Novel BCG Strategy for Bladder Cancer May Address Shortage of the Drug – Renal and Urology News

A novel strategy for using bacillus Calmette-Guérin (BCG) for high-risk nonmuscle-invasive bladder cancer (NMIBC) may provide a workaround that addresses an ongoing shortage of the therapy, according to a recent report.

The 5-year outcomes from a prospective phase 2 clinical trial found that 2 sequential induction courses of intravesical BCG (12 instillations) “demonstrated an excellent response rate,” corresponding author Harry W. Herr, MD, of Memorial Sloan Kettering Cancer Center in New York, New York, and colleagues reported in JAMA Oncology.

Of 81 patients who consented to participate in the trial, 75 remained evaluable for long-term follow-up analysis. At a median follow-up of 4.4 years, high-grade recurrence developed in 21 patients, for a 5-year recurrence-free survival rate of 69%. The 5-year cancer-specific survival rate was 97%.

Using 2 induction courses decreased the amount of BCG per patient from 27 vials to 12, according to the investigators.

“Using 12 instillations of BCG was a viable alternative to standard induction with 3 years of maintenance therapy, which may provide an alternative treatment option during the BCG shortage,” the authors wrote.

BCG has been in short supply globally since 2011, they noted.

The investigators acknowledged study limitations. In addition to being conducted at a single-institution, it had a small sample size and a single study arm, “which precludes direct comparisons between 2 induction courses and induction plus maintenance.”