Akademik Veri Yönetim Sistemi
Urologic Oncology: Seminars and Original Investigations, cilt.43, sa.12, 2025 (SCI-Expanded, Scopus)
Background: Intravesical Bacillus Calmette-Guérin (BCG) therapy is widely used as an adjuvant treatment for non-muscle-invasive bladder cancer (NMIBC). However, the optimal BCG substrain remains undetermined. This study compares the efficacy and safety of the BCG RIVM and Russian substrains in NMIBC treatment. Objective: To evaluate recurrence-free survival (RFS), progression-free survival (PFS), and adverse event profiles between the 2 substrains. Methods: In this randomized prospective trial, 149 patients with intermediate-, high-, and very high-risk NMIBC were randomized to receive either BCG RIVM or BCG Russian following transurethral resection of bladder tumor (TURBT). Patients with inadequate BCG therapy, short follow-up, or exposure to multiple strains were excluded from the per-protocol analysis (n = 125). Kaplan-Meier analysis was used to evaluate survival outcomes in both the per-protocol and intention-to-treat (ITT) populations. Adverse events were also assessed. Results: Of 125 patients, 61 received BCG RIVM and 64 received BCG Russian. Recurrence occurred in 17 (27.9%) and 19 (29.7%) patients in the RIVM and Russian groups, respectively (P = 0.822). The 48-month RFS rates were 72.1% (CI: 60.9–83.2) and 70.3% (CI: 59.2–81.4). Progression occurred in 4 patients (6.6%) vs. 8 patients (12.5%) in the RIVM and Russian groups, respectively (P = 0.365). The 48-month PFS rates were 93.4% (CI: 87.2–99.6) and 87.5% (CI: 79.4–96.9). Kaplan-Meier curves for RFS and PFS indicated no significant difference between the 2 groups (log-rank P = 0.875 for RFS and 0.267 for PFS). Similar findings were observed in the ITT analysis (log-rank P = 0.791 for RFS and 0.419 for PFS). Adverse events were reported in 76% of patients, with no significant differences between the groups in terms of toxicity (P = 0.545). Conclusions: BCG RIVM and Russian substrains demonstrated comparable efficacy and safety, supporting substrain selection based on availability and institutional preference.