforceable in June, the EEOC accepted public feedback. The guidelines received nearly 100,000 comments, spurred mainly by the inclusion of abortion care as a qualifying condition for which an employee could receive accommodations. About 54,000 comments called for abortion to be excluded from the final rule, and 40,000 supported keeping the clause. 

The EEOC issued the final rule on April 15. It includes abortion care. However, the updated rule “does not require any employee to have — or not to have — an abortion, does not require taxpayers to pay for any abortions, and does not compel health care providers to provide any abortions,” the unpublished version of the final rule said. It is scheduled to take effect 60 days after its publication in the Federal Register on April 19.
 

Increasing Support for Doctor-Moms

The PWFA supplements other EEOC protections, such as pregnancy discrimination under Title VII of the Civil Rights Act of 1964 and access to reasonable accommodations under the Americans with Disabilities Act. In addition, it builds upon Department of Labor regulations, like the PUMP Act for breastfeeding employees and the Family and Medical Leave Act, which provides 12 weeks of unpaid, job-protected leave for the arrival of a child or certain medical conditions.

FMLA applies only to employees who have worked full-time for at least 12 months for an employer with 50 or more employees. Meanwhile, the unpaid, job-protected leave under the PWFA has no waiting period, lowers the required number of employees to 15, and permits accommodations for up to 40 weeks. 

Employers are encouraged to honor “common and simple” requests, like using a closer parking space or pumping or nursing at work, without requiring a doctor’s note, the rule said. 

Efforts to improve family leave policies for physicians and residents have been gaining traction. In 2021, the American Board of Medical Specialties began requiring its member boards with training programs lasting 2 or more years to allow at least 6 weeks off for parental, caregiver, and medical leave. This time can be taken without exhausting vacation or sick leave or requiring an extension in training. Over half of the 24 member boards permit leave beyond 6 weeks, including the American Boards of Allergy and Immunology, Emergency Medicine, Family Medicine, Radiology, and Surgery. 

Estefania Oliveros, MD, MSc, cardiologist and assistant professor at the Lewis Katz School of Medicine at Temple University, Philadelphia, told this news organization that the Accreditation Council for Graduate Medical Education also requires that residents and fellows receive 6 weeks of paid leave. 

“We add to that vacation time, so it gives them at least 8 weeks,” she said. The school has created spaces for nursing mothers — something neither she nor Dr. Hussein had access to when breastfeeding — and encourages the attendings to be proactive in excusing pregnant fellows for appointments. 

This differs significantly from her fellowship training experience 6 years ago at another institution, where she worked without accommodations until the day before her cesarean delivery. Dr. Oliveros had to use all her vacation time for recovery, returning to the program after 4 weeks instead of the recommended 6. 

“And that’s the story you hear all the time. Not because people are ill-intended; I just don’t think the system is designed to accommodate women, so we lose a lot of talent that way,” said Dr. Oliveros, whose 2019 survey in the Journal of the American College of Cardiology called for more support and protections for pregnant doctors. 

Both doctors believe the PWFA will be beneficial but only if leadership in the field takes up the cause. 

“The cultures of these institutions determine whether women feel safe or even confident enough to have children in medical school or residency,” said Dr. Hussein. 
 

A version of this article appeared on Medscape.com.

How long should a woman wait before becoming pregnant again? According to the World Health Organization (WHO), it is advisable to wait at least 24 months between childbirth and a new pregnancy. But a study published in February of this year in The Lancet Regional Health — Americas, using data from more than 4.7 million live births in Brazil, suggests that this recommendation should be individualized, considering factors such as maternal obstetric history.

Researchers from the Federal University of Grande Dourados (UFGD), Oswaldo Cruz Foundation, São José do Rio Preto Medical School, Federal University of Bahia, and the London School of Hygiene and Tropical Medicine in the United Kingdom, used a birth cohort from the Center for Data Integration and Knowledge for Health, which combines data from the Ministry of Health’s Information System on Live Births (SINASC) and from a cohort of 100 million Brazilians. 

In total, the analysis included information on 3,804,152 women and 4,788,279 births. All participants had at least two consecutive live births.

Most interpregnancy intervals, ie, the difference between the previous childbirth and the subsequent conception, ranged from 23 to 58 months (39.1%). Extreme intervals of < 6 months and > 120 months occurred in 5.6% and 1.6% of cases, respectively.

Regarding adverse outcomes, the research indicated that, in the general population, small-for-gestational-age (SGA) babies were observed in 8.4% of subsequent births, while low birth weight (LBW) occurred in 5.9% and preterm birth in 7.5%.
 

Interpregnancy Interval and SGA Risk

The authors noted that the risk for subsequent adverse outcomes increased with extreme interpregnancy intervals, with SGA being the only exception. In this case, women who had an interval between the previous childbirth and the subsequent conception > 120 months had a lower risk for SGA.

According to João Guilherme Tedde, a medical student at UFGD and the first author of the study, similar patterns (extremely long interpregnancy intervals associated with a lower risk for subsequent SGA) have been described in the literature. In an interview with this news organization, he explained some hypotheses that could explain this phenomenon.

According to the researcher, the finding may reflect the distinct risk profile of mothers who wait a very long time to conceive again. “This group, composed of older women, likely has a higher prevalence of health problems, such as diabetes and obesity, which are known risk factors for having large-for-gestational-age (LGA) babies,” he said. He also highlighted the fact that the study showed that the risk for LGA also increased as the interval between pregnancies grew.

Another hypothesis suggested by the author is the possible occurrence of events between pregnancies, such as miscarriages or stillbirths. According to him, women who have experienced these events between two consecutive pregnancies may have falsely increased interpregnancy intervals, since miscarriages and stillbirths (which are considered conceptions) are not counted in SINASC.

“Thus, the lower occurrence of SGA in the group with very long intervals may reflect a competition of events between stillbirths or miscarriages and live SGAs,” he said.
 

Previous and Subsequent Adverse Events

The research also showed that the risks for subsequent SGA, LBW, and preterm birth were higher among women with a history of adverse events in previous pregnancies.

Furthermore, the authors noted that the previous occurrence of adverse outcomes seems to “have a more significant impact on the outcome of the current pregnancy than the interpregnancy interval.” 

“We found that, for women with the same interpregnancy interval (say < 6 months), but with different obstetric history (zero previous events vs one event), the absolute risk for subsequent adverse outcomes increased much more than when we change only the duration of the interval in a group with the same number of previous adverse events,” said Dr. Tedde.

There is still no convincing explanation for this fact, he said, since the cause-and-effect relationship between interpregnancy intervals and perinatal events is not clear. But the obstetrics literature generally shows that among the main risk factors for an adverse event is the previous occurrence of the same event. This effect could be related to living conditions and maternal habits, genetics, epigenetics, among others.

The researcher observed that this study is one of the largest in terms of sampling to investigate how maternal obstetric history can modulate the effect of interpregnancy interval on the risk for adverse outcomes in subsequent pregnancies.

The findings of the research published this year reinforce the importance of individualizing recommendations regarding interpregnancy intervals, considering factors such as maternal obstetric history. However, the author warns that it is still too early to point out the “best” interval for each situation.

“We need more studies that reproduce our findings and that expand the analyzed outcomes to also include those of interest to the mother, such as maternal mortality,” he concluded.

This story was translated from the Medscape Portuguese edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

How long should a woman wait before becoming pregnant again? According to the World Health Organization (WHO), it is advisable to wait at least 24 months between childbirth and a new pregnancy. But a study published in February of this year in The Lancet Regional Health — Americas, using data from more than 4.7 million live births in Brazil, suggests that this recommendation should be individualized, considering factors such as maternal obstetric history.

Researchers from the Federal University of Grande Dourados (UFGD), Oswaldo Cruz Foundation, São José do Rio Preto Medical School, Federal University of Bahia, and the London School of Hygiene and Tropical Medicine in the United Kingdom, used a birth cohort from the Center for Data Integration and Knowledge for Health, which combines data from the Ministry of Health’s Information System on Live Births (SINASC) and from a cohort of 100 million Brazilians. 

In total, the analysis included information on 3,804,152 women and 4,788,279 births. All participants had at least two consecutive live births.

Most interpregnancy intervals, ie, the difference between the previous childbirth and the subsequent conception, ranged from 23 to 58 months (39.1%). Extreme intervals of < 6 months and > 120 months occurred in 5.6% and 1.6% of cases, respectively.

Regarding adverse outcomes, the research indicated that, in the general population, small-for-gestational-age (SGA) babies were observed in 8.4% of subsequent births, while low birth weight (LBW) occurred in 5.9% and preterm birth in 7.5%.
 

Interpregnancy Interval and SGA Risk

The authors noted that the risk for subsequent adverse outcomes increased with extreme interpregnancy intervals, with SGA being the only exception. In this case, women who had an interval between the previous childbirth and the subsequent conception > 120 months had a lower risk for SGA.

According to João Guilherme Tedde, a medical student at UFGD and the first author of the study, similar patterns (extremely long interpregnancy intervals associated with a lower risk for subsequent SGA) have been described in the literature. In an interview with this news organization, he explained some hypotheses that could explain this phenomenon.

According to the researcher, the finding may reflect the distinct risk profile of mothers who wait a very long time to conceive again. “This group, composed of older women, likely has a higher prevalence of health problems, such as diabetes and obesity, which are known risk factors for having large-for-gestational-age (LGA) babies,” he said. He also highlighted the fact that the study showed that the risk for LGA also increased as the interval between pregnancies grew.

