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Nivolumab versus docetaxel in a predominantly Chinese patient population with previously treated advanced non-small cell lung cancer: 2-year follow-up from a randomized, open-label, phase 3 study (CheckMate 078)(Open Access)

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收录情况： ◇ SCIE

作者：
Shun Lu [a] * ; Jie Wang [b] ; Ying Cheng [c] ; Tony Mok [d] ; Jianhua Chang [e] ; Li Zhang [f] ; Jifeng Feng [g] ; Hai-Yan Tu [h] ; Lin Wu[i] ; Yiping Zhang[ j] ; Alexander Luft [k] ; Jian-ying Zhou [l] ; Zhiyong Ma [m] ; You Lu [n] ; Chengping Hu [o] ; Yuankai Shi [b] ; Kejing Ying [p] ; Hua Zhong [a] ; Elena Poddubskaya [q] ; Ross A Soo [r] ; Yee Hong Chia [s] ; Ang Li [t] ; Amy Li [t] ; Yi-Long Wu [h,*a] ;
机构： [a]Shanghai Chest Hospital, 241 Huaihai West Road, Shanghai, 200030, China [b]Cancer Hospital Chinese Academy of Medical Sciences, 17 Nanli Panjiayuan, Beijing, 100021, China [c]Jilin Cancer Hospital, 1018 Huguang Road, Changchun, Jilin, 130012, China [d]State Laboratory of Translational Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital, 30-32 Ngan Shing Street, Hong Kong, China [e]Fudan University Shanghai Cancer Center, 270 Dongan Road, Shanghai, 200032, China [f]Sun Yat-Sen University Cancer Center, 651 Dong Feng East Road, Guangzhou, Guangdong, 510060, China [g]Jiangsu Cancer Hospital, 42 Bai Zi Ting, Nanjing, Jiangsu, 210000, China [h]Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University ofTechnology, 106 Zhongshan Second Road, Guangzhou 510080, China [i]Hunan Cancer Hospital, 283 Tongzipo Road, Changsha, Hunan, 410013, China [j]Zhejiang Cancer Hospital, 1 Banshan East Road, Hangzhou, Zhejiang, 310022, China [k]Leningrad Regional Clinical Hospital, 45-49 Lunacharskogo Avenue, St. Petersburg, 194291, Russian Federation [l]The 1st Affiliated Hospital of College of Medicine, 79 Qingchun Road, Hangzhou, Zhejiang, 310003, China [m]The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, 127 Dongming Road, Zhengzhou, Henan, 450008, China [n]West China Hospital, Sichuan University, 37 Guoxue Lane, Chengdu, 610041, China [o]Xiangya Hospital of Central South University, 87 Xiangya Road, Changsha, Hunan, 410008, China [p]Sir Run Run Shaw Hospital, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, China [q]Clinical Center VitaMed, 10 Seslavinskaya Str, Moscow, Russian Federation [r]National University Hospital, 1E Kent Ridge Road, 119228, Singapore [s]Johns Hopkins Singapore Pte Ltd, 11 Jalan Tan Tock Seng, 308433, Singapore [t]Bristol Myers Squibb, Princeton, NJ, 08540, USA
出处：
DOI： 10.1016/j.lungcan.2020.11.013
ISSN：

关键词： Asian Immunotherapy Nivolumab PD-1 inhibitor Second-line NSCLC

摘要：
Background: In the phase 3 CheckMate 078 study, nivolumab showed significant overall survival (OS) benefit and superior tolerability versus docetaxel in a predominantly Chinese patient population with non-small cell lung cancer (NSCLC). However, data on long-term outcomes with immunotherapy in Asian patients are limited. We report 2-year efficacy and safety data. Methods: Patients with advanced/metastatic NSCLC and disease progression after platinum-doublet chemotherapy were randomized 2:1 to nivolumab (3 mg/kg every 2 weeks; n = 338) or docetaxel (75 mg/m2 every 3 weeks; n = 166) until progression, unacceptable toxicity, or other protocol-defined reasons. The primary endpoint was OS; secondary endpoints included progression-free survival, objective response rate, and safety. Results: After 25.9 months minimum follow-up, 21 patients (6 %) remained on nivolumab versus 0 on docetaxel. Median OS was 11.9 months with nivolumab versus 9.5 months with docetaxel (HR: 0.75; 95 % CI: 0.61–0.93); 2-year OS rates were 28 % versus 18 %, respectively. Survival benefits were observed across a variety of predefined subgroups. At 2 years, 39 % and 0 % of responders had ongoing responses with nivolumab and docetaxel, respectively. Grade 3–4 treatment-related adverse events occurred in 12 % of patients with nivolumab versus 47 % with docetaxel, leading to discontinuation in 4 % and 5 % of patients, respectively. No new treatment-related deaths occurred. Conclusion: At 2 years, nivolumab maintained a favorable safety profile and continued to demonstrate superior OS versus docetaxel in this predominantly Chinese patient population with previously treated NSCLC. These data are consistent with long-term outcomes from the global CheckMate 017/057 studies. © 2020 The Authors

基金：
This work was supported by Bristol Myers Squibb, Princeton, NJ .
语种：
外文
被引次数：
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2021]版：
大类 | 2 区 医学
小类 | 2 区 肿瘤学 2 区 呼吸系统
最新[2023]版：
大类 | 2 区 医学
小类 | 3 区 肿瘤学 3 区 呼吸系统
JCR分区：
出版当年[2021]版：
Q1 RESPIRATORY SYSTEM Q2 ONCOLOGY
最新[2023]版：
Q1 RESPIRATORY SYSTEM Q1 ONCOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2021版] 出版当年五年平均 出版前一年[2020版] 出版后一年[2022版]

第一作者：
第一作者机构： [a]Shanghai Chest Hospital, 241 Huaihai West Road, Shanghai, 200030, China
通讯作者：
通讯机构： [h]Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University ofTechnology, 106 Zhongshan Second Road, Guangzhou 510080, China [*a]Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital, 106 Zhongshan Second Road, Guangzhou, Guangdong, 510080, China.
推荐引用方式(GB/T 7714)：
Shun Lu,Jie Wang,Ying Cheng,et al.Nivolumab versus docetaxel in a predominantly Chinese patient population with previously treated advanced non-small cell lung cancer: 2-year follow-up from a randomized, open-label, phase 3 study (CheckMate 078)(Open Access)[J].LUNG CANCER.2021,152:7-14.doi:10.1016/j.lungcan.2020.11.013.
APA：
Shun Lu,Jie Wang,Ying Cheng,Tony Mok,Jianhua Chang...&Yi-Long Wu.(2021).Nivolumab versus docetaxel in a predominantly Chinese patient population with previously treated advanced non-small cell lung cancer: 2-year follow-up from a randomized, open-label, phase 3 study (CheckMate 078)(Open Access).LUNG CANCER,152,
MLA：
Shun Lu,et al."Nivolumab versus docetaxel in a predominantly Chinese patient population with previously treated advanced non-small cell lung cancer: 2-year follow-up from a randomized, open-label, phase 3 study (CheckMate 078)(Open Access)".LUNG CANCER 152.(2021):7-14

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