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Updated: Jun 9, 2026

An Orthotopic Bladder Cancer Model for Gene Delivery Studies
Published on: December 1, 2013
Real-World Comparison of Survival Outcomes Between Radical Cystectomy and Intravesical Bacillus Calmette-Guérin (BCG)
Makito Miyake1, Nobutaka Nishimura1, Rikiya Taoka2
1Department of Urology, Nara Medical University, Nara, Japan.
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.
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