Another hypothesis suggested by the author is the possible occurrence of events between pregnancies, such as miscarriages or stillbirths. According to him, women who have experienced these events between two consecutive pregnancies may have falsely increased interpregnancy intervals, since miscarriages and stillbirths (which are considered conceptions) are not counted in SINASC.

“Thus, the lower occurrence of SGA in the group with very long intervals may reflect a competition of events between stillbirths or miscarriages and live SGAs,” he said.
 

Previous and Subsequent Adverse Events

The research also showed that the risks for subsequent SGA, LBW, and preterm birth were higher among women with a history of adverse events in previous pregnancies.

Furthermore, the authors noted that the previous occurrence of adverse outcomes seems to “have a more significant impact on the outcome of the current pregnancy than the interpregnancy interval.” 

“We found that, for women with the same interpregnancy interval (say < 6 months), but with different obstetric history (zero previous events vs one event), the absolute risk for subsequent adverse outcomes increased much more than when we change only the duration of the interval in a group with the same number of previous adverse events,” said Dr. Tedde.

There is still no convincing explanation for this fact, he said, since the cause-and-effect relationship between interpregnancy intervals and perinatal events is not clear. But the obstetrics literature generally shows that among the main risk factors for an adverse event is the previous occurrence of the same event. This effect could be related to living conditions and maternal habits, genetics, epigenetics, among others.

The researcher observed that this study is one of the largest in terms of sampling to investigate how maternal obstetric history can modulate the effect of interpregnancy interval on the risk for adverse outcomes in subsequent pregnancies.

The findings of the research published this year reinforce the importance of individualizing recommendations regarding interpregnancy intervals, considering factors such as maternal obstetric history. However, the author warns that it is still too early to point out the “best” interval for each situation.

“We need more studies that reproduce our findings and that expand the analyzed outcomes to also include those of interest to the mother, such as maternal mortality,” he concluded.

This story was translated from the Medscape Portuguese edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

How long should a woman wait before becoming pregnant again? According to the World Health Organization (WHO), it is advisable to wait at least 24 months between childbirth and a new pregnancy. But a study published in February of this year in The Lancet Regional Health — Americas, using data from more than 4.7 million live births in Brazil, suggests that this recommendation should be individualized, considering factors such as maternal obstetric history.

Researchers from the Federal University of Grande Dourados (UFGD), Oswaldo Cruz Foundation, São José do Rio Preto Medical School, Federal University of Bahia, and the London School of Hygiene and Tropical Medicine in the United Kingdom, used a birth cohort from the Center for Data Integration and Knowledge for Health, which combines data from the Ministry of Health’s Information System on Live Births (SINASC) and from a cohort of 100 million Brazilians. 

In total, the analysis included information on 3,804,152 women and 4,788,279 births. All participants had at least two consecutive live births.

Most interpregnancy intervals, ie, the difference between the previous childbirth and the subsequent conception, ranged from 23 to 58 months (39.1%). Extreme intervals of < 6 months and > 120 months occurred in 5.6% and 1.6% of cases, respectively.

Regarding adverse outcomes, the research indicated that, in the general population, small-for-gestational-age (SGA) babies were observed in 8.4% of subsequent births, while low birth weight (LBW) occurred in 5.9% and preterm birth in 7.5%.
 

Interpregnancy Interval and SGA Risk

The authors noted that the risk for subsequent adverse outcomes increased with extreme interpregnancy intervals, with SGA being the only exception. In this case, women who had an interval between the previous childbirth and the subsequent conception > 120 months had a lower risk for SGA.

According to João Guilherme Tedde, a medical student at UFGD and the first author of the study, similar patterns (extremely long interpregnancy intervals associated with a lower risk for subsequent SGA) have been described in the literature. In an interview with this news organization, he explained some hypotheses that could explain this phenomenon.

According to the researcher, the finding may reflect the distinct risk profile of mothers who wait a very long time to conceive again. “This group, composed of older women, likely has a higher prevalence of health problems, such as diabetes and obesity, which are known risk factors for having large-for-gestational-age (LGA) babies,” he said. He also highlighted the fact that the study showed that the risk for LGA also increased as the interval between pregnancies grew.

Another hypothesis suggested by the author is the possible occurrence of events between pregnancies, such as miscarriages or stillbirths. According to him, women who have experienced these events between two consecutive pregnancies may have falsely increased interpregnancy intervals, since miscarriages and stillbirths (which are considered conceptions) are not counted in SINASC.

“Thus, the lower occurrence of SGA in the group with very long intervals may reflect a competition of events between stillbirths or miscarriages and live SGAs,” he said.
 

Previous and Subsequent Adverse Events

The research also showed that the risks for subsequent SGA, LBW, and preterm birth were higher among women with a history of adverse events in previous pregnancies.

Furthermore, the authors noted that the previous occurrence of adverse outcomes seems to “have a more significant impact on the outcome of the current pregnancy than the interpregnancy interval.” 

“We found that, for women with the same interpregnancy interval (say < 6 months), but with different obstetric history (zero previous events vs one event), the absolute risk for subsequent adverse outcomes increased much more than when we change only the duration of the interval in a group with the same number of previous adverse events,” said Dr. Tedde.

There is still no convincing explanation for this fact, he said, since the cause-and-effect relationship between interpregnancy intervals and perinatal events is not clear. But the obstetrics literature generally shows that among the main risk factors for an adverse event is the previous occurrence of the same event. This effect could be related to living conditions and maternal habits, genetics, epigenetics, among others.

The researcher observed that this study is one of the largest in terms of sampling to investigate how maternal obstetric history can modulate the effect of interpregnancy interval on the risk for adverse outcomes in subsequent pregnancies.

The findings of the research published this year reinforce the importance of individualizing recommendations regarding interpregnancy intervals, considering factors such as maternal obstetric history. However, the author warns that it is still too early to point out the “best” interval for each situation.

“We need more studies that reproduce our findings and that expand the analyzed outcomes to also include those of interest to the mother, such as maternal mortality,” he concluded.

This story was translated from the Medscape Portuguese edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

BY DEEPA VARMA

TOPLINE:

In patients with polycystic ovary syndrome (PCOS), laser and light therapies, alone or in combination with pharmacological agents, improve hirsutism and psychological well-being in women, according to the results of a systematic review.

METHODOLOGY:

• Hirsutism, which affects 70%-80% of women with PCOS, is frequently marginalized as a cosmetic issue by healthcare providers, despite its significant psychological repercussions, including diminished self-esteem, reduced quality of life, and heightened depression.
• The 2023 international evidence-based PCOS guideline considers managing hirsutism a priority in women with PCOS.
• Researchers reviewed six studies (four randomized controlled trials and two cohort studies), which included 423 patients with PCOS who underwent laser or light-based hair reduction therapies, published through 2022.
• The studies evaluated the alexandrite laser, diode laser, and intense pulsed light (IPL) therapy, with and without pharmacological treatments. The main outcomes were hirsutism severity, psychological outcome, and adverse events.

TAKEAWAY:

• Alexandrite laser (wavelength, 755 nm) showed effective hair reduction and improved patient satisfaction (one study); high-fluence treatment yielded better outcomes than low-fluence treatment (one study). Alexandrite laser 755 nm also showed longer hair-free intervals and greater hair reduction than IPL therapy at 650-1000 nm (one study).
• Combined IPL (600 nm) and metformin therapy improved hirsutism and hair count reduction compared with IPL alone, but with more side effects (one study).
• Diode laser treatments (810 nm) with combined oral contraceptives improved hirsutism and related quality of life measures compared with diode laser alone or with metformin (one study).
• Comparing two diode lasers (wavelengths, 810 nm), low-fluence, high repetition laser showed superior hair width reduction and lower pain scores than high fluence, low-repetition laser (one study).

IN PRACTICE:

Laser and light treatments alone or combined with other treatments have demonstrated “encouraging results in reducing hirsutism severity, enhancing psychological well-being, and improving overall quality of life for affected individuals,” the authors wrote, noting that additional high-quality trials evaluating these treatments, which include more patients with different skin tones, are needed.

SOURCE:

The first author of the review is Katrina Tan, MD, Monash Health, Department of Dermatology, Melbourne, Victoria, Australia, and it was published online in JAMA Dermatology.

LIMITATIONS:

Limitations include low certainty of evidence because of the observational nature of some of the studies, the small number of studies, and underrepresentation of darker skin types, limiting generalizability.

DISCLOSURES:

The review is part of an update to the PCOS guideline, which was funded by the Australian National Health and Medical Research Council through various organizations. Several authors reported receiving grants and personal fees outside this work. Dr. Tan was a member of the 2023 PCOS guideline evidence team. Other authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

BY DEEPA VARMA

TOPLINE:

In patients with polycystic ovary syndrome (PCOS), laser and light therapies, alone or in combination with pharmacological agents, improve hirsutism and psychological well-being in women, according to the results of a systematic review.

METHODOLOGY:

• Hirsutism, which affects 70%-80% of women with PCOS, is frequently marginalized as a cosmetic issue by healthcare providers, despite its significant psychological repercussions, including diminished self-esteem, reduced quality of life, and heightened depression.
• The 2023 international evidence-based PCOS guideline considers managing hirsutism a priority in women with PCOS.
• Researchers reviewed six studies (four randomized controlled trials and two cohort studies), which included 423 patients with PCOS who underwent laser or light-based hair reduction therapies, published through 2022.
• The studies evaluated the alexandrite laser, diode laser, and intense pulsed light (IPL) therapy, with and without pharmacological treatments. The main outcomes were hirsutism severity, psychological outcome, and adverse events.

