Real‐World Comparison of Survival Outcomes Between Radical Cystectomy and Intravesical Bacillus Calmette‐Guérin ( BCG ) Therapy in BCG ‐Naïve or ‐Unresponsive Non–Muscle‐Invasive Bladder Cancer

Objective To compare survival outcomes between Japanese patients receiving radical cystectomy (RC) and intravesical Bacillus Calmette–Guérin (BCG) for high‐risk non–muscle‐invasive bladder cancer (HR‐NMIBC). Methods This study was conducted within the Japanese Urological Oncology Group (JUOG) framework using two nationwide, multi‐institutional databases: JUOG‐UC‐2021‐RC, comprising 2674 patients with bladder cancer who underwent RC, and JUOG‐UC‐1901‐BCG, comprising 3226 patients who received intravesical BCG. Patients were classified according to the Japanese Urological Association guideline (version 2023) risk stratification model into three cohorts: BCG‐naïve standard HR‐NMIBC (without aggressive factors), BCG‐naïve highest‐risk NMIBC (an aggressive subgroup), and BCG‐unresponsive NMIBC. Metastasis‐free survival (MFS) and overall survival (OS) were compared between the two interventions. Propensity score matching was applied to create well‐balanced groups (BCG vs RC). Results In the adjusted BCG‐naïve standard HR‐NMIBC subcohort, both MFS and OS were longer in the BCG‐treated group than in the RC group ( p = 0.15 and p = 0.027, respectively). However, no significant differences in MFS or OS were observed in the adjusted BCG‐naïve highest‐risk NMIBC subcohort ( p = 0.20 and p = 0.47, respectively). In the adjusted BCG‐unresponsive NMIBC cohort, no differences in MFS or OS were detected ( p = 0.76 and p = 0.35, respectively), although long‐term survival outcomes appeared better in the salvage RC group than in the BCG rechallenge group. Conclusions Our findings demonstrated that the RC group had worse outcomes than the BCG group in the BCG‐naïve standard HR‐NMIBC subcohort but not in the highest‐risk or BCG‐unresponsive cohorts. Accumulating evidence is essential to guide physicians in counseling patients with HR‐NMIBC and BCG‐unresponsive NMIBC. Registry and the Registration No. of the Study/Trial The authors have nothing to report.