Women's Health

Food emulsifiers are among the most widespread food additives. A large cohort study highlighted an association between the consumption of certain emulsifiers and an increased risk for certain cancers, particularly breast and prostate cancer.

Ultraprocessed foods constitute a significant part of our diet, representing approximately 30% of energy intake in France.

Large epidemiologic studies have already linked diets rich in ultraprocessed products to an increased risk for cardiovascular diseases, diabetes, obesity, and mortality. Possible explanations for this association include the presence of additives, particularly emulsifiers. These additives are intended to improve the texture and shelf life of foods.

Recent experimental studies have shown that emulsifiers alter the gut microbiota and may lead to low-grade inflammation. Dysbiosis and chronic inflammation not only increase the risk for inflammatory bowel diseases but are also implicated in the etiology of several other chronic pathologies and certain extraintestinal cancers.

The NutriNet-Santé study provided extensive information on the dietary habits of > 100,000 French participants. A new analysis was conducted, examining the possible link between the presence of emulsifiers in the diet and cancer occurrence. Data from 92,000 participants (78.8% women) were utilized. They covered an average follow-up of 6.7 years, during which 2604 cancer cases were diagnosed, including 750 breast cancers, 322 prostate cancers, and 207 colorectal cancers.

In this cohort, the risk for cancer increased with a higher presence in the diet of products containing certain emulsifiers widely used in industrial food in Europe: Carrageenans (E407), mono- and diglycerides of fatty acids (E471), pectins (E440), and sodium carbonate (E500).

Notably, the highest consumption of mono- and diglycerides of fatty acids (E471) was associated with a 15% increase in the risk for all types of cancer, a 24% increase in breast cancer risk, and a 46% increase in prostate cancer risk. The highest consumption of carrageenans (E407) was associated with a 28% increase in breast cancer risk.

In an analysis by menopausal status, the risk for breast cancer before menopause was associated with high consumption of diphosphates (E450; 45% increase), pectins (E440; 55% increase), and sodium bicarbonate (E500; 48% increase). No link was found between emulsifier consumption and colorectal cancer risk. While some associations were observed for other emulsifiers, they did not persist in sensitivity analyses.

The European Food Safety Agency recently evaluated the risks of emulsifiers, however, and found no safety issues or need to limit daily consumption of several of them, notably E471.

It is certain that cancer is multifactorial, and a single factor (here, exposure to emulsifiers) will not significantly increase the risk. However, while not essential to human health, emulsifiers are widely prevalent in the global market. Therefore, if causality is established, the increased risk could translate into a significant number of preventable cancers at the population level. Confirmation of this causal link will need to be obtained through experimental and epidemiological studies.

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

Food emulsifiers are among the most widespread food additives. A large cohort study highlighted an association between the consumption of certain emulsifiers and an increased risk for certain cancers, particularly breast and prostate cancer.

Ultraprocessed foods constitute a significant part of our diet, representing approximately 30% of energy intake in France.

Large epidemiologic studies have already linked diets rich in ultraprocessed products to an increased risk for cardiovascular diseases, diabetes, obesity, and mortality. Possible explanations for this association include the presence of additives, particularly emulsifiers. These additives are intended to improve the texture and shelf life of foods.

Recent experimental studies have shown that emulsifiers alter the gut microbiota and may lead to low-grade inflammation. Dysbiosis and chronic inflammation not only increase the risk for inflammatory bowel diseases but are also implicated in the etiology of several other chronic pathologies and certain extraintestinal cancers.

The NutriNet-Santé study provided extensive information on the dietary habits of > 100,000 French participants. A new analysis was conducted, examining the possible link between the presence of emulsifiers in the diet and cancer occurrence. Data from 92,000 participants (78.8% women) were utilized. They covered an average follow-up of 6.7 years, during which 2604 cancer cases were diagnosed, including 750 breast cancers, 322 prostate cancers, and 207 colorectal cancers.

In this cohort, the risk for cancer increased with a higher presence in the diet of products containing certain emulsifiers widely used in industrial food in Europe: Carrageenans (E407), mono- and diglycerides of fatty acids (E471), pectins (E440), and sodium carbonate (E500).

Notably, the highest consumption of mono- and diglycerides of fatty acids (E471) was associated with a 15% increase in the risk for all types of cancer, a 24% increase in breast cancer risk, and a 46% increase in prostate cancer risk. The highest consumption of carrageenans (E407) was associated with a 28% increase in breast cancer risk.

In an analysis by menopausal status, the risk for breast cancer before menopause was associated with high consumption of diphosphates (E450; 45% increase), pectins (E440; 55% increase), and sodium bicarbonate (E500; 48% increase). No link was found between emulsifier consumption and colorectal cancer risk. While some associations were observed for other emulsifiers, they did not persist in sensitivity analyses.

The European Food Safety Agency recently evaluated the risks of emulsifiers, however, and found no safety issues or need to limit daily consumption of several of them, notably E471.

It is certain that cancer is multifactorial, and a single factor (here, exposure to emulsifiers) will not significantly increase the risk. However, while not essential to human health, emulsifiers are widely prevalent in the global market. Therefore, if causality is established, the increased risk could translate into a significant number of preventable cancers at the population level. Confirmation of this causal link will need to be obtained through experimental and epidemiological studies.

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

Food emulsifiers are among the most widespread food additives. A large cohort study highlighted an association between the consumption of certain emulsifiers and an increased risk for certain cancers, particularly breast and prostate cancer.

Ultraprocessed foods constitute a significant part of our diet, representing approximately 30% of energy intake in France.

Large epidemiologic studies have already linked diets rich in ultraprocessed products to an increased risk for cardiovascular diseases, diabetes, obesity, and mortality. Possible explanations for this association include the presence of additives, particularly emulsifiers. These additives are intended to improve the texture and shelf life of foods.

Recent experimental studies have shown that emulsifiers alter the gut microbiota and may lead to low-grade inflammation. Dysbiosis and chronic inflammation not only increase the risk for inflammatory bowel diseases but are also implicated in the etiology of several other chronic pathologies and certain extraintestinal cancers.

The NutriNet-Santé study provided extensive information on the dietary habits of > 100,000 French participants. A new analysis was conducted, examining the possible link between the presence of emulsifiers in the diet and cancer occurrence. Data from 92,000 participants (78.8% women) were utilized. They covered an average follow-up of 6.7 years, during which 2604 cancer cases were diagnosed, including 750 breast cancers, 322 prostate cancers, and 207 colorectal cancers.

In this cohort, the risk for cancer increased with a higher presence in the diet of products containing certain emulsifiers widely used in industrial food in Europe: Carrageenans (E407), mono- and diglycerides of fatty acids (E471), pectins (E440), and sodium carbonate (E500).

Notably, the highest consumption of mono- and diglycerides of fatty acids (E471) was associated with a 15% increase in the risk for all types of cancer, a 24% increase in breast cancer risk, and a 46% increase in prostate cancer risk. The highest consumption of carrageenans (E407) was associated with a 28% increase in breast cancer risk.

In an analysis by menopausal status, the risk for breast cancer before menopause was associated with high consumption of diphosphates (E450; 45% increase), pectins (E440; 55% increase), and sodium bicarbonate (E500; 48% increase). No link was found between emulsifier consumption and colorectal cancer risk. While some associations were observed for other emulsifiers, they did not persist in sensitivity analyses.

The European Food Safety Agency recently evaluated the risks of emulsifiers, however, and found no safety issues or need to limit daily consumption of several of them, notably E471.

It is certain that cancer is multifactorial, and a single factor (here, exposure to emulsifiers) will not significantly increase the risk. However, while not essential to human health, emulsifiers are widely prevalent in the global market. Therefore, if causality is established, the increased risk could translate into a significant number of preventable cancers at the population level. Confirmation of this causal link will need to be obtained through experimental and epidemiological studies.

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

“She’s, like, 90 years old. I’m not going to ask her about sex!” says the cringing resident. “She’s older than my grandmother!”

Well, my young friend, our 80- and 90-year-old patients were in their 20s and 30s in the 1960s. You can bet some of them were pretty groovy! A Swedish study of septuagenarians revealed a shift in sexual attitudes: from 5% of 70-year-old women in the 1970s citing sex as a positive aspect of life, to 78% in 2000. Those of us in practice who came of age during the AIDS era and alongside the purity movement of the 1990s can be more sexually reserved than our grandparents. We might need to catch up. In fact, in another study, 82% of 97-year-old female participants felt that being asked about their sexuality in healthcare settings was positive.

While changes do occur in sexual physiology and behavior with age, satisfying sexual engagement may be an important factor in the general well-being and overall health of older women. Given the high prevalence of dementia among this population, it may be useful to know that positive sexual expression may delay cognitive decline. We also have evidence that sexual satisfaction is important for relational health, which in turn helps predict physical health.

Shed the Dysfunction Mindset

Our medical bias has been that a fulfilling sexual life requires a hard penis and a lubricated vagina. This view of the range of healthy and satisfying sexual expression is lamentably limited. Older adults may have more problems with physiologic arousal in the form of more erectile dysfunction and decreased vaginal lubrication, but these issues may lead to partnerships in which there is less insertive/receiving sexual play and more oral sex, cuddling, kissing, and other forms of partnered sexual play. Older adults may focus less on performance and more on intimacy. In fact, as heterosexual couples encounter these physiologic changes, their sexual behavior may begin to focus more attention to female pleasure. Good news for older women!

As described by Dutch sexuality and aging expert Woet Gianotten, MD, older adults have a lot going for them in their sex lives. Many are retired with more time available, less work stress, greater comfort and familiarity with their partners, and less insecurity about their bodies.

Common Concerns

Many older adults are having satisfying sexual play and are less bothered by changes in their sexual physiology. Still, for those who aren’t happy with their sex lives, clinicians must be ready to address these concerns.

Nancy, an 87-year-old patient whose husband died 5 years ago after 59 years of marriage, has just met someone new. When they are intimate physically, she’s not feeling aroused in the way she recalls, and wonders, Where have my orgasms gone?

A host of physical changes among older women can affect the sexual experience, including the vulvovaginal changes of genitourinary syndrome of menopause (GSM), incontinence, uterine prolapse, diminished sensation, and reduced overall mobility. Although aging is responsible for some of these changes, chronic diseases and medical treatments can play an even larger role.

GSM is a major contributor to sexual pain, genital irritation, and reduced arousal and orgasm. It’s crazy that we don’t ask about and treat GSM. Beyond the sexual impact, the vaginal dryness of GSM can contribute to urinary tract infections, which can lead to sepsis and even death! Vaginal estrogens and other GSM treatments are safe and effective in the vast majority of women. Vaginal moisturizers, vaginal dilators, and increasing genital blood flow also help improve GSM.

Vaginal dilators are used in the management of vaginal stenosis, when the vaginal skin has contracted as a result of GSM or pelvic radiation to treat cancer. Dilators are also used to treat some forms of high-tone pelvic floor dysfunction. For expert guidance and coaching on the use of dilators, seek out sexual medicine specialists and pelvic floor physical therapists. Pelvic floor physical therapy is important in the management of a wide range of sexual concerns, from reduced arousal and orgasm to almost any kind of sexual pain.

For postmenopausal women who are distressed by hypoactive sexual desire disorder, transdermal low-dose testosterone may be considered when other causes of low libido have been ruled out.

Due to changes in nerve fiber sensitivity over time, older age is an ideal phase of life to incorporate higher-intensity vibration and other sexual devices into solo and partner sex. Mobility limitations and joint pain can be addressed with devices designed specifically for this purpose or with the use of pillows and other supports.

As Betty Dodson, a staunch advocate for women’s pleasure until her death in 2020 at 91, wisely said, “Masturbation will get you through childhood, puberty, romance, marriage, and divorce, and it will see you through old age.” We can encourage women to see sexual play and pleasure flexibly, as a lifelong process of self-knowledge and discovery.

Basic Tips for Patients

• More “fiction and friction,” as coined by sex therapist Barry McCarthy, is necessary. As bodies age, more stimulation, both mental and physical, is necessary and often requires more direct physical stimulation of genitals.
• More time: Everything seems to take more time as we age; sex is no different.
• Incontinence concerns can be addressed by open communication and collaboration with partners, and being prepared with waterproof pads for the bed and towels.
• Ask about medical intervention–related sexual side effects. A wide range of medications can decrease desire and arousal and delay orgasm. If a change in sexual function occurred with starting a medication, it may be worthwhile investigating alternatives or, if possible, discontinuing a medication. Surgical and procedural changes to the anatomy also can affect sexual function. While correction may be impossible once certain changes have occurred, clinicians can provide patients with both validation about the problem and hope that, for the most part, with creativity and flexibility, pleasurable sexual experience is possible in all bodies.

Pebble M. Kranz, MD, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

“She’s, like, 90 years old. I’m not going to ask her about sex!” says the cringing resident. “She’s older than my grandmother!”

Well, my young friend, our 80- and 90-year-old patients were in their 20s and 30s in the 1960s. You can bet some of them were pretty groovy! A Swedish study of septuagenarians revealed a shift in sexual attitudes: from 5% of 70-year-old women in the 1970s citing sex as a positive aspect of life, to 78% in 2000. Those of us in practice who came of age during the AIDS era and alongside the purity movement of the 1990s can be more sexually reserved than our grandparents. We might need to catch up. In fact, in another study, 82% of 97-year-old female participants felt that being asked about their sexuality in healthcare settings was positive.

While changes do occur in sexual physiology and behavior with age, satisfying sexual engagement may be an important factor in the general well-being and overall health of older women. Given the high prevalence of dementia among this population, it may be useful to know that positive sexual expression may delay cognitive decline. We also have evidence that sexual satisfaction is important for relational health, which in turn helps predict physical health.

Shed the Dysfunction Mindset

Our medical bias has been that a fulfilling sexual life requires a hard penis and a lubricated vagina. This view of the range of healthy and satisfying sexual expression is lamentably limited. Older adults may have more problems with physiologic arousal in the form of more erectile dysfunction and decreased vaginal lubrication, but these issues may lead to partnerships in which there is less insertive/receiving sexual play and more oral sex, cuddling, kissing, and other forms of partnered sexual play. Older adults may focus less on performance and more on intimacy. In fact, as heterosexual couples encounter these physiologic changes, their sexual behavior may begin to focus more attention to female pleasure. Good news for older women!

As described by Dutch sexuality and aging expert Woet Gianotten, MD, older adults have a lot going for them in their sex lives. Many are retired with more time available, less work stress, greater comfort and familiarity with their partners, and less insecurity about their bodies.

Common Concerns

Many older adults are having satisfying sexual play and are less bothered by changes in their sexual physiology. Still, for those who aren’t happy with their sex lives, clinicians must be ready to address these concerns.

Nancy, an 87-year-old patient whose husband died 5 years ago after 59 years of marriage, has just met someone new. When they are intimate physically, she’s not feeling aroused in the way she recalls, and wonders, Where have my orgasms gone?

A host of physical changes among older women can affect the sexual experience, including the vulvovaginal changes of genitourinary syndrome of menopause (GSM), incontinence, uterine prolapse, diminished sensation, and reduced overall mobility. Although aging is responsible for some of these changes, chronic diseases and medical treatments can play an even larger role.

GSM is a major contributor to sexual pain, genital irritation, and reduced arousal and orgasm. It’s crazy that we don’t ask about and treat GSM. Beyond the sexual impact, the vaginal dryness of GSM can contribute to urinary tract infections, which can lead to sepsis and even death! Vaginal estrogens and other GSM treatments are safe and effective in the vast majority of women. Vaginal moisturizers, vaginal dilators, and increasing genital blood flow also help improve GSM.

Vaginal dilators are used in the management of vaginal stenosis, when the vaginal skin has contracted as a result of GSM or pelvic radiation to treat cancer. Dilators are also used to treat some forms of high-tone pelvic floor dysfunction. For expert guidance and coaching on the use of dilators, seek out sexual medicine specialists and pelvic floor physical therapists. Pelvic floor physical therapy is important in the management of a wide range of sexual concerns, from reduced arousal and orgasm to almost any kind of sexual pain.

For postmenopausal women who are distressed by hypoactive sexual desire disorder, transdermal low-dose testosterone may be considered when other causes of low libido have been ruled out.

