title: Results at 43 months' follow-up of a double-blind, randomized, prospective clinical trial using intravesical interferon alpha-2b in the prophylaxis of stage pT1 transitional cell carcinoma of the bladder.
abstract: OBJECTIVE
  To assess the intravesical efficacy of 60 million units of interferon (IFN) alpha-2b in preventing recurrences of Stage pT1 transitional cell carcinoma of the bladder, as well as to assess its local and systemic toxicity.
  
  
  METHODS
  A total of 90 patients were included in a double-blind, randomized, prospective clinical trial and divided into two groups of 45 patients. After complete transurethral resection, 60 million units IFN alpha-2b was instilled in one group; in the other, double-distilled water was used. The therapeutic regimen consisted of weekly instillation for 12 weeks, followed by once-monthly instillation until patients had completed 1 year of treatment.
  
  
  RESULTS
  Only 78 patients were evaluable. After 12 months of follow-up, the relapse rate was 28.2% (11 of 39) for the IFN group and 35.8% (14 of 39) for the control group (P = NS). After 43 months (range 9 to 67), relapse rates were 53.8% (21 of 39) and 51.2% (20 of 39), respectively (P = NS). Progression, mortality, and local or systemic toxicity were similar in both groups. Flu-like syndrome was not reported.
  
  
  CONCLUSIONS
  At the dose used in this study, IFN alpha-2b proved ineffective in the prophylaxis of Stage pT1 transitional cell carcinoma of the bladder compared with a control group. Toxicity was virtually absent.
authors.affiliation: Urology Department, Valdecilla University Hospital, Medical School, University of Cantabria, Santander, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Portillo
authors.forename: B
authors.initials: B
authors.lastname: Martin
authors.forename: R
authors.initials: R
authors.lastname: Hernandez
authors.forename: M
authors.initials: M
authors.lastname: Correas
authors.forename: J
authors.initials: J
authors.lastname: Gutierrez
authors.forename: J
authors.initials: J
authors.lastname: Del Valle
authors.forename: A
authors.initials: A
authors.lastname: Roca
authors.forename: A
authors.initials: A
authors.lastname: Vega
authors.forename: A
authors.initials: A
authors.lastname: Villanueva
authors.forename: R
authors.initials: R
authors.lastname: Gutierrez
mesh_terms: D000283:Administration, Intravesical; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D002295:Carcinoma, Transitional Cell / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control*; D009367:Neoplasm Staging; D011446:Prospective Studies; D011994:Recombinant Proteins; D013997:Time Factors; D001749:Urinary Bladder Neoplasms / Q000517:prevention & control*
chemical_list: D000970:Antineoplastic Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins