MDedge ObGyn

Information readily available on a newborn screening, combined with clinical risk factors, may eventually be able to help identify infants at increased risk for sudden infant death syndrome (SIDS), new data suggest.

Findings of the study by Scott P. Oltman, MS, of the Department of Epidemiology & Biostatistics, University of California, San Francisco, and colleagues were published in JAMA Pediatrics.

The case-controlled study showed a link between aberrant metabolic analytes at birth and SIDS. Researchers used data from the California Office of Statewide Health Planning and Development and the California Department of Public Health and included 2.3 million infants born between 2005 and 2011 in the dataset.

Of the 2.3 million infants, 354 had SIDS. The researchers found that 14 newborn screening metabolites were significantly associated with SIDS. After the screens, the babies who had elevated metabolite markers, compared with the control babies had 14.4 times higher odds of having SIDS, the researchers reported.

“It’s really promising research,” Joanna J. Parga-Belinkie, MD, an attending neonatologist who was not involved in the study, said in an interview. She practices in the Division of Neonatology at Children’s Hospital of Philadelphia in Pennsylvania. “It doesn’t really give us the answer to what causes SIDS, but I think in the long term it’s going to inform a lot of research that will help us understand whether there are biomarkers that can predict SIDS.”

Other studies have looked at different metabolic markers to see if they can help predict SIDS, she said, but the innovation in this study is that it uses newborn screens, which are collected on all babies born in a hospital. Dr. Parga-Belinkie added that another strength of the study is its large sample size and matched controls to compare the SIDS cases with healthy babies.

“That said, newborn screens are a screening test, they are not diagnostic,” Dr. Parga-Belinkie said. “We definitely need further testing to see if (the metabolic biomarkers) really make that link to SIDS.”

It will be important to test this in a prospective study over time and in real time, she said, which is something the authors acknowledge. They list the retrospective design of the study as a major limitation.

These study results won’t change the counseling for families on decreasing risk, Dr. Parga-Belinkie said, “because there’s not a clear biomarker that has emerged and we don’t have a clear link yet.” Safe sleep hygiene will continue to be the primary focus of counseling parents, such as placing the baby on its back on a firm, flat surface with no loose bedding or stuffed animals.

The study authors said several things will need to be clarified with future research, noting that a majority of the infants in the California database were of Hispanic ethnicity. Testing other populations will help determine generalizability.

Also, there has been ambiguity in the definition of SIDS, which has led to inconsistencies in classifying a death as SIDS or death from an unknown cause of suffocation or asphyxiation.

They added: “It may also be the case that these markers are predictive and reliable but not causal in nature and distinguishing between the two is a crucial topic for future investigation.”

This work was supported in part by the California Preterm Birth Initiative within the University of California, San Francisco, and by the National Institutes of Health. Mr. Oltman reported having a patent pending for a newborn metabolic vulnerability model for identifying preterm infants at risk of adverse outcomes and uses thereof. One coauthor reported having a patent pending and a patent issued; another reported having a patent pending for a newborn metabolic vulnerability model for identifying preterm infants at risk of adverse outcomes and uses thereof. Dr. Parga-Belinkie declared no relevant financial disclosures.

Information readily available on a newborn screening, combined with clinical risk factors, may eventually be able to help identify infants at increased risk for sudden infant death syndrome (SIDS), new data suggest.

Findings of the study by Scott P. Oltman, MS, of the Department of Epidemiology & Biostatistics, University of California, San Francisco, and colleagues were published in JAMA Pediatrics.

The case-controlled study showed a link between aberrant metabolic analytes at birth and SIDS. Researchers used data from the California Office of Statewide Health Planning and Development and the California Department of Public Health and included 2.3 million infants born between 2005 and 2011 in the dataset.

Of the 2.3 million infants, 354 had SIDS. The researchers found that 14 newborn screening metabolites were significantly associated with SIDS. After the screens, the babies who had elevated metabolite markers, compared with the control babies had 14.4 times higher odds of having SIDS, the researchers reported.

“It’s really promising research,” Joanna J. Parga-Belinkie, MD, an attending neonatologist who was not involved in the study, said in an interview. She practices in the Division of Neonatology at Children’s Hospital of Philadelphia in Pennsylvania. “It doesn’t really give us the answer to what causes SIDS, but I think in the long term it’s going to inform a lot of research that will help us understand whether there are biomarkers that can predict SIDS.”

Other studies have looked at different metabolic markers to see if they can help predict SIDS, she said, but the innovation in this study is that it uses newborn screens, which are collected on all babies born in a hospital. Dr. Parga-Belinkie added that another strength of the study is its large sample size and matched controls to compare the SIDS cases with healthy babies.

“That said, newborn screens are a screening test, they are not diagnostic,” Dr. Parga-Belinkie said. “We definitely need further testing to see if (the metabolic biomarkers) really make that link to SIDS.”

It will be important to test this in a prospective study over time and in real time, she said, which is something the authors acknowledge. They list the retrospective design of the study as a major limitation.

These study results won’t change the counseling for families on decreasing risk, Dr. Parga-Belinkie said, “because there’s not a clear biomarker that has emerged and we don’t have a clear link yet.” Safe sleep hygiene will continue to be the primary focus of counseling parents, such as placing the baby on its back on a firm, flat surface with no loose bedding or stuffed animals.

The study authors said several things will need to be clarified with future research, noting that a majority of the infants in the California database were of Hispanic ethnicity. Testing other populations will help determine generalizability.

Also, there has been ambiguity in the definition of SIDS, which has led to inconsistencies in classifying a death as SIDS or death from an unknown cause of suffocation or asphyxiation.

They added: “It may also be the case that these markers are predictive and reliable but not causal in nature and distinguishing between the two is a crucial topic for future investigation.”

This work was supported in part by the California Preterm Birth Initiative within the University of California, San Francisco, and by the National Institutes of Health. Mr. Oltman reported having a patent pending for a newborn metabolic vulnerability model for identifying preterm infants at risk of adverse outcomes and uses thereof. One coauthor reported having a patent pending and a patent issued; another reported having a patent pending for a newborn metabolic vulnerability model for identifying preterm infants at risk of adverse outcomes and uses thereof. Dr. Parga-Belinkie declared no relevant financial disclosures.

Information readily available on a newborn screening, combined with clinical risk factors, may eventually be able to help identify infants at increased risk for sudden infant death syndrome (SIDS), new data suggest.

Findings of the study by Scott P. Oltman, MS, of the Department of Epidemiology & Biostatistics, University of California, San Francisco, and colleagues were published in JAMA Pediatrics.

The case-controlled study showed a link between aberrant metabolic analytes at birth and SIDS. Researchers used data from the California Office of Statewide Health Planning and Development and the California Department of Public Health and included 2.3 million infants born between 2005 and 2011 in the dataset.

Of the 2.3 million infants, 354 had SIDS. The researchers found that 14 newborn screening metabolites were significantly associated with SIDS. After the screens, the babies who had elevated metabolite markers, compared with the control babies had 14.4 times higher odds of having SIDS, the researchers reported.

“It’s really promising research,” Joanna J. Parga-Belinkie, MD, an attending neonatologist who was not involved in the study, said in an interview. She practices in the Division of Neonatology at Children’s Hospital of Philadelphia in Pennsylvania. “It doesn’t really give us the answer to what causes SIDS, but I think in the long term it’s going to inform a lot of research that will help us understand whether there are biomarkers that can predict SIDS.”

Other studies have looked at different metabolic markers to see if they can help predict SIDS, she said, but the innovation in this study is that it uses newborn screens, which are collected on all babies born in a hospital. Dr. Parga-Belinkie added that another strength of the study is its large sample size and matched controls to compare the SIDS cases with healthy babies.

“That said, newborn screens are a screening test, they are not diagnostic,” Dr. Parga-Belinkie said. “We definitely need further testing to see if (the metabolic biomarkers) really make that link to SIDS.”

It will be important to test this in a prospective study over time and in real time, she said, which is something the authors acknowledge. They list the retrospective design of the study as a major limitation.

These study results won’t change the counseling for families on decreasing risk, Dr. Parga-Belinkie said, “because there’s not a clear biomarker that has emerged and we don’t have a clear link yet.” Safe sleep hygiene will continue to be the primary focus of counseling parents, such as placing the baby on its back on a firm, flat surface with no loose bedding or stuffed animals.

The study authors said several things will need to be clarified with future research, noting that a majority of the infants in the California database were of Hispanic ethnicity. Testing other populations will help determine generalizability.

Also, there has been ambiguity in the definition of SIDS, which has led to inconsistencies in classifying a death as SIDS or death from an unknown cause of suffocation or asphyxiation.

They added: “It may also be the case that these markers are predictive and reliable but not causal in nature and distinguishing between the two is a crucial topic for future investigation.”

This work was supported in part by the California Preterm Birth Initiative within the University of California, San Francisco, and by the National Institutes of Health. Mr. Oltman reported having a patent pending for a newborn metabolic vulnerability model for identifying preterm infants at risk of adverse outcomes and uses thereof. One coauthor reported having a patent pending and a patent issued; another reported having a patent pending for a newborn metabolic vulnerability model for identifying preterm infants at risk of adverse outcomes and uses thereof. Dr. Parga-Belinkie declared no relevant financial disclosures.

A surprising new report by the Mercer consulting firm projects that the American healthcare workforce will face a small shortfall in 2028 — a shortage of less than 1% of all employees. The report even projects a surplus of tens of thousands of registered nurses and home health aides — and even a small surplus of physicians in some states.

Mercer’s projections are rosier than federal workforce projections, which paint a grimmer picture of impending shortages.

“The labor market is a little more stabilized right now, and most healthcare systems are seeing less turnover,” Dan Lezotte, PhD, a partner with Mercer, said in an interview. But he noted “critical shortages” are still expected in some areas.

Mercer last projected workforce numbers in a 2020-2021 report released during the height of the COVID-19 pandemic. Now, “the labor market is drastically different,” Dr. Lezotte said. Health workforce shortages and surpluses have long varied significantly by region across the country.

The report forecasts a small surplus of physicians in 2028 but not in states such as California, New York, and Texas. The upper Midwest states will largely see doctor surpluses while Southern states face shortages. Some states with general physician surpluses may still experience shortages of specialists.

A surplus of nearly 30,000 registered nurses is expected, but New York, New Jersey, and Connecticut are projected to have a combined shortage of 16,000 nurses.

Overall, the report projects a shortage of more than 100,000 healthcare workers nationally by 2028. That’s less than 1% of the entire healthcare workforce of 18.6 million expected by then.

The report also predicts a shortage of nurse practitioners, especially in California and New York, and a shortage of 73,000 nursing assistants, especially in California, New York, and Texas.

“Healthcare systems are having the most difficulty hiring and hanging on to those workers who are supposed to take up the load off physicians and nurses,” Dr. Lezotte said. “They’re competing not only with other healthcare systems but with other industries like Amazon warehouses or McDonald’s in California paying $20 an hour. Healthcare was a little slow to keep up with that. In a lot of healthcare systems, that’s their biggest headache right now.”

On the other hand, the report projects a national surplus of 48,000 home health/personal care aides.

That surprised Bianca K. Frogner, PhD, director of the Center for Health Workforce Studies at the University of Washington, Seattle.

“We are seeing increasing movement of investments toward moving patients out of skilled nursing facilities and keeping them in the home and community, which requires many more home health aides,” Dr. Frogner said. “Given such high turnover in this occupation, it’s hard to know if the surplus is really a surplus or if they will quickly be employed.”

Dr. Frogner receives grants and contracts from not-for-profit entities to investigate issues related to the health workforce.

Dr. Lezotte said the report’s findings are based on data from sources such as public and private databases and job postings. According to the report, “projections were made up to 2028 based on historical data up to 2023,” and “supply projections were derived using a linear autoregressive model based on historical supply within each occupation and geography.”

It’s not clear why some states like New York are expected to have huge shortages, but migration might be a factor, along with a lack of nearby nursing schools, Dr. Lezotte said.

As for shortages, Dr. Lezotte said healthcare systems will have to understand their local workforce situation and adapt. “They’ll need to be more proactive about their employee value proposition” via competitive pay and benefits Flexibility regarding scheduling is also important.

“They’re going to have to figure out how to up their game,” he said.

What about states with surpluses? They might be target-rich environments for states facing shortages, he said.
 

Positive Outlook Not Shared by Other Researchers

Other workforce projections conflict with Mercer’s, according to Jean Moore, DrPH, and Gaetano Forte, MS, director and assistant director of the Center for Health Workforce Studies, School of Public Health, University at Albany, New York.

The National Center for Health Workforce Analysis projects a 10% shortage of registered nurses and a 13% shortage of physicians in 2031. The agency didn’t make projections for home health aides because that workforce is in flux.

Why are Mercer’s projections so different? Dr. Lezotte said other projections assume that equity efforts will bring healthcare to everyone who needs it. The report assumes this won’t happen, he said. As a result, it expects there will be fewer patients who need to be served by workers.

Other projections expect a shortage of 300,000 registered nurses by 2035, Mr. Forte said. But the number of nurse practitioners in New York is growing quickly, Dr. Moore said.

Dr. Moore said it’s difficult to interpret Mercer’s findings because the company doesn’t provide enough information about its methodology.

“At some level, it’s not particularly useful regarding what the next steps are,” she said. “Projections should make you think about what you should do to change and improve, to create more of what you need.”

The Center for Health Workforce Studies at the University of Albany has provided consulting services to multiple companies that provide healthcare workforce projections. It has no relationship with Mercer.

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

A surprising new report by the Mercer consulting firm projects that the American healthcare workforce will face a small shortfall in 2028 — a shortage of less than 1% of all employees. The report even projects a surplus of tens of thousands of registered nurses and home health aides — and even a small surplus of physicians in some states.

Mercer’s projections are rosier than federal workforce projections, which paint a grimmer picture of impending shortages.

“The labor market is a little more stabilized right now, and most healthcare systems are seeing less turnover,” Dan Lezotte, PhD, a partner with Mercer, said in an interview. But he noted “critical shortages” are still expected in some areas.

Mercer last projected workforce numbers in a 2020-2021 report released during the height of the COVID-19 pandemic. Now, “the labor market is drastically different,” Dr. Lezotte said. Health workforce shortages and surpluses have long varied significantly by region across the country.

The report forecasts a small surplus of physicians in 2028 but not in states such as California, New York, and Texas. The upper Midwest states will largely see doctor surpluses while Southern states face shortages. Some states with general physician surpluses may still experience shortages of specialists.

A surplus of nearly 30,000 registered nurses is expected, but New York, New Jersey, and Connecticut are projected to have a combined shortage of 16,000 nurses.

Overall, the report projects a shortage of more than 100,000 healthcare workers nationally by 2028. That’s less than 1% of the entire healthcare workforce of 18.6 million expected by then.

The report also predicts a shortage of nurse practitioners, especially in California and New York, and a shortage of 73,000 nursing assistants, especially in California, New York, and Texas.

“Healthcare systems are having the most difficulty hiring and hanging on to those workers who are supposed to take up the load off physicians and nurses,” Dr. Lezotte said. “They’re competing not only with other healthcare systems but with other industries like Amazon warehouses or McDonald’s in California paying $20 an hour. Healthcare was a little slow to keep up with that. In a lot of healthcare systems, that’s their biggest headache right now.”

On the other hand, the report projects a national surplus of 48,000 home health/personal care aides.

That surprised Bianca K. Frogner, PhD, director of the Center for Health Workforce Studies at the University of Washington, Seattle.

“We are seeing increasing movement of investments toward moving patients out of skilled nursing facilities and keeping them in the home and community, which requires many more home health aides,” Dr. Frogner said. “Given such high turnover in this occupation, it’s hard to know if the surplus is really a surplus or if they will quickly be employed.”

Dr. Frogner receives grants and contracts from not-for-profit entities to investigate issues related to the health workforce.

