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Sex and Gender Influence Outcomes in Colorectal Cancer
BARCELONA, SPAIN — , according to experts speaking here at the European Society for Medical Oncology (ESMO) Annual Meeting 2024.
“The concepts of gender and sex are not at all new in oncology, but what is needed is a renewed focus on them and the prospective collection of data in this regard,” said Kathrin Heinrich, MD, of University Hospital LMU Munich, Germany.
Sex and Gender: What’s New?
Speaking at the conference, Dr. Heinrich cited a 2020 study published in The Lancet that stated, “Sex and gender are the foundation of precision medicine, and their differences should guide decision-making processes to promote gender equity.”
Sex differences have clear biological and pathophysiological consequences in oncology. Available data show differences between men and women in terms of gene expression, epigenetics, metabolomics, tumor microenvironment, immune system, and microbiome. These are all critical for understanding tumor biology and identifying new treatments.
Colorectal cancer provides an excellent example of how sex differences can influence treatment outcomes.
From an incidence perspective, the numbers reported by the large epidemiological GLOBOCAN study are quite similar between the two sexes, with men accounting for 56% of patients and women for 44%.
However, there are noticeable differences in tumor characteristics, with women more frequently presenting with right-sided colon tumors and BRAF mutations; both features associated with a worse prognosis.
Sex also affects body composition, influencing the percentage of metabolically active body mass, which can alter the effectiveness and distribution of a drug and the necessary dose to achieve the desired effect.
“Despite this evidence, clinical practice often overlooks differences between the sexes when planning therapies,” Dr. Heinrich said, also recalling how in many cases the side effects of treatments — from chemotherapy to immunotherapy — differ in intensity and type between men and women.
Toward a More Targeted and Inclusive Approach
Sex is a well-defined concept from a biological standpoint and, consequently, the differences between the sexes are easy to identify. Analyzing gender differences is much more complex.
“It is not enough to tick the male or female box on a questionnaire. It is necessary to consider more complex aspects to measure, such as identity, role, and gender relations,” Dr. Heinrich said, also presenting a list of specific questionnaires to assess these components.
In today’s oncology, however, such questionnaires are mainly used to analyze secondary outcomes such as quality of life, while examples from other areas of medicine, particularly cardiology, show how questionnaires on gender can predict some clinical outcomes better than those on sex alone and that studies considering sex and gender are feasible.
Gender identity influences many aspects of health, such as attitudes toward prevention, the seeking of information and medical care, and risk behaviors. “The new approach to discussing sex and gender in oncology is to consider these factors in therapeutic decisions,” Dr. Heinrich said. “I hope that within a few years this will be fully achievable, thanks to the inclusion in our studies of gender scores, ad hoc patient-reported outcomes, and information related, for example, to menopausal status or the number of pregnancies,” she added.
To harness the differences between sex and gender in favor of the patient, however, it is also necessary to change the approach to clinical studies. Currently, data on these aspects are typically collected retrospectively. However, they should be integrated prospectively from the study’s beginning.
“We look at increasingly smaller subgroups of patients, at mutations affecting 1%-2% of our patients, but we do not collect data on sex or menopausal status, which are actually extremely simple to record,” Dr. Heinrich said, calling for more inclusive studies, especially involving the LGBTQI+ community, traditionally excluded from clinical trials and many services.
“Fortunately, we live in an era in which sensitivity towards this community is continuously increasing. We must gather information on this population, which fully belongs to what we scientifically define as the ‘real-world’ approach.”
Dr. Heinrich declared honoraria, consulting and advisory roles, and travel support from several companies, including Amgen, BMS, Merck, MSD, Roche-Janssen, Taiho, Servier, and Streamed Up.
This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
BARCELONA, SPAIN — , according to experts speaking here at the European Society for Medical Oncology (ESMO) Annual Meeting 2024.
“The concepts of gender and sex are not at all new in oncology, but what is needed is a renewed focus on them and the prospective collection of data in this regard,” said Kathrin Heinrich, MD, of University Hospital LMU Munich, Germany.
