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阿维鲁单抗:在转移性 Merkel 细胞癌中的应用评价。

Avelumab: A Review of Its Application in Metastatic Merkel Cell Carcinoma.

机构信息

1 The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

出版信息

Ann Pharmacother. 2018 Sep;52(9):928-935. doi: 10.1177/1060028018768809. Epub 2018 Apr 4.

Abstract

OBJECTIVE

To summarize the clinical development of avelumab and its clinical relevance in metastatic Merkel cell carcinoma (MCC).

DATA SOURCES

An English-language literature search using PubMed was performed using the terms avelumab, anti-PD-1, anti-PD-L1, and MCC from January of 1950 to March 2018. Data were also obtained from package inserts, meeting abstracts, and clinical registries.

STUDY SELECTION/DATA EXTRACTION: All relevant published articles of avelumab were reviewed. Clinical trial registries and meeting abstracts were used for information about ongoing trials.

DATA SYNTHESIS

Avelumab is a fully human monoclonal antibody that inhibits programmed death ligand-1, which reverses T-cell exhaustion and induces antitumor responses. Avelumab is safe and effective in previously treated metastatic MCC based on a phase II trial of previously treated patients with objective response rates in 28 of 88 patients, including 10 complete responses and 19 partial responses. Median overall survival (OS) was 12.9 months, and 1-year progression-free survival and OS were 30% and 52%, respectively. Grade 3 treatment-related side effects included lymphopenia (2 patients), serum creatine phosphokinase increase (1 patient), aminotransferase elevation (1 patient), and serum cholesterol increase (1 patient). Relevance to Patient Care and Clinical Practice: This review outlines the pharmacology and clinical trial data for avelumab in metastatic MCC and guides clinicians on avelumab's place in therapy.

CONCLUSIONS

Avelumab is the first Food and Drug Administration-approved medication for metastatic MCC and provides an advantage of durable responses and possibly improved tolerability compared with traditional platinum-based chemotherapy. Clinical trials are under way to expand its utility into the adjuvant and frontline settings.

摘要

目的

总结avelumab 的临床开发及其在转移性 Merkel 细胞癌(MCC)中的临床相关性。

资料来源

通过使用术语avelumab、抗 PD-1、抗 PD-L1 和 MCC 对 1950 年 1 月至 2018 年 3 月的 PubMed 进行了英语文献检索。还从包装说明书、会议摘要和临床注册处获取了数据。

研究选择/数据提取:对所有相关的 avelumab 已发表文章进行了综述。临床试验注册处和会议摘要用于获取正在进行的试验信息。

数据综合

avelumab 是一种完全人源化单克隆抗体,可抑制程序性死亡配体-1,从而逆转 T 细胞衰竭并诱导抗肿瘤反应。基于对先前接受过治疗的转移性 MCC 患者的 II 期临床试验,avelumab 在先前接受过治疗的患者中是安全且有效的,88 例患者中有 28 例客观缓解率,包括 10 例完全缓解和 19 例部分缓解。中位总生存期(OS)为 12.9 个月,1 年无进展生存期和 OS 分别为 30%和 52%。3 级治疗相关不良反应包括淋巴细胞减少症(2 例)、血清肌酸磷酸激酶升高(1 例)、转氨酶升高(1 例)和血清胆固醇升高(1 例)。

与患者护理和临床实践的相关性

本综述概述了 avelumab 在转移性 MCC 中的药理学和临床试验数据,并指导临床医生将 avelumab 用于治疗。

结论

avelumab 是 FDA 批准用于转移性 MCC 的第一种药物,与传统铂类化疗相比,它具有持久缓解和可能改善耐受性的优势。正在进行临床试验以扩大其在辅助和一线治疗中的应用。

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