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Updated overall survival and circulating tumor DNA analysis of ensartinib for crizotinib-refractory ALK-positive NSCLC from a phase II study

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收录情况： ◇ SCIE

作者：
Zheng Jing[1] * ; Wang Tao[2] * ; Yang Yunpeng[3] ; Huang Jie[3] ; Feng Jifeng[4] ; Zhuang Wu[5] ; Chen Jianhua[6] ; Zhao Jun[7] ; Zhong Wei[8] ; Zhao Yanqiu[9] ; Zhang Yiping[10] ; Song Yong[11] ; Hu Yi[12] ; Yu Zhuang[13] ; Gong Youling[14] ; Chen Yuan[15] ; Ye Feng[16] ; Zhang Shucai[17] ; Cao Lejie[18] ; Fan Yun[10] ; Wu Gang[19] ; Guo Yubiao[20] ; Zhou Chengzhi[21] ; Ma Kewei[22] ; Fang Jian[7] ; Feng Weineng[23] ; Liu Yunpeng[24] ; Zheng Zhendong[25] ; Li Gaofeng[26] ; Wang Huijie[27] ; Cang Shundong[28] ; Wu Ning[29] ; Song Wei[30] ; Liu Xiaoqing[31] ; Zhao Shijun[32] ; Ding Lieming[33] ; Selvaggi Giovanni[34] ; Wang Yang[33] ; Xiao Shanshan[2] ; Wang Qian[2] ; Shen Zhilin[33] ; Zhou Jianya[1] ; Zhou Jianying[1] ; Zhang Li[3] ;
机构： [1]Department of Respiratory Disease, Thoracic Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University, Zhejiang Provincial Clinical Research Center for Respiratory Disease, Hangzhou, Zhejiang, P. R. China. [2]Hangzhou Repugene Technology Co., Ltd, Hangzhou, Zhejiang, P. R. China. [3]Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, P. R. China. [4]Department of Medical Oncology, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, Jiangsu, P. R. China. [5]Department of Thoracic Oncology, Fujian Provincial Cancer Hospital, Fujian Medical University Cancer Hospital, Fuzhou, Fujian, P. R. China. [6]Department of Medical Oncology-Chest, Hunan Cancer Hospital, Changsha, Hunan, P. R. China. [7]Department of Thoracic Oncology, Beijing Cancer Hospital, Beijing, P. R. China. [8]Department of Pulmonary Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, P. R. China. [9]Respiratory Department of Internal Medicine, Henan Provincial Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, Henan, P. R. China. [10]Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, Zhejiang, P. R. China. [11]Division of Respiratory Medicine, Jinling Hospital, Nanjing University School of Medicine, Nanjing, Jiangsu, P. R. China. [12]Department of Oncology, Chinese People's Liberation Army (PLA) General Hospital, Beijing, P. R. China. [13]Department of Oncology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, P. R. China. [14]Department of Thoracic Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan, P. R. China. [15]Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, P. R. China. [16]Department of Medical Oncology, Cancer Hospital, The First Affiliated Hospital of Xiamen University, School of Medicine, Xiamen University, Teaching Hospital of Fujian Medical University, Xiamen, Fujian, P. R. China. [17]Department of Medical Oncology, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, P. R. China. [18]Respiratory Medicine, The First Affiliated Hospital of the University of Science and Technology of China, Anhui Provincial Hospital, Hefei, Anhui, P. R. China. [19]Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, P. R. China. [20]Pulmonary &amp [21] Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, P. R. China. [21]Respiratory Medicine Department, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, P. R. China. [22]Cancer Center, The First Hospital of Jilin University, Changchun, Jilin, P. R. China. [23]Department of Head and Neck and Thoracic Medical Oncology, The First People's Hospital of Foshan, Foshan, Guangdong, P. R. China. [24]Oncology Medicine, The First Hospital of China Medical University, Shenyang, Liaoning, P. R. China. [25]Oncology Department, General Hospital of Northern Theater Command, Shenyang, Liaoning, P. R. China. [26]2nd Department of Thoracic Surgery, Yunnan Cancer Hospital, Kunming, Yunnan, P. R. China. [27]Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, Shanghai, P. R. China. [28]Medical Oncology, Henan Province Peoples Hospital, Zhengzhou, Henan, P. R. China. [29]PET-CT Center &amp [31] Department of Diagnostic Radiology, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, P. R. China. [30]Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, P. R. China. [31]Department of Pulmonary Oncology, The Fifth Medical Centre Chinese PLA General Hospital, Beijing, P. R. China. [32]Department of Diagnostic Radiology, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, P. R. China. [33]Betta Pharmaceuticals Co., Ltd, Hangzhou, Zhejiang, P. R. China. [34]X-covery Holdings, Palm Beach Gardens, West Palm Beach, Florida, USA.
出处：
DOI： 10.1002/cac2.12524
ISSN：

