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

Robert H I Andtbacka; Sanjiv S Agarwala; David W Ollila; Sigrun Hallmeyer; Mohammed Milhem; Thomas Amatruda; John J Nemunaitis; Kevin J Harrington; Lisa Chen; Mark Shilkrut; Merrick Ross; Howard L Kaufman

doi:10.1002/hed.24522

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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

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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

Robert H I Andtbacka, Sanjiv S Agarwala, David W Ollila, Sigrun Hallmeyer, Mohammed Milhem, Thomas Amatruda, John J Nemunaitis, Kevin J Harrington, Lisa Chen, Mark Shilkrut, …

Head & neck, Vol.38(12), pp.1752-1758

12/2016

DOI: 10.1002/hed.24522

PMCID: PMC5129499

PMID: 27407058

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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.

Multivariate Analysis

Prognosis

Humans

Middle Aged

Male

Granulocyte-Macrophage Colony-Stimulating Factor - therapeutic use

Injections, Intralesional

Neoplasm Invasiveness - pathology

Skin Neoplasms - mortality

Adult

Female

Skin Neoplasms - pathology

Skin Neoplasms - therapy

Head and Neck Neoplasms - therapy

Kaplan-Meier Estimate

Proportional Hazards Models

Treatment Outcome

Melanoma - pathology

Head and Neck Neoplasms - pathology

Disease-Free Survival

Oncolytic Virotherapy - methods

Survival Analysis

Aged

Head and Neck Neoplasms - mortality

Melanoma - therapy

Neoplasm Staging

Melanoma - mortality

Details

Title: Subtitle: 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
Creators: Robert H I Andtbacka - University of Utah Huntsman Cancer Institute, Salt Lake City, Utah
Sanjiv S Agarwala - St. Luke's University Hospital and Temple University, Philadelphia, Pennsylvania
David W Ollila - University of North Carolina, Chapel Hill, North Carolina
Sigrun Hallmeyer - Advocate Lutheran General Hospital, Park Ridge, Illinois
Mohammed Milhem - University of Iowa Hospitals and Clinics, Iowa City, Iowa
Thomas Amatruda - Minnesota Oncology, Fridley, Minnesota
John J Nemunaitis - Mary Crowley Cancer Research Center, Dallas, Texas
Kevin J Harrington - The Institute of Cancer Research/The Royal Marsden Hospital, London, UK
Lisa Chen - Amgen, Inc, Thousand Oaks, California
Mark Shilkrut - Amgen, Inc, Thousand Oaks, California
Merrick Ross - The University of Texas MD Anderson Cancer Center, Houston, Texas
Howard L Kaufman - Rutgers Cancer Institute of New Jersey, Rutgers, New Jersey
Resource Type: Journal article
Publication Details: Head & neck, Vol.38(12), pp.1752-1758
DOI: 10.1002/hed.24522
PMID: 27407058
PMCID: PMC5129499
NLM abbreviation: Head Neck
ISSN: 1043-3074
eISSN: 1097-0347
Grant note: P30 CA086862 / NCI NIH HHS
Language: English
Date published: 12/2016
Academic Unit: Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
Record Identifier: 9984094345602771

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