Due to changes in nerve fiber sensitivity over time, older age is an ideal phase of life to incorporate higher-intensity vibration and other sexual devices into solo and partner sex. Mobility limitations and joint pain can be addressed with devices designed specifically for this purpose or with the use of pillows and other supports.

As Betty Dodson, a staunch advocate for women’s pleasure until her death in 2020 at 91, wisely said, “Masturbation will get you through childhood, puberty, romance, marriage, and divorce, and it will see you through old age.” We can encourage women to see sexual play and pleasure flexibly, as a lifelong process of self-knowledge and discovery.

Basic Tips for Patients

• More “fiction and friction,” as coined by sex therapist Barry McCarthy, is necessary. As bodies age, more stimulation, both mental and physical, is necessary and often requires more direct physical stimulation of genitals.
• More time: Everything seems to take more time as we age; sex is no different.
• Incontinence concerns can be addressed by open communication and collaboration with partners, and being prepared with waterproof pads for the bed and towels.
• Ask about medical intervention–related sexual side effects. A wide range of medications can decrease desire and arousal and delay orgasm. If a change in sexual function occurred with starting a medication, it may be worthwhile investigating alternatives or, if possible, discontinuing a medication. Surgical and procedural changes to the anatomy also can affect sexual function. While correction may be impossible once certain changes have occurred, clinicians can provide patients with both validation about the problem and hope that, for the most part, with creativity and flexibility, pleasurable sexual experience is possible in all bodies.

Pebble M. Kranz, MD, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

“She’s, like, 90 years old. I’m not going to ask her about sex!” says the cringing resident. “She’s older than my grandmother!”

Well, my young friend, our 80- and 90-year-old patients were in their 20s and 30s in the 1960s. You can bet some of them were pretty groovy! A Swedish study of septuagenarians revealed a shift in sexual attitudes: from 5% of 70-year-old women in the 1970s citing sex as a positive aspect of life, to 78% in 2000. Those of us in practice who came of age during the AIDS era and alongside the purity movement of the 1990s can be more sexually reserved than our grandparents. We might need to catch up. In fact, in another study, 82% of 97-year-old female participants felt that being asked about their sexuality in healthcare settings was positive.

While changes do occur in sexual physiology and behavior with age, satisfying sexual engagement may be an important factor in the general well-being and overall health of older women. Given the high prevalence of dementia among this population, it may be useful to know that positive sexual expression may delay cognitive decline. We also have evidence that sexual satisfaction is important for relational health, which in turn helps predict physical health.

Shed the Dysfunction Mindset

Our medical bias has been that a fulfilling sexual life requires a hard penis and a lubricated vagina. This view of the range of healthy and satisfying sexual expression is lamentably limited. Older adults may have more problems with physiologic arousal in the form of more erectile dysfunction and decreased vaginal lubrication, but these issues may lead to partnerships in which there is less insertive/receiving sexual play and more oral sex, cuddling, kissing, and other forms of partnered sexual play. Older adults may focus less on performance and more on intimacy. In fact, as heterosexual couples encounter these physiologic changes, their sexual behavior may begin to focus more attention to female pleasure. Good news for older women!

As described by Dutch sexuality and aging expert Woet Gianotten, MD, older adults have a lot going for them in their sex lives. Many are retired with more time available, less work stress, greater comfort and familiarity with their partners, and less insecurity about their bodies.

Common Concerns

Many older adults are having satisfying sexual play and are less bothered by changes in their sexual physiology. Still, for those who aren’t happy with their sex lives, clinicians must be ready to address these concerns.

Nancy, an 87-year-old patient whose husband died 5 years ago after 59 years of marriage, has just met someone new. When they are intimate physically, she’s not feeling aroused in the way she recalls, and wonders, Where have my orgasms gone?

A host of physical changes among older women can affect the sexual experience, including the vulvovaginal changes of genitourinary syndrome of menopause (GSM), incontinence, uterine prolapse, diminished sensation, and reduced overall mobility. Although aging is responsible for some of these changes, chronic diseases and medical treatments can play an even larger role.

GSM is a major contributor to sexual pain, genital irritation, and reduced arousal and orgasm. It’s crazy that we don’t ask about and treat GSM. Beyond the sexual impact, the vaginal dryness of GSM can contribute to urinary tract infections, which can lead to sepsis and even death! Vaginal estrogens and other GSM treatments are safe and effective in the vast majority of women. Vaginal moisturizers, vaginal dilators, and increasing genital blood flow also help improve GSM.

Vaginal dilators are used in the management of vaginal stenosis, when the vaginal skin has contracted as a result of GSM or pelvic radiation to treat cancer. Dilators are also used to treat some forms of high-tone pelvic floor dysfunction. For expert guidance and coaching on the use of dilators, seek out sexual medicine specialists and pelvic floor physical therapists. Pelvic floor physical therapy is important in the management of a wide range of sexual concerns, from reduced arousal and orgasm to almost any kind of sexual pain.

For postmenopausal women who are distressed by hypoactive sexual desire disorder, transdermal low-dose testosterone may be considered when other causes of low libido have been ruled out.

Due to changes in nerve fiber sensitivity over time, older age is an ideal phase of life to incorporate higher-intensity vibration and other sexual devices into solo and partner sex. Mobility limitations and joint pain can be addressed with devices designed specifically for this purpose or with the use of pillows and other supports.

As Betty Dodson, a staunch advocate for women’s pleasure until her death in 2020 at 91, wisely said, “Masturbation will get you through childhood, puberty, romance, marriage, and divorce, and it will see you through old age.” We can encourage women to see sexual play and pleasure flexibly, as a lifelong process of self-knowledge and discovery.

Basic Tips for Patients

• More “fiction and friction,” as coined by sex therapist Barry McCarthy, is necessary. As bodies age, more stimulation, both mental and physical, is necessary and often requires more direct physical stimulation of genitals.
• More time: Everything seems to take more time as we age; sex is no different.
• Incontinence concerns can be addressed by open communication and collaboration with partners, and being prepared with waterproof pads for the bed and towels.
• Ask about medical intervention–related sexual side effects. A wide range of medications can decrease desire and arousal and delay orgasm. If a change in sexual function occurred with starting a medication, it may be worthwhile investigating alternatives or, if possible, discontinuing a medication. Surgical and procedural changes to the anatomy also can affect sexual function. While correction may be impossible once certain changes have occurred, clinicians can provide patients with both validation about the problem and hope that, for the most part, with creativity and flexibility, pleasurable sexual experience is possible in all bodies.

Pebble M. Kranz, MD, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

NATIONAL HARBOR, MARYLAND — Rates of maternal morbidity in individuals with placenta accreta were similar with alternative strategies to cesarean hysterectomy regardless of the severity of the condition, based on data from 60 individuals.

Currently, the recommended management strategy for placenta accreta spectrum (PAS) is a cesarean hysterectomy, but data are lacking on alternative strategies, especially for individuals wishing to keep their uterus and potentially preserve fertility, Farah H. Amro, MD, of the University of Texas Health Science Center at Houston McGovern Medical School said in a presentation at the Pregnancy Meeting (abstract 70).

Alternative options are being studied worldwide, including delayed hysterectomy (typically performed at 4-6 weeks postpartum), Dr. Amro said at the meeting, which was sponsored by the Society for Maternal-Fetal Medicine.

At UT Houston, delayed hysterectomy is performed for more aggressive PAS that involves parametrial invasion, and the placenta left in situ until resorption/passage for those wishing to keep their uterus, Dr. Amro said in an interview.

In a cohort study at UT Houston, a level IV academic center, Dr. Amro and colleagues evaluated outcomes in 60 individuals with suspected PAS who were given three management options after extensive counseling. Of these, 29 opted for a cesarean hysterectomy (CH); 16 opted for delayed interval hysterectomy (IH) performed 4-6 weeks after delivery; and 15 individuals with a preference for uterine preservation were assigned to conservative management.

The study occurred between January 2020 and July 2023. The primary outcome was composite maternal morbidity, which was further divided into composite acute morbidity (within 24 hours from cesarean delivery or hysterectomy) and composite delayed morbidity (24 hours or more postoperatively). Secondary outcomes included total estimated blood loss, need for blood transfusion, unplanned hospital readmission, and pathology diagnosis.

Overall maternal morbidity rates were 55%, 56%, and 53% in the CH, IH, and CM groups, respectively, although those who were planned for IH and CM had more severe PAS.

The planned procedure was performed in 90% of the CH patients. Approximately 20% of patients in the IH and CM groups underwent unplanned procedures. No cases of sepsis or maternal death occurred, and uterine infection rates were 0%, 6%, and 13% in the CH, IH, and CM groups, respectively.

Patients in the CM and IH groups were significantly less likely to require blood transfusions than those in the CH group. In addition, composite delayed morbidity (24 hours or more after surgery) was similar among the groups, with rates of 31%, 38%, and 33% for CH, IH, and CM, respectively (P = .94). These results are important, given the concerns regarding leaving a placenta in situ after cesarean delivery, said Dr. Amro.

The findings were limited by several factors including the use of data from a single site, the lack of randomization, patient compliance, and cost effectiveness. However, the results were strengthened by the diverse population and comparison of novel approaches that aren’t frequently utilized In the United States, as well as the large volume of PAS cases treated in a relatively short time frame, Dr. Amro said.
 

More Options Empower Mothers

Overall, the results support the use of delayed hysterectomy and conservative management as safe alternatives to cesarean hysterectomy, especially in those with severe PAS (opting for IH Instead of CH) and those seeking to preserve the uterus (CM), Dr. Amro said. However, these alternative options can be offered only to patients who can engage in frequent postpartum follow-up and live close to the hospital; with the CM group, resorption/passage of the placenta may take as long as 6 months in some cases, she explained.

The greatest concerns with leaving the placenta in place in PAS patients are the risk of infection or subsequent hemorrhage, Dr. Amro said in an interview. However, the current study showed that the infection rate was not as high as anticipated, and the frequency of unplanned procedures occurred in only 20%, which should alleviate some of these concerns, she said.

“We have completed 28 cases of conservative management since 2015, four have gone on to successful pregnancy with no cases of PAS in the subsequent pregnancies,” Dr. Amro said. Conservative management gives mothers another option, she added. “Moms feel empowered by being given a choice, especially for those that want to keep their uterus for fertility or religious/cultural considerations, and many opt for CM.”

The next step is to take the conservative management strategy to larger groups at other centers to replicate the results in other locations, said Dr. Amro. “Also, we are looking at the utility of other interventions such as uterine artery embolization and performing delayed dilation and curettage to help with passage of the placenta in those opting for CM.”
 

Study Supports Safety of Conservative Management

“There are patients that may want to preserve their reproductive organs in the face of an accreta (such as for religious, cultural, and personal reasons), and this study helps address some of the safety considerations with conservative approaches,” Corrina M. Oxford-Horrey, MD, a maternal-fetal medicine specialist at Weill Cornell Medicine, New York, said in an interview.

“I was surprised that there was not a lot of infectious morbidity (such as sepsis) in the cohorts; that was helpful to see,” said Dr. Oxford-Horrey, who served as a moderator for the session in which the study was presented.

Based on the study findings, “nontraditional approaches to placenta accreta spectrum management may be reasonable, given similar overall postoperative composite morbidity between the groups,” she said.

As for additional research, replicating the study in a multicenter fashion would add to the generalizability of the findings, Dr. Oxford-Horrey said.

The study received no outside funding. The researchers and Dr. Oxford-Horrey had no financial conflicts to disclose.

NATIONAL HARBOR, MARYLAND — Rates of maternal morbidity in individuals with placenta accreta were similar with alternative strategies to cesarean hysterectomy regardless of the severity of the condition, based on data from 60 individuals.

Currently, the recommended management strategy for placenta accreta spectrum (PAS) is a cesarean hysterectomy, but data are lacking on alternative strategies, especially for individuals wishing to keep their uterus and potentially preserve fertility, Farah H. Amro, MD, of the University of Texas Health Science Center at Houston McGovern Medical School said in a presentation at the Pregnancy Meeting (abstract 70).

Alternative options are being studied worldwide, including delayed hysterectomy (typically performed at 4-6 weeks postpartum), Dr. Amro said at the meeting, which was sponsored by the Society for Maternal-Fetal Medicine.

At UT Houston, delayed hysterectomy is performed for more aggressive PAS that involves parametrial invasion, and the placenta left in situ until resorption/passage for those wishing to keep their uterus, Dr. Amro said in an interview.

In a cohort study at UT Houston, a level IV academic center, Dr. Amro and colleagues evaluated outcomes in 60 individuals with suspected PAS who were given three management options after extensive counseling. Of these, 29 opted for a cesarean hysterectomy (CH); 16 opted for delayed interval hysterectomy (IH) performed 4-6 weeks after delivery; and 15 individuals with a preference for uterine preservation were assigned to conservative management.

The study occurred between January 2020 and July 2023. The primary outcome was composite maternal morbidity, which was further divided into composite acute morbidity (within 24 hours from cesarean delivery or hysterectomy) and composite delayed morbidity (24 hours or more postoperatively). Secondary outcomes included total estimated blood loss, need for blood transfusion, unplanned hospital readmission, and pathology diagnosis.

Overall maternal morbidity rates were 55%, 56%, and 53% in the CH, IH, and CM groups, respectively, although those who were planned for IH and CM had more severe PAS.

The planned procedure was performed in 90% of the CH patients. Approximately 20% of patients in the IH and CM groups underwent unplanned procedures. No cases of sepsis or maternal death occurred, and uterine infection rates were 0%, 6%, and 13% in the CH, IH, and CM groups, respectively.

Patients in the CM and IH groups were significantly less likely to require blood transfusions than those in the CH group. In addition, composite delayed morbidity (24 hours or more after surgery) was similar among the groups, with rates of 31%, 38%, and 33% for CH, IH, and CM, respectively (P = .94). These results are important, given the concerns regarding leaving a placenta in situ after cesarean delivery, said Dr. Amro.

The findings were limited by several factors including the use of data from a single site, the lack of randomization, patient compliance, and cost effectiveness. However, the results were strengthened by the diverse population and comparison of novel approaches that aren’t frequently utilized In the United States, as well as the large volume of PAS cases treated in a relatively short time frame, Dr. Amro said.
 

More Options Empower Mothers

Overall, the results support the use of delayed hysterectomy and conservative management as safe alternatives to cesarean hysterectomy, especially in those with severe PAS (opting for IH Instead of CH) and those seeking to preserve the uterus (CM), Dr. Amro said. However, these alternative options can be offered only to patients who can engage in frequent postpartum follow-up and live close to the hospital; with the CM group, resorption/passage of the placenta may take as long as 6 months in some cases, she explained.

The greatest concerns with leaving the placenta in place in PAS patients are the risk of infection or subsequent hemorrhage, Dr. Amro said in an interview. However, the current study showed that the infection rate was not as high as anticipated, and the frequency of unplanned procedures occurred in only 20%, which should alleviate some of these concerns, she said.

“We have completed 28 cases of conservative management since 2015, four have gone on to successful pregnancy with no cases of PAS in the subsequent pregnancies,” Dr. Amro said. Conservative management gives mothers another option, she added. “Moms feel empowered by being given a choice, especially for those that want to keep their uterus for fertility or religious/cultural considerations, and many opt for CM.”

The next step is to take the conservative management strategy to larger groups at other centers to replicate the results in other locations, said Dr. Amro. “Also, we are looking at the utility of other interventions such as uterine artery embolization and performing delayed dilation and curettage to help with passage of the placenta in those opting for CM.”
 

Study Supports Safety of Conservative Management

“There are patients that may want to preserve their reproductive organs in the face of an accreta (such as for religious, cultural, and personal reasons), and this study helps address some of the safety considerations with conservative approaches,” Corrina M. Oxford-Horrey, MD, a maternal-fetal medicine specialist at Weill Cornell Medicine, New York, said in an interview.

“I was surprised that there was not a lot of infectious morbidity (such as sepsis) in the cohorts; that was helpful to see,” said Dr. Oxford-Horrey, who served as a moderator for the session in which the study was presented.

Based on the study findings, “nontraditional approaches to placenta accreta spectrum management may be reasonable, given similar overall postoperative composite morbidity between the groups,” she said.

