AVAHO

TOPLINE:

Long-term and recurrent use of antibiotics early in life may raise the risk of early-onset colorectal cancer (CRC) and adenomas, particularly in people with a variant in a specific gut microbiota regulatory gene, a new analysis found.

METHODOLOGY:

• Researchers analyzed data from UK Biobank participants who were recruited between 2006 and 2010 and were followed up to February 2022.
• They evaluated associations between early-life factors and early-onset CRC risk overall, focusing on long-term and recurrent antibiotic use.
• The team also estimated associations between long-term and recurrent antibiotic use in early life and CRC risk by polygenic risk score using 127 CRC-related genetic variants, as well as a particular gut microbiota regulatory gene FUT2.
• Associations for early-onset colorectal adenomas, as precursor to CRC, were also evaluated.
• The study included 113,256 participants. There were 165 early-onset CRC cases and 719 early-onset adenoma cases.

TAKEAWAY:

• Early-life, long-term, and recurrent antibiotic use was “nominally” associated with an increased risk of early-onset CRC (odds ratio, 1.48; P = .046) and adenomas (OR, 1.40; P < .001).
• Regarding variants of FUT2, the risk of early-onset CRC appeared to be greater for individuals with the rs281377 TT genotype (OR, 2.74) in comparison with those with the CT and TT genotypes, but none of the estimates reached statistical significance.
• The researchers found a strong positive association between long-term and recurrent antibiotic use and adenomas, largely in patients with rs281377 TT (OR, 1.75) and CT genotypes (OR, 1.51).
• Individuals with a high polygenic risk score were at higher risk of early-onset CRC (OR, 1.72; P = .019), while those with low polygenic risk scores were not at higher risk (OR, 1.05; P = .889). The association between antibiotic use and early-onset CRC risk by family history was also higher (OR, 2.34).

IN PRACTICE:

“Our findings suggested that individuals with genetic risk factors (i.e., family history of CRC) who have experienced early-life antibiotics use on a long-term basis are probably at increased early-onset CRC risk,” the authors concluded. “Given that antibiotics remain valuable in the management of bacterial infections during early life, investigating the pros and cons of early-life antibiotic use is of great significance.”

SOURCE:

The study, led by Fangyuan Jiang, with Zhejiang University, Hangzhou, China, was published online in the International Journal of Cancer.

LIMITATIONS:

The study relied on participants’ recall of early-life antibiotics use, which could introduce recall bias and misclassification of this exposure.

DISCLOSURES:

No conflicts of interest were reported.

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

TOPLINE:

Long-term and recurrent use of antibiotics early in life may raise the risk of early-onset colorectal cancer (CRC) and adenomas, particularly in people with a variant in a specific gut microbiota regulatory gene, a new analysis found.

METHODOLOGY:

• Researchers analyzed data from UK Biobank participants who were recruited between 2006 and 2010 and were followed up to February 2022.
• They evaluated associations between early-life factors and early-onset CRC risk overall, focusing on long-term and recurrent antibiotic use.
• The team also estimated associations between long-term and recurrent antibiotic use in early life and CRC risk by polygenic risk score using 127 CRC-related genetic variants, as well as a particular gut microbiota regulatory gene FUT2.
• Associations for early-onset colorectal adenomas, as precursor to CRC, were also evaluated.
• The study included 113,256 participants. There were 165 early-onset CRC cases and 719 early-onset adenoma cases.

TAKEAWAY:

• Early-life, long-term, and recurrent antibiotic use was “nominally” associated with an increased risk of early-onset CRC (odds ratio, 1.48; P = .046) and adenomas (OR, 1.40; P < .001).
• Regarding variants of FUT2, the risk of early-onset CRC appeared to be greater for individuals with the rs281377 TT genotype (OR, 2.74) in comparison with those with the CT and TT genotypes, but none of the estimates reached statistical significance.
• The researchers found a strong positive association between long-term and recurrent antibiotic use and adenomas, largely in patients with rs281377 TT (OR, 1.75) and CT genotypes (OR, 1.51).
• Individuals with a high polygenic risk score were at higher risk of early-onset CRC (OR, 1.72; P = .019), while those with low polygenic risk scores were not at higher risk (OR, 1.05; P = .889). The association between antibiotic use and early-onset CRC risk by family history was also higher (OR, 2.34).

IN PRACTICE:

“Our findings suggested that individuals with genetic risk factors (i.e., family history of CRC) who have experienced early-life antibiotics use on a long-term basis are probably at increased early-onset CRC risk,” the authors concluded. “Given that antibiotics remain valuable in the management of bacterial infections during early life, investigating the pros and cons of early-life antibiotic use is of great significance.”

SOURCE:

The study, led by Fangyuan Jiang, with Zhejiang University, Hangzhou, China, was published online in the International Journal of Cancer.

LIMITATIONS:

The study relied on participants’ recall of early-life antibiotics use, which could introduce recall bias and misclassification of this exposure.

DISCLOSURES:

No conflicts of interest were reported.

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

TOPLINE:

Long-term and recurrent use of antibiotics early in life may raise the risk of early-onset colorectal cancer (CRC) and adenomas, particularly in people with a variant in a specific gut microbiota regulatory gene, a new analysis found.

METHODOLOGY:

• Researchers analyzed data from UK Biobank participants who were recruited between 2006 and 2010 and were followed up to February 2022.
• They evaluated associations between early-life factors and early-onset CRC risk overall, focusing on long-term and recurrent antibiotic use.
• The team also estimated associations between long-term and recurrent antibiotic use in early life and CRC risk by polygenic risk score using 127 CRC-related genetic variants, as well as a particular gut microbiota regulatory gene FUT2.
• Associations for early-onset colorectal adenomas, as precursor to CRC, were also evaluated.
• The study included 113,256 participants. There were 165 early-onset CRC cases and 719 early-onset adenoma cases.

TAKEAWAY:

• Early-life, long-term, and recurrent antibiotic use was “nominally” associated with an increased risk of early-onset CRC (odds ratio, 1.48; P = .046) and adenomas (OR, 1.40; P < .001).
• Regarding variants of FUT2, the risk of early-onset CRC appeared to be greater for individuals with the rs281377 TT genotype (OR, 2.74) in comparison with those with the CT and TT genotypes, but none of the estimates reached statistical significance.
• The researchers found a strong positive association between long-term and recurrent antibiotic use and adenomas, largely in patients with rs281377 TT (OR, 1.75) and CT genotypes (OR, 1.51).
• Individuals with a high polygenic risk score were at higher risk of early-onset CRC (OR, 1.72; P = .019), while those with low polygenic risk scores were not at higher risk (OR, 1.05; P = .889). The association between antibiotic use and early-onset CRC risk by family history was also higher (OR, 2.34).

IN PRACTICE:

“Our findings suggested that individuals with genetic risk factors (i.e., family history of CRC) who have experienced early-life antibiotics use on a long-term basis are probably at increased early-onset CRC risk,” the authors concluded. “Given that antibiotics remain valuable in the management of bacterial infections during early life, investigating the pros and cons of early-life antibiotic use is of great significance.”

SOURCE:

The study, led by Fangyuan Jiang, with Zhejiang University, Hangzhou, China, was published online in the International Journal of Cancer.

LIMITATIONS:

The study relied on participants’ recall of early-life antibiotics use, which could introduce recall bias and misclassification of this exposure.

DISCLOSURES:

No conflicts of interest were reported.

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

Deanna Denham Hughes was stunned when she was diagnosed with ovarian cancer in 2022. She was only 32. She had no family history of cancer, and tests found no genetic link. Ms. Hughes wondered why she, an otherwise healthy Black mother of two, would develop a malignancy known as a “silent killer.”

After emergency surgery to remove the mass, along with her ovaries, uterus, fallopian tubes, and appendix, Ms. Hughes said, she saw an Instagram post in which a woman with uterine cancer linked her condition to chemical hair straighteners.

“I almost fell over,” she said from her home in Smyrna, Ga.

When Ms. Hughes was about 4, her mother began applying a chemical straightener, or relaxer, to her hair every 6-8 weeks. “It burned, and it smelled awful,” Ms. Hughes recalled. “But it was just part of our routine to ‘deal with my hair.’ ”

The routine continued until she went to college and met other Black women who wore their hair naturally. Soon, Ms. Hughes quit relaxers.

Social and economic pressures have long compelled Black girls and women to straighten their hair to conform to Eurocentric beauty standards. But chemical straighteners are stinky and costly and sometimes cause painful scalp burns. Mounting evidence now shows they could be a health hazard.

Relaxers can contain carcinogens, such as formaldehyde-releasing agents, phthalates, and other endocrine-disrupting compounds, according to National Institutes of Health studies. The compounds can mimic the body’s hormones and have been linked to breast, uterine, and ovarian cancers, studies show.

African American women’s often frequent and lifelong application of chemical relaxers to their hair and scalp might explain why hormone-related cancers kill disproportionately more Black than White women, say researchers and cancer doctors.

“What’s in these products is harmful,” said Tamarra James-Todd, PhD, an epidemiology professor at Harvard T.H. Chan School of Public Health, Boston, who has studied straightening products for the past 20 years.

She believes manufacturers, policymakers, and physicians should warn consumers that relaxers might cause cancer and other health problems.

But regulators have been slow to act, physicians have been reluctant to take up the cause, and racism continues to dictate fashion standards that make it tough for women to quit relaxers, products so addictive they’re known as “creamy crack.”

Michelle Obama straightened her hair when Barack Obama served as president because she believed Americans were “not ready” to see her in braids, the former first lady said after leaving the White House. The U.S. military still prohibited popular Black hairstyles such as dreadlocks and twists while the nation’s first Black president was in office.

California in 2019 became the first of nearly two dozen states to ban race-based hair discrimination. Last year, the U.S. House of Representatives passed similar legislation, known as the CROWN Act, for Creating a Respectful and Open World for Natural Hair. But the bill failed in the Senate.

The need for legislation underscores the challenges Black girls and women face at school and in the workplace.

“You have to pick your struggles,” said Atlanta-based surgical oncologist Ryland J. Gore, MD. She informs her breast cancer patients about the increased cancer risk from relaxers. Despite her knowledge, however, Dr. Gore continues to use chemical straighteners on her own hair, as she has since she was about 7 years old.

“Your hair tells a story,” she said.

In conversations with patients, Dr. Gore sometimes talks about how African American women once wove messages into their braids about the route to take on the Underground Railroad as they sought freedom from slavery.

“It’s just a deep discussion,” one that touches on culture, history, and research into current hairstyling practices, she said. “The data is out there. So patients should be warned, and then they can make a decision.”

The first hint of a connection between hair products and health issues surfaced in the 1990s. Doctors began seeing signs of sexual maturation in Black babies and young girls who developed breasts and pubic hair after using shampoo containing estrogen or placental extract. When the girls stopped using the shampoo, the hair and breast development receded, according to a study published in the journal Clinical Pediatrics in 1998.

Since then, Dr. James-Todd and other researchers have linked chemicals in hair products to a variety of health issues more prevalent among Black women – from early puberty to preterm birth, obesity, and diabetes.

In recent years, researchers have focused on a possible connection between ingredients in chemical relaxers and hormone-related cancers, like the one Ms. Hughes developed, which tend to be more aggressive and deadly in Black women.

A 2017 study found White women who used chemical relaxers were nearly twice as likely to develop breast cancer as those who did not use them. Because the vast majority of the Black study participants used relaxers, researchers could not effectively test the association in Black women, said lead author Adana Llanos, PhD, associate professor of epidemiology at Columbia University’s Mailman School of Public Health, New York.

Researchers did test it in 2020.

The so-called Sister Study, a landmark National Institute of Environmental Health Sciences investigation into the causes of breast cancer and related diseases, followed 50,000 U.S. women whose sisters had been diagnosed with breast cancer and who were cancer-free when they enrolled. Regardless of race, women who reported using relaxers in the prior year were 18% more likely to be diagnosed with breast cancer. Those who used relaxers at least every 5-8 weeks had a 31% higher breast cancer risk.

Nearly 75% of the Black sisters used relaxers in the prior year, compared with 3% of the non-Hispanic White sisters. Three-quarters of Black women self-reported using the straighteners as adolescents, and frequent use of chemical straighteners during adolescence raised the risk of premenopausal breast cancer, a 2021 NIH-funded study in the International Journal of Cancer found.

Another 2021 analysis of the Sister Study data showed sisters who self-reported that they frequently used relaxers or pressing products doubled their ovarian cancer risk. In 2022, another study found frequent use more than doubled uterine cancer risk.

After researchers discovered the link with uterine cancer, some called for policy changes and other measures to reduce exposure to chemical relaxers.

“It is time to intervene,” Dr. Llanos and her colleagues wrote in a Journal of the National Cancer Institute editorial accompanying the uterine cancer analysis. While acknowledging the need for more research, they issued a “call for action.”

No one can say that using permanent hair straighteners will give you cancer, Dr. Llanos said in an interview. “That’s not how cancer works,” she said, noting that some smokers never develop lung cancer, despite tobacco use being a known risk factor.

The body of research linking hair straighteners and cancer is more limited, said Dr. Llanos, who quit using chemical relaxers 15 years ago. But, she asked rhetorically, “Do we need to do the research for 50 more years to know that chemical relaxers are harmful?”

Charlotte R. Gamble, MD, a gynecological oncologist whose Washington, D.C., practice includes Black women with uterine and ovarian cancer, said she and her colleagues see the uterine cancer study findings as worthy of further exploration – but not yet worthy of discussion with patients.

“The jury’s out for me personally,” she said. “There’s so much more data that’s needed.”

Meanwhile, Dr. James-Todd and other researchers believe they have built a solid body of evidence.

“There are enough things we do know to begin taking action, developing interventions, providing useful information to clinicians and patients and the general public,” said Traci N. Bethea, PhD, assistant professor in the Office of Minority Health and Health Disparities Research at Georgetown University.

