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Biosimilar candidate IBI305 plus paclitaxel/carboplatin for the treatment of non-squamous non-small cell lung cancer

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收录情况： ◇ SCIE

作者：
Yang, Yunpeng[1] * ; Wu, Bin[2] ; Huang, Linian[3] ; Shi, Meiqi[4] ; Liu, Yunpeng[5] ; Zhao, Yanqiu[6] ; Wang, Lijun[7] ; Lu, Shun[8] ; Chen, Gongyan[9] ; Li, Baolan[10] ; Xie, Conghua[11] ; Fang, Jian[12] ; Yang, Nong[13] ; Zhang, Yiping[14] ; Cui, Jiuwei[15] ; Song, Yong[16] ; Zhang, Cuiying[17] ; Mei, Xiaodong[18] ; Cao, Bangwei[19] ; Yang, Lan[20] ; Cheng, Ying[21] ; Ying, Kejing[22] ; Sun, Tao[23] ; Ren, Biyong[24] ; Yu, Qitao[25] ; Liao, Zijun[26] ; Pei, Zhidong[27] ; Wang, Mengzhao[28] ; Zhou, Jianying[29] ; Yu, Shiying[30] ; Feng, Guosheng[31] ; Wan, Huiping[32] ; Wang, Huaqing[33] ; Gao, Shegan[34] ; Wang, Jinliang[35] ; An, Guangyu[36] ; Geng, Yi[37] ; Ji, Yanxia[38] ; Yuan, Ying[39] ; Ma, Shenglin[40] ; Jia, Zhongyao[41] ; Hu, Mu[42] ; Zhou, Hui[43] ; Yu, Jie[43] ; Sun, Xing[43] ; Zhang, Li[1] ;
单位： [1]Sun Yat Sen Univ, Dept Med Oncol, State Key Lab Oncol South China, Collaborat Innovat Ctr Canc Med,Canc Ctr, Guangzhou 510000, Guangdong, Peoples R China [2]Guangdong Med Univ, Dept Resp Med, Affiliated Hosp, Zhanjiang 524002, Peoples R China [3]Bengbu Med Coll, Dept Resp Med, Affiliated Hosp 1, Bangbu 233000, Peoples R China [4]Jiangsu Canc Hosp, Dept Oncol, Nanjing 210009, Jiangsu, Peoples R China [5]China Med Univ, Dept Oncol, Hosp 1, Shenyang 110001, Liaoning, Peoples R China [6]Henan Canc Hosp, Dept Resp Med, Zhengzhou 450003, Henan, Peoples R China [7]Xingtai Med Coll, Dept Tumor Radiotherapy, Affiliated Hosp 2, Xingtai 054000, Peoples R China [8]Shanghai Chest Hosp, Dept Oncol, Shanghai 200030, Peoples R China [9]Harbin Med Univ, Canc Hosp, Dept Oncol, Harbin 150081, Heilongjiang, Peoples R China [10]Capital Med Univ, Gen Dept, Beijing Chest Hosp, Beijing 101149, Peoples R China [11]Wuhan Univ, Zhongnan Hosp, Dept Oncol, Wuhan 430071, Hubei, Peoples R China [12]Peking Univ Canc Hosp, Dept Oncol, Beijing 100142, Peoples R China [13]Hunan Canc Hosp, Dept Pulm Gastroenterol, Changsha 410006, Hunan, Peoples R China [14]Zhejiang Canc Hosp, Dept Oncol, Hangzhou 310022, Zhejiang, Peoples R China [15]First Hosp Jilin Univ, Dept Oncol, Changchun 130000, Jilin, Peoples R China [16]Eastern Theater Command, Dept Resp Med, Gen Hosp, Nanjing 210002, Jiangsu, Peoples R China [17]Inner Mongolia Peoples Hosp, Dept Oncol, Hohhot 010017, Peoples R China [18]An Hui Prov Hosp, Dept Resp Med, Hefei 230000, Anhui, Peoples R China [19]Capital Med Univ, Peking Friendship Hosp, Dept Oncol, Beijing 100050, Peoples R China [20]Xi An Jiao Tong Univ, Dept Resp Med, Affiliated Hosp 1, Xian 710061, Shaanxi, Peoples R China [21]Jilin Canc Hosp, Dept Oncol, Changchun 130000, Jilin, Peoples R China [22]Zhejiang Univ, Sch Med, Dept Resp Med, Sir Run Shaw Hosp, Hangzhou 310016, Zhejiang, Peoples R China [23]Liaoning Canc Hosp & Inst, Dept Internal Med, Shenyang 110046, Liaoning, Peoples R China [24]Chongqing Three Gorges Cent Hosp, Dept Resp Med, Chongqing 404000, Peoples R China [25]Canc Hosp Guangxi Zhuang Autonomous Reg, Dept Oncol, Nanning 530000, Peoples R China [26]Shaanxi Prov Tumor Hosp, Dept Internal Med, Xian 710061, Shaanxi, Peoples R China [27]Zhengzhou Univ, Dept Oncol, Luoyang Cent Hosp, Luoyang 471009, Peoples R China [28]Peking Union Med Coll Hosp, Dept Resp Med, Beijing 100005, Peoples R China [29]Zhejiang Univ, Dept Resp Med, Affiliated Hosp 1, Hangzhou 310003, Zhejiang, Peoples R China [30]Huazhong Univ Sci & Technol, Dept Oncol, Tongji Hosp, Tongji Med Coll, Wuhan 430000, Hubei, Peoples R China [31]Peoples Hosp Guangxi Zhuang Autonomous Reg, Dept Chemotherapy, Nanning 530000, Peoples R China [32]Jiangxi Peoples Hosp, Dept Oncol, Nanchang 330000, Jiangxi, Peoples R China [33]Tianjin Peoples Hosp, Dept Oncol, Tianjin 300121, Peoples R China [34]Henan Univ Sci & Technol, Dept Oncol, Affiliated Hosp 1, Luoyang 471000, Peoples R China [35]PLA, Dept Oncol, Gen Hosp, Beijing 100853, Peoples R China [36]Beijing Chao Yang Hosp, Dept Oncol, Beijing 100020, Peoples R China [37]Baoji Cent Hosp, Dept Oncol, Baoji 721008, Peoples R China [38]Handan Cent Hosp, Dept Oncol, Handan 056001, Peoples R China [39]Zhejiang Univ, Dept Oncol, Affiliated Hosp 2, Hangzhou 310009, Zhejiang, Peoples R China [40]Hangzhou First Peoples Hosp, Dept Oncol, Hangzhou 310002, Zhejiang, Peoples R China [41]Linyi Peoples Hosp, Dept Oncol, Linyi 276003, Shandong, Peoples R China [42]Capital Med Univ, Dept Chest Surg, Xuanwu Hosp, Beijing 100053, Peoples R China [43]Innovent Biol Inc, Suzhou 215123, Peoples R China
出处：
DOI： 10.21037/tlcr.2019.12.23
ISSN：

