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Lorlatinib for Previously Treated ALK-Positive Advanced NSCLC: Primary Efficacy and Safety From a Phase 2 Study in People's Republic of China

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收录情况： ◇ SCIE

作者：
Lu, Shun[1] ; Zhou, Qing[2] ; Liu, Xiaoqing[3] ; Du, Yingying[4] ; Fan, Yun[5] ; Cheng, Ying[6] ; Fang, Jian[7] ; Lu, You[8] ; Huang, Cheng[9] ; Zhou, Jianying[10] ; Song, Yong[11] ; Wang, Kai[12] ; Pan, Hongming[13] ; Yang, Nong[14] ; Li, Juan[15] ; Chen, Gongyan[16] ; Chang, Jianhua[17] ; Cui, Jiuwei[18] ; Liu, Zhe[19] ; Bai, Chunxue[20] ; Zhang, Helong[21] ; Zhao, Huadong[22] ; Zhang, Kaiting[22] ; Peltz, Gerson[23] ; Li, Heyan[22] ; Wu, Yi-Long[2,*1] ;
机构： [1]Shanghai Chest Hosp, Shanghai, Peoples R China [2]Guangdong Acad Med Sci, Guangdong Prov Peoples Hosp, Guangdong Lung Canc Inst, 106 Zhongshan Er Rd, Guangzhou 510080, Peoples R China [3]Peoples Liberat Army Gen Hosp, Med Ctr 5, Beijing, Peoples R China [4]Anhui Med Univ, Affiliated Hosp 1, Hefei, Anhui, Peoples R China [5]Zhejiang Canc Hosp, Hangzhou, Peoples R China [6]Jilin Prov Canc Hosp, Changchun, Peoples R China [7]Beijing Canc Hosp, Beijing, Peoples R China [8]Sichuan Univ, West China Hosp, Chengdu, Peoples R China [9]Fujian Prov Oncol Hosp, Fuzhou, Peoples R China [10]Zhejiang Med Univ, Affiliated Hosp 1, Hangzhou, Peoples R China [11]Nanjing Gen Hosp Nanjing Mil Command, Nanjing, Peoples R China [12]Zhejiang Univ, Affiliated Hosp 2, Coll Med, Hangzhou, Peoples R China [13]Zhejiang Univ, Sir Run Run Shaw Hosp, Coll Med, Hangzhou, Peoples R China [14]Hunan Prov Tumor Hosp, Changsha, Peoples R China [15]Sichuan Prov Canc Hosp, Chengdu, Peoples R China [16]Harbin Med Univ, Canc Hosp, Harbin, Peoples R China [17]Chinese Acad Med Sci, Shenzhen Ctr, Canc Hosp, Shenzhen 518116, Peoples R China [18]First Hosp Jilin Univ, Changchun, Peoples R China [19]Capital Med Univ, Beijing Chest Hosp, Beijing, Peoples R China [20]Fudan Univ, Zhongshan Hosp, Shanghai, Peoples R China [21]Fourth Mil Med Univ, Tangdu Hosp, Xian, Peoples R China [22]Pfizer, Shanghai, Peoples R China [23]Pfizer Inc, Cambridge, MA USA
出处：
DOI： 10.1016/j.jtho.2022.02.014
ISSN：

关键词： Lorlatinib ALK Tyrosine kinase inhibitor Non-small cell lung cancer China

摘要：
Introduction: Lorlatinib was found to have activity in ALKpositive NSCLC in a global phase 1 and 2 study. We report an ongoing phase 2 study in Chinese patients with ALKpositive advanced or metastatic NSCLC. Methods: Open-label, dual-cohort study (NCT03909971); patients had progressive disease after ALK tyrosine kinase inhibitor treatment (cohort 1: previous crizotinib; cohort 2: one ALK tyrosine kinase inhibitor other than crizotinib [+/- prior crizotinib]), more than or equal to one unirradiated extracranial target lesion, and Eastern Cooperative Oncology Group performance status of 0 to 2. Patients received oral lorlatinib 100 mg once daily in continuous 21-day cycles. Primary end point: objective response in cohort 1 by independent central radiology (ICR) according to Response Evaluation Criteria in Solid Tumors version 1.1. Analyses were based on patients receiving more than or equal to one dose. Results: At data cutoff (August 10, 2020), 109 patients were enrolled (cohort 1: n = 67; cohort 2: n = 42). A total of 47 patients in cohort 1 (70.1%, 95% confidence interval [CI]: 57.7-80.7, p < 0.0001; primary end point) and 20 patients in cohort 2 (47.6%, 95% CI: 32.0-63.6, secondary end point) achieved objective response by ICR. Median progression-free survival was not reached in cohort 1 and was 5.6 months in cohort 2. In patients with brain lesions at baseline, 29 of 36 patients in cohort 1 (80.6%, 95% CI: 64.0-91.8) and 10 of 21 patients in cohort 2 (47.6%, 95% CI: 25.7-70.2) achieved objective intracranial response by ICR. Hypercholesterolemia (92.7%) and hypertriglyceridemia (90.8%) (cluster terms) were common treatment-related adverse events (TRAEs). Nine patients (8.3%) had serious TRAEs; one permanently discontinued from treatment because of TRAEs. Conclusions: Lorlatinib was found to have a robust and durable response and high intracranial objective response in previously treated Chinese patients with ALK-positive NSCLC. (C) 2022 International Association for the Study of Lung Cancer. Published by Elsevier Inc.

基金：
Pfizer
语种：
外文
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中科院(CAS)分区：
出版当年[2022]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
JCR分区：
出版当年[2022]版：
Q1 ONCOLOGY Q1 RESPIRATORY SYSTEM
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[2022版] 出版当年五年平均 出版前一年[2021版] 出版后一年[2023版]

第一作者：
第一作者机构： [1]Shanghai Chest Hosp, Shanghai, Peoples R China
共同第一作者：
通讯作者：
通讯机构： [2]Guangdong Acad Med Sci, Guangdong Prov Peoples Hosp, Guangdong Lung Canc Inst, 106 Zhongshan Er Rd, Guangzhou 510080, Peoples R China [*1]Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, 106 Zhongshan Er Road, Guangzhou 510080, People’s Republic of China.
推荐引用方式(GB/T 7714)：
Lu Shun,Zhou Qing,Liu Xiaoqing,et al.Lorlatinib for Previously Treated ALK-Positive Advanced NSCLC: Primary Efficacy and Safety From a Phase 2 Study in People's Republic of China[J].JOURNAL OF THORACIC ONCOLOGY.2022,17(6):816-826.doi:10.1016/j.jtho.2022.02.014.
APA：
Lu, Shun,Zhou, Qing,Liu, Xiaoqing,Du, Yingying,Fan, Yun...&Wu, Yi-Long.(2022).Lorlatinib for Previously Treated ALK-Positive Advanced NSCLC: Primary Efficacy and Safety From a Phase 2 Study in People's Republic of China.JOURNAL OF THORACIC ONCOLOGY,17,(6)
MLA：
Lu, Shun,et al."Lorlatinib for Previously Treated ALK-Positive Advanced NSCLC: Primary Efficacy and Safety From a Phase 2 Study in People's Republic of China".JOURNAL OF THORACIC ONCOLOGY 17..6(2022):816-826

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