Breast Cancer

Women who continued breast cancer screenings when they reached age 70 had no lower chance of dying from the disease, and just getting a mammogram could instead set them on a path toward unnecessary risks, according to a new study from Yale University.

The findings, published in Annals of Internal Medicine, suggest that between 31% and 54% of all breast cancer diagnoses in women aged 70 years and older could be considered overdiagnoses, meaning that the cancer found during the screening would not have caused symptoms in a person’s lifetime. (For context, the average life expectancy of a woman in the U.S. is 79 years, according to the Centers for Disease Control and Prevention.) 

Overdiagnosis can be harmful because it carries the risks of complications from overtreatment, plus financial and emotional hardships and unnecessary use of limited resources.

For the study, researchers analyzed data for 54,635 women aged 70 and older and compared the rate of breast cancer diagnosis and death among women who did and did not have mammograms during a 15-year follow-up period. 

The rate of breast cancer in the study among women aged 70-74 was 6% for women who were screened and 4% for women who were not screened. The researchers estimated that 31% of the cases were potentially overdiagnosed. Among women aged 75-84, breast cancer was found in 5% of women who were screened, compared to less than 3% of unscreened women. Their estimated overdiagnosis rate was 47%. Finally, 3% of women aged 85 and older who were screened had breast cancer detected, compared with 1% of women in the unscreened group. For the older group, the overdiagnosis rate was 54%.

Yale University

“While our study focused on overdiagnosis, it is important to acknowledge that overdiagnosis is just one of many considerations when deciding whether to continue screening,” researcher and Yale assistant professor of medicine Ilana Richman, MD, said in a statement. “A patient’s preferences and values, personal risk factors, and the overall balance of risks and benefits from screening are also important to take into account when making screening decisions.”

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

Women who continued breast cancer screenings when they reached age 70 had no lower chance of dying from the disease, and just getting a mammogram could instead set them on a path toward unnecessary risks, according to a new study from Yale University.

The findings, published in Annals of Internal Medicine, suggest that between 31% and 54% of all breast cancer diagnoses in women aged 70 years and older could be considered overdiagnoses, meaning that the cancer found during the screening would not have caused symptoms in a person’s lifetime. (For context, the average life expectancy of a woman in the U.S. is 79 years, according to the Centers for Disease Control and Prevention.) 

Overdiagnosis can be harmful because it carries the risks of complications from overtreatment, plus financial and emotional hardships and unnecessary use of limited resources.

For the study, researchers analyzed data for 54,635 women aged 70 and older and compared the rate of breast cancer diagnosis and death among women who did and did not have mammograms during a 15-year follow-up period. 

The rate of breast cancer in the study among women aged 70-74 was 6% for women who were screened and 4% for women who were not screened. The researchers estimated that 31% of the cases were potentially overdiagnosed. Among women aged 75-84, breast cancer was found in 5% of women who were screened, compared to less than 3% of unscreened women. Their estimated overdiagnosis rate was 47%. Finally, 3% of women aged 85 and older who were screened had breast cancer detected, compared with 1% of women in the unscreened group. For the older group, the overdiagnosis rate was 54%.

Yale University

“While our study focused on overdiagnosis, it is important to acknowledge that overdiagnosis is just one of many considerations when deciding whether to continue screening,” researcher and Yale assistant professor of medicine Ilana Richman, MD, said in a statement. “A patient’s preferences and values, personal risk factors, and the overall balance of risks and benefits from screening are also important to take into account when making screening decisions.”

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

Women who continued breast cancer screenings when they reached age 70 had no lower chance of dying from the disease, and just getting a mammogram could instead set them on a path toward unnecessary risks, according to a new study from Yale University.

The findings, published in Annals of Internal Medicine, suggest that between 31% and 54% of all breast cancer diagnoses in women aged 70 years and older could be considered overdiagnoses, meaning that the cancer found during the screening would not have caused symptoms in a person’s lifetime. (For context, the average life expectancy of a woman in the U.S. is 79 years, according to the Centers for Disease Control and Prevention.) 

Overdiagnosis can be harmful because it carries the risks of complications from overtreatment, plus financial and emotional hardships and unnecessary use of limited resources.

For the study, researchers analyzed data for 54,635 women aged 70 and older and compared the rate of breast cancer diagnosis and death among women who did and did not have mammograms during a 15-year follow-up period. 

The rate of breast cancer in the study among women aged 70-74 was 6% for women who were screened and 4% for women who were not screened. The researchers estimated that 31% of the cases were potentially overdiagnosed. Among women aged 75-84, breast cancer was found in 5% of women who were screened, compared to less than 3% of unscreened women. Their estimated overdiagnosis rate was 47%. Finally, 3% of women aged 85 and older who were screened had breast cancer detected, compared with 1% of women in the unscreened group. For the older group, the overdiagnosis rate was 54%.

Yale University

“While our study focused on overdiagnosis, it is important to acknowledge that overdiagnosis is just one of many considerations when deciding whether to continue screening,” researcher and Yale assistant professor of medicine Ilana Richman, MD, said in a statement. “A patient’s preferences and values, personal risk factors, and the overall balance of risks and benefits from screening are also important to take into account when making screening decisions.”

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

TOPLINE:

Most women with breast cancer who received scalp cooling did not perceive benefits in preventing hair loss, overall quality of life, body image, and other outcomes, compared with those who opted to forgo scalp cooling.

METHODOLOGY:

• Although studies have demonstrated the effectiveness of scalp cooling to reduce hair loss during breast cancer chemotherapy, most were in the setting of single-agent regimens instead of much more commonly used combined chemotherapy, and few studies assessed patients’ subjective experience.
• To get a real-world sense of the treatment, investigators compared outcomes in 75 women who opted to use the Orbis Paxman cooling cap during taxane/anthracycline-based chemotherapy sessions with 38 women with breast cancer patients who declined to use the cooling cap.
• The women were surveyed for hair loss perception, functional health, and body image at baseline, midchemotherapy, and at their last chemotherapy cycle, as well as at 3 months and 6-9 months following chemotherapy.
• The women were treated at the Medical University of Innsbruck, Austria, for various stages of breast cancer; about half were premenopausal.

TAKEAWAY:

• There was no significant difference between the scalp-cooling and control groups in patient-reported hair loss (P = .831), overall quality of life (P = .627), emotional functioning (P = .737), social functioning (P = .635), and body image (P = .463).
• On average, women stayed on treatment with the cooling cap for about 40% of the duration of their chemotherapy.
• Overall, 53 of 75 women (70.7%) stopped scalp cooling early, with most (73.9%) citing alopecia as the primary reason; only 30% completed treatment.

