title: Co-administration of intravesical bacillus Calmette-Guérin and interferon α-2B as first line in treating superficial transitional cell carcinoma of the urinary bladder.
abstract: OBJECTIVE
  • To evaluate the efficacy and toxicity of the combination of bacillus Calmette-Guérin (BCG) and interferon α-2B (IFNα-2B) in treating superficial bladder cancer (SBC). The mentioned combination has shown synergism in pre-clinical studies.
  
  
  METHODS
  • The present study is a single-arm, open-label, single-institution prospective trial. Patients with Ta, T1 or in situ carcinoma and no previous intravesical therapy were included between July 2002 and June 2009. • Patients were treated with weekly intravesical instillation of 27 mg of BCG mixed with 10 million units (MU) of IFNα-2B for six consecutive weeks followed by 3-weekly booster instillations at 3 months if there was no recurrence. • The primary endpoint was disease recurrence. Secondary endpoints were disease progression and toxicity. • Patients were followed-up with cystoscopy and urine cytology every 3 months.
  
  
  RESULTS
  • In all, 50 patients were included. • At a median follow-up of 55.8 months, 31 (62%) patients were recurrence-free. • Progression to muscle invasion occurred in two (4%) and metastasis occurred in two (4%) patients. • Treatment was well tolerated, with grade III dysuria and frequency occurring in 18 and 14% of patients, respectively, and with 74% of patients being able to complete the maintenance dosage.
  
  
  CONCLUSIONS
  • The combination of BCG and IFNα-2B in the patient population with SBC has similar efficacy and toxicity to BCG monotherapy.
authors.affiliation: Section of Medical Oncology, King Faisal Specialist Hospital and Research Centre, Riyadh, Kingdom of Saudi Arabia.
authors.forename: Shouki
authors.initials: S
authors.lastname: Bazarbashi
authors.forename: Hussein
authors.initials: H
authors.lastname: Soudy
authors.forename: Mahmoud
authors.initials: M
authors.lastname: Abdelsalam
authors.forename: Ali
authors.initials: A
authors.lastname: Al-Jubran
authors.forename: Saad
authors.initials: S
authors.lastname: Akhtar
authors.forename: Muhammad
authors.initials: M
authors.lastname: Memon
authors.forename: Muhammad
authors.initials: M
authors.lastname: Aslam
authors.forename: Said
authors.initials: S
authors.lastname: Kattan
authors.forename: Mohamed
authors.initials: M
authors.lastname: Shoukri
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D001500:BCG Vaccine / Q000008:administration & dosage*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011994:Recombinant Proteins; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*
chemical_list: D000276:Adjuvants, Immunologic; D000970:Antineoplastic Agents; D001500:BCG Vaccine; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins