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.
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.
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.
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.
BJU international. 2025 Jan 11 [Epub ahead of print]
Pietro Scilipoti, Mattia Longoni, Mario de Angelis, Paolo Zaurito, Albane Massiet, Daniele Dutto, Francesco Soria, Mario Álvarez-Maestro, Alfredo Aguilera Bazán, Benjamin Pradere, Tobias Klatte, Roberto Contieri, Rodolfo Hurle, Wojciech Krajewski, José Daniel Subiela, Renate Pichler, Aleksandra Szostek, Gautier Marcq, José Luis Rodríguez Elena, Javier Aranda, Paolo Gontero, Morgan Rouprêt, Shahrokh F Shariat, Andrea Necchi, Francesco Montorsi, Alberto Briganti, Evanguelos Xylinas, Marco Moschini, EuroGemDoce Study Group Collaborators , European Association of Urology ‐ Young Academic Urologists (EAU‐YAU) , Urothelial Carcinoma Working Group
Division of Experimental Oncology/Unit of Urology, IRCCS Ospedale San Raffaele, Milan, Italy., Department of Urology, Bichat-Claude Bernard Hospital, AP-HP, Université de Paris Cité, Paris, France., Division of Urology, Department of Surgical Sciences, San Giovanni Battista Hospital, University of Studies of Torino, Turin, Italy., Department of Urology, Hospital Universitario La Paz, Madrid, Spain., Department of Urology UROSUD, La Croix Du Sud Hospital, Quint-Fonsegrives, France., Department of Urology, Helios Klinikum Bad Saarow, Bad Saarow, Germany., Department of Urology, Humanitas Clinical and Research Institute IRCCS, Milan, Italy., Department of Minimally Invasive and Robotic Urology, Wrocław Medical University, Wrocław, Poland., 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, Claude Huriez Hospital, CHU Lille, Lille, France., Department of Urology, Hospital Universitario de Cáceres, Cáceres, Spain., Department of Urology, GRC no 5, Predictive Onco-Urology, AP-HP, Hôpital Pitié-Salpêtrière, Sorbonne Université, Paris, France., Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.