A CONTROLLED-STUDY OF INTRAVESICAL EPIRUBICIN WITH OR WITHOUT ALPHA2B-INTERFERON AS PROPHYLAXIS FOR RECURRENT SUPERFICIAL TRANSITIONAL-CELLCARCINOMA OF THE BLADDER

Objectives To evaluate the efficacy of intravesical epirubicin with or without alpha2b-interferon (alpha2b-IFN) as a prophylactic treatment for recurrent superficial transitional cell carcinoma (TCC) of the uri nary bladder. Patients and methods A total of 81 patients with superfi cial (stage Ta and T1), well or moderately differentiated (grades 1 an d 2) TCC were treated between June 1988 and December 1993. The patient s were randomized into three groups: Group 1 was treated by transureth ral resection (TUR) alone; Group 2 received 50 mg epirubicin and Group 3 received 50 mg epirubicin combined with 10 MU alpha2b-IFN, intraves ically in 50 ml,sterile buffer solution. The instillations were starte d 1 week after TUR and were performed weekly during the first month an d then once a month for one year. The patients were followed for a tot al of 2 years. Recurrence rate and tumour rate were calculated to asse ss the behaviour of the disease. Results The patients were followed fo r a mean of 20 months, Patients receiving intravesical chemoimmunother apy (Group 3) had the most favourable outcome; they had comparatively lower recurrence and tumour rates, fewer patients with recurrences and , mast importantly, the longest disease-free interval, Side-effects we re mostly mild and transient, and no differences were found among the groups. Conclusions In reducing the number of patients having recurren ces and extending the recurrence-free interval, intravesical chemoimmu notherapy with epirubicin and alpha2b-IFN had a promising effect on th e natural course of superficial bladder cancer, particularly in patien ts with a history of prior recurrences.