Martínez-Piñeiro L., Portillo J.A., Fernández J.M., Zabala J.A., Cadierno I., Moyano J.L., Solsona E., Unda M., Beardo P., Rodríguez-Molina J., Chantada V., Palou J., Muntañola P., Alonso Dorrego J.M., Pérez-Garcia F.J., Silva J.M., Chesa N., Montesinos M., Ojea A., Madero R., Martínez-Piñeiro J.A.
European Urology 2015
Background: Bacillus Calmette-Guérin (BCG) maintenance therapy for 3 yr following BCG induction can reduce the progression of urothelial bladder carcinoma versus BCG induction alone, but is associated with high toxicity. Objective: To investigate whether a modified 3-yr BCG maintenance regimen following induction therapy is more effective than standard BCG induction therapy alone and exhibits a low toxicity profile. Design, setting, and participants: Patients from the outpatient clinics of the participating centres with high-risk non-muscle-invasive bladder carcinoma (NMIBC) were randomised between October 1999 and April 2007. Intervention: Participants received BCG induction once-weekly for 6 wk (no maintenance arm) or BCG induction followed by one BCG instillation every 3 mo for 3 yr (maintenance arm). Outcome measurements and statistical analysis: Primary endpoints were disease-free interval (DFI) and time to progression (TTP). Secondary endpoints included survival duration and toxicity. Differences between treatment arms were tested using Student’s t test and ?2 and log-rank tests. Results and limitations: A total of 397 patients were randomised, 195 to the no-maintenance and 202 to the maintenance arm. A median time to recurrence was not reached in either treatment arm. DFI was similar between the arms (hazard ration [HR] 0.83; 95% CI 0.61-1.13; p = 0.2) with disease relapse at 5 yr of 33.5% and 38.5%, respectively. TTP was also similar between the treatment arms (HR 0.79; 95% CI 0.50-1.26; p = 0.3), with a progression rate at 5 yr of…(vermás)