Urol Oncol. 2020 Aug 12:S1078-1439(20)30338-0. doi: 10.1016/j.urolonc.2020.07.014. Online ahead of print.
OBJECTIVE: To 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 METHODS: This 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.
RESULTS: Among 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.
CONCLUSIONS: High-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.