1137 A prospective, randomized, multicenter, phase III clinical trial of the effect of different initial therapy regimes and maintenance prophylaxis in superficial bladder cancer using mitomycin C

Doubts still exist over the appropriate initial regime and the length of maintenance necessary with intravesical chemotherapy for the best prophylaxis against recurrence in superficial bladder tumor. All patients with superficial bladder cancer were eligible apart from those with a solitary Ta lesion, in whom the protocol regimes would be generally unacceptable. After resection of tumors in the bladder, 1287 patients were randomized into 4 different groups. Group A received 8 weekly instillations with 40 mgs Mitomycin C in 50 cc's 0.9% saline, followed by 4 months, monthly prophylaxis with the same dose. Group B received 4 weeks initial therapy, followed by 5 months, monthly prophylaxis. Group C received the same therapy as group A but the prophylaxis was continued to 12 months and group D the same initial regime as group B but again with maintenance continued to 12 months. Groups were evenly matched with regard to stage and grade of their tumors and there was no significant sex difference between the 4 groups. The side effects were similar in groups A and B, and groups C and D, but almost twice as many patients in groups C and D missed one or more instillations due to side-effects, compared with the two groups with the shorter maintenance regime. All patients have been treated for a minimum of 12 months and there are no significant differences in the recurrence rate of rate of progression between patients in group A and B compared with those in C and D.