Gemcitabine-Docetaxel May Be a Feasible Alternative to BCG for High-Risk NMIBC

WASHINGTON, DC—Sequential intravesical gemcitabine-docetaxel (Gem-Doce) for treatment-naïve high-risk nonmuscle-invasive bladder cancer (HR-NMIBC) achieves oncologic outcomes comparable to those of intravesical bacillus Calmette-Guérin (BCG), investigators reported at the Society of Urologic Oncology’s 24th Annual Meeting. 

“Gem-Doce may fill the need for intravesical treatment of patients with high-risk, NMIBC while BCG shortages continue,” said lead author Justin Manuel Refugia, MD, of Wake Forest University School of Medicine in Winston-Salem, North Carolina. “For these patients desiring to stay within the same urology practice, Gem-Doce should be offered as an alternative to external referral for BCG.”

Dr Refugia and colleagues conducted a retrospective cohort study that included 58 patients who received first-line Gem-Doce and 30 who received first-line BCG for HR-NMIBC. The primary outcome was oncologic treatment success, defined as high-grade (HG) recurrence-free survival (RFS).

The proportion of patients experiencing HG recurrence did not differ significantly between the gemcitabine-docetaxel and BCG groups (17% vs 33%), but recurrence occurred significantly earlier in the gemcitabine-docetaxel group (median 4 months vs 12 months for BCG), Dr Refugia and colleagues reported in a poster presentation. HG-RFS rates for the Gem-Doce and BCG groups were similar at 6 months (86% for both), 12 months (83% vs 76%), and 18 months (76% for both).

“Our center’s experience adds to existing retrospective validations of the oncologic outcome of high-grade recurrences that appear to be similar between BCG and Gem-Doce cohorts compared in our study,” Dr Refugia said. “Prospective studies, such as the BRIDGE trial (ClinicalTrials.gov ID: NCT05538663), are expected to strengthen the evidence of the current work on Gem-Doce for patients with NMIBC.”

The patients in the study had similar baseline characteristics of sex, race and ethnicity, pretreatment pathologies, and smoking history. They received standardized gemcitabine-docetaxel or BCG therapy regimens because they preferred this over initial radical cystectomy or they were not surgical candidates, according to the investigators. The patients required at least 1 induction cycle (5 of 6 instillations) of gemcitabine-docetaxel or BCG and a minimum of 3 months of follow-up.

The BCG group had a significantly longer follow-up duration compared with the gemcitabine-docetaxel group (median 22 vs 9 months).

The new findings add to a growing literature on the potential usefulness of intravesical sequential Gem-Doce as an alternative to BCG for high-risk NMIBC. At the ASCO Genitourinary Cancers Symposium in 2022, Vignesh T. Packiam, MD, of the University of Iowa in Iowa City, and colleagues reported on a retrospective study demonstrating that sequential Gem-Doce therapy for patients with BCG-naïve high-risk NMIBC had a recurrence-free survival (RFS) rate of 85% and 82% at 12 and 24 months, respectively. For comparison, the investigators cited a contemporary study showing a 12-month RFS rate of 79% with intravesical BCG used to treat high-risk NMIBC.

“Our study provides evidence that using sequential intravesical gemcitabine and docetaxel is a safe and effective alternative to BCG during the now-chronic BCG shortage,” Dr Packiam said.

Reference

Refugia JM, Roebuck E, Thakker PU, Hemal A, Tsivian M. Early clinical experience with sequential intravesical gemcitabine-docetaxel for treatment-naïve high risk non-muscle invasive bladder cancer. Presented at: SUO 2023; November 28-December 1, Washington, DC. Poster 115.

This article originally appeared on Renal and Urology News