Sequential Combination of Mitomycin C Plus Bacillus Calmette-Gue´rin (BCG) Is More Effective but More Toxic Than BCG Alone in Patients with Non-Muscle-invasive Bladder Cancer in Intermediate- and High-risk Patients: Final Outcome of CUETO 93003, a Randomized Prospective Trial

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Solsona E., Madero R., Chantada V., Fernandez J.M., Zabala J.A., Portillo J.A., Alonso J.M., Astobieta A., Unda M., Martinez-Piñeiro L., Rabadan M., Ojea A., Rodriguez-Molina J., Beardo P., Muntañola P., Gomez M., Montesinos M., Martinez Piñeiro J.A.

European Urology 2014

Background: Intravesical bacillus Calmette-Gue´rin (BCG) is an effective therapy in non-muscle-invasive bladder cancer (NMIBC), but it has limitations in terms of recurrence and toxicity. Objective: To determine whether the sequential combination of mitomycin C (MMC) and BCG is superior to BCG alone in increasing a disease-free interval (DFI). Design, setting, and participants: We conducted a prospective randomized trial including 407 patients with intermediate- to high-risk NMIBC and allocated 211 to the MMC and BCG arm and 196 to the BCG-alone arm. Outcome measurements and statistical analysis: The trial was designed to provide concurrently a power of 80% for the detection of a relative risk reduction of 35% (hazard ratio [HR]: 0.65) of disease relapse with a type I error of 0.05. Times to events were estimated using cumulative incidence functions and compared using the Cox regression model. We used the Kaplan-Meier technique to estimate survival curves. Results and limitations: In the intention-to-treat analysis at 5 yr, DFI was significantly improved by the sequential scheme (HR: 0.57; 95% confidence interval [CI], 0.39-0.83; p = 0.003), reducing the disease relapse rate from…(ver más)

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