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Premenopausal women benefit from ovarian conservation with benign hysterectomies
Although bilateral salpingo-oophorectomy (BSO) with hysterectomy has been shown to reduce the risk for ovarian cancer in women at increased risk, current guidelines are touting ovarian conservation, especially in premenopausal women, wrote Mathilde Gottschau, MD, of the Danish Cancer Society Research Center, Copenhagen, and colleagues. However, post-hysterectomy outcomes in women with and without BSO have not been well examined.
In a study published in the Annals of Internal Medicine, the researchers reviewed data from a nationwide registry of women in Denmark aged 20 years and older who underwent benign hysterectomies with BSO (22,974 women) and without BSO (120,011 women) between 1977 and 2017. The women were divided into subgroups based on age; those younger than 45 years were defined as premenopausal, those aged 45-54 years were defined as perimenopausal, those aged 55-64 were defined as early postmenopausal, and those aged 65 and older were defined as late menopausal.
The primary outcomes were hospitalization for cardiovascular disease, cancer incidence, and all-cause mortality over a median follow-up period of 22 years.
For women younger than 45 years, the 10-year cumulative risk for all cancer was lower with BSO than without, but the risk of overall cardiovascular disease was higher with BSO, with higher levels of ischemic heart disease and stroke, compared with women without BSO. The 10-year cumulative mortality was higher with BSO than without (2.16% vs. 1.94%).
For women aged 45-54 years, the 10-year cumulative cancer risk was higher in those with BSO than those without BSO (risk difference, 0.73 percentage points) associated mainly with nonbreast cancer, and both 10-year and 20-year mortality were higher in those with BSO than those without.
For women aged 55-65 years, the 10-year cumulative cancer risk was higher in those with BSO than those without BSO. Cumulative overall mortality was higher at 10 years for those with BSO, but lower at 20 years.
For women aged 65 years and older, both 10-year and 20-year cumulative overall cancer risk was higher with BSO than without (RD, 2.54 and 4.57 percentage points, respectively). Cumulative mortality was higher in the BSO group at 10 years, but lower at 20 years.
The study findings were limited by several factors including the use of age to determine menopausal status and the lack of genetic predisposition data, and the focus only on a relatively homogeneous population that may not be generalizable to other populations, the researchers noted.
However, the results were strengthened by the use of a nationwide registry and the long-term follow-up period, they said. The current study indicates that the health risks outweigh the potential benefits of BSO with benign hysterectomy for premenopausal women and supports the current guidelines for ovarian conservation in these women with low lifetime ovarian cancer risk, they said. For postmenopausal women, the data support a cautious approach to BSO given the lack of a clear survival benefit and cancer excess, they concluded.
Delayed diagnosis of ovarian cancers favors BSO
“The question of removing ovaries at the time of benign hysterectomy to prevent ovarian cancer in low-risk women has been widely debated,” which has contributed to the variation in incidence rates of unilateral and bilateral oophorectomy over time, wrote Elizabeth Casiano Evans, MD, of the University of Texas, San Antonio, and Deslyn T.G. Hobson, MD, of Wayne State University, Detroit, in an accompanying editorial.
Ovarian cancer often goes undiagnosed until an advanced stage, and BSO can significantly reduce risk in women with BRCA1 and BRCA2 mutations, they noted.
For women without increased risk, those who are premenopausal may wish to preserve ovarian function, but women also may benefit from improvements in a range of menopause-related symptoms including vasomotor and urogenital symptoms, sexual dysfunction, and psychiatric and cognitive symptoms, they said.
“In addition, salpingectomy alone has a role in significantly reducing ovarian cancer incidence without compromising ovarian function because the fallopian tube has been found to be at the origin of many ovarian cancer cases,” they noted. In the current study, “the crude ovarian cancer risk was lower with BSO” across all age groups, the editorialists said.
The choice of whether to include BSO at the time of benign hysterectomy is complicated, with many factors to consider, the editorialists wrote, and the current study supports the need for informed, shared decision-making between clinicians and patients.
The study was supported by the Danish Cancer Society’s Scientific Committee and the Mermaid Project. The researchers had no financial conflicts to disclose. The editorial authors had no financial conflicts to disclose.
Although bilateral salpingo-oophorectomy (BSO) with hysterectomy has been shown to reduce the risk for ovarian cancer in women at increased risk, current guidelines are touting ovarian conservation, especially in premenopausal women, wrote Mathilde Gottschau, MD, of the Danish Cancer Society Research Center, Copenhagen, and colleagues. However, post-hysterectomy outcomes in women with and without BSO have not been well examined.
In a study published in the Annals of Internal Medicine, the researchers reviewed data from a nationwide registry of women in Denmark aged 20 years and older who underwent benign hysterectomies with BSO (22,974 women) and without BSO (120,011 women) between 1977 and 2017. The women were divided into subgroups based on age; those younger than 45 years were defined as premenopausal, those aged 45-54 years were defined as perimenopausal, those aged 55-64 were defined as early postmenopausal, and those aged 65 and older were defined as late menopausal.
The primary outcomes were hospitalization for cardiovascular disease, cancer incidence, and all-cause mortality over a median follow-up period of 22 years.
For women younger than 45 years, the 10-year cumulative risk for all cancer was lower with BSO than without, but the risk of overall cardiovascular disease was higher with BSO, with higher levels of ischemic heart disease and stroke, compared with women without BSO. The 10-year cumulative mortality was higher with BSO than without (2.16% vs. 1.94%).
For women aged 45-54 years, the 10-year cumulative cancer risk was higher in those with BSO than those without BSO (risk difference, 0.73 percentage points) associated mainly with nonbreast cancer, and both 10-year and 20-year mortality were higher in those with BSO than those without.
For women aged 55-65 years, the 10-year cumulative cancer risk was higher in those with BSO than those without BSO. Cumulative overall mortality was higher at 10 years for those with BSO, but lower at 20 years.
For women aged 65 years and older, both 10-year and 20-year cumulative overall cancer risk was higher with BSO than without (RD, 2.54 and 4.57 percentage points, respectively). Cumulative mortality was higher in the BSO group at 10 years, but lower at 20 years.
The study findings were limited by several factors including the use of age to determine menopausal status and the lack of genetic predisposition data, and the focus only on a relatively homogeneous population that may not be generalizable to other populations, the researchers noted.
However, the results were strengthened by the use of a nationwide registry and the long-term follow-up period, they said. The current study indicates that the health risks outweigh the potential benefits of BSO with benign hysterectomy for premenopausal women and supports the current guidelines for ovarian conservation in these women with low lifetime ovarian cancer risk, they said. For postmenopausal women, the data support a cautious approach to BSO given the lack of a clear survival benefit and cancer excess, they concluded.
Delayed diagnosis of ovarian cancers favors BSO
“The question of removing ovaries at the time of benign hysterectomy to prevent ovarian cancer in low-risk women has been widely debated,” which has contributed to the variation in incidence rates of unilateral and bilateral oophorectomy over time, wrote Elizabeth Casiano Evans, MD, of the University of Texas, San Antonio, and Deslyn T.G. Hobson, MD, of Wayne State University, Detroit, in an accompanying editorial.
Ovarian cancer often goes undiagnosed until an advanced stage, and BSO can significantly reduce risk in women with BRCA1 and BRCA2 mutations, they noted.
For women without increased risk, those who are premenopausal may wish to preserve ovarian function, but women also may benefit from improvements in a range of menopause-related symptoms including vasomotor and urogenital symptoms, sexual dysfunction, and psychiatric and cognitive symptoms, they said.
“In addition, salpingectomy alone has a role in significantly reducing ovarian cancer incidence without compromising ovarian function because the fallopian tube has been found to be at the origin of many ovarian cancer cases,” they noted. In the current study, “the crude ovarian cancer risk was lower with BSO” across all age groups, the editorialists said.
The choice of whether to include BSO at the time of benign hysterectomy is complicated, with many factors to consider, the editorialists wrote, and the current study supports the need for informed, shared decision-making between clinicians and patients.
The study was supported by the Danish Cancer Society’s Scientific Committee and the Mermaid Project. The researchers had no financial conflicts to disclose. The editorial authors had no financial conflicts to disclose.
Although bilateral salpingo-oophorectomy (BSO) with hysterectomy has been shown to reduce the risk for ovarian cancer in women at increased risk, current guidelines are touting ovarian conservation, especially in premenopausal women, wrote Mathilde Gottschau, MD, of the Danish Cancer Society Research Center, Copenhagen, and colleagues. However, post-hysterectomy outcomes in women with and without BSO have not been well examined.
In a study published in the Annals of Internal Medicine, the researchers reviewed data from a nationwide registry of women in Denmark aged 20 years and older who underwent benign hysterectomies with BSO (22,974 women) and without BSO (120,011 women) between 1977 and 2017. The women were divided into subgroups based on age; those younger than 45 years were defined as premenopausal, those aged 45-54 years were defined as perimenopausal, those aged 55-64 were defined as early postmenopausal, and those aged 65 and older were defined as late menopausal.
The primary outcomes were hospitalization for cardiovascular disease, cancer incidence, and all-cause mortality over a median follow-up period of 22 years.
For women younger than 45 years, the 10-year cumulative risk for all cancer was lower with BSO than without, but the risk of overall cardiovascular disease was higher with BSO, with higher levels of ischemic heart disease and stroke, compared with women without BSO. The 10-year cumulative mortality was higher with BSO than without (2.16% vs. 1.94%).
For women aged 45-54 years, the 10-year cumulative cancer risk was higher in those with BSO than those without BSO (risk difference, 0.73 percentage points) associated mainly with nonbreast cancer, and both 10-year and 20-year mortality were higher in those with BSO than those without.
For women aged 55-65 years, the 10-year cumulative cancer risk was higher in those with BSO than those without BSO. Cumulative overall mortality was higher at 10 years for those with BSO, but lower at 20 years.
For women aged 65 years and older, both 10-year and 20-year cumulative overall cancer risk was higher with BSO than without (RD, 2.54 and 4.57 percentage points, respectively). Cumulative mortality was higher in the BSO group at 10 years, but lower at 20 years.
The study findings were limited by several factors including the use of age to determine menopausal status and the lack of genetic predisposition data, and the focus only on a relatively homogeneous population that may not be generalizable to other populations, the researchers noted.
However, the results were strengthened by the use of a nationwide registry and the long-term follow-up period, they said. The current study indicates that the health risks outweigh the potential benefits of BSO with benign hysterectomy for premenopausal women and supports the current guidelines for ovarian conservation in these women with low lifetime ovarian cancer risk, they said. For postmenopausal women, the data support a cautious approach to BSO given the lack of a clear survival benefit and cancer excess, they concluded.
Delayed diagnosis of ovarian cancers favors BSO
“The question of removing ovaries at the time of benign hysterectomy to prevent ovarian cancer in low-risk women has been widely debated,” which has contributed to the variation in incidence rates of unilateral and bilateral oophorectomy over time, wrote Elizabeth Casiano Evans, MD, of the University of Texas, San Antonio, and Deslyn T.G. Hobson, MD, of Wayne State University, Detroit, in an accompanying editorial.
Ovarian cancer often goes undiagnosed until an advanced stage, and BSO can significantly reduce risk in women with BRCA1 and BRCA2 mutations, they noted.
For women without increased risk, those who are premenopausal may wish to preserve ovarian function, but women also may benefit from improvements in a range of menopause-related symptoms including vasomotor and urogenital symptoms, sexual dysfunction, and psychiatric and cognitive symptoms, they said.
“In addition, salpingectomy alone has a role in significantly reducing ovarian cancer incidence without compromising ovarian function because the fallopian tube has been found to be at the origin of many ovarian cancer cases,” they noted. In the current study, “the crude ovarian cancer risk was lower with BSO” across all age groups, the editorialists said.
The choice of whether to include BSO at the time of benign hysterectomy is complicated, with many factors to consider, the editorialists wrote, and the current study supports the need for informed, shared decision-making between clinicians and patients.
The study was supported by the Danish Cancer Society’s Scientific Committee and the Mermaid Project. The researchers had no financial conflicts to disclose. The editorial authors had no financial conflicts to disclose.
FROM THE ANNALS OF INTERNAL MEDICINE
Therapies for Advanced Parkinson's Disease
As Parkinson's disease progresses, dopamine and dopamine agonists that control tremor and stiffness can wear off too early or cause dyskinesia when they peak in the bloodstream.
In this ReCAP, Dr Michael Okun, professor and chair of neurology at the University of Florida, explains that adjustments to dose, timing, or delivery mode of these medications can smooth out some fluctuations. He reports that catechol-O-methyltransferase inhibitors, such as opicapone, tolcapone, and entacapone, can extend the effect of dopamine and the addition of amantadine or istradefylline can suppress dyskinesia.
