INTRAVESICAL INSTILLATION OF EPIRUBICIN - EFFECT ON TUMOR RECURRENCE IN PATIENTS WITH DYSPLASTIC EPITHELIUM AFTER TRANSURETHRAL RESECTION OF SUPERFICIAL BLADDER-TUMOR

Objective To evaluate whether the intravesical instillation of epirubi cin is effective in preventing the recurrence of tumour in the bladder where dysplastic mucosa remains after transurethral resection of tumo ur. Patients and methods Biopsy specimens were taken from apparently n ormal areas of the bladder mucosa in patients undergoing transurethral resection of the primary tumours. Of the 75 evaluable patients, 18 (2 4%) had abnormalities in at least one or more specimens. The patients were divided into two groups, 57 with normal and 18 with abnormal biop sy results. Intravesical chemotherapy with epirubicin (20 mg/40 mL, sa line) was randomized to patients in each group. Tumour recurrence rate s were estimated and compared amongst the groups. Factors related to t umour recurrence were evaluated using univariate and multivariate anal yses. Results The risks of tumour recurrence and progression were eval uated in 18 patients with concomitant mucosal abnormalities. All 10 pa tients with abnormal biopsy results who were treated with epirubicin h ad recurrence of tumour within a mean interval of 9 months, whereas si x 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 b iopsy results and treated with epirubicin, none of the recurrent tumou rs in six control patients with mucosal abnormalities progressed in gr ade. The overall recurrence-free rate of the patients with mucosal abn ormalities was higher in controls than in those receiving epirubicin, but the difference was not statistically significant. There were no si gnificant differences in recurrence rate for those treated with epirub icin and controls in the 57 patients with normal biopsy results, Univa riate analysis showed that the recurrence-free rates were significantl y 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 recur rence (P=0.002). Conclusions The prophylactic intravesical instillatio n of epirubicin had no effect in preventing tumour recurrence and, con versely, it may promote tumour progression in bladders with dysplastic mucosal changes.