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

BACKGROUND:

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).

METHODS:

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.

RESULTS:

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.

CONCLUSION:

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: 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
• Journal: Head & neck (Head Neck) Vol. 38 Issue 12 Pg. 1752-1758 (12 2016) ISSN: 1097-0347 [Electronic] United States
• PMID: 27407058 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2016 The Authors Head & Neck Published by Wiley Periodicals, Inc.

Chemical References

• Granulocyte-Macrophage Colony-Stimulating Factor

Topics

• Adult
• Aged
• Disease-Free Survival
• Female
• Granulocyte-Macrophage Colony-Stimulating Factor (therapeutic use)
• Head and Neck Neoplasms (mortality, pathology, therapy)
• Humans
• Injections, Intralesional
• Kaplan-Meier Estimate
• Male
• Melanoma (mortality, pathology, therapy)
• Middle Aged
• Multivariate Analysis
• Neoplasm Invasiveness (pathology)
• Neoplasm Staging
• Oncolytic Virotherapy (methods)
• Prognosis
• Proportional Hazards Models
• Skin Neoplasms (mortality, pathology, therapy)
• Survival Analysis
• Treatment Outcome