title: Single-agent interleukin-2 in the treatment of metastatic melanoma: a systematic review.
abstract: BACKGROUND
  The aim of this systematic review was to determine the role of single-agent interleukin-2 in the treatment of adults with metastatic melanoma. Outcomes of interest include objective and complete response rates, duration of response, toxicity and quality of life.
  
  
  METHODS
  A systematic review of the literature was conducted to locate randomized controlled trials, meta-analyses, and systematic reviews published between 1985 and 2006.
  
  
  RESULTS
  Data from three randomized controlled trials demonstrate that single-agent interleukin-2, when given in high-doses, elicited objective response rates of 5-27% with complete responses in 0-4% of patients. High-dose interleukin-2, administered as a single-agent or in combination with lymphokine-activated killer cells, demonstrates complete response rates ranging from 0% to 11% and has shown consistent observations of long-term responses that range from 6 to 66+ months (median 27 months). Non-comparative phase II trials of high-dose single-agent interleukin-2 have consistently reported objective response rates of 10-33% with complete response rates ranging from 0% to 15%. Complete responders in those trials also demonstrate long-term responses ranging from 1.5 to 148 months (median 70 months). No other therapy for metastatic melanoma offers the possibility for a durable complete remission.
  
  
  CONCLUSIONS
  This systematic review suggests that patients with a good performance status (ECOG 0-1), a normal lactate dehydrogenase level, less than three organs involved or cutaneous and/or subcutaneous metastases, have the highest probability of responding and achieving a durable complete response. This carefully selected group of patients should be considered for treatment with high-dose interleukin-2.
authors.affiliation: Toronto Sunnybrook Regional Cancer Centre, 2075 Bayview Avenue, Toronto, Canada M4N 3M5. teresa.petrella@sw.ca
authors.forename: Teresa
authors.initials: T
authors.lastname: Petrella
authors.forename: Ian
authors.initials: I
authors.lastname: Quirt
authors.forename: Shailendra
authors.initials: S
authors.lastname: Verma
authors.forename: Adam E
authors.initials: AE
authors.lastname: Haynes
authors.forename: Manya
authors.initials: M
authors.lastname: Charette
authors.forename: Kate
authors.initials: K
authors.lastname: Bak
mesh_terms: D017322:Clinical Trials, Phase II as Topic; D006801:Humans; D007376:Interleukin-2 / Q000627:therapeutic use*; D015979:Killer Cells, Lymphokine-Activated / Q000276:immunology; D008545:Melanoma / Q000188:drug therapy* / Q000401:mortality / Q000523:psychology / Q000556:secondary; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic
chemical_list: D007376:Interleukin-2