Sequential Intravesical Chemotherapy for Treatment Naïve, High-Risk Non-Muscle Invasive Bladder Cancer: Oncologic Outcomes, Tolerance, and Comparison to Contemporary Controls.

ABSTRACT

OBJECTIVE: To assess if receiving sequential intravesical chemotherapy (Gemcitabine-Docetaxel, Gem-Doce) therapy was associated with similar oncologic efficacy to bacillus Calmette-Guérin (BCG) in patients with treatment-naïve, high-risk non-muscle invasive bladder cancer (HR-NMIBC). METHODS: Single-center, retrospective cohort study of 80 patients with HR-NMIBC initiating first-line Gem-Doce or BCG between August 2020 and August 2023. Surveillance was conducted with cystoscopy, urine cytology, and cross-sectional imaging. The primary oncologic outcome was high-grade bladder tumor recurrence during surveillance. Kaplan-Meier method was applied to determine 12- and 24-month recurrence-free survival (RFS) after initiation of therapy. Tolerance of each intravesical therapies was assessed. RESULTS: About 53/80 (66%) received Gem-Doce and 27/80 (34%) received BCG with overall 18-month median follow-up. There were 10 recurrences after Gem-Doce and 7 after BCG. The RFS at 12- and 24-months for Gem-Doce (12-months 87%, 24-months 75%) was not significantly different than BCG (12-months 85%, 24-months 81%). Lastly, Gem-Doce had significantly fewer patients with AEs compared to BCG (40% vs 74%). Limitations include retrospective design, small cohort size, and intermediate oncologic follow-up. CONCLUSION: Our data suggest that sequential intravesical Gem-Doce is an oncologically efficacious and, potentially better tolerated, alternative to BCG for treatment-naïve HR-NMIBC.