title: Final results from a national multicenter phase II trial of combination bacillus Calmette-Guérin plus interferon alpha-2B for reducing recurrence of superficial bladder cancer.
abstract: BACKGROUND
  Both bacillus Calmette-Guérin (BCG) and interferon-alpha (IFN-alpha) express activity against superficial bladder cancer. The results of a national multicenter phase II trial of a combination of these 2 agents used in a wide range of patients are reported.
  
  
  METHODS
  Patients previously having BCG failure received IFN-alpha (50 million units) plus reduced dose BCG, while patients naïve to BCG received the same IFN-alpha dose with standard dose BCG. All patients who were relapse free received an additional 3 series of 3-week reduced dose BCG plus IFN-alpha treatments at 3, 9, and 15 months after completing induction. Any relapse during the 3-month evaluation was counted as a failure of therapy for Kaplan-Meier analysis. Multivariate analysis was performed to identify factors associated with recurrence.
  
  
  RESULTS
  Of 1,007 valuable patients, 59% and 45% of patients naïve to BCG and those having BCG failure, respectively, remained disease free at 24-month median follow-up. Stage T1, tumor size>5 cm, prior BCG failure more than once, and multifocality were all statistically significant risk factors for recurrence.
  
  
  CONCLUSIONS
  Although BCG plus IFN-alpha can be effectively applied to both patients naïve to BCG and those having BCG failure, certain patient and tumor characteristics influence durable response.
authors.affiliation: Department of Urology, University of Iowa, Iowa City, IA 52242-1089, USA.
authors.forename: Fadi N
authors.initials: FN
authors.lastname: Joudi
authors.forename: Brian J
authors.initials: BJ
authors.lastname: Smith
authors.forename: Michael A
authors.initials: MA
authors.lastname: O'Donnell
mesh_terms: D000368:Aged; D001500:BCG Vaccine / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control*; D011994:Recombinant Proteins; D001749:Urinary Bladder Neoplasms / Q000628:therapy*
chemical_list: D001500:BCG Vaccine; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins