Bacillus Calmette-Guérin Plus Mitomycin Versus Bacillus Calmette-Guérin Alone for Bacillus Calmette-Guérin–naïve Non–muscle-invasive Bladder Cancer: A Randomised Phase 3 Trial (ANZUP 1301)

Abstract

Background and objective Intravesical bacillus Calmette-Guérin (BCG) plus mitomycin (MM) had not been compared rigorously with BCG alone in BCG-naïve, non–muscle-invasive bladder cancer (NMIBC) patients. Methods Participants with BCG-naïve NMIBC (high-grade pTa or any grade pT1; concurrent carcinoma in situ [CIS] allowed) were assigned randomly (1:1) to either the BCG + MM or the BCG-alone group after maximal transurethral resection. The primary endpoint was disease-free survival (DFS); the secondary endpoints included a complete response on cystoscopy at 3 mo (CR3mos), recurrence, progression, adverse events (AEs), and deaths from any cause. Key findings and limitations We randomised 501 pa..