Intravesical doxorubicin for the prophylaxis of superficial bladder tumors. A multicenter study. Blinst Italian Cooperative Group.

A multicenter trial was carried out with patients with superficial Ta-T1 bladder tumors in 37 urology centers throughout Italy. After transurethral resection (TUR) patients were given intravesical doxorubicin instillations at the mean dose of 50 mg per instillation diluted in 50 ml of distilled water or physiologic saline. Chemoprophylaxis was performed at weekly intervals for the first 4 weeks and then monthly. Cystoscopies were taken every 3 months during the first year, every 4 months during the second year, and every 6 months thereafter. A total of 435 patients, with a median follow-up time of 436 days, were considered eligible for the evaluation of activity. The lowest recurrence rate and the longest disease-free interval was observed in the group of patients with primary or single tumor. Treatment was well tolerated; 119 patients (22.7%) complained of local adverse reactions, and 10 (1.9%) of systemic adverse reactions. In 34 of the patients (6.5%) treatment had to be discontinued.