First-line chemotherapy of superficial bladder cancer: mitomycin vs thiotepa.

A prospective randomized study has been conducted to compare the efficacy and toxicity of thiotepa with mitomycin in patients with transitional cell carcinoma of the bladder. The 156 patients entered to date in the study were distributed by tumor grade and stage as follows: grade 1, 36 patients; grade 2, 49 patients; grade 3, 18 patients; Ta, 67 patients; T1, 33 patients; and TIS, 56 patients. All patients had tumor present in the bladder on entry to the study and after eight instillations at weekly intervals; evaluative cystoscopy and biopsy were performed four weeks later. Preliminary analysis of 156 patients indicated on overall complete response of 39 per cent for mitomycin and 27 per cent for thiotepa, which is a statistically significant difference (P = 0.02). Moderate to severe leukopenia was the most common single toxic effect with thiotepa, and a rash was the most common single toxic effect with mitomycin.

RCT Entities:   Population Interventions Outcomes