ADJUVANT INTRAVESICAL MITOXANTRONE AFTER TRANSURETHRAL RESECTION OF PRIMARY SUPERFICIAL TRANSITIONAL-CELL CARCINOMA OF THE BLADDER - A PROSPECTIVE RANDOMIZED STUDY

A prospective randomised controlled clinical trial began in 1989 on 12 6 patients with superficial transitional cell carcinoma of the bladder (pTa-pT1, grades 1-3) to compare the efficacy of adjuvant topical mit oxantrone after transurethral resection versus no further treatment. 6 2 patients received no further treatment, 64 patients received weekly 20 mg mitoxantrone intravesically for 6 weeks after differentiated TUR of all visible tumours. The endpoint of the study was any progression of stage or grade or further recurrences. The median follow up was 29 months-the minimum follow up was 24 months. The percentage of recurre nces (25.8 versus 23.4), the recurrence rate (1.2 versus 0.9), the ove rall disease free interval and the tumour progression rate showed no s tatistically significant differences (P > 0.05 Mantel-Cox test). Only the comparison of time to recurrence in tumours with recurrences showe d a statistically significant difference, with a longer disease free i nterval for the TUR plus mitoxantrone group (P = 0.016 Mantel-Cox test ).