He points out that for other patients, surgical options, such as deep brain stimulation or focused ultrasound, can alter how the brain controls disordered movement or implanted pumps can better regulate the delivery of medication either subcutaneously or directly into the gut.
--
Michael S. Okun, MD, Chair of Neurology, College of Medicine; Director Norman Fixel Institute, University of Florida, Gainesville, Florida
Michael S. Okun, MD, has disclosed no relevant financial relationships
As Parkinson's disease progresses, dopamine and dopamine agonists that control tremor and stiffness can wear off too early or cause dyskinesia when they peak in the bloodstream.
In this ReCAP, Dr Michael Okun, professor and chair of neurology at the University of Florida, explains that adjustments to dose, timing, or delivery mode of these medications can smooth out some fluctuations. He reports that catechol-O-methyltransferase inhibitors, such as opicapone, tolcapone, and entacapone, can extend the effect of dopamine and the addition of amantadine or istradefylline can suppress dyskinesia.
He points out that for other patients, surgical options, such as deep brain stimulation or focused ultrasound, can alter how the brain controls disordered movement or implanted pumps can better regulate the delivery of medication either subcutaneously or directly into the gut.
--
Michael S. Okun, MD, Chair of Neurology, College of Medicine; Director Norman Fixel Institute, University of Florida, Gainesville, Florida
Michael S. Okun, MD, has disclosed no relevant financial relationships
As Parkinson's disease progresses, dopamine and dopamine agonists that control tremor and stiffness can wear off too early or cause dyskinesia when they peak in the bloodstream.
In this ReCAP, Dr Michael Okun, professor and chair of neurology at the University of Florida, explains that adjustments to dose, timing, or delivery mode of these medications can smooth out some fluctuations. He reports that catechol-O-methyltransferase inhibitors, such as opicapone, tolcapone, and entacapone, can extend the effect of dopamine and the addition of amantadine or istradefylline can suppress dyskinesia.
He points out that for other patients, surgical options, such as deep brain stimulation or focused ultrasound, can alter how the brain controls disordered movement or implanted pumps can better regulate the delivery of medication either subcutaneously or directly into the gut.
--
Michael S. Okun, MD, Chair of Neurology, College of Medicine; Director Norman Fixel Institute, University of Florida, Gainesville, Florida
Michael S. Okun, MD, has disclosed no relevant financial relationships
Relapsed CLL: New approaches prolong survival
NEW YORK –
“In people who are genomically unstable, almost half will have their CLL progress on single agent BTK inhibitor therapy. These patients, I’d like to treat with combination of a Bruton’s tyrosine kinase inhibitor plus venetoclax,” said Richard R. Furman, MD, Morton Coleman MD Distinguished Professor of medicine at Weill Cornell Medicine/New York Presbyterian Hospital. He presented on treating relapsed CLL at the Great Debates and Updates Hematologic Malignancies Conference in New York, April 13-15.
The efficacy of venetoclax (VX) in treating high risk CLL patients was demonstrated in the 2019 CLL14 trial (NCT02242942) in which the main entry criteria were being treatment-naive and being considered “unfit” for treatment, meaning that a patient’s Cumulative Illness Rating Scale score was >6, or they presented with decreased kidney function. Study participants were treated with six cycles of either venetoclax-obinutuzumab (VO) or chlorambucil-obinutuzumab (CO); the 4-year PFS was 74% vs. 35.4% (P < .0001) respectively. After 12 cycles of treatment, the 74% of patients in the VO group achieved undetectable minimal residual disease rate (MRD) vs. 32% in the CO group.
Achievement of MRD did predict for outcome, but Dr. Furman concluded that while MRD is a powerful prognostic tool, it is not clinically useful given the inability of its results to guide therapy. He went on to emphasize that “of those patients who achieved MRD levels of 10-4 after 12 cycles of venetoclax, 50% had worsening and 50% had improvement of the residual disease, suggesting that we do not know the optimal duration of venetoclax treatment, as half of the patients still continue to derive benefit.”
Dr. Furman noted that ibrutinib (IB) and the second-generation drugs zanubrutinib (ZB) and acalabrutinib (AL) are all effective, but that the second-generation Bruton’s tyrosine kinase inhibitors enable patients to derive the benefit of remaining on treatment longer, because the rate of concerning cardiac complications is lower than with IB.
The ALPINE trial (NCT03734016) confirmed ZB’s significantly improved overall response rate at 78.3% vs. IB’s 62.5%, as well as a lower rate of atrial fibrillation (2.5%) vs. IB (10.1%).
Noninferiority of AL vs. IB in high-risk relapsed CLL patients was demonstrated in the ELEVATE-RR trial (NCT02477696) with both drugs having a median PFS of 38.4 months. With a median follow up of 41 months, AL demonstrated less atrial fibrillation/atrial flutter, compared with IB (9.4% vs. 16.0%) with no difference in grade > 3 infections. Furthermore, AL’s half-life being shorter than that of IB means that side effects are shorter lived.
“That’s the advantage of the second generation of Bruton’s tyrosine kinase inhibitors,” said Stefan Glück, MD, PhD, a hematologic oncologist and independent consultant who was formerly affiliated with the Sylvester Comprehensive Cancer Center and taught at the Miller School of Medicine at the University of Miami.
Dr. Glück added that “acalabrutinib and zanubrutinib have demonstrated strong efficacy and safety. When patients no longer respond to these drugs, the addition of VX is crucial. It has a completely different mechanism of action and can reverse resistance to Bruton’s tyrosine kinase inhibitors, allowing them to start working again.”
Dr. Furman also discussed proteolysis-targeting chimeras (PROTACs), one area that he expects to make a significant impact as a future therapy for CLL and many other malignancies. Despite the fact these agents are in phase I studies, he commented that “they appear, thus far, to have tremendous potential.”
Dr. Furman disclosed relationships with Abbvie, Acerta/AstraZeneca, Beigene, Jansen, TG Therapeutics, Genentech-Roche, Incyte Corporation, Loxo Oncology, MEI Pharma, Morphosys, Pharmacyclics, Sanofi/Genzyme, and X4 Pharmaceuticals. Dr. Glück reported no conflicts of interest.
NEW YORK –
“In people who are genomically unstable, almost half will have their CLL progress on single agent BTK inhibitor therapy. These patients, I’d like to treat with combination of a Bruton’s tyrosine kinase inhibitor plus venetoclax,” said Richard R. Furman, MD, Morton Coleman MD Distinguished Professor of medicine at Weill Cornell Medicine/New York Presbyterian Hospital. He presented on treating relapsed CLL at the Great Debates and Updates Hematologic Malignancies Conference in New York, April 13-15.
The efficacy of venetoclax (VX) in treating high risk CLL patients was demonstrated in the 2019 CLL14 trial (NCT02242942) in which the main entry criteria were being treatment-naive and being considered “unfit” for treatment, meaning that a patient’s Cumulative Illness Rating Scale score was >6, or they presented with decreased kidney function. Study participants were treated with six cycles of either venetoclax-obinutuzumab (VO) or chlorambucil-obinutuzumab (CO); the 4-year PFS was 74% vs. 35.4% (P < .0001) respectively. After 12 cycles of treatment, the 74% of patients in the VO group achieved undetectable minimal residual disease rate (MRD) vs. 32% in the CO group.
Achievement of MRD did predict for outcome, but Dr. Furman concluded that while MRD is a powerful prognostic tool, it is not clinically useful given the inability of its results to guide therapy. He went on to emphasize that “of those patients who achieved MRD levels of 10-4 after 12 cycles of venetoclax, 50% had worsening and 50% had improvement of the residual disease, suggesting that we do not know the optimal duration of venetoclax treatment, as half of the patients still continue to derive benefit.”
Dr. Furman noted that ibrutinib (IB) and the second-generation drugs zanubrutinib (ZB) and acalabrutinib (AL) are all effective, but that the second-generation Bruton’s tyrosine kinase inhibitors enable patients to derive the benefit of remaining on treatment longer, because the rate of concerning cardiac complications is lower than with IB.
The ALPINE trial (NCT03734016) confirmed ZB’s significantly improved overall response rate at 78.3% vs. IB’s 62.5%, as well as a lower rate of atrial fibrillation (2.5%) vs. IB (10.1%).
Noninferiority of AL vs. IB in high-risk relapsed CLL patients was demonstrated in the ELEVATE-RR trial (NCT02477696) with both drugs having a median PFS of 38.4 months. With a median follow up of 41 months, AL demonstrated less atrial fibrillation/atrial flutter, compared with IB (9.4% vs. 16.0%) with no difference in grade > 3 infections. Furthermore, AL’s half-life being shorter than that of IB means that side effects are shorter lived.
“That’s the advantage of the second generation of Bruton’s tyrosine kinase inhibitors,” said Stefan Glück, MD, PhD, a hematologic oncologist and independent consultant who was formerly affiliated with the Sylvester Comprehensive Cancer Center and taught at the Miller School of Medicine at the University of Miami.
Dr. Glück added that “acalabrutinib and zanubrutinib have demonstrated strong efficacy and safety. When patients no longer respond to these drugs, the addition of VX is crucial. It has a completely different mechanism of action and can reverse resistance to Bruton’s tyrosine kinase inhibitors, allowing them to start working again.”
Dr. Furman also discussed proteolysis-targeting chimeras (PROTACs), one area that he expects to make a significant impact as a future therapy for CLL and many other malignancies. Despite the fact these agents are in phase I studies, he commented that “they appear, thus far, to have tremendous potential.”
Dr. Furman disclosed relationships with Abbvie, Acerta/AstraZeneca, Beigene, Jansen, TG Therapeutics, Genentech-Roche, Incyte Corporation, Loxo Oncology, MEI Pharma, Morphosys, Pharmacyclics, Sanofi/Genzyme, and X4 Pharmaceuticals. Dr. Glück reported no conflicts of interest.
NEW YORK –
“In people who are genomically unstable, almost half will have their CLL progress on single agent BTK inhibitor therapy. These patients, I’d like to treat with combination of a Bruton’s tyrosine kinase inhibitor plus venetoclax,” said Richard R. Furman, MD, Morton Coleman MD Distinguished Professor of medicine at Weill Cornell Medicine/New York Presbyterian Hospital. He presented on treating relapsed CLL at the Great Debates and Updates Hematologic Malignancies Conference in New York, April 13-15.
The efficacy of venetoclax (VX) in treating high risk CLL patients was demonstrated in the 2019 CLL14 trial (NCT02242942) in which the main entry criteria were being treatment-naive and being considered “unfit” for treatment, meaning that a patient’s Cumulative Illness Rating Scale score was >6, or they presented with decreased kidney function. Study participants were treated with six cycles of either venetoclax-obinutuzumab (VO) or chlorambucil-obinutuzumab (CO); the 4-year PFS was 74% vs. 35.4% (P < .0001) respectively. After 12 cycles of treatment, the 74% of patients in the VO group achieved undetectable minimal residual disease rate (MRD) vs. 32% in the CO group.
Achievement of MRD did predict for outcome, but Dr. Furman concluded that while MRD is a powerful prognostic tool, it is not clinically useful given the inability of its results to guide therapy. He went on to emphasize that “of those patients who achieved MRD levels of 10-4 after 12 cycles of venetoclax, 50% had worsening and 50% had improvement of the residual disease, suggesting that we do not know the optimal duration of venetoclax treatment, as half of the patients still continue to derive benefit.”
Dr. Furman noted that ibrutinib (IB) and the second-generation drugs zanubrutinib (ZB) and acalabrutinib (AL) are all effective, but that the second-generation Bruton’s tyrosine kinase inhibitors enable patients to derive the benefit of remaining on treatment longer, because the rate of concerning cardiac complications is lower than with IB.
The ALPINE trial (NCT03734016) confirmed ZB’s significantly improved overall response rate at 78.3% vs. IB’s 62.5%, as well as a lower rate of atrial fibrillation (2.5%) vs. IB (10.1%).
Noninferiority of AL vs. IB in high-risk relapsed CLL patients was demonstrated in the ELEVATE-RR trial (NCT02477696) with both drugs having a median PFS of 38.4 months. With a median follow up of 41 months, AL demonstrated less atrial fibrillation/atrial flutter, compared with IB (9.4% vs. 16.0%) with no difference in grade > 3 infections. Furthermore, AL’s half-life being shorter than that of IB means that side effects are shorter lived.
“That’s the advantage of the second generation of Bruton’s tyrosine kinase inhibitors,” said Stefan Glück, MD, PhD, a hematologic oncologist and independent consultant who was formerly affiliated with the Sylvester Comprehensive Cancer Center and taught at the Miller School of Medicine at the University of Miami.
Dr. Glück added that “acalabrutinib and zanubrutinib have demonstrated strong efficacy and safety. When patients no longer respond to these drugs, the addition of VX is crucial. It has a completely different mechanism of action and can reverse resistance to Bruton’s tyrosine kinase inhibitors, allowing them to start working again.”
