Five-year follow-up of a phase 2 trial of 2 induction courses of BCG therapy for high-risk non-muscle-invasive bladder cancer

With the ongoing bacillus Calmette- Guèrin (BCG) shortage, alternate therapeutic option for patients with high-risk non-muscle-invasive bladder cancer (NMIBC) are needed. A phase 2 trial at Memorial Sloan Kettering Cancer Center (New York, NY) investigated the therapeutic efficacy of only 2 induction courses of BCG (12 instillations) without maintenance. Five-year follow-up results of the trial have now been published. Among 77 patients, 63 (82%) were able to complete all 12 instillations with a 91% complete response rate at 6 months. The probability that responders would be free of recurrence at 5 years was 69%, and 5-year cancer specific survival was 97%. Using 2 induction courses without maintenance reduced the amount of BCG per patient from 27 to 12 vials. The authors conclude that 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.