Dr. Lezotte said the report’s findings are based on data from sources such as public and private databases and job postings. According to the report, “projections were made up to 2028 based on historical data up to 2023,” and “supply projections were derived using a linear autoregressive model based on historical supply within each occupation and geography.”

It’s not clear why some states like New York are expected to have huge shortages, but migration might be a factor, along with a lack of nearby nursing schools, Dr. Lezotte said.

As for shortages, Dr. Lezotte said healthcare systems will have to understand their local workforce situation and adapt. “They’ll need to be more proactive about their employee value proposition” via competitive pay and benefits Flexibility regarding scheduling is also important.

“They’re going to have to figure out how to up their game,” he said.

What about states with surpluses? They might be target-rich environments for states facing shortages, he said.
 

Positive Outlook Not Shared by Other Researchers

Other workforce projections conflict with Mercer’s, according to Jean Moore, DrPH, and Gaetano Forte, MS, director and assistant director of the Center for Health Workforce Studies, School of Public Health, University at Albany, New York.

The National Center for Health Workforce Analysis projects a 10% shortage of registered nurses and a 13% shortage of physicians in 2031. The agency didn’t make projections for home health aides because that workforce is in flux.

Why are Mercer’s projections so different? Dr. Lezotte said other projections assume that equity efforts will bring healthcare to everyone who needs it. The report assumes this won’t happen, he said. As a result, it expects there will be fewer patients who need to be served by workers.

Other projections expect a shortage of 300,000 registered nurses by 2035, Mr. Forte said. But the number of nurse practitioners in New York is growing quickly, Dr. Moore said.

Dr. Moore said it’s difficult to interpret Mercer’s findings because the company doesn’t provide enough information about its methodology.

“At some level, it’s not particularly useful regarding what the next steps are,” she said. “Projections should make you think about what you should do to change and improve, to create more of what you need.”

The Center for Health Workforce Studies at the University of Albany has provided consulting services to multiple companies that provide healthcare workforce projections. It has no relationship with Mercer.

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

A surprising new report by the Mercer consulting firm projects that the American healthcare workforce will face a small shortfall in 2028 — a shortage of less than 1% of all employees. The report even projects a surplus of tens of thousands of registered nurses and home health aides — and even a small surplus of physicians in some states.

Mercer’s projections are rosier than federal workforce projections, which paint a grimmer picture of impending shortages.

“The labor market is a little more stabilized right now, and most healthcare systems are seeing less turnover,” Dan Lezotte, PhD, a partner with Mercer, said in an interview. But he noted “critical shortages” are still expected in some areas.

Mercer last projected workforce numbers in a 2020-2021 report released during the height of the COVID-19 pandemic. Now, “the labor market is drastically different,” Dr. Lezotte said. Health workforce shortages and surpluses have long varied significantly by region across the country.

The report forecasts a small surplus of physicians in 2028 but not in states such as California, New York, and Texas. The upper Midwest states will largely see doctor surpluses while Southern states face shortages. Some states with general physician surpluses may still experience shortages of specialists.

A surplus of nearly 30,000 registered nurses is expected, but New York, New Jersey, and Connecticut are projected to have a combined shortage of 16,000 nurses.

Overall, the report projects a shortage of more than 100,000 healthcare workers nationally by 2028. That’s less than 1% of the entire healthcare workforce of 18.6 million expected by then.

The report also predicts a shortage of nurse practitioners, especially in California and New York, and a shortage of 73,000 nursing assistants, especially in California, New York, and Texas.

“Healthcare systems are having the most difficulty hiring and hanging on to those workers who are supposed to take up the load off physicians and nurses,” Dr. Lezotte said. “They’re competing not only with other healthcare systems but with other industries like Amazon warehouses or McDonald’s in California paying $20 an hour. Healthcare was a little slow to keep up with that. In a lot of healthcare systems, that’s their biggest headache right now.”

On the other hand, the report projects a national surplus of 48,000 home health/personal care aides.

That surprised Bianca K. Frogner, PhD, director of the Center for Health Workforce Studies at the University of Washington, Seattle.

“We are seeing increasing movement of investments toward moving patients out of skilled nursing facilities and keeping them in the home and community, which requires many more home health aides,” Dr. Frogner said. “Given such high turnover in this occupation, it’s hard to know if the surplus is really a surplus or if they will quickly be employed.”

Dr. Frogner receives grants and contracts from not-for-profit entities to investigate issues related to the health workforce.

Dr. Lezotte said the report’s findings are based on data from sources such as public and private databases and job postings. According to the report, “projections were made up to 2028 based on historical data up to 2023,” and “supply projections were derived using a linear autoregressive model based on historical supply within each occupation and geography.”

It’s not clear why some states like New York are expected to have huge shortages, but migration might be a factor, along with a lack of nearby nursing schools, Dr. Lezotte said.

As for shortages, Dr. Lezotte said healthcare systems will have to understand their local workforce situation and adapt. “They’ll need to be more proactive about their employee value proposition” via competitive pay and benefits Flexibility regarding scheduling is also important.

“They’re going to have to figure out how to up their game,” he said.

What about states with surpluses? They might be target-rich environments for states facing shortages, he said.
 

Positive Outlook Not Shared by Other Researchers

Other workforce projections conflict with Mercer’s, according to Jean Moore, DrPH, and Gaetano Forte, MS, director and assistant director of the Center for Health Workforce Studies, School of Public Health, University at Albany, New York.

The National Center for Health Workforce Analysis projects a 10% shortage of registered nurses and a 13% shortage of physicians in 2031. The agency didn’t make projections for home health aides because that workforce is in flux.

Why are Mercer’s projections so different? Dr. Lezotte said other projections assume that equity efforts will bring healthcare to everyone who needs it. The report assumes this won’t happen, he said. As a result, it expects there will be fewer patients who need to be served by workers.

Other projections expect a shortage of 300,000 registered nurses by 2035, Mr. Forte said. But the number of nurse practitioners in New York is growing quickly, Dr. Moore said.

Dr. Moore said it’s difficult to interpret Mercer’s findings because the company doesn’t provide enough information about its methodology.

“At some level, it’s not particularly useful regarding what the next steps are,” she said. “Projections should make you think about what you should do to change and improve, to create more of what you need.”

The Center for Health Workforce Studies at the University of Albany has provided consulting services to multiple companies that provide healthcare workforce projections. It has no relationship with Mercer.

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

Adjuvant radiotherapy reduces the risk for short-term recurrence in patients with early breast cancer, but it may have no impact on long-term recurrence or overall survival, based on a 30-year follow-up of the Scottish Breast Conservation Trial.

These findings suggest that patients with biology predicting late relapse may receive little benefit from adjuvant radiotherapy, lead author Linda J. Williams, PhD, of the University of Edinburgh in Scotland, and colleagues, reported.

“During the past 30 years, several randomized controlled trials have investigated the role of postoperative radiotherapy after breast-conserving surgery for early breast cancer,” the investigators wrote in The Lancet Oncology. “These trials showed that radiotherapy reduces the risk of local recurrence but were underpowered individually to detect a difference in overall survival.”
 

How Did the Present Study Increase Our Understanding of the Benefits of Adjuvant Radiotherapy in Early Breast Cancer?

The present analysis included data from a trial that began in 1985, when 589 patients with early breast cancer (tumors ≤ 4 cm [T1 or T2 and N0 or N1]) were randomized to receive either high-dose or no radiotherapy, with final cohorts including 291 patients and 294 patients, respectively. The radiotherapy was given 50 Gy in 20-25 fractions, either locally or locoregionally.

Estrogen receptor (ER)–positive patients (≥ 20 fmol/mg protein) received 5 years of daily oral tamoxifen. ER-poor patients (< 20 fmol/mg protein) received a chemotherapy combination of cyclophosphamide, methotrexate, and fluorouracil on a 21-day cycle for eight cycles.

Considering all data across a median follow-up of 17.5 years, adjuvant radiotherapy appeared to offer benefit, as it was associated with significantly lower ipsilateral breast tumor recurrence (16% vs 36%; hazard ratio [HR], 0.39; P < .0001).

But that tells only part of the story.

The positive impact of radiotherapy persisted for 1 decade (HR, 0.24; P < .0001), but risk beyond this point was no different between groups (HR, 0.98; P = .95).

“[The] benefit of radiotherapy was time dependent,” the investigators noted.

What’s more, median overall survival was no different between those who received radiotherapy and those who did not (18.7 vs 19.2 years; HR, 1.08; log-rank P = .43), and “reassuringly,” omitting radiotherapy did not increase the rate of distant metastasis.
 

How Might These Findings Influence Treatment Planning for Patients With Early Breast Cancer?

“The results can help clinicians to advise patients better about their choice to have radiotherapy or not if they better understand what benefits it does and does not bring,” the investigators wrote. “These results might provide clues perhaps to the biology of radiotherapy benefit, given that it does not prevent late recurrences, suggesting that patients whose biology predicts a late relapse only might not gain a benefit from radiotherapy.”

Gary M. Freedman, MD, chief of Women’s Health Service, Radiation Oncology, at Penn Medicine, Philadelphia, offered a different perspective.

“The study lumps together a local recurrence of breast cancer — that is relapse of the cancer years after treatment with lumpectomy and radiation — with the development of an entirely new breast cancer in the same breast,” Dr. Freedman said in a written comment. “When something comes back between years 0-5 and 0-8, we usually think of it as a true local recurrence arbitrarily, but beyond that they are new cancers.”

He went on to emphasize the clinical importance of reducing local recurrence within the first decade, noting that “this leads to much less morbidity and better quality of life for the patients.”

Dr. Freedman also shared his perspective on the survival data.

“Radiation did reduce breast cancer mortality very significantly — death from breast cancers went down from 46% to 37%,” he wrote (P = .054). “This is on the same level as chemo or hormone therapy. The study was not powered to detect significant differences in survival by radiation, but that has been shown with other meta-analyses.”
 

Are Findings From a Trial Started 30 Years Ago Still Relevant Today?

“Clearly the treatment of early breast cancer has advanced since the 1980s when the Scottish Conservation trial was launched,” study coauthor Ian Kunkler, MB, FRCR, of the University of Edinburgh, said in a written comment. “There is more breast screening, attention to clearing surgical margins of residual disease, more effective and longer periods of adjuvant hormonal therapy, reduced radiotherapy toxicity from more precise delivery. However, most anticancer treatments lose their effectiveness over time.”

He suggested that more trials are needed to confirm the present findings and reiterated that the lack of long-term recurrence benefit is most relevant for patients with disease features that predict late relapse, who “seem to gain little from adjuvant radiotherapy given as part of primary treatment.”

Dr. Kunkler noted that the observed benefit in the first decade supports the continued use of radiotherapy alongside anticancer drug treatment.

When asked the same question, Freedman emphasized the differences in treatment today vs the 1980s.

“The results of modern multidisciplinary cancer care are much, much better than these 30-year results,” Dr. Freedman said. “The risk for local recurrence in the breast after radiation is now about 2%-3% at 10 years in most studies.”

He also noted that modern radiotherapy techniques have “significantly lowered dose and risks to heart and lung,” compared with techniques used 30 years ago.

“A take-home point for the study is after breast conservation, whether or not you have radiation, you have to continue long-term screening mammograms for new breast cancers that may occur even decades later,” Dr. Freedman concluded.
 

How Might These Findings Impact Future Research Design and Funding?

“The findings should encourage trial funders to consider funding long-term follow-up beyond 10 years to assess benefits and risks of anticancer therapies,” Dr. Kunkler said. “The importance of long-term follow-up cannot be understated.”

This study was funded by Breast Cancer Institute (part of Edinburgh and Lothians Health Foundation), PFS Genomics (now part of Exact Sciences), the University of Edinburgh, and NHS Lothian. The investigators reported no conflicts of interest.

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

Adjuvant radiotherapy reduces the risk for short-term recurrence in patients with early breast cancer, but it may have no impact on long-term recurrence or overall survival, based on a 30-year follow-up of the Scottish Breast Conservation Trial.

These findings suggest that patients with biology predicting late relapse may receive little benefit from adjuvant radiotherapy, lead author Linda J. Williams, PhD, of the University of Edinburgh in Scotland, and colleagues, reported.

“During the past 30 years, several randomized controlled trials have investigated the role of postoperative radiotherapy after breast-conserving surgery for early breast cancer,” the investigators wrote in The Lancet Oncology. “These trials showed that radiotherapy reduces the risk of local recurrence but were underpowered individually to detect a difference in overall survival.”
 

How Did the Present Study Increase Our Understanding of the Benefits of Adjuvant Radiotherapy in Early Breast Cancer?

The present analysis included data from a trial that began in 1985, when 589 patients with early breast cancer (tumors ≤ 4 cm [T1 or T2 and N0 or N1]) were randomized to receive either high-dose or no radiotherapy, with final cohorts including 291 patients and 294 patients, respectively. The radiotherapy was given 50 Gy in 20-25 fractions, either locally or locoregionally.

Estrogen receptor (ER)–positive patients (≥ 20 fmol/mg protein) received 5 years of daily oral tamoxifen. ER-poor patients (< 20 fmol/mg protein) received a chemotherapy combination of cyclophosphamide, methotrexate, and fluorouracil on a 21-day cycle for eight cycles.

Considering all data across a median follow-up of 17.5 years, adjuvant radiotherapy appeared to offer benefit, as it was associated with significantly lower ipsilateral breast tumor recurrence (16% vs 36%; hazard ratio [HR], 0.39; P < .0001).

But that tells only part of the story.

The positive impact of radiotherapy persisted for 1 decade (HR, 0.24; P < .0001), but risk beyond this point was no different between groups (HR, 0.98; P = .95).

“[The] benefit of radiotherapy was time dependent,” the investigators noted.

What’s more, median overall survival was no different between those who received radiotherapy and those who did not (18.7 vs 19.2 years; HR, 1.08; log-rank P = .43), and “reassuringly,” omitting radiotherapy did not increase the rate of distant metastasis.
 

How Might These Findings Influence Treatment Planning for Patients With Early Breast Cancer?

“The results can help clinicians to advise patients better about their choice to have radiotherapy or not if they better understand what benefits it does and does not bring,” the investigators wrote. “These results might provide clues perhaps to the biology of radiotherapy benefit, given that it does not prevent late recurrences, suggesting that patients whose biology predicts a late relapse only might not gain a benefit from radiotherapy.”

Gary M. Freedman, MD, chief of Women’s Health Service, Radiation Oncology, at Penn Medicine, Philadelphia, offered a different perspective.

“The study lumps together a local recurrence of breast cancer — that is relapse of the cancer years after treatment with lumpectomy and radiation — with the development of an entirely new breast cancer in the same breast,” Dr. Freedman said in a written comment. “When something comes back between years 0-5 and 0-8, we usually think of it as a true local recurrence arbitrarily, but beyond that they are new cancers.”

He went on to emphasize the clinical importance of reducing local recurrence within the first decade, noting that “this leads to much less morbidity and better quality of life for the patients.”

Dr. Freedman also shared his perspective on the survival data.

“Radiation did reduce breast cancer mortality very significantly — death from breast cancers went down from 46% to 37%,” he wrote (P = .054). “This is on the same level as chemo or hormone therapy. The study was not powered to detect significant differences in survival by radiation, but that has been shown with other meta-analyses.”
 

Are Findings From a Trial Started 30 Years Ago Still Relevant Today?

“Clearly the treatment of early breast cancer has advanced since the 1980s when the Scottish Conservation trial was launched,” study coauthor Ian Kunkler, MB, FRCR, of the University of Edinburgh, said in a written comment. “There is more breast screening, attention to clearing surgical margins of residual disease, more effective and longer periods of adjuvant hormonal therapy, reduced radiotherapy toxicity from more precise delivery. However, most anticancer treatments lose their effectiveness over time.”

He suggested that more trials are needed to confirm the present findings and reiterated that the lack of long-term recurrence benefit is most relevant for patients with disease features that predict late relapse, who “seem to gain little from adjuvant radiotherapy given as part of primary treatment.”

Dr. Kunkler noted that the observed benefit in the first decade supports the continued use of radiotherapy alongside anticancer drug treatment.

