High-dose epirubicin in the prophylactic treatment of T1G2 superficial bladder tumors

Objectives: To evaluate the activity and safety of intravesical instillatio ns of 80 mg epirubicin in a selected patient population with T1G2 primary a nd multiple superficial bladder tumors. To assess the completeness of the t ransurethral resection (TUR) at 4 weeks (second look) and to compare the hi stology of local and review pathology. Methods: One hundred and sixty-nine patients have been histologically assessed both locally and extramurally fo r T1G2 superficial bladder tumors. Epirubicin (80 mg/instillation) started within 20 days after TUR was administered weekly during the first month and then monthly for another 11 months. Assessments for relapse were carried o ut according to the standard methods. Results: Histological consistency for T1G2 between local and extramural assessments was found in 85.2% of cases. At the median follow-up time of 38 months, the overall relapse rate was 43 .3%. Treatment was very well tolerated: no system ic adverse events were re ported a nd local adverse events were confined to chemical cystitis which i n 3% required treatment discontinuation. Conclusions: Epirubicin (80 mg/ins tillation) appeared effective in the prophylaxis of relapse in primary and multiple T1G2 superficial bladder tumors. A second TUR at 3-4 weeks is nece ssary in T1 tumors. Excellent concordance between local and review patholog y was found. Copyright (C) 2001 S. Karger AG, Basel.