- A reduced frequency of doses of bacille Calmette-Guérin (BCG) for the treatment of high-grade non-muscle invasive bladder cancer (NMIBC) resulted in worse outcomes.
- Investigators stopped recruiting patients after cognizance of the inferiority from the trial's independent safety committee.
Why this matters
- The study was conceived and conducted in response to the global shortage of BCG, which lacks a highly comparable alternative and has limited manufacturers.
- In the phase III NIMBUS trial, patients with high-grade NMIBC were randomly assigned to receive either a standard frequency or a reduced frequency dosing of BCG.
- Funding: EAU Foundation for Urological Research, Medac, Lyon Cancer Fund, and Jena Research Cancer Fund.
- In an intention-to-treat analysis of 345 patients, the number of disease recurrences in the reduced arm was substantially higher than that in the standard frequency arm (27% vs 12%).
- In the reduced arm, 33% of patients had disease recurrence at 24 months vs 14% in the standard frequency arm (HR, 0.391; 95% CI, 0.231-0.662).
- Patient enrollment was stopped prematurely.
Dr Alexander Kutikov, MD, at Fox Chase Cancer Center, Philadelphia, said: “This trial tried to answer a critical question: can we get the same results at lower costs, while expending less resources and making treatment less burdensome to patients. Level 1 evidence produced a resounding ‘No.’”