Short-changed during the bacillus Calmette–Guérin shortages?

Abstract

Objective: Intravesical bacillus Calmette–Guérin (BCG) is the first-line treatment of choice for high-risk non-muscle-invasive bladder cancer (NMIBC). Our aim was to evaluate the long-term impact of BCG shortages on oncological outcomes. Methods: All patients undertaking an initial course of intravesical BCG for intermediate or high risk NMIBC at a single UK cancer centre between August 2012 and August 2014 were evaluated. Compliance was defined as completing 12 doses of BCG within the first year following diagnosis. Results: Due to BCG shortages, 25/114 (22%) patients were compliant with planned maintenance treatment. Compared to the compliant cohort, the non-compliant due to BCG shortages cohort had a higher rate of disease recurrence (35.3% vs. 24%), required more additional intravesical treatments (14.7% vs. 12%) and had a higher rate of radical cystectomy (11.8% vs. 4%). Disease-free survival was superior in the compliant cohort at two years (88% vs. 79.5%) and at 4.5 years (72% vs. 56.1%). There was no statistically significant difference, likely due to the sample size. Conclusions: The consequences of undertreatment due to BCG shortages can impact long-term cancer outcomes. Increased vigilance, robust long-term surveillance and alternative treatment strategies are required for NMIBC patients affected by shortages in BCG supplies. Level of evidence: Level 2b