Responsibility for regulating personal-care products, including chemical hair straighteners and hair dyes – which also have been linked to hormone-related cancers – lies with the Food and Drug Administration. But the FDA does not subject personal-care products to the same approval process it uses for food and drugs. The FDA restricts only 11 categories of chemicals used in cosmetics, while concerns about health effects have prompted the European Union to restrict the use of at least 2,400 substances.

In March, Reps. Ayanna Pressley (D-Mass.) and Shontel Brown (D-Ohio) asked the FDA to investigate the potential health threat posed by chemical relaxers. An FDA representative said the agency would look into it.

Natural hairstyles are enjoying a resurgence among Black girls and women, but many continue to rely on the creamy crack, said Dede Teteh, DrPH, assistant professor of public health at Chapman University, Irvine, Calif.

She had her first straightening perm at 8 and has struggled to withdraw from relaxers as an adult, said Dr. Teteh, who now wears locs. Not long ago, she considered chemically straightening her hair for an academic job interview because she didn’t want her hair to “be a hindrance” when she appeared before White professors.

Dr. Teteh led “The Cost of Beauty,” a hair-health research project published in 2017. She and her team interviewed 91 Black women in Southern California. Some became “combative” at the idea of quitting relaxers and claimed “everything can cause cancer.”

Their reactions speak to the challenges Black women face in America, Dr. Teteh said.

“It’s not that people do not want to hear the information related to their health,” she said. “But they want people to share the information in a way that it’s really empathetic to the plight of being Black here in the United States.”
 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF – the independent source for health policy research, polling, and journalism.

Deanna Denham Hughes was stunned when she was diagnosed with ovarian cancer in 2022. She was only 32. She had no family history of cancer, and tests found no genetic link. Ms. Hughes wondered why she, an otherwise healthy Black mother of two, would develop a malignancy known as a “silent killer.”

After emergency surgery to remove the mass, along with her ovaries, uterus, fallopian tubes, and appendix, Ms. Hughes said, she saw an Instagram post in which a woman with uterine cancer linked her condition to chemical hair straighteners.

“I almost fell over,” she said from her home in Smyrna, Ga.

When Ms. Hughes was about 4, her mother began applying a chemical straightener, or relaxer, to her hair every 6-8 weeks. “It burned, and it smelled awful,” Ms. Hughes recalled. “But it was just part of our routine to ‘deal with my hair.’ ”

The routine continued until she went to college and met other Black women who wore their hair naturally. Soon, Ms. Hughes quit relaxers.

Social and economic pressures have long compelled Black girls and women to straighten their hair to conform to Eurocentric beauty standards. But chemical straighteners are stinky and costly and sometimes cause painful scalp burns. Mounting evidence now shows they could be a health hazard.

Relaxers can contain carcinogens, such as formaldehyde-releasing agents, phthalates, and other endocrine-disrupting compounds, according to National Institutes of Health studies. The compounds can mimic the body’s hormones and have been linked to breast, uterine, and ovarian cancers, studies show.

African American women’s often frequent and lifelong application of chemical relaxers to their hair and scalp might explain why hormone-related cancers kill disproportionately more Black than White women, say researchers and cancer doctors.

“What’s in these products is harmful,” said Tamarra James-Todd, PhD, an epidemiology professor at Harvard T.H. Chan School of Public Health, Boston, who has studied straightening products for the past 20 years.

She believes manufacturers, policymakers, and physicians should warn consumers that relaxers might cause cancer and other health problems.

But regulators have been slow to act, physicians have been reluctant to take up the cause, and racism continues to dictate fashion standards that make it tough for women to quit relaxers, products so addictive they’re known as “creamy crack.”

Michelle Obama straightened her hair when Barack Obama served as president because she believed Americans were “not ready” to see her in braids, the former first lady said after leaving the White House. The U.S. military still prohibited popular Black hairstyles such as dreadlocks and twists while the nation’s first Black president was in office.

California in 2019 became the first of nearly two dozen states to ban race-based hair discrimination. Last year, the U.S. House of Representatives passed similar legislation, known as the CROWN Act, for Creating a Respectful and Open World for Natural Hair. But the bill failed in the Senate.

The need for legislation underscores the challenges Black girls and women face at school and in the workplace.

“You have to pick your struggles,” said Atlanta-based surgical oncologist Ryland J. Gore, MD. She informs her breast cancer patients about the increased cancer risk from relaxers. Despite her knowledge, however, Dr. Gore continues to use chemical straighteners on her own hair, as she has since she was about 7 years old.

“Your hair tells a story,” she said.

In conversations with patients, Dr. Gore sometimes talks about how African American women once wove messages into their braids about the route to take on the Underground Railroad as they sought freedom from slavery.

“It’s just a deep discussion,” one that touches on culture, history, and research into current hairstyling practices, she said. “The data is out there. So patients should be warned, and then they can make a decision.”

The first hint of a connection between hair products and health issues surfaced in the 1990s. Doctors began seeing signs of sexual maturation in Black babies and young girls who developed breasts and pubic hair after using shampoo containing estrogen or placental extract. When the girls stopped using the shampoo, the hair and breast development receded, according to a study published in the journal Clinical Pediatrics in 1998.

Since then, Dr. James-Todd and other researchers have linked chemicals in hair products to a variety of health issues more prevalent among Black women – from early puberty to preterm birth, obesity, and diabetes.

In recent years, researchers have focused on a possible connection between ingredients in chemical relaxers and hormone-related cancers, like the one Ms. Hughes developed, which tend to be more aggressive and deadly in Black women.

A 2017 study found White women who used chemical relaxers were nearly twice as likely to develop breast cancer as those who did not use them. Because the vast majority of the Black study participants used relaxers, researchers could not effectively test the association in Black women, said lead author Adana Llanos, PhD, associate professor of epidemiology at Columbia University’s Mailman School of Public Health, New York.

Researchers did test it in 2020.

The so-called Sister Study, a landmark National Institute of Environmental Health Sciences investigation into the causes of breast cancer and related diseases, followed 50,000 U.S. women whose sisters had been diagnosed with breast cancer and who were cancer-free when they enrolled. Regardless of race, women who reported using relaxers in the prior year were 18% more likely to be diagnosed with breast cancer. Those who used relaxers at least every 5-8 weeks had a 31% higher breast cancer risk.

Nearly 75% of the Black sisters used relaxers in the prior year, compared with 3% of the non-Hispanic White sisters. Three-quarters of Black women self-reported using the straighteners as adolescents, and frequent use of chemical straighteners during adolescence raised the risk of premenopausal breast cancer, a 2021 NIH-funded study in the International Journal of Cancer found.

Another 2021 analysis of the Sister Study data showed sisters who self-reported that they frequently used relaxers or pressing products doubled their ovarian cancer risk. In 2022, another study found frequent use more than doubled uterine cancer risk.

After researchers discovered the link with uterine cancer, some called for policy changes and other measures to reduce exposure to chemical relaxers.

“It is time to intervene,” Dr. Llanos and her colleagues wrote in a Journal of the National Cancer Institute editorial accompanying the uterine cancer analysis. While acknowledging the need for more research, they issued a “call for action.”

No one can say that using permanent hair straighteners will give you cancer, Dr. Llanos said in an interview. “That’s not how cancer works,” she said, noting that some smokers never develop lung cancer, despite tobacco use being a known risk factor.

The body of research linking hair straighteners and cancer is more limited, said Dr. Llanos, who quit using chemical relaxers 15 years ago. But, she asked rhetorically, “Do we need to do the research for 50 more years to know that chemical relaxers are harmful?”

Charlotte R. Gamble, MD, a gynecological oncologist whose Washington, D.C., practice includes Black women with uterine and ovarian cancer, said she and her colleagues see the uterine cancer study findings as worthy of further exploration – but not yet worthy of discussion with patients.

“The jury’s out for me personally,” she said. “There’s so much more data that’s needed.”

Meanwhile, Dr. James-Todd and other researchers believe they have built a solid body of evidence.

“There are enough things we do know to begin taking action, developing interventions, providing useful information to clinicians and patients and the general public,” said Traci N. Bethea, PhD, assistant professor in the Office of Minority Health and Health Disparities Research at Georgetown University.

Responsibility for regulating personal-care products, including chemical hair straighteners and hair dyes – which also have been linked to hormone-related cancers – lies with the Food and Drug Administration. But the FDA does not subject personal-care products to the same approval process it uses for food and drugs. The FDA restricts only 11 categories of chemicals used in cosmetics, while concerns about health effects have prompted the European Union to restrict the use of at least 2,400 substances.

In March, Reps. Ayanna Pressley (D-Mass.) and Shontel Brown (D-Ohio) asked the FDA to investigate the potential health threat posed by chemical relaxers. An FDA representative said the agency would look into it.

Natural hairstyles are enjoying a resurgence among Black girls and women, but many continue to rely on the creamy crack, said Dede Teteh, DrPH, assistant professor of public health at Chapman University, Irvine, Calif.

She had her first straightening perm at 8 and has struggled to withdraw from relaxers as an adult, said Dr. Teteh, who now wears locs. Not long ago, she considered chemically straightening her hair for an academic job interview because she didn’t want her hair to “be a hindrance” when she appeared before White professors.

Dr. Teteh led “The Cost of Beauty,” a hair-health research project published in 2017. She and her team interviewed 91 Black women in Southern California. Some became “combative” at the idea of quitting relaxers and claimed “everything can cause cancer.”

Their reactions speak to the challenges Black women face in America, Dr. Teteh said.

“It’s not that people do not want to hear the information related to their health,” she said. “But they want people to share the information in a way that it’s really empathetic to the plight of being Black here in the United States.”
 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF – the independent source for health policy research, polling, and journalism.

Deanna Denham Hughes was stunned when she was diagnosed with ovarian cancer in 2022. She was only 32. She had no family history of cancer, and tests found no genetic link. Ms. Hughes wondered why she, an otherwise healthy Black mother of two, would develop a malignancy known as a “silent killer.”

After emergency surgery to remove the mass, along with her ovaries, uterus, fallopian tubes, and appendix, Ms. Hughes said, she saw an Instagram post in which a woman with uterine cancer linked her condition to chemical hair straighteners.

“I almost fell over,” she said from her home in Smyrna, Ga.

When Ms. Hughes was about 4, her mother began applying a chemical straightener, or relaxer, to her hair every 6-8 weeks. “It burned, and it smelled awful,” Ms. Hughes recalled. “But it was just part of our routine to ‘deal with my hair.’ ”

The routine continued until she went to college and met other Black women who wore their hair naturally. Soon, Ms. Hughes quit relaxers.

Social and economic pressures have long compelled Black girls and women to straighten their hair to conform to Eurocentric beauty standards. But chemical straighteners are stinky and costly and sometimes cause painful scalp burns. Mounting evidence now shows they could be a health hazard.

Relaxers can contain carcinogens, such as formaldehyde-releasing agents, phthalates, and other endocrine-disrupting compounds, according to National Institutes of Health studies. The compounds can mimic the body’s hormones and have been linked to breast, uterine, and ovarian cancers, studies show.

African American women’s often frequent and lifelong application of chemical relaxers to their hair and scalp might explain why hormone-related cancers kill disproportionately more Black than White women, say researchers and cancer doctors.

“What’s in these products is harmful,” said Tamarra James-Todd, PhD, an epidemiology professor at Harvard T.H. Chan School of Public Health, Boston, who has studied straightening products for the past 20 years.

She believes manufacturers, policymakers, and physicians should warn consumers that relaxers might cause cancer and other health problems.

But regulators have been slow to act, physicians have been reluctant to take up the cause, and racism continues to dictate fashion standards that make it tough for women to quit relaxers, products so addictive they’re known as “creamy crack.”

Michelle Obama straightened her hair when Barack Obama served as president because she believed Americans were “not ready” to see her in braids, the former first lady said after leaving the White House. The U.S. military still prohibited popular Black hairstyles such as dreadlocks and twists while the nation’s first Black president was in office.

California in 2019 became the first of nearly two dozen states to ban race-based hair discrimination. Last year, the U.S. House of Representatives passed similar legislation, known as the CROWN Act, for Creating a Respectful and Open World for Natural Hair. But the bill failed in the Senate.

The need for legislation underscores the challenges Black girls and women face at school and in the workplace.

“You have to pick your struggles,” said Atlanta-based surgical oncologist Ryland J. Gore, MD. She informs her breast cancer patients about the increased cancer risk from relaxers. Despite her knowledge, however, Dr. Gore continues to use chemical straighteners on her own hair, as she has since she was about 7 years old.

“Your hair tells a story,” she said.

In conversations with patients, Dr. Gore sometimes talks about how African American women once wove messages into their braids about the route to take on the Underground Railroad as they sought freedom from slavery.

“It’s just a deep discussion,” one that touches on culture, history, and research into current hairstyling practices, she said. “The data is out there. So patients should be warned, and then they can make a decision.”

The first hint of a connection between hair products and health issues surfaced in the 1990s. Doctors began seeing signs of sexual maturation in Black babies and young girls who developed breasts and pubic hair after using shampoo containing estrogen or placental extract. When the girls stopped using the shampoo, the hair and breast development receded, according to a study published in the journal Clinical Pediatrics in 1998.

Since then, Dr. James-Todd and other researchers have linked chemicals in hair products to a variety of health issues more prevalent among Black women – from early puberty to preterm birth, obesity, and diabetes.

In recent years, researchers have focused on a possible connection between ingredients in chemical relaxers and hormone-related cancers, like the one Ms. Hughes developed, which tend to be more aggressive and deadly in Black women.

A 2017 study found White women who used chemical relaxers were nearly twice as likely to develop breast cancer as those who did not use them. Because the vast majority of the Black study participants used relaxers, researchers could not effectively test the association in Black women, said lead author Adana Llanos, PhD, associate professor of epidemiology at Columbia University’s Mailman School of Public Health, New York.

Researchers did test it in 2020.

The so-called Sister Study, a landmark National Institute of Environmental Health Sciences investigation into the causes of breast cancer and related diseases, followed 50,000 U.S. women whose sisters had been diagnosed with breast cancer and who were cancer-free when they enrolled. Regardless of race, women who reported using relaxers in the prior year were 18% more likely to be diagnosed with breast cancer. Those who used relaxers at least every 5-8 weeks had a 31% higher breast cancer risk.

