Albane Massiet du Biest, Evanguelos Xylinas, Pierre-Etienne Gabriel
{"title":"Sequential intravesical gemcitabine-docetaxel after BCG failure non-muscle invasive bladder cancer: Oncological outcomes and safety profile.","authors":"Albane Massiet du Biest, Evanguelos Xylinas, Pierre-Etienne Gabriel","doi":"10.1016/j.fjurol.2026.103229","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Sequential intravesical instillation of gemcitabine and docetaxel (Gem/Doce) has emerging evidence as a bladder-sparing approach in BCG failure non-muscle-invasive bladder cancer (NMIBC). This study aimed to provide additional real-world data by reporting the oncological outcomes and safety profile of Gem/Doce in BCG-failure NMIBC.</p><p><strong>Methods: </strong>We conducted a retrospective single-arm monocentric study including all consecutive patients treated with Gem/Doce for BCG-failure NMIBC between 2023 and 2025. Oncological outcomes included overall recurrence-free survival (RFS), high-grade (HG) RFS, progression-free survival (PFS), cystectomy-free survival (CFS), metastasis-free survival (MFS), and overall survival (OS). Adverse events (AEs) were graded using CTCAE criteria.</p><p><strong>Results: </strong>A total of 47 patients were included. Median number of instillations was 10 (IQR 6-14). After a median follow-up of 12.6 months (11.6-19.7), 10 (21.3%) patients experienced disease recurrence or progression, including 5 (10.6%) with HG recurrence and 1 (2.1%) with muscle-invasive disease. Three (6.4%) patients underwent radical cystectomy, three (6.4%) developed metastases, and three (6.4%) died, including one (2.1%) from bladder cancer. 1-year RFS and HG-RFS were 89.3% (80-99.8) and 94.3% (87-100). 1-year PFS, CFS, MFS, and OS were 96.8%, 95.4%, 97.9%, and 95.3%. In BCG-unresponsive NMIBC, 1-year RFS, HG-RFS and MFS were 91.4%, 95.5% and 96.4%. Among patients with systematic bladder biopsies (n=15 at 3 months and n=9 at 12 months), 4 (26.7%) were positive at 3 months and 3 (33.3%) at 12 months. AEs occurred in 70.2% (grade 1-2) and 6.4% (grade ≥3), mainly urinary frequency, urgency, and asthenia.</p><p><strong>Conclusion: </strong>Gem/Doce shows promising real-world oncological efficacy with an acceptable safety profile in BCG-failure NMIBC, although optimal surveillance strategies remain to be defined.</p><p><strong>Level of evidence: 4: </strong></p>","PeriodicalId":516865,"journal":{"name":"The French journal of urology","volume":" ","pages":"103229"},"PeriodicalIF":1.2000,"publicationDate":"2026-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"The French journal of urology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1016/j.fjurol.2026.103229","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Introduction: Sequential intravesical instillation of gemcitabine and docetaxel (Gem/Doce) has emerging evidence as a bladder-sparing approach in BCG failure non-muscle-invasive bladder cancer (NMIBC). This study aimed to provide additional real-world data by reporting the oncological outcomes and safety profile of Gem/Doce in BCG-failure NMIBC.
Methods: We conducted a retrospective single-arm monocentric study including all consecutive patients treated with Gem/Doce for BCG-failure NMIBC between 2023 and 2025. Oncological outcomes included overall recurrence-free survival (RFS), high-grade (HG) RFS, progression-free survival (PFS), cystectomy-free survival (CFS), metastasis-free survival (MFS), and overall survival (OS). Adverse events (AEs) were graded using CTCAE criteria.
Results: A total of 47 patients were included. Median number of instillations was 10 (IQR 6-14). After a median follow-up of 12.6 months (11.6-19.7), 10 (21.3%) patients experienced disease recurrence or progression, including 5 (10.6%) with HG recurrence and 1 (2.1%) with muscle-invasive disease. Three (6.4%) patients underwent radical cystectomy, three (6.4%) developed metastases, and three (6.4%) died, including one (2.1%) from bladder cancer. 1-year RFS and HG-RFS were 89.3% (80-99.8) and 94.3% (87-100). 1-year PFS, CFS, MFS, and OS were 96.8%, 95.4%, 97.9%, and 95.3%. In BCG-unresponsive NMIBC, 1-year RFS, HG-RFS and MFS were 91.4%, 95.5% and 96.4%. Among patients with systematic bladder biopsies (n=15 at 3 months and n=9 at 12 months), 4 (26.7%) were positive at 3 months and 3 (33.3%) at 12 months. AEs occurred in 70.2% (grade 1-2) and 6.4% (grade ≥3), mainly urinary frequency, urgency, and asthenia.
Conclusion: Gem/Doce shows promising real-world oncological efficacy with an acceptable safety profile in BCG-failure NMIBC, although optimal surveillance strategies remain to be defined.
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