Failure, intolerance, or shortage of bacillus Calmette-Guerin (BCG) treatment for patients with high-risk (HR) non-muscle invasive bladder cancer (NMIBC) leaves many facing the prospect of radical cystectomy (RC). However, despite the lack of large-scale randomized controlled studies with single agent intravesical gemcitabine (Gem), it has emerged as a popular salvage agent after BCG failure or even a treatment alternative to BCG.
1. Characterization of treatment regimen details pertaining to single agent intravesical adjuvant Gem use among disease states of NMIBC characterized by risk and BCG exposure. 2. Comparison of safety and efficacy of Gem according to risk category, type of tumor (papillary vs. carcinoma in situ (CIS)), and tumor grades.
Two randomized studies in early BCG failure disease demonstrate that single-agent Gem has superior efficacy versus repeated BCG therapy or mitomycin C. Studies enrolling patients with predominantly papillary disease without CIS, intermediate-risk (IR) disease, and less BCG exposure appear to derive the highest benefits from adjuvant Gem in terms of recurrence and progression. However, studies with cohorts enriched for a predominance of CIS, HR disease and/or more extensive BCG failure have poorer 2-year recurrence free survival and a somewhat higher risk of progression and RC.
Expert opinion on pharmacotherapy. 2023 Oct 16 [Epub ahead of print]
Mohamad Abou Chakra, Vignesh T Packiam, Michael A O'Donnell
Department of Urology, University of Iowa, Iowa City, IA, USA., Section of Urologic Oncology, Rutgers Cancer Institute of New Jersey, New Jersey, USA.