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

BACKGROUND AND 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.

KEY FINDINGS AND LIMITATIONS

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 AND CLINICAL IMPLICATIONS

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.