When asked the same question, Freedman emphasized the differences in treatment today vs the 1980s.

“The results of modern multidisciplinary cancer care are much, much better than these 30-year results,” Dr. Freedman said. “The risk for local recurrence in the breast after radiation is now about 2%-3% at 10 years in most studies.”

He also noted that modern radiotherapy techniques have “significantly lowered dose and risks to heart and lung,” compared with techniques used 30 years ago.

“A take-home point for the study is after breast conservation, whether or not you have radiation, you have to continue long-term screening mammograms for new breast cancers that may occur even decades later,” Dr. Freedman concluded.
 

How Might These Findings Impact Future Research Design and Funding?

“The findings should encourage trial funders to consider funding long-term follow-up beyond 10 years to assess benefits and risks of anticancer therapies,” Dr. Kunkler said. “The importance of long-term follow-up cannot be understated.”

This study was funded by Breast Cancer Institute (part of Edinburgh and Lothians Health Foundation), PFS Genomics (now part of Exact Sciences), the University of Edinburgh, and NHS Lothian. The investigators reported no conflicts of interest.

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

Adjuvant radiotherapy reduces the risk for short-term recurrence in patients with early breast cancer, but it may have no impact on long-term recurrence or overall survival, based on a 30-year follow-up of the Scottish Breast Conservation Trial.

These findings suggest that patients with biology predicting late relapse may receive little benefit from adjuvant radiotherapy, lead author Linda J. Williams, PhD, of the University of Edinburgh in Scotland, and colleagues, reported.

“During the past 30 years, several randomized controlled trials have investigated the role of postoperative radiotherapy after breast-conserving surgery for early breast cancer,” the investigators wrote in The Lancet Oncology. “These trials showed that radiotherapy reduces the risk of local recurrence but were underpowered individually to detect a difference in overall survival.”
 

How Did the Present Study Increase Our Understanding of the Benefits of Adjuvant Radiotherapy in Early Breast Cancer?

The present analysis included data from a trial that began in 1985, when 589 patients with early breast cancer (tumors ≤ 4 cm [T1 or T2 and N0 or N1]) were randomized to receive either high-dose or no radiotherapy, with final cohorts including 291 patients and 294 patients, respectively. The radiotherapy was given 50 Gy in 20-25 fractions, either locally or locoregionally.

Estrogen receptor (ER)–positive patients (≥ 20 fmol/mg protein) received 5 years of daily oral tamoxifen. ER-poor patients (< 20 fmol/mg protein) received a chemotherapy combination of cyclophosphamide, methotrexate, and fluorouracil on a 21-day cycle for eight cycles.

Considering all data across a median follow-up of 17.5 years, adjuvant radiotherapy appeared to offer benefit, as it was associated with significantly lower ipsilateral breast tumor recurrence (16% vs 36%; hazard ratio [HR], 0.39; P < .0001).

But that tells only part of the story.

The positive impact of radiotherapy persisted for 1 decade (HR, 0.24; P < .0001), but risk beyond this point was no different between groups (HR, 0.98; P = .95).

“[The] benefit of radiotherapy was time dependent,” the investigators noted.

What’s more, median overall survival was no different between those who received radiotherapy and those who did not (18.7 vs 19.2 years; HR, 1.08; log-rank P = .43), and “reassuringly,” omitting radiotherapy did not increase the rate of distant metastasis.
 

How Might These Findings Influence Treatment Planning for Patients With Early Breast Cancer?

“The results can help clinicians to advise patients better about their choice to have radiotherapy or not if they better understand what benefits it does and does not bring,” the investigators wrote. “These results might provide clues perhaps to the biology of radiotherapy benefit, given that it does not prevent late recurrences, suggesting that patients whose biology predicts a late relapse only might not gain a benefit from radiotherapy.”

Gary M. Freedman, MD, chief of Women’s Health Service, Radiation Oncology, at Penn Medicine, Philadelphia, offered a different perspective.

“The study lumps together a local recurrence of breast cancer — that is relapse of the cancer years after treatment with lumpectomy and radiation — with the development of an entirely new breast cancer in the same breast,” Dr. Freedman said in a written comment. “When something comes back between years 0-5 and 0-8, we usually think of it as a true local recurrence arbitrarily, but beyond that they are new cancers.”

He went on to emphasize the clinical importance of reducing local recurrence within the first decade, noting that “this leads to much less morbidity and better quality of life for the patients.”

Dr. Freedman also shared his perspective on the survival data.

“Radiation did reduce breast cancer mortality very significantly — death from breast cancers went down from 46% to 37%,” he wrote (P = .054). “This is on the same level as chemo or hormone therapy. The study was not powered to detect significant differences in survival by radiation, but that has been shown with other meta-analyses.”
 

Are Findings From a Trial Started 30 Years Ago Still Relevant Today?

“Clearly the treatment of early breast cancer has advanced since the 1980s when the Scottish Conservation trial was launched,” study coauthor Ian Kunkler, MB, FRCR, of the University of Edinburgh, said in a written comment. “There is more breast screening, attention to clearing surgical margins of residual disease, more effective and longer periods of adjuvant hormonal therapy, reduced radiotherapy toxicity from more precise delivery. However, most anticancer treatments lose their effectiveness over time.”

He suggested that more trials are needed to confirm the present findings and reiterated that the lack of long-term recurrence benefit is most relevant for patients with disease features that predict late relapse, who “seem to gain little from adjuvant radiotherapy given as part of primary treatment.”

Dr. Kunkler noted that the observed benefit in the first decade supports the continued use of radiotherapy alongside anticancer drug treatment.

When asked the same question, Freedman emphasized the differences in treatment today vs the 1980s.

“The results of modern multidisciplinary cancer care are much, much better than these 30-year results,” Dr. Freedman said. “The risk for local recurrence in the breast after radiation is now about 2%-3% at 10 years in most studies.”

He also noted that modern radiotherapy techniques have “significantly lowered dose and risks to heart and lung,” compared with techniques used 30 years ago.

“A take-home point for the study is after breast conservation, whether or not you have radiation, you have to continue long-term screening mammograms for new breast cancers that may occur even decades later,” Dr. Freedman concluded.
 

How Might These Findings Impact Future Research Design and Funding?

“The findings should encourage trial funders to consider funding long-term follow-up beyond 10 years to assess benefits and risks of anticancer therapies,” Dr. Kunkler said. “The importance of long-term follow-up cannot be understated.”

This study was funded by Breast Cancer Institute (part of Edinburgh and Lothians Health Foundation), PFS Genomics (now part of Exact Sciences), the University of Edinburgh, and NHS Lothian. The investigators reported no conflicts of interest.

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

TOPLINE:

The use of menopausal hormone therapy (MHT) increases breast cancer risk in women with a strong family history of breast cancer. These women have a striking cumulative risk of developing breast cancer (age, 50-80 years) of 22.4%, according to a new modelling study of UK women.

METHODOLOGY:

This was a modeling study integrating two data-sets of UK women: the BOADICEA dataset of age-specific breast cancer risk with family history and the Collaborative Group on Hormonal Factors in Breast Cancer, which covers relative risk for breast cancer with different types and durations of MHT.

Four different breast cancer family history profiles were:

• “Average” family history of breast cancer has unknown affected family members;
• “Modest” family history comprises a single first-degree relative with breast cancer at the age of 60 years.
• “Intermediate” family history comprises a single first-degree relative who developed breast cancer at the age of 40 years.
• “Strong” family history comprises two first-degree relatives who developed breast cancer at the age of 50 years.

TAKEAWAY:

• The lowest risk category: “Average” family history with no MHT use has a cumulative breast cancer risk (age, 50-80 years) of 9.8% and a risk of dying from breast cancer of 1.7%. These risks rise with 5 years’ exposure to MHT (age, 50-55 years) to 11.0% and 1.8%, respectively.
• The highest risk category: “Strong” family history with no MHT use has a cumulative breast cancer risk (age, 50-80 years) of 19.6% and a risk of dying from breast cancer of 3.2%. These risks rise with 5 years’ exposure to MHT (age, 50-55 years) to 22.4% and 3.5%, respectively.

IN PRACTICE:

The authors concluded that, “These integrated data will enable more accurate estimates of absolute and attributable risk associated with MHT exposure for women with a family history of breast cancer, informing shared decision-making.”

SOURCE:

The lead author is Catherine Huntley of the Institute of Cancer Research, London, England. The study appeared in the British Journal of General Practice.

LIMITATIONS:

Limitations included modeling study that did not directly measure individuals with combined risks.

DISCLOSURES:

The study was funded by several sources including Cancer Research UK. The authors reported no conflicts of interest.

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

TOPLINE:

The use of menopausal hormone therapy (MHT) increases breast cancer risk in women with a strong family history of breast cancer. These women have a striking cumulative risk of developing breast cancer (age, 50-80 years) of 22.4%, according to a new modelling study of UK women.

METHODOLOGY:

This was a modeling study integrating two data-sets of UK women: the BOADICEA dataset of age-specific breast cancer risk with family history and the Collaborative Group on Hormonal Factors in Breast Cancer, which covers relative risk for breast cancer with different types and durations of MHT.

Four different breast cancer family history profiles were:

• “Average” family history of breast cancer has unknown affected family members;
• “Modest” family history comprises a single first-degree relative with breast cancer at the age of 60 years.
• “Intermediate” family history comprises a single first-degree relative who developed breast cancer at the age of 40 years.
• “Strong” family history comprises two first-degree relatives who developed breast cancer at the age of 50 years.

TAKEAWAY:

• The lowest risk category: “Average” family history with no MHT use has a cumulative breast cancer risk (age, 50-80 years) of 9.8% and a risk of dying from breast cancer of 1.7%. These risks rise with 5 years’ exposure to MHT (age, 50-55 years) to 11.0% and 1.8%, respectively.
• The highest risk category: “Strong” family history with no MHT use has a cumulative breast cancer risk (age, 50-80 years) of 19.6% and a risk of dying from breast cancer of 3.2%. These risks rise with 5 years’ exposure to MHT (age, 50-55 years) to 22.4% and 3.5%, respectively.

IN PRACTICE:

The authors concluded that, “These integrated data will enable more accurate estimates of absolute and attributable risk associated with MHT exposure for women with a family history of breast cancer, informing shared decision-making.”

SOURCE:

The lead author is Catherine Huntley of the Institute of Cancer Research, London, England. The study appeared in the British Journal of General Practice.

LIMITATIONS:

Limitations included modeling study that did not directly measure individuals with combined risks.

DISCLOSURES:

The study was funded by several sources including Cancer Research UK. The authors reported no conflicts of interest.

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

TOPLINE:

The use of menopausal hormone therapy (MHT) increases breast cancer risk in women with a strong family history of breast cancer. These women have a striking cumulative risk of developing breast cancer (age, 50-80 years) of 22.4%, according to a new modelling study of UK women.

METHODOLOGY:

This was a modeling study integrating two data-sets of UK women: the BOADICEA dataset of age-specific breast cancer risk with family history and the Collaborative Group on Hormonal Factors in Breast Cancer, which covers relative risk for breast cancer with different types and durations of MHT.

Four different breast cancer family history profiles were:

• “Average” family history of breast cancer has unknown affected family members;
• “Modest” family history comprises a single first-degree relative with breast cancer at the age of 60 years.
• “Intermediate” family history comprises a single first-degree relative who developed breast cancer at the age of 40 years.
• “Strong” family history comprises two first-degree relatives who developed breast cancer at the age of 50 years.

TAKEAWAY:

• The lowest risk category: “Average” family history with no MHT use has a cumulative breast cancer risk (age, 50-80 years) of 9.8% and a risk of dying from breast cancer of 1.7%. These risks rise with 5 years’ exposure to MHT (age, 50-55 years) to 11.0% and 1.8%, respectively.
• The highest risk category: “Strong” family history with no MHT use has a cumulative breast cancer risk (age, 50-80 years) of 19.6% and a risk of dying from breast cancer of 3.2%. These risks rise with 5 years’ exposure to MHT (age, 50-55 years) to 22.4% and 3.5%, respectively.

IN PRACTICE:

The authors concluded that, “These integrated data will enable more accurate estimates of absolute and attributable risk associated with MHT exposure for women with a family history of breast cancer, informing shared decision-making.”

SOURCE:

The lead author is Catherine Huntley of the Institute of Cancer Research, London, England. The study appeared in the British Journal of General Practice.

LIMITATIONS:

Limitations included modeling study that did not directly measure individuals with combined risks.

DISCLOSURES:

The study was funded by several sources including Cancer Research UK. The authors reported no conflicts of interest.

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

TOPLINE:

Hormone-modulating therapy for breast cancer may protect older women from Alzheimer’s disease and related dementias, although the protective effect varies by age and race, with the greatest benefit seen in younger Black women.

METHODOLOGY:

• Hormone-modulating therapy is widely used to treat hormone receptor–positive breast cancer, but the cognitive effects of the treatment, including a potential link to dementia, remain unclear.
• To investigate, researchers used the SEER-Medicare linked database to identify women aged 65 years or older with breast cancer who did and did not receive hormone-modulating therapy within 3 years following their diagnosis.
• The researchers excluded women with preexisting Alzheimer’s disease/dementia diagnoses or those who had received hormone-modulating therapy before their breast cancer diagnosis.
• Analyses were adjusted for demographic, sociocultural, and clinical variables, and subgroup analyses evaluated the impact of age, race, and type of hormone-modulating therapy on Alzheimer’s disease/dementia risk.

TAKEAWAY:

• Among the 18,808 women included in the analysis, 66% received hormone-modulating therapy and 34% did not. During the mean follow-up of 12 years, 24% of hormone-modulating therapy users and 28% of nonusers developed Alzheimer’s disease/dementia.
• Overall, hormone-modulating therapy use (vs nonuse) was associated with a significant 7% lower risk for Alzheimer’s disease/dementia (hazard ratio [HR], 0.93; P = .005), with notable age and racial differences.
• Hormone-modulating therapy use was associated with a 24% lower risk for Alzheimer’s disease/dementia in Black women aged 65-74 years (HR, 0.76), but that protective effect decreased to 19% in Black women aged 75 years or older (HR, 0.81). White women aged 65-74 years who received hormone-modulating therapy (vs those who did not) had an 11% lower risk for Alzheimer’s disease/dementia (HR, 0.89), but the association disappeared among those aged 75 years or older (HR, 0.96; 95% CI, 0.90-1.02). Other races demonstrated no significant association between hormone-modulating therapy use and Alzheimer’s disease/dementia.
• Overall, the use of an aromatase inhibitor or a selective estrogen receptor modulator was associated with a significantly lower risk for Alzheimer’s disease/dementia (HR, 0.93 and HR, 0.89, respectively).

IN PRACTICE:

Overall, the retrospective study found that “hormone therapy was associated with protection against [Alzheimer’s/dementia] in women aged 65 years or older with newly diagnosed breast cancer,” with the decrease in risk relatively greater for Black women and women younger than 75 years, the authors concluded.

“The results highlight the critical need for personalized breast cancer treatment plans that are tailored to the individual characteristics of each patient, particularly given the significantly higher likelihood (two to three times more) of Black women developing [Alzheimer’s/dementia], compared with their White counterparts,” the researchers added.
 

SOURCE:

The study, with first author Chao Cai, PhD, Department of Clinical Pharmacy and Outcomes Sciences, University of South Carolina, Columbia, was published online on July 16 in JAMA Network Open.

LIMITATIONS:

The study included only women aged 65 years or older, limiting generalizability to younger women. The dataset lacked genetic information and laboratory data related to dementia. The duration of hormone-modulating therapy use beyond 3 years and specific formulations were not assessed. Potential confounders such as variations in chemotherapy, radiation, and surgery were not fully addressed.

DISCLOSURES:

Support for the study was provided by the National Institutes of Health; Carolina Center on Alzheimer’s Disease and Minority Research pilot project; and the Dean’s Faculty Advancement Fund, University of Pittsburgh, Pennsylvania. The authors reported no relevant disclosures.

