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ipilimumab

肿瘤

关键词肿瘤 药物 基础研究

词汇介绍

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解析

Ipilimumab 

       n. 伊匹单抗

       Neoadjuvant treatment with ipilimumab plus nivolumab at the standard dosing schedule induced pathological responses in a high proportion of patients in two small independent early-phase trials, and no patients with a pathological response have relapsed after a median follow up of 32 months. 伊匹单抗联合纳武单抗在标准剂量表下的新辅助治疗在早期两个独立的小型试验结果显示,标准给药方案下新辅助疗法可诱导高比例的患者病理反应,并且在中位随访32个月后,没有病理反应患者复发。

概述

伊匹单抗又叫易普利姆玛,是百时美施贵宝研发的一款免疫检查点抑制剂和单克隆抗体,于2011年3月25日美国FDA批准可用于治疗晚期黑色素瘤。用药方法是静脉注射给药,观察输液反应。治疗时间方面,持续给药直到疾病恶化或出现不可接受的毒性。目前其适应症已经扩展为III期黑色素瘤患者、转移性结直肠癌患者以及晚期肾细胞癌患者,具体来说包括:不可切除或转移性黑色素瘤的成人及儿童患者(12岁及以上);牵涉到局部淋巴结大于1 mm的皮肤黑色素瘤,在完全切除(包括全淋巴结切除术)后的辅助治疗;与niv

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:2019-05-31

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. The primary endpoints were the proportion of patients with grade 3-4 immune-related toxicity within the first 12 weeks and the proportion of patients achieving a radiological objective response and pathological response at 6 weeks.

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。主要终点是前12周内3-4级免疫相关毒性患者的比例,以及6周时达到放射学客观反应和病理反应的患者比例。