Prophylaxis of superficial bladder cancer with a modified intravesical epirubicin treatment schedule.

A controlled prospective trial on 99 eligible patients evaluated the efficacy of intravesical epirubicin administration as prophylaxis against tumor recurrences after complete endoscopic resection of superficial bladder cancer. The treatment schedule consisting of an initial 6- or 8-week course of instillations, followed by single maintenance doses (to the responders) at follow-up examinations, was modified in those of the initial responders who were at high risk for recurrence and who received an additional separate 4-week course of therapy. Sixty percent of the epirubicin-treated patients and 41% of the controls (who underwent resection alone) remained free of recurrences for a mean follow-up of 32.1 months, but the difference was not significant. However, in terms of relative risk for recurrences (recurrence rate per 100 patient-months and disease-free interval), comparisons between the two groups of patients revealed a significant benefit of epirubicin, overall as well as for those with a history of previous tumor recurrences, multifocal disease, and stage Ta and grade 2 neoplasms. Drug-induced toxicity was acceptable.