IN PRACTICE:

“The efficacy and tolerability of [scalp cooling] applied in a clinical routine setting ... appeared to be limited,” the authors concluded. “The further determination and up-front definition of criteria prognostic for effectiveness of [scalp cooling] may be helpful to identify patient subgroups that may experience a treatment benefit.”

SOURCE:

The work, led by Christine Brunner, Medical University of Innsbruck, Austria, was published in Breast Cancer: Targets and Therapy.

LIMITATIONS:

• Shorter intervals between surveys might have given a more granular understanding of patients’ experiences with scalp cooling.
• There were no biomarker assessments to help identify patients more likely to benefit.

DISCLOSURES:

The work was supported by the Medical University of Innsbruck. Dr. Brunner disclosed a grant from Paxman UK, maker of the cooling cap used in the study. Another investigator disclosed personal fees from AstraZeneca, Daiichi Sankyo, Gilead, Lilly, Novartis, and Sirius.

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

TOPLINE:

Most women with breast cancer who received scalp cooling did not perceive benefits in preventing hair loss, overall quality of life, body image, and other outcomes, compared with those who opted to forgo scalp cooling.

METHODOLOGY:

• Although studies have demonstrated the effectiveness of scalp cooling to reduce hair loss during breast cancer chemotherapy, most were in the setting of single-agent regimens instead of much more commonly used combined chemotherapy, and few studies assessed patients’ subjective experience.
• To get a real-world sense of the treatment, investigators compared outcomes in 75 women who opted to use the Orbis Paxman cooling cap during taxane/anthracycline-based chemotherapy sessions with 38 women with breast cancer patients who declined to use the cooling cap.
• The women were surveyed for hair loss perception, functional health, and body image at baseline, midchemotherapy, and at their last chemotherapy cycle, as well as at 3 months and 6-9 months following chemotherapy.
• The women were treated at the Medical University of Innsbruck, Austria, for various stages of breast cancer; about half were premenopausal.

TAKEAWAY:

• There was no significant difference between the scalp-cooling and control groups in patient-reported hair loss (P = .831), overall quality of life (P = .627), emotional functioning (P = .737), social functioning (P = .635), and body image (P = .463).
• On average, women stayed on treatment with the cooling cap for about 40% of the duration of their chemotherapy.
• Overall, 53 of 75 women (70.7%) stopped scalp cooling early, with most (73.9%) citing alopecia as the primary reason; only 30% completed treatment.

IN PRACTICE:

“The efficacy and tolerability of [scalp cooling] applied in a clinical routine setting ... appeared to be limited,” the authors concluded. “The further determination and up-front definition of criteria prognostic for effectiveness of [scalp cooling] may be helpful to identify patient subgroups that may experience a treatment benefit.”

SOURCE:

The work, led by Christine Brunner, Medical University of Innsbruck, Austria, was published in Breast Cancer: Targets and Therapy.

LIMITATIONS:

• Shorter intervals between surveys might have given a more granular understanding of patients’ experiences with scalp cooling.
• There were no biomarker assessments to help identify patients more likely to benefit.

DISCLOSURES:

The work was supported by the Medical University of Innsbruck. Dr. Brunner disclosed a grant from Paxman UK, maker of the cooling cap used in the study. Another investigator disclosed personal fees from AstraZeneca, Daiichi Sankyo, Gilead, Lilly, Novartis, and Sirius.

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

TOPLINE:

Most women with breast cancer who received scalp cooling did not perceive benefits in preventing hair loss, overall quality of life, body image, and other outcomes, compared with those who opted to forgo scalp cooling.

METHODOLOGY:

• Although studies have demonstrated the effectiveness of scalp cooling to reduce hair loss during breast cancer chemotherapy, most were in the setting of single-agent regimens instead of much more commonly used combined chemotherapy, and few studies assessed patients’ subjective experience.
• To get a real-world sense of the treatment, investigators compared outcomes in 75 women who opted to use the Orbis Paxman cooling cap during taxane/anthracycline-based chemotherapy sessions with 38 women with breast cancer patients who declined to use the cooling cap.
• The women were surveyed for hair loss perception, functional health, and body image at baseline, midchemotherapy, and at their last chemotherapy cycle, as well as at 3 months and 6-9 months following chemotherapy.
• The women were treated at the Medical University of Innsbruck, Austria, for various stages of breast cancer; about half were premenopausal.

TAKEAWAY:

• There was no significant difference between the scalp-cooling and control groups in patient-reported hair loss (P = .831), overall quality of life (P = .627), emotional functioning (P = .737), social functioning (P = .635), and body image (P = .463).
• On average, women stayed on treatment with the cooling cap for about 40% of the duration of their chemotherapy.
• Overall, 53 of 75 women (70.7%) stopped scalp cooling early, with most (73.9%) citing alopecia as the primary reason; only 30% completed treatment.

IN PRACTICE:

“The efficacy and tolerability of [scalp cooling] applied in a clinical routine setting ... appeared to be limited,” the authors concluded. “The further determination and up-front definition of criteria prognostic for effectiveness of [scalp cooling] may be helpful to identify patient subgroups that may experience a treatment benefit.”

SOURCE:

The work, led by Christine Brunner, Medical University of Innsbruck, Austria, was published in Breast Cancer: Targets and Therapy.

LIMITATIONS:

• Shorter intervals between surveys might have given a more granular understanding of patients’ experiences with scalp cooling.
• There were no biomarker assessments to help identify patients more likely to benefit.

DISCLOSURES:

The work was supported by the Medical University of Innsbruck. Dr. Brunner disclosed a grant from Paxman UK, maker of the cooling cap used in the study. Another investigator disclosed personal fees from AstraZeneca, Daiichi Sankyo, Gilead, Lilly, Novartis, and Sirius.

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

Treatment options for patients with cancer that is detected at a late stage are severely limited, which usually leads to an unfavorable prognosis for such patients. Indeed, the options available for patients with metastatic solid cancers are scarcely curative. Therefore, early diagnosis of neoplasia remains a fundamental mainstay for improving outcomes for cancer patients.

Histopathology is the current gold standard for cancer diagnosis. Biopsy is an invasive procedure that provides physicians with further samples to test but that furnishes limited information concerning tumor heterogeneity. Biopsy specimens are usually obtained only when there is clinical evidence of neoplasia, which significantly limits their usefulness in early diagnosis.

