Phase 2 Trial of Intravesical Gemcitabine and Docetaxel as First-Line Treatment of Bacillus Calmette-Guérin‒Naïve Nonmuscle-Invasive Urothelial Carcinoma: Updated, 3-Year Outcomes.
J UrolJun 22, 2026 (epub)
Clinical ResearchUrology
Tyler S Garman, Soum Lokeshwar, Jack Campbell et al.
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In 30 seconds
This phase 2 trial evaluated the efficacy of intravesical gemcitabine and docetaxel (Gem/Doce) as first-line treatment in 25 patients with bacillus Calmette-Guérin (BCG)‒naïve high-risk nonmuscle-invasive bladder cancer (NMIBC). After 3 years, high-grade recurrence-free survival (RFS) was 80% (20/25; 95% CI, 58%-91%), indicating sustained treatment effectiveness.
Key findings
- High-grade RFS was 84% at 24 months and 80% at 36 months.
- No patients experienced disease progression during treatment with Gem/Doce.
- Grade 1 adverse events occurred in 84% of patients, primarily pain and fatigue.
- 20% of patients experienced grade 3 adverse events, including hematuria and urinary tract infections.
Why it matters
The findings suggest that intravesical Gem/Doce may provide a durable treatment option for patients with BCG-naïve high-risk NMIBC, potentially improving management strategies in this patient population.