Dr. Furman also discussed proteolysis-targeting chimeras (PROTACs), one area that he expects to make a significant impact as a future therapy for CLL and many other malignancies. Despite the fact these agents are in phase I studies, he commented that “they appear, thus far, to have tremendous potential.”
Dr. Furman disclosed relationships with Abbvie, Acerta/AstraZeneca, Beigene, Jansen, TG Therapeutics, Genentech-Roche, Incyte Corporation, Loxo Oncology, MEI Pharma, Morphosys, Pharmacyclics, Sanofi/Genzyme, and X4 Pharmaceuticals. Dr. Glück reported no conflicts of interest.
AT 2023 GREAT DEBATES AND UPDATES HEMATOLOGIC MALIGNANCIES CONFERENCE
Long-Acting Injectables for the Treatment of Patients With Bipolar Disorder
Bipolar disorder is a multifaceted condition associated with an increased risk for hospitalization and suicide as well as high costs to society and family.
In this ReCAP, Dr Martha Sajatovic, of the University Hospitals of Cleveland, discusses evidence of the short- and long-term consequences of bipolar disorder, including progressive neurologic impact such as changes in brain structure.
She discusses two FDA-approved long-acting injectables for bipolar disorder and considerations for their use, including their potential for first-line maintenance treatment and benefits for medication adherence.
Finally, she considers challenges in the clinical use of the long-acting injectables, including insufficient caregiver involvement and lack of awareness of the drugs' availability.
--
Martha Sajatovic, MD, Director, Neurological and Behavioral Outcomes Center, University Hospitals of Cleveland, Cleveland, Ohio
Martha Sajatovic, MD, has disclosed the following relevant financial relationships:
Received research grant from: Otsuka; International Society for Bipolar Disorders; National Institutes of Health
Received income in an amount equal to or greater than $250 from: Otsuka; Janssen; Lundbeck; Teva; Neurelis
Received royalties from: Springer Press; Johns Hopkins University Press
Bipolar disorder is a multifaceted condition associated with an increased risk for hospitalization and suicide as well as high costs to society and family.
In this ReCAP, Dr Martha Sajatovic, of the University Hospitals of Cleveland, discusses evidence of the short- and long-term consequences of bipolar disorder, including progressive neurologic impact such as changes in brain structure.
She discusses two FDA-approved long-acting injectables for bipolar disorder and considerations for their use, including their potential for first-line maintenance treatment and benefits for medication adherence.
Finally, she considers challenges in the clinical use of the long-acting injectables, including insufficient caregiver involvement and lack of awareness of the drugs' availability.
--
Martha Sajatovic, MD, Director, Neurological and Behavioral Outcomes Center, University Hospitals of Cleveland, Cleveland, Ohio
Martha Sajatovic, MD, has disclosed the following relevant financial relationships:
Received research grant from: Otsuka; International Society for Bipolar Disorders; National Institutes of Health
Received income in an amount equal to or greater than $250 from: Otsuka; Janssen; Lundbeck; Teva; Neurelis
Received royalties from: Springer Press; Johns Hopkins University Press
Bipolar disorder is a multifaceted condition associated with an increased risk for hospitalization and suicide as well as high costs to society and family.
In this ReCAP, Dr Martha Sajatovic, of the University Hospitals of Cleveland, discusses evidence of the short- and long-term consequences of bipolar disorder, including progressive neurologic impact such as changes in brain structure.
She discusses two FDA-approved long-acting injectables for bipolar disorder and considerations for their use, including their potential for first-line maintenance treatment and benefits for medication adherence.
Finally, she considers challenges in the clinical use of the long-acting injectables, including insufficient caregiver involvement and lack of awareness of the drugs' availability.
--
Martha Sajatovic, MD, Director, Neurological and Behavioral Outcomes Center, University Hospitals of Cleveland, Cleveland, Ohio
Martha Sajatovic, MD, has disclosed the following relevant financial relationships:
Received research grant from: Otsuka; International Society for Bipolar Disorders; National Institutes of Health
Received income in an amount equal to or greater than $250 from: Otsuka; Janssen; Lundbeck; Teva; Neurelis
Received royalties from: Springer Press; Johns Hopkins University Press
Weight loss linked to early death in older but healthy adults
suggesting the need for clinicians to be alert to such changes.
“Our study emphasizes the importance of weight loss even in relatively healthy individuals who are free from evident cardiovascular disease [CVD], dementia, physical disability, or life-limiting chronic illness,” first author Monira Hussain, MBBS, MPH, PhD, said in an interview.
“Clinicians should be aware that even minor weight loss of 5% or more in older adults without life-limiting illnesses can increase mortality risk,” Dr. Hussain said. “Regular monitoring of weight changes can help early identification of associated risks.”
The study was published online in JAMA Network Open.
The researchers noted that data on the significance of weight changes among older individuals who are otherwise relatively healthy and not diagnosed with life-limited diseases are limited, with the exception that “it is widely acknowledged that weight loss may precede a diagnosis of cancer.” But the association with the other types of non–cancer-related premature death is notable.
“In our study, weight loss also preceded an increased mortality from CVD and other causes, [such as] deaths from trauma, dementia, Parkinson disease, and other less common causes.”
Therefore, “a likely explanation for these findings is that weight loss can be an early prodromal indicator of the presence of various life-shortening diseases,” Dr. Hussain, of Monash University, Melbourne, and colleagues wrote.
In terms of why weight loss shows such a stronger link to mortality in older men, compared with women, Dr. Hussain speculated that this may be caused by “differences in body composition,” between the two sexes. “Men have a higher proportion of muscle and bone mass, and weight loss [in men] primarily involves loss of these tissues.”
10% weight loss quadrupled risk of premature death among men
To investigate this phenomenon, the researchers conducted a post hoc analysis of the Aspirin in Reducing Events in the Elderly (ASPREE) randomized trial, which included information on a variety of body size parameters, such as weight and waist circumference, measured annually, from a large population of healthy individuals with no evident CVD, dementia, physical disability, or life-limiting chronic illness.
The 16,523 participants included in the study had a mean age of 75 years and 55.6% were women. During a mean follow-up of 4.4 years, 1,256 deaths occurred in the cohort.
Looking at rates of all-cause mortality, stratified by gender, the results showed that among men who had a 5%-10% decrease in weight over the course of the study, the risk of all-cause mortality was 33% higher than that of men who had a stable weight (less than 5% change; hazard ratio, 1.33).
Among men who had a more than 10% decrease in weight, the mortality risk was as much as 289%, or nearly four times higher compared with those with a stable weight (HR, 3.89).
For women, the mortality risk was also increased, however, to a lesser degree. A 5%-10% loss of body weight was associated with a 26% increased mortality risk (HR, 1.26), and a loss of more than 10% was linked to a 114% increased risk of all-cause mortality (HR, 2.14).
In terms of cancer-specific deaths, the risk was significantly increased only among men who had a greater than 10% weight decrease (HR, 3.49), while the increased risk in women was observed with a 5%-10% decrease in weight (HR, 1.44) as well as a more than 10% decrease (HR, 2.78).
The risk of CVD-specific death was significantly increased with a more than 10% decrease in weight in both sexes, but the risk was again higher among men (HR, 3.14) than women (HR, 1.92), compared with stable weight groups.
And the noncancer, non–CVD-specific mortality risk was nearly five times higher among men who had a more than 10% decrease in weight versus stable weight (HR, 4.98); however, the association was not significant among women (HR, 1.49).
Looking at the effects of change in waist circumference, a decrease of more than 10% was associated with a higher risk in all-cause mortality that was again higher for men (HR, 2.14) versus women (HR, 1.34); however, no link with all-cause mortality was observed with a less than 10% decrease in either sex.
A greater than 10% decrease in waist circumference was also associated with higher risk of cancer death for men and women, and higher noncancer, non-CVD death among men, but not women, while there was no association between waist circumference and CVD mortality in men or women.
Association with mortality remained after adjustment for hospitalization
The results persisted after adjustment for age, frailty status, baseline body mass index, country of birth, smoking, hypertension, diabetes, and hospitalization in the previous 24 months.
The adjustment for recent hospitalization was especially important for ruling out weight loss that may have occurred because of hospitalization for acute conditions that could have contributed to mortality, the authors noted.
The authors reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
suggesting the need for clinicians to be alert to such changes.
“Our study emphasizes the importance of weight loss even in relatively healthy individuals who are free from evident cardiovascular disease [CVD], dementia, physical disability, or life-limiting chronic illness,” first author Monira Hussain, MBBS, MPH, PhD, said in an interview.
“Clinicians should be aware that even minor weight loss of 5% or more in older adults without life-limiting illnesses can increase mortality risk,” Dr. Hussain said. “Regular monitoring of weight changes can help early identification of associated risks.”
The study was published online in JAMA Network Open.
The researchers noted that data on the significance of weight changes among older individuals who are otherwise relatively healthy and not diagnosed with life-limited diseases are limited, with the exception that “it is widely acknowledged that weight loss may precede a diagnosis of cancer.” But the association with the other types of non–cancer-related premature death is notable.
“In our study, weight loss also preceded an increased mortality from CVD and other causes, [such as] deaths from trauma, dementia, Parkinson disease, and other less common causes.”
Therefore, “a likely explanation for these findings is that weight loss can be an early prodromal indicator of the presence of various life-shortening diseases,” Dr. Hussain, of Monash University, Melbourne, and colleagues wrote.
In terms of why weight loss shows such a stronger link to mortality in older men, compared with women, Dr. Hussain speculated that this may be caused by “differences in body composition,” between the two sexes. “Men have a higher proportion of muscle and bone mass, and weight loss [in men] primarily involves loss of these tissues.”
10% weight loss quadrupled risk of premature death among men
To investigate this phenomenon, the researchers conducted a post hoc analysis of the Aspirin in Reducing Events in the Elderly (ASPREE) randomized trial, which included information on a variety of body size parameters, such as weight and waist circumference, measured annually, from a large population of healthy individuals with no evident CVD, dementia, physical disability, or life-limiting chronic illness.
The 16,523 participants included in the study had a mean age of 75 years and 55.6% were women. During a mean follow-up of 4.4 years, 1,256 deaths occurred in the cohort.
Looking at rates of all-cause mortality, stratified by gender, the results showed that among men who had a 5%-10% decrease in weight over the course of the study, the risk of all-cause mortality was 33% higher than that of men who had a stable weight (less than 5% change; hazard ratio, 1.33).
Among men who had a more than 10% decrease in weight, the mortality risk was as much as 289%, or nearly four times higher compared with those with a stable weight (HR, 3.89).
For women, the mortality risk was also increased, however, to a lesser degree. A 5%-10% loss of body weight was associated with a 26% increased mortality risk (HR, 1.26), and a loss of more than 10% was linked to a 114% increased risk of all-cause mortality (HR, 2.14).
In terms of cancer-specific deaths, the risk was significantly increased only among men who had a greater than 10% weight decrease (HR, 3.49), while the increased risk in women was observed with a 5%-10% decrease in weight (HR, 1.44) as well as a more than 10% decrease (HR, 2.78).
The risk of CVD-specific death was significantly increased with a more than 10% decrease in weight in both sexes, but the risk was again higher among men (HR, 3.14) than women (HR, 1.92), compared with stable weight groups.
And the noncancer, non–CVD-specific mortality risk was nearly five times higher among men who had a more than 10% decrease in weight versus stable weight (HR, 4.98); however, the association was not significant among women (HR, 1.49).
Looking at the effects of change in waist circumference, a decrease of more than 10% was associated with a higher risk in all-cause mortality that was again higher for men (HR, 2.14) versus women (HR, 1.34); however, no link with all-cause mortality was observed with a less than 10% decrease in either sex.
A greater than 10% decrease in waist circumference was also associated with higher risk of cancer death for men and women, and higher noncancer, non-CVD death among men, but not women, while there was no association between waist circumference and CVD mortality in men or women.
Association with mortality remained after adjustment for hospitalization
The results persisted after adjustment for age, frailty status, baseline body mass index, country of birth, smoking, hypertension, diabetes, and hospitalization in the previous 24 months.
The adjustment for recent hospitalization was especially important for ruling out weight loss that may have occurred because of hospitalization for acute conditions that could have contributed to mortality, the authors noted.
The authors reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
suggesting the need for clinicians to be alert to such changes.
“Our study emphasizes the importance of weight loss even in relatively healthy individuals who are free from evident cardiovascular disease [CVD], dementia, physical disability, or life-limiting chronic illness,” first author Monira Hussain, MBBS, MPH, PhD, said in an interview.
“Clinicians should be aware that even minor weight loss of 5% or more in older adults without life-limiting illnesses can increase mortality risk,” Dr. Hussain said. “Regular monitoring of weight changes can help early identification of associated risks.”
