INTRAVESICAL BACILLUS-CALMETTE-GUERIN VERSUS EPIRUBICIN IN THE PROPHYLAXIS OF RECURRENT AND OR MULTIPLE SUPERFICIAL BLADDER-TUMORS/

A prospective, randomized trial was conducted to evaluate and compare the effects of modified adjuvant intravesical bacillus Calmette-Guerin (BCG) and epirubicin regimens in patients with superficial bladder ca ncer. One hundred thirty-two individuals with recurrent and/or multipl e neoplasms, i.e. at high risk for tumour recurrence and progression, were enrolled. After complete transurethral resection of their tumours , the patients received a B-week course of BCG instillations or an ear ly 4-week course of epirubicin instillations as their initial therapy. Those with stage Ta and grade 1 neoplasms who remained free of recurr ences received maintenance therapy consisting of single quarterly inst illations. However, for those with stage T1 cancer of any grade or sta ge Ta of grade 2 or 3 neoplasms who also remained free of recurrences, the treatment schedules were modified: they received, instead of sing le maintenance doses, 3 weekly instillations of epirubicin at months 3 and 6 of follow-up, or a 3-week course of BCG at month 6 of follow-up . The recurrence-free rates did not differ significantly between the t wo study groups (44% for epirubicin versus 55% for BCG), for an identi cal median follow-up of 43 months. However, in terms of relative risk of recurrences, disease-free intervals and recurrence rate per 100 pat ient-months, a significant benefit in favour of BCG when compared with epirubicin was demonstrated in patients who had stage T1 or grade 3 n eoplasms.