Sequential immunochemotherapy [Bacillus Calmette-Guerin and Epirubicin] versus chemoimmunotherapy [Epiviribicin and bacillus calmette-guerin] for stages pTa and pT1 transitional cell carcinoma of the bladder

ABSTRACT

Sequential immuno-chemotherapy using bacillus Calmette-Guerin [BCG] and epirubicin has been found to be as effective as and less toxic than BCG alone in recurrence prophylaxis of superficial bladder tumors. Some investigators speculated that if intravesical chemotherapy is instilled before immunotherapy it will produce inflammation and denudation of the mucosa so that the submucosa will be ready for a potentiated effect of the immunotherapy. To test this hypothesis we conducted this study. Between Jan. 1993 and July 1999 a prospective randomized trial was performed on 159 patients who underwent transurethral resection [[TURBT] of bladder transitional cell carcinoma [stages pTa and pTl]. Following TURBT, patients were randomly allocated to 2 treatment arms. Patients in arm I [78] received weekly doses of 150 mg BCG alternating with 50 mg epirubicin for 6 weeks. Maintenance was carried out by a monthly course of the same doses of BCG alternating with epirubicin for 10 months. Patients in arm II [81] received thy same protocol, but with a reversed order with epirubicin being used initially. 154 patients; 108 men and 36 women, mean age 59 years, were evaluable. 5 patients were excluded in view of severe side effects [3 in arm 1 and 2 in arm II]. Follow up ranged from 12 to 74 months [mean 38 +/- 16.9]. Recurrence rate was] comparable in the 2 arms 11/75 [14.7%] and 13/79 [16.5%], respectively. Recurrence rate per 12 patient months was again; comparable 0.08 and 0.09, respectively. Interval to first recurrence and progression rate were also comparable. Toxicity developed in 29% and 26.6% of patients, respectively [p > 0.05]. Both treatment policies were comparable in terms of efficacy and loxicity