The study was published online in JAMA Network Open.
The researchers noted that data on the significance of weight changes among older individuals who are otherwise relatively healthy and not diagnosed with life-limited diseases are limited, with the exception that “it is widely acknowledged that weight loss may precede a diagnosis of cancer.” But the association with the other types of non–cancer-related premature death is notable.
“In our study, weight loss also preceded an increased mortality from CVD and other causes, [such as] deaths from trauma, dementia, Parkinson disease, and other less common causes.”
Therefore, “a likely explanation for these findings is that weight loss can be an early prodromal indicator of the presence of various life-shortening diseases,” Dr. Hussain, of Monash University, Melbourne, and colleagues wrote.
In terms of why weight loss shows such a stronger link to mortality in older men, compared with women, Dr. Hussain speculated that this may be caused by “differences in body composition,” between the two sexes. “Men have a higher proportion of muscle and bone mass, and weight loss [in men] primarily involves loss of these tissues.”
10% weight loss quadrupled risk of premature death among men
To investigate this phenomenon, the researchers conducted a post hoc analysis of the Aspirin in Reducing Events in the Elderly (ASPREE) randomized trial, which included information on a variety of body size parameters, such as weight and waist circumference, measured annually, from a large population of healthy individuals with no evident CVD, dementia, physical disability, or life-limiting chronic illness.
The 16,523 participants included in the study had a mean age of 75 years and 55.6% were women. During a mean follow-up of 4.4 years, 1,256 deaths occurred in the cohort.
Looking at rates of all-cause mortality, stratified by gender, the results showed that among men who had a 5%-10% decrease in weight over the course of the study, the risk of all-cause mortality was 33% higher than that of men who had a stable weight (less than 5% change; hazard ratio, 1.33).
Among men who had a more than 10% decrease in weight, the mortality risk was as much as 289%, or nearly four times higher compared with those with a stable weight (HR, 3.89).
For women, the mortality risk was also increased, however, to a lesser degree. A 5%-10% loss of body weight was associated with a 26% increased mortality risk (HR, 1.26), and a loss of more than 10% was linked to a 114% increased risk of all-cause mortality (HR, 2.14).
In terms of cancer-specific deaths, the risk was significantly increased only among men who had a greater than 10% weight decrease (HR, 3.49), while the increased risk in women was observed with a 5%-10% decrease in weight (HR, 1.44) as well as a more than 10% decrease (HR, 2.78).
The risk of CVD-specific death was significantly increased with a more than 10% decrease in weight in both sexes, but the risk was again higher among men (HR, 3.14) than women (HR, 1.92), compared with stable weight groups.
And the noncancer, non–CVD-specific mortality risk was nearly five times higher among men who had a more than 10% decrease in weight versus stable weight (HR, 4.98); however, the association was not significant among women (HR, 1.49).
Looking at the effects of change in waist circumference, a decrease of more than 10% was associated with a higher risk in all-cause mortality that was again higher for men (HR, 2.14) versus women (HR, 1.34); however, no link with all-cause mortality was observed with a less than 10% decrease in either sex.
A greater than 10% decrease in waist circumference was also associated with higher risk of cancer death for men and women, and higher noncancer, non-CVD death among men, but not women, while there was no association between waist circumference and CVD mortality in men or women.
Association with mortality remained after adjustment for hospitalization
The results persisted after adjustment for age, frailty status, baseline body mass index, country of birth, smoking, hypertension, diabetes, and hospitalization in the previous 24 months.
The adjustment for recent hospitalization was especially important for ruling out weight loss that may have occurred because of hospitalization for acute conditions that could have contributed to mortality, the authors noted.
The authors reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM JAMA NETWORK OPEN
New variant jumps to second place on COVID list
Officially labeled XBB.1.16, Arcturus is a subvariant of Omicron that was first seen in India and has been on the World Health Organization’s watchlist since the end of March. The CDC’s most recent update now lists Arcturus as causing 7% of U.S. coronavirus cases, landing it in second place behind its long-predominant Omicron cousin XBB.1.5, which causes 78% of cases.
Arcturus is more transmissible but not more dangerous than recent chart-topping strains, experts say.
“It is causing increasing case counts in certain parts of the world, including India. We’re not seeing high rates of XBB.1.16 yet in the United States, but it may become more prominent in coming weeks,” Mayo Clinic viral disease expert Matthew Binnicker, PhD, told The Seattle Times.
Arcturus has been causing a new symptom in children, Indian medical providers have reported.
“One new feature of cases caused by this variant is that it seems to be causing conjunctivitis, or red and itchy eyes, in young patients,” Dr. Binnicker said. “This is not something that we’ve seen with prior strains of the virus.”
More than 11,000 people in the United States remained hospitalized with COVID at the end of last week, and 1,327 people died of the virus last week, CDC data show. To date, 6.9 million people worldwide have died from COVID, the WHO says. Of those deaths, more than 1.1 million occurred in the U.S.
A version of this article originally appeared on WebMD.com.
Officially labeled XBB.1.16, Arcturus is a subvariant of Omicron that was first seen in India and has been on the World Health Organization’s watchlist since the end of March. The CDC’s most recent update now lists Arcturus as causing 7% of U.S. coronavirus cases, landing it in second place behind its long-predominant Omicron cousin XBB.1.5, which causes 78% of cases.
Arcturus is more transmissible but not more dangerous than recent chart-topping strains, experts say.
“It is causing increasing case counts in certain parts of the world, including India. We’re not seeing high rates of XBB.1.16 yet in the United States, but it may become more prominent in coming weeks,” Mayo Clinic viral disease expert Matthew Binnicker, PhD, told The Seattle Times.
Arcturus has been causing a new symptom in children, Indian medical providers have reported.
“One new feature of cases caused by this variant is that it seems to be causing conjunctivitis, or red and itchy eyes, in young patients,” Dr. Binnicker said. “This is not something that we’ve seen with prior strains of the virus.”
More than 11,000 people in the United States remained hospitalized with COVID at the end of last week, and 1,327 people died of the virus last week, CDC data show. To date, 6.9 million people worldwide have died from COVID, the WHO says. Of those deaths, more than 1.1 million occurred in the U.S.
A version of this article originally appeared on WebMD.com.
Officially labeled XBB.1.16, Arcturus is a subvariant of Omicron that was first seen in India and has been on the World Health Organization’s watchlist since the end of March. The CDC’s most recent update now lists Arcturus as causing 7% of U.S. coronavirus cases, landing it in second place behind its long-predominant Omicron cousin XBB.1.5, which causes 78% of cases.
Arcturus is more transmissible but not more dangerous than recent chart-topping strains, experts say.
“It is causing increasing case counts in certain parts of the world, including India. We’re not seeing high rates of XBB.1.16 yet in the United States, but it may become more prominent in coming weeks,” Mayo Clinic viral disease expert Matthew Binnicker, PhD, told The Seattle Times.
Arcturus has been causing a new symptom in children, Indian medical providers have reported.
“One new feature of cases caused by this variant is that it seems to be causing conjunctivitis, or red and itchy eyes, in young patients,” Dr. Binnicker said. “This is not something that we’ve seen with prior strains of the virus.”
More than 11,000 people in the United States remained hospitalized with COVID at the end of last week, and 1,327 people died of the virus last week, CDC data show. To date, 6.9 million people worldwide have died from COVID, the WHO says. Of those deaths, more than 1.1 million occurred in the U.S.
A version of this article originally appeared on WebMD.com.
Pembrolizumab monotherapy effective for rare melanoma
The findings could represent a new standard of treatment for this extremely rare tumor.
The study was inspired by a previous retrospective analysis which found an overall response rate of 77% and a complete response of 32% to anti–PD-1 monotherapy.
The ORR is about double what is seen in melanoma more generally, according to Kari Kendra, MD, PhD, who presented the study at the annual meeting of the American Association for Cancer Research.
“Our study was a positive study. Of note, in the retrospective study, they saw a complete response rate of 32%, which was amazingly similar to what we found. [The findings support] the use of single agent anti–PD-1 immunotherapy as first line treatment for most patients with unresectable desmoplastic melanoma. [There was 89% overall response and we saw] dramatic responses across the board,” said Dr. Kendra, who is a medical oncologist at Ohio State University Wexner Medical Center, Columbus.
The findings drew a strong reaction. “In a rare tumor session, to see response curves like that, it’s just outstanding,” said the session’s cochair Brian Van Tine, MD, PhD, who is a professor of medical oncology at Washington University in St. Louis.
“This really is one of the highest tumor response rates to immunotherapy that we are seeing in any cancer. And I think may also highlight the fact that we shouldn’t think of all cutaneous melanomas as one disease, given the heterogeneity in tumor responses based on some of the pathologic and molecular characteristics,” said Zeynep Aroglu, MD, who served as a discussant but was also one of the investigators who enrolled patients for the trial.
Desmoplastic melanoma represents about 4% of all cutaneous melanoma diagnoses, and its unique pathology can make it difficult to diagnose. That often leads to a late diagnosis, according to Dr. Aroglu. They typically occur in elderly patients, in the head and neck area, and are associated with sun exposure. DM also tends to have a high mutation burden, Dr. Aroglu said during the session.
It remains to be seen why there is such a high response rate in this tumor type, even among tumor types with mutation burdens that are nearly as high. DM tumors are often driven by neurofibromatosis type 1, but other tumors driven by NF-1 don’t have as high of a response rate to immunotherapy. The tumor environment could also play a role, she said.
“Is it a combination of all these factors? I think some of the ongoing analysis of tumor samples that Dr. Kendra mentioned may help to answer some of these questions,” Dr. Aroglu continued.
She also noted that the melanoma field is increasingly turning to combination of anti–PD-1 therapy with agents like that target LAG3 or CTLA4. Such combinations can achieve higher response rates, but at a cost of higher rates of grade 3-4 adverse events than anti–PD-1 inhibitors alone. “I wonder if for desmoplastic melanomas in light of this data, do we consider de-escalating therapy, given these very high response rates to PD-1 alone, given also the elderly age of many of these patients, because even the PD-1–LAG3 combo still has a higher rate of toxicity than PD-1 monotherapy. Perhaps the immunotherapy combinations can be reserved for those rare desmoplastic patients who are resistant to PD-1 alone,” said Dr. Aroglu.
Study details and adverse events
Twenty-seven patients were enrolled in the study; 93% were male, all were White, and 22% had elevated baseline lactate dehydrogenase. About 63% had disease located in the head and neck area, 33% experienced a complete response (P < .001), and 56% had a partial response for an ORR of 89%. The result surpassed the primary endpoint target of at least a 20% complete response rate.
The 2-year progression-free survival was 74%, and 2-year overall survival was 89%. The most common toxicities were fatigue (56%), diarrhea (33%), maculopapular rash (30%), pruritus (22%), anemia (19%), arthralgia (19%), and decreased lymphocyte count (19%). There were two grade 4 adverse events: a lipase increase and a lung infection accompanied by sepsis.
The researchers also carried out whole exome sequencing of biopsies and found that 67% had NF-1 loss of function mutations.
Dr. Aroglu has served on advisory boards for Pfizer, Array, Eisai, Genentech, Natera, Novartis, OncoSec, and Regeneron. She has received research support from Boehringer Ingelheim, Pfizer, and Novartis. Dr. Kendra has received institutional support from Bristol Myers-Squibb and trial support from CheckMate Pharmaceuticals, GlaxoSmithKline, Immunocore, Medspace, Merck, Novartis, and Varian Medical Systems. Dr. Van Tine has financial relationships with a wide range of pharmaceutical companies.
The findings could represent a new standard of treatment for this extremely rare tumor.
The study was inspired by a previous retrospective analysis which found an overall response rate of 77% and a complete response of 32% to anti–PD-1 monotherapy.
The ORR is about double what is seen in melanoma more generally, according to Kari Kendra, MD, PhD, who presented the study at the annual meeting of the American Association for Cancer Research.
“Our study was a positive study. Of note, in the retrospective study, they saw a complete response rate of 32%, which was amazingly similar to what we found. [The findings support] the use of single agent anti–PD-1 immunotherapy as first line treatment for most patients with unresectable desmoplastic melanoma. [There was 89% overall response and we saw] dramatic responses across the board,” said Dr. Kendra, who is a medical oncologist at Ohio State University Wexner Medical Center, Columbus.
The findings drew a strong reaction. “In a rare tumor session, to see response curves like that, it’s just outstanding,” said the session’s cochair Brian Van Tine, MD, PhD, who is a professor of medical oncology at Washington University in St. Louis.
“This really is one of the highest tumor response rates to immunotherapy that we are seeing in any cancer. And I think may also highlight the fact that we shouldn’t think of all cutaneous melanomas as one disease, given the heterogeneity in tumor responses based on some of the pathologic and molecular characteristics,” said Zeynep Aroglu, MD, who served as a discussant but was also one of the investigators who enrolled patients for the trial.
