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nivolumab

肿瘤

关键词肿瘤 药物 疾病治疗

词汇介绍

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解析

Nivolumab 

       n. 纳武单抗;单抗;抗体;药物

       He emphasized not to "get stuck at the median, because the median will not give you the full benefit of nivolumab therapy. " 他强调不要“停留在中位数,因为中位数不会提供给你纳武单抗治疗的所有效益”。

概述

纳武单抗商品名为OPDIVO,是百时美施贵宝公司研发的一种抗PD-1的单克隆抗体,通过阻断PD-1与其配体PDL-1/2的结合从而恢复T细胞的抗肿瘤效果。2014年12月,美国FDA加速批准Opdivo用于治疗无法手术切除或已出现转移且对其它药物无应答的晚期黑色素瘤。2015年3月、10月:FDA相继批准Opdivo用于治疗铂化疗后依然进展的转移性鳞状非小细胞肺癌,和转移性非鳞状非小细胞肺癌(包括腺癌)。2015年9月:FDA批准Opdivo用于治疗潜在的晚期或转移性肾细胞癌。2016年5月

Identification of the optimal combination dosing schedule of neoadjuvant ipilimumab plus nivolumab in macroscopic stage III melanoma (OpACIN-neo): a multicentre, phase 2, randomised, controlled trial复制标题

确定新辅助ipilimumab联合nivolumab治疗宏观III期黑色素瘤 (OpACIN-neo) 的最佳组合给药方案: 一项多中心、2期、随机、对照试验

发表时间:2019-07-01

影响因子:35.4

作者: Elisa A Rozeman

期刊:Lancet Oncol.

OpACIN-neo is a multicentre, open-label, phase 2, randomised, controlled trial. Eligible patients were aged at least 18 years, had a WHO performance status of 0-1, had resectable stage III melanoma involving lymph nodes only, and measurable disease according to the Response Evaluation Criteria in Solid Tumors version 1.1. Patients were enrolled from three medical centres in Australia, Sweden, and the Netherlands, and were randomly assigned (1:1:1), stratified by site, to one of three neoadjuvant dosing schedules: group A, two cycles of ipilimumab 3 mg/kg plus nivolumab 1 mg/kg once every 3 weeks intravenously; group B, two cycles of ipilimumab 1 mg/kg plus nivolumab 3 mg/kg once every 3 weeks intravenously; or group C, two cycles of ipilimumab 3 mg/kg once every 3 weeks directly followed by two cycles of nivolumab 3 mg/kg once every 2 weeks intravenously. The investigators, site staff, and patients were aware of the treatment assignment during the study participation. Pathologists were masked to treatment allocation and all other data.

译文

OpACIN-neo是一项多中心,开放标签,2期随机对照试验。符合条件的患者年龄至少为18岁,WHO表现状态为0-1,可切除的III期黑色素瘤仅涉及淋巴结,根据实体肿瘤1.1版的反应评估标准可测量疾病。患者来自澳大利亚,瑞典和荷兰的三个医疗中心,随机分配(1:1:1),按部位分层,分为三个新辅助治疗方案之一:A组,两个周期的ipilimumab 3 mg /每3周静脉注射一次kg加nivolumab 1 mg / kg; B组,每3周静脉注射2次ipilimumab 1 mg / kg加nivolumab 3 mg / kg;或C组,每3周一次2次ipilimumab 3 mg / kg,然后每2周静脉注射2次nivolumab 3 mg / kg。研究人员,现场工作人员和患者在参与研究期间了解治疗任务。病理学家被掩盖了治疗分配和所有其他数据。