ABSTRACT
Objectives: To present an update of our experience with sequential immuno-chemotherapy using bacillus Calmette-Guerin (BCG) and epirubicin in superficial bladder tumors. In addition; the question of whether to start with BCG or epirubicin is answered. Methods: Between January 1993 and December 2001; 156 patients with histologically proven Ta and T1 bladder transitional cell carcinoma were included in a prospective randomized study. Following transurethral resection of the bladder tumor (TURBT); patients were randomly assigned to 1 of 2 groups. Patients in group 1 received weekly doses of 150 mg BCG alternating with 50 mg epirubicin for 6 weeks. Maintenance was carried out by a monthly dose of BCG alternating with epirubicin; to complete 1 year of treatment. Patients in group 2 received the same protocol; but with a reversed order with epirubicin being used initially. Results: 149 patients; 114 men and 35 women with a mean age of 55 years; were evaluable. 7 patients were excluded due to severe side effects. Mean and median follow-up was 42.8 and 43 months; respectively. In the whole series recurrence rate was 18.1; recurrence rate per year was 0.06; mean interval to first recurrence was 29 months and progression rate was 12. Side effects developed in 40 patients (25.6) and were mostly in the form of mild cystitis (26 patients). The 2 groups of therapy were comparable regarding recurrence rate; recurrence rate per year; progression rate and side effects. Conclusions: The sequential therapy is effective in recurrence prophylaxis of superficial bladder tumors. The side effects were less frequent than in our historical controls treated with BCG alone. It does not matter to start with epirubicin or BCG in this regimen