Trial with bacillus Calmette-Guérin and epirubicin combination in the prophylaxis of superficial bladder cancer.

The efficacy and side effects of the prophylactic intravesical bacillus Calmette-Guérin and epirubicin combination therapy were evaluated in 14 patients who underwent transurethral resection for Ta-T1 superficial bladder cancer. Therapy was started 7-10 days after the operation and maintained weekly for 6 weeks and then monthly for 6 months unless withdrawal due to side effects. Instillation of 50 mg epirubicin (Farmorubicin, Farmitalia Carlo Erba) diluted in 50 ml saline was followed by 80 mg of the Connaught strain bacillus Calmette-Guérin (ImmuCyst, Pasteur Mérieux) in 50 ml saline and the duration of instillation was 2 h for each drug. All the patients experienced moderate to severe cystitis and fever. Side effects necessitated discontinuation of the therapy in 5 patients (35.7%). Therapy was delayed in 7 patients (50%) for reasons related or unrelated to the side effects. Of the 9 patients who completed the course, 8 (89%) had no tumor recurrence 10-16 months (mean 14 months) after therapy. Results obtained revealed that this treatment schedule cannot be tolerated by a considerable number of the patients. Mainly the side effects of the combination are emphasized in this report. The therapeutic efficacy of such a combination has yet to be determined and further clinical studies are warranted.