OBJECTIVE: To evaluate the oncological efficacy and safety of sequential intravesical gemcitabine/docetaxel (Gem/Doce) therapy in a European cohort of patients with high-risk and very-high-risk non-muscle-invasive bladder cancer (NMIBC) after previous Bacillus Calmette-Guérin (BCG) treatment. MATERIALS AND METHODS: Data were retrospectively collected from 95 patients with NMIBC, treated with Gem/Doce at 12 European centres between 2021 and 2024. Patients previously treated with BCG who had completed a full induction course and received at least one follow-up evaluation were included. One-year disease-free survival (DFS), high-grade DFS and progression-free survival (PFS) were estimated using Kaplan-Meier curves. Adverse events (AEs) were recorded through medical interviews. RESULTS: Of 75 patients, 63 (84%) were classified as having high-risk and 12 (16%) as having very-high-risk NMIBC. Over a median (interquartile range) follow-up of 9 (5-14) months, 20 patients (27%) relapsed and five (6.7%) underwent radical cystectomy. The 1-year DFS was 73% (95% confidence interval [CI] 62-86%), 1-year high-grade DFS was 79% (95% CI 68-91%) and 1-year PFS was 95% (95% CI 90-100%). AEs occurred in 34 patients (45%), with six (8.7%) experiencing severe AEs. Limitations of the study include the short follow-up and variability in both treatment dwelling times and dosage across centres. CONCLUSION: The intravesical Gem/Doce regimen demonstrated promising short-term oncological outcomes and was well tolerated in this cohort of patients with high- and very-high-risk NMIBC previously treated with BCG. Prospective studies and randomised trials are awaited to define the ideal candidates for Gem/Doce therapy and to standardise treatment protocols.

Department of Minimally Invasive and Robotic Urology Wrocław Medical University Wrocław Poland

Department of Urology 2nd Faculty of Medicine Charles University Prague Czech Republic

Department of Urology Bichat Claude Bernard Hospital AP HP Université de Paris Cité Paris France

Department of Urology Claude Huriez Hospital CHU Lille Lille France

Department of Urology Comprehensive Cancer Center Medical University of Vienna Vienna Austria

Department of Urology GRC no 5 Predictive Onco Urology AP HP Hôpital Pitié Salpêtrière Sorbonne Université Paris France

Department of Urology Helios Klinikum Bad Saarow Bad Saarow Germany

Department of Urology Hospital Universitario de Cáceres Cáceres Spain

Department of Urology Hospital Universitario La Paz Madrid Spain

Department of Urology Humanitas Clinical and Research Institute IRCCS Milan Italy

Department of Urology Instituto Ramón y Cajal de Investigación Sanitaria Hospital Universitario Ramón y Cajal Universidad de Alcalá Madrid Spain

Department of Urology Medical University of Innsbruck Innsbruck Austria

Department of Urology University of Texas Southwestern Dallas TX USA

Department of Urology UROSUD La Croix Du Sud Hospital Quint Fonsegrives France

Department of Urology Weill Cornell Medical College New York NY USA

Division of Experimental Oncology Unit of Urology IRCCS Ospedale San Raffaele Milan Italy

Division of Urology Department of Surgical Sciences San Giovanni Battista Hospital University of Studies of Torino Turin Italy

Karl Landsteiner Institute of Urology and Andrology Vienna Austria

Vita Salute San Raffaele University Milan Italy

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