The optimal bacillus Calmette-Guérin (BCG) schedule for non–muscle invasive disease continues to be debated, and, as such, is my choice for top story in urology for 2014. A large multicenter trial, published last year, compared the efficacy of one-third–dose BCG to full-dose BCG and the efficacy of 1-year maintenance BCG to 3-year maintenance BCG in patients with intermediate- and high-risk non–muscle invasive bladder cancer.1 The study included 1355 patients and was designed as a noninferiority trial, with the primary endpoint of disease-free interval.
There were no significant differences in toxicity between one-third–dose BCG and full-dose BCG. Intermediate-risk patients treated with full-dose BCG did not benefit from an additional 2 years of maintenance therapy. However, in high-risk patients, 3-year maintenance BCG was associated with a reduction in recurrence compared with 1-year maintenance (HR, 1.61; 95% CI, 1.13–2.30; P = .009) when given at full dose. There was no difference in progression rates or survival between 1- and 3-year maintenance.
It is well-known that a 3-year BCG maintenance schedule cannot be tolerated by all patients. Furthermore, it is inconvenient and adds to healthcare costs. This study gives us more information regarding how we should potentially use BCG maintenance and which patients should be pushed toward a 3-year schedule. Practically speaking, based on this study, it would appear that there is very little toxicity difference between full-dose and one-third–dose BCG; therefore, I think there is little clinical benefit to reducing the dosage. Additionally, patients with intermediate-risk disease can undergo a 1-year maintenance schedule rather than a 3-year schedule, which is far more practical.
Oddens J, Brausi M, Sylvester R, et al. 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. Eur Urol. 2013;63(3):462-472.
Thomas J Guzzo