Sequential bacillus Calmette-Guerin and epirubicin versus bacillus Calmette-Guerin alone for superficial bladder tumors: A randomized prospective study

Purpose: This study was designed to find a new therapeutic modality that ma y have the same efficacy and lower toxicity than bacillus Calmette-Guerin ( BCG) for the treatment of superficial transitional cell carcinoma of the bl adder. Materials and Methods: Between January 1993 and July 1997 a prospective ran domized trial was conducted on 139 patients with stages pTa and pT1 bladder transitional cell carcinoma to compare the prophylactic efficacy and toxic ity of sequential BCG and epirubicin (group 1) versus BCG alone (group 2). Group 1 comprised 69 patients who received alternating doses of 150 mg. BCG and 50 mg. epirubicin (1 drug at a time), while 70 patients in group 2 rec eived 150 mg. BCG at each instillation. Treatment was continued for 6 weeks followed by 10 monthly instillations. Results: Therapy was discontinued permanently in 3 group 1 and 12 group 2 p atients due to severe side effects, and they were excluded from the study. Among the 124 evaluable patients (96 men and 28 women, mean age 58.2 years) mean followup was 30.4 months (range 12 to 50). Recurrence and progression rates were statistically comparable in both groups. Interval to first recu rrence with or without progression was longer in group 1 than in group 2 (l og rank p = 0.05). Toxicity and complications were significantly lower with sequential treatment than with BCG alone at rates of 27.3% (18 patients) a nd 70.7% (41), respectively (p = 0.001). Conclusions: Sequential BCG and epirubicin are comparable to BCG alone in e fficacy and superior in terms of toxicity.