Combination intravesical gemcitabine‒docetaxel (Gem/Doce) has demonstrated efficacy in bacillus Calmette-Guérin (BCG)‒unresponsive high-risk (HR) nonmuscle-invasive bladder cancer (NMIBC). However, its efficacy as first-line treatment for BCG-naïve HR NMIBC is unknown. We previously reported recurrence-free survival (RFS) at 1 year. Herein we present updated 3-year outcomes.
This study is a prospective, single-arm, open-label phase 2 trial for patients with BCG-naïve HR NMIBC. Intravesical Gem/Doce was given weekly for 6 weeks as induction followed by monthly maintenance therapy for 2 years. We previously reported the primary endpoint of 3-month complete response and here we present secondary endpoints of 24-month and 36-month high-grade (HG) RFS, along with updated adverse events (AEs).
Twenty-five patients were enrolled between August 2020 and August 2022 and followed for a median of 50 months with a minimum of 41-month follow-up in all patients with continued response. The cohort included 16 patients (64%) with HGT1, 8 (32%) with HGTa, and 9 (36%) with CIS present. High-grade RFS was 84% at 24 months (21/25; 95% CI, 63%-94%) and 80% at 36 months (20/25; 95% CI, 58%-91%). Recurrences occurred at 11, 11, 15, 20, 36, 49, and 65 months post induction. Six of the seven patients who had HG recurrence were treated with BCG and three have no evidence of disease to date. No patients had progression during Gem/Doce and two patients (8%) underwent cystectomy, one for recurrence during BCG and another for recurrence after a 3rd-line bladder preservation approach. Two patients had low-grade recurrence. Grade-1 AEs occurred in 21 patients (84%), commonly from pain, fatigue, and hematuria. Five patients (20%) experienced a grade-3 AE including hematuria and urinary tract infection.
The updated 3-year results of this single-arm phase 2 trial suggest continued efficacy and durability of Gem/Doce for this small cohort of BCG-naïve HR NMIBC.
The Journal of urology. 2026 Jun 22 [Epub ahead of print]
Tyler S Garman, Soum Lokeshwar, Jack Campbell, Zhuo Tony Su, Andrew T Gabrielson, Nirmish Singla, Bruce J Trock, Trinity J Bivalacqua, Sunil H Patel, Max R Kates
The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, Maryland.