ASCO-GU 2020 — High-grade bladder cancer: enrollment halted after reduced-frequency BCG fails


  • Pavankumar Kamat
  • Univadis
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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). 

Limitations

  • Patient enrollment was stopped prematurely.

Expert commentary

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.’”