ArticleJHEP reports : innovation in hepatology2026
Impact of sex on chemotherapy toxicity and efficacy in biliary tract cancer: Analysis of ABC, BILCAP trials and population data.
Article in JHEP reports : innovation in hepatology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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Who cites it
1 citing paper in PubMed.
- Patient Characteristics and Treatment Patterns of Advanced Biliary Tract Cancer (BTC): A Chinese Physician Survey.Advances in therapy · 2026Article
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10 authors.
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Abstract
BACKGROUND &
aimsIncreasing evidence suggests sexual dimorphism in treatment effects across cancers; however, its impact in biliary tract cancer (BTC) remains unclear. We compared toxicity and efficacy of palliative and adjuvant chemotherapy between male and female patients with BTC.
methodsWe conducted a retrospective cohort analysis of individual patient data from four randomized controlled trials in BTC and English population-based data. Study outcomes were adverse events and overall survival (OS), compared by sex.
resultsAmong 994 trial participants (49% male, 51% female) included in time-to-event analyses, 770 were evaluable for adverse events. Population data included 3,953 patients (46% male, 54% female) for OS analysis. Females experienced higher rates of grade 3/4 fatigue (odds ratio [OR] 2.18; 95% CI 1.02-4.67; p = 0.045). Higher rates of grade 3/4 vomiting (OR 1.97; 95% CI 1.00-3.91; p = 0.052), nausea (OR 1.99; 95% CI 0.80-4.97; p = 0.14), and fatigue in BILCAP (OR 2.31; 95% CI 0.77-6.88; p = 0.13) were observed in females but were not statistically significant. OS was similar between sexes in ABC trials (hazard ratio [HR] 0.94; 95% CI 0.79-1.11; p = 0.45) and in population data (HR 1.03; 95% CI 0.79-1.11; p = 0.45). In BILCAP, the HR for adjuvant capecitabine vs. observation was 0.71 in males (95% CI 0.50-1.00; p = 0.048) and 0.91 in females (95% CI 0.63-1.32; p = 0.625). Females with gallbladder cancer demonstrated improved OS compared with males in BILCAP (HR 0.48; 95% CI 0.24-0.98; p = 0.04).
conclusionSex differences in toxicity were observed, with higher rates of grade 3/4 fatigue in females. Survival outcomes were broadly similar; however, females with gallbladder cancer receiving adjuvant capecitabine showed improved survival compared with males. Although population analyses were limited by sample size, these findings warrant consideration in the design and interpretation of future BTC trials. IMPACT AND IMPLICATIONS: This study investigated the impact of biological sex on treatment outcomes in patients receiving chemotherapy for biliary tract cancers, which are typically associated with poor outcomes. Analysis of ABC and BILCAP clinical trials found a higher incidence of severe grade adverse events in women receiving cisplatin/gemcitabine and adjuvant capecitabine, relative to males, whilst overall survival was superior in women in the BILCAP trial. These findings are important for clinicians treating patients with biliary tract cancers and should be considered in the design and analysis of future clinical trials in biliary tract cancer, as the role of biological sex may an important determinant of chemotherapy response.
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