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

TOPLINE:

Hormone-modulating therapy for breast cancer may protect older women from Alzheimer’s disease and related dementias, although the protective effect varies by age and race, with the greatest benefit seen in younger Black women.

METHODOLOGY:

• Hormone-modulating therapy is widely used to treat hormone receptor–positive breast cancer, but the cognitive effects of the treatment, including a potential link to dementia, remain unclear.
• To investigate, researchers used the SEER-Medicare linked database to identify women aged 65 years or older with breast cancer who did and did not receive hormone-modulating therapy within 3 years following their diagnosis.
• The researchers excluded women with preexisting Alzheimer’s disease/dementia diagnoses or those who had received hormone-modulating therapy before their breast cancer diagnosis.
• Analyses were adjusted for demographic, sociocultural, and clinical variables, and subgroup analyses evaluated the impact of age, race, and type of hormone-modulating therapy on Alzheimer’s disease/dementia risk.

TAKEAWAY:

• Among the 18,808 women included in the analysis, 66% received hormone-modulating therapy and 34% did not. During the mean follow-up of 12 years, 24% of hormone-modulating therapy users and 28% of nonusers developed Alzheimer’s disease/dementia.
• Overall, hormone-modulating therapy use (vs nonuse) was associated with a significant 7% lower risk for Alzheimer’s disease/dementia (hazard ratio [HR], 0.93; P = .005), with notable age and racial differences.
• Hormone-modulating therapy use was associated with a 24% lower risk for Alzheimer’s disease/dementia in Black women aged 65-74 years (HR, 0.76), but that protective effect decreased to 19% in Black women aged 75 years or older (HR, 0.81). White women aged 65-74 years who received hormone-modulating therapy (vs those who did not) had an 11% lower risk for Alzheimer’s disease/dementia (HR, 0.89), but the association disappeared among those aged 75 years or older (HR, 0.96; 95% CI, 0.90-1.02). Other races demonstrated no significant association between hormone-modulating therapy use and Alzheimer’s disease/dementia.
• Overall, the use of an aromatase inhibitor or a selective estrogen receptor modulator was associated with a significantly lower risk for Alzheimer’s disease/dementia (HR, 0.93 and HR, 0.89, respectively).

IN PRACTICE:

Overall, the retrospective study found that “hormone therapy was associated with protection against [Alzheimer’s/dementia] in women aged 65 years or older with newly diagnosed breast cancer,” with the decrease in risk relatively greater for Black women and women younger than 75 years, the authors concluded.

“The results highlight the critical need for personalized breast cancer treatment plans that are tailored to the individual characteristics of each patient, particularly given the significantly higher likelihood (two to three times more) of Black women developing [Alzheimer’s/dementia], compared with their White counterparts,” the researchers added.
 

SOURCE:

The study, with first author Chao Cai, PhD, Department of Clinical Pharmacy and Outcomes Sciences, University of South Carolina, Columbia, was published online on July 16 in JAMA Network Open.

LIMITATIONS:

The study included only women aged 65 years or older, limiting generalizability to younger women. The dataset lacked genetic information and laboratory data related to dementia. The duration of hormone-modulating therapy use beyond 3 years and specific formulations were not assessed. Potential confounders such as variations in chemotherapy, radiation, and surgery were not fully addressed.

DISCLOSURES:

Support for the study was provided by the National Institutes of Health; Carolina Center on Alzheimer’s Disease and Minority Research pilot project; and the Dean’s Faculty Advancement Fund, University of Pittsburgh, Pennsylvania. The authors reported no relevant disclosures.

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

TOPLINE:

Hormone-modulating therapy for breast cancer may protect older women from Alzheimer’s disease and related dementias, although the protective effect varies by age and race, with the greatest benefit seen in younger Black women.

METHODOLOGY:

• Hormone-modulating therapy is widely used to treat hormone receptor–positive breast cancer, but the cognitive effects of the treatment, including a potential link to dementia, remain unclear.
• To investigate, researchers used the SEER-Medicare linked database to identify women aged 65 years or older with breast cancer who did and did not receive hormone-modulating therapy within 3 years following their diagnosis.
• The researchers excluded women with preexisting Alzheimer’s disease/dementia diagnoses or those who had received hormone-modulating therapy before their breast cancer diagnosis.
• Analyses were adjusted for demographic, sociocultural, and clinical variables, and subgroup analyses evaluated the impact of age, race, and type of hormone-modulating therapy on Alzheimer’s disease/dementia risk.

TAKEAWAY:

• Among the 18,808 women included in the analysis, 66% received hormone-modulating therapy and 34% did not. During the mean follow-up of 12 years, 24% of hormone-modulating therapy users and 28% of nonusers developed Alzheimer’s disease/dementia.
• Overall, hormone-modulating therapy use (vs nonuse) was associated with a significant 7% lower risk for Alzheimer’s disease/dementia (hazard ratio [HR], 0.93; P = .005), with notable age and racial differences.
• Hormone-modulating therapy use was associated with a 24% lower risk for Alzheimer’s disease/dementia in Black women aged 65-74 years (HR, 0.76), but that protective effect decreased to 19% in Black women aged 75 years or older (HR, 0.81). White women aged 65-74 years who received hormone-modulating therapy (vs those who did not) had an 11% lower risk for Alzheimer’s disease/dementia (HR, 0.89), but the association disappeared among those aged 75 years or older (HR, 0.96; 95% CI, 0.90-1.02). Other races demonstrated no significant association between hormone-modulating therapy use and Alzheimer’s disease/dementia.
• Overall, the use of an aromatase inhibitor or a selective estrogen receptor modulator was associated with a significantly lower risk for Alzheimer’s disease/dementia (HR, 0.93 and HR, 0.89, respectively).

IN PRACTICE:

Overall, the retrospective study found that “hormone therapy was associated with protection against [Alzheimer’s/dementia] in women aged 65 years or older with newly diagnosed breast cancer,” with the decrease in risk relatively greater for Black women and women younger than 75 years, the authors concluded.

“The results highlight the critical need for personalized breast cancer treatment plans that are tailored to the individual characteristics of each patient, particularly given the significantly higher likelihood (two to three times more) of Black women developing [Alzheimer’s/dementia], compared with their White counterparts,” the researchers added.
 

SOURCE:

The study, with first author Chao Cai, PhD, Department of Clinical Pharmacy and Outcomes Sciences, University of South Carolina, Columbia, was published online on July 16 in JAMA Network Open.

LIMITATIONS:

The study included only women aged 65 years or older, limiting generalizability to younger women. The dataset lacked genetic information and laboratory data related to dementia. The duration of hormone-modulating therapy use beyond 3 years and specific formulations were not assessed. Potential confounders such as variations in chemotherapy, radiation, and surgery were not fully addressed.

DISCLOSURES:

Support for the study was provided by the National Institutes of Health; Carolina Center on Alzheimer’s Disease and Minority Research pilot project; and the Dean’s Faculty Advancement Fund, University of Pittsburgh, Pennsylvania. The authors reported no relevant disclosures.

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

TOPLINE:

Women who received false-positive mammography results were less likely to return for future screenings.

METHODOLOGY:

• Researchers analyzed more than three million screening mammograms from more than one million women aged between 40 and 73 years at nearly 200 facilities in the Breast Cancer Surveillance Consortium between 2005 and 2017.
• Mammography results were classified as true negative or false positive; women who received false-positive results were either asked to come back for additional imaging, a short interval follow-up or biopsy recommendations.
• The primary outcome was the probability of returning for routine screening within 9-30 months after a false-positive or true-negative result, adjusted for race, ethnicity, age, and time since the last mammogram.
• Women with two screening mammograms within 5 years were also analyzed to evaluate the probability of returning for a third screening based on combinations of true-negative and false-positive results.

TAKEAWAY:

• Nearly 10.0% (95% CI, 9.1%-10.5%) of women who received screening mammograms got a false-positive result, 5.8% (95% CI, 5.5%-6.2%) of whom needed immediate additional imaging, 2.7% (95% CI, 2.3%-3.2%) needed short-interval follow-up, and 1.3% (95% CI, 1.1%-1.4%) were recommended for a biopsy.
• Women were more likely to return for screening after a true-negative result (76.9%) than after a false positive to obtain more data through additional imaging (72.4%), short-interval follow-ups (54.7%), or biopsy (61.0%).
• Asian and Hispanic/Latinx women who received a false-positive result were much less likely to return for a screening than women of the same groups who received a true-negative result, with recommendations for short interval follow-up (decrease of 20-25 percentage points) or biopsy (decrease of 13-14 percentage points).
• For women who had two screening mammograms within 5 years, receiving a false-positive result on the second was linked to a lower likelihood of returning for a third screening, regardless of results for the first.

IN PRACTICE:

“Physicians should educate their patients about the importance of continued screening after false-positive results, especially given the associated increased future risk for breast cancer,” study authors wrote.

SOURCE:

The study was led by Diana L. Miglioretti, PhD, of the Department of Public Health Sciences at the University of California, Davis, and published online on September 3 in Annals of Internal Medicine.

LIMITATIONS:

Women could receive care at facilities outside of the trial, which may have affected the accuracy of return rates. The study did not track a complete history of false-positive results. The study did not have information about how often physicians recommend screenings and did not account for other health conditions.

DISCLOSURES:

One coauthor reported receiving grants from the National Institutes of Health and the American Cancer Society, as well as consulting fees from the University of Florida, Gainesville.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Women who received false-positive mammography results were less likely to return for future screenings.

METHODOLOGY:

• Researchers analyzed more than three million screening mammograms from more than one million women aged between 40 and 73 years at nearly 200 facilities in the Breast Cancer Surveillance Consortium between 2005 and 2017.
• Mammography results were classified as true negative or false positive; women who received false-positive results were either asked to come back for additional imaging, a short interval follow-up or biopsy recommendations.
• The primary outcome was the probability of returning for routine screening within 9-30 months after a false-positive or true-negative result, adjusted for race, ethnicity, age, and time since the last mammogram.
• Women with two screening mammograms within 5 years were also analyzed to evaluate the probability of returning for a third screening based on combinations of true-negative and false-positive results.

TAKEAWAY:

• Nearly 10.0% (95% CI, 9.1%-10.5%) of women who received screening mammograms got a false-positive result, 5.8% (95% CI, 5.5%-6.2%) of whom needed immediate additional imaging, 2.7% (95% CI, 2.3%-3.2%) needed short-interval follow-up, and 1.3% (95% CI, 1.1%-1.4%) were recommended for a biopsy.
• Women were more likely to return for screening after a true-negative result (76.9%) than after a false positive to obtain more data through additional imaging (72.4%), short-interval follow-ups (54.7%), or biopsy (61.0%).
• Asian and Hispanic/Latinx women who received a false-positive result were much less likely to return for a screening than women of the same groups who received a true-negative result, with recommendations for short interval follow-up (decrease of 20-25 percentage points) or biopsy (decrease of 13-14 percentage points).
• For women who had two screening mammograms within 5 years, receiving a false-positive result on the second was linked to a lower likelihood of returning for a third screening, regardless of results for the first.

IN PRACTICE:

“Physicians should educate their patients about the importance of continued screening after false-positive results, especially given the associated increased future risk for breast cancer,” study authors wrote.

SOURCE:

The study was led by Diana L. Miglioretti, PhD, of the Department of Public Health Sciences at the University of California, Davis, and published online on September 3 in Annals of Internal Medicine.

LIMITATIONS:

Women could receive care at facilities outside of the trial, which may have affected the accuracy of return rates. The study did not track a complete history of false-positive results. The study did not have information about how often physicians recommend screenings and did not account for other health conditions.

DISCLOSURES:

One coauthor reported receiving grants from the National Institutes of Health and the American Cancer Society, as well as consulting fees from the University of Florida, Gainesville.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Women who received false-positive mammography results were less likely to return for future screenings.

METHODOLOGY:

• Researchers analyzed more than three million screening mammograms from more than one million women aged between 40 and 73 years at nearly 200 facilities in the Breast Cancer Surveillance Consortium between 2005 and 2017.
• Mammography results were classified as true negative or false positive; women who received false-positive results were either asked to come back for additional imaging, a short interval follow-up or biopsy recommendations.
• The primary outcome was the probability of returning for routine screening within 9-30 months after a false-positive or true-negative result, adjusted for race, ethnicity, age, and time since the last mammogram.
• Women with two screening mammograms within 5 years were also analyzed to evaluate the probability of returning for a third screening based on combinations of true-negative and false-positive results.

TAKEAWAY:

• Nearly 10.0% (95% CI, 9.1%-10.5%) of women who received screening mammograms got a false-positive result, 5.8% (95% CI, 5.5%-6.2%) of whom needed immediate additional imaging, 2.7% (95% CI, 2.3%-3.2%) needed short-interval follow-up, and 1.3% (95% CI, 1.1%-1.4%) were recommended for a biopsy.
• Women were more likely to return for screening after a true-negative result (76.9%) than after a false positive to obtain more data through additional imaging (72.4%), short-interval follow-ups (54.7%), or biopsy (61.0%).
• Asian and Hispanic/Latinx women who received a false-positive result were much less likely to return for a screening than women of the same groups who received a true-negative result, with recommendations for short interval follow-up (decrease of 20-25 percentage points) or biopsy (decrease of 13-14 percentage points).
• For women who had two screening mammograms within 5 years, receiving a false-positive result on the second was linked to a lower likelihood of returning for a third screening, regardless of results for the first.

IN PRACTICE:

“Physicians should educate their patients about the importance of continued screening after false-positive results, especially given the associated increased future risk for breast cancer,” study authors wrote.

SOURCE:

The study was led by Diana L. Miglioretti, PhD, of the Department of Public Health Sciences at the University of California, Davis, and published online on September 3 in Annals of Internal Medicine.

LIMITATIONS:

Women could receive care at facilities outside of the trial, which may have affected the accuracy of return rates. The study did not track a complete history of false-positive results. The study did not have information about how often physicians recommend screenings and did not account for other health conditions.

DISCLOSURES:

One coauthor reported receiving grants from the National Institutes of Health and the American Cancer Society, as well as consulting fees from the University of Florida, Gainesville.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

Clonal hematopoiesis of indeterminate potential (CHIP) and mosaic chromosomal alterations (mCAs) are associated with an increased risk for breast cancer, and CHIP is associated with increased mortality in patients with colon cancer, according to the authors of new research.

These findings, drawn from almost 11,000 patients in the Women’s Health Initiative (WHI) study, add further evidence that CHIP and mCA drive solid tumor risk, alongside known associations with hematologic malignancies, reported lead author Pinkal Desai, MD, associate professor of medicine and clinical director of molecular aging at Englander Institute for Precision Medicine, Weill Cornell Medical College, New York City, and colleagues.
 

How This Study Differs From Others of Breast Cancer Risk Factors

“The independent effect of CHIP and mCA on risk and mortality from solid tumors has not been elucidated due to lack of detailed data on mortality outcomes and risk factors,” the investigators wrote in Cancer, although some previous studies have suggested a link.

In particular, the investigators highlighted a 2022 UK Biobank study, which reported an association between CHIP and lung cancer and a borderline association with breast cancer that did not quite reach statistical significance.

But the UK Biobank study was confined to a UK population, Dr. Desai noted in an interview, and the data were less detailed than those in the present investigation.

“In terms of risk, the part that was lacking in previous studies was a comprehensive assessment of risk factors that increase risk for all these cancers,” Dr. Desai said. “For example, for breast cancer, we had very detailed data on [participants’] Gail risk score, which is known to impact breast cancer risk. We also had mammogram data and colonoscopy data.”

In an accompanying editorial, Koichi Takahashi, MD, PhD , and Nehali Shah, BS, of The University of Texas MD Anderson Cancer Center, Houston, Texas, pointed out the same UK Biobank findings, then noted that CHIP has also been linked with worse overall survival in unselected cancer patients. Still, they wrote, “the impact of CH on cancer risk and mortality remains controversial due to conflicting data and context‐dependent effects,” necessitating studies like this one by Dr. Desai and colleagues.
 

