Trial reportInternational urology and nephrology2026
Prospective comparative evaluation of clinical efficacy and safety of Intravesical gemcitabine-docetaxel versus BCG in adjuvant management of BCG-naive non-muscle invasive urothelial bladder cancer in Indian population.
Trial report in International urology and nephrology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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8 authors.
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Abstract
backgroundIntravesical Bacillus Calmette-Guérin (BCG) is the standard adjuvant therapy for intermediate/high-risk non-muscle-invasive bladder cancer (NMIBC) but is limited by failure, toxicity, and global supply constraints. Sequential Intravesical gemcitabine-docetaxel (Gem/Doce) can offer a rational chemotherapy alternative.
methodsIn this prospective randomized, parallel-arm interventional study comparing efficacy and safety of Gem/Doce versus BCG in BCG-naïve intermediate/high-risk NMIBC, patients aged 18-80 years with complete TURBT of primary localised bladder lesion(s) were included. Gem/Doce induction comprised weekly gemcitabine (1000 mg) and docetaxel (40 mg) Intravesical instillations for 6 weeks, with monthly maintenance per risk group. BCG induction (weekly 80 mg OncoBCG for 6 weeks) was followed by risk-based maintenance as per SWOG protocol. Outcomes (RFS, high-grade RFS, PFS, CSS, OS) were evaluated post-induction, and at 6 and 12 months. Adverse events were graded by CTCAE v5.0.
results91 patients (Gem/Doce n = 43; BCG n = 48) were evaluated. At 6 and 12 months, RFS was 95.35% and 90.71% in Gem/Doce versus 83.33% and 77.08% in BCG. Intermediate-risk category had higher 12 month RFS with Gem/Doce (93.55% vs 81.82%, p = 0.041). High-grade RFS was higher with Gem/Doce (97.67% and 93.02%) than BCG (93.75% and 89.58%). At 12 months, PFS, CSS, and OS were superior with Gem/Doce: PFS 97.67% vs 95.83%, CSS 100% vs 97.92%, and OS 100% vs 95.83%. Fewer patients reported AEs with Gem/Doce (13.95% vs 35.42%), with fewer Grade 1-2 events (p < 0.01) and no Grade ≥ 3 events vs. three in BCG. Dysuria, bladder spasm, and frequency were higher with BCG.
conclusionsSequential Gem/Doce is an effective and better-tolerated alternative to BCG in BCG-naïve NMIBC, demonstrating superior intermediate-risk RFS and comparable survival outcomes. Long-term validation through larger multi-centre studies is warranted.
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