Nearly 75% of the Black sisters used relaxers in the prior year, compared with 3% of the non-Hispanic White sisters. Three-quarters of Black women self-reported using the straighteners as adolescents, and frequent use of chemical straighteners during adolescence raised the risk of premenopausal breast cancer, a 2021 NIH-funded study in the International Journal of Cancer found.

Another 2021 analysis of the Sister Study data showed sisters who self-reported that they frequently used relaxers or pressing products doubled their ovarian cancer risk. In 2022, another study found frequent use more than doubled uterine cancer risk.

After researchers discovered the link with uterine cancer, some called for policy changes and other measures to reduce exposure to chemical relaxers.

“It is time to intervene,” Dr. Llanos and her colleagues wrote in a Journal of the National Cancer Institute editorial accompanying the uterine cancer analysis. While acknowledging the need for more research, they issued a “call for action.”

No one can say that using permanent hair straighteners will give you cancer, Dr. Llanos said in an interview. “That’s not how cancer works,” she said, noting that some smokers never develop lung cancer, despite tobacco use being a known risk factor.

The body of research linking hair straighteners and cancer is more limited, said Dr. Llanos, who quit using chemical relaxers 15 years ago. But, she asked rhetorically, “Do we need to do the research for 50 more years to know that chemical relaxers are harmful?”

Charlotte R. Gamble, MD, a gynecological oncologist whose Washington, D.C., practice includes Black women with uterine and ovarian cancer, said she and her colleagues see the uterine cancer study findings as worthy of further exploration – but not yet worthy of discussion with patients.

“The jury’s out for me personally,” she said. “There’s so much more data that’s needed.”

Meanwhile, Dr. James-Todd and other researchers believe they have built a solid body of evidence.

“There are enough things we do know to begin taking action, developing interventions, providing useful information to clinicians and patients and the general public,” said Traci N. Bethea, PhD, assistant professor in the Office of Minority Health and Health Disparities Research at Georgetown University.

Responsibility for regulating personal-care products, including chemical hair straighteners and hair dyes – which also have been linked to hormone-related cancers – lies with the Food and Drug Administration. But the FDA does not subject personal-care products to the same approval process it uses for food and drugs. The FDA restricts only 11 categories of chemicals used in cosmetics, while concerns about health effects have prompted the European Union to restrict the use of at least 2,400 substances.

In March, Reps. Ayanna Pressley (D-Mass.) and Shontel Brown (D-Ohio) asked the FDA to investigate the potential health threat posed by chemical relaxers. An FDA representative said the agency would look into it.

Natural hairstyles are enjoying a resurgence among Black girls and women, but many continue to rely on the creamy crack, said Dede Teteh, DrPH, assistant professor of public health at Chapman University, Irvine, Calif.

She had her first straightening perm at 8 and has struggled to withdraw from relaxers as an adult, said Dr. Teteh, who now wears locs. Not long ago, she considered chemically straightening her hair for an academic job interview because she didn’t want her hair to “be a hindrance” when she appeared before White professors.

Dr. Teteh led “The Cost of Beauty,” a hair-health research project published in 2017. She and her team interviewed 91 Black women in Southern California. Some became “combative” at the idea of quitting relaxers and claimed “everything can cause cancer.”

Their reactions speak to the challenges Black women face in America, Dr. Teteh said.

“It’s not that people do not want to hear the information related to their health,” she said. “But they want people to share the information in a way that it’s really empathetic to the plight of being Black here in the United States.”
 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF – the independent source for health policy research, polling, and journalism.

TOPLINE:

Five scleroderma immune responses have associations with cancer risk and could be used to stratify patients, researchers argue.

METHODOLOGY:

• Included patients from the Johns Hopkins Scleroderma Center Research Registry and the University of Pittsburgh Scleroderma Center, Pittsburgh.
• A total of 676 patients with scleroderma and a history of cancer were compared with 687 control patients with scleroderma but without a history of cancer.
• Serum tested via line blot and enzyme-linked immunosorbent assay for an array of scleroderma autoantibodies.
• Examined association between autoantibodies and overall cancer risk.

TAKEAWAYS:

• Anti-POLR3 and monospecific anti-Ro52 were associated with significantly increased overall cancer risk.
• Anti-centromere and anti-U1RNP were associated with a decreased cancer risk.
• These associations remained when looking specifically at cancer-associated scleroderma.
• Patients positive for anti-Ro52 in combination with either anti-U1RNP or anti-Th/To had a decreased risk of cancer, compared with those who had anti-Ro52 alone.

IN PRACTICE:

This study is too preliminary to have practice application.

SOURCE:

Ji Soo Kim, PhD, of John Hopkins University, Baltimore, was the first author of the study, published in Arthritis & Rheumatology on July 24, 2023. Fellow Johns Hopkins researchers Livia Casciola-Rosen, PhD, and Ami A. Shah, MD, were joint senior authors.

DISCLOSURES:

The study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the Donald B. and Dorothy L. Stabler Foundation, the Jerome L. Greene Foundation, the Chresanthe Staurulakis Memorial Discovery Fund, the Martha McCrory Professorship, and the Johns Hopkins inHealth initiative. The authors disclosed the following patents or patent applications: Autoimmune Antigens and Cancer, Materials and Methods for Assessing Cancer Risk and Treating Cancer.

A version of this article appeared on Medscape.com.

TOPLINE:

Five scleroderma immune responses have associations with cancer risk and could be used to stratify patients, researchers argue.

METHODOLOGY:

• Included patients from the Johns Hopkins Scleroderma Center Research Registry and the University of Pittsburgh Scleroderma Center, Pittsburgh.
• A total of 676 patients with scleroderma and a history of cancer were compared with 687 control patients with scleroderma but without a history of cancer.
• Serum tested via line blot and enzyme-linked immunosorbent assay for an array of scleroderma autoantibodies.
• Examined association between autoantibodies and overall cancer risk.

TAKEAWAYS:

• Anti-POLR3 and monospecific anti-Ro52 were associated with significantly increased overall cancer risk.
• Anti-centromere and anti-U1RNP were associated with a decreased cancer risk.
• These associations remained when looking specifically at cancer-associated scleroderma.
• Patients positive for anti-Ro52 in combination with either anti-U1RNP or anti-Th/To had a decreased risk of cancer, compared with those who had anti-Ro52 alone.

IN PRACTICE:

This study is too preliminary to have practice application.

SOURCE:

Ji Soo Kim, PhD, of John Hopkins University, Baltimore, was the first author of the study, published in Arthritis & Rheumatology on July 24, 2023. Fellow Johns Hopkins researchers Livia Casciola-Rosen, PhD, and Ami A. Shah, MD, were joint senior authors.

DISCLOSURES:

The study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the Donald B. and Dorothy L. Stabler Foundation, the Jerome L. Greene Foundation, the Chresanthe Staurulakis Memorial Discovery Fund, the Martha McCrory Professorship, and the Johns Hopkins inHealth initiative. The authors disclosed the following patents or patent applications: Autoimmune Antigens and Cancer, Materials and Methods for Assessing Cancer Risk and Treating Cancer.

A version of this article appeared on Medscape.com.

TOPLINE:

Five scleroderma immune responses have associations with cancer risk and could be used to stratify patients, researchers argue.

METHODOLOGY:

• Included patients from the Johns Hopkins Scleroderma Center Research Registry and the University of Pittsburgh Scleroderma Center, Pittsburgh.
• A total of 676 patients with scleroderma and a history of cancer were compared with 687 control patients with scleroderma but without a history of cancer.
• Serum tested via line blot and enzyme-linked immunosorbent assay for an array of scleroderma autoantibodies.
• Examined association between autoantibodies and overall cancer risk.

TAKEAWAYS:

• Anti-POLR3 and monospecific anti-Ro52 were associated with significantly increased overall cancer risk.
• Anti-centromere and anti-U1RNP were associated with a decreased cancer risk.
• These associations remained when looking specifically at cancer-associated scleroderma.
• Patients positive for anti-Ro52 in combination with either anti-U1RNP or anti-Th/To had a decreased risk of cancer, compared with those who had anti-Ro52 alone.

IN PRACTICE:

This study is too preliminary to have practice application.

SOURCE:

Ji Soo Kim, PhD, of John Hopkins University, Baltimore, was the first author of the study, published in Arthritis & Rheumatology on July 24, 2023. Fellow Johns Hopkins researchers Livia Casciola-Rosen, PhD, and Ami A. Shah, MD, were joint senior authors.

DISCLOSURES:

The study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the Donald B. and Dorothy L. Stabler Foundation, the Jerome L. Greene Foundation, the Chresanthe Staurulakis Memorial Discovery Fund, the Martha McCrory Professorship, and the Johns Hopkins inHealth initiative. The authors disclosed the following patents or patent applications: Autoimmune Antigens and Cancer, Materials and Methods for Assessing Cancer Risk and Treating Cancer.

A version of this article appeared on Medscape.com.

Artificial intelligence (AI)–supported breast cancer screening appears safe and at least as accurate as standard double reading of mammograms by two breast radiologists, according to early results from a large, randomized, population-based cohort study.

The AI-supported screening also reduced radiologist workload by nearly 44%, researchers estimated.

The trial also found a 20% increase in cancer detection using AI support compared with routine double mammography reading, underscoring AI’s potential to improve screening accuracy and efficiency.

The findings, published online in Lancet Oncology, come from a planned interim safety analysis of the Swedish Mammography Screening with Artificial Intelligence (MASAI) trial.

To date, AI has shown promise in mammography screening, with retrospective evidence demonstrating similar accuracy, compared with standard double readings as well as reduced workload for radiologists. Still, randomized trials assessing the efficacy of AI-supported breast screening are needed.

The aim of the current interim randomized analysis was to assess early screening performance, which included cancer detection, recall, and false positive rates as well as cancer type detected and workload.

The MASAI trial randomized 80,033 women, with a median age of 54, to AI-supported screening (n = 40,003) or double reading without AI (n = 40,030).

The AI system provided malignancy risk scores from 1 to 10, with low-risk scores ranging from 1 to 7, intermediate risk from 8 to 9, and high risk at 10. These risk scores were used to triage screening exams to a single radiologist reading (score of 1-9) or double reading (score of 10), given that cancer prevalence “increases sharply” for those with a risk score of 10, the researchers explained. The AI system also provided computer-aided detection marks for exams with risk scores of 8-10 to radiologists.

Among nearly 40,000 women screened with AI support, 244 cancers were detected, including 184 invasive cancers (75%) and 60 in situ cancers (25%), and resulted in 861 recalls. Among 40,024 participants receiving standard screening, radiologists detected 203 cancers, including 165 invasive cancers (81%) and 38 in situ cancers (19%), and resulted in 817 recalls.

Overall, the detection rate using AI support versus standard screening was 6.1 per 1000 screened participants versus 5.1 per 1,000. The recall rates were 2.2% versus 2.0%, respectively.

The false positive rates were the same in both groups (1.5%) while the positive predictive value (PPV) of recall – how likely a recall of a participant ultimately led to a cancer diagnosis – was higher in the AI group: 28.3% versus 24.8%.

The cancer detection rate in the high-risk group – patients with a risk score of 10 – was 72.3 per 1000 participants screened, or one cancer per 14 screening exams. And, overall, 189 of 490 screening exams flagged as extra-high risk by AI (the highest 1% risk) were recalled. Of the 189 recalled participants, 136 had cancer, representing a PPV of recall of 72%.

Overall, “we found that the benefit of AI-supported screening in terms of screen-reading workload reduction was considerable,” the authors said.

Assuming a radiologist can read 50 mammograms an hour, the researchers estimated that a radiologist would take 4.6 fewer months to read more than 46,000 screening exams in the intervention group compared with more than 83,000 in the control group.

Although these early safety results are “promising,” the findings “are not enough on their own to confirm that AI is ready to be implemented in mammography screening,” lead author Kristina Lång, PhD, of Lund (Sweden) University, said in a press release.

“We still need to understand the implications on patients’ outcomes, especially whether combining radiologists’ expertise with AI can help detect interval cancers that are often missed by traditional screening, as well as the cost-effectiveness of the technology,” she said, adding that “the greatest potential of AI right now is that it could allow radiologists to be less burdened by the excessive amount of reading.”

In an accompanying editorial, Nereo Segnan, MD, and Antonio Ponti, MD, both of CPO Piemonte in Torino, Italy, said that the AI risk score for breast cancer in the trial “seems very accurate at being able to separate high-risk from low-risk women.”

However, the potential for overdiagnosis or overdetection of indolent lesions in the intervention group should “prompt caution in the interpretation of results that otherwise seem straightforward in favoring the use of AI,” the editorialists noted.

The authors agreed that increased detection of in situ cancers with AI-supported screening compared with standard screening – 25% versus 19% – “could be concerning in terms of overdiagnosis,” as the risk of overtreatment is more likely with these low-grade cancers.

In the final analysis, Dr. Lång and colleagues plan to characterize the biological features of detected lesions to provide further insight on AI-supported screening, including the risk for overdiagnosis.

In a statement to the U.K.-based Science Media Centre, Stephen Duffy, professor of cancer screening, Wolfson Institute of Population Health, Queen Mary University of London, commented that the “results illustrate the potential for artificial intelligence to reduce the burden on radiologists’ time,” which is “an issue of considerable importance in many breast screening programs.”

The MASAI study was funded by the Swedish Cancer Society, Confederation of Regional Cancer Centres, and government funding for clinical research. Dr. Lång has been an advisory board member for Siemens Healthineers and has received lecture honorarium from AstraZeneca. Dr. Segnan and Dr. Hall reported no relevant financial relationships.

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

Artificial intelligence (AI)–supported breast cancer screening appears safe and at least as accurate as standard double reading of mammograms by two breast radiologists, according to early results from a large, randomized, population-based cohort study.