How Was the Relationship Between CHIP, MCA, and Solid Tumor Risk Assessed?

To explore possible associations between CHIP, mCA, and solid tumors, the investigators analyzed whole genome sequencing data from 10,866 women in the WHI, a multi-study program that began in 1992 and involved 161,808 women in both observational and clinical trial cohorts.

In 2002, the first big data release from the WHI suggested that hormone replacement therapy (HRT) increased breast cancer risk, leading to widespread reduction in HRT use.

More recent reports continue to shape our understanding of these risks, suggesting differences across cancer types. For breast cancer, the WHI data suggested that HRT-associated risk was largely driven by formulations involving progesterone and estrogen, whereas estrogen-only formulations, now more common, are generally considered to present an acceptable risk profile for suitable patients.

The new study accounted for this potential HRT-associated risk, including by adjusting for patients who received HRT, type of HRT received, and duration of HRT received. According to Desai, this approach is commonly used when analyzing data from the WHI, nullifying concerns about the potentially deleterious effects of the hormones used in the study.

“Our question was not ‘does HRT cause cancer?’ ” Dr. Desai said in an interview. “But HRT can be linked to breast cancer risk and has a potential to be a confounder, and hence the above methodology.

“So I can say that the confounding/effect modification that HRT would have contributed to in the relationship between exposure (CH and mCA) and outcome (cancer) is well adjusted for as described above. This is standard in WHI analyses,” she continued.

“Every Women’s Health Initiative analysis that comes out — not just for our study — uses a standard method ... where you account for hormonal therapy,” Dr. Desai added, again noting that many other potential risk factors were considered, enabling a “detailed, robust” analysis.

Dr. Takahashi and Ms. Shah agreed. “A notable strength of this study is its adjustment for many confounding factors,” they wrote. “The cohort’s well‐annotated data on other known cancer risk factors allowed for a robust assessment of CH’s independent risk.”
 

How Do Findings Compare With Those of the UK Biobank Study?

CHIP was associated with a 30% increased risk for breast cancer (hazard ratio [HR], 1.30; 95% CI, 1.03-1.64; P = .02), strengthening the borderline association reported by the UK Biobank study.

In contrast with the UK Biobank study, CHIP was not associated with lung cancer risk, although this may have been caused by fewer cases of lung cancer and a lack of male patients, Dr. Desai suggested.

“The discrepancy between the studies lies in the risk of lung cancer, although the point estimate in the current study suggested a positive association,” wrote Dr. Takahashi and Ms. Shah.

As in the UK Biobank study, CHIP was not associated with increased risk of developing colorectal cancer.

Mortality analysis, however, which was not conducted in the UK Biobank study, offered a new insight: Patients with existing colorectal cancer and CHIP had a significantly higher mortality risk than those without CHIP. Before stage adjustment, risk for mortality among those with colorectal cancer and CHIP was fourfold higher than those without CHIP (HR, 3.99; 95% CI, 2.41-6.62; P < .001). After stage adjustment, CHIP was still associated with a twofold higher mortality risk (HR, 2.50; 95% CI, 1.32-4.72; P = .004).

The investigators’ first mCA analyses, which employed a cell fraction cutoff greater than 3%, were unfruitful. But raising the cell fraction threshold to 5% in an exploratory analysis showed that autosomal mCA was associated with a 39% increased risk for breast cancer (HR, 1.39; 95% CI, 1.06-1.83; P = .01). No such associations were found between mCA and colorectal or lung cancer, regardless of cell fraction threshold.

The original 3% cell fraction threshold was selected on the basis of previous studies reporting a link between mCA and hematologic malignancies at this cutoff, Dr. Desai said.

She and her colleagues said a higher 5% cutoff might be needed, as they suspected that the link between mCA and solid tumors may not be causal, requiring a higher mutation rate.
 

Why Do Results Differ Between These Types of Studies?

Dr. Takahashi and Ms. Shah suggested that one possible limitation of the new study, and an obstacle to comparing results with the UK Biobank study and others like it, goes beyond population heterogeneity; incongruent findings could also be explained by differences in whole genome sequencing (WGS) technique.

“Although WGS allows sensitive detection of mCA through broad genomic coverage, it is less effective at detecting CHIP with low variant allele frequency (VAF) due to its relatively shallow depth (30x),” they wrote. “Consequently, the prevalence of mCA (18.8%) was much higher than that of CHIP (8.3%) in this cohort, contrasting with other studies using deeper sequencing.” As a result, the present study may have underestimated CHIP prevalence because of shallow sequencing depth.

“This inconsistency is a common challenge in CH population studies due to the lack of standardized methodologies and the frequent reliance on preexisting data not originally intended for CH detection,” Dr. Takahashi and Ms. Shah said.

Even so, despite the “heavily context-dependent” nature of these reported risks, the body of evidence to date now offers a convincing biological rationale linking CH with cancer development and outcomes, they added.
 

How Do the CHIP- and mCA-associated Risks Differ Between Solid Tumors and Blood Cancers?

“[These solid tumor risks are] not causal in the way CHIP mutations are causal for blood cancers,” Dr. Desai said. “Here we are talking about solid tumor risk, and it’s kind of scattered. It’s not just breast cancer ... there’s also increased colon cancer mortality. So I feel these mutations are doing something different ... they are sort of an added factor.”

Specific mechanisms remain unclear, Dr. Desai said, although she speculated about possible impacts on the inflammatory state or alterations to the tumor microenvironment.

“These are blood cells, right?” Dr. Desai asked. “They’re everywhere, and they’re changing something inherently in these tumors.”
 

Future research and therapeutic development

Siddhartha Jaiswal, MD, PhD, assistant professor in the Department of Pathology at Stanford University in California, whose lab focuses on clonal hematopoiesis, said the causality question is central to future research.

“The key question is, are these mutations acting because they alter the function of blood cells in some way to promote cancer risk, or is it reflective of some sort of shared etiology that’s not causal?” Dr. Jaiswal said in an interview.

Available data support both possibilities.

On one side, “reasonable evidence” supports the noncausal view, Dr. Jaiswal noted, because telomere length is one of the most common genetic risk factors for clonal hematopoiesis and also for solid tumors, suggesting a shared genetic factor. On the other hand, CHIP and mCA could be directly protumorigenic via conferred disturbances of immune cell function.

When asked if both causal and noncausal factors could be at play, Dr. Jaiswal said, “yeah, absolutely.”

The presence of a causal association could be promising from a therapeutic standpoint.

“If it turns out that this association is driven by a direct causal effect of the mutations, perhaps related to immune cell function or dysfunction, then targeting that dysfunction could be a therapeutic path to improve outcomes in people, and there’s a lot of interest in this,” Dr. Jaiswal said. He went on to explain how a trial exploring this approach via interleukin-8 inhibition in lung cancer fell short.

Yet earlier intervention may still hold promise, according to experts.

“[This study] provokes the hypothesis that CH‐targeted interventions could potentially reduce cancer risk in the future,” Dr. Takahashi and Ms. Shah said in their editorial.

The WHI program is funded by the National Heart, Lung, and Blood Institute; National Institutes of Health; and the Department of Health & Human Services. The investigators disclosed relationships with Eli Lilly, AbbVie, Celgene, and others. Dr. Jaiswal reported stock equity in a company that has an interest in clonal hematopoiesis.

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

Clonal hematopoiesis of indeterminate potential (CHIP) and mosaic chromosomal alterations (mCAs) are associated with an increased risk for breast cancer, and CHIP is associated with increased mortality in patients with colon cancer, according to the authors of new research.

These findings, drawn from almost 11,000 patients in the Women’s Health Initiative (WHI) study, add further evidence that CHIP and mCA drive solid tumor risk, alongside known associations with hematologic malignancies, reported lead author Pinkal Desai, MD, associate professor of medicine and clinical director of molecular aging at Englander Institute for Precision Medicine, Weill Cornell Medical College, New York City, and colleagues.
 

How This Study Differs From Others of Breast Cancer Risk Factors

“The independent effect of CHIP and mCA on risk and mortality from solid tumors has not been elucidated due to lack of detailed data on mortality outcomes and risk factors,” the investigators wrote in Cancer, although some previous studies have suggested a link.

In particular, the investigators highlighted a 2022 UK Biobank study, which reported an association between CHIP and lung cancer and a borderline association with breast cancer that did not quite reach statistical significance.

But the UK Biobank study was confined to a UK population, Dr. Desai noted in an interview, and the data were less detailed than those in the present investigation.

“In terms of risk, the part that was lacking in previous studies was a comprehensive assessment of risk factors that increase risk for all these cancers,” Dr. Desai said. “For example, for breast cancer, we had very detailed data on [participants’] Gail risk score, which is known to impact breast cancer risk. We also had mammogram data and colonoscopy data.”

In an accompanying editorial, Koichi Takahashi, MD, PhD , and Nehali Shah, BS, of The University of Texas MD Anderson Cancer Center, Houston, Texas, pointed out the same UK Biobank findings, then noted that CHIP has also been linked with worse overall survival in unselected cancer patients. Still, they wrote, “the impact of CH on cancer risk and mortality remains controversial due to conflicting data and context‐dependent effects,” necessitating studies like this one by Dr. Desai and colleagues.
 

How Was the Relationship Between CHIP, MCA, and Solid Tumor Risk Assessed?

To explore possible associations between CHIP, mCA, and solid tumors, the investigators analyzed whole genome sequencing data from 10,866 women in the WHI, a multi-study program that began in 1992 and involved 161,808 women in both observational and clinical trial cohorts.

In 2002, the first big data release from the WHI suggested that hormone replacement therapy (HRT) increased breast cancer risk, leading to widespread reduction in HRT use.

More recent reports continue to shape our understanding of these risks, suggesting differences across cancer types. For breast cancer, the WHI data suggested that HRT-associated risk was largely driven by formulations involving progesterone and estrogen, whereas estrogen-only formulations, now more common, are generally considered to present an acceptable risk profile for suitable patients.

The new study accounted for this potential HRT-associated risk, including by adjusting for patients who received HRT, type of HRT received, and duration of HRT received. According to Desai, this approach is commonly used when analyzing data from the WHI, nullifying concerns about the potentially deleterious effects of the hormones used in the study.

“Our question was not ‘does HRT cause cancer?’ ” Dr. Desai said in an interview. “But HRT can be linked to breast cancer risk and has a potential to be a confounder, and hence the above methodology.

“So I can say that the confounding/effect modification that HRT would have contributed to in the relationship between exposure (CH and mCA) and outcome (cancer) is well adjusted for as described above. This is standard in WHI analyses,” she continued.

“Every Women’s Health Initiative analysis that comes out — not just for our study — uses a standard method ... where you account for hormonal therapy,” Dr. Desai added, again noting that many other potential risk factors were considered, enabling a “detailed, robust” analysis.

Dr. Takahashi and Ms. Shah agreed. “A notable strength of this study is its adjustment for many confounding factors,” they wrote. “The cohort’s well‐annotated data on other known cancer risk factors allowed for a robust assessment of CH’s independent risk.”
 

How Do Findings Compare With Those of the UK Biobank Study?

CHIP was associated with a 30% increased risk for breast cancer (hazard ratio [HR], 1.30; 95% CI, 1.03-1.64; P = .02), strengthening the borderline association reported by the UK Biobank study.

In contrast with the UK Biobank study, CHIP was not associated with lung cancer risk, although this may have been caused by fewer cases of lung cancer and a lack of male patients, Dr. Desai suggested.

“The discrepancy between the studies lies in the risk of lung cancer, although the point estimate in the current study suggested a positive association,” wrote Dr. Takahashi and Ms. Shah.

As in the UK Biobank study, CHIP was not associated with increased risk of developing colorectal cancer.

Mortality analysis, however, which was not conducted in the UK Biobank study, offered a new insight: Patients with existing colorectal cancer and CHIP had a significantly higher mortality risk than those without CHIP. Before stage adjustment, risk for mortality among those with colorectal cancer and CHIP was fourfold higher than those without CHIP (HR, 3.99; 95% CI, 2.41-6.62; P < .001). After stage adjustment, CHIP was still associated with a twofold higher mortality risk (HR, 2.50; 95% CI, 1.32-4.72; P = .004).

The investigators’ first mCA analyses, which employed a cell fraction cutoff greater than 3%, were unfruitful. But raising the cell fraction threshold to 5% in an exploratory analysis showed that autosomal mCA was associated with a 39% increased risk for breast cancer (HR, 1.39; 95% CI, 1.06-1.83; P = .01). No such associations were found between mCA and colorectal or lung cancer, regardless of cell fraction threshold.

The original 3% cell fraction threshold was selected on the basis of previous studies reporting a link between mCA and hematologic malignancies at this cutoff, Dr. Desai said.

She and her colleagues said a higher 5% cutoff might be needed, as they suspected that the link between mCA and solid tumors may not be causal, requiring a higher mutation rate.
 

Why Do Results Differ Between These Types of Studies?

Dr. Takahashi and Ms. Shah suggested that one possible limitation of the new study, and an obstacle to comparing results with the UK Biobank study and others like it, goes beyond population heterogeneity; incongruent findings could also be explained by differences in whole genome sequencing (WGS) technique.

“Although WGS allows sensitive detection of mCA through broad genomic coverage, it is less effective at detecting CHIP with low variant allele frequency (VAF) due to its relatively shallow depth (30x),” they wrote. “Consequently, the prevalence of mCA (18.8%) was much higher than that of CHIP (8.3%) in this cohort, contrasting with other studies using deeper sequencing.” As a result, the present study may have underestimated CHIP prevalence because of shallow sequencing depth.

“This inconsistency is a common challenge in CH population studies due to the lack of standardized methodologies and the frequent reliance on preexisting data not originally intended for CH detection,” Dr. Takahashi and Ms. Shah said.

Even so, despite the “heavily context-dependent” nature of these reported risks, the body of evidence to date now offers a convincing biological rationale linking CH with cancer development and outcomes, they added.
 

How Do the CHIP- and mCA-associated Risks Differ Between Solid Tumors and Blood Cancers?

“[These solid tumor risks are] not causal in the way CHIP mutations are causal for blood cancers,” Dr. Desai said. “Here we are talking about solid tumor risk, and it’s kind of scattered. It’s not just breast cancer ... there’s also increased colon cancer mortality. So I feel these mutations are doing something different ... they are sort of an added factor.”

Specific mechanisms remain unclear, Dr. Desai said, although she speculated about possible impacts on the inflammatory state or alterations to the tumor microenvironment.

“These are blood cells, right?” Dr. Desai asked. “They’re everywhere, and they’re changing something inherently in these tumors.”
 

Future research and therapeutic development

Siddhartha Jaiswal, MD, PhD, assistant professor in the Department of Pathology at Stanford University in California, whose lab focuses on clonal hematopoiesis, said the causality question is central to future research.

“The key question is, are these mutations acting because they alter the function of blood cells in some way to promote cancer risk, or is it reflective of some sort of shared etiology that’s not causal?” Dr. Jaiswal said in an interview.

Available data support both possibilities.

On one side, “reasonable evidence” supports the noncausal view, Dr. Jaiswal noted, because telomere length is one of the most common genetic risk factors for clonal hematopoiesis and also for solid tumors, suggesting a shared genetic factor. On the other hand, CHIP and mCA could be directly protumorigenic via conferred disturbances of immune cell function.

When asked if both causal and noncausal factors could be at play, Dr. Jaiswal said, “yeah, absolutely.”

The presence of a causal association could be promising from a therapeutic standpoint.

“If it turns out that this association is driven by a direct causal effect of the mutations, perhaps related to immune cell function or dysfunction, then targeting that dysfunction could be a therapeutic path to improve outcomes in people, and there’s a lot of interest in this,” Dr. Jaiswal said. He went on to explain how a trial exploring this approach via interleukin-8 inhibition in lung cancer fell short.

Yet earlier intervention may still hold promise, according to experts.

