A controlled study of intravesical epirubicin with or without alpha 2b-interferon as prophylaxis for recurrent superficial transitional cell carcinoma of the bladder. Finnish Multicentre Study Group.

Abstract

To evaluate the efficacy of intravesical epirubicin with or without alpha 2b-interferon (alpha 2b-IFN) as a prophylactic treatment for recurrent superficial transitional cell carcinoma (TCC) of the urinary bladder. A total of 81 patients with superficial (stage Ta and T1), well or moderately differentiated (grades 1 and 2) TCC were treated between June 1988 and December 1993. The patients were randomized into three groups: Group 1 was treated by transurethral resection (TUR) alone; Group 2 received 50 mg epirubicin and Group 3 received 50 mg epirubicin combined with 10 MU alpha 2b-IFN, intravesically in 50 mL sterile buffer solution. The instillations were started 1 week after TUR and were performed weekly during the first month and then once a month for one year. The patients were followed for a total of 2 years. Recurrence rate and tumour rate were calculated to assess the behaviour of the disease. The patients were followed for a mean of 20 months. Patients receiving intravesical chemoimmunotherapy (Group 3) had the most favourable outcome; they had comparatively lower recurrence and tumour rates, fewer patients with recurrences and, most importantly, the longest disease-free interval. Side-effects were mostly mild and transient, and no differences were found among the groups. In reducing the number of patients having recurrences and extending the recurrence-free interval, intravesical chemoimmunotherapy with epirubicin and alpha 2b-IFN had a promising effect on the natural course of superficial bladder cancer, particularly in patients with a history of prior recurrences.