The French journal of urology · 2026
SEQUENTIAL INTRAVESICAL GEMCITABINE-DOCETAXEL AFTER BCG FAILURE NON-MUSCLE INVASIVE BLADDER CANCER: ONCOLOGICAL OUTCOMES AND SAFETY PROFILE.
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Biest Albane Massiet du, Xylinas Evanguelos, Gabriel Pierre-Etienne
Аннотация
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.
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.