TAKEAWAY:

• Alexandrite laser (wavelength, 755 nm) showed effective hair reduction and improved patient satisfaction (one study); high-fluence treatment yielded better outcomes than low-fluence treatment (one study). Alexandrite laser 755 nm also showed longer hair-free intervals and greater hair reduction than IPL therapy at 650-1000 nm (one study).
• Combined IPL (600 nm) and metformin therapy improved hirsutism and hair count reduction compared with IPL alone, but with more side effects (one study).
• Diode laser treatments (810 nm) with combined oral contraceptives improved hirsutism and related quality of life measures compared with diode laser alone or with metformin (one study).
• Comparing two diode lasers (wavelengths, 810 nm), low-fluence, high repetition laser showed superior hair width reduction and lower pain scores than high fluence, low-repetition laser (one study).

IN PRACTICE:

Laser and light treatments alone or combined with other treatments have demonstrated “encouraging results in reducing hirsutism severity, enhancing psychological well-being, and improving overall quality of life for affected individuals,” the authors wrote, noting that additional high-quality trials evaluating these treatments, which include more patients with different skin tones, are needed.

SOURCE:

The first author of the review is Katrina Tan, MD, Monash Health, Department of Dermatology, Melbourne, Victoria, Australia, and it was published online in JAMA Dermatology.

LIMITATIONS:

Limitations include low certainty of evidence because of the observational nature of some of the studies, the small number of studies, and underrepresentation of darker skin types, limiting generalizability.

DISCLOSURES:

The review is part of an update to the PCOS guideline, which was funded by the Australian National Health and Medical Research Council through various organizations. Several authors reported receiving grants and personal fees outside this work. Dr. Tan was a member of the 2023 PCOS guideline evidence team. Other authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

BY DEEPA VARMA

TOPLINE:

In patients with polycystic ovary syndrome (PCOS), laser and light therapies, alone or in combination with pharmacological agents, improve hirsutism and psychological well-being in women, according to the results of a systematic review.

METHODOLOGY:

• Hirsutism, which affects 70%-80% of women with PCOS, is frequently marginalized as a cosmetic issue by healthcare providers, despite its significant psychological repercussions, including diminished self-esteem, reduced quality of life, and heightened depression.
• The 2023 international evidence-based PCOS guideline considers managing hirsutism a priority in women with PCOS.
• Researchers reviewed six studies (four randomized controlled trials and two cohort studies), which included 423 patients with PCOS who underwent laser or light-based hair reduction therapies, published through 2022.
• The studies evaluated the alexandrite laser, diode laser, and intense pulsed light (IPL) therapy, with and without pharmacological treatments. The main outcomes were hirsutism severity, psychological outcome, and adverse events.

TAKEAWAY:

• Alexandrite laser (wavelength, 755 nm) showed effective hair reduction and improved patient satisfaction (one study); high-fluence treatment yielded better outcomes than low-fluence treatment (one study). Alexandrite laser 755 nm also showed longer hair-free intervals and greater hair reduction than IPL therapy at 650-1000 nm (one study).
• Combined IPL (600 nm) and metformin therapy improved hirsutism and hair count reduction compared with IPL alone, but with more side effects (one study).
• Diode laser treatments (810 nm) with combined oral contraceptives improved hirsutism and related quality of life measures compared with diode laser alone or with metformin (one study).
• Comparing two diode lasers (wavelengths, 810 nm), low-fluence, high repetition laser showed superior hair width reduction and lower pain scores than high fluence, low-repetition laser (one study).

IN PRACTICE:

Laser and light treatments alone or combined with other treatments have demonstrated “encouraging results in reducing hirsutism severity, enhancing psychological well-being, and improving overall quality of life for affected individuals,” the authors wrote, noting that additional high-quality trials evaluating these treatments, which include more patients with different skin tones, are needed.

SOURCE:

The first author of the review is Katrina Tan, MD, Monash Health, Department of Dermatology, Melbourne, Victoria, Australia, and it was published online in JAMA Dermatology.

LIMITATIONS:

Limitations include low certainty of evidence because of the observational nature of some of the studies, the small number of studies, and underrepresentation of darker skin types, limiting generalizability.

DISCLOSURES:

The review is part of an update to the PCOS guideline, which was funded by the Australian National Health and Medical Research Council through various organizations. Several authors reported receiving grants and personal fees outside this work. Dr. Tan was a member of the 2023 PCOS guideline evidence team. Other authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

More women today are surviving breast cancer if it’s caught early, largely because of better screening and more effective and targeted treatments.

However, not everyone has benefited equitably from this progress. Critical gaps in breast cancer outcomes and survival remain for women in racial and ethnic minority groups.

Black women for instance, have a 41% higher death rate from breast cancer compared with White patients. They also have a greater incidence of aggressive disease like triple-negative breast cancer. Native American and Hispanic women, meanwhile, are more likely to be diagnosed with breast cancer at an earlier age than White women and experience more aggressive breast cancers.

In 2023, Farhad Islami, MD, PhD, and his team published an updated analysis of racial/ethnic and socioeconomic disparities in cancer trends based on data from 2014 to 2020. The analysis found that Black women in particular, were the least likely to have an early-stage diagnosis of breast cancer. Localized‐stage breast cancer was diagnosed in 57% of Black women versus 68% of White women.

Islami_Farhad_web.jpg

“Despite substantial progress in cancer prevention, early detection, and treatments, the burden of cancer remains greater among populations that have been historically marginalized, including people of color, people with lower socioeconomic status, and people living in nonmetropolitan areas,” said Dr. Islami, who is senior scientific director of cancer disparity research in the Surveillance & Health Equity Science Department at the American Cancer Society.

The reasons behind outcomes disparities in breast cancer are complex, making solutions challenging, say experts researching racial differences in cancer outcomes.

While social determinants of health (SDH) seem to be drivers of higher breast cancer mortality in Black women, biological differences between Black and White women are also linked to poorer outcomes in Black women with breast cancer, new studies suggest. Among the findings of this research is that breast cancer tests may be contributing to the disparities and misguiding care for some patients of color.
 

SDH and Screening Rates Differences By Race

A range of factors contribute to racial and ethnic disparities in breast cancer outcomes, said Pamela Ganschow, MD, an associate professor in the Department of Internal Medicine at the University of Illinois Cancer Center in Chicago and part of the university’s Cancer Prevention and Control research program. These include socioeconomic status, access to timely and high-quality care across the cancer control continuum, cultural beliefs, differences in genetic makeup and tumor biology, as well as system biases, such as implicit biases and systemic racism, Dr. Ganschow said.

Dr. Islami adds that gaps in access to cancer prevention, early detection, and treatment are largely rooted in fundamental inequities in social determinants of health (SDH), such as whether a patient has safe housing, transportation, education, job opportunities, income, access to nutritious foods, and language and literacy skills, among others.

Dr. Islami’s analysis, for example, shows that people of color are generally more likely to have lower educational attainment and to experience poverty, food insecurity, and housing insecurity compared with White people. Among people aged 18-64 years, the age-adjusted proportion of individuals with no health insurance in 2021 was also higher among Black (13.7%), American Indian/Alaskan Native (18.7%), and Hispanic (28.7%) patients than among White (7.8%) or Asian (5.9%) people, according to the report.

Competing needs can also get in the way of prioritizing cancer screenings, especially for patients in lower socio-economic populations, Dr. Ganschow said.

Ganschow_Pamela_CHICAGO_web.JPG

Biological Differences, Bad Testing Recommendations May Contribute to Poor Outcomes

Differences in biology may be one overlooked internal driver of lower breast cancer survival in Black women.

Researchers at Sanford Burnham Prebys in La Jolla, California, recently analyzed the breast cells of White and Black women, finding significant molecular differences that may be contributing to higher breast cancer mortality rates in Black women.

Investigators analyzed both healthy tissue and tumor tissue from 185 Black women and compared the samples to that of White women. They discovered differences among Black and White women in the way their DNA repair genes are expressed, both in healthy breast tissue and in tumors positive for estrogen receptor breast cancer. Molecular differences were also present in the cellular signals that control how fast cells, including cancer cells, grow.

DNA repair is part of normal cellular function and helps cells recover from damage that can occur during DNA replication or in response to external factors, such as stress.

“One of the first lines of defense, to prevent the cell from becoming a tumor are DNA damage repair pathways,” said Svasti Haricharan, PhD, a coauthor of the study and an assistant professor at Sanford Burnham Prebys. “We know there are many different DNA damage repair pathways that respond to different types of DNA damage. What we didn’t know was that, even in our normal cells, based on your race and ethnicity, you have different levels of DNA repair proteins.”

Haricharan_Svasti_CALIF_web.jpg

Hoskins_Kent_CHICAGO_web.jpg

How Neighborhood Impacts Breast Cancer, Death Rates

Living in a disadvantaged neighborhood also lowers breast cancer survival, according to new research. A disadvantaged neighborhood is generally defined as a location associated with higher concentrations of poverty, higher rates of unemployment, and less access to health care, quality housing, food, and community resources, according to the Centers for Disease Control and Prevention.

