Final results from a national multicenter phase II trial of combination bacillus Calmette-Guerin plus interferon α-2B for reducing recurrence of superficial bladder cancer

Background: Both bacillus Calmette-Guerin (BCG) and interferon-alpha (IFN-alpha) express activity against superficial bladder cancer. The results of a national multicenter phase II trial of a combination of these 2 agents used in a wide range of patients are reported. Materials and Methods: Patients previously having BCG failure received IFN-alpha (50 million units) plus reduced dose BCG, while patients naive to BCG received the same IFN-alpha dose with standard dose BCG. All patients who were relapse free received an additional 3 series of 3-week reduced dose BCG plus IFN-alpha treatments at 3, 9, and 15 months after completing induction. Any relapse during the 3-month evaluation was counted as a failure of therapy for Kaplan-Meier analysis. Multivariate analysis was performed to identify factors associated with recurrence. Results: Of 1,007 valuable patients, 59% and 45% of patients naive to BCG and those having BCG failure, respectively, remained disease free at 24-month median follow-up. Stage T1, tumor size >5 cm, prior BCG failure more than once, and multifocality were all statistically significant risk factors for recurrence. Conclusions: Although BCG plus IFN-alpha can be effectively applied to both patients naive to BCG and those having BCG failure, certain patient and tumor characteristics influence durable response. (C) 2006 Elsevier Inc. All rights reserved.