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 total of 68 patients received prophylactic/adjuvant intravesical Pasteur strain bacillus Calmette-Guérin (BCG) instillations following transurethral resection for superficial bladder carcinoma. An induction phase consisting of 6 weekly instillations was followed by a maintenance phase consisting of 1 instillation given every 3 months. A second 6-week course of BCG was administered to initial failure followed again by a quarterly maintenance therapy. The response rate for patients treated with one 6-week course was 56%, while complete response was achieved in 72% when both treatment courses were considered. Follow-up period lasted at least 2 years after each course of BCG. These results suggest that additional courses of BCG increase the prophylactic efficacy of intracavitary BCG. Regarding the purified protein derivative (PPD) skin test and granulomatous response in the bladder, it has been shown in the present study that, although favourable results occurred more frequently among patients with either PPD conversion from negative to positive or vesical granuloma formation, neither of these indices should be considered reliable prognostic indicators.
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