Gem/Doce maintenance shows comparable outcomes to BCG in NMIBC

Maintenance therapy with intravesical gemcitabine and docetaxel (gem/doce) following BCG induction demonstrated recurrence-free and progression-free outcomes comparable to those of standard BCG maintenance in patients with non–muscle invasive bladder cancer (NMIBC), according to a retrospective analysis.¹

The findings, published in Urologic Oncology, have important implications amid persistent global BCG shortages.

“The findings of our study suggest that gem/doce can possibly be used for maintenance therapy with similar efficacy to BCG maintenance after an initial BCG induction course, thus allowing urologists to prioritize BCG for induction therapy,” explained lead author Kaushik P. Kolanukuduru, MD, a urology resident at Weill Cornell Medicine, in correspondence with Urology Times®. “This is especially relevant in the context of BCG shortage as this approach will allow a greater number of patients to receive the benefits of induction BCG, without compromising on longer-term oncological control.”

Trial overview

The retrospective study evaluated 127 patients with treatment-naive NMIBC who underwent transurethral resection of bladder tumor, followed by standard 6-week BCG induction between 2018 and 2023. Patients without evidence of recurrence post induction proceeded to maintenance therapy with either BCG (per Southwest Oncology Group protocol) or monthly intravesical gem/doce.

Of the total cohort, 107 patients received BCG maintenance and 20 received gem/doce. To mitigate selection bias, investigators performed 1:1 propensity matching, yielding 20 patients in each arm. The median follow-up was 45.3 months (IQR, 39.6 to 61.8) in the BCG-BCG arm and 20.2 months (IQR, 9.8 to 37) in the BCG–gem/doce arm.

The completion rate for planned maintenance therapy was 85% in the gem/doce group and 78.5% in the BCG group.

At 2 years, high-grade recurrence-free survival (RFS) was 69.6% (95% CI, 52% to 93.2%) with BCG maintenance and 88.2% (95% CI, 74.2% to 100%) with gem/doce (log-rank P = .5). Any-grade RFS rates were 64.6% (95% CI, 46.6% to 89.6%) vs 83.8% (95% CI, 68.6% to 100%), respectively (P = .45). Progression-free survival at 2 years was 89.7% (95% CI, 77.2% to 100%) for BCG vs 88.9% (95% CI, 75.5% to 100%) for gem/doce (P = .91).

The safety profile for BCG–gem/doce was favorable, which the authors suggested may “potentially increase compliance with maintenance regimens.”

Limitations and next steps

The current analysis suggests that gem/doce maintenance following BCG induction may achieve oncologic outcomes similar to those of continued BCG maintenance in the short term. However, the study is limited by its retrospective design and small sample size following propensity matching.

The authors note that while larger prospective trials are needed to validate these findings, gem/doce may be considered as an alternative maintenance strategy during the ongoing BCG shortage.

“Further randomized, multicenter trials comparing BCG maintenance and gem/doce maintenance after initial BCG induction would be necessary to truly ascertain the value of gem/doce as a maintenance option,” concluded Kolanukuduru, in correspondence with Urology Times. “Data pertaining to this should ideally explore both the recurrence and progression rates in patients with NMIBC, while also comparing [the safety] profiles of the 2 treatments. After the findings of our current studies, we have noted a rising interest in using gem/doce as a maintenance option in other centers, and we are working toward multicenter collaborative trials soon.”

REFERENCE

1. Kolanukuduru KP, Ben-David R, Hug B, et al. Therapeutic efficacy of gemcitabine/docetaxel maintenance in patients with non-muscle-invasive bladder cancer receiving initial bacillus Calmette-Guérin induction. Urol Oncol. 2026;44(5):111078. doi:10.1016/j.urolonc.2026.111078