title: Long-term outcomes of helper peptide vaccination for metastatic melanoma.
abstract: OBJECTIVE
  The objective of this study was to compare the long-term outcome of patients with metastatic melanoma vaccinated with 6MHP to that of a group of unvaccinated historical controls.
  
  
  BACKGROUND
  A multipeptide vaccine (6MHP), designed to induce helper T cells against melanocytic and cancer-testis antigens, has been shown to induce specific Th1-dominant CD4+ T cell responses.
  
  
  METHODS
  The 6MHP vaccine was administered to patients with metastatic melanoma. Circulating CD4+ T cell responses were measured by proliferation or direct IFN-gamma ELIspot assay. Overall survival of vaccinated patients was compared to a group of clinically comparable historical controls using multivariable Cox regression analysis and Kaplan-Meier survival analysis, taking into account age, metastatic site, and resection status.
  
  
  RESULTS
  Across 40 vaccinated patients and 87 controls, resection status (HR 0.54, P = 0.004) and vaccination (HR 0.24, P < 0.001) were associated with improved overall survival. Forty pairs of vaccinated patients and controls were matched by metastatic site, resection status, and age within 10 years. Median survival was significantly longer for vaccinated patients (5.4 vs 1.3 years, P < 0.001). Among the vaccinated patients, the development of a specific immune response after vaccination was associated with improved survival (HR 0.35, P = 0.040).
  
  
  CONCLUSIONS
  Helper peptide vaccination is associated with improved overall survival among patients with metastatic melanoma. These data support a randomized prospective trial of the 6MHP vaccine.
authors.affiliation: From the Department of Surgery/Division of Surgical Oncology, University of Virginia School of Medicine, Charlottesville, VA.
authors.forename: Yinin
authors.initials: Y
authors.lastname: Hu
authors.forename: Helen
authors.initials: H
authors.lastname: Kim
authors.forename: Christopher M
authors.initials: CM
authors.lastname: Blackwell
authors.forename: Craig L
authors.initials: CL
authors.lastname: Slingluff
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D019496:Cancer Vaccines / Q000008:administration & dosage*; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008545:Melanoma / Q000276:immunology / Q000401:mortality* / Q000517:prevention & control*; D008875:Middle Aged; D009361:Neoplasm Invasiveness / Q000473:pathology; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012016:Reference Values; D018570:Risk Assessment; D012737:Sex Factors; D012878:Skin Neoplasms / Q000276:immunology / Q000401:mortality* / Q000517:prevention & control*; D016019:Survival Analysis; D006377:T-Lymphocytes, Helper-Inducer / Q000276:immunology*; D013997:Time Factors; D014481:United States; D014611:Vaccination / Q000379:methods
chemical_list: D019496:Cancer Vaccines