Long-term efficacy and safety of intravesical Bacillus Calmette-Guerin Moreau Polish substrain in the treatment of non-muscle invasive bladder cancer.

Abstract

Introduction: Bacillus Calmette-Guerin (BCG) Moreau is under-represented in literature and comparisons with other BCG strains are rare.

Material and methods: We conducted a retrospective data analysis in patients with intermediate or high-risk non-muscle invasive bladder cancer (NMIBC) to assess effectiveness and safety of BCG Moreau Polish substrain to BCG RIVM. The primary objective was to describe the real-world effectiveness of BCG Moreau in the treatment of patients with NMIBC in terms of recurrence free survival (RFS) 2 years post-treatment initiation compared to BCG RIVM.

Results: The database to be analysed comprised of 967 patients with NMIBC. The primary endpoint was met since BCG Moreau was non-inferior to BCG RIVM in terms of RFS [HR: 0.920 (95%CI: 0.725; 1.168)]. There was no statistically significant difference in all secondary endpoints including time to recurrence, progression-free survival, time to progression, and overall survival. The safety profile of BCG Moreau Polish substrain was consistent with side effects and frequency of complications observed with BCG RIVM and study reports in the literature.

Conclusions: BCG Moreau was effective and safe in the treatment of patients with intermediate- or high-risk non-muscle invasive bladder cancer. There was no statistically significant difference in treatment outcome between BCG Moreau and BCG RIVM strains based on real-world data.