{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,4]],"date-time":"2026-08-04T23:49:23Z","timestamp":1785887363725,"version":"3.56.0"},"reference-count":62,"publisher":"Georg Thieme Verlag KG","funder":[{"name":"University of Luebeck","award":["MCR: LACS05-2024"],"award-info":[{"award-number":["MCR: LACS05-2024"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Aktuelle Urol"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Treatment outcomes after systemic cancer therapies exhibit sex-specific differences. Real-world data do not necessarily reflect the results of randomized clinical trials (RCTs).<\/jats:p>\n                  <jats:p>To compare sex-specific outcomes between RCTs and subsequent real-world data in patients with urothelial cancer (UC) receiving systemic therapies.<\/jats:p>\n                  <jats:p>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.<\/jats:p>\n                  <jats:p>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.<\/jats:p>\n                  <jats:p>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.<\/jats:p>","DOI":"10.1055\/a-2897-1443","type":"journal-article","created":{"date-parts":[[2026,8,4]],"date-time":"2026-08-04T23:15:17Z","timestamp":1785885317000},"source":"Crossref","is-referenced-by-count":0,"title":["Comparison of Sex-Specific Treatment Outcomes in Clinical Trials and Subsequent Real-World Data on Systemic Therapies for Urothelial Carcinoma: A Systematic Review"],"prefix":"10.1055","author":[{"given":"Marie Christine","family":"Roesch","sequence":"additional","affiliation":[{"name":"University Hospital Schleswig-Holstein Campus L\u00fcbeck, Germany","place":["L\u00fcbeck"],"department":["Department of Urology"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lea Sophie","family":"L\u00fctje","sequence":"additional","affiliation":[{"name":"University Hospital Schleswig-Holstein Campus L\u00fcbeck, Germany","place":["L\u00fcbeck"],"department":["Department of Urology"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marten","family":"M\u00fcller","sequence":"additional","affiliation":[{"name":"University Hospital Schleswig-Holstein Campus L\u00fcbeck, Germany","place":["L\u00fcbeck"],"department":["Department of Urology"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Axel S.","family":"Merseburger","sequence":"additional","affiliation":[{"name":"University Hospital Schleswig-Holstein Campus L\u00fcbeck, Germany","place":["L\u00fcbeck"],"department":["Department of Urology"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniar","family":"Osmonov","sequence":"additional","affiliation":[{"name":"University Hospital Schleswig-Holstein Campus L\u00fcbeck, Germany","place":["L\u00fcbeck"],"department":["Department of Urology"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nils","family":"Gilbert","sequence":"additional","affiliation":[{"name":"University Hospital Schleswig-Holstein Campus L\u00fcbeck, Germany","place":["L\u00fcbeck"],"department":["Department of Urology"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"194","published-online":{"date-parts":[[2026,8,4]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"znae179","DOI":"10.1093\/bjs\/znae179","article-title":"Sex-related differences in oncological surgery and postoperative outcomes: comprehensive, nationwide study in France","volume":"111","author":"F Jochum","year":"2024","journal-title":"Br J Surg"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"442.e9","DOI":"10.1016\/j.urolonc.2025.01.002","article-title":"Sex-related differences in response to neoadjuvant and adjuvant chemotherapy in urothelial carcinoma of urinary bladder treated with radical cystectomy","volume":"43","author":"M de Angelis","year":"2025","journal-title":"Urol 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