title: Intravesical chemotherapy with epirubicin: a dose response study.
abstract: OBJECTIVE
  We determined the difference in response to high and standard doses of intravesical epirubicin for treatment of superficial bladder cancer.
  
  
  METHODS
  A total of 122 patients were entered into a randomized trial to compare the response of a marker tumor at 3 months, time to first recurrence and recurrence rates for 2 years after intravesical chemotherapy for superficial (pTa/pT1) bladder cancer. Patients were randomized to receive treatment for 1 hour with 1 (standard dose) or 2 mg./ml. (high dose) epirubicin (50 or 100 mg./50 ml. solution).
  
  
  RESULTS
  There was no difference in the marker tumor response rate in 24 of 52 patients treated with the standard dose compared with 21 of 50 treated with the higher dose of epirubicin (p = 0.67). Similarly, the higher dose was not superior in regard to time to first recurrence, with a hazard ratio of 1.46 (p = 0.14, 95% confidence intervals 0.88 to 2.42). Considering the upper end of the confidence interval, we can reliably exclude an absolute difference of greater than 4% at 1 year for time to first recurrence in favor of higher dose chemotherapy.
  
  
  CONCLUSIONS
  Epirubicin at double the standard dose for intravesical chemotherapy of superficial bladder cancer is not superior in regard to marker tumor response, time to first recurrence or recurrence rate.
authors: Institute of Urology and Nephrology, University College and Department of Urology, King's College Hospital, London, United Kingdom.
authors: J R
authors: JR
authors: Masters
authors: R J
authors: RJ
authors: Popert
authors: P M
authors: PM
authors: Thompson
authors: D
authors: D
authors: Gibson
authors: M J
authors: MJ
authors: Coptcoat
authors: M K
authors: MK
authors: Parmar
mesh_terms: D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004305:Dose-Response Relationship, Drug; D015251:Epirubicin / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*
chemical_list: D015251:Epirubicin