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雷莫芦单抗:治疗肝细胞癌的研究进展。

Ramucirumab: A Review in Hepatocellular Carcinoma.

机构信息

Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

出版信息

Drugs. 2020 Feb;80(3):315-322. doi: 10.1007/s40265-020-01263-6.

Abstract

Ramucirumab (Cyramza), a fully human anti-VEGFR-2 monoclonal antibody, has been approved as monotherapy for the treatment of patients with hepatocellular carcinoma (HCC) and α-fetoprotein levels ≥ 400 ng/mL who have been treated with sorafenib. Ramucirumab significantly prolonged overall survival (OS) and progression-free survival (PFS) relative to placebo in this population in the randomized, double-blind phase 3 REACH 2 trial. These benefits were seen in key prespecified subgroups based on demographic and disease characteristics. Ramucirumab had an acceptable tolerability profile and manageable safety profile in these patients, with the majority of treatment-related adverse events being mild or moderate in severity. The safety profile of ramucirumab was consistent with that expected for agents targeting the VEGF/VEGFR axis. Currently, ramucirumab is the only therapy specifically tested in patients with α-fetoprotein levels ≥ 400 ng/mL, which is associated with an aggressive disease and poor prognosis. Therefore, ramucirumab is an important treatment option for patients with HCC and α-fetoprotein levels ≥ 400 ng/mL who have been treated with sorafenib.

摘要

雷莫芦单抗(Cyramza)是一种完全人源化的抗血管内皮生长因子受体-2 单克隆抗体,已被批准用于治疗索拉非尼治疗后甲胎蛋白水平≥400ng/ml的肝细胞癌(HCC)患者的单药治疗。在这项随机、双盲的 3 期 REACH 2 试验中,雷莫芦单抗与安慰剂相比,显著延长了这一人群的总生存期(OS)和无进展生存期(PFS)。这些获益在基于人口统计学和疾病特征的关键预设亚组中可见。在这些患者中,雷莫芦单抗具有可接受的耐受性和可管理的安全性,大多数与治疗相关的不良事件为轻度或中度。雷莫芦单抗的安全性与靶向 VEGF/VEGFR 轴的药物一致。目前,雷莫芦单抗是唯一在甲胎蛋白水平≥400ng/ml的患者中经过专门测试的治疗方法,这些患者疾病侵袭性强,预后差。因此,雷莫芦单抗是索拉非尼治疗后甲胎蛋白水平≥400ng/ml的 HCC 患者的重要治疗选择。

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