Around 20 years ago, it was discovered that the presence of circulating tumor cells (CTC) in patients with metastatic breast cancer who were about to begin a new line of treatment was predictive of overall and progression-free survival. The prognostic value of CTC was independent of the line of treatment (first or second) and was greater than that of the site of metastasis, the type of therapy, and the time to metastasis after complete primary resection. These results support the idea that the presence of CTC could be used to modify the system for staging advanced disease.

Since then, research into liquid biopsy assays has expanded rapidly, and many biomarkers have been studied in various body fluids for their usefulness in assessing solid tumors.
 

Liquid vs. tissue

Liquid biopsy is a minimally invasive tool that is easy to use. It is employed to detect cancer, to assess treatment response, or to monitor disease progression. Liquid biopsy produces test material from primary and metastatic (or micrometastatic) sites and provides a more heterogeneous picture of the entire tumor cell population, compared with specimens obtained with tissue biopsy.

Metastasis

The notion that metastatic lesions are formed from cancer cells that have disseminated from advanced primary tumors has been substantially revised following the identification of disseminated tumor cells (DTC) in the bone marrow of patients with early-stage disease. These results have led researchers to no longer view cancer metastasis as a linear cascade of events but rather as a series of concurrent, partially overlapping processes, as metastasizing cells assume new phenotypes while abandoning older behaviors.

The initiation of metastasis is not simply a cell-autonomous event but is heavily influenced by complex tissue microenvironments. Although colonization of distant tissues by DTC is an extremely inefficient process, at times, relatively numerous CTC can be detected in the blood of cancer patients (> 1,000 CTC/mL of blood plasma), whereas the number of clinically detectable metastases is disproportionately low, confirming that tumor cell diffusion can happen at an early stage but usually occurs later on.
 

Early dissemination

Little is currently known about the preference of cancer subtypes for distinct tissues or about the receptiveness of a tissue as a metastatic site. What endures as one of the most confounding clinical phenomena is that patients may undergo tumor resection and remain apparently disease free for months, years, and even decades, only to experience relapse and be diagnosed with late-stage metastatic disease. This course may be a result of cell seeding from minimal residual disease after resection of the primary tumor or of preexisting clinically undetectable micrometastases. It may also arise from early disseminated cells that remain dormant and resistant to therapy until they suddenly reawaken to initiate proliferation into clinically detectable macrometastases.

Dormant DTC could be the main reason for delayed detection of metastases. It is thought that around 40% of patients with prostate cancer who undergo radical prostatectomy present with biochemical recurrence, suggesting that it is likely that hidden DTC or micrometastases are present at the time of the procedure. The finding is consistent with the detection of DTC many years after tumor resection, suggesting they were released before surgical treatment. Nevertheless, research into tumor cell dormancy is limited, owing to the invasive and technically challenging nature of obtaining DTC samples, which are predominantly taken from the bone marrow.
 

CTC metastases

Cancer cells can undergo epithelial-to-mesenchymal transition to facilitate their detachment from the primary tumor and intravasation into the blood circulation (step 1). Dissemination of cancer cells from the primary tumor into circulation can involve either single cells or cell clusters containing multiple CTC as well as immune cells and platelets, known as microemboli. CTC that can survive in circulation (step 2) can exit the bloodstream (step 3) and establish metastatic tumors (step 4), or they can enter dormancy and reside in distant organs, such as the bone marrow.

Use in practice

CTC were discovered over a century ago, but only in recent years has technology been sufficiently advanced to study CTC and to assess their usefulness as biomarkers. Recent evidence suggests that not only do the number of CTC increase during sleep and rest phases but also that these CTC are better able to metastasize, compared to those generated during periods of wakefulness or activity.

CTC clusters (microemboli) are defined as groups of two or more CTC. They can consist of CTC alone (homotypic) or can include various stromal cells, such as cancer-associated fibroblasts or platelets and immune cells (heterotypic). CTC clusters (with or without leukocytes) seem to have greater metastatic capacity, compared with individual CTC.

A multitude of characteristics can be measured in CTC, including genetics and epigenetics, as well as protein levels, which might help in understanding many processes involved in the formation of metastases.

Quantitative assessment of CTC could indicate tumor burden in patients with aggressive cancers, as has been seen in patients with primary lung cancer.
 

Early cancer diagnosis

Early research into CTC didn’t explore their usefulness in diagnosing early-stage tumors because it was thought that CTC were characteristic of advanced-stage disease. This hypothesis was later rejected following evidence of local intravascular invasion of very early cancer cells, even over a period of several hours. This feature may allow CTC to be detected before the clinical diagnosis of cancer.

CTC have been detected in various neoplastic conditions: in breast cancer, seen in 20% of patients with stage I disease, in 26.8% with stage II disease, and 26.7% with stage III disease; in nonmetastatic colorectal cancer, including stage I and II disease; and in prostate cancer, seen in over 50% of patients with localized disease.

The presence of CTC has been proven to be an unfavorable prognostic predictor of overall survival among patients with early-stage non–small cell lung cancer. It distinguishes patients with pancreatic ductal adenocarcinoma from those with noncancerous pancreatic diseases with a sensitivity of 75% and a specificity of 96.3%.

CTC positivity scoring (appropriately defined), combined with serum prostate-specific antigen level, was predictive of a biopsy diagnosis of clinically significant prostate cancer.

All these data support the utility of CTC in early cancer diagnosis. Their link with metastases, and thus with aggressive tumors, gives them an advantage over other (noninvasive or minimally invasive) biomarkers in the early identification of invasive tumors for therapeutic intervention with better cure rates.
 

This article was translated from Univadis Italy. A version appeared on Medscape.com.

Treatment options for patients with cancer that is detected at a late stage are severely limited, which usually leads to an unfavorable prognosis for such patients. Indeed, the options available for patients with metastatic solid cancers are scarcely curative. Therefore, early diagnosis of neoplasia remains a fundamental mainstay for improving outcomes for cancer patients.

Histopathology is the current gold standard for cancer diagnosis. Biopsy is an invasive procedure that provides physicians with further samples to test but that furnishes limited information concerning tumor heterogeneity. Biopsy specimens are usually obtained only when there is clinical evidence of neoplasia, which significantly limits their usefulness in early diagnosis.

Around 20 years ago, it was discovered that the presence of circulating tumor cells (CTC) in patients with metastatic breast cancer who were about to begin a new line of treatment was predictive of overall and progression-free survival. The prognostic value of CTC was independent of the line of treatment (first or second) and was greater than that of the site of metastasis, the type of therapy, and the time to metastasis after complete primary resection. These results support the idea that the presence of CTC could be used to modify the system for staging advanced disease.

