Intravesical mitozantrone in recurrent superficial bladder cancer: a phase II study.

OBJECTIVE To assess the efficacy of adjuvant intravesical mitozantrone in recurrent superficial bladder cancer. PATIENTS AND METHODS Twenty-one patients (15 men and six women, mean age 69 years, range 50-91) with recurrent superficial bladder cancer were recruited for the trial between 1990 and 1992. After transurethral resection or diathermy of the tumour, each patient received 20 mg mitozantrone intravesically in 50 mL normal saline, which was retained for 1 h. The instillations were repeated at 2-weekly intervals to a total of four instillations. The patients were followed up for 1 year. RESULTS Ten patients had a complete response, but only four were free of tumour at 1 year. Seven patients had a partial response whilst four had progression of their tumour. Only two patients withdrew from treatment due to chemical cystitis. CONCLUSION Mitozantrone at the dose used in this study produced a high response rate and a low incidence of side-effects compared with established agents.