Sex and Gender: What’s New?
Speaking at the conference, Dr. Heinrich cited a 2020 study published in The Lancet that stated, “Sex and gender are the foundation of precision medicine, and their differences should guide decision-making processes to promote gender equity.”
Sex differences have clear biological and pathophysiological consequences in oncology. Available data show differences between men and women in terms of gene expression, epigenetics, metabolomics, tumor microenvironment, immune system, and microbiome. These are all critical for understanding tumor biology and identifying new treatments.
Colorectal cancer provides an excellent example of how sex differences can influence treatment outcomes.
From an incidence perspective, the numbers reported by the large epidemiological GLOBOCAN study are quite similar between the two sexes, with men accounting for 56% of patients and women for 44%.
However, there are noticeable differences in tumor characteristics, with women more frequently presenting with right-sided colon tumors and BRAF mutations; both features associated with a worse prognosis.
Sex also affects body composition, influencing the percentage of metabolically active body mass, which can alter the effectiveness and distribution of a drug and the necessary dose to achieve the desired effect.
“Despite this evidence, clinical practice often overlooks differences between the sexes when planning therapies,” Dr. Heinrich said, also recalling how in many cases the side effects of treatments — from chemotherapy to immunotherapy — differ in intensity and type between men and women.
Toward a More Targeted and Inclusive Approach
Sex is a well-defined concept from a biological standpoint and, consequently, the differences between the sexes are easy to identify. Analyzing gender differences is much more complex.
“It is not enough to tick the male or female box on a questionnaire. It is necessary to consider more complex aspects to measure, such as identity, role, and gender relations,” Dr. Heinrich said, also presenting a list of specific questionnaires to assess these components.
In today’s oncology, however, such questionnaires are mainly used to analyze secondary outcomes such as quality of life, while examples from other areas of medicine, particularly cardiology, show how questionnaires on gender can predict some clinical outcomes better than those on sex alone and that studies considering sex and gender are feasible.
Gender identity influences many aspects of health, such as attitudes toward prevention, the seeking of information and medical care, and risk behaviors. “The new approach to discussing sex and gender in oncology is to consider these factors in therapeutic decisions,” Dr. Heinrich said. “I hope that within a few years this will be fully achievable, thanks to the inclusion in our studies of gender scores, ad hoc patient-reported outcomes, and information related, for example, to menopausal status or the number of pregnancies,” she added.
To harness the differences between sex and gender in favor of the patient, however, it is also necessary to change the approach to clinical studies. Currently, data on these aspects are typically collected retrospectively. However, they should be integrated prospectively from the study’s beginning.
“We look at increasingly smaller subgroups of patients, at mutations affecting 1%-2% of our patients, but we do not collect data on sex or menopausal status, which are actually extremely simple to record,” Dr. Heinrich said, calling for more inclusive studies, especially involving the LGBTQI+ community, traditionally excluded from clinical trials and many services.
“Fortunately, we live in an era in which sensitivity towards this community is continuously increasing. We must gather information on this population, which fully belongs to what we scientifically define as the ‘real-world’ approach.”
Dr. Heinrich declared honoraria, consulting and advisory roles, and travel support from several companies, including Amgen, BMS, Merck, MSD, Roche-Janssen, Taiho, Servier, and Streamed Up.
This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
BARCELONA, SPAIN — , according to experts speaking here at the European Society for Medical Oncology (ESMO) Annual Meeting 2024.
“The concepts of gender and sex are not at all new in oncology, but what is needed is a renewed focus on them and the prospective collection of data in this regard,” said Kathrin Heinrich, MD, of University Hospital LMU Munich, Germany.
Sex and Gender: What’s New?
Speaking at the conference, Dr. Heinrich cited a 2020 study published in The Lancet that stated, “Sex and gender are the foundation of precision medicine, and their differences should guide decision-making processes to promote gender equity.”
