title: Cutaneous head and neck melanoma in OPTiM, a randomized phase 3 trial of talimogene laherparepvec versus granulocyte-macrophage colony-stimulating factor for the treatment of unresected stage IIIB/IIIC/IV melanoma.
abstract: Cutaneous head and neck melanoma has poor outcomes and limited treatment options. In OPTiM, a phase 3 study in patients with unresectable stage IIIB/IIIC/IV melanoma, intralesional administration of the oncolytic virus talimogene laherparepvec improved durable response rate (DRR; continuous response ≥6 months) compared with subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF).
  
  
  
  Retrospective review of OPTiM identified patients with cutaneous head and neck melanoma given talimogene laherparepvec (n = 61) or GM-CSF (n = 26). Outcomes were compared between talimogene laherparepvec and GM-CSF treated patients with cutaneous head and neck melanoma.
  
  
  
  DRR was higher for talimogene laherparepvec-treated patients than for GM-CSF treated patients (36.1% vs 3.8%; p = .001). A total of 29.5% of patients had a complete response with talimogene laherparepvec versus 0% with GM-CSF. Among talimogene laherparepvec-treated patients with a response, the probability of still being in response after 12 months was 73%. Median overall survival (OS) was 25.2 months for GM-CSF and had not been reached with talimogene laherparepvec.
  
  
  
  Treatment with talimogene laherparepvec was associated with improved response and survival compared with GM-CSF in patients with cutaneous head and neck melanoma. © 2016 Wiley Periodicals, Inc. Head Neck 38: 1752-1758, 2016.
authors.affiliation: University of Utah Huntsman Cancer Institute, Salt Lake City, Utah.
authors.forename: Robert H I
authors.initials: RH
authors.lastname: Andtbacka
authors.affiliation: St. Luke's University Hospital and Temple University, Philadelphia, Pennsylvania.
authors.forename: Sanjiv S
authors.initials: SS
authors.lastname: Agarwala
authors.affiliation: University of North Carolina, Chapel Hill, North Carolina.
authors.forename: David W
authors.initials: DW
authors.lastname: Ollila
authors.affiliation: Advocate Lutheran General Hospital, Park Ridge, Illinois.
authors.forename: Sigrun
authors.initials: S
authors.lastname: Hallmeyer
authors.affiliation: University of Iowa Hospitals and Clinics, Iowa City, Iowa.
authors.forename: Mohammed
authors.initials: M
authors.lastname: Milhem
authors.affiliation: Minnesota Oncology, Fridley, Minnesota.
authors.forename: Thomas
authors.initials: T
authors.lastname: Amatruda
authors.affiliation: Mary Crowley Cancer Research Center, Dallas, Texas.
authors.forename: John J
authors.initials: JJ
authors.lastname: Nemunaitis
authors.affiliation: The Institute of Cancer Research/The Royal Marsden Hospital, London, UK.
authors.forename: Kevin J
authors.initials: KJ
authors.lastname: Harrington
authors.affiliation: Amgen, Inc, Thousand Oaks, California.
authors.forename: Lisa
authors.initials: L
authors.lastname: Chen
authors.affiliation: Amgen, Inc, Thousand Oaks, California.
authors.forename: Mark
authors.initials: M
authors.lastname: Shilkrut
authors.affiliation: The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Merrick
authors.initials: M
authors.lastname: Ross
authors.affiliation: Rutgers Cancer Institute of New Jersey, Rutgers, New Jersey.
authors.forename: Howard L
authors.initials: HL
authors.lastname: Kaufman
mesh_terms: D000328:Adult; D000368:Aged; D018572:Disease-Free Survival; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000627:therapeutic use*; D006258:Head and Neck Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D006801:Humans; D015552:Injections, Intralesional; D053208:Kaplan-Meier Estimate; D008297:Male; D008545:Melanoma / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D008875:Middle Aged; D015999:Multivariate Analysis; D009361:Neoplasm Invasiveness / Q000473:pathology; D009367:Neoplasm Staging; D050130:Oncolytic Virotherapy / Q000379:methods*; D011379:Prognosis; D016016:Proportional Hazards Models; D012878:Skin Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D016178:Granulocyte-Macrophage Colony-Stimulating Factor
keywords: cancer immunotherapy; cutaneous head and neck melanoma; oncolytic virus; talimogene laherparepvec