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Efficacy and safety of sintilimab plus pemetrexed and platinum as first-line treatment for locally advanced or metastatic nonsquamous non-small cell lung cancer: a randomized, double-blind, phase 3 study (ORIENT-11).

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作者：
Yang Yunpeng[1] ; Wang Zhehai[2] ; Fang Jian[3] ; Yu Qitao[4] ; Han Baohui[5] ; Cang Shundong[6] ; Chen Gongyan[7] ; Mei Xiaodong[8] ; Yang Zhixiong[9] ; Ma Rui[10] ; Bi Minghong[11] ; Ren Xiubao[12] ; Zhou Jianying[13] ; Li Baolan[14] ; Song Yong[15] ; Feng Jifeng[16] ; Li Juan[17] ; He Zhiyong[18] ; Zhou Rui[19] ; Li Weimin[20] ; Lu You[21] ; Wang Yingyi[22] ; Wang Lijun[23] ; Yang Nong[24] ; Zhang Yan[25] ; Yu Zhuang[26] ; Zhao Yanqiu[27] ; Xie Conghua[28] ; Cheng Ying[29] ; Zhou Hui[30] ; Wang Shuyan[30] ; Zhu Donglei[30] ; Zhang Wen[31] ; Zhang Li[1,*1] ;
机构： [1]Medical Oncology Department, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine. [2]Medical Oncology Department, Shandong Cancer Hospital. [3]Department of Thoracic Oncology II, Peking University Cancer Hospital. [4]Department of Respiratory Oncology, Affiliated Tumor Hospital of Guangxi Medical University. [5]Department of Respiration, Shanghai Chest Hospital. [6]Department of Oncology, The Henan Province Hospital of Zhengzhou University. [7]Department of Respiration, Harbin Medical University Cancer Hospital. [8]Department of Respiration, Anhui Provincial Hospital. [9]Department of Oncology, Affiliated Hospital of Guangdong Medical University. [10]Medical Oncology Department of Thoracic Cancer, Liaoning Cancer Hospital. [11]Department of Oncology, The First Affiliated Hospital of Bengbu Medical College. [12]Department of Immunology, Tianjin Medical University Cancer Institute and Hospital. [13]Department of Respiratory Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University. [14]Department of Oncology, Beijing Chest Hospital, Capital Medical University. [15]Department of Respiratory and Critical Care Medicine, Jinling Hospital, The First School of Clinical Medicine, Southern Medical University. [16]Department of Medical Oncology, Jiangsu Cancer Hospital. [17]Department of Medical Oncology, Sichuan Cancer Hospital. [18]Department of Medical Oncology, Fujian Provincial Cancer Hospital. [19]Department of Respiration, Xiangya Second Hospital. [20]Department of Pulmonary and Critical Care Medicine, West China Hospital, Sichuan University. [21]Department of Thoracic Oncology, West China Hospital, Sichuan University. [22]Department of Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College. [23]Department of Tumor radiotherapy, The Second Affiliated Hospital of Xingtai Medical College. [24]Department of Medical Oncology, Lung Cancer and Gastrointestinal Unit, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine. [25]Department of Oncology IV, First Hospital of Shijiazhuang. [26]Department of Oncology, The Affiliated Hospital of Qingdao University. [27]Department of Internal Medicine, Affiliated Cancer Hospital of Zhengzhou University. [28]Department of Radiation and Medical Oncology, Zhongnan Hospital of Wuhan University. [29]Department of Medical Oncology, Jilin Cancer Hospital. [30]Medical science and strategy oncology, Innovent Biologics, Inc. [31]Department of Biostatistics and Information, Innovent Biologics, Inc.
出处：
DOI： 10.1016/j.jtho.2020.07.014
ISSN：

关键词： nonsquamous NSCLC Sintilimab Pemetrexed Platinum Phase III study

摘要：
Sintilimab, an anti-programmed death 1 antibody, plus pemetrexed and platinum had shown promising efficacy for nonsquamous non-small cell lung cancer in a phase 1b study. We conducted a randomized, double-blind, phase 3 study to compare the efficacy and safety of sintilimab with placebo, both in combination with such chemotherapy. (ClinicalTrials.gov: NCT03607539) METHODS: A total of 397 patients with previously untreated locally advanced or metastatic nonsquamous NSCLC without sensitizing epidermal growth factor receptor or anaplastic lymphoma kinase genomic aberration were randomized (2:1 ratio) to receive either sintilimab 200 mg or placebo plus pemetrexed and platinum Q3W for 4 cycles, followed by sintilimab or placebo plus pemetrexed therapy. Crossover or treatment beyond disease progression was allowed. The primary endpoint was progression-free survival (PFS) by independent radiographic review committee. As of Nov. 15, 2019, the median follow-up was 8.9 months. The median PFS was significantly longer in the sintilimab-combination group than that in the placebo-combination group (8.9 vs. 5.0 months; HR, 0.482, 95%CI, 0.362 to 0.643; p < 0.00001). The confirmed objective response rate was 51.9 % (95% CI, 45.7% to 58.0%) in sintilimab-combination group and 29.8% (95% CI, 22.1% to 38.4%) in placebo-combination group. The incidence of grade 3 or higher adverse events was 61.7% in sintilimab-combination group and 58.8% in placebo-combination group. In Chinese patients with previously untreated locally advanced or metastatic nonsquamous NSCLC, the addition of sintilimab to chemotherapy of pemetrexed and platinum resulted in significantly longer PFS than that of chemotherapy alone with manageable safety profiles. Copyright © 2020. Published by Elsevier Inc.

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出版当年[2020]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学 1 区 呼吸系统
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学 1 区 呼吸系统
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出版当年[2020]版：
Q1 RESPIRATORY SYSTEM Q1 ONCOLOGY
最新[2023]版：
Q1 ONCOLOGY Q1 RESPIRATORY SYSTEM

影响因子： 最新[2023版] 最新五年平均 出版当年[2020版] 出版当年五年平均 出版前一年[2019版] 出版后一年[2021版]

第一作者：
第一作者机构： [1]Medical Oncology Department, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine.
通讯作者：
通讯机构： [1]Medical Oncology Department, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine. [*1]Medical Oncology Department, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine.@sysucc.org.cn.
推荐引用方式(GB/T 7714)：
Yang Yunpeng,Wang Zhehai,Fang Jian,et al.Efficacy and safety of sintilimab plus pemetrexed and platinum as first-line treatment for locally advanced or metastatic nonsquamous non-small cell lung cancer: a randomized, double-blind, phase 3 study (ORIENT-11).[J].JOURNAL OF THORACIC ONCOLOGY.2020,15(10):1636-1646.doi:10.1016/j.jtho.2020.07.014.
APA：
Yang Yunpeng,Wang Zhehai,Fang Jian,Yu Qitao,Han Baohui...&Zhang Li.(2020).Efficacy and safety of sintilimab plus pemetrexed and platinum as first-line treatment for locally advanced or metastatic nonsquamous non-small cell lung cancer: a randomized, double-blind, phase 3 study (ORIENT-11)..JOURNAL OF THORACIC ONCOLOGY,15,(10)
MLA：
Yang Yunpeng,et al."Efficacy and safety of sintilimab plus pemetrexed and platinum as first-line treatment for locally advanced or metastatic nonsquamous non-small cell lung cancer: a randomized, double-blind, phase 3 study (ORIENT-11).".JOURNAL OF THORACIC ONCOLOGY 15..10(2020):1636-1646

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