Combination regimen of intravesical docetaxel, gemcitabine, and cisplatin in patients with BCG-unresponsive bladder cancer: clinical outcomes and genomic correlations.

Abstract

Purpose: Approximately 40% of non-muscle invasive bladder cancer patients who are treated with Bacillus Calmette-Guerin will experience treatment failure and recurrence. Many patients either refuse or are medically unfit for radical cystectomy. We aim to determine the efficacy and long-term durability of the novel triplet intravesical regimen of docetaxel, gemcitabine, and cisplatin as treatment for these patients.

Materials and methods: This is a retrospective analysis of 16 patients recruited via volunteer sample at a tertiary care referral center in 2018-2023. Patients underwent a 6-week intravesical induction of weekly docetaxel, weekly gemcitabine, and biweekly cisplatin. In patients with treatment response, a maintenance regimen of monthly docetaxel and gemcitabine was initiated. Complete response was defined as negative cystoscopy with biopsy. Primary outcomes of interest were biopsy-proven recurrence, metastasis, and/or proceeding to cystectomy. Survival analysis was performed via Kaplan-Meier analysis.

Results: Full induction was completed in all patients. At first follow-up, 12 patients (75%) had complete response and went on to maintenance therapy. Over follow-up, 7 patients (58%) recurred. By end of study period, 4/16 patients (25%) progressed, and 6/16 patients (37%) underwent cystectomy.

Conclusions: In this highly-pretreated cohort of Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer patients, treatment with intravesical docetaxel, gemcitabine, and cisplatin shows a 75% complete response rate at 3-month follow up and a durable rate of 19%. These results are similar to various other options in this high-risk population.