Intravesical therapy with adriamycin and 4-epirubicin for superficial bladder cancer: the experience of the EORTC GU Group.

The anthracycline derivatives Adriamycin and 4-epirubicin are used to prevent recurrent tumors after transurethral resection of superficial bladder tumors. Both drugs are instilled intravesically. The present report describes the results of two multicenter, prospective, randomized phase III studies carried out by the EORTC GU Group. In protocol 30,790, after a mean follow-up period of 26.6 months, the recurrence rate for 165 patients treated with Adriamycin was 0.29 and the tumor rate was 0.74. For 156 patients treated with Epodyl, the recurrence rate was 0.29 and the tumor rate was 0.57. This difference was not statistically significant. For 70 patients who received transurethral resection alone, the recurrence rate was 0.65 and the tumor rate, 2.04. In protocol 30,763, patients with good prognostic factors were treated with one single instillation of 4-epirubicin versus sterile water. After a mean follow-up period of 16 months, in 190 patients treated with 4-epirubicin the recurrence rate was 0.20 and the tumor rate was 0.35; in 196 patients treated with sterile water, the recurrence rate was 0.37 and the tumor rate was 0.65 (P = 0.0001). Adriamycin and 4-epirubicin were efficacious, and severe side effects were not encountered. The superiority of Adriamycin over Epodyl could not be proven.

RCT Entities:   Population Interventions Outcomes