The AI-supported screening also reduced radiologist workload by nearly 44%, researchers estimated.

The trial also found a 20% increase in cancer detection using AI support compared with routine double mammography reading, underscoring AI’s potential to improve screening accuracy and efficiency.

The findings, published online in Lancet Oncology, come from a planned interim safety analysis of the Swedish Mammography Screening with Artificial Intelligence (MASAI) trial.

To date, AI has shown promise in mammography screening, with retrospective evidence demonstrating similar accuracy, compared with standard double readings as well as reduced workload for radiologists. Still, randomized trials assessing the efficacy of AI-supported breast screening are needed.

The aim of the current interim randomized analysis was to assess early screening performance, which included cancer detection, recall, and false positive rates as well as cancer type detected and workload.

The MASAI trial randomized 80,033 women, with a median age of 54, to AI-supported screening (n = 40,003) or double reading without AI (n = 40,030).

The AI system provided malignancy risk scores from 1 to 10, with low-risk scores ranging from 1 to 7, intermediate risk from 8 to 9, and high risk at 10. These risk scores were used to triage screening exams to a single radiologist reading (score of 1-9) or double reading (score of 10), given that cancer prevalence “increases sharply” for those with a risk score of 10, the researchers explained. The AI system also provided computer-aided detection marks for exams with risk scores of 8-10 to radiologists.

Among nearly 40,000 women screened with AI support, 244 cancers were detected, including 184 invasive cancers (75%) and 60 in situ cancers (25%), and resulted in 861 recalls. Among 40,024 participants receiving standard screening, radiologists detected 203 cancers, including 165 invasive cancers (81%) and 38 in situ cancers (19%), and resulted in 817 recalls.

Overall, the detection rate using AI support versus standard screening was 6.1 per 1000 screened participants versus 5.1 per 1,000. The recall rates were 2.2% versus 2.0%, respectively.

The false positive rates were the same in both groups (1.5%) while the positive predictive value (PPV) of recall – how likely a recall of a participant ultimately led to a cancer diagnosis – was higher in the AI group: 28.3% versus 24.8%.

The cancer detection rate in the high-risk group – patients with a risk score of 10 – was 72.3 per 1000 participants screened, or one cancer per 14 screening exams. And, overall, 189 of 490 screening exams flagged as extra-high risk by AI (the highest 1% risk) were recalled. Of the 189 recalled participants, 136 had cancer, representing a PPV of recall of 72%.

Overall, “we found that the benefit of AI-supported screening in terms of screen-reading workload reduction was considerable,” the authors said.

Assuming a radiologist can read 50 mammograms an hour, the researchers estimated that a radiologist would take 4.6 fewer months to read more than 46,000 screening exams in the intervention group compared with more than 83,000 in the control group.

Although these early safety results are “promising,” the findings “are not enough on their own to confirm that AI is ready to be implemented in mammography screening,” lead author Kristina Lång, PhD, of Lund (Sweden) University, said in a press release.

“We still need to understand the implications on patients’ outcomes, especially whether combining radiologists’ expertise with AI can help detect interval cancers that are often missed by traditional screening, as well as the cost-effectiveness of the technology,” she said, adding that “the greatest potential of AI right now is that it could allow radiologists to be less burdened by the excessive amount of reading.”

In an accompanying editorial, Nereo Segnan, MD, and Antonio Ponti, MD, both of CPO Piemonte in Torino, Italy, said that the AI risk score for breast cancer in the trial “seems very accurate at being able to separate high-risk from low-risk women.”

However, the potential for overdiagnosis or overdetection of indolent lesions in the intervention group should “prompt caution in the interpretation of results that otherwise seem straightforward in favoring the use of AI,” the editorialists noted.

The authors agreed that increased detection of in situ cancers with AI-supported screening compared with standard screening – 25% versus 19% – “could be concerning in terms of overdiagnosis,” as the risk of overtreatment is more likely with these low-grade cancers.

In the final analysis, Dr. Lång and colleagues plan to characterize the biological features of detected lesions to provide further insight on AI-supported screening, including the risk for overdiagnosis.

In a statement to the U.K.-based Science Media Centre, Stephen Duffy, professor of cancer screening, Wolfson Institute of Population Health, Queen Mary University of London, commented that the “results illustrate the potential for artificial intelligence to reduce the burden on radiologists’ time,” which is “an issue of considerable importance in many breast screening programs.”

The MASAI study was funded by the Swedish Cancer Society, Confederation of Regional Cancer Centres, and government funding for clinical research. Dr. Lång has been an advisory board member for Siemens Healthineers and has received lecture honorarium from AstraZeneca. Dr. Segnan and Dr. Hall reported no relevant financial relationships.

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

Artificial intelligence (AI)–supported breast cancer screening appears safe and at least as accurate as standard double reading of mammograms by two breast radiologists, according to early results from a large, randomized, population-based cohort study.

The AI-supported screening also reduced radiologist workload by nearly 44%, researchers estimated.

The trial also found a 20% increase in cancer detection using AI support compared with routine double mammography reading, underscoring AI’s potential to improve screening accuracy and efficiency.

The findings, published online in Lancet Oncology, come from a planned interim safety analysis of the Swedish Mammography Screening with Artificial Intelligence (MASAI) trial.

To date, AI has shown promise in mammography screening, with retrospective evidence demonstrating similar accuracy, compared with standard double readings as well as reduced workload for radiologists. Still, randomized trials assessing the efficacy of AI-supported breast screening are needed.

The aim of the current interim randomized analysis was to assess early screening performance, which included cancer detection, recall, and false positive rates as well as cancer type detected and workload.

The MASAI trial randomized 80,033 women, with a median age of 54, to AI-supported screening (n = 40,003) or double reading without AI (n = 40,030).

The AI system provided malignancy risk scores from 1 to 10, with low-risk scores ranging from 1 to 7, intermediate risk from 8 to 9, and high risk at 10. These risk scores were used to triage screening exams to a single radiologist reading (score of 1-9) or double reading (score of 10), given that cancer prevalence “increases sharply” for those with a risk score of 10, the researchers explained. The AI system also provided computer-aided detection marks for exams with risk scores of 8-10 to radiologists.

Among nearly 40,000 women screened with AI support, 244 cancers were detected, including 184 invasive cancers (75%) and 60 in situ cancers (25%), and resulted in 861 recalls. Among 40,024 participants receiving standard screening, radiologists detected 203 cancers, including 165 invasive cancers (81%) and 38 in situ cancers (19%), and resulted in 817 recalls.

Overall, the detection rate using AI support versus standard screening was 6.1 per 1000 screened participants versus 5.1 per 1,000. The recall rates were 2.2% versus 2.0%, respectively.

The false positive rates were the same in both groups (1.5%) while the positive predictive value (PPV) of recall – how likely a recall of a participant ultimately led to a cancer diagnosis – was higher in the AI group: 28.3% versus 24.8%.

The cancer detection rate in the high-risk group – patients with a risk score of 10 – was 72.3 per 1000 participants screened, or one cancer per 14 screening exams. And, overall, 189 of 490 screening exams flagged as extra-high risk by AI (the highest 1% risk) were recalled. Of the 189 recalled participants, 136 had cancer, representing a PPV of recall of 72%.

Overall, “we found that the benefit of AI-supported screening in terms of screen-reading workload reduction was considerable,” the authors said.

Assuming a radiologist can read 50 mammograms an hour, the researchers estimated that a radiologist would take 4.6 fewer months to read more than 46,000 screening exams in the intervention group compared with more than 83,000 in the control group.

Although these early safety results are “promising,” the findings “are not enough on their own to confirm that AI is ready to be implemented in mammography screening,” lead author Kristina Lång, PhD, of Lund (Sweden) University, said in a press release.

“We still need to understand the implications on patients’ outcomes, especially whether combining radiologists’ expertise with AI can help detect interval cancers that are often missed by traditional screening, as well as the cost-effectiveness of the technology,” she said, adding that “the greatest potential of AI right now is that it could allow radiologists to be less burdened by the excessive amount of reading.”

In an accompanying editorial, Nereo Segnan, MD, and Antonio Ponti, MD, both of CPO Piemonte in Torino, Italy, said that the AI risk score for breast cancer in the trial “seems very accurate at being able to separate high-risk from low-risk women.”

However, the potential for overdiagnosis or overdetection of indolent lesions in the intervention group should “prompt caution in the interpretation of results that otherwise seem straightforward in favoring the use of AI,” the editorialists noted.

The authors agreed that increased detection of in situ cancers with AI-supported screening compared with standard screening – 25% versus 19% – “could be concerning in terms of overdiagnosis,” as the risk of overtreatment is more likely with these low-grade cancers.

In the final analysis, Dr. Lång and colleagues plan to characterize the biological features of detected lesions to provide further insight on AI-supported screening, including the risk for overdiagnosis.

In a statement to the U.K.-based Science Media Centre, Stephen Duffy, professor of cancer screening, Wolfson Institute of Population Health, Queen Mary University of London, commented that the “results illustrate the potential for artificial intelligence to reduce the burden on radiologists’ time,” which is “an issue of considerable importance in many breast screening programs.”

The MASAI study was funded by the Swedish Cancer Society, Confederation of Regional Cancer Centres, and government funding for clinical research. Dr. Lång has been an advisory board member for Siemens Healthineers and has received lecture honorarium from AstraZeneca. Dr. Segnan and Dr. Hall reported no relevant financial relationships.

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

TOPLINE:

A dramatic increase in cancer diagnoses following Medicaid expansion in Ohio suggests that expanding the program improves access to cancer care.

METHODOLOGY:

• To assess the impact of Medicaid expansion on cancer diagnosis, investigators compared the volume of patients with newly diagnosed cancer in Ohio, which expanded its Medicaid coverage in 2014, with that of Georgia, which did not.
• State cancer registries were queried from 2010 to 2017 to identify adults younger than 64 years with incident female breast cancer, cervical cancer, or colorectal cancer (CRC).

TAKEAWAY:

• In Ohio, researchers found a substantial increase in diagnoses for all three cancers among Medicaid patients after expansion. The increase ranged from 42% for breast cancer to 77% for CRC.
• In Georgia, fewer Medicaid patients were diagnosed with breast cancer in the postexpansion period. There were also smaller increases in the number of patients diagnosed with cervical cancer (6%) and CRC (13%), compared with the postexpansion increases seen in Ohio.
• The risk of being diagnosed with late-stage breast cancer fell 7% among Medicaid patients in Ohio after expansion.
• The risk of being diagnosed with late-stage CRC fell 6% among Medicaid patients in George and Ohio. The Georgia results are potentially attributable to increases in state and local screening programs, especially in rural areas.

IN PRACTICE:

“These starkly different patterns in changes in the number of diagnosed [breast cancer], [cervical cancer], and CRC cases among patients on Medicaid in Ohio versus Georgia in the postexpansion period suggest that expanding insurance coverage might have effectively improved access to care,” the authors wrote.

SOURCE:

The study, led by Kirsten Eom, PhD, of the MetroHealth Population Health Research Institute, Cleveland, was published online in Cancer.

LIMITATIONS:

• Medicaid status was determined at diagnosis; past studies have associated being enrolled in Medicaid at the time of cancer diagnosis, rather than before, with late‐stage disease.
• The team could not assess the effectiveness of state and local cancer screening programs in preventing late-stage cancer.

DISCLOSURES:

• The study was funded by the Ohio Department of Health and the Georgia Department of Public Health.
• One researcher reported a grant from Celgene.

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

TOPLINE:

A dramatic increase in cancer diagnoses following Medicaid expansion in Ohio suggests that expanding the program improves access to cancer care.

METHODOLOGY:

• To assess the impact of Medicaid expansion on cancer diagnosis, investigators compared the volume of patients with newly diagnosed cancer in Ohio, which expanded its Medicaid coverage in 2014, with that of Georgia, which did not.
• State cancer registries were queried from 2010 to 2017 to identify adults younger than 64 years with incident female breast cancer, cervical cancer, or colorectal cancer (CRC).

TAKEAWAY:

• In Ohio, researchers found a substantial increase in diagnoses for all three cancers among Medicaid patients after expansion. The increase ranged from 42% for breast cancer to 77% for CRC.
• In Georgia, fewer Medicaid patients were diagnosed with breast cancer in the postexpansion period. There were also smaller increases in the number of patients diagnosed with cervical cancer (6%) and CRC (13%), compared with the postexpansion increases seen in Ohio.
• The risk of being diagnosed with late-stage breast cancer fell 7% among Medicaid patients in Ohio after expansion.
• The risk of being diagnosed with late-stage CRC fell 6% among Medicaid patients in George and Ohio. The Georgia results are potentially attributable to increases in state and local screening programs, especially in rural areas.

IN PRACTICE:

“These starkly different patterns in changes in the number of diagnosed [breast cancer], [cervical cancer], and CRC cases among patients on Medicaid in Ohio versus Georgia in the postexpansion period suggest that expanding insurance coverage might have effectively improved access to care,” the authors wrote.

SOURCE:

The study, led by Kirsten Eom, PhD, of the MetroHealth Population Health Research Institute, Cleveland, was published online in Cancer.

LIMITATIONS:

• Medicaid status was determined at diagnosis; past studies have associated being enrolled in Medicaid at the time of cancer diagnosis, rather than before, with late‐stage disease.
• The team could not assess the effectiveness of state and local cancer screening programs in preventing late-stage cancer.

DISCLOSURES:

• The study was funded by the Ohio Department of Health and the Georgia Department of Public Health.
• One researcher reported a grant from Celgene.

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

TOPLINE:

A dramatic increase in cancer diagnoses following Medicaid expansion in Ohio suggests that expanding the program improves access to cancer care.

METHODOLOGY:

• To assess the impact of Medicaid expansion on cancer diagnosis, investigators compared the volume of patients with newly diagnosed cancer in Ohio, which expanded its Medicaid coverage in 2014, with that of Georgia, which did not.
• State cancer registries were queried from 2010 to 2017 to identify adults younger than 64 years with incident female breast cancer, cervical cancer, or colorectal cancer (CRC).