As for additional research, replicating the study in a multicenter fashion would add to the generalizability of the findings, Dr. Oxford-Horrey said.

The study received no outside funding. The researchers and Dr. Oxford-Horrey had no financial conflicts to disclose.

NATIONAL HARBOR, MARYLAND — Rates of maternal morbidity in individuals with placenta accreta were similar with alternative strategies to cesarean hysterectomy regardless of the severity of the condition, based on data from 60 individuals.

Currently, the recommended management strategy for placenta accreta spectrum (PAS) is a cesarean hysterectomy, but data are lacking on alternative strategies, especially for individuals wishing to keep their uterus and potentially preserve fertility, Farah H. Amro, MD, of the University of Texas Health Science Center at Houston McGovern Medical School said in a presentation at the Pregnancy Meeting (abstract 70).

Alternative options are being studied worldwide, including delayed hysterectomy (typically performed at 4-6 weeks postpartum), Dr. Amro said at the meeting, which was sponsored by the Society for Maternal-Fetal Medicine.

At UT Houston, delayed hysterectomy is performed for more aggressive PAS that involves parametrial invasion, and the placenta left in situ until resorption/passage for those wishing to keep their uterus, Dr. Amro said in an interview.

In a cohort study at UT Houston, a level IV academic center, Dr. Amro and colleagues evaluated outcomes in 60 individuals with suspected PAS who were given three management options after extensive counseling. Of these, 29 opted for a cesarean hysterectomy (CH); 16 opted for delayed interval hysterectomy (IH) performed 4-6 weeks after delivery; and 15 individuals with a preference for uterine preservation were assigned to conservative management.

The study occurred between January 2020 and July 2023. The primary outcome was composite maternal morbidity, which was further divided into composite acute morbidity (within 24 hours from cesarean delivery or hysterectomy) and composite delayed morbidity (24 hours or more postoperatively). Secondary outcomes included total estimated blood loss, need for blood transfusion, unplanned hospital readmission, and pathology diagnosis.

Overall maternal morbidity rates were 55%, 56%, and 53% in the CH, IH, and CM groups, respectively, although those who were planned for IH and CM had more severe PAS.

The planned procedure was performed in 90% of the CH patients. Approximately 20% of patients in the IH and CM groups underwent unplanned procedures. No cases of sepsis or maternal death occurred, and uterine infection rates were 0%, 6%, and 13% in the CH, IH, and CM groups, respectively.

Patients in the CM and IH groups were significantly less likely to require blood transfusions than those in the CH group. In addition, composite delayed morbidity (24 hours or more after surgery) was similar among the groups, with rates of 31%, 38%, and 33% for CH, IH, and CM, respectively (P = .94). These results are important, given the concerns regarding leaving a placenta in situ after cesarean delivery, said Dr. Amro.

The findings were limited by several factors including the use of data from a single site, the lack of randomization, patient compliance, and cost effectiveness. However, the results were strengthened by the diverse population and comparison of novel approaches that aren’t frequently utilized In the United States, as well as the large volume of PAS cases treated in a relatively short time frame, Dr. Amro said.
 

More Options Empower Mothers

Overall, the results support the use of delayed hysterectomy and conservative management as safe alternatives to cesarean hysterectomy, especially in those with severe PAS (opting for IH Instead of CH) and those seeking to preserve the uterus (CM), Dr. Amro said. However, these alternative options can be offered only to patients who can engage in frequent postpartum follow-up and live close to the hospital; with the CM group, resorption/passage of the placenta may take as long as 6 months in some cases, she explained.

The greatest concerns with leaving the placenta in place in PAS patients are the risk of infection or subsequent hemorrhage, Dr. Amro said in an interview. However, the current study showed that the infection rate was not as high as anticipated, and the frequency of unplanned procedures occurred in only 20%, which should alleviate some of these concerns, she said.

“We have completed 28 cases of conservative management since 2015, four have gone on to successful pregnancy with no cases of PAS in the subsequent pregnancies,” Dr. Amro said. Conservative management gives mothers another option, she added. “Moms feel empowered by being given a choice, especially for those that want to keep their uterus for fertility or religious/cultural considerations, and many opt for CM.”

The next step is to take the conservative management strategy to larger groups at other centers to replicate the results in other locations, said Dr. Amro. “Also, we are looking at the utility of other interventions such as uterine artery embolization and performing delayed dilation and curettage to help with passage of the placenta in those opting for CM.”
 

Study Supports Safety of Conservative Management

“There are patients that may want to preserve their reproductive organs in the face of an accreta (such as for religious, cultural, and personal reasons), and this study helps address some of the safety considerations with conservative approaches,” Corrina M. Oxford-Horrey, MD, a maternal-fetal medicine specialist at Weill Cornell Medicine, New York, said in an interview.

“I was surprised that there was not a lot of infectious morbidity (such as sepsis) in the cohorts; that was helpful to see,” said Dr. Oxford-Horrey, who served as a moderator for the session in which the study was presented.

Based on the study findings, “nontraditional approaches to placenta accreta spectrum management may be reasonable, given similar overall postoperative composite morbidity between the groups,” she said.

As for additional research, replicating the study in a multicenter fashion would add to the generalizability of the findings, Dr. Oxford-Horrey said.

The study received no outside funding. The researchers and Dr. Oxford-Horrey had no financial conflicts to disclose.

This transcript has been edited for clarity.

The American Cancer Society has just published its cancer statistics for 2024. This is an annual report, the latest version of which has some alarming news for gastroenterologists. Usually, we think of being “number one” as a positive thing, but that’s not the case this year when it comes to the projections for colorectal cancer.

But first, let’s discuss the report’s overall findings. Broadly speaking, the news is quite good in that there’s been an aversion of over 4 million deaths since 1991. That decline over the past four decades is due to reductions in smoking, earlier detection, and improved screening and treatments for localized or metastatic disease. But these gains are now threatened by some offsets that we’re seeing, with increasing rates of six of the top 10 cancers in the past several years.
 

Increasing Rates of Gastrointestinal Cancers

The incidence rate of pancreas cancer has increased from 0.6% to 1% annually.

Pancreas cancer has a 5-year relative survival rate of 13%, which ranks as one of the three worst rates for cancers. This cancer represents a real screening challenge for us, as it typically presents asymptomatically.

Women have experienced a 2%-3% annual increase in incidence rates for liver cancer.

I suspect that this is due to cases of fibrotic liver disease resulting from viral hepatitis and metabolic liver diseases with nonalcoholic fatty liver and advanced fibrosis (F3 and F4). These cases may be carried over from before, thereby contributing to the increasing incremental cancer risk.

We can’t overlook the need for risk reduction here and should focus on applying regular screening efforts in our female patients. However, it’s also true that we require better liver cancer screening tests to accomplish that goal.
 

In Those Under 50, CRC the Leading Cause of Cancer Death in Men, Second in Women

I really want to focus on the news around colorectal cancer.

To put this in perspective, in the late 1990s, colorectal cancer was the fourth leading cause of death in men and women. The current report extrapolated 2024 projections using the Surveillance, Epidemiology, and End Results (SEER) database ending in 2020, which was necessary given the incremental time it takes to develop cancers. The SEER database suggests that in 2024, colorectal cancer in those younger than 50 years of age will become the number-one leading cause of cancer death in men and number-two in women. The increasing incidence of colorectal cancer in younger people is probably the result of a number of epidemiologic and other reasons.

The current report offers evidence of racial disparities in cancer mortality rates in general, which are twofold higher in Black people compared with White people, particularly for gastric cancer. There is also an evident disparity in Native Americans, who have higher rates of gastric and liver cancer. This is a reminder of the increasing need for equity to address racial disparities across these populations.

But returning to colon cancer, it’s a marked change to go from being the fourth-leading cause of cancer death in those younger than 50 years of age to being number one for men and number two for women.

Being “number one” is supposed to make you famous. This “number one,” however, should in fact be infamous. It’s a travesty, because colorectal cancer is a potentially preventable disease.

As we move into March, which happens to be Colorectal Cancer Awareness Month, hopefully this fires up some of the conversations you have with your younger at-risk population, who may be reticent or resistant to colorectal cancer screening.

We have to do better at getting this message out to that population at large. “Number one” is not where we want to be for this potentially preventable problem.
 

Dr. Johnson is professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, Virginia, and a past president of the American College of Gastroenterology. His primary focus is the clinical practice of gastroenterology. He has published extensively in the internal medicine/gastroenterology literature, with principal research interests in esophageal and colon disease, and more recently in sleep and microbiome effects on gastrointestinal health and disease. He has disclosed ties with ISOTHRIVE and Johnson & Johnson.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

The American Cancer Society has just published its cancer statistics for 2024. This is an annual report, the latest version of which has some alarming news for gastroenterologists. Usually, we think of being “number one” as a positive thing, but that’s not the case this year when it comes to the projections for colorectal cancer.

But first, let’s discuss the report’s overall findings. Broadly speaking, the news is quite good in that there’s been an aversion of over 4 million deaths since 1991. That decline over the past four decades is due to reductions in smoking, earlier detection, and improved screening and treatments for localized or metastatic disease. But these gains are now threatened by some offsets that we’re seeing, with increasing rates of six of the top 10 cancers in the past several years.
 

Increasing Rates of Gastrointestinal Cancers

The incidence rate of pancreas cancer has increased from 0.6% to 1% annually.

Pancreas cancer has a 5-year relative survival rate of 13%, which ranks as one of the three worst rates for cancers. This cancer represents a real screening challenge for us, as it typically presents asymptomatically.

Women have experienced a 2%-3% annual increase in incidence rates for liver cancer.

I suspect that this is due to cases of fibrotic liver disease resulting from viral hepatitis and metabolic liver diseases with nonalcoholic fatty liver and advanced fibrosis (F3 and F4). These cases may be carried over from before, thereby contributing to the increasing incremental cancer risk.

We can’t overlook the need for risk reduction here and should focus on applying regular screening efforts in our female patients. However, it’s also true that we require better liver cancer screening tests to accomplish that goal.
 

In Those Under 50, CRC the Leading Cause of Cancer Death in Men, Second in Women

I really want to focus on the news around colorectal cancer.

To put this in perspective, in the late 1990s, colorectal cancer was the fourth leading cause of death in men and women. The current report extrapolated 2024 projections using the Surveillance, Epidemiology, and End Results (SEER) database ending in 2020, which was necessary given the incremental time it takes to develop cancers. The SEER database suggests that in 2024, colorectal cancer in those younger than 50 years of age will become the number-one leading cause of cancer death in men and number-two in women. The increasing incidence of colorectal cancer in younger people is probably the result of a number of epidemiologic and other reasons.

The current report offers evidence of racial disparities in cancer mortality rates in general, which are twofold higher in Black people compared with White people, particularly for gastric cancer. There is also an evident disparity in Native Americans, who have higher rates of gastric and liver cancer. This is a reminder of the increasing need for equity to address racial disparities across these populations.

But returning to colon cancer, it’s a marked change to go from being the fourth-leading cause of cancer death in those younger than 50 years of age to being number one for men and number two for women.

Being “number one” is supposed to make you famous. This “number one,” however, should in fact be infamous. It’s a travesty, because colorectal cancer is a potentially preventable disease.

As we move into March, which happens to be Colorectal Cancer Awareness Month, hopefully this fires up some of the conversations you have with your younger at-risk population, who may be reticent or resistant to colorectal cancer screening.

We have to do better at getting this message out to that population at large. “Number one” is not where we want to be for this potentially preventable problem.
 

Dr. Johnson is professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, Virginia, and a past president of the American College of Gastroenterology. His primary focus is the clinical practice of gastroenterology. He has published extensively in the internal medicine/gastroenterology literature, with principal research interests in esophageal and colon disease, and more recently in sleep and microbiome effects on gastrointestinal health and disease. He has disclosed ties with ISOTHRIVE and Johnson & Johnson.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

The American Cancer Society has just published its cancer statistics for 2024. This is an annual report, the latest version of which has some alarming news for gastroenterologists. Usually, we think of being “number one” as a positive thing, but that’s not the case this year when it comes to the projections for colorectal cancer.

But first, let’s discuss the report’s overall findings. Broadly speaking, the news is quite good in that there’s been an aversion of over 4 million deaths since 1991. That decline over the past four decades is due to reductions in smoking, earlier detection, and improved screening and treatments for localized or metastatic disease. But these gains are now threatened by some offsets that we’re seeing, with increasing rates of six of the top 10 cancers in the past several years.
 

Increasing Rates of Gastrointestinal Cancers

The incidence rate of pancreas cancer has increased from 0.6% to 1% annually.

Pancreas cancer has a 5-year relative survival rate of 13%, which ranks as one of the three worst rates for cancers. This cancer represents a real screening challenge for us, as it typically presents asymptomatically.

Women have experienced a 2%-3% annual increase in incidence rates for liver cancer.

I suspect that this is due to cases of fibrotic liver disease resulting from viral hepatitis and metabolic liver diseases with nonalcoholic fatty liver and advanced fibrosis (F3 and F4). These cases may be carried over from before, thereby contributing to the increasing incremental cancer risk.

We can’t overlook the need for risk reduction here and should focus on applying regular screening efforts in our female patients. However, it’s also true that we require better liver cancer screening tests to accomplish that goal.
 

In Those Under 50, CRC the Leading Cause of Cancer Death in Men, Second in Women

I really want to focus on the news around colorectal cancer.

To put this in perspective, in the late 1990s, colorectal cancer was the fourth leading cause of death in men and women. The current report extrapolated 2024 projections using the Surveillance, Epidemiology, and End Results (SEER) database ending in 2020, which was necessary given the incremental time it takes to develop cancers. The SEER database suggests that in 2024, colorectal cancer in those younger than 50 years of age will become the number-one leading cause of cancer death in men and number-two in women. The increasing incidence of colorectal cancer in younger people is probably the result of a number of epidemiologic and other reasons.

The current report offers evidence of racial disparities in cancer mortality rates in general, which are twofold higher in Black people compared with White people, particularly for gastric cancer. There is also an evident disparity in Native Americans, who have higher rates of gastric and liver cancer. This is a reminder of the increasing need for equity to address racial disparities across these populations.

But returning to colon cancer, it’s a marked change to go from being the fourth-leading cause of cancer death in those younger than 50 years of age to being number one for men and number two for women.

Being “number one” is supposed to make you famous. This “number one,” however, should in fact be infamous. It’s a travesty, because colorectal cancer is a potentially preventable disease.

As we move into March, which happens to be Colorectal Cancer Awareness Month, hopefully this fires up some of the conversations you have with your younger at-risk population, who may be reticent or resistant to colorectal cancer screening.

We have to do better at getting this message out to that population at large. “Number one” is not where we want to be for this potentially preventable problem.
 

Dr. Johnson is professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, Virginia, and a past president of the American College of Gastroenterology. His primary focus is the clinical practice of gastroenterology. He has published extensively in the internal medicine/gastroenterology literature, with principal research interests in esophageal and colon disease, and more recently in sleep and microbiome effects on gastrointestinal health and disease. He has disclosed ties with ISOTHRIVE and Johnson & Johnson.

A version of this article appeared on Medscape.com.

TOPLINE:

Women with steatotic liver disease (SLD) related to alcohol consumption are at greater risk of mortality than men with the same condition, new research suggested.

METHODOLOGY:

• Researchers analyzed data from the US National Health and Nutrition Examination Survey III (NHANES III, 1988-1994), which included standardized ultrasonographic measures of hepatic steatosis, assessment of cardiometabolic risk traits, and questionnaire data on alcohol intake.
• Among 10,007 participants aged 20 years and older (mean age, 42 years; 50.3% men) who were included and followed for a median of 26.7 years, 1461 had metabolic dysfunction–associated steatotic liver disease (MASLD), 105 alcohol-related liver disease (ALD), 225 metabolic dysfunction-associated and alcohol-related liver disease (MetALD), 180 other types of SLD, and 8036 no SLD.
• Researchers examined SLD-associated risks for all-cause mortality after adjustment for baseline age, smoking status, systolic blood pressure, antihypertensives, type 2 diabetes, diabetic medication use, body mass index, total cholesterol, high-density lipoprotein cholesterol, lipid-lowering therapy, race, and family income.