“[This study] provokes the hypothesis that CH‐targeted interventions could potentially reduce cancer risk in the future,” Dr. Takahashi and Ms. Shah said in their editorial.

The WHI program is funded by the National Heart, Lung, and Blood Institute; National Institutes of Health; and the Department of Health & Human Services. The investigators disclosed relationships with Eli Lilly, AbbVie, Celgene, and others. Dr. Jaiswal reported stock equity in a company that has an interest in clonal hematopoiesis.

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

Clonal hematopoiesis of indeterminate potential (CHIP) and mosaic chromosomal alterations (mCAs) are associated with an increased risk for breast cancer, and CHIP is associated with increased mortality in patients with colon cancer, according to the authors of new research.

These findings, drawn from almost 11,000 patients in the Women’s Health Initiative (WHI) study, add further evidence that CHIP and mCA drive solid tumor risk, alongside known associations with hematologic malignancies, reported lead author Pinkal Desai, MD, associate professor of medicine and clinical director of molecular aging at Englander Institute for Precision Medicine, Weill Cornell Medical College, New York City, and colleagues.
 

How This Study Differs From Others of Breast Cancer Risk Factors

“The independent effect of CHIP and mCA on risk and mortality from solid tumors has not been elucidated due to lack of detailed data on mortality outcomes and risk factors,” the investigators wrote in Cancer, although some previous studies have suggested a link.

In particular, the investigators highlighted a 2022 UK Biobank study, which reported an association between CHIP and lung cancer and a borderline association with breast cancer that did not quite reach statistical significance.

But the UK Biobank study was confined to a UK population, Dr. Desai noted in an interview, and the data were less detailed than those in the present investigation.

“In terms of risk, the part that was lacking in previous studies was a comprehensive assessment of risk factors that increase risk for all these cancers,” Dr. Desai said. “For example, for breast cancer, we had very detailed data on [participants’] Gail risk score, which is known to impact breast cancer risk. We also had mammogram data and colonoscopy data.”

In an accompanying editorial, Koichi Takahashi, MD, PhD , and Nehali Shah, BS, of The University of Texas MD Anderson Cancer Center, Houston, Texas, pointed out the same UK Biobank findings, then noted that CHIP has also been linked with worse overall survival in unselected cancer patients. Still, they wrote, “the impact of CH on cancer risk and mortality remains controversial due to conflicting data and context‐dependent effects,” necessitating studies like this one by Dr. Desai and colleagues.
 

How Was the Relationship Between CHIP, MCA, and Solid Tumor Risk Assessed?

To explore possible associations between CHIP, mCA, and solid tumors, the investigators analyzed whole genome sequencing data from 10,866 women in the WHI, a multi-study program that began in 1992 and involved 161,808 women in both observational and clinical trial cohorts.

In 2002, the first big data release from the WHI suggested that hormone replacement therapy (HRT) increased breast cancer risk, leading to widespread reduction in HRT use.

More recent reports continue to shape our understanding of these risks, suggesting differences across cancer types. For breast cancer, the WHI data suggested that HRT-associated risk was largely driven by formulations involving progesterone and estrogen, whereas estrogen-only formulations, now more common, are generally considered to present an acceptable risk profile for suitable patients.

The new study accounted for this potential HRT-associated risk, including by adjusting for patients who received HRT, type of HRT received, and duration of HRT received. According to Desai, this approach is commonly used when analyzing data from the WHI, nullifying concerns about the potentially deleterious effects of the hormones used in the study.

“Our question was not ‘does HRT cause cancer?’ ” Dr. Desai said in an interview. “But HRT can be linked to breast cancer risk and has a potential to be a confounder, and hence the above methodology.

“So I can say that the confounding/effect modification that HRT would have contributed to in the relationship between exposure (CH and mCA) and outcome (cancer) is well adjusted for as described above. This is standard in WHI analyses,” she continued.

“Every Women’s Health Initiative analysis that comes out — not just for our study — uses a standard method ... where you account for hormonal therapy,” Dr. Desai added, again noting that many other potential risk factors were considered, enabling a “detailed, robust” analysis.

Dr. Takahashi and Ms. Shah agreed. “A notable strength of this study is its adjustment for many confounding factors,” they wrote. “The cohort’s well‐annotated data on other known cancer risk factors allowed for a robust assessment of CH’s independent risk.”
 

How Do Findings Compare With Those of the UK Biobank Study?

CHIP was associated with a 30% increased risk for breast cancer (hazard ratio [HR], 1.30; 95% CI, 1.03-1.64; P = .02), strengthening the borderline association reported by the UK Biobank study.

In contrast with the UK Biobank study, CHIP was not associated with lung cancer risk, although this may have been caused by fewer cases of lung cancer and a lack of male patients, Dr. Desai suggested.

“The discrepancy between the studies lies in the risk of lung cancer, although the point estimate in the current study suggested a positive association,” wrote Dr. Takahashi and Ms. Shah.

As in the UK Biobank study, CHIP was not associated with increased risk of developing colorectal cancer.

Mortality analysis, however, which was not conducted in the UK Biobank study, offered a new insight: Patients with existing colorectal cancer and CHIP had a significantly higher mortality risk than those without CHIP. Before stage adjustment, risk for mortality among those with colorectal cancer and CHIP was fourfold higher than those without CHIP (HR, 3.99; 95% CI, 2.41-6.62; P < .001). After stage adjustment, CHIP was still associated with a twofold higher mortality risk (HR, 2.50; 95% CI, 1.32-4.72; P = .004).

The investigators’ first mCA analyses, which employed a cell fraction cutoff greater than 3%, were unfruitful. But raising the cell fraction threshold to 5% in an exploratory analysis showed that autosomal mCA was associated with a 39% increased risk for breast cancer (HR, 1.39; 95% CI, 1.06-1.83; P = .01). No such associations were found between mCA and colorectal or lung cancer, regardless of cell fraction threshold.

The original 3% cell fraction threshold was selected on the basis of previous studies reporting a link between mCA and hematologic malignancies at this cutoff, Dr. Desai said.

She and her colleagues said a higher 5% cutoff might be needed, as they suspected that the link between mCA and solid tumors may not be causal, requiring a higher mutation rate.
 

Why Do Results Differ Between These Types of Studies?

Dr. Takahashi and Ms. Shah suggested that one possible limitation of the new study, and an obstacle to comparing results with the UK Biobank study and others like it, goes beyond population heterogeneity; incongruent findings could also be explained by differences in whole genome sequencing (WGS) technique.

“Although WGS allows sensitive detection of mCA through broad genomic coverage, it is less effective at detecting CHIP with low variant allele frequency (VAF) due to its relatively shallow depth (30x),” they wrote. “Consequently, the prevalence of mCA (18.8%) was much higher than that of CHIP (8.3%) in this cohort, contrasting with other studies using deeper sequencing.” As a result, the present study may have underestimated CHIP prevalence because of shallow sequencing depth.

“This inconsistency is a common challenge in CH population studies due to the lack of standardized methodologies and the frequent reliance on preexisting data not originally intended for CH detection,” Dr. Takahashi and Ms. Shah said.

Even so, despite the “heavily context-dependent” nature of these reported risks, the body of evidence to date now offers a convincing biological rationale linking CH with cancer development and outcomes, they added.
 

How Do the CHIP- and mCA-associated Risks Differ Between Solid Tumors and Blood Cancers?

“[These solid tumor risks are] not causal in the way CHIP mutations are causal for blood cancers,” Dr. Desai said. “Here we are talking about solid tumor risk, and it’s kind of scattered. It’s not just breast cancer ... there’s also increased colon cancer mortality. So I feel these mutations are doing something different ... they are sort of an added factor.”

Specific mechanisms remain unclear, Dr. Desai said, although she speculated about possible impacts on the inflammatory state or alterations to the tumor microenvironment.

“These are blood cells, right?” Dr. Desai asked. “They’re everywhere, and they’re changing something inherently in these tumors.”
 

Future research and therapeutic development

Siddhartha Jaiswal, MD, PhD, assistant professor in the Department of Pathology at Stanford University in California, whose lab focuses on clonal hematopoiesis, said the causality question is central to future research.

“The key question is, are these mutations acting because they alter the function of blood cells in some way to promote cancer risk, or is it reflective of some sort of shared etiology that’s not causal?” Dr. Jaiswal said in an interview.

Available data support both possibilities.

On one side, “reasonable evidence” supports the noncausal view, Dr. Jaiswal noted, because telomere length is one of the most common genetic risk factors for clonal hematopoiesis and also for solid tumors, suggesting a shared genetic factor. On the other hand, CHIP and mCA could be directly protumorigenic via conferred disturbances of immune cell function.

When asked if both causal and noncausal factors could be at play, Dr. Jaiswal said, “yeah, absolutely.”

The presence of a causal association could be promising from a therapeutic standpoint.

“If it turns out that this association is driven by a direct causal effect of the mutations, perhaps related to immune cell function or dysfunction, then targeting that dysfunction could be a therapeutic path to improve outcomes in people, and there’s a lot of interest in this,” Dr. Jaiswal said. He went on to explain how a trial exploring this approach via interleukin-8 inhibition in lung cancer fell short.

Yet earlier intervention may still hold promise, according to experts.

“[This study] provokes the hypothesis that CH‐targeted interventions could potentially reduce cancer risk in the future,” Dr. Takahashi and Ms. Shah said in their editorial.

The WHI program is funded by the National Heart, Lung, and Blood Institute; National Institutes of Health; and the Department of Health & Human Services. The investigators disclosed relationships with Eli Lilly, AbbVie, Celgene, and others. Dr. Jaiswal reported stock equity in a company that has an interest in clonal hematopoiesis.

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

One of California’s two programs for training nurse-midwives has stopped admitting students while it revamps its curriculum to offer only doctoral degrees, a move that’s drawn howls of protest from alumni, health policy experts, and faculty who accuse the University of California of putting profits above public health needs.

The University of California San Francisco’s (UCSF) renowned nursing school will graduate its final class of certified nurse-midwives in the spring of 2025. Then the university will cancel its 2-year master’s program in nurse-midwifery, along with other nursing disciplines, in favor of a 3-year doctor of nursing practice, or DNP, degree. The change will pause UCSF’s nearly 5 decades–long training of nurse-midwives until at least 2025 and will more than double the cost to students.

State Assembly member Mia Bonta, who chairs the health committee, said she was “disheartened” to learn that UCSF was eliminating its master’s nurse-midwifery program and feared the additional time and costs to get a doctorate would deter potential applicants. “Instead of adding hurdles, we need to be building and expanding a pipeline of culturally and racially concordant providers to support improved birth outcomes, especially for Black and Latina birthing people,” she said in an email.

The switch to doctoral education is part of a national movement to require all advanced-practice registered nurses, including nurse-midwives and nurse practitioners, to earn doctoral degrees, Kristen Bole, a UCSF spokesperson, said in response to written questions. The doctoral training will feature additional classes in leadership and quality improvement.

But the movement, which dates to 2004, has not caught on the way the American Association of Colleges of Nursing envisioned when it called for doctorate-level education to be required for entry-level advanced nursing practice by 2015. That deadline came and went. Now, an acute need for maternal health practitioners has some universities moving in the other direction.

This year, Rutgers University reinstated the nurse-midwifery master’s training it had eliminated in 2016. The University of Alabama at Birmingham also restarted its master’s in nurse-midwifery program in 2022 after a 25-year hiatus. In addition, George Washington University in Washington, DC, Loyola University in New Orleans, and the University of Nevada in Las Vagas added master’s training in nurse-midwifery.

UCSF estimates tuition and fees will cost $152,000 for a 3-year doctoral degree in midwifery, compared with $65,000 for a 2-year master’s. Studies show that 71% of nursing master’s students and 74% of nursing doctoral students rely on student loans, and nurses with doctorates earn negligibly or no more than nurses with master’s degrees.

Kim Q. Dau, who ran UCSF’s nurse-midwifery program for a decade, resigned in June because she was uncomfortable with the elimination of the master’s in favor of a doctoral requirement, she said, which is at odds with the state’s workforce needs and unnecessary for clinical practice.

“They’ll be equally prepared clinically but at more expense to the student and with a greater time investment,” she said.

Nurse-midwives are registered nurses with graduate degrees in nurse-midwifery. Licensed in all 50 states, they work mostly in hospitals and can perform abortions and prescribe medications, though they are also trained in managing labor pain with showers, massage, and other natural means. Certified midwives, by contrast, study midwifery at the graduate level outside of nursing schools and are licensed only in some states. Certified professional midwives attend births outside of hospitals.

The California Nurse-Midwives Association also criticized UCSF’s program change, which comes amid a national maternal mortality crisis, a serious shortage of obstetric providers, and a growing reliance on midwives. According to the 2022 “White House Blueprint for Addressing the Maternal Health Crisis” report, the United States has the highest maternal mortality rate of any developed nation and needs thousands more midwives and other women’s health providers to bridge the swelling gap.

Ginger Breedlove, founder and CEO of Grow Midwives, a national consulting firm, likened UCSF’s switch from master’s to doctoral training to “an earthquake.”

“Why are we delaying the entry of essential care providers by making them go to an additional year of school, which adds nothing to their clinical preparedness or safety to serve the community?” asked Ms. Breedlove, a past president of the American College of Nurse-Midwives. “Why they have chosen this during one of the worst workforce shortages combined with the worst maternal health crisis we have had in 50 years is beyond my imagination.”

A 2020 report published in Nursing Outlook failed to find that advanced-practice registered nurses with doctorates were more clinically proficient than those with master’s degrees. “Unfortunately, to date, the data are sparse,” it concluded.

The American College of Nurse-Midwives also denounced the doctoral requirement, as have trade associations for neonatal nurse practitioners and neonatal nurses, citing “the lack of scientific evidence that ... doctoral-level education is beneficial to patients, practitioners, or society.”

There is no evidence that doctoral-level nurse-midwives will provide better care, Ms. Breedlove said.

“This is profit over purpose,” she added.

Ms. Bole disputed Ms. Breedlove’s accusation of a profit motive. Asked for reasons for the change, she offered broad statements: “The decision to upgrade our program was made to ensure that our graduates are prepared for the challenges they will face in the evolving health care landscape.”

Like Ms. Breedlove, Liz Donnelly, vice chair of the health policy committee for the California Nurse-Midwives Association, worries that UCSF’s switch to a doctoral degree will exacerbate the twin crises of maternal mortality and a shrinking obstetrics workforce across California and the nation.

On average, 10-12 nurse-midwives graduated from the UCSF master’s program each year over the past decade, Ms. Bole said. California’s remaining master’s program in nurse-midwifery is at California State University in Fullerton, south of Los Angeles, and it graduated 8 nurse-midwives in 2023 and 11 in 2024.

More than half of rural counties in the United States lacked obstetric care in 2018, according to a Government Accountability Office report.

In some parts of California, expectant mothers must drive 2 hours for care, said Bethany Sasaki, who runs Midtown Nurse Midwives, a Sacramento birth center. It has had to stop accepting new clients because it cannot find midwives.

Ms. Donnelly predicted the closure of UCSF’s midwifery program will significantly reduce the number of nurse-midwives entering the workforce and will inhibit people with fewer resources from attending the program. “Specifically, I think it’s going to reduce folks of color, people from rural communities, people from poor communities,” she said.

UCSF’s change will also likely undercut efforts to train providers from diverse backgrounds.

Natasha, a 37-year-old Afro-Puerto Rican mother of two, has spent a decade preparing to train as a nurse-midwife so she could help women like herself through pregnancy and childbirth. She asked to be identified only by her first name out of fear of reducing her chances of graduate school admission.

The UCSF program’s pause, plus the added time and expense to get a doctoral degree, has muddied her career path.

“The master’s was just the perfect program,” said Natasha, who lives in the Bay Area and cannot travel to the other end of the state to attend California State University-Fullerton. “I’m frustrated, and I feel deflated. I now have to find another career path.”