TAKEAWAY:

• In Ohio, researchers found a substantial increase in diagnoses for all three cancers among Medicaid patients after expansion. The increase ranged from 42% for breast cancer to 77% for CRC.
• In Georgia, fewer Medicaid patients were diagnosed with breast cancer in the postexpansion period. There were also smaller increases in the number of patients diagnosed with cervical cancer (6%) and CRC (13%), compared with the postexpansion increases seen in Ohio.
• The risk of being diagnosed with late-stage breast cancer fell 7% among Medicaid patients in Ohio after expansion.
• The risk of being diagnosed with late-stage CRC fell 6% among Medicaid patients in George and Ohio. The Georgia results are potentially attributable to increases in state and local screening programs, especially in rural areas.

IN PRACTICE:

“These starkly different patterns in changes in the number of diagnosed [breast cancer], [cervical cancer], and CRC cases among patients on Medicaid in Ohio versus Georgia in the postexpansion period suggest that expanding insurance coverage might have effectively improved access to care,” the authors wrote.

SOURCE:

The study, led by Kirsten Eom, PhD, of the MetroHealth Population Health Research Institute, Cleveland, was published online in Cancer.

LIMITATIONS:

• Medicaid status was determined at diagnosis; past studies have associated being enrolled in Medicaid at the time of cancer diagnosis, rather than before, with late‐stage disease.
• The team could not assess the effectiveness of state and local cancer screening programs in preventing late-stage cancer.

DISCLOSURES:

• The study was funded by the Ohio Department of Health and the Georgia Department of Public Health.
• One researcher reported a grant from Celgene.

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

Neutropenia and radiological findings affected the presentation and diagnosis of pulmonary mucormycosis in adult patients, based on data from 114 individuals.

Diagnosis of pulmonary mucormycosis (PM), an invasive and potentially life-threatening fungal infection, is often delayed because of its variable presentation, wrote Anne Coste, MD, of La Cavale Blanche Hospital and Brest (France) University Hospital, and colleagues.

Improved diagnostic tools including molecular identification and image-guided lung biopsies are now available in many centers, but relations between underlying conditions, clinical presentations, and diagnostic methods have not been described, they said.

In a study published in the journal Chest, the researchers reviewed data from all cases of PM seen at six hospitals in France between 2008 and 2019. PM cases were based on European Organization for Research and Treatment of Cancer and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) criteria. Diabetes and trauma were included as additional host factors, and positive serum or tissue PCR (serum qPCR) were included as mycological evidence. Participants also underwent thoracic computed tomography (CT) scans.

The most common underlying conditions among the 114 patients were hematological malignancy (49%), allogeneic hematopoietic stem-cell transplantation (21%), and solid organ transplantation (17%).

Among the 40% of the cases that involved dissemination, the most common sites were the liver (48%), spleen (48%), brain (44%), and kidneys (37%).

A review of radiology findings showed consolidation in a majority of patients (58%), as well as pleural effusion (52%). Other findings included reversed halo sign (RHS, 26%), halo sign (24%), vascular abnormalities (26%), and cavity (23%).

Bronchoalveolar lavage (BAL) was present in 46 of 96 patients (50%), and transthoracic lung biopsy was used for diagnosis in 8 of 11 (73%) patients with previous negative BALs.

Seventy patients had neutropenia. Overall, patients with neutropenia were significantly more likely than were those without neutropenia to show an angioinvasive presentation that included both RHS and disease dissemination (P < .05).

In addition, serum qPCR was positive in 42 of 53 patients for whom data were available (79%). Serum qPCR was significantly more likely to be positive in neutropenic patients (91% vs. 62%, P = .02). Positive qPCR was associated with an early diagnosis (P = .03) and treatment onset (P = .01).

Possible reasons for the high rate of disseminated PM in the current study may be the large number of patients with pulmonary involvement, use of body CT data, and availability of autopsy results (for 11% of cases), the researchers wrote in their discussion.

Neutropenia and radiological findings influence disease presentation and contribution of diagnostic tools during PM. Serum qPCR is more contributive in neutropenic patients and BAL examination in nonneutropenic patients. Lung biopsies are highly contributive in case of non-contributive BAL.

The findings were limited by several factors including the retrospective design, the inability to calculate sensitivity and specificity of diagnostic methods, and lack of data on patients with COVID-19, the researchers noted. However, the results provide real-life information for clinicians in centers with current mycological platforms, they concluded.

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

Neutropenia and radiological findings affected the presentation and diagnosis of pulmonary mucormycosis in adult patients, based on data from 114 individuals.

Diagnosis of pulmonary mucormycosis (PM), an invasive and potentially life-threatening fungal infection, is often delayed because of its variable presentation, wrote Anne Coste, MD, of La Cavale Blanche Hospital and Brest (France) University Hospital, and colleagues.

Improved diagnostic tools including molecular identification and image-guided lung biopsies are now available in many centers, but relations between underlying conditions, clinical presentations, and diagnostic methods have not been described, they said.

In a study published in the journal Chest, the researchers reviewed data from all cases of PM seen at six hospitals in France between 2008 and 2019. PM cases were based on European Organization for Research and Treatment of Cancer and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) criteria. Diabetes and trauma were included as additional host factors, and positive serum or tissue PCR (serum qPCR) were included as mycological evidence. Participants also underwent thoracic computed tomography (CT) scans.

The most common underlying conditions among the 114 patients were hematological malignancy (49%), allogeneic hematopoietic stem-cell transplantation (21%), and solid organ transplantation (17%).

Among the 40% of the cases that involved dissemination, the most common sites were the liver (48%), spleen (48%), brain (44%), and kidneys (37%).

A review of radiology findings showed consolidation in a majority of patients (58%), as well as pleural effusion (52%). Other findings included reversed halo sign (RHS, 26%), halo sign (24%), vascular abnormalities (26%), and cavity (23%).

Bronchoalveolar lavage (BAL) was present in 46 of 96 patients (50%), and transthoracic lung biopsy was used for diagnosis in 8 of 11 (73%) patients with previous negative BALs.

Seventy patients had neutropenia. Overall, patients with neutropenia were significantly more likely than were those without neutropenia to show an angioinvasive presentation that included both RHS and disease dissemination (P < .05).

In addition, serum qPCR was positive in 42 of 53 patients for whom data were available (79%). Serum qPCR was significantly more likely to be positive in neutropenic patients (91% vs. 62%, P = .02). Positive qPCR was associated with an early diagnosis (P = .03) and treatment onset (P = .01).

Possible reasons for the high rate of disseminated PM in the current study may be the large number of patients with pulmonary involvement, use of body CT data, and availability of autopsy results (for 11% of cases), the researchers wrote in their discussion.

Neutropenia and radiological findings influence disease presentation and contribution of diagnostic tools during PM. Serum qPCR is more contributive in neutropenic patients and BAL examination in nonneutropenic patients. Lung biopsies are highly contributive in case of non-contributive BAL.

The findings were limited by several factors including the retrospective design, the inability to calculate sensitivity and specificity of diagnostic methods, and lack of data on patients with COVID-19, the researchers noted. However, the results provide real-life information for clinicians in centers with current mycological platforms, they concluded.

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

Neutropenia and radiological findings affected the presentation and diagnosis of pulmonary mucormycosis in adult patients, based on data from 114 individuals.

Diagnosis of pulmonary mucormycosis (PM), an invasive and potentially life-threatening fungal infection, is often delayed because of its variable presentation, wrote Anne Coste, MD, of La Cavale Blanche Hospital and Brest (France) University Hospital, and colleagues.

Improved diagnostic tools including molecular identification and image-guided lung biopsies are now available in many centers, but relations between underlying conditions, clinical presentations, and diagnostic methods have not been described, they said.

In a study published in the journal Chest, the researchers reviewed data from all cases of PM seen at six hospitals in France between 2008 and 2019. PM cases were based on European Organization for Research and Treatment of Cancer and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) criteria. Diabetes and trauma were included as additional host factors, and positive serum or tissue PCR (serum qPCR) were included as mycological evidence. Participants also underwent thoracic computed tomography (CT) scans.

The most common underlying conditions among the 114 patients were hematological malignancy (49%), allogeneic hematopoietic stem-cell transplantation (21%), and solid organ transplantation (17%).

Among the 40% of the cases that involved dissemination, the most common sites were the liver (48%), spleen (48%), brain (44%), and kidneys (37%).

A review of radiology findings showed consolidation in a majority of patients (58%), as well as pleural effusion (52%). Other findings included reversed halo sign (RHS, 26%), halo sign (24%), vascular abnormalities (26%), and cavity (23%).

Bronchoalveolar lavage (BAL) was present in 46 of 96 patients (50%), and transthoracic lung biopsy was used for diagnosis in 8 of 11 (73%) patients with previous negative BALs.

Seventy patients had neutropenia. Overall, patients with neutropenia were significantly more likely than were those without neutropenia to show an angioinvasive presentation that included both RHS and disease dissemination (P < .05).

In addition, serum qPCR was positive in 42 of 53 patients for whom data were available (79%). Serum qPCR was significantly more likely to be positive in neutropenic patients (91% vs. 62%, P = .02). Positive qPCR was associated with an early diagnosis (P = .03) and treatment onset (P = .01).

Possible reasons for the high rate of disseminated PM in the current study may be the large number of patients with pulmonary involvement, use of body CT data, and availability of autopsy results (for 11% of cases), the researchers wrote in their discussion.

Neutropenia and radiological findings influence disease presentation and contribution of diagnostic tools during PM. Serum qPCR is more contributive in neutropenic patients and BAL examination in nonneutropenic patients. Lung biopsies are highly contributive in case of non-contributive BAL.

The findings were limited by several factors including the retrospective design, the inability to calculate sensitivity and specificity of diagnostic methods, and lack of data on patients with COVID-19, the researchers noted. However, the results provide real-life information for clinicians in centers with current mycological platforms, they concluded.

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

A petition demanding an end to maintenance of certification (MOC) requirements from the American Board of Internal Medicine (ABIM) gained traction among oncologists in late July, garnering nearly 7,500 signatures in 10 days.

The MOC program, “originally intended to uphold the standards of medical practice and promote lifelong learning, has evolved into a complex and time-consuming process that poses significant challenges to practicing physicians,” according to the petition launched on July 21 by hematologist-oncologist Aaron Goodman, MD. The MOC “has become burdensome, costly, and lacks evidence to support its effectiveness in improving patient care or physician competence.”

Dr. Goodman, assistant professor at the University of California, San Diego, is scheduled to debate the matter with ABIM President and Chief Executive Officer Richard J. Baron, MD, during a Healthcare Unfiltered podcast recorded and hosted by Chadi Nabhan, MD. In the August 3 podcast, Dr. Goodman and Dr. Baron will respond to questions posed via tweets, Dr. Goodman said.

A Twitter survey posted by Dr. Nabhan in advance of the debate asked physicians whether the cost of the MOC, the time required for testing, or data sharing by ABIM is most bothersome. Of 158 respondents, 71% selected “all of the above.”
 

ABIM touts MOC ‘values’  

The ABIM requires an initial certification assessment that costs thousands of dollars and must be repeated every 10 years. The annual MOC requirements, which were tacked on within the last decade, involve tests that cost $220 for the first certificate a physician holds and about $120 for each subsequent one.

Over the course of his career, Dr. Goodman estimates he will spend over $40,000 to maintain his three ABIM boards in medicine, hematology, and oncology.

The ABIM did not immediately respond to a request for comment on the petition and debate, but a page on the ABIM website touts the “values of MOC” and says there is “compelling evidence” that the MOC improves the value of care without sacrificing quality and that board-certified physicians earn more.

According to the website, the MOC program “provides doctors with a pathway to know that they are staying current in the medical knowledge they use to treat patients and make important care decisions daily.” The ABIM also says that the “program has evolved to include new assessment options and an increased recognition of the work doctors do every day” and that the ABIM “continuously collaborates with doctors to increase the relevance of exams.”

Aniruddha Singh, MD, also weighed in on the value of MOC in a July 13 ABIM blog post. Dr. Singh is a member of this year’s Cardiovascular Disease Traditional, 10-Year MOC Exam Approval Committee and program director for the General Cardiovascular Fellowship at Drexel University College of Medicine, Reading, Pa.

In his post, Dr. Singh states that the MOC “facilitates a broader perspective on a range of topics [and] enables me to delve deeper into relevant areas, fostering a comprehensive understanding that enhances my quality of care.”
 

Growing resistance

Although Dr. Goodman acknowledged the merit of board testing every decade or so, physicians already do continuing medical education (CME) to keep up-to-date on their specialties. Dr. Goodman believes that most physicians, other than those who work for ABIM, would agree that MOC is a waste of time and money.

“It’s a pain-in-the-ass module that you sit at home and Google – it’s not really any sort of assessment,” nor does it help protect the public, said Goodman. The MOC is ultimately “just a money grab.”

According to the ABIM’s website, the nonprofit has net assets of more than $73.2 million as of June 30, 2022. Last year, the ABIM’s revenue hit $71.9 million, with more than half coming from MOC fees and 48% from certification.

The ABIM also says it spent $58 million in 2022. A breakdown shows about 63% of that money went to administering (28%), researching (13%), overseeing (4%), and developing (18%) the certification and MOC exams and program. ABIM’s CEO Dr. Baron makes about $1.2 million a year, according to recent tax filings. The COO makes about $550,000 from the ABIM and “related” organizations.

Fed up with the requirements and cost, Dr. Goodman decided to launch the petition to see if others agreed and how many.

His petition, addressed to the ABIM, expresses “deep dissatisfaction” with the ABIM MOC program and “respectfully request[s] that the ABIM take immediate action to eliminate the MOC program and adopt alternative, less burdensome methods of ensuring physician competence and continuous professional development.” Dr. Goodman, alongside Vinay Prasad, MD, a hematologist-oncologist and professor at the University of California, San Francisco, reiterated these points in a piece highlighting the petition.

