A RANDOMIZED STUDY OF SHORT-TERM VERSUS LONG-TERM INTRAVESICAL EPIRUBICIN INSTILLATION FOR SUPERFICIAL BLADDER-CANCER

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 wi th resectable superficial bladder cancer (Ta-1, single, multiple, prim ary or recurrent with, however, no recurrence during the last year) we re enrolled in this study, In both arms, epirubicin (40 mg/ml in norma l saline) was administered six times within 4 weeks after a transureth ral resection of the bladder tumor(s), In arm A, the patients received 11 additional monthly instillations of epirubicin, Results: Of the 14 8 patients, 138 (93.2%) were eligible and followed for an average of 2 9.6 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 to xicity was observed between the two arms, Conclusion: These data sugge st that maintenance instillation of epirubicin does not reduce superfi cial bladder cancer recurrence.