Since then, research into liquid biopsy assays has expanded rapidly, and many biomarkers have been studied in various body fluids for their usefulness in assessing solid tumors.
 

Liquid vs. tissue

Liquid biopsy is a minimally invasive tool that is easy to use. It is employed to detect cancer, to assess treatment response, or to monitor disease progression. Liquid biopsy produces test material from primary and metastatic (or micrometastatic) sites and provides a more heterogeneous picture of the entire tumor cell population, compared with specimens obtained with tissue biopsy.

Metastasis

The notion that metastatic lesions are formed from cancer cells that have disseminated from advanced primary tumors has been substantially revised following the identification of disseminated tumor cells (DTC) in the bone marrow of patients with early-stage disease. These results have led researchers to no longer view cancer metastasis as a linear cascade of events but rather as a series of concurrent, partially overlapping processes, as metastasizing cells assume new phenotypes while abandoning older behaviors.

The initiation of metastasis is not simply a cell-autonomous event but is heavily influenced by complex tissue microenvironments. Although colonization of distant tissues by DTC is an extremely inefficient process, at times, relatively numerous CTC can be detected in the blood of cancer patients (> 1,000 CTC/mL of blood plasma), whereas the number of clinically detectable metastases is disproportionately low, confirming that tumor cell diffusion can happen at an early stage but usually occurs later on.
 

Early dissemination

Little is currently known about the preference of cancer subtypes for distinct tissues or about the receptiveness of a tissue as a metastatic site. What endures as one of the most confounding clinical phenomena is that patients may undergo tumor resection and remain apparently disease free for months, years, and even decades, only to experience relapse and be diagnosed with late-stage metastatic disease. This course may be a result of cell seeding from minimal residual disease after resection of the primary tumor or of preexisting clinically undetectable micrometastases. It may also arise from early disseminated cells that remain dormant and resistant to therapy until they suddenly reawaken to initiate proliferation into clinically detectable macrometastases.

Dormant DTC could be the main reason for delayed detection of metastases. It is thought that around 40% of patients with prostate cancer who undergo radical prostatectomy present with biochemical recurrence, suggesting that it is likely that hidden DTC or micrometastases are present at the time of the procedure. The finding is consistent with the detection of DTC many years after tumor resection, suggesting they were released before surgical treatment. Nevertheless, research into tumor cell dormancy is limited, owing to the invasive and technically challenging nature of obtaining DTC samples, which are predominantly taken from the bone marrow.
 

CTC metastases

Cancer cells can undergo epithelial-to-mesenchymal transition to facilitate their detachment from the primary tumor and intravasation into the blood circulation (step 1). Dissemination of cancer cells from the primary tumor into circulation can involve either single cells or cell clusters containing multiple CTC as well as immune cells and platelets, known as microemboli. CTC that can survive in circulation (step 2) can exit the bloodstream (step 3) and establish metastatic tumors (step 4), or they can enter dormancy and reside in distant organs, such as the bone marrow.

Use in practice

CTC were discovered over a century ago, but only in recent years has technology been sufficiently advanced to study CTC and to assess their usefulness as biomarkers. Recent evidence suggests that not only do the number of CTC increase during sleep and rest phases but also that these CTC are better able to metastasize, compared to those generated during periods of wakefulness or activity.

CTC clusters (microemboli) are defined as groups of two or more CTC. They can consist of CTC alone (homotypic) or can include various stromal cells, such as cancer-associated fibroblasts or platelets and immune cells (heterotypic). CTC clusters (with or without leukocytes) seem to have greater metastatic capacity, compared with individual CTC.

A multitude of characteristics can be measured in CTC, including genetics and epigenetics, as well as protein levels, which might help in understanding many processes involved in the formation of metastases.

Quantitative assessment of CTC could indicate tumor burden in patients with aggressive cancers, as has been seen in patients with primary lung cancer.
 

Early cancer diagnosis

Early research into CTC didn’t explore their usefulness in diagnosing early-stage tumors because it was thought that CTC were characteristic of advanced-stage disease. This hypothesis was later rejected following evidence of local intravascular invasion of very early cancer cells, even over a period of several hours. This feature may allow CTC to be detected before the clinical diagnosis of cancer.

CTC have been detected in various neoplastic conditions: in breast cancer, seen in 20% of patients with stage I disease, in 26.8% with stage II disease, and 26.7% with stage III disease; in nonmetastatic colorectal cancer, including stage I and II disease; and in prostate cancer, seen in over 50% of patients with localized disease.

The presence of CTC has been proven to be an unfavorable prognostic predictor of overall survival among patients with early-stage non–small cell lung cancer. It distinguishes patients with pancreatic ductal adenocarcinoma from those with noncancerous pancreatic diseases with a sensitivity of 75% and a specificity of 96.3%.

CTC positivity scoring (appropriately defined), combined with serum prostate-specific antigen level, was predictive of a biopsy diagnosis of clinically significant prostate cancer.

All these data support the utility of CTC in early cancer diagnosis. Their link with metastases, and thus with aggressive tumors, gives them an advantage over other (noninvasive or minimally invasive) biomarkers in the early identification of invasive tumors for therapeutic intervention with better cure rates.
 

This article was translated from Univadis Italy. A version appeared on Medscape.com.

Treatment options for patients with cancer that is detected at a late stage are severely limited, which usually leads to an unfavorable prognosis for such patients. Indeed, the options available for patients with metastatic solid cancers are scarcely curative. Therefore, early diagnosis of neoplasia remains a fundamental mainstay for improving outcomes for cancer patients.

Histopathology is the current gold standard for cancer diagnosis. Biopsy is an invasive procedure that provides physicians with further samples to test but that furnishes limited information concerning tumor heterogeneity. Biopsy specimens are usually obtained only when there is clinical evidence of neoplasia, which significantly limits their usefulness in early diagnosis.

Around 20 years ago, it was discovered that the presence of circulating tumor cells (CTC) in patients with metastatic breast cancer who were about to begin a new line of treatment was predictive of overall and progression-free survival. The prognostic value of CTC was independent of the line of treatment (first or second) and was greater than that of the site of metastasis, the type of therapy, and the time to metastasis after complete primary resection. These results support the idea that the presence of CTC could be used to modify the system for staging advanced disease.

Since then, research into liquid biopsy assays has expanded rapidly, and many biomarkers have been studied in various body fluids for their usefulness in assessing solid tumors.
 

