Impact of Intravesical Bacillus Calmette-Guérin Therapy Following Transurethral En Bloc Resection of Bladder Tumour: Post Hoc Analysis of a Randomised, Multicentre, Phase 3 Trial.

We conducted a post hoc analysis of the EB-StaR study (NCT02993211) to assess the impact of intravesical bacillus Calmette-Guérin (BCG) therapy following en bloc resection of bladder tumour (ERBT) or standard resection (SR) in patients with non-muscle-invasive bladder cancer (NMIBC). The outcome measures were the 1-yr recurrence and progression rates. Among the 276 patients included in the analysis, 1-yr recurrence rates were 33% (95% confidence interval [CI] 21-43%) in the ERBT alone group versus 41% (95% CI 30-50%) in the SR alone group (p = 0.02); and 5% (95% CI 0-14%) in the ERBT + BCG group versus 26% (95% CI 5.8-42%) in the SR + BCG group (p = 0.059). The 1-yr progression rates were 0% in the ERBT alone group versus 2% (95% CI 0-4.6%) in the SR alone group (p = 0.13); and 0% in the ERBT + BCG group versus 5.6% (95% CI 0-16%) in the SR + BCG group (p = 0.4). The combination of ERBT and intravesical BCG therapy appeared to yield excellent oncological control, resulting in a 1-yr recurrence rate of 5% among patients with high-risk NMIBC. Good-quality surgery plus good adjuvant therapy should be considered vital components in optimising long-term oncological outcomes in NMIBC.