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: M D Melekos, I Zarakovitis, K Dandinis, E Fokaefs, H Chionis, H Dauaher, G Barbalias
• Journal: International urology and nephrology (Int Urol Nephrol) Vol. 28 Issue 4 Pg. 499-509 ( 1996) ISSN: 0301-1623 [Print] Netherlands
• PMID: 9119635 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Adjuvants, Immunologic
• Antibiotics, Antineoplastic
• BCG Vaccine
• Epirubicin

Topics

• Adjuvants, Immunologic (therapeutic use)
• Administration, Intravesical
• Aged
• Antibiotics, Antineoplastic (therapeutic use)
• BCG Vaccine (administration & dosage, 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, mortality, therapy)