title: Factors affecting response to bacillus Calmette-Guérin plus interferon for urothelial carcinoma in situ.
abstract: OBJECTIVE
  The unpredictable behavior of carcinoma in situ and its high potential for recurrence and progression make identifying patient characteristics predicting a poor prognosis a priority. We assessed which factors affect the response to bacillus Calmette-Guérin plus interferon-α therapy in patients with urothelial carcinoma in situ.
  
  
  METHODS
  We analyzed data on a subset of 231 patients with carcinoma in situ enrolled in a multicenter, phase II trial of bacillus Calmette-Guérin plus interferon-α therapy for nonmuscle invasive bladder cancer. Analysis included patients who were bacillus Calmette-Guérin naïve and those with previous exposure to failed bacillus Calmette-Guérin therapy. We evaluated factors potentially affecting the bacillus Calmette-Guérin plus interferon-α response, including patient age, gender, tumor stage, multifocality, prior tumor stage, the previous bacillus Calmette-Guérin failure pattern, courses and maintenance, and prior chemotherapy.
  
  
  RESULTS
  The complete response rate at 3 and 6 months in naïve vs previously failed bacillus Calmette-Guérin cases was 76% and 70% vs 76% and 66%, respectively. The 24-month disease-free rate was decreased in the 53 patients with a history of 2 or more failed bacillus Calmette-Guérin courses vs that in the 71 with a history of 1 failed course and bacillus Calmette-Guérin naïve patients (23% vs 57% and 60%, respectively). The 22 patients with refractory carcinoma in situ had the worst outcome of a 23% disease-free rate at 24 months while the 59 with relapse within 1 year had an intermediate outcome of 42% vs 59% in the 33 with relapse after 1 year. Patients with a history of papillary disease did better than those without such a history (p=0.019).
  
  
  CONCLUSIONS
  Factors associated with a poor response to bacillus Calmette-Guérin plus interferon-α therapy in patients with carcinoma in situ are prior tumor stage, 2 or more prior bacillus Calmette-Guérin failures and a bacillus Calmette-Guérin failure pattern.
authors.affiliation: Department of Urology, University of Iowa, Iowa City, Iowa 52242-1089, USA.
authors.forename: Henry M
authors.initials: HM
authors.lastname: Rosevear
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Lightfoot
authors.forename: Kevin K
authors.initials: KK
authors.lastname: Birusingh
authors.forename: José L
authors.initials: JL
authors.lastname: Maymí
authors.forename: Kenneth G
authors.initials: KG
authors.lastname: Nepple
authors.forename: Michael A
authors.initials: MA
authors.lastname: O'Donnell
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000368:Aged; D001500:BCG Vaccine / Q000627:therapeutic use*; D002278:Carcinoma in Situ / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*; D019459:Urothelium
chemical_list: D000276:Adjuvants, Immunologic; D001500:BCG Vaccine; D007155:Immunologic Factors; D016898:Interferon-alpha