Introduction:

There is a great need to explore alternative therapeutics in the treatment of HR NMIBC, particularly in an era of a BCG shortage. In the setting of limited BCG availability, our HR NMIBC patients’ options included a 6-week sequential-intravesical Gemcitabine-Docetaxel induction (with monthly Gem-Doce maintenance), clinical trial, or radical cystectomy. There is a paucity of studies on Gem-Doce as first-line treatment for HR NMIBC and comparing responses between treatment-naïve groups treated with Gem-Doce versus BCG. We present our early clinical experience and oncologic outcomes in a modern cohort of patients receiving Gem-Doce as a feasible alternative for the treatment of HR NMIBC in the era of BCG shortage. 

Methods:

We conducted a retrospective cohort study of a contemporary group of patients with HR-NMIBC treated with first line Gem-Doce or BCG. The included patients had HR NMIBC on TURBT with a subsequent re-TURBT, as indicated, to remove all tumor. The patients included initiated standardized Gem-Doce or BCG therapy regimens due to preference over initial radical cystectomy or not being surgical candidates. Patients required at least one induction cycle (5 of 6 instillations) of Gem-Doce or BCG and minimum of 3-month follow up. Surveillance conducted according to established guidelines. The primary outcome was oncologic treatment success, reported as HG recurrence-free survival (probability of not having biopsy or cytology proven HG bladder cancer recurrence) at 6-, 12-, and 18-months after initiation of therapy. Groups were compared with univariate analyses (Mann-Whitney U and Fischer’s exact tests). The survival probabilities were estimated with Kaplan-Meier method and compared with log-rank tests.

Results:

We identified 88 patients meeting inclusion criteria, with 58 initiating Gem-Doce and 30 initiating BCG between August 2020 and June 2023. Patients had similar baseline characteristics of sex, race and ethnicity, smoking history, and treatment pathologies (Table 1). Patients in the BCG cohort were younger than the Gem-Doce cohort (median age 70 years versus 73 years, respectively, P = 0.02). The number of HG recurrences were similar (Gem-Doce 17%, BCG 33%, P = 0.11), however occurred sooner for Gem-Doce patients (median 4 months versus 12 months for BCG, P = 0.01). Between the BCG and Gem-Doce cohorts, the HG-RFS was similar at 6-months (86% vs 86%), 12-months (83% vs 76%), and 18-months (76% vs 76%), respectively (P = 0.71) (Figure 1).

Conclusion:

Amidst waning BCG availability, alternatives to radical cystectomy and clinical trial are necessary for urologists treating patients with HR-NMIBC. Our study suggests that oncologic treatment success with Gem-Doce was attainable with similar oncologic outcomes compared to a contemporary BCG population. Taken together, our findings bolster the preceding initiatives for inclusion of first-line Gem-Doce in the armamentarium for managing HR-NMIBC in treatment naïve populations.  

Funding: N/A