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

Abstract

Background: Both bacillus Calmette-Guérin (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 naïve 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 naïve 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 naïve to BCG and those having BCG failure, certain patient and tumor characteristics influence durable response.