A randomized study of short-versus long-term intravesical epirubicin instillation for superficial bladder cancer. Nagoya University Urological Oncology Group.

OBJECTIVE: A prospective randomized study was undertaken to determine whether prophylactic maintenance instillation of epirubicin following induction treatment is beneficial in patients with superficial bladder cancer. PATIENTS AND METHODS: One hundred and forty-eight patients with resectable superficial bladder cancer (Ta-1, single, multiple, primary or recurrent with, however, no recurrence during the last year) were enrolled in this study. In both arms, epirubicin (40 mg/ml in normal saline) was administered six times within 4 weeks after a transurethral resection of the bladder tumor(s). In arm A, the patients received 11 additional monthly instillations of epirubicin.
RESULTS: Of the 148 patients, 138 (93.2%) were eligible and followed for an average of 29.6 months. 93 (67.4%) had a solitary tumor. No significant difference in the recurrence-free curve was observed between the two arms (p = 0.62). The recurrence rate per year was 0.16 in arm A and 0.17 in arm B. Toxicity included vesical irritability in 10 (7.2%) and hematuria in 1 patient. No significant difference in the frequency or degree of toxicity was observed between the two arms.
CONCLUSION: These data suggest that maintenance instillation of epirubicin does not reduce superficial bladder cancer recurrence.

RCT Entities:   Population Interventions Outcomes