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

Int Urol Nephrol. 1996;28(4):499-509. 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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • 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*


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