Intravesical instillation of epirubicin: Effect on tumour recurrence in patients with dysplastic epithelium after transurethral resection of superficial bladder tumour

Objective To evaluate whether the intravesical instillation of epirubicin is effective in preventing the recurrence of tumour in the bladder where dysplastic mucosa remains after transurethral resection of tumour. Patients and methods Biopsy specimens were taken from apparently normal areas of the bladder mucosa in patients undergoing transurethral resection of the primary tumours. Of the 75 evaluable patients, 18 (24%) had abnormalities in at least one or more specimens. The patients were divided into two groups, 57 with normal and 18 with abnormal biopsy results. Intravesical chemotherapy with epirubicin (20 mg/40 mL, saline) was randomized to patients in each group. Tumour recurrence rates were estimated and compared amongst the groups. Factors related to tumour recurrence were evaluated using univariate and multivariate analyses. Results The risks of tumour recurrence and progression were evaluated in 18 patients with concomitant mucosal abnormalities. All 10 patients with abnormal biopsy results who were treated with epirubicin had recurrence of tumour within a mean interval of 9 months, whereas six of eight controls had recurrence within a mean of 10.9 months. While there was progression in grade in four of 10 patients with abnormal biopsy results and treated with epirubicin, none of the recurrent tumours in six control patients with mucosal abnormalities progressed in grade. The overall recurrence-free rate of the patients with mucosal abnormalities was higher in controls than in those receiving epirubicin, but the difference was not statistically significant. There were no significant differences in recurrence rate for those treated with epirubicin and controls in the 57 patients with normal biopsy results, Univariate analysis showed that the recurrence-free rates were significantly influenced by tumour multiplicity and the mucosal biopsy results (P<0.001 and P=0.02, respectively). In a Cox proportional-hazards model, tumour multiplicity alone had prognostic significance for tumour recurrence (P=0.002). Conclusions The prophylactic intravesical instillation of epirubicin had no effect in preventing tumour recurrence and, conversely, it may promote tumour progression in bladders with dysplastic mucosal changes.