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First-line zorifertinib for EGFR-mutant non-small cell lung cancer with central nervous system metastases: The phase 3 EVEREST trial

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作者：
Zhou Qing[1] * ; Yu Yan[2] ; Xing Ligang[3] ; Cheng Ying[4] ; Wang Ying[5] ; Pan Yueyin[6] ; Fan Yun[7] ; Shi Jianhua[8] ; Zhang Guojun[9] ; Cui Jiuwei[10] ; Zhou Jianying[11] ; Song Yong[12] ; Zhuang Wu[13] ; Ma Zhiyong[14] ; Hu Yanping[15] ; Li Gaofeng[16] ; Dong Xiaorong[17] ; Feng Jifeng[18] ; Lu Shun[19] ; Wu Jingxun[20] ; Li Juan[21] ; Zhang Longzhen[22] ; Wang Dong[23] ; Xu Xinhua[24] ; Yang Tsung-Ying[25] ; Yang Nong[26] ; Guo Yubiao[27] ; Zhao Jun[28] ; Yao Yu[29] ; Zhong Diansheng[30] ; Xia Bing[31] ; Yang Cheng-Ta[32] ; Zhu Bo[33] ; Sun Ping[34] ; Shim Byoung Yong[35] ; Chen Yuan[36] ; Wang Zhen[37] ; Ahn Myung-Ju[38] ; Wang Jie[39] ; Wu Yi-Long[40] ;
机构： [1]Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, Guangdong 510080, China. [2]Department of Thoracic Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, Heilongjiang 150081, China. [3]Department of Radiation Oncology, Shandong Cancer Hospital Affiliated to Shandong First Medical University, Jinan, Shandong 250117, China. [4]Department of Thoracic Oncology, Jilin Cancer Hospital, Changchun, Jilin 130021, China. [5]Department of Radiation Oncology, Chongqing University Cancer Hospital, Chongqing Cancer Institute, and Chongqing Cancer Hospital, Chongqing 400030, China. [6]Department of Medical Oncology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China. [7]Zhejiang Cancer Hospital, Institute of Basic Medicine and Cancer (IBMC), Chinese Academy of Sciences, Hangzhou, Zhejiang 310022, China. [8]Department of Medical Oncology, Linyi Cancer Hospital, Linyi, Shandong 276000, China. [9]Department of Respiratory Medicine, First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450052, China. [10]Department of Oncology, Cancer Center, First Hospital of Jilin University, Changchun, Jilin 130031, China. [11]Department of Respiratory Medicine, First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang 310003, China. [12]Department of Respiratory and Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, Nanjing, Jiangsu 210002, China. [13]Department of Thoracic Oncology, Fujian Cancer Hospital & Fujian Medical University Cancer Hospital, Fuzhou, Fujian 350014, China. [14]Department of Medical Oncology, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, Henan 450003, China. [15]Department of Thoracic Oncology, Hubei Cancer Hospital, Wuhan, Hubei 430079, China. [16]Department of Thoracic Surgery, Yunnan Cancer Hospital, The Third Affiliated Hospital of Kunming Medical University Kunming, Kunming, Yunnan 650118, China. [17]Cancer Center, Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430022, China. [18]Department of Medical Oncology, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, Nanjing Medical University Affiliated Cancer Hospital, Nanjing, Jiangsu 210009, China. [19]Department of Oncology, Shanghai Chest Hospital, Shanghai 200030, China. [20]Department of Medical Oncology, The First Affiliated Hospital of Xiamen University, Xiamen, Fujian 361003, China. [21]Department of Medical Oncology, Sichuan Cancer Hospital, Chengdu, Sichuan 610041, China. [22]Department of Radiation Oncology, Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu 221006, China. [23]Department of Oncology, Army Medical Center of the People's Liberation Army of China, Chongqing 400042, China. [24]Department of Oncology, The First College of Clinical Medical Science, China Three Gorges University and Yichang Central People's Hospital, Yichang, Hubei 443000, China. [25]Department of Internal Medicine, Taichung Veterans General Hospital (TCVGH), Taichung 40705, Taiwan. [26]Department of Medical Oncology, Lung Cancer and Gastrointestinal Unit, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan 410013, China. [27]Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510080, China. [28]Department of Thoracic Oncology, Beijing Cancer Hospital, Beijing 100142, China. [29]Department of Medical Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi 710061, China. [30]Department of Medical Oncology, Tianjin Medical University General Hospital, Tianjin 300070, China. [31]Department of Thoracic Cancer, Hangzhou Cancer Hospital, Zhejiang University School of Medicine, and Cancer Center, Zhejiang University, Hangzhou, Zhejiang 310006, China. [32]Department of Thoracic Medicine, Linkou Chang Gung Memorial Hospital (CGMH-LK), Taoyuan City 33305, Taiwan. [33]Institute of Cancer, Xinqiao Hospital, The Third Military Medical University, Chongqing 400037, China. [34]Department of Oncology 2, Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong 264000, China. [35]Division of Medical Oncology, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon 16247, South Korea. [36]Department of Oncology, Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei 430030, China. [37]Department of Medical Sciences, Alpha Biopharma (Jiangsu) Co., Ltd,, Shanghai 200086, China. [38]Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, South Korea. Electronic address: silkahn@skku.edu. [39]State Key Laboratory of Molecular Oncology, Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100021, China. Electronic address: zlhuxi@163.com. [40]Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, Guangdong 510080, China. Electronic address: syylwu@live.cn.
出处：
DOI： 10.1016/j.medj.2024.09.002
ISSN：

