title: Clinical outcome of combined immunotherapy with low-dose interleukin-2 and interferon-alpha for Japanese patients with metastatic renal cell carcinoma who had undergone radical nephrectomy: a preliminary report.
abstract: BACKGROUND
  The objective of this study was to evaluate the clinical outcome of combined immunotherapy with interferon-alpha (IFN-alpha) and low-dose interleukin-2 (IL-2) for Japanese patients with metastatic renal cell carcinoma (RCC) who had undergone radical nephrectomy.
  
  
  METHODS
  This study included 13 patients who were diagnosed as having metastatic RCC following radical nephrectomy. These patients received a subcutaneous injection of IFN-alpha (6 x 10(6) IU per day) three times per week and an intravenous injection of IL-2 (1.4 x 10(6) IU per day) twice per week. Tumor response was evaluated every 16 weeks, and as a rule, this weekly regimen was repeated 50 times in patients with evidence of objective response or stable disease.
  
  
  RESULTS
  One of the 13 patients dropped out because of severe toxicity; hence, 12 patients were evaluable, with a median follow-up period of 18 months after the start of this combined therapy. Six patients (50.0%) achieved objective responses, with 1 complete response (CR), while only 2 (16.7%) demonstrated progressive disease. The median duration of response in the 6 responders was 13.5 months. Toxicity associated with this combined immunotherapy was limited to WHO grade 1 or 2 in these 12 patients. All patients were alive at last follow-up, and 2 remain disease-free after 1 additional patient showed a CR following surgical resection of the remaining metastatic disease.
  
  
  CONCLUSIONS
  Our preliminary experience suggests that long-term, repeated treatment with IFN-alpha and low-dose IL-2 is feasible in Japanese patients with metastatic RCC who have undergone radical nephrectomy. Although it will be necessary to accumulate data from a larger number of patients with a longer follow-up period, the combined immunotherapy tested in this study may become the preferred therapy for Japanese patients with metastatic RCC.
authors.affiliation: Department of Urology, Hyogo Medical Center for Adults, 13-70 Kitaohji-cho, Akashi 673-8558, Japan. hideakimiyake@hotmail.com
authors.forename: Hideaki
authors.initials: H
authors.lastname: Miyake
authors.forename: Isao
authors.initials: I
authors.lastname: Hara
authors.forename: Iori
authors.initials: I
authors.lastname: Sakai
authors.forename: Ken-ichi
authors.initials: K
authors.lastname: Harada
authors.forename: Taka-aki
authors.initials: TA
authors.lastname: Inoue
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Eto
authors.forename: Yoshizumi
authors.initials: Y
authors.lastname: Takechi
authors.forename: Masato
authors.initials: M
authors.lastname: Fujisawa
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000556:secondary*; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D007279:Injections, Subcutaneous; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects; D007376:Interleukin-2 / Q000008:administration & dosage / Q000009:adverse effects; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D008297:Male; D008875:Middle Aged; D009392:Nephrectomy
chemical_list: D016898:Interferon-alpha; D007376:Interleukin-2