Desmoplastic melanoma represents about 4% of all cutaneous melanoma diagnoses, and its unique pathology can make it difficult to diagnose. That often leads to a late diagnosis, according to Dr. Aroglu. They typically occur in elderly patients, in the head and neck area, and are associated with sun exposure. DM also tends to have a high mutation burden, Dr. Aroglu said during the session.
It remains to be seen why there is such a high response rate in this tumor type, even among tumor types with mutation burdens that are nearly as high. DM tumors are often driven by neurofibromatosis type 1, but other tumors driven by NF-1 don’t have as high of a response rate to immunotherapy. The tumor environment could also play a role, she said.
“Is it a combination of all these factors? I think some of the ongoing analysis of tumor samples that Dr. Kendra mentioned may help to answer some of these questions,” Dr. Aroglu continued.
She also noted that the melanoma field is increasingly turning to combination of anti–PD-1 therapy with agents like that target LAG3 or CTLA4. Such combinations can achieve higher response rates, but at a cost of higher rates of grade 3-4 adverse events than anti–PD-1 inhibitors alone. “I wonder if for desmoplastic melanomas in light of this data, do we consider de-escalating therapy, given these very high response rates to PD-1 alone, given also the elderly age of many of these patients, because even the PD-1–LAG3 combo still has a higher rate of toxicity than PD-1 monotherapy. Perhaps the immunotherapy combinations can be reserved for those rare desmoplastic patients who are resistant to PD-1 alone,” said Dr. Aroglu.
Study details and adverse events
Twenty-seven patients were enrolled in the study; 93% were male, all were White, and 22% had elevated baseline lactate dehydrogenase. About 63% had disease located in the head and neck area, 33% experienced a complete response (P < .001), and 56% had a partial response for an ORR of 89%. The result surpassed the primary endpoint target of at least a 20% complete response rate.
The 2-year progression-free survival was 74%, and 2-year overall survival was 89%. The most common toxicities were fatigue (56%), diarrhea (33%), maculopapular rash (30%), pruritus (22%), anemia (19%), arthralgia (19%), and decreased lymphocyte count (19%). There were two grade 4 adverse events: a lipase increase and a lung infection accompanied by sepsis.
The researchers also carried out whole exome sequencing of biopsies and found that 67% had NF-1 loss of function mutations.
Dr. Aroglu has served on advisory boards for Pfizer, Array, Eisai, Genentech, Natera, Novartis, OncoSec, and Regeneron. She has received research support from Boehringer Ingelheim, Pfizer, and Novartis. Dr. Kendra has received institutional support from Bristol Myers-Squibb and trial support from CheckMate Pharmaceuticals, GlaxoSmithKline, Immunocore, Medspace, Merck, Novartis, and Varian Medical Systems. Dr. Van Tine has financial relationships with a wide range of pharmaceutical companies.
The findings could represent a new standard of treatment for this extremely rare tumor.
The study was inspired by a previous retrospective analysis which found an overall response rate of 77% and a complete response of 32% to anti–PD-1 monotherapy.
The ORR is about double what is seen in melanoma more generally, according to Kari Kendra, MD, PhD, who presented the study at the annual meeting of the American Association for Cancer Research.
“Our study was a positive study. Of note, in the retrospective study, they saw a complete response rate of 32%, which was amazingly similar to what we found. [The findings support] the use of single agent anti–PD-1 immunotherapy as first line treatment for most patients with unresectable desmoplastic melanoma. [There was 89% overall response and we saw] dramatic responses across the board,” said Dr. Kendra, who is a medical oncologist at Ohio State University Wexner Medical Center, Columbus.
The findings drew a strong reaction. “In a rare tumor session, to see response curves like that, it’s just outstanding,” said the session’s cochair Brian Van Tine, MD, PhD, who is a professor of medical oncology at Washington University in St. Louis.
“This really is one of the highest tumor response rates to immunotherapy that we are seeing in any cancer. And I think may also highlight the fact that we shouldn’t think of all cutaneous melanomas as one disease, given the heterogeneity in tumor responses based on some of the pathologic and molecular characteristics,” said Zeynep Aroglu, MD, who served as a discussant but was also one of the investigators who enrolled patients for the trial.
Desmoplastic melanoma represents about 4% of all cutaneous melanoma diagnoses, and its unique pathology can make it difficult to diagnose. That often leads to a late diagnosis, according to Dr. Aroglu. They typically occur in elderly patients, in the head and neck area, and are associated with sun exposure. DM also tends to have a high mutation burden, Dr. Aroglu said during the session.
It remains to be seen why there is such a high response rate in this tumor type, even among tumor types with mutation burdens that are nearly as high. DM tumors are often driven by neurofibromatosis type 1, but other tumors driven by NF-1 don’t have as high of a response rate to immunotherapy. The tumor environment could also play a role, she said.
“Is it a combination of all these factors? I think some of the ongoing analysis of tumor samples that Dr. Kendra mentioned may help to answer some of these questions,” Dr. Aroglu continued.
She also noted that the melanoma field is increasingly turning to combination of anti–PD-1 therapy with agents like that target LAG3 or CTLA4. Such combinations can achieve higher response rates, but at a cost of higher rates of grade 3-4 adverse events than anti–PD-1 inhibitors alone. “I wonder if for desmoplastic melanomas in light of this data, do we consider de-escalating therapy, given these very high response rates to PD-1 alone, given also the elderly age of many of these patients, because even the PD-1–LAG3 combo still has a higher rate of toxicity than PD-1 monotherapy. Perhaps the immunotherapy combinations can be reserved for those rare desmoplastic patients who are resistant to PD-1 alone,” said Dr. Aroglu.
Study details and adverse events
Twenty-seven patients were enrolled in the study; 93% were male, all were White, and 22% had elevated baseline lactate dehydrogenase. About 63% had disease located in the head and neck area, 33% experienced a complete response (P < .001), and 56% had a partial response for an ORR of 89%. The result surpassed the primary endpoint target of at least a 20% complete response rate.
The 2-year progression-free survival was 74%, and 2-year overall survival was 89%. The most common toxicities were fatigue (56%), diarrhea (33%), maculopapular rash (30%), pruritus (22%), anemia (19%), arthralgia (19%), and decreased lymphocyte count (19%). There were two grade 4 adverse events: a lipase increase and a lung infection accompanied by sepsis.
The researchers also carried out whole exome sequencing of biopsies and found that 67% had NF-1 loss of function mutations.
Dr. Aroglu has served on advisory boards for Pfizer, Array, Eisai, Genentech, Natera, Novartis, OncoSec, and Regeneron. She has received research support from Boehringer Ingelheim, Pfizer, and Novartis. Dr. Kendra has received institutional support from Bristol Myers-Squibb and trial support from CheckMate Pharmaceuticals, GlaxoSmithKline, Immunocore, Medspace, Merck, Novartis, and Varian Medical Systems. Dr. Van Tine has financial relationships with a wide range of pharmaceutical companies.
FROM AACR 2023
Use age, not weight, to screen for diabetes; assess over 35s
Universal screening of all U.S. adults aged 35-70 years for prediabetes and type 2 diabetes, regardless of body mass index, would provide the fairest means of detection, according to a new analysis.
This would better detect prediabetes and diabetes in ethnic groups that have a higher risk of diabetes at lower cutoffs. Compared with White individuals, Black or Hispanic adults have a higher risk of developing type 2 diabetes at a younger age, and Asian, Hispanic, and Black Americans all have a higher risk of developing it at a lower BMI.
In the new study, researchers examined six different screening scenarios in a nationally representative sample without diabetes.
They compared screening for prediabetes and type 2 diabetes using criteria from the 2021 U.S. Preventive Services Task Force (USPSTF) recommendations with the 2015 USPSTF recommendations, as well as four other screening thresholds with lower age or weight.
Universal screening for prediabetes and diabetes at age 35-70, regardless of BMI – which appears to be the sweet spot for most equitable detection in different races – may be easier to put into practice because it will mean clinicians don’t have to remember alternate cutoffs for different patient groups, the researchers suggested.
“All major racial and ethnic minority groups develop diabetes at lower weights than White adults, and it’s most pronounced for Asian Americans,” lead author Matthew J. O’Brien, MD, explained in a press release.
“If we make decisions about diabetes testing based on weight we will miss some people from racial and ethnic minority groups who are developing prediabetes and diabetes at lower weights,” said Dr. O’Brien, of Northwestern University, Chicago.
Going forward, to achieve equity in diagnosing prediabetes and diabetes “also requires addressing structural barriers [facing racial and ethnic minorities], which include not having a usual source of primary care, lacking health insurance, or having copays for screening tests based on insurance coverage,” the authors noted in their paper, published online in the American Journal of Preventive Medicine.
There is also a need for further study to examine the cost-effectiveness of any approach, and to study the impact of screening criteria on diagnosis, treatment, and outcomes in diverse populations.
Nationally representative sample, six screening scenarios
In the overall U.S. population, 81% of adults with prediabetes are unaware they have it, said Dr. O’Brien and colleagues, and 23% of diabetes cases are undiagnosed.
And Black, Hispanic, or Asian individuals have a nearly twofold higher prevalence of diabetes compared with White individuals.
The 2021 USPSTF recommendations state that clinicians should screen asymptomatic adults aged 35-70 years with overweight/obesity (BMI ≥ 25 kg/m2) and “should consider screening at an earlier age in persons from groups with disproportionately high incidence and prevalence (American Indian/Alaska Native, Asian American, Black, Hispanic/Latino, or Native Hawaiian/Pacific Islander persons) or in persons who have a family history of diabetes, a history of gestational diabetes, or a history of polycystic ovarian syndrome, and at a lower BMI in Asian American persons. Data suggest that a BMI of 23 or greater may be an appropriate cut point in Asian American persons.”
Dr. O’Brien and colleagues identified 3,243 nonpregnant adults without diagnosed diabetes who participated in the National Health and Nutrition Examination Survey (NHANES) in 2017-2020 and had an A1c blood test. (Half also had a fasting plasma glucose test.)
First, they compared screening using the more recent and earlier USPSTF criteria: BMI of at least 25 kg/m2 and age 35-70 (2021 criteria) and BMI of at least 25 kg/m2 and age 40-70 (2015 criteria).
They estimated that 13.9 million more adults would be eligible for screening using the 2021 versus the 2015 screening criteria.
The increases in screening eligibility were highest in Hispanic individuals (30.6%), followed by Asian individuals (17.9%), White individuals (14.0%), and Black individuals (13.9%).
Using the USPSTF 2021 versus 2015 screening criteria resulted in marginally higher sensitivity (58.6% vs. 52.9%) but lower specificity (69.3% vs. 76.4%) overall, as well as within each racial group.
Next, the researchers examined screening at two lower age cutoffs and two lower BMI cutoffs: BMI of at least 25 kg/m2 and age 30-70, BMI of at least 25 kg/m2 and age 18-70, age 35-70 and BMI of at least 23 kg/m2, and age 35-70 and any BMI.
Screening at these lower age and weight thresholds resulted in even greater sensitivity and lower specificity than using the 2021 USPSTF criteria, especially among Hispanic, non-Hispanic Black, and Asian adults.
However, screening all adults aged 35-70 years regardless of BMI yielded the most equitable detection of prediabetes and diabetes – with a sensitivity of 67.8% and a specificity of 52.1% in the overall population, and a sensitivity of 70.1%, 70.4%, 68.4%, and 67.6%, and a specificity of 53.8%, 59.9%, 56.2%, and 48.9%, in the Asian, Black, Hispanic, and White subgroups, respectively.
The American Diabetes Association currently recommends screening all adults aged ≥ 35 years, or at any age if they have overweight/obesity and an additional diabetes risk factor, the researchers noted.
The study was partly funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. The authors have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Universal screening of all U.S. adults aged 35-70 years for prediabetes and type 2 diabetes, regardless of body mass index, would provide the fairest means of detection, according to a new analysis.
This would better detect prediabetes and diabetes in ethnic groups that have a higher risk of diabetes at lower cutoffs. Compared with White individuals, Black or Hispanic adults have a higher risk of developing type 2 diabetes at a younger age, and Asian, Hispanic, and Black Americans all have a higher risk of developing it at a lower BMI.
In the new study, researchers examined six different screening scenarios in a nationally representative sample without diabetes.
They compared screening for prediabetes and type 2 diabetes using criteria from the 2021 U.S. Preventive Services Task Force (USPSTF) recommendations with the 2015 USPSTF recommendations, as well as four other screening thresholds with lower age or weight.
Universal screening for prediabetes and diabetes at age 35-70, regardless of BMI – which appears to be the sweet spot for most equitable detection in different races – may be easier to put into practice because it will mean clinicians don’t have to remember alternate cutoffs for different patient groups, the researchers suggested.
