title: Long-term survival of high-risk melanoma patients immunized with a Hyper-IL-6-modified allogeneic whole-cell vaccine after complete resection.
abstract: OBJECTIVE
  Two single arm, Phase II trials (3 and 5) were undertaken to determine the efficacy and toxicity of an adjuvant treatment using Hyper-IL-6 gene-modified whole-cell allogeneic melanoma vaccine in patients with stage IIIB-IV resected disease.
  
  
  METHODS
  Ninety-seven and 99 patients were enrolled into Trials 3 and 5, respectively. The primary endpoint was disease-free survival (DFS), and the secondary was overall survival (OS). Vaccine was administered eight times every 2 weeks (induction), every month (maintenance) until patient's death. At progression, maintenance was continued or induction was repeated followed by maintenance.
  
  
  RESULTS
  Median follow-up was 10.5 and 6.2 years for Trials 3 and 5, respectively. No grade 3 or 4 toxicities were observed. An extension of DFS and OS was observed, when compared with historical non-treated controls. DFS probability at 5 years for Trials 3 and 5 was, respectively, 54.8% and 40.6% for stage IIIB, 25.0% and 24.0% for IIIC, and 8.5% and 17.7% for IV. OS probability at 5 years was, respectively, 66.7% and 56.3% for IIIB, 43.8% and 39.8% for IIIC, and 26.1% and 41.2% for IV.
  
  
  CONCLUSIONS
  Continuous vaccination, regardless of the disease progression, re-induction, and immunization of patients until death resulted in patients a long-term survival.
authors.affiliation: University of Medical Sciences in Poznan, Chair of Medical Biotechnology, Poznan, Poland. andrzej.mackiewicz@wco.pl
authors.forename: Andrzej
authors.initials: A
authors.lastname: Mackiewicz
authors.forename: Jacek
authors.initials: J
authors.lastname: Mackiewicz
authors.forename: Piotr J
authors.initials: PJ
authors.lastname: Wysocki
authors.forename: Maciej
authors.initials: M
authors.lastname: Wiznerowicz
authors.forename: Malgorzata
authors.initials: M
authors.lastname: Kapcinska
authors.forename: Maria
authors.initials: M
authors.lastname: Laciak
authors.forename: Stefan
authors.initials: S
authors.lastname: Rose-John
authors.forename: Dariusz
authors.initials: D
authors.lastname: Izycki
authors.forename: Tomasz
authors.initials: T
authors.lastname: Burzykowski
authors.forename: Aldona
authors.initials: A
authors.lastname: Karczewska-Dzionk
mesh_terms: D000328:Adult; D019496:Cancer Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015850:Interleukin-6 / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D008297:Male; D008545:Melanoma / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D008875:Middle Aged; D009367:Neoplasm Staging; D012878:Skin Neoplasms / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D019496:Cancer Vaccines; D015850:Interleukin-6