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Bevacizumab biosimilar LY01008 compared with bevacizumab (Avastin) as first-line treatment for Chinese patients with unresectable, metastatic, or recurrent non-squamous non-small-cell lung cancer: A multicenter, randomized, double-blinded, phase III trial.

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收录情况： ◇ SCIE

作者：
Yuankai Shi[1,*1] * ; Kaijian Lei[2] ; Yuming Jia[2] ; Bingqiang Ni[3] ; Zhiyong He[4] ; Minghong Bi[5] ; XichengWang[6] ; Jianhua Shi[7] ; Ming Zhou[8] ; Qian Sun[9] ; GuoleiWang[9] ; Dongji Chen[10] ; Yongqian Shu[11] ; Lianke Liu[11] ; Zhongliang Guo[12] ; Yong Liu[13] ; Junquan Yang[14] ; KeWang[15] ; Ke Xiao[16] ; LinWu[17] ; Tienan Yi[18] ; Debin Sun[19] ; Mafei Kang[20] ; TianjiangMa[21] ; Yimin Mao[22] ; Jinsheng Shi[23] ; Tiegang Tang[24] ; YanWang[1] ; Puyuan Xing[1] ; Dongqing Lv[25] ; Wangjun Liao[26] ; Zhiguo Luo[27] ; BinWang[28] ; XiaohongWu[29] ; Xiaoli Zhu[30] ; Shuhua Han[30] ; Qisen Guo[31] ; Rongyu Liu[32] ; Zhiwei Lu[33] ; Jianyong Zhang[34] ; Jian Fang[35] ; Changlu Hu[36] ; Yinghua Ji[37] ; Guolong Liu[38] ; Hong Lu[39] ; DedongWu[40] ; Junhong Zhang[41] ; Shuyang Zhu[42] ; Zheng Liu[43] ; Wensheng Qiu[44] ; Feng Ye[45] ; Yan Yu[46] ; Yanqiu Zhao[47] ; Qinhong Zheng[48] ; Jun Chen[49] ; Zhanyu Pan[50] ; Yiping Zhang[51] ; Wenjuan Lian[52] ; Bo Jiang[53] ; Bo Qiu[54] ; Guojun Zhang[55] ; Hua Zhang[56] ; Yanju Chen[57] ; Yuan Chen[58] ; Hongbing Duan[59] ; Manxiang Li[60] ; Shengming Liu[61] ; LijunMa[62] ; Hongming Pan[63] ; Xia Yuan[64] ; ueli Yuan[65] ; Yulong Zheng[66] ; Emei Gao[67] ; Li Zhao[67] ; ShuminWang[67] ; CanWu[67] ;
机构： [1]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 Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing 100021, P. R. China [2]Department of Oncology, Yibin Second People’s Hospital, Yibin, Sichuan 644000, P. R. China [3]Department of Oncology, Liuzhou People’s Hospital, Liuzhou, Guangxi 545006, P. R. China [4]Department of Thoracic Oncology, Fujian Provincial Cancer Hospital, Fuzhou, Fujian 350014, P. R. China [5]Oncology Department, the First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui 233030, P. R. China [6]Department of Oncology, the First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, Guangdong 510030, P. R. China [7]Department of Internal medicine, Linyi Cancer Hospital, Linyi, Shandong 276002, P. R. China [8]Department of Thoracic Surgery, the Affiliated Cancer Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510095, P. R. China [9]Department of Internal Medicine-Oncology/Department of thoracic oncology, Henan Chest Hospital, Zhengzhou, Henan 450003, P. R. China [10]The Second Department of Radiotherapy,Wuwei Cancer Hospital of Gansu Province,Wuwei, Gansu 730000, P. R. China [11]Department of Oncology, the People’s Hospital of Jiangsu Province, Nanjing, Jiangsu 210000, P. R. China [12]Respiratory Medicine Department, Shanghai East Hospital, Shanghai 200120, P. R. China [13]The Second Department of Internal Medicine-Oncology, Xuzhou Central Hospital, Xuzhou, Jiangsu 221009, P. R. China [14]Oncology Department, Tangshan People’s Hospital, Tangshan, Hebei 063001, P. R. China [15]Respiratory Medicine Department,West China ,Hospital of Sichuan University, Chengdu, Sichuan 610041, P. R. China [16]Thoracic Surgery, the Second Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong 515051, P. R. China [17]Internal Medicine-Oncology, Hunan Cancer Hospital, Changsha, Hunan 410013, P. R. China [18]Department of Oncology, Xiangyang Central Hospital, Xiangyang, Hubei 441021, P. R. China [19]Respiratory Department, Lishui Central Hospital, Lishui, Zhejiang 323000, P. R. China [20]Oncology Department, The Affiliated Hospital of Guilin Medical College, Guilin, Guangxi 541001, P. R. China [21]Internal Medicine-Oncology, Luohe Central Hospital, Luohe, Henan 462000, P. R. China [22]Respiratory Department, the First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan 471003, P. R. China [23]Oncology Department, Cangzhou People’s Hospital, Cangzhou, Hebei 061000, P. R. China [24]Oncology Department, Xiangtan Central Hospital, Xiangtan, Hunan 411100, P. R. China [25]Respiratory Department, Taizhou Hospital of Zhejiang Province, Taizhou, Zhejiang 317000, P. R. China [26]Department of Oncology, Nanfang Hospital of Southern Medical University, Guangzhou, Guangdong 510515, P. R. China [27]Department of Oncology, Taihe Hospital of Shiyan City, Shiyan, Hubei 442000, P. R. China [28]Respiratory Department, Huzhou Central Hospital, Huzhou, Zhejiang 313003, P. R. China [29]Internal Medicine-Oncology, the Fourth People’s Hospital of Wuxi City,Wuxi, Jiangsu 214062, P. R. China [30]Department of Oncology, Zhongda Hospital of Southeast University, Nanjing, Jiangsu 210009, P. R. China [31]The Second Department of Internal Medicine, Shandong Cancer Hospital, Jinan, Shandong 250117, P. R. China [32]Respiratory Department, the First Affiliated Hospital of Anhui Medical University, Hefei, Anhui 230022, P. R. China [33]Respiratory Department, The First Affiliated Hospital of Wannan Medical College,Wuhu, Anhui 241001, P. R. China [34]The Second Department of Respiratory Medicine, the Affiliated Hospital of Zunyi Medical College, Zunyi, Guizhou 563099, P. R. China [35]The Second Department of thoracic oncology, Beijing Cancer Hospital, Beijing 100142, P. R. China [36]Department of Oncology, Anhui Cancer Hospital, Hefei, Anhui 233004, P. R. China [37]Oncology Department, the First Affiliated Hospital of Xinxiang Medical College, Xinxiang, Henan 453100, P. R. China [38]Department of Oncology, the First People’s Hospital of Guangzhou, Guangzhou, Guangdong 510180, P. R. China [39]Oncology Department, Huaihe Hospital of Henan University, Kaifeng, Henan 475000, P. R. China [40]Department of Oncology and Hematology, The First People’s Hospital of Zhengzhou, Zhengzhou, Henan 450004, P. R. China [41]Oncology Department, Zhongnan Hospital of Wuhan University,Wuhan, Hubei 430071, P. R. China [42]Respiratory Department, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu 221006, P. R. China [43]The Third Department of Oncology, Handan Central Hospital, Handan, Hebei 056001, P. R. China [44]Oncology Department, The Affiliated Hospital of Qingdao University, Qingdao, Shandong 266011, P. R. China [45]Oncology Department, the First Affiliated Hospital of Xiamen University, Xiamen, Fujian 361003, P. R. China [46]The Sixth Department of Internal Medicine, the Affiliated Cancer Hospital of Harbin Medical University, Harbin, Heilongjiang 150081, P. R. China [47]Respiratory Department, Henan Cancer Hospital, Zhengzhou, Henan 450008, P. R. China [48]Internal Medicine-Oncology, Quzhou People’s Hospital, Quzhou, Zhejiang 324000, P. R. China [49]Lung tumor surgery Department, General Hospital of Tianjin Medical University, Tianjin 300052, P. R. China [50]Integrated Traditional Chinese andWestern Medicine Department, Tianjin Cancer Hospital, Tianjin 300060, P. R. China [51]Department of Thoracic Cancer, Zhejiang Cancer Hospital, Hangzhou, Zhejiang 310022, P. R. China [52]Department of Oncology, Xi’an Chest Hospital, Xi’an, Shanxi 710061, P. R. China [53]Special Medical Treatment, Yunnan Cancer Hospital, Kunming, Yunnan 650106, P. R. China [54]Department of Oncology, Zhuzhou Central Hospital, Zhuzhou, Hunan 412007, P. R. China [55]Respiratory Department, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450052, P. R. China [56]Second Department of Cancer Center, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang 830054, P. R. China [57]Internal Medicine-Oncology, Hainan Provincial People’s Hospital, Haikou, Hainan 570311, P. R. China [58]Oncology Department, Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology,Wuhan, Hubei430030, P. R. China [59]Thoracic Surgery, Zhongshan Hospital Affiliated to Xiamen University, Xiamen, Fujian 361004, P. R. China [60]Respiratory Department, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, Shanxi 710061, P. R. China [61]Respiratory Department, The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong 510632, P. R. China [62]Oncology Department, Shanghai Tongren Hospital, Shanghai 200336, P. R. China [63]Internal Medicine-Oncology, Shaoyifu Hospital Affiliated to Medical College of Zhejiang University, Hangzhou, Zhejiang 310016, P. R. China [64]Internal Medicine-Oncology, Huizhou Central People’s Hospital, Huizhou, Guangdong 516008, P. R. China [65]Oncology Department, the Fourth Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang 150001, P. R. China [66]Respiratory Department, Huai’an Second People’s Hospital, Huai’an, Jiangsu 223002, P. R. China [67]Clinical Research Center of Luye Pharma Group Ltd, Luye Life Sciences Group, Beijing 100025, P. R. China
出处：
DOI： 10.1002/cac2.12179
ISSN：

