Re: Final results of an EORTC-GU cancers group randomized study of maintenance bacillus Calmette-Guérin in intermediate- and high-risk Ta, T1 papillary carcinoma of the urinary bladder: One-third dose versus full dose and 1 year versus 3 years of maintenance

摘要

This large multicenter prospective and randomized trial included 1355 patients with non-muscle-invasive bladder cancer who were at intermediate and high risk. The primary objective of this trial was the duration of the disease-free interval (DFI), and secondary objectives were progression, survival, and toxicity. The trial was designed as a noninfer-iority study, and two comparisons were foreseen for each of the two null hypotheses, thus being randomly allocated in four groups. The primary objectives were evaluated comparing the following: (1) The efficacy of a one-third dose (1/3D) of bacillus Calmette-Guerin (BCG) is inferior to the full dose (FD) of BCG (1/3D compared with FD BCG with 1-yr maintenance [1 yr] and 1/3D compared with FD BCG with 3-yr maintenance [3 yr]) and (2) the efficacy of 1-yr maintenance is inferior to 3-yr maintenance (1-yr compared with 3-yr maintenance with 1/3D BCG and 1-yr compared with 3-yr maintenance with FD BCG).