NMIBC: reducing BCG frequency leads to inferior outcomes

  • Grimma M & et al.
  • Eur Urol
  • 20 May 2020

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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).

Limitations

  • A central pathology review was not performed.
  • Enrollment was stopped before full accrual because of futility.