TAKEAWAY:

• In men, the prevalence of MASLD, MetALD, and ALD was 18.5%, 3.2%, and 1.7%, respectively, whereas the corresponding prevalence among women was 10.3%, 1.2%, and 0.3%, respectively.
• In multivariable-adjusted survival analyses, MASLD was not significantly associated with all-cause mortality for either sex compared with those without SLD.
• In contrast, MetALD was associated with an 83% higher hazard of all-cause mortality in women (hazard ratio [HR], 1.83), but not significantly associated with mortality in men.
• ALD was significantly associated with all-cause mortality in both sexes, with a greater magnitude in women than men (HRs, 3.49 vs 1.89, respectively) — the equivalent of about a 160% higher mortality risk for women.
• With regard to SLD severity, the trend across worsening phenotypes (ie, MASLD, MetALD, or ALD) was significant for sex differences in mortality but not in prevalence.

IN PRACTICE:

“Because alcohol consumption is modifiable, limiting alcohol intake particularly in women at risk for SLD could be critical as part of efforts to mitigate mortality risk in patients with SLD,” the authors wrote.

SOURCE:

The study, led by Hongwei Ji of Qingdao University, Qingdao, Shandong, China, and Susan Cheng, MD, Cedars-Sinai Medical Center, Los Angeles, was published in the February issue of Journal of Hepatology.

LIMITATIONS:

The study data came from NHANES III, which was conducted between 1988 and 1994. This is a potential limitation, as the prevalence of metabolic dysfunction and alcohol use may have changed since then.

DISCLOSURES:

The study was funded in part by the National Natural Science Foundation of China, the Taishan Scholar Program of Shandong Province, the Shandong Provincial Natural Science Foundation, the National Institutes of Health, and the NIH National Center for Advancing Translational Sciences UCLA Clinical and Translational Research Center. The authors declared no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Women with steatotic liver disease (SLD) related to alcohol consumption are at greater risk of mortality than men with the same condition, new research suggested.

METHODOLOGY:

• Researchers analyzed data from the US National Health and Nutrition Examination Survey III (NHANES III, 1988-1994), which included standardized ultrasonographic measures of hepatic steatosis, assessment of cardiometabolic risk traits, and questionnaire data on alcohol intake.
• Among 10,007 participants aged 20 years and older (mean age, 42 years; 50.3% men) who were included and followed for a median of 26.7 years, 1461 had metabolic dysfunction–associated steatotic liver disease (MASLD), 105 alcohol-related liver disease (ALD), 225 metabolic dysfunction-associated and alcohol-related liver disease (MetALD), 180 other types of SLD, and 8036 no SLD.
• Researchers examined SLD-associated risks for all-cause mortality after adjustment for baseline age, smoking status, systolic blood pressure, antihypertensives, type 2 diabetes, diabetic medication use, body mass index, total cholesterol, high-density lipoprotein cholesterol, lipid-lowering therapy, race, and family income.

TAKEAWAY:

• In men, the prevalence of MASLD, MetALD, and ALD was 18.5%, 3.2%, and 1.7%, respectively, whereas the corresponding prevalence among women was 10.3%, 1.2%, and 0.3%, respectively.
• In multivariable-adjusted survival analyses, MASLD was not significantly associated with all-cause mortality for either sex compared with those without SLD.
• In contrast, MetALD was associated with an 83% higher hazard of all-cause mortality in women (hazard ratio [HR], 1.83), but not significantly associated with mortality in men.
• ALD was significantly associated with all-cause mortality in both sexes, with a greater magnitude in women than men (HRs, 3.49 vs 1.89, respectively) — the equivalent of about a 160% higher mortality risk for women.
• With regard to SLD severity, the trend across worsening phenotypes (ie, MASLD, MetALD, or ALD) was significant for sex differences in mortality but not in prevalence.

IN PRACTICE:

“Because alcohol consumption is modifiable, limiting alcohol intake particularly in women at risk for SLD could be critical as part of efforts to mitigate mortality risk in patients with SLD,” the authors wrote.

SOURCE:

The study, led by Hongwei Ji of Qingdao University, Qingdao, Shandong, China, and Susan Cheng, MD, Cedars-Sinai Medical Center, Los Angeles, was published in the February issue of Journal of Hepatology.

LIMITATIONS:

The study data came from NHANES III, which was conducted between 1988 and 1994. This is a potential limitation, as the prevalence of metabolic dysfunction and alcohol use may have changed since then.

DISCLOSURES:

The study was funded in part by the National Natural Science Foundation of China, the Taishan Scholar Program of Shandong Province, the Shandong Provincial Natural Science Foundation, the National Institutes of Health, and the NIH National Center for Advancing Translational Sciences UCLA Clinical and Translational Research Center. The authors declared no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Women with steatotic liver disease (SLD) related to alcohol consumption are at greater risk of mortality than men with the same condition, new research suggested.

METHODOLOGY:

• Researchers analyzed data from the US National Health and Nutrition Examination Survey III (NHANES III, 1988-1994), which included standardized ultrasonographic measures of hepatic steatosis, assessment of cardiometabolic risk traits, and questionnaire data on alcohol intake.
• Among 10,007 participants aged 20 years and older (mean age, 42 years; 50.3% men) who were included and followed for a median of 26.7 years, 1461 had metabolic dysfunction–associated steatotic liver disease (MASLD), 105 alcohol-related liver disease (ALD), 225 metabolic dysfunction-associated and alcohol-related liver disease (MetALD), 180 other types of SLD, and 8036 no SLD.
• Researchers examined SLD-associated risks for all-cause mortality after adjustment for baseline age, smoking status, systolic blood pressure, antihypertensives, type 2 diabetes, diabetic medication use, body mass index, total cholesterol, high-density lipoprotein cholesterol, lipid-lowering therapy, race, and family income.

TAKEAWAY:

• In men, the prevalence of MASLD, MetALD, and ALD was 18.5%, 3.2%, and 1.7%, respectively, whereas the corresponding prevalence among women was 10.3%, 1.2%, and 0.3%, respectively.
• In multivariable-adjusted survival analyses, MASLD was not significantly associated with all-cause mortality for either sex compared with those without SLD.
• In contrast, MetALD was associated with an 83% higher hazard of all-cause mortality in women (hazard ratio [HR], 1.83), but not significantly associated with mortality in men.
• ALD was significantly associated with all-cause mortality in both sexes, with a greater magnitude in women than men (HRs, 3.49 vs 1.89, respectively) — the equivalent of about a 160% higher mortality risk for women.
• With regard to SLD severity, the trend across worsening phenotypes (ie, MASLD, MetALD, or ALD) was significant for sex differences in mortality but not in prevalence.

IN PRACTICE:

“Because alcohol consumption is modifiable, limiting alcohol intake particularly in women at risk for SLD could be critical as part of efforts to mitigate mortality risk in patients with SLD,” the authors wrote.

SOURCE:

The study, led by Hongwei Ji of Qingdao University, Qingdao, Shandong, China, and Susan Cheng, MD, Cedars-Sinai Medical Center, Los Angeles, was published in the February issue of Journal of Hepatology.

LIMITATIONS:

The study data came from NHANES III, which was conducted between 1988 and 1994. This is a potential limitation, as the prevalence of metabolic dysfunction and alcohol use may have changed since then.

DISCLOSURES:

The study was funded in part by the National Natural Science Foundation of China, the Taishan Scholar Program of Shandong Province, the Shandong Provincial Natural Science Foundation, the National Institutes of Health, and the NIH National Center for Advancing Translational Sciences UCLA Clinical and Translational Research Center. The authors declared no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

Women may gain greater health benefits from regular physical activity at equivalent or lower doses of activity, compared with men, according to data from more than 400,000 US adults. 

Over two decades, with any regular physical activity, all-cause mortality risk was reduced by 24% in women vs 15% in men, and cardiovascular mortality risk was reduced by 36% and 14%, respectively, compared with inactivity, researchers found. 

Participating in strength training exercises (vs not) was associated with a reduced risk for all-cause death of 19% in women and 11% men and reductions in cardiovascular death of 30% and 11%, respectively.

“Women have historically and statistically lagged behind men in engaging in meaningful exercise,” co–lead author Martha Gulati, MD, with the Smidt Heart Institute at Cedars-Sinai, Los Angeles, said in a statement. “The beauty of this study is learning that women can get more out of each minute of moderate to vigorous activity than men do. It’s an incentivizing notion that we hope women will take to heart.”

The study was published online February 19 in the Journal of the American College of Cardiology. 
 

Sex-Specific Exercise Advice? 

The findings are based on leisure-time physical activity data collected over roughly 20 years via the National Health Interview Survey for 412,413 US adults aged 27-61 years. During roughly 4.9 million person-years of follow-up, there were 39,935 all-cause deaths and 11,670 cardiovascular deaths.

Both men and women achieved a peak survival benefit at 300 minutes of weekly moderate to vigorous aerobic physical activity. But the mortality reduction was substantially greater in women than in men for the same amount of regular exercise (24% vs 18%). 

Similarly, for any given dose of physical activity leading up to 300 minutes per week, women derived proportionately greater survival benefits than did men, the authors reported. 

“Importantly, the greater magnitude of physical activity-related survival benefit in women than men was consistently found across varied measures and types of physical activity including frequency, duration per session, and intensity of aerobic physical activity, as well as frequency of muscle strengthening activities,” they wrote. 

They say multiple factors, including variations in anatomy and physiology, may account for the differences in outcomes between men and women. For example, compared with men, women may use more respiratory, metabolic, and strength demands to conduct the same movement and in turn, reap greater health benefits.

The study also showed only 33% of women and 43% of men regularly engaged in aerobic physical activity, whereas only 20% of women and 28% of men completed a weekly strength training session.

“We hope this study will help everyone, especially women, understand they are poised to gain tremendous benefits from exercise,” senior author Susan Cheng, MD, with the Smidt Heart Institute at Cedars-Sinai, Los Angeles, said in a statement.

In an accompanying editorial, Wael A. Jaber, MD, and Erika Hutt, MD, from Cleveland Clinic Ohio, wrote that this analysis “brings us one step farther in gaining insights into the role and influence of physiological responses to exercise with a sex-specific lens.” 

The study is “well designed and adds important information to the body of literature that can potentially close the gender gap and optimize sex-specific physical activity recommendations by policy makers and societal guidelines,” they wrote. 

“This study emphasizes that there is no singular approach for exercise. A person’s physical activity needs and goals may change based on their age, health status, and schedule — but the value of any type of exercise is irrefutable,” Eric J. Shiroma, ScD, with the National Heart, Lung, and Blood Institute, said in a statement. 

The study was supported in part by grants from the National Institutes of Health. The authors and editorial writers have declared no relevant conflicts of interest.
 

A version of this article appeared on Medscape.com.

Women may gain greater health benefits from regular physical activity at equivalent or lower doses of activity, compared with men, according to data from more than 400,000 US adults. 

Over two decades, with any regular physical activity, all-cause mortality risk was reduced by 24% in women vs 15% in men, and cardiovascular mortality risk was reduced by 36% and 14%, respectively, compared with inactivity, researchers found. 

Participating in strength training exercises (vs not) was associated with a reduced risk for all-cause death of 19% in women and 11% men and reductions in cardiovascular death of 30% and 11%, respectively.

“Women have historically and statistically lagged behind men in engaging in meaningful exercise,” co–lead author Martha Gulati, MD, with the Smidt Heart Institute at Cedars-Sinai, Los Angeles, said in a statement. “The beauty of this study is learning that women can get more out of each minute of moderate to vigorous activity than men do. It’s an incentivizing notion that we hope women will take to heart.”

The study was published online February 19 in the Journal of the American College of Cardiology. 
 

Sex-Specific Exercise Advice? 

The findings are based on leisure-time physical activity data collected over roughly 20 years via the National Health Interview Survey for 412,413 US adults aged 27-61 years. During roughly 4.9 million person-years of follow-up, there were 39,935 all-cause deaths and 11,670 cardiovascular deaths.

Both men and women achieved a peak survival benefit at 300 minutes of weekly moderate to vigorous aerobic physical activity. But the mortality reduction was substantially greater in women than in men for the same amount of regular exercise (24% vs 18%). 

Similarly, for any given dose of physical activity leading up to 300 minutes per week, women derived proportionately greater survival benefits than did men, the authors reported. 

“Importantly, the greater magnitude of physical activity-related survival benefit in women than men was consistently found across varied measures and types of physical activity including frequency, duration per session, and intensity of aerobic physical activity, as well as frequency of muscle strengthening activities,” they wrote. 

They say multiple factors, including variations in anatomy and physiology, may account for the differences in outcomes between men and women. For example, compared with men, women may use more respiratory, metabolic, and strength demands to conduct the same movement and in turn, reap greater health benefits.

The study also showed only 33% of women and 43% of men regularly engaged in aerobic physical activity, whereas only 20% of women and 28% of men completed a weekly strength training session.

“We hope this study will help everyone, especially women, understand they are poised to gain tremendous benefits from exercise,” senior author Susan Cheng, MD, with the Smidt Heart Institute at Cedars-Sinai, Los Angeles, said in a statement.

In an accompanying editorial, Wael A. Jaber, MD, and Erika Hutt, MD, from Cleveland Clinic Ohio, wrote that this analysis “brings us one step farther in gaining insights into the role and influence of physiological responses to exercise with a sex-specific lens.” 

The study is “well designed and adds important information to the body of literature that can potentially close the gender gap and optimize sex-specific physical activity recommendations by policy makers and societal guidelines,” they wrote. 

“This study emphasizes that there is no singular approach for exercise. A person’s physical activity needs and goals may change based on their age, health status, and schedule — but the value of any type of exercise is irrefutable,” Eric J. Shiroma, ScD, with the National Heart, Lung, and Blood Institute, said in a statement. 

The study was supported in part by grants from the National Institutes of Health. The authors and editorial writers have declared no relevant conflicts of interest.
 

A version of this article appeared on Medscape.com.

Women may gain greater health benefits from regular physical activity at equivalent or lower doses of activity, compared with men, according to data from more than 400,000 US adults. 

Over two decades, with any regular physical activity, all-cause mortality risk was reduced by 24% in women vs 15% in men, and cardiovascular mortality risk was reduced by 36% and 14%, respectively, compared with inactivity, researchers found. 

Participating in strength training exercises (vs not) was associated with a reduced risk for all-cause death of 19% in women and 11% men and reductions in cardiovascular death of 30% and 11%, respectively.

“Women have historically and statistically lagged behind men in engaging in meaningful exercise,” co–lead author Martha Gulati, MD, with the Smidt Heart Institute at Cedars-Sinai, Los Angeles, said in a statement. “The beauty of this study is learning that women can get more out of each minute of moderate to vigorous activity than men do. It’s an incentivizing notion that we hope women will take to heart.”

The study was published online February 19 in the Journal of the American College of Cardiology. 
 

Sex-Specific Exercise Advice? 

The findings are based on leisure-time physical activity data collected over roughly 20 years via the National Health Interview Survey for 412,413 US adults aged 27-61 years. During roughly 4.9 million person-years of follow-up, there were 39,935 all-cause deaths and 11,670 cardiovascular deaths.

Both men and women achieved a peak survival benefit at 300 minutes of weekly moderate to vigorous aerobic physical activity. But the mortality reduction was substantially greater in women than in men for the same amount of regular exercise (24% vs 18%). 

Similarly, for any given dose of physical activity leading up to 300 minutes per week, women derived proportionately greater survival benefits than did men, the authors reported. 

“Importantly, the greater magnitude of physical activity-related survival benefit in women than men was consistently found across varied measures and types of physical activity including frequency, duration per session, and intensity of aerobic physical activity, as well as frequency of muscle strengthening activities,” they wrote. 

They say multiple factors, including variations in anatomy and physiology, may account for the differences in outcomes between men and women. For example, compared with men, women may use more respiratory, metabolic, and strength demands to conduct the same movement and in turn, reap greater health benefits.

The study also showed only 33% of women and 43% of men regularly engaged in aerobic physical activity, whereas only 20% of women and 28% of men completed a weekly strength training session.

