The efficacy of sequential intravesical gemcitabine and docetaxel versus BCG for the treatment of European association of urology very-high risk non-muscle invasive bladder cancer.

BACKGROUND

The European Association of Urology (EAU) recommends early radical cystectomy (RC) for very-high-risk (VHR) nonmuscle invasive bladder cancer (NMIBC), in part due to suboptimal efficacy from BCG in this setting. Effective bladder-sparing alternatives are needed. We compared the oncological outcomes of Gemcitabine/Docetaxel (Gem/Doce) to BCG therapy in patients with VHR NMIBC.

METHODS

Retrospective analysis of oncological outcomes in 129 treatment naïve VHR NMIBC patients receiving intravesical Gem/Doce (n = 65) was compared to BCG (n = 64) using Cox regression.

RESULTS

Recurrence-free survival (RFS) at 12- and 24-months was 63% and 54% for BCG compared to 79% and 73% for Gem/Doce. Progression-free survival (PFS) at 24-months for BCG was 88% compared to 97% for Gem/Doce. Gem/Doce showed a decreased risk of tumor recurrence compared to BCG (hazard ratio, 0.55; 95% confidence interval, 0.30-0.99; P = 0.05). Moreover, patients in the Gem/Doce group were less prone to discontinue therapy (3.1% vs. 14.1%; P = 0.03).

CONCLUSIONS

Gem/Doce provides a level of efficacy in terms of RFS and PFS at least as good as BCG for treatment naïve VHR NMIBC. Prospective validation is needed.