关键词： anti-angiogenesis anti-VEGF monoclonal antibody avastin bevacizumab biosimilar nonsmall cell lung cancer LY01008 vascular endothelial growth factor

摘要：
Previous studies have demonstrated the preclinical pharmacological and toxicological consistency, and clinical pharmacokinetic equivalence of bevacizumab biosimilar LY01008 with reference bevacizumab (Avastin). This randomized controlled trial aimed to compare the efficacy and safety of LY01008 with Avastin in first-line treatment of Chinese patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC).Stage IIIB-IV NSCLC patients with evaluable lesions, good physical status, and adequate organ functions from 67 centers across China were randomized in a ratio of 1:1 to receive LY01008 or Avastin 15 mg/kg intravenously in combination with paclitaxel/carboplatin (combined treatment) for 4-6 cycles, followed by maintenance monotherapy with LY01008 until disease progression, intolerable toxicity, or death. The primary endpoint was objective response rate (ORR) in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 confirmed by independent radiological review committees (IRRC). Secondary endpoints included disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety. This study was registered in ClinicalTrials.gov (NCT03533127).Between December 15th , 2017, and May 15th , 2019, a total of 649 patients were randomized to the LY01008 (n = 324) or Avastin (n = 325) group. As of September 25th , 2019 for primary endpoint analysis, 589 patients received ORR evaluation, with a median number of combined treatment cycles of 5 (range 1-6) and median duration of treatment of 3.0 (range 0.0-5.1) months. ORR of response-evaluable patients in the LY01008 and Avastin groups were 48.5% and 53.0%, respectively. The stratified ORR ratio was 0.91 (90% CI 0.80-1.04, within the prespecified equivalence margin of 0.75-1.33). Up to May 15th , 2020, with a median follow-up of 13.6 (range 0.8-28.4) months, no notable differences in DCR, median DoR, median PFS, median OS, and 1-year OS rate were observed between the LY01008 and Avastin groups. There were no clinically meaningful differences in safety and immunogenicity across treatment groups.LY01008 demonstrated similarity to Avastin in terms of efficacy and safety in Chinese patients with advanced or recurrent non-squamous NSCLC. LY01008 combined with paclitaxel/carboplatin is expected to become a new treatment option for unresectable, metastatic, or recurrent non-squamous NSCLC patients in the first-line setting.© 2021 The Authors. Cancer Communications published by John Wiley & Sons Australia, Ltd. on behalf of Sun Yat-sen University Cancer Center.

