Docetaxel, Gemcitabine, Cisplatin for Patients With BCG-Unresponsive NMIBC

While bacillus Calmette-Guérin (BCG) is the current standard-of-care treatment for patients with high-risk non-muscle invasive bladder cancer (NMIBC), around 40% of patients report treatment failure and recurrence. Those who do not respond to BCG are recommended radical cystectomy (RC); however, many are unfit for extensive surgery or refuse the treatment.

Benjamin I. Joffe, MD, and colleagues conducted a retrospective review of patients with NMIBC who received docetaxel, gemcitabine, and cisplatin from January 2018 to July 2023 to determine the potential benefits of the combination treatment.

The study was presented at the 2024 American Urological Association Annual Meeting.

Over a 6-week period, patients received weekly doses of docetaxel 80 mg, gemcitabine 1000 mg or 2000 mg, and biweekly cisplatin 100 mg. Patients with treatment response underwent a maintenance regimen of separate-day monthly docetaxel 80 mg and gemcitabine 1000 mg.

Primary end points included biopsy-proven recurrence, progression (increase in T stage), metastasis, and/or proceeding to RC.

Of the 16 patients who received the combination treatment, 45% had high-grade T1, 56% had concomitant carcinoma in situ, and 13% had variant histology. Sixty-three percent of patients previously underwent treatment with another intravesical agent, and 6% previously received systemic pembrolizumab. Thirteen (82%) patients completed full induction.

The median follow-up period was 41 months. Four (57%) patients experienced recurrence, of whom 3 received docetaxel, gemcitabine, and cisplatin reinduction, with complete response (CR) in 1. At the study’s end, 5 (31%) patients had progressed and 6 (37%) received RC.

“In this highly pretreated cohort of BCG-unresponsive NMIBC, most patients tolerated induction docetaxel, gemcitabine, and cisplatin,” the researchers wrote. “Docetaxel, gemcitabine, and cisplatin resulted in a CR rate of nearly 45%, and approximately two-thirds of patients avoided RC over the study period.”