title: Management of bacillus Calmette-Guerin (BCG) refractory superficial bladder cancer: results with intravesical BCG and Interferon combination therapy.
abstract: OBJECTIVE
  BCG is the most efficacious intravesical treatment for superficial bladder cancer. However, 30%-40% of tumors are refractory. BCG failure is an indication for cystectomy but several salvage intravesical (IVe) strategies have been proposed. Early results with reduced dose BCG in combination with IFN-a in patients are currently the most promising. We have adopted this approach and now report our preliminary results. This is the first report of this salvage therapy from Canada, the birthplace of IVe BCG therapy for superficial bladder cancer.
  
  
  METHODS
  The "O'Donnell protocol" of reduced dose IVe BCG plus IFN-a was followed in 12 patients with BCG refractory superficial transitional cell carcinoma. A retrospective review of the efficacy and toxicity of the treatment was conducted.
  
  
  RESULTS
  One year from induction therapy with salvage BCG/IFN-a, 6 of the 12 (50%) of patients were tumor free. Of the six recurrences, 3(50%) did not respond to the IVe therapy and had residual/recurrent tumor at the first follow-up visit. Risk factors for treatment failure were identified. The combinative therapy was well tolerated with minimal toxicity compared to previous full dose BCG.
  
  
  CONCLUSIONS
  Our 12 month data with reduced dose IVe BCG plus IFN-a salvage therapy for BCG refractory superficial TCC confirm previous reports of >50% complete response rates. We need longer follow up in a larger patient population to determine the durability of this promising therapy in patients who would otherwise undergo radical cystectomy.
authors.affiliation: Divisions of Urology, University of Toronto and The University of Western Ontario, Department of Surgical Oncology, Princess Margaret Hospital, Toronto, Ontario, Canada.
authors.forename: Sanoj P
authors.initials: SP
authors.lastname: Punnen
authors.forename: Joseph L
authors.initials: JL
authors.lastname: Chin
authors.forename: Michael A S
authors.initials: MA
authors.lastname: Jewett
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001500:BCG Vaccine / Q000627:therapeutic use*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*
chemical_list: D000970:Antineoplastic Agents; D001500:BCG Vaccine; D016898:Interferon-alpha