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The preliminary results of a randomized ongoing study performed in order to evaluate the efficacy and the relative toxicity of a low dose (75 mg). BCG regimen in the treatment of superficial bladder cancer were considered. Ninety-eight patients (58 patients for prophylaxis of the recurrences of Ta-T1 papillary tumors; 40 patients for therapy of carcinoma in situ) received a 6-weeks course of 75 mg. BCG Pasteur vaccine. An additional course was given to non-responders. A maintenance therapy was administered in complete responders monthly for the first year and quarterly for the second. The prophylaxis group (TUR + BCG) was randomized vs TUR alone (40 patients = control group). Complete response in evaluated patients of the prophylaxis, control and therapy groups achieved 86%, 17% and 78%, respectively, after 18 months; 5%, 20% and 9% of patients, respectively, experienced tumor progression. As regards the toxicity, irritative disturbances (27%) and fever (16%) appeared significantly decreased in comparison with those reported in the literature. No major complications were experienced. In conclusion, the low dose (75 mg.) Pasteur BCG regimen used in our trial was effective as a prophylaxis against recurrent superficial papillary tumors and as a treatment of carcinoma in situ, with a significant decrease in toxicity.

From January 1982 to October 1987, 100 patients with multifocal superficial bladder cancer received intravesical MMC at the Institute of Urology, University of Padova. Seventy-three patients had papillary multifocal superficial bladder carcinoma (stages Ta-T1): treatment was divided into therapeutic (18 cases), and prophylactic (55 cases). 27 patients had carcinoma in situ. 39 patients affected by neoplasia relapsed to previous intravesical ADM treatment. All patients received 40 mg. intravesical MMC weekly for 8 consecutive weeks, repeating the cycle in cases of relapse. Complete response rates at 12 months was 53%, 50 to 67% for each group, respectively. Recurrence rate was lower compared to that before treatment; progression rate was also lower compared to a group who received only endoscopic treatment. In patients who relapsed with ADM treatment, the percentage of complete response was 69%. We underscore the efficacy of MMC in lowering relapse and progression in multifocal superficial bladder cancer, which represents the best indication for this kind of treatment.