title: Chronically administered immunotherapy with low-dose IL-2 and IFN-alpha in metastatic renal cell carcinoma: a feasible option for patients with a good prognostic profile.
abstract: OBJECTIVE
  We report the results obtained using an original immunotherapy schedule featuring chronically administered low-dose interleukin-2 (IL-2) and interferon-alpha (IFN-alpha) in patients with metastatic renal cell carcinoma (mRCC), and we assess treatment efficacy according to the patients' prognostic profiles.
  
  
  METHODS
  138 consecutive patients were enrolled, and received IL-2 (1 million IU/m(2)) subcutaneously twice daily on days 1 and 2, and once daily on days 3-5 of each week, and IFN-alpha (1.8 million IU/m(2)) intramuscularly once daily on days 3 and 5. Each cycle consisted of 4 consecutive weeks and was repeated indefinitely at 4-month intervals regardless of response. The patients' baseline risk profile was assessed using Negrier's stratification system.
  
  
  RESULTS
  The overall response rate was 10.9% (95% CI 6.7-17.2), and median overall survival was 19.6 months (95% CI 14.2-28.2). Treatment-related toxicity was mostly WHO grade 2 or below. Survival in the low-, intermediate- and high-risk groups was significantly different (p for trend <0.001), with low-risk patients having a median survival of 65.1 months (95% CI 42.7-84.2).
  
  
  CONCLUSIONS
  Chronically administered low-dose IL-2 and IFN-alpha may be a safe and effective option for low-risk mRCC patients.
authors.affiliation: Department of Clinical Medicine, Nephrology and Health Science, University of Parma, Parma, Italy. augusto.vaglio@virgilio.it
authors.forename: Augusto
authors.initials: A
authors.lastname: Vaglio
authors.forename: Federico
authors.initials: F
authors.lastname: Alberici
authors.forename: Umberto
authors.initials: U
authors.lastname: Maggiore
authors.forename: Sebastiano
authors.initials: S
authors.lastname: Buti
authors.forename: Domenico
authors.initials: D
authors.lastname: Potenzoni
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Passalacqua
authors.forename: Carlo
authors.initials: C
authors.lastname: Buzio
mesh_terms: D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000276:immunology* / Q000473:pathology / Q000601:surgery; D003131:Combined Modality Therapy; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D007376:Interleukin-2 / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000276:immunology* / Q000473:pathology / Q000601:surgery; D009367:Neoplasm Staging; D011379:Prognosis; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D016898:Interferon-alpha; D007376:Interleukin-2