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

One of California’s two programs for training nurse-midwives has stopped admitting students while it revamps its curriculum to offer only doctoral degrees, a move that’s drawn howls of protest from alumni, health policy experts, and faculty who accuse the University of California of putting profits above public health needs.

The University of California San Francisco’s (UCSF) renowned nursing school will graduate its final class of certified nurse-midwives in the spring of 2025. Then the university will cancel its 2-year master’s program in nurse-midwifery, along with other nursing disciplines, in favor of a 3-year doctor of nursing practice, or DNP, degree. The change will pause UCSF’s nearly 5 decades–long training of nurse-midwives until at least 2025 and will more than double the cost to students.

State Assembly member Mia Bonta, who chairs the health committee, said she was “disheartened” to learn that UCSF was eliminating its master’s nurse-midwifery program and feared the additional time and costs to get a doctorate would deter potential applicants. “Instead of adding hurdles, we need to be building and expanding a pipeline of culturally and racially concordant providers to support improved birth outcomes, especially for Black and Latina birthing people,” she said in an email.

The switch to doctoral education is part of a national movement to require all advanced-practice registered nurses, including nurse-midwives and nurse practitioners, to earn doctoral degrees, Kristen Bole, a UCSF spokesperson, said in response to written questions. The doctoral training will feature additional classes in leadership and quality improvement.

But the movement, which dates to 2004, has not caught on the way the American Association of Colleges of Nursing envisioned when it called for doctorate-level education to be required for entry-level advanced nursing practice by 2015. That deadline came and went. Now, an acute need for maternal health practitioners has some universities moving in the other direction.

This year, Rutgers University reinstated the nurse-midwifery master’s training it had eliminated in 2016. The University of Alabama at Birmingham also restarted its master’s in nurse-midwifery program in 2022 after a 25-year hiatus. In addition, George Washington University in Washington, DC, Loyola University in New Orleans, and the University of Nevada in Las Vagas added master’s training in nurse-midwifery.

UCSF estimates tuition and fees will cost $152,000 for a 3-year doctoral degree in midwifery, compared with $65,000 for a 2-year master’s. Studies show that 71% of nursing master’s students and 74% of nursing doctoral students rely on student loans, and nurses with doctorates earn negligibly or no more than nurses with master’s degrees.

Kim Q. Dau, who ran UCSF’s nurse-midwifery program for a decade, resigned in June because she was uncomfortable with the elimination of the master’s in favor of a doctoral requirement, she said, which is at odds with the state’s workforce needs and unnecessary for clinical practice.

“They’ll be equally prepared clinically but at more expense to the student and with a greater time investment,” she said.

Nurse-midwives are registered nurses with graduate degrees in nurse-midwifery. Licensed in all 50 states, they work mostly in hospitals and can perform abortions and prescribe medications, though they are also trained in managing labor pain with showers, massage, and other natural means. Certified midwives, by contrast, study midwifery at the graduate level outside of nursing schools and are licensed only in some states. Certified professional midwives attend births outside of hospitals.

The California Nurse-Midwives Association also criticized UCSF’s program change, which comes amid a national maternal mortality crisis, a serious shortage of obstetric providers, and a growing reliance on midwives. According to the 2022 “White House Blueprint for Addressing the Maternal Health Crisis” report, the United States has the highest maternal mortality rate of any developed nation and needs thousands more midwives and other women’s health providers to bridge the swelling gap.

Ginger Breedlove, founder and CEO of Grow Midwives, a national consulting firm, likened UCSF’s switch from master’s to doctoral training to “an earthquake.”

“Why are we delaying the entry of essential care providers by making them go to an additional year of school, which adds nothing to their clinical preparedness or safety to serve the community?” asked Ms. Breedlove, a past president of the American College of Nurse-Midwives. “Why they have chosen this during one of the worst workforce shortages combined with the worst maternal health crisis we have had in 50 years is beyond my imagination.”

A 2020 report published in Nursing Outlook failed to find that advanced-practice registered nurses with doctorates were more clinically proficient than those with master’s degrees. “Unfortunately, to date, the data are sparse,” it concluded.

The American College of Nurse-Midwives also denounced the doctoral requirement, as have trade associations for neonatal nurse practitioners and neonatal nurses, citing “the lack of scientific evidence that ... doctoral-level education is beneficial to patients, practitioners, or society.”

There is no evidence that doctoral-level nurse-midwives will provide better care, Ms. Breedlove said.

“This is profit over purpose,” she added.

Ms. Bole disputed Ms. Breedlove’s accusation of a profit motive. Asked for reasons for the change, she offered broad statements: “The decision to upgrade our program was made to ensure that our graduates are prepared for the challenges they will face in the evolving health care landscape.”

Like Ms. Breedlove, Liz Donnelly, vice chair of the health policy committee for the California Nurse-Midwives Association, worries that UCSF’s switch to a doctoral degree will exacerbate the twin crises of maternal mortality and a shrinking obstetrics workforce across California and the nation.

On average, 10-12 nurse-midwives graduated from the UCSF master’s program each year over the past decade, Ms. Bole said. California’s remaining master’s program in nurse-midwifery is at California State University in Fullerton, south of Los Angeles, and it graduated 8 nurse-midwives in 2023 and 11 in 2024.

More than half of rural counties in the United States lacked obstetric care in 2018, according to a Government Accountability Office report.

In some parts of California, expectant mothers must drive 2 hours for care, said Bethany Sasaki, who runs Midtown Nurse Midwives, a Sacramento birth center. It has had to stop accepting new clients because it cannot find midwives.

Ms. Donnelly predicted the closure of UCSF’s midwifery program will significantly reduce the number of nurse-midwives entering the workforce and will inhibit people with fewer resources from attending the program. “Specifically, I think it’s going to reduce folks of color, people from rural communities, people from poor communities,” she said.

UCSF’s change will also likely undercut efforts to train providers from diverse backgrounds.

Natasha, a 37-year-old Afro-Puerto Rican mother of two, has spent a decade preparing to train as a nurse-midwife so she could help women like herself through pregnancy and childbirth. She asked to be identified only by her first name out of fear of reducing her chances of graduate school admission.

The UCSF program’s pause, plus the added time and expense to get a doctoral degree, has muddied her career path.

“The master’s was just the perfect program,” said Natasha, who lives in the Bay Area and cannot travel to the other end of the state to attend California State University-Fullerton. “I’m frustrated, and I feel deflated. I now have to find another career path.”

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

One of California’s two programs for training nurse-midwives has stopped admitting students while it revamps its curriculum to offer only doctoral degrees, a move that’s drawn howls of protest from alumni, health policy experts, and faculty who accuse the University of California of putting profits above public health needs.

The University of California San Francisco’s (UCSF) renowned nursing school will graduate its final class of certified nurse-midwives in the spring of 2025. Then the university will cancel its 2-year master’s program in nurse-midwifery, along with other nursing disciplines, in favor of a 3-year doctor of nursing practice, or DNP, degree. The change will pause UCSF’s nearly 5 decades–long training of nurse-midwives until at least 2025 and will more than double the cost to students.

State Assembly member Mia Bonta, who chairs the health committee, said she was “disheartened” to learn that UCSF was eliminating its master’s nurse-midwifery program and feared the additional time and costs to get a doctorate would deter potential applicants. “Instead of adding hurdles, we need to be building and expanding a pipeline of culturally and racially concordant providers to support improved birth outcomes, especially for Black and Latina birthing people,” she said in an email.

The switch to doctoral education is part of a national movement to require all advanced-practice registered nurses, including nurse-midwives and nurse practitioners, to earn doctoral degrees, Kristen Bole, a UCSF spokesperson, said in response to written questions. The doctoral training will feature additional classes in leadership and quality improvement.

But the movement, which dates to 2004, has not caught on the way the American Association of Colleges of Nursing envisioned when it called for doctorate-level education to be required for entry-level advanced nursing practice by 2015. That deadline came and went. Now, an acute need for maternal health practitioners has some universities moving in the other direction.

This year, Rutgers University reinstated the nurse-midwifery master’s training it had eliminated in 2016. The University of Alabama at Birmingham also restarted its master’s in nurse-midwifery program in 2022 after a 25-year hiatus. In addition, George Washington University in Washington, DC, Loyola University in New Orleans, and the University of Nevada in Las Vagas added master’s training in nurse-midwifery.

UCSF estimates tuition and fees will cost $152,000 for a 3-year doctoral degree in midwifery, compared with $65,000 for a 2-year master’s. Studies show that 71% of nursing master’s students and 74% of nursing doctoral students rely on student loans, and nurses with doctorates earn negligibly or no more than nurses with master’s degrees.

Kim Q. Dau, who ran UCSF’s nurse-midwifery program for a decade, resigned in June because she was uncomfortable with the elimination of the master’s in favor of a doctoral requirement, she said, which is at odds with the state’s workforce needs and unnecessary for clinical practice.

“They’ll be equally prepared clinically but at more expense to the student and with a greater time investment,” she said.

Nurse-midwives are registered nurses with graduate degrees in nurse-midwifery. Licensed in all 50 states, they work mostly in hospitals and can perform abortions and prescribe medications, though they are also trained in managing labor pain with showers, massage, and other natural means. Certified midwives, by contrast, study midwifery at the graduate level outside of nursing schools and are licensed only in some states. Certified professional midwives attend births outside of hospitals.

The California Nurse-Midwives Association also criticized UCSF’s program change, which comes amid a national maternal mortality crisis, a serious shortage of obstetric providers, and a growing reliance on midwives. According to the 2022 “White House Blueprint for Addressing the Maternal Health Crisis” report, the United States has the highest maternal mortality rate of any developed nation and needs thousands more midwives and other women’s health providers to bridge the swelling gap.

Ginger Breedlove, founder and CEO of Grow Midwives, a national consulting firm, likened UCSF’s switch from master’s to doctoral training to “an earthquake.”

“Why are we delaying the entry of essential care providers by making them go to an additional year of school, which adds nothing to their clinical preparedness or safety to serve the community?” asked Ms. Breedlove, a past president of the American College of Nurse-Midwives. “Why they have chosen this during one of the worst workforce shortages combined with the worst maternal health crisis we have had in 50 years is beyond my imagination.”

A 2020 report published in Nursing Outlook failed to find that advanced-practice registered nurses with doctorates were more clinically proficient than those with master’s degrees. “Unfortunately, to date, the data are sparse,” it concluded.

The American College of Nurse-Midwives also denounced the doctoral requirement, as have trade associations for neonatal nurse practitioners and neonatal nurses, citing “the lack of scientific evidence that ... doctoral-level education is beneficial to patients, practitioners, or society.”

There is no evidence that doctoral-level nurse-midwives will provide better care, Ms. Breedlove said.

“This is profit over purpose,” she added.

Ms. Bole disputed Ms. Breedlove’s accusation of a profit motive. Asked for reasons for the change, she offered broad statements: “The decision to upgrade our program was made to ensure that our graduates are prepared for the challenges they will face in the evolving health care landscape.”

Like Ms. Breedlove, Liz Donnelly, vice chair of the health policy committee for the California Nurse-Midwives Association, worries that UCSF’s switch to a doctoral degree will exacerbate the twin crises of maternal mortality and a shrinking obstetrics workforce across California and the nation.

On average, 10-12 nurse-midwives graduated from the UCSF master’s program each year over the past decade, Ms. Bole said. California’s remaining master’s program in nurse-midwifery is at California State University in Fullerton, south of Los Angeles, and it graduated 8 nurse-midwives in 2023 and 11 in 2024.

More than half of rural counties in the United States lacked obstetric care in 2018, according to a Government Accountability Office report.

In some parts of California, expectant mothers must drive 2 hours for care, said Bethany Sasaki, who runs Midtown Nurse Midwives, a Sacramento birth center. It has had to stop accepting new clients because it cannot find midwives.

Ms. Donnelly predicted the closure of UCSF’s midwifery program will significantly reduce the number of nurse-midwives entering the workforce and will inhibit people with fewer resources from attending the program. “Specifically, I think it’s going to reduce folks of color, people from rural communities, people from poor communities,” she said.

UCSF’s change will also likely undercut efforts to train providers from diverse backgrounds.

Natasha, a 37-year-old Afro-Puerto Rican mother of two, has spent a decade preparing to train as a nurse-midwife so she could help women like herself through pregnancy and childbirth. She asked to be identified only by her first name out of fear of reducing her chances of graduate school admission.

The UCSF program’s pause, plus the added time and expense to get a doctoral degree, has muddied her career path.

“The master’s was just the perfect program,” said Natasha, who lives in the Bay Area and cannot travel to the other end of the state to attend California State University-Fullerton. “I’m frustrated, and I feel deflated. I now have to find another career path.”

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

This transcript has been edited for clarity.

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at the NYU Grossman School of Medicine in New York City. 

We have many debates and arguments that are swirling around about the out-of-control costs of Medicare. Many people are arguing we’ve got to trim it and cut back, and many people note that we can’t just go on and on with that kind of expenditure.

People look around for savings. Rightly, we can’t go on with the prices that we’re paying. No system could. We’ll bankrupt ourselves if we don’t drive prices down. 

There’s another area that is driving up cost where, despite the fact that Medicare doesn’t pay for it, we could capture resources and hopefully shift them back to things like Medicare coverage or the insurance of other efficacious procedures. That area is the wellness industry. 

I looked up a number recently, and I was shocked to see that worldwide, $1.8 trillion is being spent on wellness, including billions in the US. Again, Medicare doesn’t pay for that. That’s money coming out of people’s pockets that we could hopefully aim at the payment of things that we know work, not seeing the money drain out to cover bunk, nonsense, and charlatanism.

Does any or most of this stuff work? Do anything? Help anybody? No. We are spending money on charlatans and quacks. The US Food and Drug Administration (FDA), which you might think is the agency that could step in and start to get rid of some of this nonsense, is just too overwhelmed trying to track drugs, devices, and vaccines to give much attention to the wellness industry.

What am I talking about specifically? I’m talking about everything from gut probiotics that are sold in sodas to probiotic facial creams and the Goop industry of Gwyneth Paltrow, where you have people buying things like wellness mats or vaginal eggs that are supposed to maintain gynecologic health.

We’re talking about things like PEMF, or pulse electronic magnetic fields, where you buy a machine and expose yourself to mild magnetic pulses. I went online to look them up, and the machines cost $5000-$50,000. There’s no evidence that it works. By the way, the machines are not only out there as being sold for pain relief and many other things to humans, but also they’re being sold for your pets.

That industry is completely out of control. Wellness interventions, whether it’s transcranial magnetism or all manner of supplements that are sold in health food stores, over and over again, we see a world in which wellness is promoted but no data are introduced to show that any of it helps, works, or does anybody any good.

It may not be all that harmful, but it’s certainly financially toxic to many people who end up spending good amounts of money using these things. I think doctors need to ask patients if they are using any of these things, particularly if they have chronic conditions. They’re likely, many of them, to be seduced by online advertisement to get involved with this stuff because it’s preventive or it’ll help treat some condition that they have. 

The industry is out of control. We’re trying to figure out how to spend money on things we know work in medicine, and yet we continue to tolerate bunk, nonsense, quackery, and charlatanism, just letting it grow and grow and grow in terms of cost.

That’s money that could go elsewhere. That is money that is being taken out of the pockets of patients. They’re doing things that may even delay medical treatment, which won’t really help them, and they are doing things that perhaps might even interfere with medical care that really is known to be beneficial.

I think it’s time to push for more money for the FDA to regulate the wellness side. I think it’s time for the Federal Trade Commission to go after ads that promise health benefits. I think it’s time to have some honest conversations with patients: What are you using? What are you doing? Tell me about it, and here’s why I think you could probably spend your money in a better way. 
 

Dr. Caplan, director, Division of Medical Ethics, New York University Langone Medical Center, New York, disclosed ties with Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). He serves as a contributing author and adviser for Medscape.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at the NYU Grossman School of Medicine in New York City. 

We have many debates and arguments that are swirling around about the out-of-control costs of Medicare. Many people are arguing we’ve got to trim it and cut back, and many people note that we can’t just go on and on with that kind of expenditure.

