- A reduced-frequency (RF) schedule of Bacillus Calmette-Guérin (BCG) instillations in patients with high-grade nonmuscle-invasive bladder cancer (NMIBC) is inferior to the standard schedule regarding time to first recurrence.
Why this matters
- The standard BCG dose and schedule are associated with significant toxicity, but studies evaluating reduced dose and frequency have reported inferior outcomes.
- The randomized, multicenter, noninferiority NIMBUS trial.
- 345 patients with high-grade NMIBC were randomly assigned to receive RF or standard-frequency (SF) BCG instillations (9 vs 15).
- Inferiority of the RF group was defined as the upper part of the 97.5% CI
- Funding: Deutsche Krebshilfe; others.
- Median follow-up, 14.0 months.
- Disease recurrence was observed in 67/345 patients:
- 46/170 in the RF group.
- 21/175 in the SF group.
- HR: 0.40 (upper limit of 97.5% CI: 0.68).
- In patients with ≥6 months of follow-up, RF was associated with higher risk for recurrence:
- HR: 0.39 (upper limit of 97.5% CI: 0.66).
- Safety analysis (n=330):
- 2139 adverse events were reported in 249 patients: 670 in the RF group (n=113) and 1469 in the SF group (n=136).
- A central pathology review was not performed.
- Enrollment was stopped before full accrual because of futility.