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Efficacy and Safety of Niraparib as Maintenance Treatment in Patients with Extensive-Stage Small Cell Lung Cancer after First-Line Chemotherapy: A Randomized, Double-Blind, Phase 3 Study.

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作者：
Xinghao Ai[1] * ; Yueyin Pan[2] ; Jianhua Shi[3] ; Nong Yang[4] ; Chunling Liu[5] ; Jianying Zhou[6] ; Xiaodong Zhang[7] ; Xiaorong Dong[8] ; Jianxing He[9] ; Xiaoling Li[10] ; Gongyan Chen[11] ; Xingya Li[12] ; Helong Zhang[13] ; Wangjun Liao[14] ; Yiping Zhang[15] ; Zhiyong Ma[16] ; Liyan Jiang[17] ; Jiuwei Cui[18] ; Chunhong Hu[19] ; Wei Wang[20] ; Cheng Huang[21] ; Jun Zhao[22] ; Cuimin Ding[23] ; Xiaohua Hu[24] ; Kai Wang[25] ; Beili Gao[26] ; Yong Song[27] ; Xiaoqing Liu[28] ; Jianping Xiong[29] ; Anwen Liu[30] ; Junling Li[31] ; Zhe Liu[32] ; Yinyin Li[33] ; Mengzhao Wang[34] ; Biao Zhang[35] ; Dan Zhang[35] ; Shun Lu[1,*1] ;
机构： [1]Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University,Shanghai, China [2]Department of Chemotherapy, Anhui Provincial Hospital, Hefei, China [3]Department of Medical Oncology, Linyi Cancer Hospital, Linyi, China [4]Lung & Gastrointestinal Oncology Department, Hunan Cancer Hospital, Changsha, China [5]Department of Pulmonary Medicine, Cancer Hospital Affiliated to Xinjiang MedicalUniversity, Urumqi, China [6]Department of Respiratory Medicine, First Affiliated Hospital, Zhejiang University,Hangzhou, China [7]Department of Medical Oncology, Nantong Tumor Hospital, Nantong, China [8]Cancer Center, Union Hospital, Tongji Medical College, Huazhong Universityof Science and Technology, Wuhan, China [9]Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou MedicalUniversity, Guangzhou, China [10]Department of Thoracic Medicine, Liaoning Cancer Hospital & Institute, Shenyang, China [11]Department of Respiratory Medicine, Harbin Medical University Cancer Hospital, Harbin,China [12]Department of Oncology, The First Affiliated Hospital of Zhengzhou University,Zhengzhou, China [13]Department of Oncology, Tangdu Hospital, Xi'an, China, [14]Department of Oncology, Nanfang Hospital, Guangzhou, China [15]Department of Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China [16]Department of Respiratory Medicine, Affiliated Cancer Hospital of ZhengzhouUniversity/Henan Cancer Hospital, Zhengzhou, China [17]Department of Respiration, Shanghai Chest Hospital, Shanghai, China [18]The First Bethune Hospital of Jilin University, Changchun, China [19]Department of Oncology, The Second Xiangya Hospital of Central South University,Changsha, China [20]Jinzhou Central Hospital, Jinzhou, China [21]Fujian Cancer Hospital, Fuzhou, China [22]Beijing Cancer Hospital, Beijing, China [23]The Fourth Hospital of Hebei Medical University and Hebei Cancer Hospital, Shijiazhuang,China [24]The First Affiliated Hospital of Guangxi Medical University, Nanning, China [25]The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou,China [26]Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China [27]Nanjing General Hospital of Nanjing Military Command, Nanjing, China [28]The 307th Hospital of the Chinese People's Liberation Army, Beijing, China [29]The First Affiliated Hospital of Nanchang University, Nanchang, China [30]The Second Affiliated Hospital of Nanchang University, Nanchang, China [31]Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China [32]Beijing Chest Hospital, Capital Medical University, Beijing, China [33]Shenyang the Tenth People’s Hospital, Shenyang, China [34]Peking Union Medical College Hospital, Beijing, China [35]R&D Department, Zai Lab (Shanghai) Co., Ltd, Shanghai, China
出处：
DOI： 10.1016/j.jtho.2021.04.001
ISSN：

