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Medical AI Inquiry: You was designed to assist in medical decision-making based on the provided user questions. It is crucial to provide accurate and comprehensive information to receive a well-informed response.  Labels: BACKGROUND, OBJECTIVE, METHODS, METHODS, METHODS. Meshes: Administration, Intravesical, Adult, Aged, Aged, 80 and over, Ambulatory Care, Antineoplastic Agents, BCG Vaccine, Carcinoma, Chi-Square Distribution, Disease Progression, Disease-Free Survival, Drug Administration Schedule, Female, Humans, Induction Chemotherapy, Kaplan-Meier Estimate, Maintenance Chemotherapy, Male, Middle Aged, Multivariate Analysis, Risk Factors, Spain, Time Factors, Treatment Outcome, Urinary Bladder Neoplasms, Urothelium.
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Is maintenance Therapy with 3-monthly Bacillus Calmette-Guérin for 3 Years Superior to Standard Induction Therapy in High-risk Non-muscle-invasive Urothelial Bladder Carcinoma : Final Results of Randomised CUETO Study 98013? Context: 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. 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. 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. 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). 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 χ(2) and log-rank tests.
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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 16% and 19.5%, respectively. There were no significant differences between the treatment groups for overall survival and cancer-specific survival at 5 yr. Twenty and five patients in the maintenance and no-maintenance arms, respectively, stopped treatment because of toxicity. The most common local side effects were frequency (65% of patients), dysuria (63%), and haematuria (43%); the most frequent systemic side effects were general malaise (7.2%) and fever (34%). Final Decision: no