EARLY CLINICAL EXPERIENCE WITH SEQUENTIAL INTRAVESICAL GEMCITABINE-DOCETAXEL FOR TREATMENT-NAIVE HIGH RISK NON-MUSCLE INVASIVE BLADDER CANCER

• Published in: Urologic oncology 2024-03, Vol.42, p.S49-S50
• Main Authors: Refugia, Justin Manuel, Roebuck, Emily, Thakker, Parth U., Hemal, Ashok, Tsivian, Matvey
• Format: Article
• Language: English
• ISSN: 1078-1439; 1873-2496
• DOI: 10.1016/j.urolonc.2024.01.153

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. 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. 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). Amidst waning BCG availab