Shortly before the petition went public but after he had been vocal on Twitter about issues with the MOC, Dr. Goodman said he received an invitation to join the ABIM Board of Governors. “My hypothesis is they are trying to ‘friend’ me, so I get credentialed, and they get me to stop yelling. It just made me more pissed off. I don’t want to be any part of that,” he said.

H. Jack West, MD, a thoracic oncologist and associate professor at City of Hope Comprehensive Cancer Center, signed the petition without hesitation.

Dr. West agreed with Dr. Goodman that the 10-year ABIM recertification is sufficient. He also denounced the ABIM testing process, costs, and content, saying he found the questions “so ambiguous that even knowing everything about the subject, I found the assignment of the ‘best’ answer to be a Talmudic interpretation.”

“The questions seem to have a sadistic level of complexity and ambiguity baked into them, rather than being a direct assessment of knowledge,” he explained.

The ABIM is also “completely opaque” about their process of developing questions and defining answers, Dr. West said. And “the ABIM offers no data to support that their processes improve any clinical outcomes.”

Yet, the MOC “forces physicians to spend several hundred dollars every year as well as an incredible amount of their time jumping through hoops at the behest of ABIM to satisfy these imposed requirements,” Dr. West said. The time spent satisfying these requirements is also “strip-mining physician morale” by taking time away from families and personal lives.

As for ABIM finances, Dr. West said the organization offers no justification for “the extortionate costs imposed by this de facto monopoly.”

The glimpses we do see, however, “indicate an organization spending on a lavish condominium and offering conspicuously generous remuneration to its own leadership. The only thing that is assured by the ABIM’s MOC program is that it is wildly profitable for the ABIM,” he added.

In a tweet, he called on physicians to take a stand: “If you think MOC is good, say it. Otherwise, if you don’t sign [the petition], ask yourself why you don’t have the courage & character to do so.”
 

Next steps?

Dr. Goodman’s petition lays out potential alternatives to the MOC that “would better support physician competence and continuing education without imposing unnecessary hurdles.”

Alternatives include encouraging voluntary, accessible, and evidence-based CME programs to promote lifelong learning among physicians, establishing a system for peer evaluation and feedback, encouraging self-assessment, and fostering a culture of continuous quality improvement.

Dr. Goodman’s goal is to garner at least 10,000 signatures and reach out to credentialing committees around the country with the results to promote alternatives to MOC. As of the morning of August 1, the petition had more than 7,900 signatures.

He also gives Dr. Baron credit for his willingness to have a conversation about the MOC and intends for that conversation to be a civil, respectful debate.

“I can’t think of anything he could say that will convince me [MOC] is the right thing to do, but we’ll see what he has to say,” Dr. Goodman said.

A version of this article appeared on Medscape.com.

A petition demanding an end to maintenance of certification (MOC) requirements from the American Board of Internal Medicine (ABIM) gained traction among oncologists in late July, garnering nearly 7,500 signatures in 10 days.

The MOC program, “originally intended to uphold the standards of medical practice and promote lifelong learning, has evolved into a complex and time-consuming process that poses significant challenges to practicing physicians,” according to the petition launched on July 21 by hematologist-oncologist Aaron Goodman, MD. The MOC “has become burdensome, costly, and lacks evidence to support its effectiveness in improving patient care or physician competence.”

Dr. Goodman, assistant professor at the University of California, San Diego, is scheduled to debate the matter with ABIM President and Chief Executive Officer Richard J. Baron, MD, during a Healthcare Unfiltered podcast recorded and hosted by Chadi Nabhan, MD. In the August 3 podcast, Dr. Goodman and Dr. Baron will respond to questions posed via tweets, Dr. Goodman said.

A Twitter survey posted by Dr. Nabhan in advance of the debate asked physicians whether the cost of the MOC, the time required for testing, or data sharing by ABIM is most bothersome. Of 158 respondents, 71% selected “all of the above.”
 

ABIM touts MOC ‘values’  

The ABIM requires an initial certification assessment that costs thousands of dollars and must be repeated every 10 years. The annual MOC requirements, which were tacked on within the last decade, involve tests that cost $220 for the first certificate a physician holds and about $120 for each subsequent one.

Over the course of his career, Dr. Goodman estimates he will spend over $40,000 to maintain his three ABIM boards in medicine, hematology, and oncology.

The ABIM did not immediately respond to a request for comment on the petition and debate, but a page on the ABIM website touts the “values of MOC” and says there is “compelling evidence” that the MOC improves the value of care without sacrificing quality and that board-certified physicians earn more.

According to the website, the MOC program “provides doctors with a pathway to know that they are staying current in the medical knowledge they use to treat patients and make important care decisions daily.” The ABIM also says that the “program has evolved to include new assessment options and an increased recognition of the work doctors do every day” and that the ABIM “continuously collaborates with doctors to increase the relevance of exams.”

Aniruddha Singh, MD, also weighed in on the value of MOC in a July 13 ABIM blog post. Dr. Singh is a member of this year’s Cardiovascular Disease Traditional, 10-Year MOC Exam Approval Committee and program director for the General Cardiovascular Fellowship at Drexel University College of Medicine, Reading, Pa.

In his post, Dr. Singh states that the MOC “facilitates a broader perspective on a range of topics [and] enables me to delve deeper into relevant areas, fostering a comprehensive understanding that enhances my quality of care.”
 

Growing resistance

Although Dr. Goodman acknowledged the merit of board testing every decade or so, physicians already do continuing medical education (CME) to keep up-to-date on their specialties. Dr. Goodman believes that most physicians, other than those who work for ABIM, would agree that MOC is a waste of time and money.

“It’s a pain-in-the-ass module that you sit at home and Google – it’s not really any sort of assessment,” nor does it help protect the public, said Goodman. The MOC is ultimately “just a money grab.”

According to the ABIM’s website, the nonprofit has net assets of more than $73.2 million as of June 30, 2022. Last year, the ABIM’s revenue hit $71.9 million, with more than half coming from MOC fees and 48% from certification.

The ABIM also says it spent $58 million in 2022. A breakdown shows about 63% of that money went to administering (28%), researching (13%), overseeing (4%), and developing (18%) the certification and MOC exams and program. ABIM’s CEO Dr. Baron makes about $1.2 million a year, according to recent tax filings. The COO makes about $550,000 from the ABIM and “related” organizations.

Fed up with the requirements and cost, Dr. Goodman decided to launch the petition to see if others agreed and how many.

His petition, addressed to the ABIM, expresses “deep dissatisfaction” with the ABIM MOC program and “respectfully request[s] that the ABIM take immediate action to eliminate the MOC program and adopt alternative, less burdensome methods of ensuring physician competence and continuous professional development.” Dr. Goodman, alongside Vinay Prasad, MD, a hematologist-oncologist and professor at the University of California, San Francisco, reiterated these points in a piece highlighting the petition.

Shortly before the petition went public but after he had been vocal on Twitter about issues with the MOC, Dr. Goodman said he received an invitation to join the ABIM Board of Governors. “My hypothesis is they are trying to ‘friend’ me, so I get credentialed, and they get me to stop yelling. It just made me more pissed off. I don’t want to be any part of that,” he said.

H. Jack West, MD, a thoracic oncologist and associate professor at City of Hope Comprehensive Cancer Center, signed the petition without hesitation.

Dr. West agreed with Dr. Goodman that the 10-year ABIM recertification is sufficient. He also denounced the ABIM testing process, costs, and content, saying he found the questions “so ambiguous that even knowing everything about the subject, I found the assignment of the ‘best’ answer to be a Talmudic interpretation.”

“The questions seem to have a sadistic level of complexity and ambiguity baked into them, rather than being a direct assessment of knowledge,” he explained.

The ABIM is also “completely opaque” about their process of developing questions and defining answers, Dr. West said. And “the ABIM offers no data to support that their processes improve any clinical outcomes.”

Yet, the MOC “forces physicians to spend several hundred dollars every year as well as an incredible amount of their time jumping through hoops at the behest of ABIM to satisfy these imposed requirements,” Dr. West said. The time spent satisfying these requirements is also “strip-mining physician morale” by taking time away from families and personal lives.

As for ABIM finances, Dr. West said the organization offers no justification for “the extortionate costs imposed by this de facto monopoly.”

The glimpses we do see, however, “indicate an organization spending on a lavish condominium and offering conspicuously generous remuneration to its own leadership. The only thing that is assured by the ABIM’s MOC program is that it is wildly profitable for the ABIM,” he added.

In a tweet, he called on physicians to take a stand: “If you think MOC is good, say it. Otherwise, if you don’t sign [the petition], ask yourself why you don’t have the courage & character to do so.”
 

Next steps?

Dr. Goodman’s petition lays out potential alternatives to the MOC that “would better support physician competence and continuing education without imposing unnecessary hurdles.”

Alternatives include encouraging voluntary, accessible, and evidence-based CME programs to promote lifelong learning among physicians, establishing a system for peer evaluation and feedback, encouraging self-assessment, and fostering a culture of continuous quality improvement.

Dr. Goodman’s goal is to garner at least 10,000 signatures and reach out to credentialing committees around the country with the results to promote alternatives to MOC. As of the morning of August 1, the petition had more than 7,900 signatures.

He also gives Dr. Baron credit for his willingness to have a conversation about the MOC and intends for that conversation to be a civil, respectful debate.

“I can’t think of anything he could say that will convince me [MOC] is the right thing to do, but we’ll see what he has to say,” Dr. Goodman said.

A version of this article appeared on Medscape.com.

A petition demanding an end to maintenance of certification (MOC) requirements from the American Board of Internal Medicine (ABIM) gained traction among oncologists in late July, garnering nearly 7,500 signatures in 10 days.

The MOC program, “originally intended to uphold the standards of medical practice and promote lifelong learning, has evolved into a complex and time-consuming process that poses significant challenges to practicing physicians,” according to the petition launched on July 21 by hematologist-oncologist Aaron Goodman, MD. The MOC “has become burdensome, costly, and lacks evidence to support its effectiveness in improving patient care or physician competence.”

Dr. Goodman, assistant professor at the University of California, San Diego, is scheduled to debate the matter with ABIM President and Chief Executive Officer Richard J. Baron, MD, during a Healthcare Unfiltered podcast recorded and hosted by Chadi Nabhan, MD. In the August 3 podcast, Dr. Goodman and Dr. Baron will respond to questions posed via tweets, Dr. Goodman said.

A Twitter survey posted by Dr. Nabhan in advance of the debate asked physicians whether the cost of the MOC, the time required for testing, or data sharing by ABIM is most bothersome. Of 158 respondents, 71% selected “all of the above.”
 

ABIM touts MOC ‘values’  

The ABIM requires an initial certification assessment that costs thousands of dollars and must be repeated every 10 years. The annual MOC requirements, which were tacked on within the last decade, involve tests that cost $220 for the first certificate a physician holds and about $120 for each subsequent one.

Over the course of his career, Dr. Goodman estimates he will spend over $40,000 to maintain his three ABIM boards in medicine, hematology, and oncology.

The ABIM did not immediately respond to a request for comment on the petition and debate, but a page on the ABIM website touts the “values of MOC” and says there is “compelling evidence” that the MOC improves the value of care without sacrificing quality and that board-certified physicians earn more.

According to the website, the MOC program “provides doctors with a pathway to know that they are staying current in the medical knowledge they use to treat patients and make important care decisions daily.” The ABIM also says that the “program has evolved to include new assessment options and an increased recognition of the work doctors do every day” and that the ABIM “continuously collaborates with doctors to increase the relevance of exams.”

Aniruddha Singh, MD, also weighed in on the value of MOC in a July 13 ABIM blog post. Dr. Singh is a member of this year’s Cardiovascular Disease Traditional, 10-Year MOC Exam Approval Committee and program director for the General Cardiovascular Fellowship at Drexel University College of Medicine, Reading, Pa.

In his post, Dr. Singh states that the MOC “facilitates a broader perspective on a range of topics [and] enables me to delve deeper into relevant areas, fostering a comprehensive understanding that enhances my quality of care.”
 

Growing resistance

Although Dr. Goodman acknowledged the merit of board testing every decade or so, physicians already do continuing medical education (CME) to keep up-to-date on their specialties. Dr. Goodman believes that most physicians, other than those who work for ABIM, would agree that MOC is a waste of time and money.

“It’s a pain-in-the-ass module that you sit at home and Google – it’s not really any sort of assessment,” nor does it help protect the public, said Goodman. The MOC is ultimately “just a money grab.”

According to the ABIM’s website, the nonprofit has net assets of more than $73.2 million as of June 30, 2022. Last year, the ABIM’s revenue hit $71.9 million, with more than half coming from MOC fees and 48% from certification.

The ABIM also says it spent $58 million in 2022. A breakdown shows about 63% of that money went to administering (28%), researching (13%), overseeing (4%), and developing (18%) the certification and MOC exams and program. ABIM’s CEO Dr. Baron makes about $1.2 million a year, according to recent tax filings. The COO makes about $550,000 from the ABIM and “related” organizations.

Fed up with the requirements and cost, Dr. Goodman decided to launch the petition to see if others agreed and how many.

His petition, addressed to the ABIM, expresses “deep dissatisfaction” with the ABIM MOC program and “respectfully request[s] that the ABIM take immediate action to eliminate the MOC program and adopt alternative, less burdensome methods of ensuring physician competence and continuous professional development.” Dr. Goodman, alongside Vinay Prasad, MD, a hematologist-oncologist and professor at the University of California, San Francisco, reiterated these points in a piece highlighting the petition.

Shortly before the petition went public but after he had been vocal on Twitter about issues with the MOC, Dr. Goodman said he received an invitation to join the ABIM Board of Governors. “My hypothesis is they are trying to ‘friend’ me, so I get credentialed, and they get me to stop yelling. It just made me more pissed off. I don’t want to be any part of that,” he said.

H. Jack West, MD, a thoracic oncologist and associate professor at City of Hope Comprehensive Cancer Center, signed the petition without hesitation.

