Intravesical bacillus Calmette-Guérin (BCG) instillation is recommended for intermediate-risk (IR) and high-risk (HiR) non-muscle-invasive bladder cancer (NMIBC). There are limited comparisons of long-term outcomes between adequate and inadequate BCG.
We analyzed data from a multicenter European database (2010-2024) for 1558 patients diagnosed with IR- or HiR-NMIBC who underwent BCG treatment and received at least five BCG instillations. Adequate BCG was defined as at least five of six induction instillations and two of three maintenance doses, or two of six doses of a reinduction course. A 3-mo landmark analysis was conducted. Recurrence-free survival (RFS), high-grade RFS (HG-RFS), progression-free survival (PFS), and overall survival (OS) were estimated using inverse probability of treatment weighting (IPTW)-adjusted Kaplan-Meier curves and IPTW-adjusted multivariable Cox regression models. Cancer-specific mortality (CSM) was assessed via cumulative incidence curves and Fine-Gray competing-risks regression analysis.
The cohort included 606 IR-NMIBC (39%), 840 HiR-NMIBC (54%), and 112 very HiR (VHR)-NMIBC (7.1%) cases. Adequate BCG was administered to 1226 patients (78%). Among 1239 patients (80%) with documented treatment termination reasons, 503 (41%) completed guideline-recommended treatment and 150 (12%) discontinued because of BCG intolerance. Over median follow-up of 37 mo, adequate BCG was associated with higher IPTW-adjusted 5-yr RFS (72% vs 52%; hazard ratio [HR] 0.40, 95% confidence interval [CI] 0.31-0.85; p < 0.001), HG-RFS (83% vs 68%; HR 0.43, 95% CI 0.32-0.58; p < 0.001), PFS (92% vs 85%; HR 0.47, 95% CI 0.30-0.74; p = 0.001), and OS (88% vs 71%; HR 0.52, 95% CI 0.37-0.74; p = 0.001). CSM rates were comparable between the groups (3% vs 4.9%; p = 0.3).
Adequate BCG, as defined by the International Bladder Cancer Group (IBCG), was associated with significantly better RFS, PFS, and OS. These findings support use of the IBCG definition as a standardized benchmark for BCG exposure. However, further prospective validation to confirm causality is needed.
European urology focus. 2025 May 19 [Epub ahead of print]
Pietro Scilipoti, Mattia Longoni, Mario de Angelis, Paolo Zaurito, Aleksander Ślusarczyk, Francesco Soria, Benjamin Pradere, Wojciech Krajewski, David D'Andrea, Andrea Mari, Francesco Del Giudice, Renate Pichler, José Daniel Subiela, Gautier Marcq, Andrea Gallioli, Luca Afferi, Riccardo Mastroianni, Giuseppe Simone, Simone Albisinni, Laura S Mertens, Ekaterina Laukhtina, Katharina Oberneder, José Luis Rodríguez Elena, Javier Aranda, Alfonso Lafuente Puentedura, Jorge Caño Velasco, Roberto Contieri, Rodolfo Hurle, Keiichiro Mori, Piotr Radziszewski, Shahrokh F Shariat, Paolo Gontero, Andrea Necchi, Morgan Rouprêt, Francesco Montorsi, Andrea Salonia, Alberto Briganti, Marco Moschini, European Association of Urology Young Academic Urologists Urothelial Carcinoma Working Group
Department of Experimental Oncology/Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy., Department of General, Oncological and Functional Urology, Medical University of Warsaw, Warsaw, Poland., Division of Urology, Department of Surgical Sciences, San Giovanni Battista Hospital, University of Studies of Torino, Turin, Italy., Department of Urology, La Croix Du Sud Hospital, Quint-Fonsegrives, France., Department of Urology and Oncologic Urology, Wrocław Medical University, Wroclaw, Poland., Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria., Department of Experimental and Clinical Medicine, University of Florence, Unit of Oncologic Minimally Invasive Urology and Andrology, Careggi Hospital, Florence, Italy., Department of Maternal Infant and Urologic Sciences, Policlinico Umberto I Hospital, Sapienza University of Rome, Rome, Italy., Department of Urology, Medical University of Innsbruck, Innsbruck, Austria., Department of Urology, Instituto Ramón y Cajal de Investigación Sanitaria, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Madrid, Spain., Department of Urology, Claude Huriez Hospital, CHU Lille, Lille, France., Department of Urology, Fundació Puigvert, Autonomous University of Barcelona, Barcelona, Spain., Department of Urology, Luzerner Kantonsspital, Lucerne, Switzerland., IRCCS Regina Elena National Cancer Institute, Rome, Italy., Department of Urology, University of Tor Vergata, Rome, Italy., Department of Urology, Netherlands Cancer Institute, Amsterdam, The Netherlands., Department of Urology, Hospital Universitario de Cáceres, Cáceres, Spain., Department of Urology, Gregorio Marañón University Hospital, Madrid, Spain., Department of Urology, Humanitas Clinical and Research Institute IRCCS, Rozzano, Italy., Department of Urology, The Jikei University School of Medicine, Tokyo, Japan., Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Department of Urology, University of Texas Southwestern, Dallas, TX, USA; Karl Landsteiner Institute of Urology and Andrology, Vienna, Austria; Department of Urology, Weill Cornell Medical College, New York, NY, USA; Department of Urology, Second Faculty of Medicine, Charles University, Prague, Czechia., GRC 5 Predictive Onco-Uro, Sorbonne University, Pitie-Salpetriere Hospital, AP-HP, Paris, France., Department of Experimental Oncology/Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy. Electronic address: .
PubMed http://www.ncbi.nlm.nih.gov/pubmed/40393853