关键词： anaplastic lymphoma kinase ctDNA ensartinib non-small cell lung cancer overall survival

摘要：
The initial phase II stuty (NCT03215693) demonstrated that ensartinib has shown clinical activity in patients with advanced crizotinib-refractory, anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Herein, we reported the updated data on overall survival (OS) and molecular profiling from the initial phase II study.In this study, 180 patients received 225 mg of ensartinib orally once daily until disease progression, death or withdrawal. OS was estimated by Kaplan-Meier methods with two-sided 95% confidence intervals (CIs). Next-generation sequencing was employed to explore prognostic biomarkers based on plasma samples collected at baseline and after initiating ensartinib. Circulating tumor DNA (ctDNA) was detected to dynamically monitor the genomic alternations during treatment and indicate the existence of molecular residual disease, facilitating improvement of clinical management.At the data cut-off date (August 31, 2022), with a median follow-up time of 53.2 months, 97 of 180 (53.9%) patients had died. The median OS was 42.8 months (95% CI: 29.3-53.2 months). A total of 333 plasma samples from 168 patients were included for ctDNA analysis. An inferior OS correlated significantly with baseline ALK or tumor protein 53 (TP53) mutation. In addition, patients with concurrent TP53 mutations had shorter OS than those without concurrent TP53 mutations. High ctDNA levels evaluated by variant allele frequency (VAF) and haploid genome equivalents per milliliter of plasma (hGE/mL) at baseline were associated with poor OS. Additionally, patients with ctDNA clearance at 6 weeks and slow ascent growth had dramatically longer OS than those with ctDNA residual and fast ascent growth, respectively. Furthermore, patients who had a lower tumor burden, as evaluated by the diameter of target lesions, had a longer OS. Multivariate Cox regression analysis further uncovered the independent prognostic values of bone metastases, higher hGE, and elevated ALK mutation abundance at 6 weeks.Ensartinib led to a favorable OS in patients with advanced, crizotinib-resistant, and ALK-positive NSCLC. Quantification of ctDNA levels also provided valuable prognostic information for risk stratification.© 2024 The Authors. Cancer Communications published by John Wiley & Sons Australia, Ltd. on behalf of Sun Yat-sen University Cancer Center.

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外文
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出版当年[2024]版：
无
最新[2023]版：
大类 | 1 区 医学
小类 | 2 区 肿瘤学
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出版当年[2024]版：
无
最新[2023]版：
Q1 ONCOLOGY

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

第一作者：
第一作者机构： [1]Department of Respiratory Disease, Thoracic Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University, Zhejiang Provincial Clinical Research Center for Respiratory Disease, Hangzhou, Zhejiang, P. R. China.
共同第一作者：
通讯作者：
推荐引用方式(GB/T 7714)：
Zheng Jing,Wang Tao,Yang Yunpeng,et al.Updated overall survival and circulating tumor DNA analysis of ensartinib for crizotinib-refractory ALK-positive NSCLC from a phase II study[J].CANCER COMMUNICATIONS.2024,44(4):455-468.doi:10.1002/cac2.12524.
APA：
Zheng Jing,Wang Tao,Yang Yunpeng,Huang Jie,Feng Jifeng...&Zhang Li.(2024).Updated overall survival and circulating tumor DNA analysis of ensartinib for crizotinib-refractory ALK-positive NSCLC from a phase II study.CANCER COMMUNICATIONS,44,(4)
MLA：
Zheng Jing,et al."Updated overall survival and circulating tumor DNA analysis of ensartinib for crizotinib-refractory ALK-positive NSCLC from a phase II study".CANCER COMMUNICATIONS 44..4(2024):455-468

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