INTRODUCTION:The purpose of the present study was to compare the outcomes of patients receiving sequential chemoimmunotherapy using mitomycin (MMC) and bacillus Calmette-Guerin (BCG) with the outcomes of patients receiving BCG alone for the treatment of recurrent superficial bladder tumors. METHODS:A total of 56 patients with recurrent Ta or T1 bladder tumors were enrolled in this prospective randomized study. Group 1 (n = 29 patients) received MMC instillation immediately after resection followed by weekly instillation for 4 weeks. Patients then received BCG monthly for 1 year. Group 2 (n = 27) received only BCG, instilled weekly for 6 weeks and then monthly for 1 year. RESULTS:There was a significant treatment effect for both groups, as indicated by a reduction in mean recurrence rate and recurrence index (P = .001). However, the difference in recurrence rate and recurrence index distributions after treatment was significant in favor of group 1. The mean follow-up period was 24 months (range, 3-30 months).Recurrent tumors were found in 9 patients (31%) in group 1 and 16 patients (70%) in group 2 at the end of the follow-up period. Kaplan-Meier estimates were significantly different throughout the follow-up period. MMC followed by monthly BCG was significantly superior to BCG in the time to initial recurrence (log rank P < .0024). CONCLUSIONS:Patients receiving BCG single-agent immunotherapy and patients receiving sequential chemoimmunotherapy using MMC instillations followed by monthly BCG instillation both had significant treatment effects. However, the difference in recurrence rate and recurrence index distributions after treatment was significant in favor of the group receiving the sequential therapy.UroToday International Journal ® UI J

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