BACKGROUND:Bacillus Calmette-Guérin (BCG) and epirubicin have both been shown to be effective in the treatment of superficial bladder cancer. We studied whether the alternating combination of these agents could improve the efficacy with tolerable side-effects in the treatment of high-risk superficial bladder tumors. METHODS:Forty-one patients with high-risk superficial bladder transitional carcinoma were included in this study. Twenty-one patients were randomized into the BCG group and 20 patients were treated with sequential BCG and epirubicin. The patients were followed for 9-24 months (mean 18 months). Recurrence rates, median time to the first recurrence, progression rate and complications were compared. RESULTS: Fifteen percent of the patients in the BCG and epirubicin group and 19% of the patients in the BCG alone group developed tumor recurrence. Tumor progression was observed in 4.7% and 10% in the BCG/epirubicin group and the BCG alone group, respectively. Median time to first recurrence was 11 months for the BCG/epirubicin group and 16 months for the BCG group (P > 0.05). Three patients in the BCG/epirubicin treatment group developed serious side-effects, which necessitated antituberculosis treatment. CONCLUSION: Because the efficacy of combination was no better than the standard treatment and the alternating combination seemed to be related to a higher incidence of side-effects, this study albeit small, does not recommend combination therapy of BCG and epirubicin in high risk patients with superficial bladder cancer.
RCT Entities:
BACKGROUND: Bacillus Calmette-Guérin (BCG) and epirubicin have both been shown to be effective in the treatment of superficial bladder cancer. We studied whether the alternating combination of these agents could improve the efficacy with tolerable side-effects in the treatment of high-risk superficial bladder tumors. METHODS: Forty-one patients with high-risk superficial bladder transitional carcinoma were included in this study. Twenty-one patients were randomized into the BCG group and 20 patients were treated with sequential BCG and epirubicin. The patients were followed for 9-24 months (mean 18 months). Recurrence rates, median time to the first recurrence, progression rate and complications were compared. RESULTS: Fifteen percent of the patients in the BCG and epirubicin group and 19% of the patients in the BCG alone group developed tumor recurrence. Tumor progression was observed in 4.7% and 10% in the BCG/epirubicin group and the BCG alone group, respectively. Median time to first recurrence was 11 months for the BCG/epirubicin group and 16 months for the BCG group (P > 0.05). Three patients in the BCG/epirubicin treatment group developed serious side-effects, which necessitated antituberculosis treatment. CONCLUSION: Because the efficacy of combination was no better than the standard treatment and the alternating combination seemed to be related to a higher incidence of side-effects, this study albeit small, does not recommend combination therapy of BCG and epirubicin in high risk patients with superficial bladder cancer.