“We hope this study will help everyone, especially women, understand they are poised to gain tremendous benefits from exercise,” senior author Susan Cheng, MD, with the Smidt Heart Institute at Cedars-Sinai, Los Angeles, said in a statement.

In an accompanying editorial, Wael A. Jaber, MD, and Erika Hutt, MD, from Cleveland Clinic Ohio, wrote that this analysis “brings us one step farther in gaining insights into the role and influence of physiological responses to exercise with a sex-specific lens.” 

The study is “well designed and adds important information to the body of literature that can potentially close the gender gap and optimize sex-specific physical activity recommendations by policy makers and societal guidelines,” they wrote. 

“This study emphasizes that there is no singular approach for exercise. A person’s physical activity needs and goals may change based on their age, health status, and schedule — but the value of any type of exercise is irrefutable,” Eric J. Shiroma, ScD, with the National Heart, Lung, and Blood Institute, said in a statement. 

The study was supported in part by grants from the National Institutes of Health. The authors and editorial writers have declared no relevant conflicts of interest.
 

A version of this article appeared on Medscape.com.

Screening mammograms miss close to one in eight breast cancers. But early research suggests artificial intelligence (AI) could close this detection gap and markedly improve early diagnosis of the disease. Still, questions remain regarding how to best incorporate AI into screenings and whether it’s too soon to deploy the technology.

Already, some radiology clinics are offering AI analysis of mammograms through an add-on cost method.

Mammography patients who visit RadNet facilities, for example, have the option of an additional AI screening of their images. RadNet, the largest national owner and operator of fixed-site diagnostic imaging centers in the United States with more than 370 locations, first launched its AI program in the Northeast. The company has now rolled out its product across all regions in the country.

Because the AI is not reimbursed by insurers, patients must pay a $40 out-of-pocket fee if they want the AI analysis.

“RadNet practices have identified more than 400 women whose cancer was found earlier than it would have been had the AI not been present,” said Greg Sorensen MD, chief science officer for RadNet.
 

How RadNet’s AI Program Works

Patients coming to RadNet facilities for screening mammography undergo 3D high-resolution mammography that includes the use of 70-micron resolution detector technology, said Dr. Sorensen. The mammogram is reviewed by a qualified radiologist with assistance from two Food and Drug Administration–cleared AI programs, Saige-Q and Saige-Density. The radiologist then makes an interpretation.

Saige-Q is an AI tool that helps identify more suspicious mammograms by providing a quick signal to radiologists if the AI considers a given mammogram to be in a suspicious category, according to Dr. Sorensen. Saige-Density provides a density rating for each mammogram using one of the four standard categories:

• A. Almost entirely fatty
• B. Scattered areas of fibroglandular density
• C. Heterogeneously dense
• D. Extremely dense

Starting in September 2024, the FDA will require all mammogram reports to indicate density.

For patients who choose the $40 add-on service, called Enhanced Breast Cancer Detection, two other FDA-registered AI programs are also applied: Saige-Dx and Saige-Assure. These AI programs go a step further by placing marks on areas within the images that they find suspicious. Mammograms flagged as “high-suspicion” by the AI are then reviewed by a second human radiologist. The first and second radiologists confer to agree on a final diagnosis, Dr. Sorensen explained.

“Our research shows that approximately 20% more cancers are found when the safeguard review process is in place,” Dr. Sorensen said. “We also have seen [30%] decreases in recall rates” — the percentage of screening cases in which further tests are recommended by the radiologist.

Bethesda radiologist Janet Storella, MD, has used the AI program for about 3 years and said the technology has improved her screening performance.

The AI is linked to her practice’s imaging software, and radiologists have the option of turning the AI on at any time during their reading of screening mammograms, Dr. Storella explained. Some radiologists review the mammogram first and then initiate the AI, while others like Dr. Storella turn it on at the start, she said. Once initiated, the AI draws bounding boxes — or outlines — around areas that it deems suspicious.

The AI helps focus Dr. Storella’s attention on suspicious areas and grades the level of suspicion into one of four categories: high, intermediate, low, and minimal, she said.

“I find it especially useful in patients who have dense breast tissue,” said Dr. Storella, medical director of women’s imaging at Community Radiology Associates, a RadNet practice. “In these situations, the tissue on the mammogram is a field of white, and cancers are also white, so you’re looking for that little white golf ball on a sea of snow. The AI really helps hone that down to specific areas.”

About 35% of RadNet’s screening mammography patients have enrolled in the Enhanced Breast Cancer Detection program, according to RadNet data. In a recent study of nine general radiologists and nine breast imaging specialists, all radiologists improved their interpretation performance of DBT screening mammograms when reading with RadNet’s AI versus without it. (An average AUC [area under the receiver operating characteristic curve] of 0.93 versus 0.87, demonstrating a difference in AUC of 0.06 (95% CI, 0.04-0.08; P < .001)
 

Is Mammography Ready for AI?

RadNet is among a growing number of commercial companies offering AI solutions for mammography. MammoScreen and Hologic, for example, are two other companies that provide AI programs to assist radiologists in reading screening mammograms.

“We are at the start of the AI integration into breast imaging at this point,” said Laura Heacock, MD, a breast imaging radiologist and associate professor of radiology at NYU Langone Health. “There are multiple commercial AI models now available to radiologists to use in their practice [ and] there will likely be more. We’re in the transition stage where people are still deciding: Which is the best model to go with? How do I put it in my system? How do I ensure it works they way it was intended? Every practice and medical system will have a different answer to that question.”

At NYU Langone Health, researchers have been developing and studying optimal AI models for breast imaging for several years, Dr. Heacock said. Researchers thus far, have developed AI models for 2D digital mammography, 3D mammograms, breast ultrasound, and breast MRI. Similar to commercial AI systems, the AI is embedded into the picture archiving and communication (PACS) system used by radiologists to review images. Radiologists press a button to launch the AI, which draws a box around suspicious areas of the image and scores the suspicion.

“I take a look of where it is on the mammogram and decide whether that fits my level of suspicion,” Dr. Heacock said. The AI may not understand things about the mammogram like we do. For example, surgical scars look very suspicious to an AI model. But if I’m looking at a mammogram where [the patient] has had a stable scar that hasn’t changed in 10 years, I’m not concerned that the AI found it suspicious. My clinical judgment is the ultimate decider. This is just an additional piece of information that’s helpful to me.”

Research by New York University (NYU) has shown that when used by an expert radiologist the AI models have improved breast cancer detection in all four modalities, she said.

However, the AI has not yet launched at NYU Langone. More research is needed before deploying the technology, according to Dr. Heacock.

“At NYU, we are still testing the benefits to patients,” she said. “We know it improves cancer detection, but we want to make sure there are no drawbacks. We are still exploring the best ways to put it into effect at our institution.”

Dr. Heacock pointed to recent studies on AI in screening mammography that show promise.

An analysis of more than 80,000 women, for example, published in The Lancet Oncology in August, found that AI-supported screen reading led to a similar cancer detection rate as compared with a two-person reader system. This screening resulted in 244 screen-detected cancers, 861 recalls, and a total of 46,345 screen readings, according to the study. Standard screening resulted in 203 screen-detected cancers, 817 recalls, and a total of 83,231 screen readings.

The AI system also reduced the screen-reading workload for radiologists by 44%, the study found.

Meanwhile, a September 2023 study, published in The Lancet Digital Health, found that replacing one radiologist with AI resulted in more cancer detection without a large increase in false-positive cases. The AI led to a 4% higher, noninferior cancer detection rate, compared with radiologist double reading, the study found.

Dr. Heacock emphasized that both studies were conducted in Europe where the standard is for two radiologists to evaluate mammograms.

“That makes the results exciting, but not directly applicable to US practice just yet,” she said.
 

What Do the Experts Recommend?

Stamatia V. Destounis, MD, FACR, chair of the American College of Radiology (ACR) Breast Imaging Commission, said the college welcomes ongoing research into the efficacy of AI technologies and that AI may prove to be beneficial as an improved workflow tool.

The ACR has not released any guidance about the use of AI for radiologists and have no recommendation about best practices, Dr. Destounis said.

“The decisions regarding which technologies that various health systems and radiology sites choose to use are made by those facilities,” she said.

Dr. Destounis said more research is needed to demonstrate whether or not AI technologies help radiologists produce better results in identifying disease, injury, and illnesses among the general population or in specific groups — whether based on age, physical characteristics, race, ethnicity or risk status for breast cancer.

“Also, a way to measure each AI product is needed so that we can be certain they are relatively equivalent in their efficacy and accuracy — initially and over a prolonged period of time,” she said.

No consensus or concrete recommendation exists about the use of AI in mammography screening, adds Peter P. Yu, MD, FACP, FASCO, physician-in-chief at the Hartford HealthCare Cancer Institute and a member of the newly-created American Society of Clinical Oncology AI task force.

One of the many discussions concerning AI is to what degree patients should be aware that AI is being used in their healthcare and whether they should be required to give consent to its use, Dr. Yu said.

If AI is used to assist radiologists with mammographic interpretation, radiologists should discuss with patients how it’s being used and explain the ultimate reading is in the hands of their physician radiologist, he said.

“In the unlikely situation where there wasn’t a human in the loop and AI was in effect making a medical decision, the patient needs to be aware,” he said. “I’m not aware that any such situation exists today. AI is more likely to be subtly embedded in the software that operates technology, much like it is embedded in manufacturing and transportation.”
 

Who Will Pay for AI?

When it comes to payment, Dr. Yu said shifting the cost of AI to patients creates serious risk.

“It has enormous potential to increase health inequities,” he said. “If we believe health care is a fundamental human right, AI should inure to the benefit of all, not just those who can afford it. Healthcare should not be a luxury item; if it works, it works for all.”

In general, the issue of payment for AI is still pretty “thorny,” Dr. Heacock noted. Currently, there’s no way for physicians to request direct reimbursement for AI reads of mammograms.

While Dr. Heacock says she is sympathetic to the companies that spend significant time and effort on their AI technology, she doesn’t think charging patients is the right solution.

“We know that many women already have difficulty in paying for mammography-related services and this is just one more charge to confuse them or that they can’t pay,” she said.

Dr. Sorensen expects that, similar to 3D mammography, payers will eventually cover RadNet’s AI technology and that patients will no longer need to pay out of pocket. One Blue Cross carrier will start covering the AI in April 2024, he said.

Screening mammograms miss close to one in eight breast cancers. But early research suggests artificial intelligence (AI) could close this detection gap and markedly improve early diagnosis of the disease. Still, questions remain regarding how to best incorporate AI into screenings and whether it’s too soon to deploy the technology.

Already, some radiology clinics are offering AI analysis of mammograms through an add-on cost method.

Mammography patients who visit RadNet facilities, for example, have the option of an additional AI screening of their images. RadNet, the largest national owner and operator of fixed-site diagnostic imaging centers in the United States with more than 370 locations, first launched its AI program in the Northeast. The company has now rolled out its product across all regions in the country.

Because the AI is not reimbursed by insurers, patients must pay a $40 out-of-pocket fee if they want the AI analysis.

“RadNet practices have identified more than 400 women whose cancer was found earlier than it would have been had the AI not been present,” said Greg Sorensen MD, chief science officer for RadNet.
 

How RadNet’s AI Program Works

Patients coming to RadNet facilities for screening mammography undergo 3D high-resolution mammography that includes the use of 70-micron resolution detector technology, said Dr. Sorensen. The mammogram is reviewed by a qualified radiologist with assistance from two Food and Drug Administration–cleared AI programs, Saige-Q and Saige-Density. The radiologist then makes an interpretation.

Saige-Q is an AI tool that helps identify more suspicious mammograms by providing a quick signal to radiologists if the AI considers a given mammogram to be in a suspicious category, according to Dr. Sorensen. Saige-Density provides a density rating for each mammogram using one of the four standard categories:

• A. Almost entirely fatty
• B. Scattered areas of fibroglandular density
• C. Heterogeneously dense
• D. Extremely dense

Starting in September 2024, the FDA will require all mammogram reports to indicate density.

For patients who choose the $40 add-on service, called Enhanced Breast Cancer Detection, two other FDA-registered AI programs are also applied: Saige-Dx and Saige-Assure. These AI programs go a step further by placing marks on areas within the images that they find suspicious. Mammograms flagged as “high-suspicion” by the AI are then reviewed by a second human radiologist. The first and second radiologists confer to agree on a final diagnosis, Dr. Sorensen explained.

“Our research shows that approximately 20% more cancers are found when the safeguard review process is in place,” Dr. Sorensen said. “We also have seen [30%] decreases in recall rates” — the percentage of screening cases in which further tests are recommended by the radiologist.

Bethesda radiologist Janet Storella, MD, has used the AI program for about 3 years and said the technology has improved her screening performance.

The AI is linked to her practice’s imaging software, and radiologists have the option of turning the AI on at any time during their reading of screening mammograms, Dr. Storella explained. Some radiologists review the mammogram first and then initiate the AI, while others like Dr. Storella turn it on at the start, she said. Once initiated, the AI draws bounding boxes — or outlines — around areas that it deems suspicious.

The AI helps focus Dr. Storella’s attention on suspicious areas and grades the level of suspicion into one of four categories: high, intermediate, low, and minimal, she said.

“I find it especially useful in patients who have dense breast tissue,” said Dr. Storella, medical director of women’s imaging at Community Radiology Associates, a RadNet practice. “In these situations, the tissue on the mammogram is a field of white, and cancers are also white, so you’re looking for that little white golf ball on a sea of snow. The AI really helps hone that down to specific areas.”

About 35% of RadNet’s screening mammography patients have enrolled in the Enhanced Breast Cancer Detection program, according to RadNet data. In a recent study of nine general radiologists and nine breast imaging specialists, all radiologists improved their interpretation performance of DBT screening mammograms when reading with RadNet’s AI versus without it. (An average AUC [area under the receiver operating characteristic curve] of 0.93 versus 0.87, demonstrating a difference in AUC of 0.06 (95% CI, 0.04-0.08; P < .001)
 

Is Mammography Ready for AI?

RadNet is among a growing number of commercial companies offering AI solutions for mammography. MammoScreen and Hologic, for example, are two other companies that provide AI programs to assist radiologists in reading screening mammograms.

“We are at the start of the AI integration into breast imaging at this point,” said Laura Heacock, MD, a breast imaging radiologist and associate professor of radiology at NYU Langone Health. “There are multiple commercial AI models now available to radiologists to use in their practice [ and] there will likely be more. We’re in the transition stage where people are still deciding: Which is the best model to go with? How do I put it in my system? How do I ensure it works they way it was intended? Every practice and medical system will have a different answer to that question.”

At NYU Langone Health, researchers have been developing and studying optimal AI models for breast imaging for several years, Dr. Heacock said. Researchers thus far, have developed AI models for 2D digital mammography, 3D mammograms, breast ultrasound, and breast MRI. Similar to commercial AI systems, the AI is embedded into the picture archiving and communication (PACS) system used by radiologists to review images. Radiologists press a button to launch the AI, which draws a box around suspicious areas of the image and scores the suspicion.

“I take a look of where it is on the mammogram and decide whether that fits my level of suspicion,” Dr. Heacock said. The AI may not understand things about the mammogram like we do. For example, surgical scars look very suspicious to an AI model. But if I’m looking at a mammogram where [the patient] has had a stable scar that hasn’t changed in 10 years, I’m not concerned that the AI found it suspicious. My clinical judgment is the ultimate decider. This is just an additional piece of information that’s helpful to me.”

Research by New York University (NYU) has shown that when used by an expert radiologist the AI models have improved breast cancer detection in all four modalities, she said.

However, the AI has not yet launched at NYU Langone. More research is needed before deploying the technology, according to Dr. Heacock.

“At NYU, we are still testing the benefits to patients,” she said. “We know it improves cancer detection, but we want to make sure there are no drawbacks. We are still exploring the best ways to put it into effect at our institution.”

Dr. Heacock pointed to recent studies on AI in screening mammography that show promise.

An analysis of more than 80,000 women, for example, published in The Lancet Oncology in August, found that AI-supported screen reading led to a similar cancer detection rate as compared with a two-person reader system. This screening resulted in 244 screen-detected cancers, 861 recalls, and a total of 46,345 screen readings, according to the study. Standard screening resulted in 203 screen-detected cancers, 817 recalls, and a total of 83,231 screen readings.