Dr. West agreed with Dr. Goodman that the 10-year ABIM recertification is sufficient. He also denounced the ABIM testing process, costs, and content, saying he found the questions “so ambiguous that even knowing everything about the subject, I found the assignment of the ‘best’ answer to be a Talmudic interpretation.”

“The questions seem to have a sadistic level of complexity and ambiguity baked into them, rather than being a direct assessment of knowledge,” he explained.

The ABIM is also “completely opaque” about their process of developing questions and defining answers, Dr. West said. And “the ABIM offers no data to support that their processes improve any clinical outcomes.”

Yet, the MOC “forces physicians to spend several hundred dollars every year as well as an incredible amount of their time jumping through hoops at the behest of ABIM to satisfy these imposed requirements,” Dr. West said. The time spent satisfying these requirements is also “strip-mining physician morale” by taking time away from families and personal lives.

As for ABIM finances, Dr. West said the organization offers no justification for “the extortionate costs imposed by this de facto monopoly.”

The glimpses we do see, however, “indicate an organization spending on a lavish condominium and offering conspicuously generous remuneration to its own leadership. The only thing that is assured by the ABIM’s MOC program is that it is wildly profitable for the ABIM,” he added.

In a tweet, he called on physicians to take a stand: “If you think MOC is good, say it. Otherwise, if you don’t sign [the petition], ask yourself why you don’t have the courage & character to do so.”
 

Next steps?

Dr. Goodman’s petition lays out potential alternatives to the MOC that “would better support physician competence and continuing education without imposing unnecessary hurdles.”

Alternatives include encouraging voluntary, accessible, and evidence-based CME programs to promote lifelong learning among physicians, establishing a system for peer evaluation and feedback, encouraging self-assessment, and fostering a culture of continuous quality improvement.

Dr. Goodman’s goal is to garner at least 10,000 signatures and reach out to credentialing committees around the country with the results to promote alternatives to MOC. As of the morning of August 1, the petition had more than 7,900 signatures.

He also gives Dr. Baron credit for his willingness to have a conversation about the MOC and intends for that conversation to be a civil, respectful debate.

“I can’t think of anything he could say that will convince me [MOC] is the right thing to do, but we’ll see what he has to say,” Dr. Goodman said.

A version of this article appeared on Medscape.com.

The U.S. Food and Drug Administration has approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) with carboplatin and paclitaxel, followed by single-agent dostarlimab, for primary advanced or recurrent endometrial cancer that is mismatch repair–deficient (dMMR), as determined by an FDA-approved test or microsatellite instability–high (MSI-H).

The approval was based on GSK’s RUBY trial. Across 122 patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer, progression-free survival was 30.3 months in women randomly assigned to dostarlimab on a background of carboplatin and paclitaxel, followed by dostarlimab monotherapy, vs. 7.7 months among women randomly assigned to placebo (hazard ratio, 0.29; P < .0001), according to the FDA’s press release.

MMR/MSI tumor status was determined by local testing or by the Ventana MMR RxDx Panel when local testing was unavailable.

“Until now, chemotherapy alone has been the standard of care with many patients experiencing disease progression,” GSK executive Hesham Abdullah said in the company’s press release. The trial results “and today’s approval underscore our belief in the potential for Jemperli to transform cancer treatment as a backbone immuno-oncology therapy.”

Dostarlimab was already approved in the United States as monotherapy for adults with dMMR recurrent or advanced endometrial cancer that has progressed on or following a platinum-containing chemotherapy and is not a candidate for curative surgery or radiation. The latest approval means that the agent “is now indicated earlier in treatment in combination with chemotherapy,” GSK said.

Dostarlimab also carries an indication for dMMR recurrent or advanced solid tumors that have progressed on or following prior treatment when there are no satisfactory alternative treatment options.

Immune-mediated adverse reactions with dostarlimab include pneumonitis, colitis, hepatitis, endocrinopathies such as hypothyroidism, nephritis with renal dysfunction, and skin adverse reactions. The most common adverse reactions (≥ 20%) with carboplatin and paclitaxel in the Ruby trial were rash, diarrhea, hypothyroidism, and hypertension.

The recommended dostarlimab dose is 500 mg every 3 weeks for 6 doses with carboplatin and paclitaxel, followed by 1,000 mg monotherapy every 6 weeks until disease progression or unacceptable toxicity, or up to 3 years.

Drugs.com lists dostarlimab’s price at $11,712.66 for 500 mg/10 mL intravenous solution.

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

The U.S. Food and Drug Administration has approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) with carboplatin and paclitaxel, followed by single-agent dostarlimab, for primary advanced or recurrent endometrial cancer that is mismatch repair–deficient (dMMR), as determined by an FDA-approved test or microsatellite instability–high (MSI-H).

The approval was based on GSK’s RUBY trial. Across 122 patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer, progression-free survival was 30.3 months in women randomly assigned to dostarlimab on a background of carboplatin and paclitaxel, followed by dostarlimab monotherapy, vs. 7.7 months among women randomly assigned to placebo (hazard ratio, 0.29; P < .0001), according to the FDA’s press release.

MMR/MSI tumor status was determined by local testing or by the Ventana MMR RxDx Panel when local testing was unavailable.

“Until now, chemotherapy alone has been the standard of care with many patients experiencing disease progression,” GSK executive Hesham Abdullah said in the company’s press release. The trial results “and today’s approval underscore our belief in the potential for Jemperli to transform cancer treatment as a backbone immuno-oncology therapy.”

Dostarlimab was already approved in the United States as monotherapy for adults with dMMR recurrent or advanced endometrial cancer that has progressed on or following a platinum-containing chemotherapy and is not a candidate for curative surgery or radiation. The latest approval means that the agent “is now indicated earlier in treatment in combination with chemotherapy,” GSK said.

Dostarlimab also carries an indication for dMMR recurrent or advanced solid tumors that have progressed on or following prior treatment when there are no satisfactory alternative treatment options.

Immune-mediated adverse reactions with dostarlimab include pneumonitis, colitis, hepatitis, endocrinopathies such as hypothyroidism, nephritis with renal dysfunction, and skin adverse reactions. The most common adverse reactions (≥ 20%) with carboplatin and paclitaxel in the Ruby trial were rash, diarrhea, hypothyroidism, and hypertension.

The recommended dostarlimab dose is 500 mg every 3 weeks for 6 doses with carboplatin and paclitaxel, followed by 1,000 mg monotherapy every 6 weeks until disease progression or unacceptable toxicity, or up to 3 years.

Drugs.com lists dostarlimab’s price at $11,712.66 for 500 mg/10 mL intravenous solution.

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

The U.S. Food and Drug Administration has approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) with carboplatin and paclitaxel, followed by single-agent dostarlimab, for primary advanced or recurrent endometrial cancer that is mismatch repair–deficient (dMMR), as determined by an FDA-approved test or microsatellite instability–high (MSI-H).

The approval was based on GSK’s RUBY trial. Across 122 patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer, progression-free survival was 30.3 months in women randomly assigned to dostarlimab on a background of carboplatin and paclitaxel, followed by dostarlimab monotherapy, vs. 7.7 months among women randomly assigned to placebo (hazard ratio, 0.29; P < .0001), according to the FDA’s press release.

MMR/MSI tumor status was determined by local testing or by the Ventana MMR RxDx Panel when local testing was unavailable.

“Until now, chemotherapy alone has been the standard of care with many patients experiencing disease progression,” GSK executive Hesham Abdullah said in the company’s press release. The trial results “and today’s approval underscore our belief in the potential for Jemperli to transform cancer treatment as a backbone immuno-oncology therapy.”

Dostarlimab was already approved in the United States as monotherapy for adults with dMMR recurrent or advanced endometrial cancer that has progressed on or following a platinum-containing chemotherapy and is not a candidate for curative surgery or radiation. The latest approval means that the agent “is now indicated earlier in treatment in combination with chemotherapy,” GSK said.

Dostarlimab also carries an indication for dMMR recurrent or advanced solid tumors that have progressed on or following prior treatment when there are no satisfactory alternative treatment options.

Immune-mediated adverse reactions with dostarlimab include pneumonitis, colitis, hepatitis, endocrinopathies such as hypothyroidism, nephritis with renal dysfunction, and skin adverse reactions. The most common adverse reactions (≥ 20%) with carboplatin and paclitaxel in the Ruby trial were rash, diarrhea, hypothyroidism, and hypertension.

The recommended dostarlimab dose is 500 mg every 3 weeks for 6 doses with carboplatin and paclitaxel, followed by 1,000 mg monotherapy every 6 weeks until disease progression or unacceptable toxicity, or up to 3 years.

Drugs.com lists dostarlimab’s price at $11,712.66 for 500 mg/10 mL intravenous solution.

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

Women diagnosed with early-stage breast cancer are more likely to become long-term survivors of the disease now than they were 20 years ago, a new study found.

Researchers at the University of Oxford (England) conducted an observational study that examined case fatality rates for women with breast cancer and found that the prognosis for women has “improved substantially” over the past few decades. For women diagnosed with early invasive breast cancer during the 1990s, the risk of death within 5 years of diagnosis was just over 14% on average. For women diagnosed during the 2010s, it was nearly 5% on average.

“The take-home message in our study is that it’s good news for women who are diagnosed with early breast cancer today because most of them can expect to become long-term cancer survivors, and so I think our results are reassuring,” said lead study author Carolyn Taylor, DPhil, a clinical oncologist from the Nuffield Department Of Population Health, University of Oxford.

The study was published online in the BMJ.

Although breast cancer survival has improved, recent estimates don’t incorporate detailed data on age, tumor size, tumor grade, and nodal and receptor status. In the current population-based study, researchers explored improvement in survival from early-stage breast cancer. They used nine patient and tumor characteristics as factors in their analysis.

The study is based on data from the National Cancer Registration for 512,447 women in England who were diagnosed with early-stage invasive breast cancer between 1993 and 2015. Women were broken into four groups: those diagnosed during 1993-1999, 2000-2004, 2005-2009, and 2010-2015.

The study focused on women who initially underwent either breast-conserving surgery or mastectomy as their first treatment. Data included age, tumor size, tumor grade, number of positive nodes, and estrogen receptor (ER) status. For women who were diagnosed from 2010 to 2015, HER2 status was included. Data regarding recurrence, receipt of neoadjuvant therapy, and patients who were diagnosed with more than one cancer were not included.

The major finding: Among women diagnosed with early-stage invasive breast cancer, the risk of dying decreased almost threefold between 1993 and 2015. The 5-year cumulative case fatality risk was 14.4% for women diagnosed in the 1990s (1993-1999) versus 4.9% for women diagnosed about 2 decades later (2010-2015).

Dr. Taylor and colleagues found that the case fatality rate was highest during the 5 years after diagnosis; within those years, the rates typically increased during the first 2 years, peaked during the third, and declined thereafter.

The 5-year risk of death, however, varied widely among women in the population. For most (62.8%) who were diagnosed between 2010 and 2015, the case fatality risk was 3% or less; however, for a small subset of women (4.6%), the risk reached 20% or higher.

Patients with ER-negative tumors tended to have worse prognoses in the first decade following their diagnosis. Overall, higher tumor size and grade, more positive nodes, and older age tended to be associated with worse prognoses.

Overall, the annual case fatality rates decreased over time in nearly every patient group.

While Dr. Taylor said these findings are encouraging, she added that the investigators did not analyze why survival rates have improved over 2 decades.

“We didn’t explain how much of the improvement was due to advances treatments, improved screening rates, etc,” Dr. Taylor said. Another limitation is that data on recurrence were not available.

Kathy Miller, MD, who specializes in breast cancer at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis, said the 5-year mark for survival is great news for some patients with breast cancer but that the time frame doesn’t apply to all.

While the risk of case fatality from breast cancer may be higher during the first 5 years after diagnosis, Dr. Miller said that is not the case for women with ER-positive breast cancer. In the study, the researchers highlighted this trend for ER status: before the 10-year mark, survival rates for women with ER-positive disease were better, but after the 10-year mark, those with ER-negative tumors seemed to fare slightly better.

“Many patients have heard this very arbitrary 5-year mark, and for patients with ER-positive disease, that 5-year mark has no meaning, because their risk in any given year is very low and it stays at that very low consistent level for at least 15 years, probably longer,” Dr. Miller said in an interview. “I think a better way to think about this for ER-positive patients is that every day that goes by without a problem makes it a tiny bit less likely that you will ever have a problem.”

The authors took a similar view for the overall population, concluding that, “although deaths from breast cancer will continue to occur beyond this [5-year mark], the risk during each subsequent 5-year period is likely to be lower than during the first 5 years.”

The research was funded by Cancer Research UK, the National Institute for Health Research Oxford Biomedical Research Centre, the U.K. Medical Research Council, and the University of Oxford. Some study authors received support for several of these institutions, but they reported no financial relationships with organizations that might have had an interest in the submitted work during the previous 3 years.

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

Women diagnosed with early-stage breast cancer are more likely to become long-term survivors of the disease now than they were 20 years ago, a new study found.

Researchers at the University of Oxford (England) conducted an observational study that examined case fatality rates for women with breast cancer and found that the prognosis for women has “improved substantially” over the past few decades. For women diagnosed with early invasive breast cancer during the 1990s, the risk of death within 5 years of diagnosis was just over 14% on average. For women diagnosed during the 2010s, it was nearly 5% on average.

“The take-home message in our study is that it’s good news for women who are diagnosed with early breast cancer today because most of them can expect to become long-term cancer survivors, and so I think our results are reassuring,” said lead study author Carolyn Taylor, DPhil, a clinical oncologist from the Nuffield Department Of Population Health, University of Oxford.

The study was published online in the BMJ.

Although breast cancer survival has improved, recent estimates don’t incorporate detailed data on age, tumor size, tumor grade, and nodal and receptor status. In the current population-based study, researchers explored improvement in survival from early-stage breast cancer. They used nine patient and tumor characteristics as factors in their analysis.

