Re: Side Effects of Bacillus Calmette-Guerin (BCG) in the Treatment of Intermediate- and High-Risk Ta, T1 Papillary Carcinoma of the Bladder: Results of the EORTC Genito-Urinary Cancers Group Randomised Phase 3 Study Comparing One-Third Dose with Full Dose and 1 Year with 3 Years of Maintenance BCG

Abstract

Since the first report on the use of intravesical BCG in 1976 the optimal dose and duration of treatment is controversial. The main concern on defining the optimal BCG dose is to have fewer side effects while keeping anti-tumor efficacy. Efficacy of 1/3 dose (1/3D) vs. full dose (FD) BCGwas previouslyreportedto be equalin the EORTC trial 30962 (1). The present study is addressing intravesical BCG side effects in this EORTC trial 30962. Aim of the present randomized prospective study was to determine whether reducing the dose or treatment duration was associated with fewer side effects. Four arms of the study consisted of 1/3D-1 year (n=341), FD-1 year (n=339), 1/3D-3 year (n=337) and FD- 3 year (n=338). Regarding intravesical BCG toxicity, neither reducing the dose (1/3D vs. FD) nor the treatment duration (1 year vs. 3 years) wassignificantly different from each other. NMIBC management with 1/3D of BCG was one of the recommendations because of current BCG supplementlimitations (2,3). It may be a reseanble option in this conjuncture but one should remember both 1/3D and FD have similar side effects and there is no advantage of using low dose BCG.