Aktuelle Urologie · 2026
Comparison of Sex-Specific Treatment Outcomes in Clinical Trials and Subsequent Real-World Data on Systemic Therapies for Urothelial Carcinoma: A Systematic Review.
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Roesch Marie Christine, Lütje Lea Sophie, Müller Marten, Merseburger Axel S, Osmonov Daniar, Gilbert Nils
Аннотация
BACKGROUND/CONTEXT: Treatment outcomes after systemic cancer therapies exhibit sex-specific differences. Real-world data do not necessarily reflect the results of randomized clinical trials (RCTs).
OBJECTIVE: To compare sex-specific outcomes between RCTs and subsequent real-world data in patients with urothelial cancer (UC) receiving systemic therapies.
METHODS: A systematic literature search on systemic therapies for UC was conducted in Embase, PubMed, MEDLINE, and Scopus up to February 2025. Eligible studies included phase II/III trials, RCTs, prospective non-interventional studies, retrospective studies, and case series. Extracted parameters comprised hazard ratios for overall survival and progression-free survival (or disease-free survival for adjuvant therapies), sex-specific enrollment rates, and discontinuation rates due to adverse effects. This review is registered with PROSPERO and was conducted in accordance with PRISMA guidelines.
RESULTS: A total of 52 articles were included. The proportion of female patients enrolled in UC RCTs did not reflect epidemiologic data, and only a few real-world studies reached the expected benchmark. The following approval studies showed a survival benefit for men compared with women: JAVELIN Bladder 100 (Avelumab), Keynote 045 (Pembrolizumab), EV-301 (Enfortumab Vedotin), CheckMate 901 (Gemcitabine + Cisplatin + Nivolumab), and CheckMate 274 (adjuvant Nivolumab). Only a limited number of real-world studies reported sex-specific outcome analyses, and none demonstrated a clear benefit for either sex. No sex-specific toxicity analyses were published.
CONCLUSION: Several approval studies investigating therapies for urothelial cancer suggest a survival benefit for male patients. However, this finding was not confirmed in real-world data. Female patients remain underrepresented in approval trials for UC, and sex-specific toxicity analyses are lacking. Such analyses should be mandatory in future RCTs.
OBJECTIVE: To compare sex-specific outcomes between RCTs and subsequent real-world data in patients with urothelial cancer (UC) receiving systemic therapies.
METHODS: A systematic literature search on systemic therapies for UC was conducted in Embase, PubMed, MEDLINE, and Scopus up to February 2025. Eligible studies included phase II/III trials, RCTs, prospective non-interventional studies, retrospective studies, and case series. Extracted parameters comprised hazard ratios for overall survival and progression-free survival (or disease-free survival for adjuvant therapies), sex-specific enrollment rates, and discontinuation rates due to adverse effects. This review is registered with PROSPERO and was conducted in accordance with PRISMA guidelines.
RESULTS: A total of 52 articles were included. The proportion of female patients enrolled in UC RCTs did not reflect epidemiologic data, and only a few real-world studies reached the expected benchmark. The following approval studies showed a survival benefit for men compared with women: JAVELIN Bladder 100 (Avelumab), Keynote 045 (Pembrolizumab), EV-301 (Enfortumab Vedotin), CheckMate 901 (Gemcitabine + Cisplatin + Nivolumab), and CheckMate 274 (adjuvant Nivolumab). Only a limited number of real-world studies reported sex-specific outcome analyses, and none demonstrated a clear benefit for either sex. No sex-specific toxicity analyses were published.
CONCLUSION: Several approval studies investigating therapies for urothelial cancer suggest a survival benefit for male patients. However, this finding was not confirmed in real-world data. Female patients remain underrepresented in approval trials for UC, and sex-specific toxicity analyses are lacking. Such analyses should be mandatory in future RCTs.