title: Prospective study of combined treatment with interferon-alpha and active vitamin D3 for Japanese patients with metastatic renal cell carcinoma.
abstract: OBJECTIVE
  To assess the safety and efficacy of combined therapy with interferon-alpha (INF-alpha) and active vitamin D(3) for metastatic renal cell carcinoma (RCC).
  
  
  METHODS
  Sixteen patients with metastatic RCC were enrolled in this prospective study. All received oral alfacalcidol (1 microg once daily) and INF-alpha (Sumiferon; 3 million units, three times a week). The primary endpoint was the response rate (defined as complete + partial remission). Secondary endpoints were cancer-specific survival and toxicity. The median follow-up period was 17 months (range: 5-49 months).
  
  
  RESULTS
  The median age of the patients was 68 years (range: 41-73 years). The sites of metastases were: lung in 13 patients, bone in one, lung and bone in one, and lung, bone, and lymph nodes in one. Four patients (25%) had a partial response (PR), 10 patients (62.5%) showed no change (NC), and two patients (12.5%) had progressive disease (PD). The median cancer-specific survival time was 45 months. One patient had to discontinue vitamin D(3) because of hypercalcemia. Kaplan-Meier survival analysis revealed that metastasis at the time of initial diagnosis and older than average age were significant predictors of poor survival (P < 0.05).
  
  
  CONCLUSIONS
  Combined treatment with INF-alpha and active vitamin D(3) has shown to be safe and effective for metastatic RCC patients.
authors.affiliation: Departments of Urology, Iwate Medical University School of Medicine, Morioka, Iwate, Japan.
authors.forename: Wataru
authors.initials: W
authors.lastname: Obara
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Mizutani
authors.forename: Chikara
authors.initials: C
authors.lastname: Oyama
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Akaza
authors.forename: Nobuhisa
authors.initials: N
authors.lastname: Ishii
authors.forename: Kenjiro
authors.initials: K
authors.lastname: Kohri
authors.forename: Mikio
authors.initials: M
authors.lastname: Namiki
authors.forename: Akihiko
authors.initials: A
authors.lastname: Okuyama
authors.forename: Hiroki
authors.initials: H
authors.lastname: Shima
authors.forename: Masayoshi
authors.initials: M
authors.lastname: Yokoyama
authors.forename: Taro
authors.initials: T
authors.lastname: Shuin
authors.forename: Tsuneharu
authors.initials: T
authors.lastname: Miki
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Watanabe
authors.forename: Tomoaki
authors.initials: T
authors.lastname: Fujioka
mesh_terms: D000328:Adult; D000368:Aged; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000556:secondary*; D002762:Cholecalciferol / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D014815:Vitamins / Q000627:therapeutic use*
chemical_list: D016898:Interferon-alpha; D014815:Vitamins; D002762:Cholecalciferol