Authors of a study published in JAMA Network Open on April 18 identified 350,824 patients with breast cancer. Of these, 41,519 (11.8%) were Hispanic, 39,631 (11.3%) were non-Hispanic Black, and 234,698 (66.9%) were non-Hispanic White. Investigators divided the patients into five groups representing the lowest to highest neighborhood socioeconomic indices using the Yost Index. (The Yost Index is used by the National Cancer Institute for cancer surveillance and is based on variables such as household income, home value, median rent, percentage below 150% of the poverty line, education, and unemployment.)

Of the Black and Hispanic patients in the study, the highest proportions of both demographics lived in the most disadvantaged neighborhoods. (16,141 Black patients [30.9%]) and 10,168 Hispanic patients [19.5%]). Although 45% of White patients also fell into that same category, the highest proportion of White patients in the study lived in the most advantaged neighborhoods (66,529 patients [76.2%]).

Findings showed patients in the most disadvantaged neighborhoods had the highest proportion of triple-negative breast cancer. Patients in this group also had the lowest proportion of patients who completed surgery and radiation, and the highest proportion of patients who received chemotherapy, compared with all other neighborhood groups. The most advantaged neighborhoods group had higher proportions of localized-stage cancer, a higher proportion of patients who underwent surgery and radiation, and the lowest proportion of patients receiving chemotherapy treatment.

Patients in the most disadvantaged neighborhoods also had the highest risk of mortality (hazard ratio [HR,] 1.53; 95% CI, 1.48-1.59; P less than .001) compared with patients living in the most advantaged neighborhoods. Non-Hispanic Black patients in particular, had the highest risk of mortality, compared with non-Hispanic White patients (HR, 1.16; 95% CI, 1.13-1.20; P less than .001).

Authors wrote that the findings suggest neighborhood disadvantage is independently associated with shorter survival in patients with breast cancer, even after controlling for individual-level factors, tumor characteristics, and treatment.

“To address these residual disparities associated with neighborhood disadvantage, research must focus on which components of the built environment influence outcomes,” the authors said.

Another recent study also found correlations among where breast cancer patients lived and how they fared with the disease.

Jasmine M. Miller-Kleinhenz, PhD, an assistant professor at University of Mississippi Medical Center in Jackson, studied how historical redlining impacts breast cancer development and outcomes in her research published in JAMA Network Open, earlier this year. Redlining refers to the practice of denying people access to credit because of where they live. Historically, mortgage lenders widely redlined neighborhoods with predominantly Black residents. The 1968 Fair Housing Act outlawed racially motivated redlining, but consequences from historical redlining still exist.

Miller_Kleinhenz_Jasmine_MS_web.jpg

Hope for Improved Outcomes, Higher Survival Rates

Investigators hope the findings of all of this new research lead to better, more targeted treatments and, in turn, improved outcomes.

Dr. Haricharan is optimistic about the improvement of breast cancer outcomes as more is learned about the biology of Black patients and other non-White patients.

There is a growing effort to include more data from minoritized populations in breast cancer research studies, Dr. Haricharan said, and she foresees associated changes to clinical protocols in the future. Her own team is working on creating larger data sets that are more representative of non-White patients to further analyze the differences found in their prior study.

“I think there’s this understanding that, until we have data sets that are more representative, we really are catering to [only one] population in terms of our diagnostic and therapeutic technological advances,” she said.

The American Cancer Society meanwhile, is launching a new initiative in May that aims to collect more health data from Black women to ultimately develop more effective cancer interventions. VOICES of Black Women will focus on collecting and studying health data from Black women through online surveys. The society’s goal is to enroll at least 100,000 Black women in the United States between ages 25 and 55.

Dr. Miller-Kleinhenz called the initiative “an important step to starting to research and answer some of these lingering questions about why there continue to be breast cancer disparities.”

More women today are surviving breast cancer if it’s caught early, largely because of better screening and more effective and targeted treatments.

However, not everyone has benefited equitably from this progress. Critical gaps in breast cancer outcomes and survival remain for women in racial and ethnic minority groups.

Black women for instance, have a 41% higher death rate from breast cancer compared with White patients. They also have a greater incidence of aggressive disease like triple-negative breast cancer. Native American and Hispanic women, meanwhile, are more likely to be diagnosed with breast cancer at an earlier age than White women and experience more aggressive breast cancers.

In 2023, Farhad Islami, MD, PhD, and his team published an updated analysis of racial/ethnic and socioeconomic disparities in cancer trends based on data from 2014 to 2020. The analysis found that Black women in particular, were the least likely to have an early-stage diagnosis of breast cancer. Localized‐stage breast cancer was diagnosed in 57% of Black women versus 68% of White women.

Islami_Farhad_web.jpg

“Despite substantial progress in cancer prevention, early detection, and treatments, the burden of cancer remains greater among populations that have been historically marginalized, including people of color, people with lower socioeconomic status, and people living in nonmetropolitan areas,” said Dr. Islami, who is senior scientific director of cancer disparity research in the Surveillance & Health Equity Science Department at the American Cancer Society.

The reasons behind outcomes disparities in breast cancer are complex, making solutions challenging, say experts researching racial differences in cancer outcomes.

While social determinants of health (SDH) seem to be drivers of higher breast cancer mortality in Black women, biological differences between Black and White women are also linked to poorer outcomes in Black women with breast cancer, new studies suggest. Among the findings of this research is that breast cancer tests may be contributing to the disparities and misguiding care for some patients of color.
 

SDH and Screening Rates Differences By Race

A range of factors contribute to racial and ethnic disparities in breast cancer outcomes, said Pamela Ganschow, MD, an associate professor in the Department of Internal Medicine at the University of Illinois Cancer Center in Chicago and part of the university’s Cancer Prevention and Control research program. These include socioeconomic status, access to timely and high-quality care across the cancer control continuum, cultural beliefs, differences in genetic makeup and tumor biology, as well as system biases, such as implicit biases and systemic racism, Dr. Ganschow said.

Dr. Islami adds that gaps in access to cancer prevention, early detection, and treatment are largely rooted in fundamental inequities in social determinants of health (SDH), such as whether a patient has safe housing, transportation, education, job opportunities, income, access to nutritious foods, and language and literacy skills, among others.

Dr. Islami’s analysis, for example, shows that people of color are generally more likely to have lower educational attainment and to experience poverty, food insecurity, and housing insecurity compared with White people. Among people aged 18-64 years, the age-adjusted proportion of individuals with no health insurance in 2021 was also higher among Black (13.7%), American Indian/Alaskan Native (18.7%), and Hispanic (28.7%) patients than among White (7.8%) or Asian (5.9%) people, according to the report.

Competing needs can also get in the way of prioritizing cancer screenings, especially for patients in lower socio-economic populations, Dr. Ganschow said.

Ganschow_Pamela_CHICAGO_web.JPG

Biological Differences, Bad Testing Recommendations May Contribute to Poor Outcomes

Differences in biology may be one overlooked internal driver of lower breast cancer survival in Black women.

Researchers at Sanford Burnham Prebys in La Jolla, California, recently analyzed the breast cells of White and Black women, finding significant molecular differences that may be contributing to higher breast cancer mortality rates in Black women.

Investigators analyzed both healthy tissue and tumor tissue from 185 Black women and compared the samples to that of White women. They discovered differences among Black and White women in the way their DNA repair genes are expressed, both in healthy breast tissue and in tumors positive for estrogen receptor breast cancer. Molecular differences were also present in the cellular signals that control how fast cells, including cancer cells, grow.

DNA repair is part of normal cellular function and helps cells recover from damage that can occur during DNA replication or in response to external factors, such as stress.

“One of the first lines of defense, to prevent the cell from becoming a tumor are DNA damage repair pathways,” said Svasti Haricharan, PhD, a coauthor of the study and an assistant professor at Sanford Burnham Prebys. “We know there are many different DNA damage repair pathways that respond to different types of DNA damage. What we didn’t know was that, even in our normal cells, based on your race and ethnicity, you have different levels of DNA repair proteins.”

Haricharan_Svasti_CALIF_web.jpg

Hoskins_Kent_CHICAGO_web.jpg

How Neighborhood Impacts Breast Cancer, Death Rates

Living in a disadvantaged neighborhood also lowers breast cancer survival, according to new research. A disadvantaged neighborhood is generally defined as a location associated with higher concentrations of poverty, higher rates of unemployment, and less access to health care, quality housing, food, and community resources, according to the Centers for Disease Control and Prevention.

Authors of a study published in JAMA Network Open on April 18 identified 350,824 patients with breast cancer. Of these, 41,519 (11.8%) were Hispanic, 39,631 (11.3%) were non-Hispanic Black, and 234,698 (66.9%) were non-Hispanic White. Investigators divided the patients into five groups representing the lowest to highest neighborhood socioeconomic indices using the Yost Index. (The Yost Index is used by the National Cancer Institute for cancer surveillance and is based on variables such as household income, home value, median rent, percentage below 150% of the poverty line, education, and unemployment.)

Of the Black and Hispanic patients in the study, the highest proportions of both demographics lived in the most disadvantaged neighborhoods. (16,141 Black patients [30.9%]) and 10,168 Hispanic patients [19.5%]). Although 45% of White patients also fell into that same category, the highest proportion of White patients in the study lived in the most advantaged neighborhoods (66,529 patients [76.2%]).

Findings showed patients in the most disadvantaged neighborhoods had the highest proportion of triple-negative breast cancer. Patients in this group also had the lowest proportion of patients who completed surgery and radiation, and the highest proportion of patients who received chemotherapy, compared with all other neighborhood groups. The most advantaged neighborhoods group had higher proportions of localized-stage cancer, a higher proportion of patients who underwent surgery and radiation, and the lowest proportion of patients receiving chemotherapy treatment.

