Intravesical gemcitabine versus mitomycin for recurrent superficial bladder tumors (Stages pTa and pT1): A randomized prospective study

5075 Background: Approximately 30–40% of patients with a superficial bladder cancer treated with Bacille Calmette-Guerin (BCG) or epirubicin do not respond and other 35% of initial responders have a relapse within 5 years. We have compared the therapeutic efficacy and toxicity of intravesical Gemcitabine (GEM) with Mitomycin C (MMC) in patients with recurrent superficial bladder cancer. Methods: Patients with previously treated recurrent Ta-T1, G1-G2 bladder transitional cell carcinoma were enrolled in the present study and randomized to a 6-week course of GEM instillations (2000 mg in 50 ml saline) or 4-week course of MMC (40 mg). In both arms, for the initial responders who remained free of recurrences, maintenance therapy consisted of a 10 monthly treatment during the first year. All patients were followed every 6 months by cystourethroscopy. Results: 120 patients were included in the present study. 109 patients (55 in MMC arm and 54 in GEM arm) were evaluable. The median duration of follow-up was (ide...