The AI system also reduced the screen-reading workload for radiologists by 44%, the study found.

Meanwhile, a September 2023 study, published in The Lancet Digital Health, found that replacing one radiologist with AI resulted in more cancer detection without a large increase in false-positive cases. The AI led to a 4% higher, noninferior cancer detection rate, compared with radiologist double reading, the study found.

Dr. Heacock emphasized that both studies were conducted in Europe where the standard is for two radiologists to evaluate mammograms.

“That makes the results exciting, but not directly applicable to US practice just yet,” she said.
 

What Do the Experts Recommend?

Stamatia V. Destounis, MD, FACR, chair of the American College of Radiology (ACR) Breast Imaging Commission, said the college welcomes ongoing research into the efficacy of AI technologies and that AI may prove to be beneficial as an improved workflow tool.

The ACR has not released any guidance about the use of AI for radiologists and have no recommendation about best practices, Dr. Destounis said.

“The decisions regarding which technologies that various health systems and radiology sites choose to use are made by those facilities,” she said.

Dr. Destounis said more research is needed to demonstrate whether or not AI technologies help radiologists produce better results in identifying disease, injury, and illnesses among the general population or in specific groups — whether based on age, physical characteristics, race, ethnicity or risk status for breast cancer.

“Also, a way to measure each AI product is needed so that we can be certain they are relatively equivalent in their efficacy and accuracy — initially and over a prolonged period of time,” she said.

No consensus or concrete recommendation exists about the use of AI in mammography screening, adds Peter P. Yu, MD, FACP, FASCO, physician-in-chief at the Hartford HealthCare Cancer Institute and a member of the newly-created American Society of Clinical Oncology AI task force.

One of the many discussions concerning AI is to what degree patients should be aware that AI is being used in their healthcare and whether they should be required to give consent to its use, Dr. Yu said.

If AI is used to assist radiologists with mammographic interpretation, radiologists should discuss with patients how it’s being used and explain the ultimate reading is in the hands of their physician radiologist, he said.

“In the unlikely situation where there wasn’t a human in the loop and AI was in effect making a medical decision, the patient needs to be aware,” he said. “I’m not aware that any such situation exists today. AI is more likely to be subtly embedded in the software that operates technology, much like it is embedded in manufacturing and transportation.”
 

Who Will Pay for AI?

When it comes to payment, Dr. Yu said shifting the cost of AI to patients creates serious risk.

“It has enormous potential to increase health inequities,” he said. “If we believe health care is a fundamental human right, AI should inure to the benefit of all, not just those who can afford it. Healthcare should not be a luxury item; if it works, it works for all.”

In general, the issue of payment for AI is still pretty “thorny,” Dr. Heacock noted. Currently, there’s no way for physicians to request direct reimbursement for AI reads of mammograms.

While Dr. Heacock says she is sympathetic to the companies that spend significant time and effort on their AI technology, she doesn’t think charging patients is the right solution.

“We know that many women already have difficulty in paying for mammography-related services and this is just one more charge to confuse them or that they can’t pay,” she said.

Dr. Sorensen expects that, similar to 3D mammography, payers will eventually cover RadNet’s AI technology and that patients will no longer need to pay out of pocket. One Blue Cross carrier will start covering the AI in April 2024, he said.

Screening mammograms miss close to one in eight breast cancers. But early research suggests artificial intelligence (AI) could close this detection gap and markedly improve early diagnosis of the disease. Still, questions remain regarding how to best incorporate AI into screenings and whether it’s too soon to deploy the technology.

Already, some radiology clinics are offering AI analysis of mammograms through an add-on cost method.

Mammography patients who visit RadNet facilities, for example, have the option of an additional AI screening of their images. RadNet, the largest national owner and operator of fixed-site diagnostic imaging centers in the United States with more than 370 locations, first launched its AI program in the Northeast. The company has now rolled out its product across all regions in the country.

Because the AI is not reimbursed by insurers, patients must pay a $40 out-of-pocket fee if they want the AI analysis.

“RadNet practices have identified more than 400 women whose cancer was found earlier than it would have been had the AI not been present,” said Greg Sorensen MD, chief science officer for RadNet.
 

How RadNet’s AI Program Works

Patients coming to RadNet facilities for screening mammography undergo 3D high-resolution mammography that includes the use of 70-micron resolution detector technology, said Dr. Sorensen. The mammogram is reviewed by a qualified radiologist with assistance from two Food and Drug Administration–cleared AI programs, Saige-Q and Saige-Density. The radiologist then makes an interpretation.

Saige-Q is an AI tool that helps identify more suspicious mammograms by providing a quick signal to radiologists if the AI considers a given mammogram to be in a suspicious category, according to Dr. Sorensen. Saige-Density provides a density rating for each mammogram using one of the four standard categories:

• A. Almost entirely fatty
• B. Scattered areas of fibroglandular density
• C. Heterogeneously dense
• D. Extremely dense

Starting in September 2024, the FDA will require all mammogram reports to indicate density.

For patients who choose the $40 add-on service, called Enhanced Breast Cancer Detection, two other FDA-registered AI programs are also applied: Saige-Dx and Saige-Assure. These AI programs go a step further by placing marks on areas within the images that they find suspicious. Mammograms flagged as “high-suspicion” by the AI are then reviewed by a second human radiologist. The first and second radiologists confer to agree on a final diagnosis, Dr. Sorensen explained.

“Our research shows that approximately 20% more cancers are found when the safeguard review process is in place,” Dr. Sorensen said. “We also have seen [30%] decreases in recall rates” — the percentage of screening cases in which further tests are recommended by the radiologist.

Bethesda radiologist Janet Storella, MD, has used the AI program for about 3 years and said the technology has improved her screening performance.

The AI is linked to her practice’s imaging software, and radiologists have the option of turning the AI on at any time during their reading of screening mammograms, Dr. Storella explained. Some radiologists review the mammogram first and then initiate the AI, while others like Dr. Storella turn it on at the start, she said. Once initiated, the AI draws bounding boxes — or outlines — around areas that it deems suspicious.

The AI helps focus Dr. Storella’s attention on suspicious areas and grades the level of suspicion into one of four categories: high, intermediate, low, and minimal, she said.

“I find it especially useful in patients who have dense breast tissue,” said Dr. Storella, medical director of women’s imaging at Community Radiology Associates, a RadNet practice. “In these situations, the tissue on the mammogram is a field of white, and cancers are also white, so you’re looking for that little white golf ball on a sea of snow. The AI really helps hone that down to specific areas.”

About 35% of RadNet’s screening mammography patients have enrolled in the Enhanced Breast Cancer Detection program, according to RadNet data. In a recent study of nine general radiologists and nine breast imaging specialists, all radiologists improved their interpretation performance of DBT screening mammograms when reading with RadNet’s AI versus without it. (An average AUC [area under the receiver operating characteristic curve] of 0.93 versus 0.87, demonstrating a difference in AUC of 0.06 (95% CI, 0.04-0.08; P < .001)
 

Is Mammography Ready for AI?

RadNet is among a growing number of commercial companies offering AI solutions for mammography. MammoScreen and Hologic, for example, are two other companies that provide AI programs to assist radiologists in reading screening mammograms.

“We are at the start of the AI integration into breast imaging at this point,” said Laura Heacock, MD, a breast imaging radiologist and associate professor of radiology at NYU Langone Health. “There are multiple commercial AI models now available to radiologists to use in their practice [ and] there will likely be more. We’re in the transition stage where people are still deciding: Which is the best model to go with? How do I put it in my system? How do I ensure it works they way it was intended? Every practice and medical system will have a different answer to that question.”

At NYU Langone Health, researchers have been developing and studying optimal AI models for breast imaging for several years, Dr. Heacock said. Researchers thus far, have developed AI models for 2D digital mammography, 3D mammograms, breast ultrasound, and breast MRI. Similar to commercial AI systems, the AI is embedded into the picture archiving and communication (PACS) system used by radiologists to review images. Radiologists press a button to launch the AI, which draws a box around suspicious areas of the image and scores the suspicion.

“I take a look of where it is on the mammogram and decide whether that fits my level of suspicion,” Dr. Heacock said. The AI may not understand things about the mammogram like we do. For example, surgical scars look very suspicious to an AI model. But if I’m looking at a mammogram where [the patient] has had a stable scar that hasn’t changed in 10 years, I’m not concerned that the AI found it suspicious. My clinical judgment is the ultimate decider. This is just an additional piece of information that’s helpful to me.”

Research by New York University (NYU) has shown that when used by an expert radiologist the AI models have improved breast cancer detection in all four modalities, she said.

However, the AI has not yet launched at NYU Langone. More research is needed before deploying the technology, according to Dr. Heacock.

“At NYU, we are still testing the benefits to patients,” she said. “We know it improves cancer detection, but we want to make sure there are no drawbacks. We are still exploring the best ways to put it into effect at our institution.”

Dr. Heacock pointed to recent studies on AI in screening mammography that show promise.

An analysis of more than 80,000 women, for example, published in The Lancet Oncology in August, found that AI-supported screen reading led to a similar cancer detection rate as compared with a two-person reader system. This screening resulted in 244 screen-detected cancers, 861 recalls, and a total of 46,345 screen readings, according to the study. Standard screening resulted in 203 screen-detected cancers, 817 recalls, and a total of 83,231 screen readings.

The AI system also reduced the screen-reading workload for radiologists by 44%, the study found.

Meanwhile, a September 2023 study, published in The Lancet Digital Health, found that replacing one radiologist with AI resulted in more cancer detection without a large increase in false-positive cases. The AI led to a 4% higher, noninferior cancer detection rate, compared with radiologist double reading, the study found.

Dr. Heacock emphasized that both studies were conducted in Europe where the standard is for two radiologists to evaluate mammograms.

“That makes the results exciting, but not directly applicable to US practice just yet,” she said.
 

What Do the Experts Recommend?

Stamatia V. Destounis, MD, FACR, chair of the American College of Radiology (ACR) Breast Imaging Commission, said the college welcomes ongoing research into the efficacy of AI technologies and that AI may prove to be beneficial as an improved workflow tool.

The ACR has not released any guidance about the use of AI for radiologists and have no recommendation about best practices, Dr. Destounis said.

“The decisions regarding which technologies that various health systems and radiology sites choose to use are made by those facilities,” she said.

Dr. Destounis said more research is needed to demonstrate whether or not AI technologies help radiologists produce better results in identifying disease, injury, and illnesses among the general population or in specific groups — whether based on age, physical characteristics, race, ethnicity or risk status for breast cancer.

“Also, a way to measure each AI product is needed so that we can be certain they are relatively equivalent in their efficacy and accuracy — initially and over a prolonged period of time,” she said.

No consensus or concrete recommendation exists about the use of AI in mammography screening, adds Peter P. Yu, MD, FACP, FASCO, physician-in-chief at the Hartford HealthCare Cancer Institute and a member of the newly-created American Society of Clinical Oncology AI task force.

One of the many discussions concerning AI is to what degree patients should be aware that AI is being used in their healthcare and whether they should be required to give consent to its use, Dr. Yu said.

If AI is used to assist radiologists with mammographic interpretation, radiologists should discuss with patients how it’s being used and explain the ultimate reading is in the hands of their physician radiologist, he said.

“In the unlikely situation where there wasn’t a human in the loop and AI was in effect making a medical decision, the patient needs to be aware,” he said. “I’m not aware that any such situation exists today. AI is more likely to be subtly embedded in the software that operates technology, much like it is embedded in manufacturing and transportation.”
 

Who Will Pay for AI?

When it comes to payment, Dr. Yu said shifting the cost of AI to patients creates serious risk.

“It has enormous potential to increase health inequities,” he said. “If we believe health care is a fundamental human right, AI should inure to the benefit of all, not just those who can afford it. Healthcare should not be a luxury item; if it works, it works for all.”

In general, the issue of payment for AI is still pretty “thorny,” Dr. Heacock noted. Currently, there’s no way for physicians to request direct reimbursement for AI reads of mammograms.

While Dr. Heacock says she is sympathetic to the companies that spend significant time and effort on their AI technology, she doesn’t think charging patients is the right solution.

“We know that many women already have difficulty in paying for mammography-related services and this is just one more charge to confuse them or that they can’t pay,” she said.

Dr. Sorensen expects that, similar to 3D mammography, payers will eventually cover RadNet’s AI technology and that patients will no longer need to pay out of pocket. One Blue Cross carrier will start covering the AI in April 2024, he said.

TOPLINE:

Several female reproductive factors across the life cycle were significantly associated with increased COPD risk, including age at menarche, number of children, infertility, pregnancy outcomes, and age at menopause.

METHODOLOGY:

• The researchers reviewed data from women in the International Collaboration for a Life Course Approach to Reproductive Health and Chronic Disease Events (InterLACE) consortium, which includes 27 observational studies involving more than 850,000 women in 12 countries.
• The current study included 283,070 women, 3.8% of whom developed COPD over a median of 11 years.
• The researchers examined the association between COPD and age at menarche, number of children, infertility, miscarriage, stillbirth, and age at natural menopause.

TAKEAWAY: 

• Higher risk of COPD was significantly associated with menarche at age 11 years or younger (hazard ratio [HR], 1.17), and at 16 years and older (HR, 1.24), as well as having three or more children.
• Higher risk of COPD was significantly associated with a history of infertility, and with miscarriage, or stillbirth compared with no miscarriages or stillbirths; the risk increased with the number of miscarriages or stillbirths (HR, 1.36 for ≥ 3 miscarriages and 1.67 for ≥ 2 stillbirths). 
• COPD risk was significantly increased with earlier age at the time of natural menopause (HR, 1.69 for those aged < 40 years and 1.42 for those aged 40-44 years compared with those aged 50-51 years). 

IN PRACTICE:

“Further research is needed to understand the mechanisms linking multiple female reproductive histories and COPD,” which could include autoimmune components and social/environmental factors, the researchers wrote. 

SOURCE:

The lead author on the study was Chen Liang, MD, of the University of Queensland, Australia. The study was published online in BMJ Thorax). 

LIMITATIONS: 

Study limitations included volunteer bias, underreporting of COPD, potential confounders such as childhood respiratory infections and smoking history, and the inability to assess the effects of medications including contraceptives and hormone replacement therapy on COPD. 

DISCLOSURES:

The InterLACE project is supported by the Australian National Health and Medical Research Council and Centres of Research Excellence. Corresponding author Gita D. Mishra disclosed support from the Australian National Health and Medical Research Council Leadership Fellowship. 

A version of this article appeared on Medscape.com.

TOPLINE:

Several female reproductive factors across the life cycle were significantly associated with increased COPD risk, including age at menarche, number of children, infertility, pregnancy outcomes, and age at menopause.

METHODOLOGY:

• The researchers reviewed data from women in the International Collaboration for a Life Course Approach to Reproductive Health and Chronic Disease Events (InterLACE) consortium, which includes 27 observational studies involving more than 850,000 women in 12 countries.
• The current study included 283,070 women, 3.8% of whom developed COPD over a median of 11 years.
• The researchers examined the association between COPD and age at menarche, number of children, infertility, miscarriage, stillbirth, and age at natural menopause.

TAKEAWAY: 

• Higher risk of COPD was significantly associated with menarche at age 11 years or younger (hazard ratio [HR], 1.17), and at 16 years and older (HR, 1.24), as well as having three or more children.
• Higher risk of COPD was significantly associated with a history of infertility, and with miscarriage, or stillbirth compared with no miscarriages or stillbirths; the risk increased with the number of miscarriages or stillbirths (HR, 1.36 for ≥ 3 miscarriages and 1.67 for ≥ 2 stillbirths). 
• COPD risk was significantly increased with earlier age at the time of natural menopause (HR, 1.69 for those aged < 40 years and 1.42 for those aged 40-44 years compared with those aged 50-51 years). 

IN PRACTICE:

“Further research is needed to understand the mechanisms linking multiple female reproductive histories and COPD,” which could include autoimmune components and social/environmental factors, the researchers wrote. 

SOURCE:

The lead author on the study was Chen Liang, MD, of the University of Queensland, Australia. The study was published online in BMJ Thorax). 

