Introduction:

During the modern bacillus Calmette-Guérin (BCG) shortages, sequential intravesical chemotherapy (Gemcitabine-Docetaxel, Gem-Doce) therapy has gained traction for treatment patients with treatment-naïve, high-risk non-muscle invasive bladder cancer (HR-NMIBC). In this study, we assessed if Gem-Doce was associated with similar oncologic efficacy to BCG as first line treatment of HR-NMIBC. 

Methods:

Multi-center, retrospective cohort study of 136 patients with HR-NMIBC that initiated intravesical treatment between August 2020 and August 2023. Included patients required Gem-Doce or BCG induction and had option for maintenance therapy. Patients with history of any upper tract urothelial carcinoma were excluded. The primary outcome was histologic, high-grade bladder cancer recurrence during routine surveillance (quarterly cystoscopy and urine cytology). Oncologic efficacy (high-grade recurrence free survival [RFS]) of first-line Gem-Doce versus BCG at 12- and 24-months after initiation was compared with the Kaplan-Meier method.  

Results:

During an overall median follow up of 21 months, a cohort of 55 patients received Gem-Doce to the contemporary cohort of 81 patients that received BCG. There were comparable distributions of bladder cancer pathologies for Gem-Doce and BCG (any HG Ta: 62% vs 51%; any T1: 39% vs 36%; any CIS: 28% vs 18%, respectively). There were 30 high-grade recurrences identified (Gem-Doce: 12; BCG: 18). Gem-Doce did not have significantly differing oncologic efficacy compared to BCG (12-months RFS: 87% vs 84%; 24-months RFS: 74% vs 81%, respectively).  

Conclusion:

In this multicenter study, first-line Gem-Doce for HR-NMIBC yields comparable oncologic efficacy to BCG at intermediate-term follow up. As clinical trials for patients with treatment-naïve, HR-NMIBC await completion, our study suggests that Gem-Doce should remain in a urologist’s repertoire. 

Funding: N/A