Patients in the most disadvantaged neighborhoods also had the highest risk of mortality (hazard ratio [HR,] 1.53; 95% CI, 1.48-1.59; P less than .001) compared with patients living in the most advantaged neighborhoods. Non-Hispanic Black patients in particular, had the highest risk of mortality, compared with non-Hispanic White patients (HR, 1.16; 95% CI, 1.13-1.20; P less than .001).

Authors wrote that the findings suggest neighborhood disadvantage is independently associated with shorter survival in patients with breast cancer, even after controlling for individual-level factors, tumor characteristics, and treatment.

“To address these residual disparities associated with neighborhood disadvantage, research must focus on which components of the built environment influence outcomes,” the authors said.

Another recent study also found correlations among where breast cancer patients lived and how they fared with the disease.

Jasmine M. Miller-Kleinhenz, PhD, an assistant professor at University of Mississippi Medical Center in Jackson, studied how historical redlining impacts breast cancer development and outcomes in her research published in JAMA Network Open, earlier this year. Redlining refers to the practice of denying people access to credit because of where they live. Historically, mortgage lenders widely redlined neighborhoods with predominantly Black residents. The 1968 Fair Housing Act outlawed racially motivated redlining, but consequences from historical redlining still exist.

Miller_Kleinhenz_Jasmine_MS_web.jpg

Hope for Improved Outcomes, Higher Survival Rates

Investigators hope the findings of all of this new research lead to better, more targeted treatments and, in turn, improved outcomes.

Dr. Haricharan is optimistic about the improvement of breast cancer outcomes as more is learned about the biology of Black patients and other non-White patients.

There is a growing effort to include more data from minoritized populations in breast cancer research studies, Dr. Haricharan said, and she foresees associated changes to clinical protocols in the future. Her own team is working on creating larger data sets that are more representative of non-White patients to further analyze the differences found in their prior study.

“I think there’s this understanding that, until we have data sets that are more representative, we really are catering to [only one] population in terms of our diagnostic and therapeutic technological advances,” she said.

The American Cancer Society meanwhile, is launching a new initiative in May that aims to collect more health data from Black women to ultimately develop more effective cancer interventions. VOICES of Black Women will focus on collecting and studying health data from Black women through online surveys. The society’s goal is to enroll at least 100,000 Black women in the United States between ages 25 and 55.

Dr. Miller-Kleinhenz called the initiative “an important step to starting to research and answer some of these lingering questions about why there continue to be breast cancer disparities.”

More women today are surviving breast cancer if it’s caught early, largely because of better screening and more effective and targeted treatments.

However, not everyone has benefited equitably from this progress. Critical gaps in breast cancer outcomes and survival remain for women in racial and ethnic minority groups.

Black women for instance, have a 41% higher death rate from breast cancer compared with White patients. They also have a greater incidence of aggressive disease like triple-negative breast cancer. Native American and Hispanic women, meanwhile, are more likely to be diagnosed with breast cancer at an earlier age than White women and experience more aggressive breast cancers.

In 2023, Farhad Islami, MD, PhD, and his team published an updated analysis of racial/ethnic and socioeconomic disparities in cancer trends based on data from 2014 to 2020. The analysis found that Black women in particular, were the least likely to have an early-stage diagnosis of breast cancer. Localized‐stage breast cancer was diagnosed in 57% of Black women versus 68% of White women.

Islami_Farhad_web.jpg

“Despite substantial progress in cancer prevention, early detection, and treatments, the burden of cancer remains greater among populations that have been historically marginalized, including people of color, people with lower socioeconomic status, and people living in nonmetropolitan areas,” said Dr. Islami, who is senior scientific director of cancer disparity research in the Surveillance & Health Equity Science Department at the American Cancer Society.

The reasons behind outcomes disparities in breast cancer are complex, making solutions challenging, say experts researching racial differences in cancer outcomes.

While social determinants of health (SDH) seem to be drivers of higher breast cancer mortality in Black women, biological differences between Black and White women are also linked to poorer outcomes in Black women with breast cancer, new studies suggest. Among the findings of this research is that breast cancer tests may be contributing to the disparities and misguiding care for some patients of color.
 

SDH and Screening Rates Differences By Race

A range of factors contribute to racial and ethnic disparities in breast cancer outcomes, said Pamela Ganschow, MD, an associate professor in the Department of Internal Medicine at the University of Illinois Cancer Center in Chicago and part of the university’s Cancer Prevention and Control research program. These include socioeconomic status, access to timely and high-quality care across the cancer control continuum, cultural beliefs, differences in genetic makeup and tumor biology, as well as system biases, such as implicit biases and systemic racism, Dr. Ganschow said.

Dr. Islami adds that gaps in access to cancer prevention, early detection, and treatment are largely rooted in fundamental inequities in social determinants of health (SDH), such as whether a patient has safe housing, transportation, education, job opportunities, income, access to nutritious foods, and language and literacy skills, among others.

Dr. Islami’s analysis, for example, shows that people of color are generally more likely to have lower educational attainment and to experience poverty, food insecurity, and housing insecurity compared with White people. Among people aged 18-64 years, the age-adjusted proportion of individuals with no health insurance in 2021 was also higher among Black (13.7%), American Indian/Alaskan Native (18.7%), and Hispanic (28.7%) patients than among White (7.8%) or Asian (5.9%) people, according to the report.

Competing needs can also get in the way of prioritizing cancer screenings, especially for patients in lower socio-economic populations, Dr. Ganschow said.

Ganschow_Pamela_CHICAGO_web.JPG

Biological Differences, Bad Testing Recommendations May Contribute to Poor Outcomes

Differences in biology may be one overlooked internal driver of lower breast cancer survival in Black women.

Researchers at Sanford Burnham Prebys in La Jolla, California, recently analyzed the breast cells of White and Black women, finding significant molecular differences that may be contributing to higher breast cancer mortality rates in Black women.

Investigators analyzed both healthy tissue and tumor tissue from 185 Black women and compared the samples to that of White women. They discovered differences among Black and White women in the way their DNA repair genes are expressed, both in healthy breast tissue and in tumors positive for estrogen receptor breast cancer. Molecular differences were also present in the cellular signals that control how fast cells, including cancer cells, grow.

DNA repair is part of normal cellular function and helps cells recover from damage that can occur during DNA replication or in response to external factors, such as stress.

“One of the first lines of defense, to prevent the cell from becoming a tumor are DNA damage repair pathways,” said Svasti Haricharan, PhD, a coauthor of the study and an assistant professor at Sanford Burnham Prebys. “We know there are many different DNA damage repair pathways that respond to different types of DNA damage. What we didn’t know was that, even in our normal cells, based on your race and ethnicity, you have different levels of DNA repair proteins.”

Haricharan_Svasti_CALIF_web.jpg

Hoskins_Kent_CHICAGO_web.jpg

How Neighborhood Impacts Breast Cancer, Death Rates

Living in a disadvantaged neighborhood also lowers breast cancer survival, according to new research. A disadvantaged neighborhood is generally defined as a location associated with higher concentrations of poverty, higher rates of unemployment, and less access to health care, quality housing, food, and community resources, according to the Centers for Disease Control and Prevention.

Authors of a study published in JAMA Network Open on April 18 identified 350,824 patients with breast cancer. Of these, 41,519 (11.8%) were Hispanic, 39,631 (11.3%) were non-Hispanic Black, and 234,698 (66.9%) were non-Hispanic White. Investigators divided the patients into five groups representing the lowest to highest neighborhood socioeconomic indices using the Yost Index. (The Yost Index is used by the National Cancer Institute for cancer surveillance and is based on variables such as household income, home value, median rent, percentage below 150% of the poverty line, education, and unemployment.)

Of the Black and Hispanic patients in the study, the highest proportions of both demographics lived in the most disadvantaged neighborhoods. (16,141 Black patients [30.9%]) and 10,168 Hispanic patients [19.5%]). Although 45% of White patients also fell into that same category, the highest proportion of White patients in the study lived in the most advantaged neighborhoods (66,529 patients [76.2%]).

Findings showed patients in the most disadvantaged neighborhoods had the highest proportion of triple-negative breast cancer. Patients in this group also had the lowest proportion of patients who completed surgery and radiation, and the highest proportion of patients who received chemotherapy, compared with all other neighborhood groups. The most advantaged neighborhoods group had higher proportions of localized-stage cancer, a higher proportion of patients who underwent surgery and radiation, and the lowest proportion of patients receiving chemotherapy treatment.

Patients in the most disadvantaged neighborhoods also had the highest risk of mortality (hazard ratio [HR,] 1.53; 95% CI, 1.48-1.59; P less than .001) compared with patients living in the most advantaged neighborhoods. Non-Hispanic Black patients in particular, had the highest risk of mortality, compared with non-Hispanic White patients (HR, 1.16; 95% CI, 1.13-1.20; P less than .001).

Authors wrote that the findings suggest neighborhood disadvantage is independently associated with shorter survival in patients with breast cancer, even after controlling for individual-level factors, tumor characteristics, and treatment.

“To address these residual disparities associated with neighborhood disadvantage, research must focus on which components of the built environment influence outcomes,” the authors said.

Another recent study also found correlations among where breast cancer patients lived and how they fared with the disease.

