Opinion
Video
NMIBC Treatment Decisions in the Age of BCG Shortages
Panelists discuss how the ongoing BCG shortage has forced clinicians to adapt treatment strategies for non–muscle-invasive bladder cancer (NMIBC), balancing resource constraints with patient outcomes through dose adjustments, chemotherapy substitution, and earlier cystectomy, while emphasizing the importance of maintaining trial eligibility and adhering as closely as possible to evidence-based protocols.
The ongoing shortage of BCG has significantly impacted clinical practice, particularly in the management of non–muscle-invasive bladder cancer. A major challenge lies in the unpredictability of supply, which complicates treatment planning. To address this, clinicians prioritize full-strength BCG for high-risk patients undergoing induction therapy, while often resorting to dose splitting or shortened maintenance schedules. In cases where the ability to complete maintenance therapy is uncertain, early cystectomy may be considered, especially for patients at very high risk.
Guidelines from professional organizations offer some flexibility, which helps clinicians make decisions during these shortages. In intermediate-risk patients, BCG is often avoided altogether in favor of chemotherapy. Additionally, efforts are made to ensure patients receive enough BCG to meet the criteria for being classified as “BCG unresponsive.” This is crucial for maintaining eligibility for clinical trials, which may offer alternative therapies. The overall goal is to strike a balance between resource limitations and optimal patient outcomes.
Despite creative approaches like dose reduction and abbreviated regimens, the shortage continues to create challenges. Lessons from studies such as the NIMBUS trial show that significant deviations from standard protocols can reduce treatment efficacy. However, the FDA permits some flexibility—such as accepting 5 of 6 induction doses and 2 of 3 maintenance doses—which clinicians use when resources are limited. Dose-reduction strategies in intermediate-risk patients have also shown promise, maintaining efficacy while reducing adverse effects. Nonetheless, the shortage has emphasized the importance of trial eligibility and has, in some cases, prompted earlier consideration of radical cystectomy in order to ensure patients receive definitive care.