基金：
Luye Pharma Group Ltd.; Luye Life SciencesGroup, Beijing,China; China National Major Project forNewDrug Innovation,Grant/Award Number: 2017ZX09304015; ChineseAcademy of Medical Sciences Innovation Fund for Medical Sciences (CIFMS), Grant/Award Number: 2016-I2M-1-001
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外文
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中科院(CAS)分区：
出版当年[2021]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
最新[2023]版：
大类 | 1 区 医学
小类 | 2 区 肿瘤学
JCR分区：
出版当年[2020]版：
Q1 ONCOLOGY
最新[2023]版：
Q1 ONCOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2020版] 出版当年五年平均 出版前一年[2019版] 出版后一年[2021版]

第一作者：
第一作者机构： [1]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 Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing 100021, P. R. China [*1]Department of MedicalOncology, National Cancer Center/ National ClinicalResearch Center forCancer/Cancer Hospital,Chinese Academy ofMedical Sciences&Peking UnionMedical College,BeijingKey Laboratory ofClinical Study on Anticancer MolecularTargetedDrugs.No. 17 PanjiayuanNanli, Chaoyang District, Beijing 100021, P.R.China
通讯作者：
通讯机构： [1]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 Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing 100021, P. R. China [*1]Department of MedicalOncology, National Cancer Center/ National ClinicalResearch Center forCancer/Cancer Hospital,Chinese Academy ofMedical Sciences&Peking UnionMedical College,BeijingKey Laboratory ofClinical Study on Anticancer MolecularTargetedDrugs.No. 17 PanjiayuanNanli, Chaoyang District, Beijing 100021, P.R.China
推荐引用方式(GB/T 7714)：
Yuankai Shi,Kaijian Lei,Yuming Jia,et al.Bevacizumab biosimilar LY01008 compared with bevacizumab (Avastin) as first-line treatment for Chinese patients with unresectable, metastatic, or recurrent non-squamous non-small-cell lung cancer: A multicenter, randomized, double-blinded, phase III trial.[J].CANCER COMMUNICATIONS.2021,41(9):889-903.doi:10.1002/cac2.12179.
APA：
Yuankai Shi,Kaijian Lei,Yuming Jia,Bingqiang Ni,Zhiyong He...&CanWu.(2021).Bevacizumab biosimilar LY01008 compared with bevacizumab (Avastin) as first-line treatment for Chinese patients with unresectable, metastatic, or recurrent non-squamous non-small-cell lung cancer: A multicenter, randomized, double-blinded, phase III trial..CANCER COMMUNICATIONS,41,(9)
MLA：
Yuankai Shi,et al."Bevacizumab biosimilar LY01008 compared with bevacizumab (Avastin) as first-line treatment for Chinese patients with unresectable, metastatic, or recurrent non-squamous non-small-cell lung cancer: A multicenter, randomized, double-blinded, phase III trial.".CANCER COMMUNICATIONS 41..9(2021):889-903

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