BCG versus epirubicin in the prophylaxis of multiple superficial bladder tumours: results of a prospective randomized study using modified treatment schemes

• Published in: International urology and nephrology Vol. 28; no. 4; p. 499
• Main Authors: Melekos, M D, Zarakovitis, I, Dandinis, K, Fokaefs, E, Chionis, H, Dauaher, H, Barbalias, G
• Format: Journal Article
• Language: English
• Published: Netherlands 1996
• Subjects: Adjuvants, Immunologic - therapeutic use; Administration, Intravesical; Aged; Antibiotics, Antineoplastic - therapeutic use; BCG Vaccine - administration & dosage; BCG Vaccine - therapeutic use; Disease-Free Survival; Epirubicin - therapeutic use; Female; Humans; Immunotherapy; Male; Neoplasm Recurrence, Local - prevention & control; Prospective Studies; Treatment Outcome; Urinary Bladder Neoplasms - drug therapy; Urinary Bladder Neoplasms - mortality; Urinary Bladder Neoplasms - therapy
• ISSN: 0301-1623
• DOI: 10.1007/BF02550957

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.