Efficacy of Bacillus Calmette-Guérin compared to sequential gemcitabine and docetaxel in Ta high-grade non-muscle invasive bladder cancer.

PURPOSE: Sequential gemcitabine and docetaxel (Gem/Doce) therapy is increasingly regarded as a promising substitute for Bacillus Calmette-Guérin (BCG) for non-muscle-invasive bladder cancer (NMIBC). This study compares the efficacy of Gem/Doce and BCG in managing Ta high-grade (TaHG) NMIBC.

METHODS

Patients with TaHG NMIBC treated with Gem/Doce or BCG therapy following transurethral resection of the bladder tumor (TURBT) were analyzed. A one-year maintenance protocol when applicable. Recurrence-free survival (RFS) and progression-free survival (PFS) were assessed using Kaplan-Meier analysis, and multivariate Cox regression identified predictors for recurrence and progression.

RESULTS

A total of 172 patients (99 BCG, 73 Gem/Doce) were included, with longer median follow-up in the BCG group (47 vs. 20 months, p < 0.001). Progression was more frequent in the Gem/Doce group (18% vs. 4%, p = 0.003). BCG demonstrated superior 2-year RFS for any recurrence (62.3% vs. 37.9%, p = 0.018), high-grade recurrence (72.7% vs. 61.3%, p = 0.049), and 2-year PFS (97.4% vs. 83.3%, p < 0.0001). Maintenance therapy improved high-grade RFS (p = 0.019) and PFS (p = 0.033) in the Gem/Doce group but had no significant impact in the BCG group. On multivariate analysis, Gem/Doce was an independent risk factor for any recurrence (HR = 2.03, p < 0.001), high-grade recurrence (HR = 1.95, p = 0.03), and progression (HR = 13.55, p < 0.001).

CONCLUSION

BCG appears to provide superior recurrence and progression control over Gem/Doce in TaHG NMIBC with a one-year maintenance protocol. Future studies should explore extended maintenance regimens, particularly for Gem/Doce.