Jasmine M. Miller-Kleinhenz, PhD, an assistant professor at University of Mississippi Medical Center in Jackson, studied how historical redlining impacts breast cancer development and outcomes in her research published in JAMA Network Open, earlier this year. Redlining refers to the practice of denying people access to credit because of where they live. Historically, mortgage lenders widely redlined neighborhoods with predominantly Black residents. The 1968 Fair Housing Act outlawed racially motivated redlining, but consequences from historical redlining still exist.

Miller_Kleinhenz_Jasmine_MS_web.jpg

Hope for Improved Outcomes, Higher Survival Rates

Investigators hope the findings of all of this new research lead to better, more targeted treatments and, in turn, improved outcomes.

Dr. Haricharan is optimistic about the improvement of breast cancer outcomes as more is learned about the biology of Black patients and other non-White patients.

There is a growing effort to include more data from minoritized populations in breast cancer research studies, Dr. Haricharan said, and she foresees associated changes to clinical protocols in the future. Her own team is working on creating larger data sets that are more representative of non-White patients to further analyze the differences found in their prior study.

“I think there’s this understanding that, until we have data sets that are more representative, we really are catering to [only one] population in terms of our diagnostic and therapeutic technological advances,” she said.

The American Cancer Society meanwhile, is launching a new initiative in May that aims to collect more health data from Black women to ultimately develop more effective cancer interventions. VOICES of Black Women will focus on collecting and studying health data from Black women through online surveys. The society’s goal is to enroll at least 100,000 Black women in the United States between ages 25 and 55.

Dr. Miller-Kleinhenz called the initiative “an important step to starting to research and answer some of these lingering questions about why there continue to be breast cancer disparities.”

TOPLINE:

A recent study suggests that younger breast cancer survivors with a germline pathogenic variant or those with an initial diagnosis of in situ vs invasive primary breast cancer have a significantly higher risk for a second primary breast cancer.

METHODOLOGY:

• Women who are diagnosed with breast cancer at age 40 or younger are about two to three times more likely to develop second primary breast cancer compared with women who are older when first diagnosed.
• However, data are lacking on whether certain factors increase a woman’s risk for a second primary breast cancer.
• To classify the risk of developing a second primary breast cancer, the researchers evaluated a main cohort of 685 patients with stages 0-III breast cancer who were diagnosed at age 40 years or younger and had undergone unilateral mastectomy or lumpectomy as primary surgery between August 2006 and June 2015. The team also analyzed data on 547 younger women who had a bilateral mastectomy.
• The researchers assessed various breast cancer risk factors, including self-reported ethnicity, race, age, family history of breast or ovarian cancer, germline genetics, tumor stage, grade, and receptor status.
• The primary outcome was the diagnosis of a second primary breast cancer that occurred at least 6 months after the initial diagnosis of primary breast cancer.

TAKEAWAY:

• Among the 685 main study participants, 17 (2.5%) developed a second primary breast cancer (15 contralateral and 2 ipsilateral) over a median of 4.2 years since their primary diagnosis. The 5- and 10-year cumulative incidence of a second primary breast cancer was 1.5% and 2.6%, respectively.
• Overall, only 33 women were positive for a germline pathogenic variant, and having a pathogenic variant was associated with a fourfold higher risk for second primary breast cancer compared with noncarriers at 5 years (5.5% vs 1.3%) and at 10 years (8.9% vs 2.2%). These findings were held in multivariate models.
• Patients initially diagnosed with in situ disease had more than a fivefold higher risk for second primary breast cancer compared with those initially diagnosed with invasive disease — 6.2% vs 1.2% at 5 years and 10.4% vs 2.1% at 10 years (hazard ratio, 5.25; P = .004). These findings were held in multivariate models (adjusted sub-hazard ratio [sHR], 5.61; 95% CI, 1.52-20.70) and among women without a pathogenic variant (adjusted sHR, 5.67; 95% CI, 1.54-20.90).
• The researchers also found a low risk for contralateral breast cancer among women without pathogenic variants, which could inform surgical decision-making.

IN PRACTICE:

Although the number of women positive for a germline pathogenic variant was small (n = 33) and “results should be interpreted cautiously,” the analysis signals “the importance of genetic testing” in younger breast cancer survivors to gauge their risk for a second primary breast cancer, the authors concluded. The authors added that their “finding of a higher risk of [second primary breast cancer] among those diagnosed with in situ primary [breast cancer] merits further investigation.”

SOURCE:

This study, led by Kristen D. Brantley, PhD, from Harvard T. H. Chan School of Public Health, Boston, was published online in JAMA Oncology.

LIMITATIONS:

A small number of second breast cancer events limited the authors’ ability to assess the effects of multiple risk factors together. Data on risk factors might be incomplete. About 9% of participants completed abbreviated questionnaires that did not include information on body mass index, alcohol, smoking, and family history. Frequencies of pathogenic variants besides BRCA1 and BRCA2 may be underestimated.

DISCLOSURES:

This study received no external funding. Four authors reported receiving grants or royalties outside this work. Other reported no competing interests.

A version of this article appeared on Medscape.com.

TOPLINE:

A recent study suggests that younger breast cancer survivors with a germline pathogenic variant or those with an initial diagnosis of in situ vs invasive primary breast cancer have a significantly higher risk for a second primary breast cancer.

METHODOLOGY:

• Women who are diagnosed with breast cancer at age 40 or younger are about two to three times more likely to develop second primary breast cancer compared with women who are older when first diagnosed.
• However, data are lacking on whether certain factors increase a woman’s risk for a second primary breast cancer.
• To classify the risk of developing a second primary breast cancer, the researchers evaluated a main cohort of 685 patients with stages 0-III breast cancer who were diagnosed at age 40 years or younger and had undergone unilateral mastectomy or lumpectomy as primary surgery between August 2006 and June 2015. The team also analyzed data on 547 younger women who had a bilateral mastectomy.
• The researchers assessed various breast cancer risk factors, including self-reported ethnicity, race, age, family history of breast or ovarian cancer, germline genetics, tumor stage, grade, and receptor status.
• The primary outcome was the diagnosis of a second primary breast cancer that occurred at least 6 months after the initial diagnosis of primary breast cancer.

TAKEAWAY:

• Among the 685 main study participants, 17 (2.5%) developed a second primary breast cancer (15 contralateral and 2 ipsilateral) over a median of 4.2 years since their primary diagnosis. The 5- and 10-year cumulative incidence of a second primary breast cancer was 1.5% and 2.6%, respectively.
• Overall, only 33 women were positive for a germline pathogenic variant, and having a pathogenic variant was associated with a fourfold higher risk for second primary breast cancer compared with noncarriers at 5 years (5.5% vs 1.3%) and at 10 years (8.9% vs 2.2%). These findings were held in multivariate models.
• Patients initially diagnosed with in situ disease had more than a fivefold higher risk for second primary breast cancer compared with those initially diagnosed with invasive disease — 6.2% vs 1.2% at 5 years and 10.4% vs 2.1% at 10 years (hazard ratio, 5.25; P = .004). These findings were held in multivariate models (adjusted sub-hazard ratio [sHR], 5.61; 95% CI, 1.52-20.70) and among women without a pathogenic variant (adjusted sHR, 5.67; 95% CI, 1.54-20.90).
• The researchers also found a low risk for contralateral breast cancer among women without pathogenic variants, which could inform surgical decision-making.

IN PRACTICE:

Although the number of women positive for a germline pathogenic variant was small (n = 33) and “results should be interpreted cautiously,” the analysis signals “the importance of genetic testing” in younger breast cancer survivors to gauge their risk for a second primary breast cancer, the authors concluded. The authors added that their “finding of a higher risk of [second primary breast cancer] among those diagnosed with in situ primary [breast cancer] merits further investigation.”

SOURCE:

This study, led by Kristen D. Brantley, PhD, from Harvard T. H. Chan School of Public Health, Boston, was published online in JAMA Oncology.

LIMITATIONS:

A small number of second breast cancer events limited the authors’ ability to assess the effects of multiple risk factors together. Data on risk factors might be incomplete. About 9% of participants completed abbreviated questionnaires that did not include information on body mass index, alcohol, smoking, and family history. Frequencies of pathogenic variants besides BRCA1 and BRCA2 may be underestimated.

DISCLOSURES:

This study received no external funding. Four authors reported receiving grants or royalties outside this work. Other reported no competing interests.

A version of this article appeared on Medscape.com.

TOPLINE:

A recent study suggests that younger breast cancer survivors with a germline pathogenic variant or those with an initial diagnosis of in situ vs invasive primary breast cancer have a significantly higher risk for a second primary breast cancer.

METHODOLOGY:

• Women who are diagnosed with breast cancer at age 40 or younger are about two to three times more likely to develop second primary breast cancer compared with women who are older when first diagnosed.
• However, data are lacking on whether certain factors increase a woman’s risk for a second primary breast cancer.
• To classify the risk of developing a second primary breast cancer, the researchers evaluated a main cohort of 685 patients with stages 0-III breast cancer who were diagnosed at age 40 years or younger and had undergone unilateral mastectomy or lumpectomy as primary surgery between August 2006 and June 2015. The team also analyzed data on 547 younger women who had a bilateral mastectomy.
• The researchers assessed various breast cancer risk factors, including self-reported ethnicity, race, age, family history of breast or ovarian cancer, germline genetics, tumor stage, grade, and receptor status.
• The primary outcome was the diagnosis of a second primary breast cancer that occurred at least 6 months after the initial diagnosis of primary breast cancer.

