Intravesical gemcitabine and docetaxel in patients with recurrent high-grade nonmuscle invasive bladder cancer-A prospective cohort study.

Objective: Intravesical instillations with gemcitabine and docetaxel (gem/doce) is an alternative treatment option in patients with nonmuscle invasive bladder cancer (NMIBC) in whom Bacillus Calmette-Guerin (BCG) failed or is contraindicated. However, prospective data on the efficacy is lacking. This study prospectively evaluated the efficacy and safety of intravesical gem/doce.

Methods: This single-arm, prospective, observational study included patients with recurrent high-grade (HG) NMIBC who received intravesical gem/doce. Treatment involved 6 weekly instillations (induction), followed by monthly instillations for 1 year (maintenance). Follow-up included cystoscopy every 3 months. Histological confirmation of intravesical recurrences was mandatory. The efficacy evaluation was assessed among 37 patients who received at least 4 instillations and had at least 1 cystoscopic evaluation. Primary outcome was HG disease-free survival, defined as time to histologically confirmed HG recurrence, and/or radiologically confirmed lymph node involvement, or distant metastasis. Adverse events were assessed. Thirty-nine patients with NMIBC were enrolled of whom 31 (79%) had Carcinoma in situ. Gem/doce was provided as third-line treatment in 87% (34/39) of the patients. Thirty-five patients had received BCG of whom 72% (28/39) were BCG-unresponsive. The median follow-up for patients without HG recurrence was 14 months (IQR: 7-25). The overall 1-year HG disease-free survival was 67% (95% CI: 53-85), and 73% (57-94) in patients with BCG-unresponsive NMIBC. Only one serious adverse event (grade 3) occurred. A limitation was the small sample size.

Conclusions: In patients with recurrent HG NMIBC who are unfit or reluctant to undergo radical cystectomy and in whom BCG failed, intravesical gem/doce was effective and safe.