title: Randomized controlled study of natural interferon α as adjuvant treatment for stage II or III renal cell carcinoma.
abstract: BACKGROUND
  The prophylactic effect of postoperative interferon on recurrence and distant metastasis in stage II or III renal cell carcinoma is unclear. In most studies, interferon has been administered for 6 months or less. Therefore, we performed a clinical study of the efficacy of 1-year postoperative administration of natural interferon α, which is generally used in Japan.
  
  
  METHODS
  The subjects were patients diagnosed with stage II or III renal cell carcinoma who underwent radical nephrectomy. The subjects were randomly allocated to receive an intramuscular injection of natural interferon α (3 million to 6 million units) 3 times a week for 1 year or to receive follow-up observation until recurrence or metastasis occurred. Chest and abdominal CT were performed once yearly for all patients. The primary endpoint was progression-free survival.
  
  
  RESULTS
  From September 2001 to August 2006, a total of 107 patients were registered, but 7 subsequently withdrew from the study. Therefore, 100 patients were included in the analysis. The primary endpoint of progression-free survival did not differ significantly between the groups that received natural interferon α or follow-up observation (p = 0.456, log-rank test). However, peak hazards of progression in the interferon group were delayed for about 6-10 months compared with the observation group.
  
  
  CONCLUSIONS
  Progression-free survival showed no improvement after administration of natural interferon α to patients with stage II or III renal cell carcinoma for 1 year after radical nephrectomy. The peak hazards of progression might be delayed by about 6 months by interferon administration.
authors: Department of Pharmacoepidemiology, Kyoto University, Kyoto, Japan.
authors: Shiro
authors: S
authors: Hinotsu
authors: Koji
authors: K
authors: Kawai
authors: Seiichiro
authors: S
authors: Ozono
authors: Tomoyasu
authors: T
authors: Tsushima
authors: Noriaki
authors: N
authors: Tokuda
authors: Koichiro
authors: K
authors: Nomata
authors: Seiji
authors: S
authors: Naito
authors: Hideyuki
authors: H
authors: Akaza
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D007564:Japan; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000188:drug therapy / Q000473:pathology; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D009367:Neoplasm Staging; D009392:Nephrectomy; D011994:Recombinant Proteins / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D020533:Angiogenesis Inhibitors; D016898:Interferon-alpha; D011994:Recombinant Proteins