Sex differences have clear biological and pathophysiological consequences in oncology. Available data show differences between men and women in terms of gene expression, epigenetics, metabolomics, tumor microenvironment, immune system, and microbiome. These are all critical for understanding tumor biology and identifying new treatments.
Colorectal cancer provides an excellent example of how sex differences can influence treatment outcomes.
From an incidence perspective, the numbers reported by the large epidemiological GLOBOCAN study are quite similar between the two sexes, with men accounting for 56% of patients and women for 44%.
However, there are noticeable differences in tumor characteristics, with women more frequently presenting with right-sided colon tumors and BRAF mutations; both features associated with a worse prognosis.
Sex also affects body composition, influencing the percentage of metabolically active body mass, which can alter the effectiveness and distribution of a drug and the necessary dose to achieve the desired effect.
“Despite this evidence, clinical practice often overlooks differences between the sexes when planning therapies,” Dr. Heinrich said, also recalling how in many cases the side effects of treatments — from chemotherapy to immunotherapy — differ in intensity and type between men and women.
Toward a More Targeted and Inclusive Approach
Sex is a well-defined concept from a biological standpoint and, consequently, the differences between the sexes are easy to identify. Analyzing gender differences is much more complex.
“It is not enough to tick the male or female box on a questionnaire. It is necessary to consider more complex aspects to measure, such as identity, role, and gender relations,” Dr. Heinrich said, also presenting a list of specific questionnaires to assess these components.
In today’s oncology, however, such questionnaires are mainly used to analyze secondary outcomes such as quality of life, while examples from other areas of medicine, particularly cardiology, show how questionnaires on gender can predict some clinical outcomes better than those on sex alone and that studies considering sex and gender are feasible.
Gender identity influences many aspects of health, such as attitudes toward prevention, the seeking of information and medical care, and risk behaviors. “The new approach to discussing sex and gender in oncology is to consider these factors in therapeutic decisions,” Dr. Heinrich said. “I hope that within a few years this will be fully achievable, thanks to the inclusion in our studies of gender scores, ad hoc patient-reported outcomes, and information related, for example, to menopausal status or the number of pregnancies,” she added.
To harness the differences between sex and gender in favor of the patient, however, it is also necessary to change the approach to clinical studies. Currently, data on these aspects are typically collected retrospectively. However, they should be integrated prospectively from the study’s beginning.
“We look at increasingly smaller subgroups of patients, at mutations affecting 1%-2% of our patients, but we do not collect data on sex or menopausal status, which are actually extremely simple to record,” Dr. Heinrich said, calling for more inclusive studies, especially involving the LGBTQI+ community, traditionally excluded from clinical trials and many services.
“Fortunately, we live in an era in which sensitivity towards this community is continuously increasing. We must gather information on this population, which fully belongs to what we scientifically define as the ‘real-world’ approach.”
Dr. Heinrich declared honoraria, consulting and advisory roles, and travel support from several companies, including Amgen, BMS, Merck, MSD, Roche-Janssen, Taiho, Servier, and Streamed Up.
This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
FROM ESMO CONGRESS 2024
Nonhormonal Treatment May Ease Menopausal Symptoms
Elinzanetant, the selective antagonist of neurokinin 1 and 3 receptors, led to rapid improvement in the frequency of vasomotor symptoms and significant improvements in the severity of symptoms, sleep disturbances, and menopause-related quality of life in two phase 3 studies. Researchers led by JoAnn V. Pinkerton, MD, from the University of Virginia Health in Charlottesville, reported their findings, which resulted from the randomized OASIS 1 and 2 studies, in JAMA.
“Women experience a variety of symptoms during their menopausal transition, including vasomotor symptoms ... and sleep disturbances, reported by up to 80% and 60%, respectively,” wrote the researchers. “Menopausal symptoms can negatively impact quality of life, reducing the capacity for daily activities and work productivity, and may be associated with long-term negative health outcomes such as cardiovascular events, depressive symptoms, cognitive decline, and other adverse brain outcomes.” The researchers also noted that some therapeutic options are available, including hormone replacement therapy and, in some countries, paroxetine, a selective serotonin reuptake inhibitor.