Liquid vs. tissue

Liquid biopsy is a minimally invasive tool that is easy to use. It is employed to detect cancer, to assess treatment response, or to monitor disease progression. Liquid biopsy produces test material from primary and metastatic (or micrometastatic) sites and provides a more heterogeneous picture of the entire tumor cell population, compared with specimens obtained with tissue biopsy.

Metastasis

The notion that metastatic lesions are formed from cancer cells that have disseminated from advanced primary tumors has been substantially revised following the identification of disseminated tumor cells (DTC) in the bone marrow of patients with early-stage disease. These results have led researchers to no longer view cancer metastasis as a linear cascade of events but rather as a series of concurrent, partially overlapping processes, as metastasizing cells assume new phenotypes while abandoning older behaviors.

The initiation of metastasis is not simply a cell-autonomous event but is heavily influenced by complex tissue microenvironments. Although colonization of distant tissues by DTC is an extremely inefficient process, at times, relatively numerous CTC can be detected in the blood of cancer patients (> 1,000 CTC/mL of blood plasma), whereas the number of clinically detectable metastases is disproportionately low, confirming that tumor cell diffusion can happen at an early stage but usually occurs later on.
 

Early dissemination

Little is currently known about the preference of cancer subtypes for distinct tissues or about the receptiveness of a tissue as a metastatic site. What endures as one of the most confounding clinical phenomena is that patients may undergo tumor resection and remain apparently disease free for months, years, and even decades, only to experience relapse and be diagnosed with late-stage metastatic disease. This course may be a result of cell seeding from minimal residual disease after resection of the primary tumor or of preexisting clinically undetectable micrometastases. It may also arise from early disseminated cells that remain dormant and resistant to therapy until they suddenly reawaken to initiate proliferation into clinically detectable macrometastases.

Dormant DTC could be the main reason for delayed detection of metastases. It is thought that around 40% of patients with prostate cancer who undergo radical prostatectomy present with biochemical recurrence, suggesting that it is likely that hidden DTC or micrometastases are present at the time of the procedure. The finding is consistent with the detection of DTC many years after tumor resection, suggesting they were released before surgical treatment. Nevertheless, research into tumor cell dormancy is limited, owing to the invasive and technically challenging nature of obtaining DTC samples, which are predominantly taken from the bone marrow.
 

CTC metastases

Cancer cells can undergo epithelial-to-mesenchymal transition to facilitate their detachment from the primary tumor and intravasation into the blood circulation (step 1). Dissemination of cancer cells from the primary tumor into circulation can involve either single cells or cell clusters containing multiple CTC as well as immune cells and platelets, known as microemboli. CTC that can survive in circulation (step 2) can exit the bloodstream (step 3) and establish metastatic tumors (step 4), or they can enter dormancy and reside in distant organs, such as the bone marrow.

Use in practice

CTC were discovered over a century ago, but only in recent years has technology been sufficiently advanced to study CTC and to assess their usefulness as biomarkers. Recent evidence suggests that not only do the number of CTC increase during sleep and rest phases but also that these CTC are better able to metastasize, compared to those generated during periods of wakefulness or activity.

CTC clusters (microemboli) are defined as groups of two or more CTC. They can consist of CTC alone (homotypic) or can include various stromal cells, such as cancer-associated fibroblasts or platelets and immune cells (heterotypic). CTC clusters (with or without leukocytes) seem to have greater metastatic capacity, compared with individual CTC.

A multitude of characteristics can be measured in CTC, including genetics and epigenetics, as well as protein levels, which might help in understanding many processes involved in the formation of metastases.

Quantitative assessment of CTC could indicate tumor burden in patients with aggressive cancers, as has been seen in patients with primary lung cancer.
 

Early cancer diagnosis

Early research into CTC didn’t explore their usefulness in diagnosing early-stage tumors because it was thought that CTC were characteristic of advanced-stage disease. This hypothesis was later rejected following evidence of local intravascular invasion of very early cancer cells, even over a period of several hours. This feature may allow CTC to be detected before the clinical diagnosis of cancer.

CTC have been detected in various neoplastic conditions: in breast cancer, seen in 20% of patients with stage I disease, in 26.8% with stage II disease, and 26.7% with stage III disease; in nonmetastatic colorectal cancer, including stage I and II disease; and in prostate cancer, seen in over 50% of patients with localized disease.

The presence of CTC has been proven to be an unfavorable prognostic predictor of overall survival among patients with early-stage non–small cell lung cancer. It distinguishes patients with pancreatic ductal adenocarcinoma from those with noncancerous pancreatic diseases with a sensitivity of 75% and a specificity of 96.3%.

CTC positivity scoring (appropriately defined), combined with serum prostate-specific antigen level, was predictive of a biopsy diagnosis of clinically significant prostate cancer.

All these data support the utility of CTC in early cancer diagnosis. Their link with metastases, and thus with aggressive tumors, gives them an advantage over other (noninvasive or minimally invasive) biomarkers in the early identification of invasive tumors for therapeutic intervention with better cure rates.
 

This article was translated from Univadis Italy. A version appeared on Medscape.com.

This transcript has been edited for clarity.

We need to think about the ways that participating in clinical trials results in increased out-of-pocket costs to our patients and how that limits the ability of marginalized groups to participate. That should be a problem for us.

There are many subtle and some egregious ways that participating in clinical trials can result in increased costs. We may ask patients to come to the clinic more frequently. That may mean costs for transportation, wear and tear on your car, and gas prices. It may also mean that if you work in a job where you don’t have time off, and if you’re not at work, you don’t get paid. That’s a major hit to your take-home pay.

We also need to take a close and more honest look at our study budgets and what we consider standard of care. Now, this becomes a slippery slope because there are clear recommendations that we would all agree, but there are also differences of practice and differences of opinion.

How often should patients with advanced disease, who clinically are doing well, have scans to evaluate their disease status and look for subtle evidence of progression? Are laboratory studies part of the follow-up in patients in the adjuvant setting? Did you really need a urinalysis in somebody who’s going to be starting chemotherapy? Do you need an EKG if you’re going to be giving them a drug that doesn’t have potential cardiac toxicity, for which QTc prolongation is not a problem?

Those are often included in our clinical trials. In some cases, they might be paid for by the trial. In other cases, they’re billed to the insurance provider, which means they’ll contribute to deductibles and copays will apply. It is very likely that they will cost your patient something out of pocket.

Now, this becomes important because many of our consent forms would specifically say that things that are only done for the study are paid for by the study. How we define standard of care becomes vitally important. These issues have not been linked in this way frequently. It is time for us to tackle this problem and think about how we financially support the additional costs of care that can be real barriers for patients to participate in clinical trials.