“All major racial and ethnic minority groups develop diabetes at lower weights than White adults, and it’s most pronounced for Asian Americans,” lead author Matthew J. O’Brien, MD, explained in a press release.
“If we make decisions about diabetes testing based on weight we will miss some people from racial and ethnic minority groups who are developing prediabetes and diabetes at lower weights,” said Dr. O’Brien, of Northwestern University, Chicago.
Going forward, to achieve equity in diagnosing prediabetes and diabetes “also requires addressing structural barriers [facing racial and ethnic minorities], which include not having a usual source of primary care, lacking health insurance, or having copays for screening tests based on insurance coverage,” the authors noted in their paper, published online in the American Journal of Preventive Medicine.
There is also a need for further study to examine the cost-effectiveness of any approach, and to study the impact of screening criteria on diagnosis, treatment, and outcomes in diverse populations.
Nationally representative sample, six screening scenarios
In the overall U.S. population, 81% of adults with prediabetes are unaware they have it, said Dr. O’Brien and colleagues, and 23% of diabetes cases are undiagnosed.
And Black, Hispanic, or Asian individuals have a nearly twofold higher prevalence of diabetes compared with White individuals.
The 2021 USPSTF recommendations state that clinicians should screen asymptomatic adults aged 35-70 years with overweight/obesity (BMI ≥ 25 kg/m2) and “should consider screening at an earlier age in persons from groups with disproportionately high incidence and prevalence (American Indian/Alaska Native, Asian American, Black, Hispanic/Latino, or Native Hawaiian/Pacific Islander persons) or in persons who have a family history of diabetes, a history of gestational diabetes, or a history of polycystic ovarian syndrome, and at a lower BMI in Asian American persons. Data suggest that a BMI of 23 or greater may be an appropriate cut point in Asian American persons.”
Dr. O’Brien and colleagues identified 3,243 nonpregnant adults without diagnosed diabetes who participated in the National Health and Nutrition Examination Survey (NHANES) in 2017-2020 and had an A1c blood test. (Half also had a fasting plasma glucose test.)
First, they compared screening using the more recent and earlier USPSTF criteria: BMI of at least 25 kg/m2 and age 35-70 (2021 criteria) and BMI of at least 25 kg/m2 and age 40-70 (2015 criteria).
They estimated that 13.9 million more adults would be eligible for screening using the 2021 versus the 2015 screening criteria.
The increases in screening eligibility were highest in Hispanic individuals (30.6%), followed by Asian individuals (17.9%), White individuals (14.0%), and Black individuals (13.9%).
Using the USPSTF 2021 versus 2015 screening criteria resulted in marginally higher sensitivity (58.6% vs. 52.9%) but lower specificity (69.3% vs. 76.4%) overall, as well as within each racial group.
Next, the researchers examined screening at two lower age cutoffs and two lower BMI cutoffs: BMI of at least 25 kg/m2 and age 30-70, BMI of at least 25 kg/m2 and age 18-70, age 35-70 and BMI of at least 23 kg/m2, and age 35-70 and any BMI.
Screening at these lower age and weight thresholds resulted in even greater sensitivity and lower specificity than using the 2021 USPSTF criteria, especially among Hispanic, non-Hispanic Black, and Asian adults.
However, screening all adults aged 35-70 years regardless of BMI yielded the most equitable detection of prediabetes and diabetes – with a sensitivity of 67.8% and a specificity of 52.1% in the overall population, and a sensitivity of 70.1%, 70.4%, 68.4%, and 67.6%, and a specificity of 53.8%, 59.9%, 56.2%, and 48.9%, in the Asian, Black, Hispanic, and White subgroups, respectively.
The American Diabetes Association currently recommends screening all adults aged ≥ 35 years, or at any age if they have overweight/obesity and an additional diabetes risk factor, the researchers noted.
The study was partly funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. The authors have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Universal screening of all U.S. adults aged 35-70 years for prediabetes and type 2 diabetes, regardless of body mass index, would provide the fairest means of detection, according to a new analysis.
This would better detect prediabetes and diabetes in ethnic groups that have a higher risk of diabetes at lower cutoffs. Compared with White individuals, Black or Hispanic adults have a higher risk of developing type 2 diabetes at a younger age, and Asian, Hispanic, and Black Americans all have a higher risk of developing it at a lower BMI.
In the new study, researchers examined six different screening scenarios in a nationally representative sample without diabetes.
They compared screening for prediabetes and type 2 diabetes using criteria from the 2021 U.S. Preventive Services Task Force (USPSTF) recommendations with the 2015 USPSTF recommendations, as well as four other screening thresholds with lower age or weight.
Universal screening for prediabetes and diabetes at age 35-70, regardless of BMI – which appears to be the sweet spot for most equitable detection in different races – may be easier to put into practice because it will mean clinicians don’t have to remember alternate cutoffs for different patient groups, the researchers suggested.
“All major racial and ethnic minority groups develop diabetes at lower weights than White adults, and it’s most pronounced for Asian Americans,” lead author Matthew J. O’Brien, MD, explained in a press release.
“If we make decisions about diabetes testing based on weight we will miss some people from racial and ethnic minority groups who are developing prediabetes and diabetes at lower weights,” said Dr. O’Brien, of Northwestern University, Chicago.
Going forward, to achieve equity in diagnosing prediabetes and diabetes “also requires addressing structural barriers [facing racial and ethnic minorities], which include not having a usual source of primary care, lacking health insurance, or having copays for screening tests based on insurance coverage,” the authors noted in their paper, published online in the American Journal of Preventive Medicine.
There is also a need for further study to examine the cost-effectiveness of any approach, and to study the impact of screening criteria on diagnosis, treatment, and outcomes in diverse populations.
Nationally representative sample, six screening scenarios
In the overall U.S. population, 81% of adults with prediabetes are unaware they have it, said Dr. O’Brien and colleagues, and 23% of diabetes cases are undiagnosed.
And Black, Hispanic, or Asian individuals have a nearly twofold higher prevalence of diabetes compared with White individuals.
The 2021 USPSTF recommendations state that clinicians should screen asymptomatic adults aged 35-70 years with overweight/obesity (BMI ≥ 25 kg/m2) and “should consider screening at an earlier age in persons from groups with disproportionately high incidence and prevalence (American Indian/Alaska Native, Asian American, Black, Hispanic/Latino, or Native Hawaiian/Pacific Islander persons) or in persons who have a family history of diabetes, a history of gestational diabetes, or a history of polycystic ovarian syndrome, and at a lower BMI in Asian American persons. Data suggest that a BMI of 23 or greater may be an appropriate cut point in Asian American persons.”
Dr. O’Brien and colleagues identified 3,243 nonpregnant adults without diagnosed diabetes who participated in the National Health and Nutrition Examination Survey (NHANES) in 2017-2020 and had an A1c blood test. (Half also had a fasting plasma glucose test.)
First, they compared screening using the more recent and earlier USPSTF criteria: BMI of at least 25 kg/m2 and age 35-70 (2021 criteria) and BMI of at least 25 kg/m2 and age 40-70 (2015 criteria).
They estimated that 13.9 million more adults would be eligible for screening using the 2021 versus the 2015 screening criteria.
The increases in screening eligibility were highest in Hispanic individuals (30.6%), followed by Asian individuals (17.9%), White individuals (14.0%), and Black individuals (13.9%).
Using the USPSTF 2021 versus 2015 screening criteria resulted in marginally higher sensitivity (58.6% vs. 52.9%) but lower specificity (69.3% vs. 76.4%) overall, as well as within each racial group.
Next, the researchers examined screening at two lower age cutoffs and two lower BMI cutoffs: BMI of at least 25 kg/m2 and age 30-70, BMI of at least 25 kg/m2 and age 18-70, age 35-70 and BMI of at least 23 kg/m2, and age 35-70 and any BMI.
Screening at these lower age and weight thresholds resulted in even greater sensitivity and lower specificity than using the 2021 USPSTF criteria, especially among Hispanic, non-Hispanic Black, and Asian adults.
However, screening all adults aged 35-70 years regardless of BMI yielded the most equitable detection of prediabetes and diabetes – with a sensitivity of 67.8% and a specificity of 52.1% in the overall population, and a sensitivity of 70.1%, 70.4%, 68.4%, and 67.6%, and a specificity of 53.8%, 59.9%, 56.2%, and 48.9%, in the Asian, Black, Hispanic, and White subgroups, respectively.
The American Diabetes Association currently recommends screening all adults aged ≥ 35 years, or at any age if they have overweight/obesity and an additional diabetes risk factor, the researchers noted.
The study was partly funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. The authors have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE AMERICAN JOURNAL OF PREVENTIVE MEDICINE
Suicidal thoughts decline in endocrinologists: Survey
Rates of suicidal thoughts and attempted suicide among endocrinologists declined from 2022 and now rank similar to the average rate among physicians overall, but these rates are still higher than the general public, according to survey findings.
The current report about suicide among endocrinologists, titled, “Doctors’ Burden: Endocrinologist Suicide Report 2023,” was recently published.
A report about suicide among physicians overall, based on the same survey, titled, “Doctors’ Burden: Medscape Physician Suicide Report 2023,” was published previously.
Improved rates among 28 medical specialties
In the 2022 survey of a representative national sample of 13,069 U.S. physicians, 10% of endocrinologists reported having suicidal thoughts, ranking the specialty sixth among 29 medical specialties that year.
The 2023 survey found that in a representative national sample of 9,175 U.S. physicians, 8% of endocrinologists reported having suicidal thoughts, roughly the average rate among clinicians overall, ranking it 20th among 29 medical specialties.
The highest rates of thoughts of suicide in the latest survey were reported by physicians in otolaryngology (13%), followed by physicians in psychiatry, family medicine, anesthesiology, obstetrics/gynecology, and emergency medicine (roughly 12% in each specialty).
The rate of attempted suicide was 1% among endocrinologists, which was also the rate among physicians overall.
More female than male endocrinologists reported contemplating suicide (8% versus 5%). In addition, 1% of male endocrinologists reported that they had attempted suicide and 2% of female endocrinologists replied they preferred not to answer the question about attempted suicide.
In contrast, in 2020, an estimated 4.9% of U.S. adults aged 18 and older had serious thoughts about suicide and 0.5% attempted suicide, according to the National Institutes of Health website, the latest report states.
Rates of suicidal thoughts and suicide attempts among physicians overall “are worryingly high numbers,” Peter Yellowlees, MBBS, MD, emeritus professor of psychiatry at University of California, Davis, Health, and chief executive officer, Asynchealth, said in the report.
Confiding in others, good mental health habits, resources
In the 2023 survey, half of the endocrinologists who had thought about suicide had confided in a therapist and 41% had spoken to a family member, but none had told a colleague or a friend, or phoned a suicide hotline.
On the other hand, 7% of male and 10% of female endocrinologists, and 9% of male and 11% of female physicians overall, reported that a colleague had shared suicidal thoughts with them.
“It’s pleasing that physicians overall have shown themselves slightly more likely to bring ideas about suicide to a therapist and less likely to keep their distress entirely to themselves,” Dr. Yellowlees said.
“It’s possible that the need for health care is becoming less stigmatized nationally, with large and increasing emphasis on physician well-being during and after the COVID-19 pandemic,” he suggested.
Endocrinologists reported that to keep happy and have good mental health, they engaged in activities and hobbies (70%), exercised (66%), spent time with family and friends (63%), got enough sleep (56%), ate healthy (48%), went to therapy (11%), or did other things (8%), which was similar to that reported by physicians overall.
The report lists several resources that are specific for physicians having suicidal thoughts (Physician Support Line, 988 Suicide and Crisis Lifeline, Peer RxMed, International Association for Suicide Prevention, and the American Foundation for Suicide Prevention) along with contact information.
The 2023 survey was conducted from June 28, 2022, to Oct. 3, 2022, and the 2022 survey was conducted from June 29, 2021, to Sept. 26, 2021.
A version of this article first appeared on Medscape.com.
Rates of suicidal thoughts and attempted suicide among endocrinologists declined from 2022 and now rank similar to the average rate among physicians overall, but these rates are still higher than the general public, according to survey findings.
The current report about suicide among endocrinologists, titled, “Doctors’ Burden: Endocrinologist Suicide Report 2023,” was recently published.
A report about suicide among physicians overall, based on the same survey, titled, “Doctors’ Burden: Medscape Physician Suicide Report 2023,” was published previously.
Improved rates among 28 medical specialties
In the 2022 survey of a representative national sample of 13,069 U.S. physicians, 10% of endocrinologists reported having suicidal thoughts, ranking the specialty sixth among 29 medical specialties that year.
The 2023 survey found that in a representative national sample of 9,175 U.S. physicians, 8% of endocrinologists reported having suicidal thoughts, roughly the average rate among clinicians overall, ranking it 20th among 29 medical specialties.
