title: Treatment of metastatic melanoma using interleukin-2 alone or in conjunction with vaccines.
abstract: OBJECTIVE
  To identify prognostic factors associated with survival beyond 4 years and overall response in patients with metastatic melanoma treated with high-dose bolus i.v. interleukin-2 (IL-2) given either alone or in combination with a variety of melanoma vaccines.
  
  
  METHODS
  684 consecutive patients with metastatic melanoma received high-dose bolus i.v. IL-2 either alone or in conjunction with a variety of melanoma vaccines. Treatments occurred between August 1, 1985 and January 1, 2006.
  
  
  RESULTS
  The overall objective response rate was 13% for patients receiving IL-2 alone and 16% for patients who received IL-2 with vaccine. In patients treated with IL-2 alone (n=305) and IL-2 with vaccine (n=379), having an objective response was associated with survival beyond 4 years (P<0.0001). No pretreatment factors could be identified that were strongly associated with increased rate of objective response or long-term survival in patients receiving IL-2 alone. In patients receiving IL-2 with vaccines, there were increased response rates in patients with s.c. or cutaneous disease only and lower response rates with visceral disease only. Patients who received the gp100:209-217(210M) peptide plus IL-2 showed a strong trend to increased objective responses compared with IL-2 alone (22% versus 12.8%; P=0.01) and also compared with patients who received a variety of vaccines that did not include this immunogenic peptide (13.8%; P=0.009).
  
  
  CONCLUSIONS
  IL-2 can produce a modest response rate in patients with metastatic melanoma including patients with durable complete responses. S.c. or cutaneous disease only and vaccination with gp100:209-217(210M) peptide was associated with significant increase in response rates.
authors.affiliation: Surgery Branch, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland 20892-1201, USA. franz_smith@nih.gov
authors.forename: Franz O
authors.initials: FO
authors.lastname: Smith
authors.forename: Stephanie G
authors.initials: SG
authors.lastname: Downey
authors.forename: Jacob A
authors.initials: JA
authors.lastname: Klapper
authors.forename: James C
authors.initials: JC
authors.lastname: Yang
authors.forename: Richard M
authors.initials: RM
authors.lastname: Sherry
authors.forename: Richard E
authors.initials: RE
authors.lastname: Royal
authors.forename: Udai S
authors.initials: US
authors.lastname: Kammula
authors.forename: Marybeth S
authors.initials: MS
authors.lastname: Hughes
authors.forename: Nicholas P
authors.initials: NP
authors.lastname: Restifo
authors.forename: Catherine L
authors.initials: CL
authors.lastname: Levy
authors.forename: Donald E
authors.initials: DE
authors.lastname: White
authors.forename: Seth M
authors.initials: SM
authors.lastname: Steinberg
authors.forename: Steven A
authors.initials: SA
authors.lastname: Rosenberg