A controlled prospective trial on 94 patients evaluated the efficacy of intravesical Pasteur strain bacillus Calmette-Guerin (BCG) administration as prophylaxis against tumor recurrences after complete endoscopic resection of superficial bladder cancer. The treatment schedule, consisting of an initial 6-week course of instillations and a single quarterly maintenance dose to the responders, was modified to those of the latter who were at high risk for recurrence and who received an additional separate 4-week course of therapy. The percentage of the patients treated prophylactically with BCG and who remained free of recurrences (68%, mean followup 33.8 months) was significantly higher than that of the controls who underwent transurethral resection only (41%, mean followup 30.2 months). In terms of relative risk of recurrences, recurrence rate per 100 patient-months and disease-free interval, comparisons between the 2 groups of patients revealed a significant benefit for the BCG group overall as for those subjects having stages Ta and T1 tumors, multifocal tumors, a history of disease, and grades 2 and 3 carcinoma. Drug-induced toxicity was acceptable. Our study suggests that our modified treatment protocol is notably safe and effective against recurrent superficial bladder cancer.
A controlled prospective study in 65 patients was done to evaluate the efficacy of intravesical epirubicin administration as prophylactic treatment in regard to the pattern of tumor recurrences after complete endoscopic resection of superficial transitional cell carcinoma of the bladder. Intravesical instillations of the drug were given weekly for 6 consecutive weeks and to the responders an intermittent maintenance therapy was administered for the first 2 years after each followup examination. Of the patients treated prophylactically with epirubicin 37% had recurrence within a total of 1,136 patient-months compared to 55% of the controls who were followed for a total of 436 months, a difference that was not statistically significant (p greater than 0.05). However, examining the results in another manner, the control patients demonstrated a significantly shorter mean interval to recurrence and higher recurrent tumor rate per 100 patient-months. To clarify further the efficacy of epirubicin therapy, comparisons of the treatment outcome according to several tumor factors were done. These comparisons revealed a significant benefit for those who received epirubicin with respect to history of tumor recurrences and multiplicity at presentation. Drug-induced toxicity was acceptable. Our study suggests that epirubicin is safe and effective against the recurrence of superficial bladder cancer.
A prospective randomized trial on 94 eligible patients evaluated and compared the efficacy of adjuvant intravesical epirubicin and bacillus Calmette-Guérin (BCG) after complete resection of multifocal superficial bladder cancer. BCG treatment schedule consisted of an induction 6-week course of instillations (150 mg Pasteur BCG per instillation) and single maintenance doses to patients who remained free of recurrences at follow-up examinations for a total treatment period of 2 years. These initial responders received additionally a separate 4-week course of therapy 6 months after the start of treatment. Chemoprophylaxis included an early (on the second postoperative day) instillation followed by 4 weekly treatments with epirubicin (50 mg per instillation) and then by 10 monthly treatments for the initial responders during the first year of follow-up and at every follow-up examination for a total treatment period of 2 years. The overall treatment results did not differ significantly between the 2 arms (54% of patients of the epirubicin group remained free of recurrences compared to 65% of those treated with BCG) for an identical mean follow-up of 35.1 months. However, a significant benefit in favour of BCG when compared with epirubicin was shown in patients who had stage T1 and grade 3 tumours and in terms of relative risk of recurrences, disease-free interval and recurrence rate per 100 patient-months. Both drugs were proved to be safe with manageable toxicity.
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