The highest rates of thoughts of suicide in the latest survey were reported by physicians in otolaryngology (13%), followed by physicians in psychiatry, family medicine, anesthesiology, obstetrics/gynecology, and emergency medicine (roughly 12% in each specialty).
The rate of attempted suicide was 1% among endocrinologists, which was also the rate among physicians overall.
More female than male endocrinologists reported contemplating suicide (8% versus 5%). In addition, 1% of male endocrinologists reported that they had attempted suicide and 2% of female endocrinologists replied they preferred not to answer the question about attempted suicide.
In contrast, in 2020, an estimated 4.9% of U.S. adults aged 18 and older had serious thoughts about suicide and 0.5% attempted suicide, according to the National Institutes of Health website, the latest report states.
Rates of suicidal thoughts and suicide attempts among physicians overall “are worryingly high numbers,” Peter Yellowlees, MBBS, MD, emeritus professor of psychiatry at University of California, Davis, Health, and chief executive officer, Asynchealth, said in the report.
Confiding in others, good mental health habits, resources
In the 2023 survey, half of the endocrinologists who had thought about suicide had confided in a therapist and 41% had spoken to a family member, but none had told a colleague or a friend, or phoned a suicide hotline.
On the other hand, 7% of male and 10% of female endocrinologists, and 9% of male and 11% of female physicians overall, reported that a colleague had shared suicidal thoughts with them.
“It’s pleasing that physicians overall have shown themselves slightly more likely to bring ideas about suicide to a therapist and less likely to keep their distress entirely to themselves,” Dr. Yellowlees said.
“It’s possible that the need for health care is becoming less stigmatized nationally, with large and increasing emphasis on physician well-being during and after the COVID-19 pandemic,” he suggested.
Endocrinologists reported that to keep happy and have good mental health, they engaged in activities and hobbies (70%), exercised (66%), spent time with family and friends (63%), got enough sleep (56%), ate healthy (48%), went to therapy (11%), or did other things (8%), which was similar to that reported by physicians overall.
The report lists several resources that are specific for physicians having suicidal thoughts (Physician Support Line, 988 Suicide and Crisis Lifeline, Peer RxMed, International Association for Suicide Prevention, and the American Foundation for Suicide Prevention) along with contact information.
The 2023 survey was conducted from June 28, 2022, to Oct. 3, 2022, and the 2022 survey was conducted from June 29, 2021, to Sept. 26, 2021.
A version of this article first appeared on Medscape.com.
Rates of suicidal thoughts and attempted suicide among endocrinologists declined from 2022 and now rank similar to the average rate among physicians overall, but these rates are still higher than the general public, according to survey findings.
The current report about suicide among endocrinologists, titled, “Doctors’ Burden: Endocrinologist Suicide Report 2023,” was recently published.
A report about suicide among physicians overall, based on the same survey, titled, “Doctors’ Burden: Medscape Physician Suicide Report 2023,” was published previously.
Improved rates among 28 medical specialties
In the 2022 survey of a representative national sample of 13,069 U.S. physicians, 10% of endocrinologists reported having suicidal thoughts, ranking the specialty sixth among 29 medical specialties that year.
The 2023 survey found that in a representative national sample of 9,175 U.S. physicians, 8% of endocrinologists reported having suicidal thoughts, roughly the average rate among clinicians overall, ranking it 20th among 29 medical specialties.
The highest rates of thoughts of suicide in the latest survey were reported by physicians in otolaryngology (13%), followed by physicians in psychiatry, family medicine, anesthesiology, obstetrics/gynecology, and emergency medicine (roughly 12% in each specialty).
The rate of attempted suicide was 1% among endocrinologists, which was also the rate among physicians overall.
More female than male endocrinologists reported contemplating suicide (8% versus 5%). In addition, 1% of male endocrinologists reported that they had attempted suicide and 2% of female endocrinologists replied they preferred not to answer the question about attempted suicide.
In contrast, in 2020, an estimated 4.9% of U.S. adults aged 18 and older had serious thoughts about suicide and 0.5% attempted suicide, according to the National Institutes of Health website, the latest report states.
Rates of suicidal thoughts and suicide attempts among physicians overall “are worryingly high numbers,” Peter Yellowlees, MBBS, MD, emeritus professor of psychiatry at University of California, Davis, Health, and chief executive officer, Asynchealth, said in the report.
Confiding in others, good mental health habits, resources
In the 2023 survey, half of the endocrinologists who had thought about suicide had confided in a therapist and 41% had spoken to a family member, but none had told a colleague or a friend, or phoned a suicide hotline.
On the other hand, 7% of male and 10% of female endocrinologists, and 9% of male and 11% of female physicians overall, reported that a colleague had shared suicidal thoughts with them.
“It’s pleasing that physicians overall have shown themselves slightly more likely to bring ideas about suicide to a therapist and less likely to keep their distress entirely to themselves,” Dr. Yellowlees said.
“It’s possible that the need for health care is becoming less stigmatized nationally, with large and increasing emphasis on physician well-being during and after the COVID-19 pandemic,” he suggested.
Endocrinologists reported that to keep happy and have good mental health, they engaged in activities and hobbies (70%), exercised (66%), spent time with family and friends (63%), got enough sleep (56%), ate healthy (48%), went to therapy (11%), or did other things (8%), which was similar to that reported by physicians overall.
The report lists several resources that are specific for physicians having suicidal thoughts (Physician Support Line, 988 Suicide and Crisis Lifeline, Peer RxMed, International Association for Suicide Prevention, and the American Foundation for Suicide Prevention) along with contact information.
The 2023 survey was conducted from June 28, 2022, to Oct. 3, 2022, and the 2022 survey was conducted from June 29, 2021, to Sept. 26, 2021.
A version of this article first appeared on Medscape.com.
More states nix nonconsensual pelvic exams by med students
Performing intimate exams under anesthesia (EUA) is a standard part of medical training. Yet,
“Whenever I talk about this at conferences around the country, people always come up to me and say it’s still happening at their institutions,” Lori Bruce, MA, MBE, HEC-C, associate director of the Interdisciplinary Center for Bioethics at Yale University, New Haven, Conn., told this news organization.
Most think this is a women’s issue, which occurs only in unconscious patients, she said. But Ms. Bruce found otherwise in a survey last year in which she polled the general public about their intimate exam experiences.
“Unconsented exams happen much more than we imagined, and they happen as often to men [having] prostate exams without consent as to women. Black [respondents] were nearly four times more likely to have reported receiving an unconsented intimate pelvic or prostate exam,” she said, based on her research. And Ms. Bruce believes it can happen across the economic spectrum.
Concern about unconsented EUAs arose in the early 2000s. In a study at that time, 75% of medical students reported that their patients had not given consent to be examined during surgical procedures. An ethics committee of the American College of Obstetricians and Gynecologists published guidelines for EUAs and states began passing legislation with patient protections and medical training consent policies.
California is believed to be the first to adopt legislation outlawing unconsented pelvic exams for training purposes in 2003, followed by Virginia in 2007, along with a handful of other states.
In 2019, on the heels of the #MeToo movement and renewed calls to end unconsented exams, more patients and providers began to speak publicly about their experiences with the practice. Some posted on social media using the #MeTooPelvic hashtag. In 2022, an award-winning documentary was also released about consent, “At Your Cervix.”More states subsequently passed legislation, and some medical schools strengthened their EUA consent policies.
Today, nearly half the states in the country have enacted laws against unconsented intimate EUAs, with some carrying misdemeanor charges for both the individual conducting the exam and the supervising physician. Other states leave open the option to fine the physician and revoke or suspend medical licenses.
Much of the new legislation requires explicit consent for intimate exams involving the pelvis, prostate, and rectum, with exceptions for emergency procedures and, in some cases, the collection of court-ordered forensic evidence. In addition, several states, including Colorado, Indiana, and Ohio, have pending or recently introduced bills. Last month, sister bills in Missouri passed the House and Senate, gaining more traction than previous legislative attempts. A similar bill was introduced in the Kansas House several times, including this year, and is expected to be on the agenda again in the next session.
Intimate exams on patients without consent are “unethical and unacceptable,” said Alison Whelan, MD, chief academic officer of the Association of American Medical Colleges. Although medical students learn sensitive procedures through simulation labs and gynecological teaching associates – individuals specifically trained to help students develop physical exam skills – EUAs require strict adherence to widely accepted guidelines.
“Learners in the clinical setting should only perform such examinations for teaching purposes when the exam is explicitly consented to, related to the planned procedure, performed by a student who is recognized by the patient as a part of their care team, and done under direct supervision by an educator,” Dr. Whelan said.
Medical students bear moral burden
Arthur Caplan, PhD, director of medical ethics at New York University, has called unconsented intimate exams a “cousin issue” to abusive predatory behavior.
If the public is outraged that physicians “have misused their authority with athletes, then we should be equally outraged if that authority, even for a higher purpose [like] teaching and training, is still misused in terms of getting permission and consent,” he said in a video discussing Connecticut’s legislation to strengthen intimate exam requirements, which went into effect Jan. 1.
Advocates of stricter EUA consent policies say the variability in consent practices destroys patient trust by ignoring the basic principles of respect and autonomy. Because patients are usually unaware a violation has occurred, reporting typically depends on medical students raising questions with educators and attendings, which they may hesitate to do for fear of repercussions.
Current practices, such as patients signing consent documents in the outpatient setting where students aren’t always privy to the discussion, contribute to the lack of transparency, Karampreet Kaur, MD, a 2nd-year ob.gyn. resident at the Hospital of the University of Pennsylvania, Philadelphia, said.
A 2019 survey of medical students by Elle magazine found that nearly half did not meet patients before conducting an intimate EUA. Of the 92% who performed a pelvic EUA, 61% reported doing so without obtaining explicit patient consent.
Dr. Kaur recently coauthored a survey of students from six medical schools and found that 84% completed at least one pelvic EUA during their ob.gyn. clerkships. About half of the students surveyed observed patients giving informed consent most or every time. Of those, 67% reported they never or rarely witnessed an explicit explanation that a medical student may perform a pelvic EUA.
This burden weighs on the consciences of medical students. Respondents reported that they wanted to honor patient autonomy but felt they lacked the authority to object to pelvic EUAs when consent was unclear, which led to significant emotional distress.
“It’s not that physicians don’t care,” Dr. Kaur said. “I think most want to make sure patients feel safe and fully informed of the care they are receiving.”
To consent or not
Incorporating a separate EUA consent form, typically signed during a preoperative visit but occasionally on the day of surgery, offers one potential solution as it ensures “clear and consistent language is used and forces documentation of this conversation,” said Dr. Kaur. At her current institution, providers and medical students must review charted EUA documentation, then that information is “made clear to attendings, fellows, residents, students, and even the OR staff,” she said.
In Dr. Kaur’s survey, 11% of respondents supported a separate consent. Another study of 3rd- and 4th-year medical students published last year found that 45% agreed with having a separate signature line on the surgical consent form.
Legislation introduced recently in Colorado states that medical students must meet the patient, and patients must receive a written or electronic document titled, in at least 18-point bolded font, “consent for examination of breasts, pelvic region, rectum, and/or prostate.” The form must also include the names of medical students performing or observing an intimate exam for educational purposes.
Elizabeth Newman, MPP, public policy director at the Colorado Coalition Against Sexual Assault and supporter of the state’s intimate exam bill, said the legislation will allow medical students to learn the intricacies of these sensitive body systems and provide better patient care, particularly following the rollback of Roe v. Wade.
“Abortion is available and accessible in Colorado, and we are surrounded by states where it’s not,” said Ms. Newman. “Medical students in states where it’s outright banned are coming to Colorado to learn how to provide abortion care in their residencies and fellowships, so we want to maintain that access and not take those learning opportunities away with this law.”
Opponents of a separate form say it complicates the consent process. Dr. Kaur said she originally thought it would involve a lot of extra work, but it only takes 3-5 minutes. Few patients decline the exam after the conversation, and students benefit from the clear guidelines and transparency, she said.
“I had hoped that the many medical association guidelines [supporting] explicit consent would have influenced hospital policy, but it did not have that effect,” said Ms. Bruce, adding that recent legislative efforts have largely been driven by concerned bioethicists, lawmakers, and some medical students and physicians. “It all circles back to the patient having the right to refuse; it’s their body.”
A version of this article first appeared on Medscape.com.
Performing intimate exams under anesthesia (EUA) is a standard part of medical training. Yet,
“Whenever I talk about this at conferences around the country, people always come up to me and say it’s still happening at their institutions,” Lori Bruce, MA, MBE, HEC-C, associate director of the Interdisciplinary Center for Bioethics at Yale University, New Haven, Conn., told this news organization.