LIMITATIONS: 

Study limitations included volunteer bias, underreporting of COPD, potential confounders such as childhood respiratory infections and smoking history, and the inability to assess the effects of medications including contraceptives and hormone replacement therapy on COPD. 

DISCLOSURES:

The InterLACE project is supported by the Australian National Health and Medical Research Council and Centres of Research Excellence. Corresponding author Gita D. Mishra disclosed support from the Australian National Health and Medical Research Council Leadership Fellowship. 

A version of this article appeared on Medscape.com.

TOPLINE:

Several female reproductive factors across the life cycle were significantly associated with increased COPD risk, including age at menarche, number of children, infertility, pregnancy outcomes, and age at menopause.

METHODOLOGY:

• The researchers reviewed data from women in the International Collaboration for a Life Course Approach to Reproductive Health and Chronic Disease Events (InterLACE) consortium, which includes 27 observational studies involving more than 850,000 women in 12 countries.
• The current study included 283,070 women, 3.8% of whom developed COPD over a median of 11 years.
• The researchers examined the association between COPD and age at menarche, number of children, infertility, miscarriage, stillbirth, and age at natural menopause.

TAKEAWAY: 

• Higher risk of COPD was significantly associated with menarche at age 11 years or younger (hazard ratio [HR], 1.17), and at 16 years and older (HR, 1.24), as well as having three or more children.
• Higher risk of COPD was significantly associated with a history of infertility, and with miscarriage, or stillbirth compared with no miscarriages or stillbirths; the risk increased with the number of miscarriages or stillbirths (HR, 1.36 for ≥ 3 miscarriages and 1.67 for ≥ 2 stillbirths). 
• COPD risk was significantly increased with earlier age at the time of natural menopause (HR, 1.69 for those aged < 40 years and 1.42 for those aged 40-44 years compared with those aged 50-51 years). 

IN PRACTICE:

“Further research is needed to understand the mechanisms linking multiple female reproductive histories and COPD,” which could include autoimmune components and social/environmental factors, the researchers wrote. 

SOURCE:

The lead author on the study was Chen Liang, MD, of the University of Queensland, Australia. The study was published online in BMJ Thorax). 

LIMITATIONS: 

Study limitations included volunteer bias, underreporting of COPD, potential confounders such as childhood respiratory infections and smoking history, and the inability to assess the effects of medications including contraceptives and hormone replacement therapy on COPD. 

DISCLOSURES:

The InterLACE project is supported by the Australian National Health and Medical Research Council and Centres of Research Excellence. Corresponding author Gita D. Mishra disclosed support from the Australian National Health and Medical Research Council Leadership Fellowship. 

A version of this article appeared on Medscape.com.

Complications during pregnancy may be a wake-up call pointing to a higher risk for cardiovascular (CVD) and other diseases later in life. Therefore, the postpartum and interpregnancy periods are opportune windows for reducing CVD susceptibility and providing preventive care, especially for mothers with a history of adverse pregnancy outcomes (APOs). To that end, the American Heart Association recently released a scientific statement in Circulation outlining pregnancy-related CVD risks and reviewing evidence for preventive lifestyle strategies based on the AHA’s Life’s Essential 8 recommendations.

The Life’s Essential 8 encompass healthy eating, sleeping, and activity patterns; controlling weight, blood pressure, cholesterol, and blood sugar; and avoiding tobacco use.

“The motivation behind this statement was that complications in pregnancy are becoming more common and we now have more understanding that these serve as important risk factors for heart disease later in life,” said Jennifer Lewey, MD, MPH, director of the Penn Women’s Cardiovascular Health Program and an assistant professor of medicine at the University of Pennsylvania Perelman School of Medicine in Philadelphia.

Perelman School of Medicine

“These risk factors are underrecognized and underappreciated. Clinicians don’t feel comfortable counseling their patients about how to reduce their cardiovascular disease risk,” Dr. Lewey, chair of the AHA writing group, said in an interview.

“So we thought this was the perfect time to highlight what we know and don’t know about how to care for this population,” she said.

APOs predispose mothers to heart disease and other long-term complications, including heart failure, stroke, chronic kidney disease, and vascular dementia. “Pregnancy is a significant stress on the body, and APOs such as preeclampsia can lead to vascular changes in the blood vessels and structural changes to the heart that can persist long term,” Dr. Lewey explained. Reduced maternal physical activity and unshed weight can compound the problem.

Varying by race and ethnicity, the proportion of mothers experiencing pregnancy complications, such as high blood pressure, gestational diabetes, and/or preterm birth is estimated at 10%-20%, the statement authors noted. These complications may serve as a wake-up call to young mothers.

The AHA panel believes that identifying at-risk women at younger ages will enable prevention through lifestyle changes and timely treatment. Little is known, however about what specific care may best reduce long-term CVD risk in women who had pregnancy complications, Dr. Lewey said. While randomized clinical trials have yet to evaluate the effects of postpartum interventions on CVD outcomes, the need for strategies supported by rigorous evidence is clear. “In particular, the fourth trimester, defined as the 12 weeks after delivery, is an optimal time to engage postpartum individuals in care to reduce maternal morbidity and improve care transitions,” the AHA group wrote.

An earlier AHA statement in 2021 recommended frequent cardiac risk factor screening in the first year postpartum at 6 and 12 weeks and again at 6 and 12 months, with appropriate transition from postpartum to longitudinal primary care around the 8- to 12-week mark.

Among the current statement’s findings: High blood pressure is the most prevalent cardiovascular condition during pregnancy, and the last two decades have seen a 25% increase in preeclampsia.

Hypertension during pregnancy carries a two- to fourfold higher risk of chronic hypertension within 2-7 years.

Women with one or more APOs experience heart attack and stroke at younger ages. Commenting on the statement but not involved in it, internist Natalie A. Cameron, MD, a primary and preventive care physician at Northwestern Medicine in Chicago, said, “This statement will be very helpful for physicians from a primary care perspective, especially since in internal medicine we don’t standardly receive education in cardiovascular health in the context of pregnancy and the first year postpartum.”

Northwestern Medicine

Complications during pregnancy may be a wake-up call pointing to a higher risk for cardiovascular (CVD) and other diseases later in life. Therefore, the postpartum and interpregnancy periods are opportune windows for reducing CVD susceptibility and providing preventive care, especially for mothers with a history of adverse pregnancy outcomes (APOs). To that end, the American Heart Association recently released a scientific statement in Circulation outlining pregnancy-related CVD risks and reviewing evidence for preventive lifestyle strategies based on the AHA’s Life’s Essential 8 recommendations.

The Life’s Essential 8 encompass healthy eating, sleeping, and activity patterns; controlling weight, blood pressure, cholesterol, and blood sugar; and avoiding tobacco use.

“The motivation behind this statement was that complications in pregnancy are becoming more common and we now have more understanding that these serve as important risk factors for heart disease later in life,” said Jennifer Lewey, MD, MPH, director of the Penn Women’s Cardiovascular Health Program and an assistant professor of medicine at the University of Pennsylvania Perelman School of Medicine in Philadelphia.

Perelman School of Medicine

“These risk factors are underrecognized and underappreciated. Clinicians don’t feel comfortable counseling their patients about how to reduce their cardiovascular disease risk,” Dr. Lewey, chair of the AHA writing group, said in an interview.

“So we thought this was the perfect time to highlight what we know and don’t know about how to care for this population,” she said.

APOs predispose mothers to heart disease and other long-term complications, including heart failure, stroke, chronic kidney disease, and vascular dementia. “Pregnancy is a significant stress on the body, and APOs such as preeclampsia can lead to vascular changes in the blood vessels and structural changes to the heart that can persist long term,” Dr. Lewey explained. Reduced maternal physical activity and unshed weight can compound the problem.

Varying by race and ethnicity, the proportion of mothers experiencing pregnancy complications, such as high blood pressure, gestational diabetes, and/or preterm birth is estimated at 10%-20%, the statement authors noted. These complications may serve as a wake-up call to young mothers.

The AHA panel believes that identifying at-risk women at younger ages will enable prevention through lifestyle changes and timely treatment. Little is known, however about what specific care may best reduce long-term CVD risk in women who had pregnancy complications, Dr. Lewey said. While randomized clinical trials have yet to evaluate the effects of postpartum interventions on CVD outcomes, the need for strategies supported by rigorous evidence is clear. “In particular, the fourth trimester, defined as the 12 weeks after delivery, is an optimal time to engage postpartum individuals in care to reduce maternal morbidity and improve care transitions,” the AHA group wrote.

An earlier AHA statement in 2021 recommended frequent cardiac risk factor screening in the first year postpartum at 6 and 12 weeks and again at 6 and 12 months, with appropriate transition from postpartum to longitudinal primary care around the 8- to 12-week mark.

Among the current statement’s findings: High blood pressure is the most prevalent cardiovascular condition during pregnancy, and the last two decades have seen a 25% increase in preeclampsia.

Hypertension during pregnancy carries a two- to fourfold higher risk of chronic hypertension within 2-7 years.

Women with one or more APOs experience heart attack and stroke at younger ages. Commenting on the statement but not involved in it, internist Natalie A. Cameron, MD, a primary and preventive care physician at Northwestern Medicine in Chicago, said, “This statement will be very helpful for physicians from a primary care perspective, especially since in internal medicine we don’t standardly receive education in cardiovascular health in the context of pregnancy and the first year postpartum.”

Northwestern Medicine

Complications during pregnancy may be a wake-up call pointing to a higher risk for cardiovascular (CVD) and other diseases later in life. Therefore, the postpartum and interpregnancy periods are opportune windows for reducing CVD susceptibility and providing preventive care, especially for mothers with a history of adverse pregnancy outcomes (APOs). To that end, the American Heart Association recently released a scientific statement in Circulation outlining pregnancy-related CVD risks and reviewing evidence for preventive lifestyle strategies based on the AHA’s Life’s Essential 8 recommendations.

The Life’s Essential 8 encompass healthy eating, sleeping, and activity patterns; controlling weight, blood pressure, cholesterol, and blood sugar; and avoiding tobacco use.

“The motivation behind this statement was that complications in pregnancy are becoming more common and we now have more understanding that these serve as important risk factors for heart disease later in life,” said Jennifer Lewey, MD, MPH, director of the Penn Women’s Cardiovascular Health Program and an assistant professor of medicine at the University of Pennsylvania Perelman School of Medicine in Philadelphia.

Perelman School of Medicine

“These risk factors are underrecognized and underappreciated. Clinicians don’t feel comfortable counseling their patients about how to reduce their cardiovascular disease risk,” Dr. Lewey, chair of the AHA writing group, said in an interview.

“So we thought this was the perfect time to highlight what we know and don’t know about how to care for this population,” she said.

APOs predispose mothers to heart disease and other long-term complications, including heart failure, stroke, chronic kidney disease, and vascular dementia. “Pregnancy is a significant stress on the body, and APOs such as preeclampsia can lead to vascular changes in the blood vessels and structural changes to the heart that can persist long term,” Dr. Lewey explained. Reduced maternal physical activity and unshed weight can compound the problem.

Varying by race and ethnicity, the proportion of mothers experiencing pregnancy complications, such as high blood pressure, gestational diabetes, and/or preterm birth is estimated at 10%-20%, the statement authors noted. These complications may serve as a wake-up call to young mothers.

The AHA panel believes that identifying at-risk women at younger ages will enable prevention through lifestyle changes and timely treatment. Little is known, however about what specific care may best reduce long-term CVD risk in women who had pregnancy complications, Dr. Lewey said. While randomized clinical trials have yet to evaluate the effects of postpartum interventions on CVD outcomes, the need for strategies supported by rigorous evidence is clear. “In particular, the fourth trimester, defined as the 12 weeks after delivery, is an optimal time to engage postpartum individuals in care to reduce maternal morbidity and improve care transitions,” the AHA group wrote.

An earlier AHA statement in 2021 recommended frequent cardiac risk factor screening in the first year postpartum at 6 and 12 weeks and again at 6 and 12 months, with appropriate transition from postpartum to longitudinal primary care around the 8- to 12-week mark.

Among the current statement’s findings: High blood pressure is the most prevalent cardiovascular condition during pregnancy, and the last two decades have seen a 25% increase in preeclampsia.

Hypertension during pregnancy carries a two- to fourfold higher risk of chronic hypertension within 2-7 years.

Women with one or more APOs experience heart attack and stroke at younger ages. Commenting on the statement but not involved in it, internist Natalie A. Cameron, MD, a primary and preventive care physician at Northwestern Medicine in Chicago, said, “This statement will be very helpful for physicians from a primary care perspective, especially since in internal medicine we don’t standardly receive education in cardiovascular health in the context of pregnancy and the first year postpartum.”

Northwestern Medicine

Several new clinical trials in gynecologic cancers have started enrolling recently. Perhaps one of your patients is eligible to take part?

Persistent or recurrent endometrial cancer or any advanced solid gynecologic tumor with appropriate ATR mutations. Patients with one of these diagnoses may be eligible to join a phase 2, randomized, open-label study of an experimental drug called ART0380. ART0380 inhibits the ability of cancer cells to repair DNA damage by targeting a DNA repair kinase called ATR (ataxia telangiectasia–mutated and Rad3-related) protein, which is faulty in some tumors. The hope is that ART0380 will overwhelm the inadequate DNA repair processes of these cancer cells while sparing the more robust DNA repair in healthy cells. 

All participants in the trial will take daily oral ART0380 until disease progression, withdrawal of consent, or unacceptable toxicity, whichever happens first. Some individuals will receive the treatment for 3 weeks out of every 4. Sites in California, Illinois, Massachusetts, New York, Oklahoma, Pennsylvania, Rhode Island, and France started recruiting 60 participants with endometrial cancer or any solid tumor in September 2023. The primary outcome is objective response rate. Overall survival is a secondary measure and quality of life (QOL) is not assessed. More details at ClinicalTrials.gov

Maurie Markman, MD, president of medicine and science at City of Hope, Atlanta, who is not involved in this trial, explained that because “ a meaningful proportion of this population may have a defect in this DNA repair mechanism,” this hypothesis seems “worthy of clinical exploration.” 

Cancer of the endometrium, cervix, vagina, or vulva. Women with one of these types of cancer who can read and understand English or Spanish can join a randomized, open-label phase 2 trial to determine whether Reiki therapy can reduce pain and distress associated with brachytherapy. 

Reiki is a complementary therapy that involves a Reiki practitioner holding their hands lightly on or above the patient’s body for several minutes. Some hospitals in the US and the UK offer Reiki as a relaxation aid, although high-quality science is lacking.

In this study, one group of participants will each undergo Reiki in a quiet clinic room during the lengthy waiting period between placement of the vaginal cylinder and infusion of the radiation source, which is a time of anxiety and discomfort for many women. A second group of women will simply lie and wait in a clinic room, if desired accompanied by a friend or family member. 

The Huntsman Cancer Institute, Salt Lake City, Utah, started recruiting its 68 participants in October 2023. The primary outcome is self-reported anxiety. The secondary outcomes are other validated measures of anxiety, pain, and depression. Overall survival and broader measures of QOL will not be assessed. More details at ClinicalTrials.gov

Dr. Markman said that the benefits of Reiki may be “nothing more than a placebo effect.” But he highlighted the novelty of conducting a randomized trial to scientifically test Reiki’s “widely applied (without any real evidence) ‘integrative medicine’ approach to symptom management.”

Unresectable or metastatic endometrial cancer with deficient mismatch repair /high microsatellite instability. People in this clinical situation whose disease has progressed after one or two lines of prior chemotherapy, including platinum-based treatment, may be interested in an open-label nonrandomized, phase 2 investigation of bispecific antibody acasunlimab in combination with pembrolizumab (Keytruda). 

Acasunlimab stimulates T-cell antitumor activity as well as blocking programmed death ligand 1 (PD-L1) and is being tested in several types of solid-tumor cancer. For up to 2 years, all participants will receive intravenous (IV) infusions of the drug combination. Study sites in Florida and Europe opened in January 2024, ready for 80 participants. The primary outcome is objective response rate. Overall survival will not be assessed. More details at ClinicalTrials.gov

“In the absence of a randomized population to compare treatment outcomes, the results of this trial will likely provide limited data upon which to determine the clinical benefits of this novel drug combination strategy,” said Dr. Markman. However, he added, “the results will be helpful in assessing the potential toxicity of this approach.”