Clinical trials are how we make progress. The more patients who are able to participate in clinical trials, the better it is for all of us and all our future patients.

Kathy D. Miller, MD, is associate director of clinical research and codirector of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis. She disclosed no relevant conflicts of interest.
 

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

This transcript has been edited for clarity.

We need to think about the ways that participating in clinical trials results in increased out-of-pocket costs to our patients and how that limits the ability of marginalized groups to participate. That should be a problem for us.

There are many subtle and some egregious ways that participating in clinical trials can result in increased costs. We may ask patients to come to the clinic more frequently. That may mean costs for transportation, wear and tear on your car, and gas prices. It may also mean that if you work in a job where you don’t have time off, and if you’re not at work, you don’t get paid. That’s a major hit to your take-home pay.

We also need to take a close and more honest look at our study budgets and what we consider standard of care. Now, this becomes a slippery slope because there are clear recommendations that we would all agree, but there are also differences of practice and differences of opinion.

How often should patients with advanced disease, who clinically are doing well, have scans to evaluate their disease status and look for subtle evidence of progression? Are laboratory studies part of the follow-up in patients in the adjuvant setting? Did you really need a urinalysis in somebody who’s going to be starting chemotherapy? Do you need an EKG if you’re going to be giving them a drug that doesn’t have potential cardiac toxicity, for which QTc prolongation is not a problem?

Those are often included in our clinical trials. In some cases, they might be paid for by the trial. In other cases, they’re billed to the insurance provider, which means they’ll contribute to deductibles and copays will apply. It is very likely that they will cost your patient something out of pocket.

Now, this becomes important because many of our consent forms would specifically say that things that are only done for the study are paid for by the study. How we define standard of care becomes vitally important. These issues have not been linked in this way frequently. It is time for us to tackle this problem and think about how we financially support the additional costs of care that can be real barriers for patients to participate in clinical trials.

Clinical trials are how we make progress. The more patients who are able to participate in clinical trials, the better it is for all of us and all our future patients.

Kathy D. Miller, MD, is associate director of clinical research and codirector of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis. She disclosed no relevant conflicts of interest.
 

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

This transcript has been edited for clarity.

We need to think about the ways that participating in clinical trials results in increased out-of-pocket costs to our patients and how that limits the ability of marginalized groups to participate. That should be a problem for us.

There are many subtle and some egregious ways that participating in clinical trials can result in increased costs. We may ask patients to come to the clinic more frequently. That may mean costs for transportation, wear and tear on your car, and gas prices. It may also mean that if you work in a job where you don’t have time off, and if you’re not at work, you don’t get paid. That’s a major hit to your take-home pay.

We also need to take a close and more honest look at our study budgets and what we consider standard of care. Now, this becomes a slippery slope because there are clear recommendations that we would all agree, but there are also differences of practice and differences of opinion.

How often should patients with advanced disease, who clinically are doing well, have scans to evaluate their disease status and look for subtle evidence of progression? Are laboratory studies part of the follow-up in patients in the adjuvant setting? Did you really need a urinalysis in somebody who’s going to be starting chemotherapy? Do you need an EKG if you’re going to be giving them a drug that doesn’t have potential cardiac toxicity, for which QTc prolongation is not a problem?

Those are often included in our clinical trials. In some cases, they might be paid for by the trial. In other cases, they’re billed to the insurance provider, which means they’ll contribute to deductibles and copays will apply. It is very likely that they will cost your patient something out of pocket.

Now, this becomes important because many of our consent forms would specifically say that things that are only done for the study are paid for by the study. How we define standard of care becomes vitally important. These issues have not been linked in this way frequently. It is time for us to tackle this problem and think about how we financially support the additional costs of care that can be real barriers for patients to participate in clinical trials.

Clinical trials are how we make progress. The more patients who are able to participate in clinical trials, the better it is for all of us and all our future patients.

Kathy D. Miller, MD, is associate director of clinical research and codirector of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis. She disclosed no relevant conflicts of interest.
 

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

TOPLINE:
 

Taking a proton pump inhibitor (PPI) with the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor palbociclib could diminish the full therapeutic benefit of palbociclib in women with breast cancer and lead to worse progression-free survival (PFS) and overall survival, new data suggest.

METHODOLOGY:

• The study retrospectively identified 1,310 women with advanced breast cancer receiving palbociclib using South Korean nationwide claims data.
• Overall, 344 women in the concomitant group, those who were coadministered a PPI for more than one-third of their palbociclib treatment duration, were propensity-score matched to 966 women who did not have PPI exposure: the nonconcomitant group.
• Main outcomes were time to progression and death, presented as PFS and overall survival.

TAKEAWAY:

• Median clinical PFS was significantly shorter by about 15 months in the concomitant PPI group vs. the nonconcomitant group (25.3 vs. 39.8 months; adjusted hazard ratio, 1.76).
• Concomitant PPI use was also associated with shorter overall survival (HR, 2.71).
• Overall, 83.1% of patients in the concomitant group were alive at 1 year vs. 94.0% in the nonconcomitant group (P < .001), and 69.5% vs. 89.3%, respectively, were alive at 2 years (P < .001), though the median overall survival was not reached in either group.
• In a subgroup analysis, concomitant PPI use was associated with shorter clinical PFS (HR, 1.75 for those receiving endocrine-sensitive treatment and 1.82 for those receiving endocrine-resistant treatment), and shorter overall survival (HR, 2.68 in the endocrine-sensitive subgroup and 2.98 in the endocrine-resistant subgroup).

IN PRACTICE:

“The findings suggest that taking PPIs with palbociclib may interrupt the full therapeutic benefits of palbociclib,” the authors conclude. “Physicians should be cautious when prescribing PPIs to patients who are receiving palbociclib.”

SOURCE:

The study, led by Ju-Eun Lee, MS, PharmD, School of Pharmacy, Sungkyunkwan University, South Korea, was published online in JAMA Network Open.

LIMITATIONS:

The study was limited by its retrospective design and use of claims data as well as the inability to confirm whether patients actually took the PPI medication.

DISCLOSURES:

The authors report no relevant financial relationships. The study reported no commercial funding.

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

TOPLINE:
 

Taking a proton pump inhibitor (PPI) with the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor palbociclib could diminish the full therapeutic benefit of palbociclib in women with breast cancer and lead to worse progression-free survival (PFS) and overall survival, new data suggest.

