Gemcitabine plus docetaxel improves high-grade recurrence-free survival (RFS) when compared with bacillus Calmette-Guérin (BCG) in patients with high-risk non-muscle-invasive bladder cancer (NMIBC), according to study results published in JAMA Network Open.

“These findings suggest that gemcitabine and docetaxel may serve as a reasonable alternative first-line therapy for patients with high-risk NMIBC during the ongoing BCG shortage,” the researchers wrote.

They conducted a single-center, retrospective study of 312 patients with high-grade NMIBC. The patients were treated between 2011 and 2021 with sequential intravesical gemcitabine plus docetaxel or BCG after complete transurethral resection of bladder tumor. Patients in both groups could receive maintenance therapy. 

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Patient characteristics were similar between the treatment groups, except the median age was 71 years in the BCG group and 74 years in the gemcitabine-docetaxel group (P =.002). Patients were more likely to receive BCG in 2011-2018 (76.4%) than in 2019-2021 (23.6%), while the reverse was true for gemcitabine-docetaxel (22.5% vs 77.5%).

The primary outcome was high-grade RFS, and it was superior in the gemcitabine-docetaxel group. At 6 months, the high-grade RFS rate was 92% in the gemcitabine-docetaxel group and 76% in the BCG group. At 1 year, the high-grade RFS rate was 85% and 71%, respectively. At 2 years, it was 81% and 69%, respectively. 

The 2-year progression-free survival rate was 97% in the gemcitabine-docetaxel group and 92% in the BCG group. The 2-year overall survival rate was 89% and 93%, respectively.

In a multivariate analysis, gemcitabine-docetaxel was associated with a lower risk of recurrence (hazard ratio [HR], 0.56; 95% CI, 0.34-0.92; P =.02) and high-grade recurrence (HR, 0.57; 95% CI, 0.33-0.97; P =.04) compared with BCG.

The majority of adverse events were grade 1 or 2 in both treatment groups. Treatment discontinuation was more likely in the BCG group than in the gemcitabine-docetaxel group (9.2% and 2.9%, respectively; P =.02).

“In this cohort study, gemcitabine and docetaxel therapy was associated with less high-grade disease recurrence and treatment discontinuation than BCG therapy,” the researchers noted. “These findings suggest that, while awaiting results from an ongoing randomized clinical trial during the current BCG shortage, use of gemcitabine and docetaxel can be considered for recommendation in updated practice guidelines.”

Disclosures: One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


McElree IM, Steinberg RL, Mott SL, O’Donnell, MA, Packiam, VT. Comparison of sequential intravesical gemcitabine and docetaxel vs bacillus Calmette-Guérin for the treatment of patients with high-risk non–muscle-invasive bladder cancer. JAMA Netw Open. Published online February 28, 2023. doi:10.1001/jamanetworkopen.2023.0849