Reporting of sex-related data in landmark phase III solid tumor trials presented at ASCO 2025.

11088 Background: Sex-related differences may influence cancer biology, treatment efficacy, and toxicity. Although consideration of sex as a biologically relevant variable is increasingly encouraged in oncology research, the extent to which sex-specific information is visible at the time of initial presentation of practice-changing clinical trial results remains unclear. Methods: We conducted a cross-sectional review of phase III solid tumor trial abstracts enrolling mixed-sex populations presented at the ASCO Annual Meeting 2025. Plenary, oral, and rapid oral abstracts representing practice-changing studies across tumor types and treatment modalities were included. Abstracts were systematically assessed for reporting of sex distribution and for sex-stratified efficacy or toxicity outcomes. Results: Ten landmark phase III trials across gastrointestinal, lung, genitourinary, head and neck, and melanoma cancers were included. Female representation was reported in 1 of 10 abstracts (10%). None of the abstracts reported sex-stratified efficacy analyses, and none reported sex-stratified toxicity outcomes. The absence of sex-specific reporting was consistent across tumor types, therapeutic classes, and session formats, including plenary presentations. Conclusions: Among landmark phase III solid tumor trials presented at ASCO 2025, sex-specific reporting was largely absent at the abstract level, including in practice-changing studies. Limited visibility of sex-specific data at abstract presentation may constrain clinical interpretation and highlights an opportunity to improve reporting practices in oncology trials.

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Publication Details

Journal
Journal of Clinical Oncology
Published
2026-05-27
DOI
https://doi.org/10.1200/jco.2026.44.16_suppl.11088
Primary Topic
Sex and Gender in Healthcare
Type
article
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article

Reporting of sex-related data in landmark phase III solid tumor trials presented at ASCO 2025.

Marine Rushanyan, Davit Zohrabyan, Samvel Bardakhchyan, Amalya Sargsyan et al.
Journal of Clinical Oncology
Sex and Gender in Healthcare
article

Reporting of sex-related data in landmark phase III solid tumor trials presented at ASCO 2025.

Marine Rushanyan, Davit Zohrabyan, Samvel Bardakhchyan, Amalya Sargsyan, Liana Safaryan, Mariam Mailyan, Nune Karapetyan, Gohar Mkrtchyan
article en

Abstract

11088 Background: Sex-related differences may influence cancer biology, treatment efficacy, and toxicity. Although consideration of sex as a biologically relevant variable is increasingly encouraged in oncology research, the extent to which sex-specific information is visible at the time of initial presentation of practice-changing clinical trial results remains unclear. Methods: We conducted a cross-sectional review of phase III solid tumor trial abstracts enrolling mixed-sex populations presented at the ASCO Annual Meeting 2025. Plenary, oral, and rapid oral abstracts representing practice-changing studies across tumor types and treatment modalities were included. Abstracts were systematically assessed for reporting of sex distribution and for sex-stratified efficacy or toxicity outcomes. Results: Ten landmark phase III trials across gastrointestinal, lung, genitourinary, head and neck, and melanoma cancers were included. Female representation was reported in 1 of 10 abstracts (10%). None of the abstracts reported sex-stratified efficacy analyses, and none reported sex-stratified toxicity outcomes. The absence of sex-specific reporting was consistent across tumor types, therapeutic classes, and session formats, including plenary presentations. Conclusions: Among landmark phase III solid tumor trials presented at ASCO 2025, sex-specific reporting was largely absent at the abstract level, including in practice-changing studies. Limited visibility of sex-specific data at abstract presentation may constrain clinical interpretation and highlights an opportunity to improve reporting practices in oncology trials.

Journal of Clinical OncologyVol. 44(16_suppl)
Yerevan State Medical University (AM)
Good health and well-being
Openalex Percentile: Top 5%
Sex and Gender in Healthcare
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