Association of Bacillus Calmette–Guerin shortages with bladder cancer recurrence: A single-center retrospective study

Abstract

ObjectiveTo examine the association between Bacillus Calmette–Guerin (BCG) shortage and bladder cancer recurrence in high-risk non-muscle-invasive bladder cancer (NMIBC) patients. Materials and MethodsThis retrospective study included 333 BCG-naive patients who underwent transurethral resection of bladder tumor for high-risk NMIBC between January 2014 and December 2017. The primary outcome was disease recurrence after operation. The secondary outcomes were trends in BCG shortages and differences in post-transurethral resection of bladder tumor intravesical treatments according to shortage. Multivariable Cox regression modeling was used to assess outcomes. ResultsAmong 333 patients (median age, 67 years; men, 270 [81.1%]), 94 (28.2%) experienced BCG shortage (BCG shortage group). Eleven episodes of BCG shortage occurred during the study period (median 10 days, range 2–97 days). Although we observed no statistically significant differences in clinical and pathological characteristics, there were significant differences in post-transurethral resection of bladder tumor intravesical treatments between the shortage and control groups (BCG: 28.7% vs. 68.1%, mitomycin/epirubicin: 27.7% vs. 1.7%, P < 0.001). The 3-year recurrence-free survival rate was significantly lower in the shortage group than that in the control group (38.0% vs. 60.2%, log-rank test, P = 0.010). In multivariable analysis, shortage (hazard ratio [HR] = 1.55, 95% confidence interval [CI] 1.09–2.21, P = 0.016) and tumor multiplicity (HR = 1.55, 95% CI 1.05–2.29, P = 0.028) were independent factors associated with the recurrence of bladder cancer. ConclusionsHigh-risk NMIBC patients who experienced BCG shortage had a high risk of bladder cancer recurrence. Clinical trials of alternative treatment strategies and efforts to increase BCG supply are required.