TAKEAWAY:

• Among the 685 main study participants, 17 (2.5%) developed a second primary breast cancer (15 contralateral and 2 ipsilateral) over a median of 4.2 years since their primary diagnosis. The 5- and 10-year cumulative incidence of a second primary breast cancer was 1.5% and 2.6%, respectively.
• Overall, only 33 women were positive for a germline pathogenic variant, and having a pathogenic variant was associated with a fourfold higher risk for second primary breast cancer compared with noncarriers at 5 years (5.5% vs 1.3%) and at 10 years (8.9% vs 2.2%). These findings were held in multivariate models.
• Patients initially diagnosed with in situ disease had more than a fivefold higher risk for second primary breast cancer compared with those initially diagnosed with invasive disease — 6.2% vs 1.2% at 5 years and 10.4% vs 2.1% at 10 years (hazard ratio, 5.25; P = .004). These findings were held in multivariate models (adjusted sub-hazard ratio [sHR], 5.61; 95% CI, 1.52-20.70) and among women without a pathogenic variant (adjusted sHR, 5.67; 95% CI, 1.54-20.90).
• The researchers also found a low risk for contralateral breast cancer among women without pathogenic variants, which could inform surgical decision-making.

IN PRACTICE:

Although the number of women positive for a germline pathogenic variant was small (n = 33) and “results should be interpreted cautiously,” the analysis signals “the importance of genetic testing” in younger breast cancer survivors to gauge their risk for a second primary breast cancer, the authors concluded. The authors added that their “finding of a higher risk of [second primary breast cancer] among those diagnosed with in situ primary [breast cancer] merits further investigation.”

SOURCE:

This study, led by Kristen D. Brantley, PhD, from Harvard T. H. Chan School of Public Health, Boston, was published online in JAMA Oncology.

LIMITATIONS:

A small number of second breast cancer events limited the authors’ ability to assess the effects of multiple risk factors together. Data on risk factors might be incomplete. About 9% of participants completed abbreviated questionnaires that did not include information on body mass index, alcohol, smoking, and family history. Frequencies of pathogenic variants besides BRCA1 and BRCA2 may be underestimated.

DISCLOSURES:

This study received no external funding. Four authors reported receiving grants or royalties outside this work. Other reported no competing interests.

A version of this article appeared on Medscape.com.

TOPLINE:

A natural sugar used to treat recurring urinary tract infections (rUTIs) did not reduce future episodes, outpatient visits, the use of antibiotics, or symptoms compared with a placebo, according to a new study.

METHODOLOGY:

• D-Mannose is recommended as a natural alternative to antibiotics and sold as a dietary supplement; research showing the efficacy of D-mannose in treating UTIs is mixed.
• The double-blind, randomized controlled trial followed 598 women older than 18 years (median age, 61.3; range 18.2-93.5 years) with a history of rUTIs over 6 months from nearly 100 primary care clinics in the United Kingdom.
• Patients took 2 g of D-mannose or placebo powder daily and recorded their symptoms using a daily diary or through responses to health surveys, weekly questionnaires, and phone calls.
• Researchers checked medical records for urine culture results, antibiotic prescriptions, hospitalizations, and outpatient visits for UTIs.

TAKEAWAY:

• Approximately 51% of participants who took D-mannose and 55.7% of those who took a placebo contacted a healthcare professional reporting a UTI (relative risk, 0.92; 95% CI, 0.80-1.05; P = .22).
• Women in both groups reported similar durations of “moderately bad” or “worse” symptoms, and the number of antibiotic courses, instances of clinically suspected UTIs, and hospital admissions were similar between the two groups.
• Some studies have reported that synthetic mannosides are promising alternatives to D-mannose.

IN PRACTICE:

“D-Mannose should not be recommended to prevent future episodes of medically attended UTI in women with recurrent UTI in primary care,” the study authors wrote.

SOURCE:

The study was led by Gail Hayward, DPhil, associate professor at the Nuffield Department of Primary Care Health Sciences at the University of Oxford in England, and was published online in JAMA Internal Medicine.

LIMITATIONS:

Some participants may have taken less than 2 mg/d or skipped days. Because researchers used powder rather than capsules, dosing could have been inconsistent. Researchers did not obtain a microbiologic confirmation for each rUTI. A small percentage of women were taking antibiotics.

DISCLOSURES:

The study was funded by the National Institute for Health and Care Research (NIHR) School for Primary Care Research and the NIHR Oxford Biomedical Research Centre. Various authors reported receiving support from the NIHR Health Protection Research Unit on Healthcare-Associated Infections and Antimicrobial Resistance and were NIHR investigators.

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

TOPLINE:

A natural sugar used to treat recurring urinary tract infections (rUTIs) did not reduce future episodes, outpatient visits, the use of antibiotics, or symptoms compared with a placebo, according to a new study.

METHODOLOGY:

• D-Mannose is recommended as a natural alternative to antibiotics and sold as a dietary supplement; research showing the efficacy of D-mannose in treating UTIs is mixed.
• The double-blind, randomized controlled trial followed 598 women older than 18 years (median age, 61.3; range 18.2-93.5 years) with a history of rUTIs over 6 months from nearly 100 primary care clinics in the United Kingdom.
• Patients took 2 g of D-mannose or placebo powder daily and recorded their symptoms using a daily diary or through responses to health surveys, weekly questionnaires, and phone calls.
• Researchers checked medical records for urine culture results, antibiotic prescriptions, hospitalizations, and outpatient visits for UTIs.

TAKEAWAY:

• Approximately 51% of participants who took D-mannose and 55.7% of those who took a placebo contacted a healthcare professional reporting a UTI (relative risk, 0.92; 95% CI, 0.80-1.05; P = .22).
• Women in both groups reported similar durations of “moderately bad” or “worse” symptoms, and the number of antibiotic courses, instances of clinically suspected UTIs, and hospital admissions were similar between the two groups.
• Some studies have reported that synthetic mannosides are promising alternatives to D-mannose.

IN PRACTICE:

“D-Mannose should not be recommended to prevent future episodes of medically attended UTI in women with recurrent UTI in primary care,” the study authors wrote.

SOURCE:

The study was led by Gail Hayward, DPhil, associate professor at the Nuffield Department of Primary Care Health Sciences at the University of Oxford in England, and was published online in JAMA Internal Medicine.

LIMITATIONS:

Some participants may have taken less than 2 mg/d or skipped days. Because researchers used powder rather than capsules, dosing could have been inconsistent. Researchers did not obtain a microbiologic confirmation for each rUTI. A small percentage of women were taking antibiotics.

DISCLOSURES:

The study was funded by the National Institute for Health and Care Research (NIHR) School for Primary Care Research and the NIHR Oxford Biomedical Research Centre. Various authors reported receiving support from the NIHR Health Protection Research Unit on Healthcare-Associated Infections and Antimicrobial Resistance and were NIHR investigators.

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

TOPLINE:

A natural sugar used to treat recurring urinary tract infections (rUTIs) did not reduce future episodes, outpatient visits, the use of antibiotics, or symptoms compared with a placebo, according to a new study.

METHODOLOGY:

• D-Mannose is recommended as a natural alternative to antibiotics and sold as a dietary supplement; research showing the efficacy of D-mannose in treating UTIs is mixed.
• The double-blind, randomized controlled trial followed 598 women older than 18 years (median age, 61.3; range 18.2-93.5 years) with a history of rUTIs over 6 months from nearly 100 primary care clinics in the United Kingdom.
• Patients took 2 g of D-mannose or placebo powder daily and recorded their symptoms using a daily diary or through responses to health surveys, weekly questionnaires, and phone calls.
• Researchers checked medical records for urine culture results, antibiotic prescriptions, hospitalizations, and outpatient visits for UTIs.

TAKEAWAY:

• Approximately 51% of participants who took D-mannose and 55.7% of those who took a placebo contacted a healthcare professional reporting a UTI (relative risk, 0.92; 95% CI, 0.80-1.05; P = .22).
• Women in both groups reported similar durations of “moderately bad” or “worse” symptoms, and the number of antibiotic courses, instances of clinically suspected UTIs, and hospital admissions were similar between the two groups.
• Some studies have reported that synthetic mannosides are promising alternatives to D-mannose.

IN PRACTICE:

“D-Mannose should not be recommended to prevent future episodes of medically attended UTI in women with recurrent UTI in primary care,” the study authors wrote.

SOURCE:

The study was led by Gail Hayward, DPhil, associate professor at the Nuffield Department of Primary Care Health Sciences at the University of Oxford in England, and was published online in JAMA Internal Medicine.

LIMITATIONS:

Some participants may have taken less than 2 mg/d or skipped days. Because researchers used powder rather than capsules, dosing could have been inconsistent. Researchers did not obtain a microbiologic confirmation for each rUTI. A small percentage of women were taking antibiotics.

DISCLOSURES:

The study was funded by the National Institute for Health and Care Research (NIHR) School for Primary Care Research and the NIHR Oxford Biomedical Research Centre. Various authors reported receiving support from the NIHR Health Protection Research Unit on Healthcare-Associated Infections and Antimicrobial Resistance and were NIHR investigators.

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

SAN DIEGO — A new blood test that combines cell-free DNA fragmentomes and protein biomarkers to screen for ovarian cancer shows promising results, according to an initial analysis. 

The test, under development by Delfi Diagnostics, “looks very sensitive for detecting ovarian cancer early,” said company founder and board member Victor E. Velculescu, MD, PhD, codirector of Cancer Genetics and Epigenetics at Johns Hopkins University, Baltimore. 

