Transurethral resection with perioperative instillation of interferon-α or epirubicin for the prophylaxis of recurrent primary superficial bladder cancer:: A prospective randomized multicenter study -: Finnbladder III

Purpose: We evaluated the efficacy of single dose of interferon or epirubicin administered immediately after transurethral resection compared with transurethral resection only on the recurrence of primary (not recurrent) superficial bladder cancer. Materials and Methods: A total of 283 patients with stages Ta to T1 primary superficial, grades 1 to 3 bladder cancer was randomized into study groups 1--transurethral resection only, 2-transurethral resection plus 50 million units interferon-alpha 2b and 3-transurethral resection plus 100 mg, epirubicin. Eligible for final analysis were 200 patients, including 66 in group 1, 66 in group 2 and 68 in group 3. Patients were followed with cystoscopy every 3 months for 2 years or until the initial recurrence. Results: Group 3 had the most favorable outcome, since 45 of the 68 patients (66%) were without recurrence after 2 years compared to 24 of the 66 (37%) in group 2 and 26 of the 66 (40%) in group 1 (log rank test p < 0.001). Side effects were mostly mild and transient, and no differences were found among the groups. Conclusions: A single 100 mg. dose of epirubicin given intravesically immediately after transurethral resection is safe, and significantly decreases the recurrence of primary superficial bladder cancer. A 50 million unit dose of interferon-alpha 2b is well tolerated but it has no effect on recurrence as a single dose. The long-term effect of this treatment remains to be studied.