METHODOLOGY:

• The study retrospectively identified 1,310 women with advanced breast cancer receiving palbociclib using South Korean nationwide claims data.
• Overall, 344 women in the concomitant group, those who were coadministered a PPI for more than one-third of their palbociclib treatment duration, were propensity-score matched to 966 women who did not have PPI exposure: the nonconcomitant group.
• Main outcomes were time to progression and death, presented as PFS and overall survival.

TAKEAWAY:

• Median clinical PFS was significantly shorter by about 15 months in the concomitant PPI group vs. the nonconcomitant group (25.3 vs. 39.8 months; adjusted hazard ratio, 1.76).
• Concomitant PPI use was also associated with shorter overall survival (HR, 2.71).
• Overall, 83.1% of patients in the concomitant group were alive at 1 year vs. 94.0% in the nonconcomitant group (P < .001), and 69.5% vs. 89.3%, respectively, were alive at 2 years (P < .001), though the median overall survival was not reached in either group.
• In a subgroup analysis, concomitant PPI use was associated with shorter clinical PFS (HR, 1.75 for those receiving endocrine-sensitive treatment and 1.82 for those receiving endocrine-resistant treatment), and shorter overall survival (HR, 2.68 in the endocrine-sensitive subgroup and 2.98 in the endocrine-resistant subgroup).

IN PRACTICE:

“The findings suggest that taking PPIs with palbociclib may interrupt the full therapeutic benefits of palbociclib,” the authors conclude. “Physicians should be cautious when prescribing PPIs to patients who are receiving palbociclib.”

SOURCE:

The study, led by Ju-Eun Lee, MS, PharmD, School of Pharmacy, Sungkyunkwan University, South Korea, was published online in JAMA Network Open.

LIMITATIONS:

The study was limited by its retrospective design and use of claims data as well as the inability to confirm whether patients actually took the PPI medication.

DISCLOSURES:

The authors report no relevant financial relationships. The study reported no commercial funding.

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

TOPLINE:
 

Taking a proton pump inhibitor (PPI) with the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor palbociclib could diminish the full therapeutic benefit of palbociclib in women with breast cancer and lead to worse progression-free survival (PFS) and overall survival, new data suggest.

METHODOLOGY:

• The study retrospectively identified 1,310 women with advanced breast cancer receiving palbociclib using South Korean nationwide claims data.
• Overall, 344 women in the concomitant group, those who were coadministered a PPI for more than one-third of their palbociclib treatment duration, were propensity-score matched to 966 women who did not have PPI exposure: the nonconcomitant group.
• Main outcomes were time to progression and death, presented as PFS and overall survival.

TAKEAWAY:

• Median clinical PFS was significantly shorter by about 15 months in the concomitant PPI group vs. the nonconcomitant group (25.3 vs. 39.8 months; adjusted hazard ratio, 1.76).
• Concomitant PPI use was also associated with shorter overall survival (HR, 2.71).
• Overall, 83.1% of patients in the concomitant group were alive at 1 year vs. 94.0% in the nonconcomitant group (P < .001), and 69.5% vs. 89.3%, respectively, were alive at 2 years (P < .001), though the median overall survival was not reached in either group.
• In a subgroup analysis, concomitant PPI use was associated with shorter clinical PFS (HR, 1.75 for those receiving endocrine-sensitive treatment and 1.82 for those receiving endocrine-resistant treatment), and shorter overall survival (HR, 2.68 in the endocrine-sensitive subgroup and 2.98 in the endocrine-resistant subgroup).

IN PRACTICE:

“The findings suggest that taking PPIs with palbociclib may interrupt the full therapeutic benefits of palbociclib,” the authors conclude. “Physicians should be cautious when prescribing PPIs to patients who are receiving palbociclib.”

SOURCE:

The study, led by Ju-Eun Lee, MS, PharmD, School of Pharmacy, Sungkyunkwan University, South Korea, was published online in JAMA Network Open.

LIMITATIONS:

The study was limited by its retrospective design and use of claims data as well as the inability to confirm whether patients actually took the PPI medication.

DISCLOSURES:

The authors report no relevant financial relationships. The study reported no commercial funding.

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.

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.

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.

Who owns your genes? The assumption of any sane person would be that he or she owns his or her own genes. I mean, how dumb a question is that?
 

Yet, in 2007, Dov Michaeli, MD, PhD, described how an American company had claimed ownership of genetic materials and believed that it had the right to commercialize those naturally occurring bits of DNA. Myriad Genetics began by patenting mutations of BRCA. Dr. Michaeli issued a call for action to support early efforts to pass legislation to restore and preserve individual ownership of one’s own genes. This is a historically important quick read/watch/listen. Give it a click.

In related legislation, the Genetic Information Nondiscrimination Act (GINA), originally introduced by New York Rep. Louise Slaughter in 1995, was ultimately spearheaded by California Rep. Xavier Becerra (now Secretary of Health & Human Services) to passage by the House of Representatives on April 25, 2007, by a vote of 420-9-3. Led by Sen. Edward Kennedy of Massachusetts, it was passed by the Senate on April 24, 2008, by a vote of 95-0. President George W. Bush signed the bill into law on May 21, 2008.

GINA is a landmark piece of legislation that protects Americans. It prohibits employers and health insurers from discriminating against people on the basis of their genetic information, and it also prohibits the use of genetic information in life insurance and long-term care insurance.

Its impact has been immense. GINA has been indispensable in promoting progress in the field of human genetics. By safeguarding individuals against discrimination based on genetic information, it has encouraged broader participation in research, built public trust, and stimulated advancements in genetic testing and personalized medicine. GINA’s impact extends beyond borders and has influenced much of the rest of the world.

As important as GINA was to the field, more was needed. National legislation to protect ownership of genetic materials has, despite many attempts, still not become law in the United States. However, in our system of divided government and balance of power, we also have independent courts.

June 13, 2023, was the 10th anniversary of another landmark event. The legal case is that of the Association for Molecular Pathology v. Myriad Genetics, a Salt Lake City–based biotech company that held patents on isolated DNA sequences associated with breast and ovarian cancer. The AMP, joined by several other organizations and researchers, challenged Myriad’s gene patents, arguing that human genes are naturally occurring and, therefore, should not be subject to patenting. In a unanimous decision, the Supreme Court held that naturally occurring DNA segments are products of nature and therefore are not eligible for patent protection.

This was a pivotal decision in the field of human genetics and had a broad impact on genetic research. The decision clarified that naturally occurring DNA sequences cannot be patented, which means that researchers are free to use these sequences in their research without fear of patent infringement. This has led to a vast increase in the amount of genetic research being conducted, and it has also led to the development of new genetic tests and treatments.

