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

Mohamad Abou Chakra; Vignesh T Packiam; Ian M McElree; Sarah L Mott; Michael A O'Donnell

doi:10.1016/j.urolonc.2024.10.012

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

Urol Oncol. 2024 Nov 25:S1078-1439(24)00692-6. doi: 10.1016/j.urolonc.2024.10.012. Online ahead of print.

Authors

Mohamad Abou Chakra¹, Vignesh T Packiam², Ian M McElree³, Sarah L Mott⁴, Michael A O'Donnell⁵

Affiliations

¹ Department of Urology, University of Iowa, Iowa City, Iowa, USA.
² Section of Urologic Oncology, Rutgers Cancer Institute of New Jersey, New Jersey, USA.
³ Carver College of Medicine, University of Iowa, Iowa City, Iowa, USA.
⁴ Holden Comprehensive Cancer Center, University of Iowa, Iowa City, Iowa, USA.
⁵ Department of Urology, University of Iowa, Iowa City, Iowa, USA. Electronic address: michael-odonnell@uiowa.edu.

PMID: 39592360
DOI: 10.1016/j.urolonc.2024.10.012

Abstract

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.

Keywords: BCG; Docetaxel; EAU; Gemcitabine; Non-muscle invasive bladder cancer; Survival; Very High-risk.