title: Intravesical bacillus Calmette-Guerin immunoprophylaxis of superficial bladder cancer: results of a controlled prospective trial with modified treatment schedule.
abstract: 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.
authors.affiliation: Department of Urology, University of Patras School of Medicine, Rio Greece.
authors.forename: M D
authors.initials: MD
authors.lastname: Melekos
authors.forename: H
authors.initials: H
authors.lastname: Chionis
authors.forename: A
authors.initials: A
authors.lastname: Pantazakos
authors.forename: E
authors.initials: E
authors.lastname: Fokaefs
authors.forename: G
authors.initials: G
authors.lastname: Paranychianakis
authors.forename: H
authors.initials: H
authors.lastname: Dauaher
mesh_terms: D000283:Administration, Intravesical; D000368:Aged; D001500:BCG Vaccine / Q000008:administration & dosage / Q000627:therapeutic use*; D002295:Carcinoma, Transitional Cell / Q000453:epidemiology / Q000517:prevention & control*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D015993:Life Tables; D008297:Male; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology / Q000517:prevention & control*; D011446:Prospective Studies; D001749:Urinary Bladder Neoplasms / Q000453:epidemiology / Q000517:prevention & control*
chemical_list: D001500:BCG Vaccine