The assay uses machine learning to integrate cell-free DNA fragment patterns with concentrations of two ovarian cancer biomarkers — CA125 and HE4 — to detect tumors. 

While fragmentation patterns are organized in healthy people, they are chaotic in cancer and reveal both its presence and location, said Velculescu who presented the findings at the American Association for Cancer Research annual meeting.

The researchers tested the assay in 134 women with ovarian cancer, 204 women without cancer, and 203 women with benign adnexal masses. The approach identified 69% of stage 1 cancers, 76% of stage 2, 85% of stage 3, and 100% of stage 4 at a specificity of over 99% and an area under the curve (AUC) of 0.97.

The test identified 91% of high-grade serous ovarian cancers — the most common type of ovarian cancer.

The AUC for distinguishing benign masses from cancer was 0.87, with 60% of ovarian cancers detected at a specificity of 95%. 

“In the preoperative setting where lower specificity is acceptable, this approach may improve management of adnexal masses,” the investigators said in their abstract.

Dr. Velculescu cautioned that the report “is an initial analysis” and that his team is working on validating the finding on a larger scale in both average and high-risk women.

If validated, the test “could enable population-wide ovarian cancer screening,” he added.

Delfi recently launched a lung cancer screening blood test — FirstLook Lung— that also uses a “fragmentomics” approach to detect tumors. The company is hopeful it will reach the market with a similar test for ovarian cancer, but it’s not a certainty. 

With lung cancer, we know screening helps. For ovarian cancer, however, it’s unclear whether this will help or not, said Dr. Velculescu. But based on the study findings, but “we are now optimistic that this could make an impact. We have more work to do.” 

This presentation was one of many at the meeting about liquid biopsies using DNA, RNA, and proteins to detect cancer, including a new assay for pancreatic cancer, another cancer that like ovarian cancer is difficult to detect in the early stages. 

“This is the future,” said study moderator Roy S. Herbst, MD, PhD, chief of medical oncology at Yale University in New Haven, Connecticut. 

He called liquid biopsy “a great advance” in many oncology settings, including cancer screening because finding tumors early offers the best chance at cure. 

However, one of the main concerns about rolling out liquid biopsies for wide-scale cancer screening is the possibility that a test will come back positive, but no tumor will be seen on diagnostic imaging, said Herbst. It won’t be clear if the test was a false positive or if the patient has a brewing tumor that can’t be located and treated, a difficult situation for both patients and doctors. 

What to do in that situation is “a policy question that the entire country is asking now as liquid biopsies are moving forward,” he said. We are going to have to come together to figure it out and learn how to use these tests.

The work was funded by Delfi Diagnostics, the National Institutes of Health, and others. Dr. Velculescu, in addition to founding Delfi, holds patents on the technology. Dr. Herbst is a consultant, researcher, and/or holds stock in many companies, including AstraZeneca, Pfizer, and Checkpoint Therapeutics. 
 

A version of this article appeared on Medscape.com .

SAN DIEGO — A new blood test that combines cell-free DNA fragmentomes and protein biomarkers to screen for ovarian cancer shows promising results, according to an initial analysis. 

The test, under development by Delfi Diagnostics, “looks very sensitive for detecting ovarian cancer early,” said company founder and board member Victor E. Velculescu, MD, PhD, codirector of Cancer Genetics and Epigenetics at Johns Hopkins University, Baltimore. 

The assay uses machine learning to integrate cell-free DNA fragment patterns with concentrations of two ovarian cancer biomarkers — CA125 and HE4 — to detect tumors. 

While fragmentation patterns are organized in healthy people, they are chaotic in cancer and reveal both its presence and location, said Velculescu who presented the findings at the American Association for Cancer Research annual meeting.

The researchers tested the assay in 134 women with ovarian cancer, 204 women without cancer, and 203 women with benign adnexal masses. The approach identified 69% of stage 1 cancers, 76% of stage 2, 85% of stage 3, and 100% of stage 4 at a specificity of over 99% and an area under the curve (AUC) of 0.97.

The test identified 91% of high-grade serous ovarian cancers — the most common type of ovarian cancer.

The AUC for distinguishing benign masses from cancer was 0.87, with 60% of ovarian cancers detected at a specificity of 95%. 

“In the preoperative setting where lower specificity is acceptable, this approach may improve management of adnexal masses,” the investigators said in their abstract.

Dr. Velculescu cautioned that the report “is an initial analysis” and that his team is working on validating the finding on a larger scale in both average and high-risk women.

If validated, the test “could enable population-wide ovarian cancer screening,” he added.

Delfi recently launched a lung cancer screening blood test — FirstLook Lung— that also uses a “fragmentomics” approach to detect tumors. The company is hopeful it will reach the market with a similar test for ovarian cancer, but it’s not a certainty. 

With lung cancer, we know screening helps. For ovarian cancer, however, it’s unclear whether this will help or not, said Dr. Velculescu. But based on the study findings, but “we are now optimistic that this could make an impact. We have more work to do.” 

This presentation was one of many at the meeting about liquid biopsies using DNA, RNA, and proteins to detect cancer, including a new assay for pancreatic cancer, another cancer that like ovarian cancer is difficult to detect in the early stages. 

“This is the future,” said study moderator Roy S. Herbst, MD, PhD, chief of medical oncology at Yale University in New Haven, Connecticut. 

He called liquid biopsy “a great advance” in many oncology settings, including cancer screening because finding tumors early offers the best chance at cure. 

However, one of the main concerns about rolling out liquid biopsies for wide-scale cancer screening is the possibility that a test will come back positive, but no tumor will be seen on diagnostic imaging, said Herbst. It won’t be clear if the test was a false positive or if the patient has a brewing tumor that can’t be located and treated, a difficult situation for both patients and doctors. 

What to do in that situation is “a policy question that the entire country is asking now as liquid biopsies are moving forward,” he said. We are going to have to come together to figure it out and learn how to use these tests.

The work was funded by Delfi Diagnostics, the National Institutes of Health, and others. Dr. Velculescu, in addition to founding Delfi, holds patents on the technology. Dr. Herbst is a consultant, researcher, and/or holds stock in many companies, including AstraZeneca, Pfizer, and Checkpoint Therapeutics. 
 

A version of this article appeared on Medscape.com .

SAN DIEGO — A new blood test that combines cell-free DNA fragmentomes and protein biomarkers to screen for ovarian cancer shows promising results, according to an initial analysis. 

The test, under development by Delfi Diagnostics, “looks very sensitive for detecting ovarian cancer early,” said company founder and board member Victor E. Velculescu, MD, PhD, codirector of Cancer Genetics and Epigenetics at Johns Hopkins University, Baltimore. 

The assay uses machine learning to integrate cell-free DNA fragment patterns with concentrations of two ovarian cancer biomarkers — CA125 and HE4 — to detect tumors. 

While fragmentation patterns are organized in healthy people, they are chaotic in cancer and reveal both its presence and location, said Velculescu who presented the findings at the American Association for Cancer Research annual meeting.

The researchers tested the assay in 134 women with ovarian cancer, 204 women without cancer, and 203 women with benign adnexal masses. The approach identified 69% of stage 1 cancers, 76% of stage 2, 85% of stage 3, and 100% of stage 4 at a specificity of over 99% and an area under the curve (AUC) of 0.97.

The test identified 91% of high-grade serous ovarian cancers — the most common type of ovarian cancer.

The AUC for distinguishing benign masses from cancer was 0.87, with 60% of ovarian cancers detected at a specificity of 95%. 

“In the preoperative setting where lower specificity is acceptable, this approach may improve management of adnexal masses,” the investigators said in their abstract.

Dr. Velculescu cautioned that the report “is an initial analysis” and that his team is working on validating the finding on a larger scale in both average and high-risk women.

If validated, the test “could enable population-wide ovarian cancer screening,” he added.

Delfi recently launched a lung cancer screening blood test — FirstLook Lung— that also uses a “fragmentomics” approach to detect tumors. The company is hopeful it will reach the market with a similar test for ovarian cancer, but it’s not a certainty. 

With lung cancer, we know screening helps. For ovarian cancer, however, it’s unclear whether this will help or not, said Dr. Velculescu. But based on the study findings, but “we are now optimistic that this could make an impact. We have more work to do.” 

This presentation was one of many at the meeting about liquid biopsies using DNA, RNA, and proteins to detect cancer, including a new assay for pancreatic cancer, another cancer that like ovarian cancer is difficult to detect in the early stages. 

“This is the future,” said study moderator Roy S. Herbst, MD, PhD, chief of medical oncology at Yale University in New Haven, Connecticut. 

He called liquid biopsy “a great advance” in many oncology settings, including cancer screening because finding tumors early offers the best chance at cure. 

However, one of the main concerns about rolling out liquid biopsies for wide-scale cancer screening is the possibility that a test will come back positive, but no tumor will be seen on diagnostic imaging, said Herbst. It won’t be clear if the test was a false positive or if the patient has a brewing tumor that can’t be located and treated, a difficult situation for both patients and doctors. 

What to do in that situation is “a policy question that the entire country is asking now as liquid biopsies are moving forward,” he said. We are going to have to come together to figure it out and learn how to use these tests.

The work was funded by Delfi Diagnostics, the National Institutes of Health, and others. Dr. Velculescu, in addition to founding Delfi, holds patents on the technology. Dr. Herbst is a consultant, researcher, and/or holds stock in many companies, including AstraZeneca, Pfizer, and Checkpoint Therapeutics. 
 

A version of this article appeared on Medscape.com .