伊匹单抗治疗肢端黑色素瘤的临床活性：一项回顾性研究。
Clinical Activity of Ipilimumab in Acral Melanoma: A Retrospective Review.
作者信息
Johnson Douglas B, Peng Chengwei, Abramson Richard G, Ye Fei, Zhao Shilin, Wolchok Jedd D, Sosman Jeffrey A, Carvajal Richard D, Ariyan Charlotte E
机构信息
Department of Medicine, School of Medicine, Department of Radiology, Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA; Departments of Medicine and Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA; Department of Medicine, Columbia University Medical Center, New York, New York, USA
Department of Medicine, School of Medicine, Department of Radiology, Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA; Departments of Medicine and Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA; Department of Medicine, Columbia University Medical Center, New York, New York, USA.
出版信息
Oncologist. 2015 Jun;20(6):648-52. doi: 10.1634/theoncologist.2014-0468. Epub 2015 May 11.
BACKGROUND
Ipilimumab improves overall survival (OS) in advanced melanoma. Acral melanoma is an uncommon clinical subtype of this disease associated with poor prognosis. The clinical activity of ipilimumab has not been well-defined in advanced acral melanoma.
METHODS
We retrospectively reviewed the demographics, treatment history, and clinical outcomes for all patients with acral melanoma treated with ipilimumab from two academic centers between February 2006 and June 2013. Using Cox proportional hazards models, we assessed for factors that correlated with OS.
RESULTS
A total of 35 patients with acral melanoma received ipilimumab. Melanomas arose on volar surfaces (n = 28) and subungual sites (n = 7); stage M1c disease was present in 54%, and 45% had elevated serum lactate dehydrogenase (LDH). Best response by RECIST 1.1 criteria was complete response in 1 patient, partial response in 3, and stable disease (SD) in 4 for an objective response rate (ORR) of 11.4% and a clinical benefit rate (ORR + SD) at 24 weeks of 22.9%. Median progression-free survival was 2.5 months (95% confidence interval [CI]: 2.3-2.7 months); median OS was 16.7 months (95% CI: 10.9-22.5 months). Normal LDH and absolute lymphocyte count ≥1,000 at 7 weeks predicted longer OS. Immune-related adverse events (irAEs) were noted in 16 patients including 7 with grade 3/4 irAEs (20%).
CONCLUSION
Ipilimumab is clinically active in acral melanoma with similar ORR and OS compared with unselected melanoma populations. Ipilimumab remains a viable therapeutic option for patients with advanced acral melanoma.
IMPLICATIONS FOR PRACTICE
Ipilimumab is a commonly used immune therapy that improves survival in metastatic melanoma. The clinical activity of ipilimumab in certain rare melanoma subtypes, such as uveal or mucosal melanomas, is suboptimal. Acral melanoma is another unusual subtype of this disease that arises on the palms, soles, and nailbeds. In this study of 35 patients with acral melanoma from 2 centers, ipilimumab was found to have activity that appears equivalent to unselected melanoma (response rate of 11.4%, median overall survival of 16.7 months). Ipilimumab remains a viable treatment option for this melanoma subpopulation.
背景
伊匹单抗可改善晚期黑色素瘤的总生存期（OS）。肢端黑色素瘤是该疾病的一种罕见临床亚型，预后较差。伊匹单抗在晚期肢端黑色素瘤中的临床活性尚未明确。
方法
我们回顾性分析了2006年2月至2013年6月期间在两个学术中心接受伊匹单抗治疗的所有肢端黑色素瘤患者的人口统计学资料、治疗史和临床结局。使用Cox比例风险模型，我们评估了与总生存期相关的因素。
结果
共有35例肢端黑色素瘤患者接受了伊匹单抗治疗。黑色素瘤发生于手掌（n = 28）和甲下部位（n = 7）；54%为M1c期疾病，45%的患者血清乳酸脱氢酶（LDH）升高。根据RECIST 1.1标准，最佳反应为1例患者完全缓解，3例部分缓解，4例疾病稳定（SD），客观缓解率（ORR）为11.4%，24周时的临床获益率（ORR + SD）为22.9%。中位无进展生存期为2.5个月（95%置信区间[CI]：2.3 - 2.7个月）；中位总生存期为16.7个月（95% CI：10.9 - 22.5个月）。7周时LDH正常且绝对淋巴细胞计数≥1000预测总生存期更长。16例患者出现免疫相关不良事件（irAEs），其中7例为3/4级irAEs（20%）。
结论
伊匹单抗在肢端黑色素瘤中具有临床活性，与未选择的黑色素瘤人群相比，ORR和OS相似。伊匹单抗仍然是晚期肢端黑色素瘤患者的一种可行治疗选择。
对实践的启示
伊匹单抗是一种常用的免疫疗法，可改善转移性黑色素瘤的生存期。伊匹单抗在某些罕见黑色素瘤亚型（如葡萄膜或黏膜黑色素瘤）中的临床活性欠佳。肢端黑色素瘤是该疾病的另一种不寻常亚型，发生于手掌、足底和甲床。在这项对来自2个中心的35例肢端黑色素瘤患者的研究中，发现伊匹单抗具有与未选择的黑色素瘤相当的活性（缓解率为11.4%，中位总生存期为16.7个月）。伊匹单抗仍然是这一黑色素瘤亚群的一种可行治疗选择。
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