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
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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DOI：
10.1002/hed.24522
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发表时间：
2016-12-01
影响因子：
2.9
通讯作者：
Kaufman, Howard L.
中科院分区：
文献类型：
--
作者：
Andtbacka, Robert H. I.;Agarwala, Sanjiv S.;Kaufman, Howard L.
背景皮肤头颈部黑色素瘤的结果较差，治疗选择有限。在OPTiM中，一项在不可切除的IIIB/IIIC/IV期黑色素瘤患者中进行的3期研究，与皮下注射粒细胞-巨噬细胞集落刺激因子（GM-CSF）相比，病灶内注射溶瘤病毒Talimogene Laherparepvec可提高持久缓解率（DRR;持续缓解≥ 6个月）。OPTIM的回顾性审查确定了接受拉他莫基（n = 61）或GMCSF（n = 26）治疗的皮肤头颈部黑色素瘤患者。比较拉他莫基与GM-CSF治疗头颈部皮肤黑色素瘤的疗效。拉他莫基治疗患者的DRR高于GM-CSF治疗患者（36.1% vs 3.8%; p = .001）。总共有29.5%的患者使用拉他莫基完全缓解，而GM-CSF完全缓解率为0%。在接受拉他莫基治疗的患者中，12个月后仍有反应的概率为73%。GM-CSF组的中位总生存期（OS）为25.2个月，拉他莫基组尚未达到。与GM-CSF相比，Talimogene Laherparepvec治疗与改善头颈部皮肤黑色素瘤患者的反应和生存相关。(C)2016年《The Authors Head & Neck》由Wiley Periodicals，Inc.出版。
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 GMCSF (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. (C) 2016 The Authors Head & Neck Published by Wiley Periodicals, Inc.