People look around for savings. Rightly, we can’t go on with the prices that we’re paying. No system could. We’ll bankrupt ourselves if we don’t drive prices down. 

There’s another area that is driving up cost where, despite the fact that Medicare doesn’t pay for it, we could capture resources and hopefully shift them back to things like Medicare coverage or the insurance of other efficacious procedures. That area is the wellness industry. 

I looked up a number recently, and I was shocked to see that worldwide, $1.8 trillion is being spent on wellness, including billions in the US. Again, Medicare doesn’t pay for that. That’s money coming out of people’s pockets that we could hopefully aim at the payment of things that we know work, not seeing the money drain out to cover bunk, nonsense, and charlatanism.

Does any or most of this stuff work? Do anything? Help anybody? No. We are spending money on charlatans and quacks. The US Food and Drug Administration (FDA), which you might think is the agency that could step in and start to get rid of some of this nonsense, is just too overwhelmed trying to track drugs, devices, and vaccines to give much attention to the wellness industry.

What am I talking about specifically? I’m talking about everything from gut probiotics that are sold in sodas to probiotic facial creams and the Goop industry of Gwyneth Paltrow, where you have people buying things like wellness mats or vaginal eggs that are supposed to maintain gynecologic health.

We’re talking about things like PEMF, or pulse electronic magnetic fields, where you buy a machine and expose yourself to mild magnetic pulses. I went online to look them up, and the machines cost $5000-$50,000. There’s no evidence that it works. By the way, the machines are not only out there as being sold for pain relief and many other things to humans, but also they’re being sold for your pets.

That industry is completely out of control. Wellness interventions, whether it’s transcranial magnetism or all manner of supplements that are sold in health food stores, over and over again, we see a world in which wellness is promoted but no data are introduced to show that any of it helps, works, or does anybody any good.

It may not be all that harmful, but it’s certainly financially toxic to many people who end up spending good amounts of money using these things. I think doctors need to ask patients if they are using any of these things, particularly if they have chronic conditions. They’re likely, many of them, to be seduced by online advertisement to get involved with this stuff because it’s preventive or it’ll help treat some condition that they have. 

The industry is out of control. We’re trying to figure out how to spend money on things we know work in medicine, and yet we continue to tolerate bunk, nonsense, quackery, and charlatanism, just letting it grow and grow and grow in terms of cost.

That’s money that could go elsewhere. That is money that is being taken out of the pockets of patients. They’re doing things that may even delay medical treatment, which won’t really help them, and they are doing things that perhaps might even interfere with medical care that really is known to be beneficial.

I think it’s time to push for more money for the FDA to regulate the wellness side. I think it’s time for the Federal Trade Commission to go after ads that promise health benefits. I think it’s time to have some honest conversations with patients: What are you using? What are you doing? Tell me about it, and here’s why I think you could probably spend your money in a better way. 
 

Dr. Caplan, director, Division of Medical Ethics, New York University Langone Medical Center, New York, disclosed ties with Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). He serves as a contributing author and adviser for Medscape.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at the NYU Grossman School of Medicine in New York City. 

We have many debates and arguments that are swirling around about the out-of-control costs of Medicare. Many people are arguing we’ve got to trim it and cut back, and many people note that we can’t just go on and on with that kind of expenditure.

People look around for savings. Rightly, we can’t go on with the prices that we’re paying. No system could. We’ll bankrupt ourselves if we don’t drive prices down. 

There’s another area that is driving up cost where, despite the fact that Medicare doesn’t pay for it, we could capture resources and hopefully shift them back to things like Medicare coverage or the insurance of other efficacious procedures. That area is the wellness industry. 

I looked up a number recently, and I was shocked to see that worldwide, $1.8 trillion is being spent on wellness, including billions in the US. Again, Medicare doesn’t pay for that. That’s money coming out of people’s pockets that we could hopefully aim at the payment of things that we know work, not seeing the money drain out to cover bunk, nonsense, and charlatanism.

Does any or most of this stuff work? Do anything? Help anybody? No. We are spending money on charlatans and quacks. The US Food and Drug Administration (FDA), which you might think is the agency that could step in and start to get rid of some of this nonsense, is just too overwhelmed trying to track drugs, devices, and vaccines to give much attention to the wellness industry.

What am I talking about specifically? I’m talking about everything from gut probiotics that are sold in sodas to probiotic facial creams and the Goop industry of Gwyneth Paltrow, where you have people buying things like wellness mats or vaginal eggs that are supposed to maintain gynecologic health.

We’re talking about things like PEMF, or pulse electronic magnetic fields, where you buy a machine and expose yourself to mild magnetic pulses. I went online to look them up, and the machines cost $5000-$50,000. There’s no evidence that it works. By the way, the machines are not only out there as being sold for pain relief and many other things to humans, but also they’re being sold for your pets.

That industry is completely out of control. Wellness interventions, whether it’s transcranial magnetism or all manner of supplements that are sold in health food stores, over and over again, we see a world in which wellness is promoted but no data are introduced to show that any of it helps, works, or does anybody any good.

It may not be all that harmful, but it’s certainly financially toxic to many people who end up spending good amounts of money using these things. I think doctors need to ask patients if they are using any of these things, particularly if they have chronic conditions. They’re likely, many of them, to be seduced by online advertisement to get involved with this stuff because it’s preventive or it’ll help treat some condition that they have. 

The industry is out of control. We’re trying to figure out how to spend money on things we know work in medicine, and yet we continue to tolerate bunk, nonsense, quackery, and charlatanism, just letting it grow and grow and grow in terms of cost.

That’s money that could go elsewhere. That is money that is being taken out of the pockets of patients. They’re doing things that may even delay medical treatment, which won’t really help them, and they are doing things that perhaps might even interfere with medical care that really is known to be beneficial.

I think it’s time to push for more money for the FDA to regulate the wellness side. I think it’s time for the Federal Trade Commission to go after ads that promise health benefits. I think it’s time to have some honest conversations with patients: What are you using? What are you doing? Tell me about it, and here’s why I think you could probably spend your money in a better way. 
 

Dr. Caplan, director, Division of Medical Ethics, New York University Langone Medical Center, New York, disclosed ties with Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). He serves as a contributing author and adviser for Medscape.

A version of this article appeared on Medscape.com.

Listeriosis during pregnancy, when invasive, can be fatal for the fetus, with a rate of fetal loss or neonatal death of 29%, investigators reported in an article alerting clinicians to this condition.

The article was prompted when the Reproductive Infectious Diseases team at The University of British Columbia in Vancouver, British Columbia, Canada, “received many phone calls from concerned doctors and patients after the plant-based milk recall in early July,” Jeffrey Man Hay Wong, MD, told this news organization. “With such concerns, we updated our British Columbia guidelines for our patients but quickly realized that our recommendations would be useful across the country.”

The article was published online in the Canadian Medical Association Journal.


 

Five Key Points

Dr. Wong and colleagues provided the following five points and recommendations:

First, invasive listeriosis (bacteremia or meningitis) in pregnancy can have major fetal consequences, including fetal loss or neonatal death in 29% of cases. Affected patients can be asymptomatic or experience gastrointestinal symptoms, myalgias, fevers, acute respiratory distress syndrome, or sepsis.

Second, pregnant people should avoid foods at a high risk for Listeria monocytogenes contamination, including unpasteurized dairy products, luncheon meats, refrigerated meat spreads, and prepared salads. They also should stay aware of Health Canada recalls.

Third, it is not necessary to investigate or treat patients who may have ingested contaminated food but are asymptomatic. Listeriosis can present at 2-3 months after exposure because the incubation period can be as long as 70 days.

Fourth, for patients with mild gastroenteritis or flu-like symptoms who may have ingested contaminated food, obtaining blood cultures or starting a 2-week course of oral amoxicillin (500 mg, three times daily) could be considered.

Fifth, for patients with fever and possible exposure to L monocytogenes, blood cultures should be drawn immediately, and high-dose ampicillin should be initiated, along with electronic fetal heart rate monitoring.

“While choosing safer foods in pregnancy is recommended, it is most important to be aware of Health Canada food recalls and pay attention to symptoms if you’ve ingested these foods,” said Dr. Wong. “Working with the BC Centre for Disease Control, our teams are actively monitoring for cases of listeriosis in pregnancy here in British Columbia.

“Thankfully,” he said, “there haven’t been any confirmed cases in British Columbia related to the plant-based milk recall, though the bacteria’s incubation period can be up to 70 days in pregnancy.”
 

No Increase Suspected

Commenting on the article, Khady Diouf, MD, director of global obstetrics and gynecology at Brigham and Women’s Hospital in Boston, said, “It summarizes the main management, which is based mostly on expert opinion.”

US clinicians also should be reminded about listeriosis in pregnancy, she noted, pointing to “helpful guidance” from the American College of Obstetrics and Gynecology.

Although the United States similarly experienced a recent listeriosis outbreak resulting from contaminated deli meats, both Dr. Wong and Dr. Diouf said that these outbreaks do not seem to signal an increase in listeriosis cases overall.

“Food-borne listeriosis seems to come in waves,” said Dr. Wong. “At a public health level, we certainly have better surveillance programs for Listeria infections. In 2023, Health Canada updated its Policy on L monocytogenes in ready-to-eat foods, which emphasizes the good manufacturing practices recommended for food processing environments to identify outbreaks earlier.”

“I think we get these recalls yearly, and this has been the case for as long as I can remember,” Dr. Diouf agreed.

No funding was declared, and the authors declared no relevant financial relationships.

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

Listeriosis during pregnancy, when invasive, can be fatal for the fetus, with a rate of fetal loss or neonatal death of 29%, investigators reported in an article alerting clinicians to this condition.

The article was prompted when the Reproductive Infectious Diseases team at The University of British Columbia in Vancouver, British Columbia, Canada, “received many phone calls from concerned doctors and patients after the plant-based milk recall in early July,” Jeffrey Man Hay Wong, MD, told this news organization. “With such concerns, we updated our British Columbia guidelines for our patients but quickly realized that our recommendations would be useful across the country.”

The article was published online in the Canadian Medical Association Journal.


 

Five Key Points

Dr. Wong and colleagues provided the following five points and recommendations:

First, invasive listeriosis (bacteremia or meningitis) in pregnancy can have major fetal consequences, including fetal loss or neonatal death in 29% of cases. Affected patients can be asymptomatic or experience gastrointestinal symptoms, myalgias, fevers, acute respiratory distress syndrome, or sepsis.

Second, pregnant people should avoid foods at a high risk for Listeria monocytogenes contamination, including unpasteurized dairy products, luncheon meats, refrigerated meat spreads, and prepared salads. They also should stay aware of Health Canada recalls.

Third, it is not necessary to investigate or treat patients who may have ingested contaminated food but are asymptomatic. Listeriosis can present at 2-3 months after exposure because the incubation period can be as long as 70 days.

Fourth, for patients with mild gastroenteritis or flu-like symptoms who may have ingested contaminated food, obtaining blood cultures or starting a 2-week course of oral amoxicillin (500 mg, three times daily) could be considered.

Fifth, for patients with fever and possible exposure to L monocytogenes, blood cultures should be drawn immediately, and high-dose ampicillin should be initiated, along with electronic fetal heart rate monitoring.

“While choosing safer foods in pregnancy is recommended, it is most important to be aware of Health Canada food recalls and pay attention to symptoms if you’ve ingested these foods,” said Dr. Wong. “Working with the BC Centre for Disease Control, our teams are actively monitoring for cases of listeriosis in pregnancy here in British Columbia.

“Thankfully,” he said, “there haven’t been any confirmed cases in British Columbia related to the plant-based milk recall, though the bacteria’s incubation period can be up to 70 days in pregnancy.”
 

No Increase Suspected

Commenting on the article, Khady Diouf, MD, director of global obstetrics and gynecology at Brigham and Women’s Hospital in Boston, said, “It summarizes the main management, which is based mostly on expert opinion.”

US clinicians also should be reminded about listeriosis in pregnancy, she noted, pointing to “helpful guidance” from the American College of Obstetrics and Gynecology.

Although the United States similarly experienced a recent listeriosis outbreak resulting from contaminated deli meats, both Dr. Wong and Dr. Diouf said that these outbreaks do not seem to signal an increase in listeriosis cases overall.

“Food-borne listeriosis seems to come in waves,” said Dr. Wong. “At a public health level, we certainly have better surveillance programs for Listeria infections. In 2023, Health Canada updated its Policy on L monocytogenes in ready-to-eat foods, which emphasizes the good manufacturing practices recommended for food processing environments to identify outbreaks earlier.”

“I think we get these recalls yearly, and this has been the case for as long as I can remember,” Dr. Diouf agreed.

No funding was declared, and the authors declared no relevant financial relationships.

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

Listeriosis during pregnancy, when invasive, can be fatal for the fetus, with a rate of fetal loss or neonatal death of 29%, investigators reported in an article alerting clinicians to this condition.

The article was prompted when the Reproductive Infectious Diseases team at The University of British Columbia in Vancouver, British Columbia, Canada, “received many phone calls from concerned doctors and patients after the plant-based milk recall in early July,” Jeffrey Man Hay Wong, MD, told this news organization. “With such concerns, we updated our British Columbia guidelines for our patients but quickly realized that our recommendations would be useful across the country.”

The article was published online in the Canadian Medical Association Journal.


 

Five Key Points

Dr. Wong and colleagues provided the following five points and recommendations:

First, invasive listeriosis (bacteremia or meningitis) in pregnancy can have major fetal consequences, including fetal loss or neonatal death in 29% of cases. Affected patients can be asymptomatic or experience gastrointestinal symptoms, myalgias, fevers, acute respiratory distress syndrome, or sepsis.

Second, pregnant people should avoid foods at a high risk for Listeria monocytogenes contamination, including unpasteurized dairy products, luncheon meats, refrigerated meat spreads, and prepared salads. They also should stay aware of Health Canada recalls.

Third, it is not necessary to investigate or treat patients who may have ingested contaminated food but are asymptomatic. Listeriosis can present at 2-3 months after exposure because the incubation period can be as long as 70 days.

Fourth, for patients with mild gastroenteritis or flu-like symptoms who may have ingested contaminated food, obtaining blood cultures or starting a 2-week course of oral amoxicillin (500 mg, three times daily) could be considered.

Fifth, for patients with fever and possible exposure to L monocytogenes, blood cultures should be drawn immediately, and high-dose ampicillin should be initiated, along with electronic fetal heart rate monitoring.

“While choosing safer foods in pregnancy is recommended, it is most important to be aware of Health Canada food recalls and pay attention to symptoms if you’ve ingested these foods,” said Dr. Wong. “Working with the BC Centre for Disease Control, our teams are actively monitoring for cases of listeriosis in pregnancy here in British Columbia.

“Thankfully,” he said, “there haven’t been any confirmed cases in British Columbia related to the plant-based milk recall, though the bacteria’s incubation period can be up to 70 days in pregnancy.”
 

No Increase Suspected

Commenting on the article, Khady Diouf, MD, director of global obstetrics and gynecology at Brigham and Women’s Hospital in Boston, said, “It summarizes the main management, which is based mostly on expert opinion.”

US clinicians also should be reminded about listeriosis in pregnancy, she noted, pointing to “helpful guidance” from the American College of Obstetrics and Gynecology.

Although the United States similarly experienced a recent listeriosis outbreak resulting from contaminated deli meats, both Dr. Wong and Dr. Diouf said that these outbreaks do not seem to signal an increase in listeriosis cases overall.

“Food-borne listeriosis seems to come in waves,” said Dr. Wong. “At a public health level, we certainly have better surveillance programs for Listeria infections. In 2023, Health Canada updated its Policy on L monocytogenes in ready-to-eat foods, which emphasizes the good manufacturing practices recommended for food processing environments to identify outbreaks earlier.”

“I think we get these recalls yearly, and this has been the case for as long as I can remember,” Dr. Diouf agreed.

No funding was declared, and the authors declared no relevant financial relationships.

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