The Italian Ministry of Health’s menopause website points out that the transition generally occurs between ages 45 and 55 years. This huge hormonal change has consequences for women’s health. Ministry experts explain that diet and hormone replacement therapy (which should be taken under medical supervision) can prevent or counteract these consequences.
“Many women have contraindications, have tolerability issues leading to discontinuation, or prefer not to take these treatments,” wrote Dr. Pinkerton and colleagues, who evaluated the efficacy and tolerability of elinzanetant, a nonhormonal alternative treatment in development. The two double-blind, randomized, phase 3 studies (OASIS 1 and 2) included postmenopausal participants between ages 40 and 65 years with moderate to severe vasomotor symptoms who were treated with elinzanetant (OASIS 1, n = 199; OASIS 2, n = 200) or placebo (OASIS 1, n = 197; OASIS 2, n = 200).
After 4 weeks of treatment, 62.8% of participants in the OASIS 1 study and 62.2% in the OASIS 2 study reported at least a 50% reduction in the frequency of vasomotor symptoms (29.2% and 32.3% in the respective placebo groups). Improvements increased by week 12, with 71.4% and 74.7% of women in the elinzanetant group achieving this reduction (42.0% and 48.3% in the respective placebo groups). Women who took the medication also reported a reduction in the severity of vasomotor symptoms and improvements in sleep and menopause-related quality of life, with no significant tolerability and safety issues. “Elinzanetant has the potential to provide a well-tolerated and efficacious nonhormonal treatment option to address the unmet health needs of many menopausal individuals with moderate to severe vasomotor symptoms,” the authors concluded.
“With the discovery of nonhormonal treatment options targeting the neurons responsible for vasomotor symptoms, menopause care should advance on this solid scientific footing to benefit affected individuals,” wrote Stephanie S. Faubion, MD, and Chrisandra L. Shufelt, MD, who are affiliated with the Mayo Clinic in Rochester, Minnesota, and Jacksonville, Florida, in an accompanying editorial.
This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Elinzanetant, the selective antagonist of neurokinin 1 and 3 receptors, led to rapid improvement in the frequency of vasomotor symptoms and significant improvements in the severity of symptoms, sleep disturbances, and menopause-related quality of life in two phase 3 studies. Researchers led by JoAnn V. Pinkerton, MD, from the University of Virginia Health in Charlottesville, reported their findings, which resulted from the randomized OASIS 1 and 2 studies, in JAMA.
“Women experience a variety of symptoms during their menopausal transition, including vasomotor symptoms ... and sleep disturbances, reported by up to 80% and 60%, respectively,” wrote the researchers. “Menopausal symptoms can negatively impact quality of life, reducing the capacity for daily activities and work productivity, and may be associated with long-term negative health outcomes such as cardiovascular events, depressive symptoms, cognitive decline, and other adverse brain outcomes.” The researchers also noted that some therapeutic options are available, including hormone replacement therapy and, in some countries, paroxetine, a selective serotonin reuptake inhibitor.
The Italian Ministry of Health’s menopause website points out that the transition generally occurs between ages 45 and 55 years. This huge hormonal change has consequences for women’s health. Ministry experts explain that diet and hormone replacement therapy (which should be taken under medical supervision) can prevent or counteract these consequences.
“Many women have contraindications, have tolerability issues leading to discontinuation, or prefer not to take these treatments,” wrote Dr. Pinkerton and colleagues, who evaluated the efficacy and tolerability of elinzanetant, a nonhormonal alternative treatment in development. The two double-blind, randomized, phase 3 studies (OASIS 1 and 2) included postmenopausal participants between ages 40 and 65 years with moderate to severe vasomotor symptoms who were treated with elinzanetant (OASIS 1, n = 199; OASIS 2, n = 200) or placebo (OASIS 1, n = 197; OASIS 2, n = 200).
