title: BCG versus epirubicin in the prophylaxis of multiple superficial bladder tumours: results of a prospective randomized study using modified treatment schemes.
abstract: 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.
authors.affiliation: Department of Urology, University of Patras School of Medicine, Greece.
authors.forename: M D
authors.initials: MD
authors.lastname: Melekos
authors.forename: I
authors.initials: I
authors.lastname: Zarakovitis
authors.forename: K
authors.initials: K
authors.lastname: Dandinis
authors.forename: E
authors.initials: E
authors.lastname: Fokaefs
authors.forename: H
authors.initials: H
authors.lastname: Chionis
authors.forename: H
authors.initials: H
authors.lastname: Dauaher
authors.forename: G
authors.initials: G
authors.lastname: Barbalias
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000283:Administration, Intravesical; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use*; D001500:BCG Vaccine / Q000008:administration & dosage / Q000627:therapeutic use*; D018572:Disease-Free Survival; D015251:Epirubicin / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007167:Immunotherapy; D008297:Male; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control; D011446:Prospective Studies; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*
chemical_list: D000276:Adjuvants, Immunologic; D000903:Antibiotics, Antineoplastic; D001500:BCG Vaccine; D015251:Epirubicin