The numbers of genetic research papers published in scientific journals and of genetic tests available to consumers have increased significantly, while the cost of genetic testing has decreased significantly. The AMP v. Myriad decision is likely to continue to have an impact for many years to come.

In 2023, Americans do own their own genes and can feel secure in them not being used against us. Thank you, common sense, activist American molecular pathologists, Congress, the President, and the Supreme Court for siding with the people.Dr. Lundbert is editor in chief of Cancer Commons. He has disclosed no relevant financial relationships.

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

Who owns your genes? The assumption of any sane person would be that he or she owns his or her own genes. I mean, how dumb a question is that?
 

Yet, in 2007, Dov Michaeli, MD, PhD, described how an American company had claimed ownership of genetic materials and believed that it had the right to commercialize those naturally occurring bits of DNA. Myriad Genetics began by patenting mutations of BRCA. Dr. Michaeli issued a call for action to support early efforts to pass legislation to restore and preserve individual ownership of one’s own genes. This is a historically important quick read/watch/listen. Give it a click.

In related legislation, the Genetic Information Nondiscrimination Act (GINA), originally introduced by New York Rep. Louise Slaughter in 1995, was ultimately spearheaded by California Rep. Xavier Becerra (now Secretary of Health & Human Services) to passage by the House of Representatives on April 25, 2007, by a vote of 420-9-3. Led by Sen. Edward Kennedy of Massachusetts, it was passed by the Senate on April 24, 2008, by a vote of 95-0. President George W. Bush signed the bill into law on May 21, 2008.

GINA is a landmark piece of legislation that protects Americans. It prohibits employers and health insurers from discriminating against people on the basis of their genetic information, and it also prohibits the use of genetic information in life insurance and long-term care insurance.

Its impact has been immense. GINA has been indispensable in promoting progress in the field of human genetics. By safeguarding individuals against discrimination based on genetic information, it has encouraged broader participation in research, built public trust, and stimulated advancements in genetic testing and personalized medicine. GINA’s impact extends beyond borders and has influenced much of the rest of the world.

As important as GINA was to the field, more was needed. National legislation to protect ownership of genetic materials has, despite many attempts, still not become law in the United States. However, in our system of divided government and balance of power, we also have independent courts.

June 13, 2023, was the 10th anniversary of another landmark event. The legal case is that of the Association for Molecular Pathology v. Myriad Genetics, a Salt Lake City–based biotech company that held patents on isolated DNA sequences associated with breast and ovarian cancer. The AMP, joined by several other organizations and researchers, challenged Myriad’s gene patents, arguing that human genes are naturally occurring and, therefore, should not be subject to patenting. In a unanimous decision, the Supreme Court held that naturally occurring DNA segments are products of nature and therefore are not eligible for patent protection.

This was a pivotal decision in the field of human genetics and had a broad impact on genetic research. The decision clarified that naturally occurring DNA sequences cannot be patented, which means that researchers are free to use these sequences in their research without fear of patent infringement. This has led to a vast increase in the amount of genetic research being conducted, and it has also led to the development of new genetic tests and treatments.

The numbers of genetic research papers published in scientific journals and of genetic tests available to consumers have increased significantly, while the cost of genetic testing has decreased significantly. The AMP v. Myriad decision is likely to continue to have an impact for many years to come.

In 2023, Americans do own their own genes and can feel secure in them not being used against us. Thank you, common sense, activist American molecular pathologists, Congress, the President, and the Supreme Court for siding with the people.Dr. Lundbert is editor in chief of Cancer Commons. He has disclosed no relevant financial relationships.

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

Who owns your genes? The assumption of any sane person would be that he or she owns his or her own genes. I mean, how dumb a question is that?
 

Yet, in 2007, Dov Michaeli, MD, PhD, described how an American company had claimed ownership of genetic materials and believed that it had the right to commercialize those naturally occurring bits of DNA. Myriad Genetics began by patenting mutations of BRCA. Dr. Michaeli issued a call for action to support early efforts to pass legislation to restore and preserve individual ownership of one’s own genes. This is a historically important quick read/watch/listen. Give it a click.

In related legislation, the Genetic Information Nondiscrimination Act (GINA), originally introduced by New York Rep. Louise Slaughter in 1995, was ultimately spearheaded by California Rep. Xavier Becerra (now Secretary of Health & Human Services) to passage by the House of Representatives on April 25, 2007, by a vote of 420-9-3. Led by Sen. Edward Kennedy of Massachusetts, it was passed by the Senate on April 24, 2008, by a vote of 95-0. President George W. Bush signed the bill into law on May 21, 2008.

GINA is a landmark piece of legislation that protects Americans. It prohibits employers and health insurers from discriminating against people on the basis of their genetic information, and it also prohibits the use of genetic information in life insurance and long-term care insurance.

Its impact has been immense. GINA has been indispensable in promoting progress in the field of human genetics. By safeguarding individuals against discrimination based on genetic information, it has encouraged broader participation in research, built public trust, and stimulated advancements in genetic testing and personalized medicine. GINA’s impact extends beyond borders and has influenced much of the rest of the world.

As important as GINA was to the field, more was needed. National legislation to protect ownership of genetic materials has, despite many attempts, still not become law in the United States. However, in our system of divided government and balance of power, we also have independent courts.

June 13, 2023, was the 10th anniversary of another landmark event. The legal case is that of the Association for Molecular Pathology v. Myriad Genetics, a Salt Lake City–based biotech company that held patents on isolated DNA sequences associated with breast and ovarian cancer. The AMP, joined by several other organizations and researchers, challenged Myriad’s gene patents, arguing that human genes are naturally occurring and, therefore, should not be subject to patenting. In a unanimous decision, the Supreme Court held that naturally occurring DNA segments are products of nature and therefore are not eligible for patent protection.

This was a pivotal decision in the field of human genetics and had a broad impact on genetic research. The decision clarified that naturally occurring DNA sequences cannot be patented, which means that researchers are free to use these sequences in their research without fear of patent infringement. This has led to a vast increase in the amount of genetic research being conducted, and it has also led to the development of new genetic tests and treatments.

The numbers of genetic research papers published in scientific journals and of genetic tests available to consumers have increased significantly, while the cost of genetic testing has decreased significantly. The AMP v. Myriad decision is likely to continue to have an impact for many years to come.

In 2023, Americans do own their own genes and can feel secure in them not being used against us. Thank you, common sense, activist American molecular pathologists, Congress, the President, and the Supreme Court for siding with the people.Dr. Lundbert is editor in chief of Cancer Commons. He has disclosed no relevant financial relationships.

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