After 4 weeks of treatment, 62.8% of participants in the OASIS 1 study and 62.2% in the OASIS 2 study reported at least a 50% reduction in the frequency of vasomotor symptoms (29.2% and 32.3% in the respective placebo groups). Improvements increased by week 12, with 71.4% and 74.7% of women in the elinzanetant group achieving this reduction (42.0% and 48.3% in the respective placebo groups). Women who took the medication also reported a reduction in the severity of vasomotor symptoms and improvements in sleep and menopause-related quality of life, with no significant tolerability and safety issues. “Elinzanetant has the potential to provide a well-tolerated and efficacious nonhormonal treatment option to address the unmet health needs of many menopausal individuals with moderate to severe vasomotor symptoms,” the authors concluded.
“With the discovery of nonhormonal treatment options targeting the neurons responsible for vasomotor symptoms, menopause care should advance on this solid scientific footing to benefit affected individuals,” wrote Stephanie S. Faubion, MD, and Chrisandra L. Shufelt, MD, who are affiliated with the Mayo Clinic in Rochester, Minnesota, and Jacksonville, Florida, in an accompanying editorial.
This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Elinzanetant, the selective antagonist of neurokinin 1 and 3 receptors, led to rapid improvement in the frequency of vasomotor symptoms and significant improvements in the severity of symptoms, sleep disturbances, and menopause-related quality of life in two phase 3 studies. Researchers led by JoAnn V. Pinkerton, MD, from the University of Virginia Health in Charlottesville, reported their findings, which resulted from the randomized OASIS 1 and 2 studies, in JAMA.
“Women experience a variety of symptoms during their menopausal transition, including vasomotor symptoms ... and sleep disturbances, reported by up to 80% and 60%, respectively,” wrote the researchers. “Menopausal symptoms can negatively impact quality of life, reducing the capacity for daily activities and work productivity, and may be associated with long-term negative health outcomes such as cardiovascular events, depressive symptoms, cognitive decline, and other adverse brain outcomes.” The researchers also noted that some therapeutic options are available, including hormone replacement therapy and, in some countries, paroxetine, a selective serotonin reuptake inhibitor.
The Italian Ministry of Health’s menopause website points out that the transition generally occurs between ages 45 and 55 years. This huge hormonal change has consequences for women’s health. Ministry experts explain that diet and hormone replacement therapy (which should be taken under medical supervision) can prevent or counteract these consequences.
“Many women have contraindications, have tolerability issues leading to discontinuation, or prefer not to take these treatments,” wrote Dr. Pinkerton and colleagues, who evaluated the efficacy and tolerability of elinzanetant, a nonhormonal alternative treatment in development. The two double-blind, randomized, phase 3 studies (OASIS 1 and 2) included postmenopausal participants between ages 40 and 65 years with moderate to severe vasomotor symptoms who were treated with elinzanetant (OASIS 1, n = 199; OASIS 2, n = 200) or placebo (OASIS 1, n = 197; OASIS 2, n = 200).
After 4 weeks of treatment, 62.8% of participants in the OASIS 1 study and 62.2% in the OASIS 2 study reported at least a 50% reduction in the frequency of vasomotor symptoms (29.2% and 32.3% in the respective placebo groups). Improvements increased by week 12, with 71.4% and 74.7% of women in the elinzanetant group achieving this reduction (42.0% and 48.3% in the respective placebo groups). Women who took the medication also reported a reduction in the severity of vasomotor symptoms and improvements in sleep and menopause-related quality of life, with no significant tolerability and safety issues. “Elinzanetant has the potential to provide a well-tolerated and efficacious nonhormonal treatment option to address the unmet health needs of many menopausal individuals with moderate to severe vasomotor symptoms,” the authors concluded.
“With the discovery of nonhormonal treatment options targeting the neurons responsible for vasomotor symptoms, menopause care should advance on this solid scientific footing to benefit affected individuals,” wrote Stephanie S. Faubion, MD, and Chrisandra L. Shufelt, MD, who are affiliated with the Mayo Clinic in Rochester, Minnesota, and Jacksonville, Florida, in an accompanying editorial.
This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
FROM JAMA