Recurrent or metastatic endometrial cancer with proficient mismatch repair. Women with this diagnosis who have progressed after one prior platinum chemotherapy regimen in any setting may wish to consider a randomized, triple-blind, phase 2 trial of pembrolizumab plus favezelimab. Favezelimab, which blocks the lymphocyte activation gene 3 (LAG3), appears to boost the antitumor activity of programmed cell death protein 1 (PD-1) inhibition in other cancers such as classic Hodgkin lymphoma. 

In the trial, participants will be assigned to one of four groups. One group will receive 17 doses of the combination treatment IV every 3 weeks — three doses in the neoadjuvant period and 14 as adjuvant therapy. A second group of individuals will receive IV pembrolizumab monotherapy on the same schedule. A third will be given up to 35 doses of the combo therapy every 3 weeks plus a daily capsule of lenvatinib (Lenvima). The fourth group will receive 35 doses of pembrolizumab plus daily lenvatinib. 

Sites in North Carolina, New Jersey, Pennsylvania, and four countries other than the US started recruiting 60 participants with a solid tumor in September 2023. Pathologic complete response and objective response rate are the primary endpoints. Overall survival over approximately 3.5 years is a secondary endpoint, and QOL will not be measured. More details at ClinicalTrials.gov

Unresectable advanced or metastatic HER2-positive endometrial or ovarian cancer. Adults with one of these diagnoses in whom failed platinum-based therapy has failed may enroll in an open-label, phase 2 study to see whether their disease will respond to the antibody-drug conjugate disitamab vedotin. Everyone in the trial will receive IV disitamab vedotin every 2 weeks for up to approximately 5 years. 

Study sites in California, Connecticut, Michigan, Minnesota, Montana, New York, Ohio, Texas, and Canada began welcoming their 190 participants with one of a range of solid cancers in November 2023. The primary outcome is objective response rate. Overall survival is a secondary measure and QOL will not be tracked. More details at ClinicalTrials.gov

High-risk locally advanced cervical cancer. Girls and women older than 14 years with this cancer that has not progressed after platinum-based chemoradiation are sought for a randomized, quadruple-blind, phase 3 trial to determine whether the investigational immunotherapy volrustomig can slow disease progression. Volrustomig targets PD-1 and cytotoxic T lymphocyte protein 4 (CTLA4) and is being tested in a wide range of solid cancers. 

For approximately 3 years or until disease progression or death, whichever happens first, half of participants will receive IV infusions of volrustomig while the others will receive saline. Asian research sites started seeking the study’s 1000 participants in September 2023, while centers in 12 US states and eight other countries are gearing up for patient enrollment. Progression-free survival in participants with PD-L1 expression is the primary endpoint; overall survival and QOL are secondary endpoints. More details at ClinicalTrials.gov

All trial information is from the National Institutes of Health US National Library of Medicine (online at ClinicalTrials.gov). Dr. Markman declared he is not involved with these trials.

A version of this article appeared on Medscape.com .

Several new clinical trials in gynecologic cancers have started enrolling recently. Perhaps one of your patients is eligible to take part?

Persistent or recurrent endometrial cancer or any advanced solid gynecologic tumor with appropriate ATR mutations. Patients with one of these diagnoses may be eligible to join a phase 2, randomized, open-label study of an experimental drug called ART0380. ART0380 inhibits the ability of cancer cells to repair DNA damage by targeting a DNA repair kinase called ATR (ataxia telangiectasia–mutated and Rad3-related) protein, which is faulty in some tumors. The hope is that ART0380 will overwhelm the inadequate DNA repair processes of these cancer cells while sparing the more robust DNA repair in healthy cells. 

All participants in the trial will take daily oral ART0380 until disease progression, withdrawal of consent, or unacceptable toxicity, whichever happens first. Some individuals will receive the treatment for 3 weeks out of every 4. Sites in California, Illinois, Massachusetts, New York, Oklahoma, Pennsylvania, Rhode Island, and France started recruiting 60 participants with endometrial cancer or any solid tumor in September 2023. The primary outcome is objective response rate. Overall survival is a secondary measure and quality of life (QOL) is not assessed. More details at ClinicalTrials.gov

Maurie Markman, MD, president of medicine and science at City of Hope, Atlanta, who is not involved in this trial, explained that because “ a meaningful proportion of this population may have a defect in this DNA repair mechanism,” this hypothesis seems “worthy of clinical exploration.” 

Cancer of the endometrium, cervix, vagina, or vulva. Women with one of these types of cancer who can read and understand English or Spanish can join a randomized, open-label phase 2 trial to determine whether Reiki therapy can reduce pain and distress associated with brachytherapy. 

Reiki is a complementary therapy that involves a Reiki practitioner holding their hands lightly on or above the patient’s body for several minutes. Some hospitals in the US and the UK offer Reiki as a relaxation aid, although high-quality science is lacking.

In this study, one group of participants will each undergo Reiki in a quiet clinic room during the lengthy waiting period between placement of the vaginal cylinder and infusion of the radiation source, which is a time of anxiety and discomfort for many women. A second group of women will simply lie and wait in a clinic room, if desired accompanied by a friend or family member. 

The Huntsman Cancer Institute, Salt Lake City, Utah, started recruiting its 68 participants in October 2023. The primary outcome is self-reported anxiety. The secondary outcomes are other validated measures of anxiety, pain, and depression. Overall survival and broader measures of QOL will not be assessed. More details at ClinicalTrials.gov

Dr. Markman said that the benefits of Reiki may be “nothing more than a placebo effect.” But he highlighted the novelty of conducting a randomized trial to scientifically test Reiki’s “widely applied (without any real evidence) ‘integrative medicine’ approach to symptom management.”

Unresectable or metastatic endometrial cancer with deficient mismatch repair /high microsatellite instability. People in this clinical situation whose disease has progressed after one or two lines of prior chemotherapy, including platinum-based treatment, may be interested in an open-label nonrandomized, phase 2 investigation of bispecific antibody acasunlimab in combination with pembrolizumab (Keytruda). 

Acasunlimab stimulates T-cell antitumor activity as well as blocking programmed death ligand 1 (PD-L1) and is being tested in several types of solid-tumor cancer. For up to 2 years, all participants will receive intravenous (IV) infusions of the drug combination. Study sites in Florida and Europe opened in January 2024, ready for 80 participants. The primary outcome is objective response rate. Overall survival will not be assessed. More details at ClinicalTrials.gov

“In the absence of a randomized population to compare treatment outcomes, the results of this trial will likely provide limited data upon which to determine the clinical benefits of this novel drug combination strategy,” said Dr. Markman. However, he added, “the results will be helpful in assessing the potential toxicity of this approach.”

Recurrent or metastatic endometrial cancer with proficient mismatch repair. Women with this diagnosis who have progressed after one prior platinum chemotherapy regimen in any setting may wish to consider a randomized, triple-blind, phase 2 trial of pembrolizumab plus favezelimab. Favezelimab, which blocks the lymphocyte activation gene 3 (LAG3), appears to boost the antitumor activity of programmed cell death protein 1 (PD-1) inhibition in other cancers such as classic Hodgkin lymphoma. 

In the trial, participants will be assigned to one of four groups. One group will receive 17 doses of the combination treatment IV every 3 weeks — three doses in the neoadjuvant period and 14 as adjuvant therapy. A second group of individuals will receive IV pembrolizumab monotherapy on the same schedule. A third will be given up to 35 doses of the combo therapy every 3 weeks plus a daily capsule of lenvatinib (Lenvima). The fourth group will receive 35 doses of pembrolizumab plus daily lenvatinib. 

Sites in North Carolina, New Jersey, Pennsylvania, and four countries other than the US started recruiting 60 participants with a solid tumor in September 2023. Pathologic complete response and objective response rate are the primary endpoints. Overall survival over approximately 3.5 years is a secondary endpoint, and QOL will not be measured. More details at ClinicalTrials.gov

Unresectable advanced or metastatic HER2-positive endometrial or ovarian cancer. Adults with one of these diagnoses in whom failed platinum-based therapy has failed may enroll in an open-label, phase 2 study to see whether their disease will respond to the antibody-drug conjugate disitamab vedotin. Everyone in the trial will receive IV disitamab vedotin every 2 weeks for up to approximately 5 years. 

Study sites in California, Connecticut, Michigan, Minnesota, Montana, New York, Ohio, Texas, and Canada began welcoming their 190 participants with one of a range of solid cancers in November 2023. The primary outcome is objective response rate. Overall survival is a secondary measure and QOL will not be tracked. More details at ClinicalTrials.gov

High-risk locally advanced cervical cancer. Girls and women older than 14 years with this cancer that has not progressed after platinum-based chemoradiation are sought for a randomized, quadruple-blind, phase 3 trial to determine whether the investigational immunotherapy volrustomig can slow disease progression. Volrustomig targets PD-1 and cytotoxic T lymphocyte protein 4 (CTLA4) and is being tested in a wide range of solid cancers. 

For approximately 3 years or until disease progression or death, whichever happens first, half of participants will receive IV infusions of volrustomig while the others will receive saline. Asian research sites started seeking the study’s 1000 participants in September 2023, while centers in 12 US states and eight other countries are gearing up for patient enrollment. Progression-free survival in participants with PD-L1 expression is the primary endpoint; overall survival and QOL are secondary endpoints. More details at ClinicalTrials.gov

All trial information is from the National Institutes of Health US National Library of Medicine (online at ClinicalTrials.gov). Dr. Markman declared he is not involved with these trials.

A version of this article appeared on Medscape.com .

Several new clinical trials in gynecologic cancers have started enrolling recently. Perhaps one of your patients is eligible to take part?

Persistent or recurrent endometrial cancer or any advanced solid gynecologic tumor with appropriate ATR mutations. Patients with one of these diagnoses may be eligible to join a phase 2, randomized, open-label study of an experimental drug called ART0380. ART0380 inhibits the ability of cancer cells to repair DNA damage by targeting a DNA repair kinase called ATR (ataxia telangiectasia–mutated and Rad3-related) protein, which is faulty in some tumors. The hope is that ART0380 will overwhelm the inadequate DNA repair processes of these cancer cells while sparing the more robust DNA repair in healthy cells. 

All participants in the trial will take daily oral ART0380 until disease progression, withdrawal of consent, or unacceptable toxicity, whichever happens first. Some individuals will receive the treatment for 3 weeks out of every 4. Sites in California, Illinois, Massachusetts, New York, Oklahoma, Pennsylvania, Rhode Island, and France started recruiting 60 participants with endometrial cancer or any solid tumor in September 2023. The primary outcome is objective response rate. Overall survival is a secondary measure and quality of life (QOL) is not assessed. More details at ClinicalTrials.gov

Maurie Markman, MD, president of medicine and science at City of Hope, Atlanta, who is not involved in this trial, explained that because “ a meaningful proportion of this population may have a defect in this DNA repair mechanism,” this hypothesis seems “worthy of clinical exploration.” 

Cancer of the endometrium, cervix, vagina, or vulva. Women with one of these types of cancer who can read and understand English or Spanish can join a randomized, open-label phase 2 trial to determine whether Reiki therapy can reduce pain and distress associated with brachytherapy. 

Reiki is a complementary therapy that involves a Reiki practitioner holding their hands lightly on or above the patient’s body for several minutes. Some hospitals in the US and the UK offer Reiki as a relaxation aid, although high-quality science is lacking.

In this study, one group of participants will each undergo Reiki in a quiet clinic room during the lengthy waiting period between placement of the vaginal cylinder and infusion of the radiation source, which is a time of anxiety and discomfort for many women. A second group of women will simply lie and wait in a clinic room, if desired accompanied by a friend or family member. 

The Huntsman Cancer Institute, Salt Lake City, Utah, started recruiting its 68 participants in October 2023. The primary outcome is self-reported anxiety. The secondary outcomes are other validated measures of anxiety, pain, and depression. Overall survival and broader measures of QOL will not be assessed. More details at ClinicalTrials.gov

Dr. Markman said that the benefits of Reiki may be “nothing more than a placebo effect.” But he highlighted the novelty of conducting a randomized trial to scientifically test Reiki’s “widely applied (without any real evidence) ‘integrative medicine’ approach to symptom management.”

Unresectable or metastatic endometrial cancer with deficient mismatch repair /high microsatellite instability. People in this clinical situation whose disease has progressed after one or two lines of prior chemotherapy, including platinum-based treatment, may be interested in an open-label nonrandomized, phase 2 investigation of bispecific antibody acasunlimab in combination with pembrolizumab (Keytruda). 

Acasunlimab stimulates T-cell antitumor activity as well as blocking programmed death ligand 1 (PD-L1) and is being tested in several types of solid-tumor cancer. For up to 2 years, all participants will receive intravenous (IV) infusions of the drug combination. Study sites in Florida and Europe opened in January 2024, ready for 80 participants. The primary outcome is objective response rate. Overall survival will not be assessed. More details at ClinicalTrials.gov

“In the absence of a randomized population to compare treatment outcomes, the results of this trial will likely provide limited data upon which to determine the clinical benefits of this novel drug combination strategy,” said Dr. Markman. However, he added, “the results will be helpful in assessing the potential toxicity of this approach.”

Recurrent or metastatic endometrial cancer with proficient mismatch repair. Women with this diagnosis who have progressed after one prior platinum chemotherapy regimen in any setting may wish to consider a randomized, triple-blind, phase 2 trial of pembrolizumab plus favezelimab. Favezelimab, which blocks the lymphocyte activation gene 3 (LAG3), appears to boost the antitumor activity of programmed cell death protein 1 (PD-1) inhibition in other cancers such as classic Hodgkin lymphoma. 

In the trial, participants will be assigned to one of four groups. One group will receive 17 doses of the combination treatment IV every 3 weeks — three doses in the neoadjuvant period and 14 as adjuvant therapy. A second group of individuals will receive IV pembrolizumab monotherapy on the same schedule. A third will be given up to 35 doses of the combo therapy every 3 weeks plus a daily capsule of lenvatinib (Lenvima). The fourth group will receive 35 doses of pembrolizumab plus daily lenvatinib. 

Sites in North Carolina, New Jersey, Pennsylvania, and four countries other than the US started recruiting 60 participants with a solid tumor in September 2023. Pathologic complete response and objective response rate are the primary endpoints. Overall survival over approximately 3.5 years is a secondary endpoint, and QOL will not be measured. More details at ClinicalTrials.gov

Unresectable advanced or metastatic HER2-positive endometrial or ovarian cancer. Adults with one of these diagnoses in whom failed platinum-based therapy has failed may enroll in an open-label, phase 2 study to see whether their disease will respond to the antibody-drug conjugate disitamab vedotin. Everyone in the trial will receive IV disitamab vedotin every 2 weeks for up to approximately 5 years. 

Study sites in California, Connecticut, Michigan, Minnesota, Montana, New York, Ohio, Texas, and Canada began welcoming their 190 participants with one of a range of solid cancers in November 2023. The primary outcome is objective response rate. Overall survival is a secondary measure and QOL will not be tracked. More details at ClinicalTrials.gov

High-risk locally advanced cervical cancer. Girls and women older than 14 years with this cancer that has not progressed after platinum-based chemoradiation are sought for a randomized, quadruple-blind, phase 3 trial to determine whether the investigational immunotherapy volrustomig can slow disease progression. Volrustomig targets PD-1 and cytotoxic T lymphocyte protein 4 (CTLA4) and is being tested in a wide range of solid cancers. 

For approximately 3 years or until disease progression or death, whichever happens first, half of participants will receive IV infusions of volrustomig while the others will receive saline. Asian research sites started seeking the study’s 1000 participants in September 2023, while centers in 12 US states and eight other countries are gearing up for patient enrollment. Progression-free survival in participants with PD-L1 expression is the primary endpoint; overall survival and QOL are secondary endpoints. More details at ClinicalTrials.gov

All trial information is from the National Institutes of Health US National Library of Medicine (online at ClinicalTrials.gov). Dr. Markman declared he is not involved with these trials.

A version of this article appeared on Medscape.com .