Combination intravesical gemcitabine‒docetaxel (GemDoce) 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 1-year recurrence-free survival (RFS) results. 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 GemDoce 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 (Patel, S et al., J Urol 2024). Here we present secondary endpoints of 24-month and 36-month high-grade RFS, along with updated adverse events (AEs).
Twenty-five patients were enrolled between August 2020 and August 2022 and followed for a median of 40.1 months with a minimum of 34-month follow-up in all patients. The cohort included 16 patients (64%) with HGT1, 8 (32%) with HGTa, and 4 (16%) with CIS present. High-grade RFS was 84.0% at 24 months and 82.6% at 36 months (Figure 1). 6 patients (24%) had HG recurrence noted at 11, 11, 15, 20, 37, and 50 months respectively (Figure 2). Among those with HG recurrence, 4 continued to BCG therapy and 2 showed a sustained complete response to BCG. One patient who was lost to follow-up progressed with metastatic disease, and two patients (8%) underwent cystectomy, one for HGTa recurrence during BCG and another for T2 progression after failing 2nd line immune checkpoint therapy. Two patients had low-grade recurrence. Grade-1 AEs occurred in 21 patients (84%) including hematuria, urinary frequency, urgency, and fatigue. 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 strong efficacy of GemDoce for patients with BCG-naïve HR NMIBC.
Chad Holliday Research Fund