摘要：
Zorifertinib (AZD3759), an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) with high blood-brain barrier penetration capability, demonstrated promising intracranial and systemic antitumor activity in phase 1 and 2 studies in central nervous system (CNS)-metastatic patients.In this phase 3 EVEREST trial (ClinicalTrials.gov: NCT03653546), patients with EGFR-sensitizing mutations, advanced treatment-naive non-small cell lung cancer (NSCLC), and non-irradiated symptomatic or asymptomatic CNS metastases were randomized (1:1) to zorifertinib or first-generation EGFR-TKI (gefitinib or erlotinib; control). The primary endpoint was blinded independent central review (BICR)-assessed progression-free survival (PFS) per RECIST1.1.Overall, 439 patients were randomized (zorifertinib n = 220; control n = 219). Most patients had the EGFR L858R mutation (55%) or >3 CNS lesions (54%). Median PFS was significantly longer with zorifertinib versus control (9.6 versus 6.9 months; hazard ratio [HR], 0.719; 95% confidence interval [CI], 0.580-0.893; p = 0.0024). Zorifertinib significantly prolonged intracranial PFS versus control (BICR per modified RECIST1.1: HR, 0.467; 95% CI, 0.352-0.619; investigator per RANO-BM: HR, 0.627; 95% CI, 0.466-0.844). Overall survival (OS) was immature; the estimated median OS was 37.3 months with zorifertinib and 31.8 months with control (HR, 0.833; 95% CI, 0.524-1.283) in patients subsequently treated with third-generation EGFR-TKIs. Safety profiles were consistent with previously reported data for zorifertinib.Zorifertinib significantly improved systemic and intracranial PFS versus first-generation EGFR-TKIs; adverse events were manageable. Sequential use of zorifertinib and third-generation EGFR-TKIs showed the potential to prolong patients' survival. The results favor zorifertinib as a novel, well-validated first-line option for CNS-metastatic patients with EGFR-mutant NSCLC.This work was funded by Alpha Biopharma (Jiangsu) Co., Ltd., China.Copyright © 2024 Elsevier Inc. All rights reserved.

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出版当年[2025]版：
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最新[2023]版：
Q1 MEDICINE, RESEARCH & EXPERIMENTAL

影响因子： 最新[2023版] 最新五年平均 出版当年[2024版] 出版当年五年平均 出版前一年[2024版]

第一作者：
第一作者机构： [1]Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, Guangdong 510080, China.
推荐引用方式(GB/T 7714)：
Zhou Qing,Yu Yan,Xing Ligang,et al.First-line zorifertinib for EGFR-mutant non-small cell lung cancer with central nervous system metastases: The phase 3 EVEREST trial[J].Med (New York, N.Y.).2025,6(1):doi:10.1016/j.medj.2024.09.002.
APA：
Zhou Qing,Yu Yan,Xing Ligang,Cheng Ying,Wang Ying...&Wu Yi-Long.(2025).First-line zorifertinib for EGFR-mutant non-small cell lung cancer with central nervous system metastases: The phase 3 EVEREST trial.Med (New York, N.Y.),6,(1)
MLA：
Zhou Qing,et al."First-line zorifertinib for EGFR-mutant non-small cell lung cancer with central nervous system metastases: The phase 3 EVEREST trial".Med (New York, N.Y.) 6..1(2025)

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