关键词： PARP inhibitor niraparib extensive-stage small cell lung cancer maintenance Chinese

摘要：
ZL-2306-005 is a randomized, double-blind, multicenter phase 3 study evaluating the efficacy and safety of niraparib, a poly(ADP-ribose) polymerase inhibitor, as first-line maintenance therapy in Chinese patients with platinum-responsive, extensive-stage small cell lung cancer (ES-SCLC). Patients with complete/partial response (CR/PR) to standardized, platinum-based first-line chemotherapy were randomized 2:1 to receive niraparib or placebo (300 mg [baseline body weight ≥77 kg, platelet count ≥150,000/μL] or 200 mg) once daily until progression or unacceptable toxicity. Primary endpoints were progression-free survival (PFS) (blinded independent central review, BICR) and overall survival (OS) (sample size planned: 591 patients). Secondary endpoints included investigator-assessed PFS and safety. ZL-2306-005 was terminated early due to ES-SCLC treatment landscape changes (data cut-off: 20 Mar 2020). During July 2018-February 2020, 185 of 272 patients screened were randomized (niraparib: n=125 [CR=1, PR=124]; placebo: n=60 [CR=1, PR=59]). Median (95% confidence interval [CI]) PFS (BICR) was 1.54 months (1.41-2.69, niraparib) and 1.36 months (1.31-1.48, placebo); hazard ratio [HR]=0.66 (95% CI: 0.46-0.95; p=0.0242). Median OS was 9.92 months (9.33-13.54, niraparib) and 11.43 months (9.53-not estimable, placebo); HR=1.03 (95% CI: 0.62-1.73; p=0.9052). Median investigator-assessed PFS was 1.48 months (1.41-2.56, niraparib) and 1.41 months (1.31-2.00, placebo); HR=0.88 (95% CI: 0.61-1.26; p=0.4653). Grade ≥3 adverse events occurred in 34.4% (niraparib) and 25.0% (placebo) of patients. ZL-2306-005 did not reach primary endpoints. However, niraparib as maintenance therapy modestly improved PFS in patients with platinum-responsive ES-SCLC, with acceptable tolerability profile and no new safety signal. Copyright © 2021. Published by Elsevier Inc.

基金：
This article is based on the original study NCT03516084, a study sponsored by Zai Lab, Shanghai and partially supported by Shanghai Science and Technology Commission (grant numbers 18DZ1910700, 18DZ1910702). Third-party writing assistance for this article was funded by Zai Lab, Shanghai, in accordance with Good Publication Practice (GPP3) guidelines.
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外文
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中科院分区：
出版当年[2021]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学 1 区 呼吸系统
最新[2025]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[2021]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[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： [1]Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University,Shanghai, China
通讯作者：
通讯机构： [1]Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University,Shanghai, China [*1]Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University 241 West Huaihai Road, Shanghai 200030, China
推荐引用方式(GB/T 7714)：
Xinghao Ai,Yueyin Pan,Jianhua Shi,et al.Efficacy and Safety of Niraparib as Maintenance Treatment in Patients with Extensive-Stage Small Cell Lung Cancer after First-Line Chemotherapy: A Randomized, Double-Blind, Phase 3 Study.[J].JOURNAL OF THORACIC ONCOLOGY.2021,16(8):1403-1414.doi:10.1016/j.jtho.2021.04.001.
APA：
Xinghao Ai,Yueyin Pan,Jianhua Shi,Nong Yang,Chunling Liu...&Shun Lu.(2021).Efficacy and Safety of Niraparib as Maintenance Treatment in Patients with Extensive-Stage Small Cell Lung Cancer after First-Line Chemotherapy: A Randomized, Double-Blind, Phase 3 Study..JOURNAL OF THORACIC ONCOLOGY,16,(8)
MLA：
Xinghao Ai,et al."Efficacy and Safety of Niraparib as Maintenance Treatment in Patients with Extensive-Stage Small Cell Lung Cancer after First-Line Chemotherapy: A Randomized, Double-Blind, Phase 3 Study.".JOURNAL OF THORACIC ONCOLOGY 16..8(2021):1403-1414

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