The study is based on data from the National Cancer Registration for 512,447 women in England who were diagnosed with early-stage invasive breast cancer between 1993 and 2015. Women were broken into four groups: those diagnosed during 1993-1999, 2000-2004, 2005-2009, and 2010-2015.

The study focused on women who initially underwent either breast-conserving surgery or mastectomy as their first treatment. Data included age, tumor size, tumor grade, number of positive nodes, and estrogen receptor (ER) status. For women who were diagnosed from 2010 to 2015, HER2 status was included. Data regarding recurrence, receipt of neoadjuvant therapy, and patients who were diagnosed with more than one cancer were not included.

The major finding: Among women diagnosed with early-stage invasive breast cancer, the risk of dying decreased almost threefold between 1993 and 2015. The 5-year cumulative case fatality risk was 14.4% for women diagnosed in the 1990s (1993-1999) versus 4.9% for women diagnosed about 2 decades later (2010-2015).

Dr. Taylor and colleagues found that the case fatality rate was highest during the 5 years after diagnosis; within those years, the rates typically increased during the first 2 years, peaked during the third, and declined thereafter.

The 5-year risk of death, however, varied widely among women in the population. For most (62.8%) who were diagnosed between 2010 and 2015, the case fatality risk was 3% or less; however, for a small subset of women (4.6%), the risk reached 20% or higher.

Patients with ER-negative tumors tended to have worse prognoses in the first decade following their diagnosis. Overall, higher tumor size and grade, more positive nodes, and older age tended to be associated with worse prognoses.

Overall, the annual case fatality rates decreased over time in nearly every patient group.

While Dr. Taylor said these findings are encouraging, she added that the investigators did not analyze why survival rates have improved over 2 decades.

“We didn’t explain how much of the improvement was due to advances treatments, improved screening rates, etc,” Dr. Taylor said. Another limitation is that data on recurrence were not available.

Kathy Miller, MD, who specializes in breast cancer at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis, said the 5-year mark for survival is great news for some patients with breast cancer but that the time frame doesn’t apply to all.

While the risk of case fatality from breast cancer may be higher during the first 5 years after diagnosis, Dr. Miller said that is not the case for women with ER-positive breast cancer. In the study, the researchers highlighted this trend for ER status: before the 10-year mark, survival rates for women with ER-positive disease were better, but after the 10-year mark, those with ER-negative tumors seemed to fare slightly better.

“Many patients have heard this very arbitrary 5-year mark, and for patients with ER-positive disease, that 5-year mark has no meaning, because their risk in any given year is very low and it stays at that very low consistent level for at least 15 years, probably longer,” Dr. Miller said in an interview. “I think a better way to think about this for ER-positive patients is that every day that goes by without a problem makes it a tiny bit less likely that you will ever have a problem.”

The authors took a similar view for the overall population, concluding that, “although deaths from breast cancer will continue to occur beyond this [5-year mark], the risk during each subsequent 5-year period is likely to be lower than during the first 5 years.”

The research was funded by Cancer Research UK, the National Institute for Health Research Oxford Biomedical Research Centre, the U.K. Medical Research Council, and the University of Oxford. Some study authors received support for several of these institutions, but they reported no financial relationships with organizations that might have had an interest in the submitted work during the previous 3 years.

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

Women diagnosed with early-stage breast cancer are more likely to become long-term survivors of the disease now than they were 20 years ago, a new study found.

Researchers at the University of Oxford (England) conducted an observational study that examined case fatality rates for women with breast cancer and found that the prognosis for women has “improved substantially” over the past few decades. For women diagnosed with early invasive breast cancer during the 1990s, the risk of death within 5 years of diagnosis was just over 14% on average. For women diagnosed during the 2010s, it was nearly 5% on average.

“The take-home message in our study is that it’s good news for women who are diagnosed with early breast cancer today because most of them can expect to become long-term cancer survivors, and so I think our results are reassuring,” said lead study author Carolyn Taylor, DPhil, a clinical oncologist from the Nuffield Department Of Population Health, University of Oxford.

The study was published online in the BMJ.

Although breast cancer survival has improved, recent estimates don’t incorporate detailed data on age, tumor size, tumor grade, and nodal and receptor status. In the current population-based study, researchers explored improvement in survival from early-stage breast cancer. They used nine patient and tumor characteristics as factors in their analysis.

The study is based on data from the National Cancer Registration for 512,447 women in England who were diagnosed with early-stage invasive breast cancer between 1993 and 2015. Women were broken into four groups: those diagnosed during 1993-1999, 2000-2004, 2005-2009, and 2010-2015.

The study focused on women who initially underwent either breast-conserving surgery or mastectomy as their first treatment. Data included age, tumor size, tumor grade, number of positive nodes, and estrogen receptor (ER) status. For women who were diagnosed from 2010 to 2015, HER2 status was included. Data regarding recurrence, receipt of neoadjuvant therapy, and patients who were diagnosed with more than one cancer were not included.

The major finding: Among women diagnosed with early-stage invasive breast cancer, the risk of dying decreased almost threefold between 1993 and 2015. The 5-year cumulative case fatality risk was 14.4% for women diagnosed in the 1990s (1993-1999) versus 4.9% for women diagnosed about 2 decades later (2010-2015).

Dr. Taylor and colleagues found that the case fatality rate was highest during the 5 years after diagnosis; within those years, the rates typically increased during the first 2 years, peaked during the third, and declined thereafter.

The 5-year risk of death, however, varied widely among women in the population. For most (62.8%) who were diagnosed between 2010 and 2015, the case fatality risk was 3% or less; however, for a small subset of women (4.6%), the risk reached 20% or higher.

Patients with ER-negative tumors tended to have worse prognoses in the first decade following their diagnosis. Overall, higher tumor size and grade, more positive nodes, and older age tended to be associated with worse prognoses.

Overall, the annual case fatality rates decreased over time in nearly every patient group.

While Dr. Taylor said these findings are encouraging, she added that the investigators did not analyze why survival rates have improved over 2 decades.

“We didn’t explain how much of the improvement was due to advances treatments, improved screening rates, etc,” Dr. Taylor said. Another limitation is that data on recurrence were not available.

Kathy Miller, MD, who specializes in breast cancer at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis, said the 5-year mark for survival is great news for some patients with breast cancer but that the time frame doesn’t apply to all.

While the risk of case fatality from breast cancer may be higher during the first 5 years after diagnosis, Dr. Miller said that is not the case for women with ER-positive breast cancer. In the study, the researchers highlighted this trend for ER status: before the 10-year mark, survival rates for women with ER-positive disease were better, but after the 10-year mark, those with ER-negative tumors seemed to fare slightly better.

“Many patients have heard this very arbitrary 5-year mark, and for patients with ER-positive disease, that 5-year mark has no meaning, because their risk in any given year is very low and it stays at that very low consistent level for at least 15 years, probably longer,” Dr. Miller said in an interview. “I think a better way to think about this for ER-positive patients is that every day that goes by without a problem makes it a tiny bit less likely that you will ever have a problem.”

The authors took a similar view for the overall population, concluding that, “although deaths from breast cancer will continue to occur beyond this [5-year mark], the risk during each subsequent 5-year period is likely to be lower than during the first 5 years.”

The research was funded by Cancer Research UK, the National Institute for Health Research Oxford Biomedical Research Centre, the U.K. Medical Research Council, and the University of Oxford. Some study authors received support for several of these institutions, but they reported no financial relationships with organizations that might have had an interest in the submitted work during the previous 3 years.

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

The U.S. Food and Drug Administration today cleared an artificial intelligence (AI)-assisted colonoscopy device called the MAGENTIQ-COLO, according to the Israeli-based manufacturer of the same name.

The device helps identify lesions in real time and is associated with a significant increase in the adenoma detection rate (ADR), according to the press release.

The device was cleared under the FDA’s 510(k) process, and follows the European CE Mark and Israel AMAR approval, which were received in mid-2021. It will be available in the United States in the coming weeks.

In a study performed in 2022 with 29 endoscopy experts and more than 950 patients, the device was validated as “one of the best-performing AI solutions in the category, increasing ADR by 26% relatively (7% in absolute values), which translated into a 21% decrease in colorectal cancer occurrence and a 35% decrease in patient mortality,” according to the press release.

In this multicenter, randomized, controlled trial conducted at 10 hospitals in Europe, the United States, and Israel, and presented at United European Gastroenterology Week 2022, the authors noted that “apart from diminutive lesions, [MAGENTIQ-COLO] increased the detection of 6- to 9-mm adenomas, suggesting that this novel [computer-aided polyp detection] system is also able to detect more clinically relevant lesions.”

The device “takes the video out of the colonoscopy device, breaks it into frames, and analyzes them in real time with its AI engine to detect polyps in them,” Dror Zur, founder and CEO of MAGENTIQ-EYE, explained in an interview. “If a polyp is detected, then MAGENTIQ-COLO signs it with a bounding box on the video’s overlay and sends it as a video with an overlay to the display monitor so the doctor can look at it and find more polyps.”

As previously reported by this news organization, research has shown that conventional colonoscopies miss about a quarter of adenomas. Many AI systems have recently come on the market, promising to improve detection by overcoming human error in detecting polyps.

Colonoscopy has become standard in most developed countries, with 15-20 million procedures performed every year in the United States alone; however, high missed rates and undetected adenomas during the procedures mean that even patients who get regular, recommended screenings are still at risk of developing colon cancer, notes the press release.

“A missed polyp can lead to interval cancer, which accounts for approximately 8%-10% of all CRC in the U.S., translated to over 13,500 cancer cases that could be prevented every year with better detection,” the press release also states.

According to the National Institutes of Health, colorectal cancer is the third leading cause of cancer-related death in the United States.

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

The U.S. Food and Drug Administration today cleared an artificial intelligence (AI)-assisted colonoscopy device called the MAGENTIQ-COLO, according to the Israeli-based manufacturer of the same name.

The device helps identify lesions in real time and is associated with a significant increase in the adenoma detection rate (ADR), according to the press release.

The device was cleared under the FDA’s 510(k) process, and follows the European CE Mark and Israel AMAR approval, which were received in mid-2021. It will be available in the United States in the coming weeks.

In a study performed in 2022 with 29 endoscopy experts and more than 950 patients, the device was validated as “one of the best-performing AI solutions in the category, increasing ADR by 26% relatively (7% in absolute values), which translated into a 21% decrease in colorectal cancer occurrence and a 35% decrease in patient mortality,” according to the press release.

In this multicenter, randomized, controlled trial conducted at 10 hospitals in Europe, the United States, and Israel, and presented at United European Gastroenterology Week 2022, the authors noted that “apart from diminutive lesions, [MAGENTIQ-COLO] increased the detection of 6- to 9-mm adenomas, suggesting that this novel [computer-aided polyp detection] system is also able to detect more clinically relevant lesions.”

The device “takes the video out of the colonoscopy device, breaks it into frames, and analyzes them in real time with its AI engine to detect polyps in them,” Dror Zur, founder and CEO of MAGENTIQ-EYE, explained in an interview. “If a polyp is detected, then MAGENTIQ-COLO signs it with a bounding box on the video’s overlay and sends it as a video with an overlay to the display monitor so the doctor can look at it and find more polyps.”

As previously reported by this news organization, research has shown that conventional colonoscopies miss about a quarter of adenomas. Many AI systems have recently come on the market, promising to improve detection by overcoming human error in detecting polyps.

Colonoscopy has become standard in most developed countries, with 15-20 million procedures performed every year in the United States alone; however, high missed rates and undetected adenomas during the procedures mean that even patients who get regular, recommended screenings are still at risk of developing colon cancer, notes the press release.

“A missed polyp can lead to interval cancer, which accounts for approximately 8%-10% of all CRC in the U.S., translated to over 13,500 cancer cases that could be prevented every year with better detection,” the press release also states.

According to the National Institutes of Health, colorectal cancer is the third leading cause of cancer-related death in the United States.

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

The U.S. Food and Drug Administration today cleared an artificial intelligence (AI)-assisted colonoscopy device called the MAGENTIQ-COLO, according to the Israeli-based manufacturer of the same name.

The device helps identify lesions in real time and is associated with a significant increase in the adenoma detection rate (ADR), according to the press release.

The device was cleared under the FDA’s 510(k) process, and follows the European CE Mark and Israel AMAR approval, which were received in mid-2021. It will be available in the United States in the coming weeks.

In a study performed in 2022 with 29 endoscopy experts and more than 950 patients, the device was validated as “one of the best-performing AI solutions in the category, increasing ADR by 26% relatively (7% in absolute values), which translated into a 21% decrease in colorectal cancer occurrence and a 35% decrease in patient mortality,” according to the press release.

In this multicenter, randomized, controlled trial conducted at 10 hospitals in Europe, the United States, and Israel, and presented at United European Gastroenterology Week 2022, the authors noted that “apart from diminutive lesions, [MAGENTIQ-COLO] increased the detection of 6- to 9-mm adenomas, suggesting that this novel [computer-aided polyp detection] system is also able to detect more clinically relevant lesions.”

The device “takes the video out of the colonoscopy device, breaks it into frames, and analyzes them in real time with its AI engine to detect polyps in them,” Dror Zur, founder and CEO of MAGENTIQ-EYE, explained in an interview. “If a polyp is detected, then MAGENTIQ-COLO signs it with a bounding box on the video’s overlay and sends it as a video with an overlay to the display monitor so the doctor can look at it and find more polyps.”

As previously reported by this news organization, research has shown that conventional colonoscopies miss about a quarter of adenomas. Many AI systems have recently come on the market, promising to improve detection by overcoming human error in detecting polyps.

Colonoscopy has become standard in most developed countries, with 15-20 million procedures performed every year in the United States alone; however, high missed rates and undetected adenomas during the procedures mean that even patients who get regular, recommended screenings are still at risk of developing colon cancer, notes the press release.

“A missed polyp can lead to interval cancer, which accounts for approximately 8%-10% of all CRC in the U.S., translated to over 13,500 cancer cases that could be prevented every year with better detection,” the press release also states.

According to the National Institutes of Health, colorectal cancer is the third leading cause of cancer-related death in the United States.

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