Most think this is a women’s issue, which occurs only in unconscious patients, she said. But Ms. Bruce found otherwise in a survey last year in which she polled the general public about their intimate exam experiences.
“Unconsented exams happen much more than we imagined, and they happen as often to men [having] prostate exams without consent as to women. Black [respondents] were nearly four times more likely to have reported receiving an unconsented intimate pelvic or prostate exam,” she said, based on her research. And Ms. Bruce believes it can happen across the economic spectrum.
Concern about unconsented EUAs arose in the early 2000s. In a study at that time, 75% of medical students reported that their patients had not given consent to be examined during surgical procedures. An ethics committee of the American College of Obstetricians and Gynecologists published guidelines for EUAs and states began passing legislation with patient protections and medical training consent policies.
California is believed to be the first to adopt legislation outlawing unconsented pelvic exams for training purposes in 2003, followed by Virginia in 2007, along with a handful of other states.
In 2019, on the heels of the #MeToo movement and renewed calls to end unconsented exams, more patients and providers began to speak publicly about their experiences with the practice. Some posted on social media using the #MeTooPelvic hashtag. In 2022, an award-winning documentary was also released about consent, “At Your Cervix.”More states subsequently passed legislation, and some medical schools strengthened their EUA consent policies.
Today, nearly half the states in the country have enacted laws against unconsented intimate EUAs, with some carrying misdemeanor charges for both the individual conducting the exam and the supervising physician. Other states leave open the option to fine the physician and revoke or suspend medical licenses.
Much of the new legislation requires explicit consent for intimate exams involving the pelvis, prostate, and rectum, with exceptions for emergency procedures and, in some cases, the collection of court-ordered forensic evidence. In addition, several states, including Colorado, Indiana, and Ohio, have pending or recently introduced bills. Last month, sister bills in Missouri passed the House and Senate, gaining more traction than previous legislative attempts. A similar bill was introduced in the Kansas House several times, including this year, and is expected to be on the agenda again in the next session.
Intimate exams on patients without consent are “unethical and unacceptable,” said Alison Whelan, MD, chief academic officer of the Association of American Medical Colleges. Although medical students learn sensitive procedures through simulation labs and gynecological teaching associates – individuals specifically trained to help students develop physical exam skills – EUAs require strict adherence to widely accepted guidelines.
“Learners in the clinical setting should only perform such examinations for teaching purposes when the exam is explicitly consented to, related to the planned procedure, performed by a student who is recognized by the patient as a part of their care team, and done under direct supervision by an educator,” Dr. Whelan said.
Medical students bear moral burden
Arthur Caplan, PhD, director of medical ethics at New York University, has called unconsented intimate exams a “cousin issue” to abusive predatory behavior.
If the public is outraged that physicians “have misused their authority with athletes, then we should be equally outraged if that authority, even for a higher purpose [like] teaching and training, is still misused in terms of getting permission and consent,” he said in a video discussing Connecticut’s legislation to strengthen intimate exam requirements, which went into effect Jan. 1.
Advocates of stricter EUA consent policies say the variability in consent practices destroys patient trust by ignoring the basic principles of respect and autonomy. Because patients are usually unaware a violation has occurred, reporting typically depends on medical students raising questions with educators and attendings, which they may hesitate to do for fear of repercussions.
Current practices, such as patients signing consent documents in the outpatient setting where students aren’t always privy to the discussion, contribute to the lack of transparency, Karampreet Kaur, MD, a 2nd-year ob.gyn. resident at the Hospital of the University of Pennsylvania, Philadelphia, said.
A 2019 survey of medical students by Elle magazine found that nearly half did not meet patients before conducting an intimate EUA. Of the 92% who performed a pelvic EUA, 61% reported doing so without obtaining explicit patient consent.
Dr. Kaur recently coauthored a survey of students from six medical schools and found that 84% completed at least one pelvic EUA during their ob.gyn. clerkships. About half of the students surveyed observed patients giving informed consent most or every time. Of those, 67% reported they never or rarely witnessed an explicit explanation that a medical student may perform a pelvic EUA.
This burden weighs on the consciences of medical students. Respondents reported that they wanted to honor patient autonomy but felt they lacked the authority to object to pelvic EUAs when consent was unclear, which led to significant emotional distress.
“It’s not that physicians don’t care,” Dr. Kaur said. “I think most want to make sure patients feel safe and fully informed of the care they are receiving.”
To consent or not
Incorporating a separate EUA consent form, typically signed during a preoperative visit but occasionally on the day of surgery, offers one potential solution as it ensures “clear and consistent language is used and forces documentation of this conversation,” said Dr. Kaur. At her current institution, providers and medical students must review charted EUA documentation, then that information is “made clear to attendings, fellows, residents, students, and even the OR staff,” she said.
In Dr. Kaur’s survey, 11% of respondents supported a separate consent. Another study of 3rd- and 4th-year medical students published last year found that 45% agreed with having a separate signature line on the surgical consent form.
Legislation introduced recently in Colorado states that medical students must meet the patient, and patients must receive a written or electronic document titled, in at least 18-point bolded font, “consent for examination of breasts, pelvic region, rectum, and/or prostate.” The form must also include the names of medical students performing or observing an intimate exam for educational purposes.
Elizabeth Newman, MPP, public policy director at the Colorado Coalition Against Sexual Assault and supporter of the state’s intimate exam bill, said the legislation will allow medical students to learn the intricacies of these sensitive body systems and provide better patient care, particularly following the rollback of Roe v. Wade.
“Abortion is available and accessible in Colorado, and we are surrounded by states where it’s not,” said Ms. Newman. “Medical students in states where it’s outright banned are coming to Colorado to learn how to provide abortion care in their residencies and fellowships, so we want to maintain that access and not take those learning opportunities away with this law.”
Opponents of a separate form say it complicates the consent process. Dr. Kaur said she originally thought it would involve a lot of extra work, but it only takes 3-5 minutes. Few patients decline the exam after the conversation, and students benefit from the clear guidelines and transparency, she said.
“I had hoped that the many medical association guidelines [supporting] explicit consent would have influenced hospital policy, but it did not have that effect,” said Ms. Bruce, adding that recent legislative efforts have largely been driven by concerned bioethicists, lawmakers, and some medical students and physicians. “It all circles back to the patient having the right to refuse; it’s their body.”
A version of this article first appeared on Medscape.com.
Performing intimate exams under anesthesia (EUA) is a standard part of medical training. Yet,
“Whenever I talk about this at conferences around the country, people always come up to me and say it’s still happening at their institutions,” Lori Bruce, MA, MBE, HEC-C, associate director of the Interdisciplinary Center for Bioethics at Yale University, New Haven, Conn., told this news organization.
Most think this is a women’s issue, which occurs only in unconscious patients, she said. But Ms. Bruce found otherwise in a survey last year in which she polled the general public about their intimate exam experiences.
“Unconsented exams happen much more than we imagined, and they happen as often to men [having] prostate exams without consent as to women. Black [respondents] were nearly four times more likely to have reported receiving an unconsented intimate pelvic or prostate exam,” she said, based on her research. And Ms. Bruce believes it can happen across the economic spectrum.
Concern about unconsented EUAs arose in the early 2000s. In a study at that time, 75% of medical students reported that their patients had not given consent to be examined during surgical procedures. An ethics committee of the American College of Obstetricians and Gynecologists published guidelines for EUAs and states began passing legislation with patient protections and medical training consent policies.
California is believed to be the first to adopt legislation outlawing unconsented pelvic exams for training purposes in 2003, followed by Virginia in 2007, along with a handful of other states.
In 2019, on the heels of the #MeToo movement and renewed calls to end unconsented exams, more patients and providers began to speak publicly about their experiences with the practice. Some posted on social media using the #MeTooPelvic hashtag. In 2022, an award-winning documentary was also released about consent, “At Your Cervix.”More states subsequently passed legislation, and some medical schools strengthened their EUA consent policies.
Today, nearly half the states in the country have enacted laws against unconsented intimate EUAs, with some carrying misdemeanor charges for both the individual conducting the exam and the supervising physician. Other states leave open the option to fine the physician and revoke or suspend medical licenses.
Much of the new legislation requires explicit consent for intimate exams involving the pelvis, prostate, and rectum, with exceptions for emergency procedures and, in some cases, the collection of court-ordered forensic evidence. In addition, several states, including Colorado, Indiana, and Ohio, have pending or recently introduced bills. Last month, sister bills in Missouri passed the House and Senate, gaining more traction than previous legislative attempts. A similar bill was introduced in the Kansas House several times, including this year, and is expected to be on the agenda again in the next session.
Intimate exams on patients without consent are “unethical and unacceptable,” said Alison Whelan, MD, chief academic officer of the Association of American Medical Colleges. Although medical students learn sensitive procedures through simulation labs and gynecological teaching associates – individuals specifically trained to help students develop physical exam skills – EUAs require strict adherence to widely accepted guidelines.
“Learners in the clinical setting should only perform such examinations for teaching purposes when the exam is explicitly consented to, related to the planned procedure, performed by a student who is recognized by the patient as a part of their care team, and done under direct supervision by an educator,” Dr. Whelan said.
Medical students bear moral burden
Arthur Caplan, PhD, director of medical ethics at New York University, has called unconsented intimate exams a “cousin issue” to abusive predatory behavior.
If the public is outraged that physicians “have misused their authority with athletes, then we should be equally outraged if that authority, even for a higher purpose [like] teaching and training, is still misused in terms of getting permission and consent,” he said in a video discussing Connecticut’s legislation to strengthen intimate exam requirements, which went into effect Jan. 1.
Advocates of stricter EUA consent policies say the variability in consent practices destroys patient trust by ignoring the basic principles of respect and autonomy. Because patients are usually unaware a violation has occurred, reporting typically depends on medical students raising questions with educators and attendings, which they may hesitate to do for fear of repercussions.
Current practices, such as patients signing consent documents in the outpatient setting where students aren’t always privy to the discussion, contribute to the lack of transparency, Karampreet Kaur, MD, a 2nd-year ob.gyn. resident at the Hospital of the University of Pennsylvania, Philadelphia, said.
A 2019 survey of medical students by Elle magazine found that nearly half did not meet patients before conducting an intimate EUA. Of the 92% who performed a pelvic EUA, 61% reported doing so without obtaining explicit patient consent.
Dr. Kaur recently coauthored a survey of students from six medical schools and found that 84% completed at least one pelvic EUA during their ob.gyn. clerkships. About half of the students surveyed observed patients giving informed consent most or every time. Of those, 67% reported they never or rarely witnessed an explicit explanation that a medical student may perform a pelvic EUA.
This burden weighs on the consciences of medical students. Respondents reported that they wanted to honor patient autonomy but felt they lacked the authority to object to pelvic EUAs when consent was unclear, which led to significant emotional distress.
“It’s not that physicians don’t care,” Dr. Kaur said. “I think most want to make sure patients feel safe and fully informed of the care they are receiving.”
To consent or not
Incorporating a separate EUA consent form, typically signed during a preoperative visit but occasionally on the day of surgery, offers one potential solution as it ensures “clear and consistent language is used and forces documentation of this conversation,” said Dr. Kaur. At her current institution, providers and medical students must review charted EUA documentation, then that information is “made clear to attendings, fellows, residents, students, and even the OR staff,” she said.
In Dr. Kaur’s survey, 11% of respondents supported a separate consent. Another study of 3rd- and 4th-year medical students published last year found that 45% agreed with having a separate signature line on the surgical consent form.
Legislation introduced recently in Colorado states that medical students must meet the patient, and patients must receive a written or electronic document titled, in at least 18-point bolded font, “consent for examination of breasts, pelvic region, rectum, and/or prostate.” The form must also include the names of medical students performing or observing an intimate exam for educational purposes.
Elizabeth Newman, MPP, public policy director at the Colorado Coalition Against Sexual Assault and supporter of the state’s intimate exam bill, said the legislation will allow medical students to learn the intricacies of these sensitive body systems and provide better patient care, particularly following the rollback of Roe v. Wade.
“Abortion is available and accessible in Colorado, and we are surrounded by states where it’s not,” said Ms. Newman. “Medical students in states where it’s outright banned are coming to Colorado to learn how to provide abortion care in their residencies and fellowships, so we want to maintain that access and not take those learning opportunities away with this law.”
Opponents of a separate form say it complicates the consent process. Dr. Kaur said she originally thought it would involve a lot of extra work, but it only takes 3-5 minutes. Few patients decline the exam after the conversation, and students benefit from the clear guidelines and transparency, she said.
“I had hoped that the many medical association guidelines [supporting] explicit consent would have influenced hospital policy, but it did not have that effect,” said Ms. Bruce, adding that recent legislative efforts have largely been driven by concerned bioethicists, lawmakers, and some medical students and physicians. “It all circles back to the patient having the right to refuse; it’s their body.”
A version of this article first appeared on Medscape.com.