关键词： Bevacizumab IBI305 non-small cell lung cancer (NSCLC) biosimilar vascular endothelial growth factor (VEGF)

摘要：
Background: Bevacizumab is a monoclonal antibody (mAb) against vascular endothelial growth factor (VEGF) and used for treatments of various cancers. Due to the high casts of bevacizumab treatments, a biosimilar provides an affordable alternative therapy for cancer patients. Methods: In this randomized, double-blind, multicenter, phase 3 study, locally advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) patients with wild-type epidermal growth factor receptor were enrolled and randomized (1:1) into IBI305 or bevacizumab groups. Patients received 6 cycles of paclitaxel/carboplatin plus IBI305 or bevacizumab 15 mg/kg intravenously followed by IBI305 or bevacizumab 7.5 mg/kg maintenance until disease progression, unacceptable toxicity or death. The primary endpoint was confirmed objective response rate (ORR) by an independent radiological review committee (IRRC) and secondary endpoints included disease control rate (DCR), progression-free survival (PFS), duration of response (DOR), overall survival (OS) and safety. Results: A total of 450 NSCLC patients were enrolled (224 in IBI305 group and 226 in bevacizumab group). ORRs were 44.3% for IBI305 and 46.4% for bevacizumab, and the ORR ratio was 0.95 (90% CI: 0.803 to 1.135), within the predefined equivalence margin of 0.75 to 1.33. No significant difference in PFS (7.64 vs. 7.77 m, P=0.9987) was observed between the 2 groups. Serious adverse events (AEs) occurred in 33.5% (75/224) of patients in the IBI305 group and 37.6% (85/226) in the bevacizumab group. AEs >= grade 3 were similar in the IBI305 and bevacizumab groups [84.4% (189/224) vs. 89.8% (203/226), P=0.085]. Conclusions: IBI305 is similar to bevacizumab in terms of efficacy and safety.

基金：
Innovent Biologics, Inc.
语种：
外文
被引次数：
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2018]版：
无
最新[2025]版：
大类 | 3 区 医学
小类 | 3 区 肿瘤学 3 区 呼吸系统
JCR分区：
出版当年[2017]版：
无
最新[2023]版：
Q1 RESPIRATORY SYSTEM Q2 ONCOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2017版] 出版当年五年平均 出版前一年[2016版] 出版后一年[2018版]

第一作者：
第一作者单位： [1]Sun Yat Sen Univ, Dept Med Oncol, State Key Lab Oncol South China, Collaborat Innovat Ctr Canc Med,Canc Ctr, Guangzhou 510000, Guangdong, Peoples R China
通讯作者：
推荐引用方式(GB/T 7714)：
Yang Yunpeng,Wu Bin,Huang Linian,et al.Biosimilar candidate IBI305 plus paclitaxel/carboplatin for the treatment of non-squamous non-small cell lung cancer[J].TRANSLATIONAL LUNG CANCER RESEARCH.2019,8(6):989-+.doi:10.21037/tlcr.2019.12.23.
APA：
Yang, Yunpeng,Wu, Bin,Huang, Linian,Shi, Meiqi,Liu, Yunpeng...&Zhang, Li.(2019).Biosimilar candidate IBI305 plus paclitaxel/carboplatin for the treatment of non-squamous non-small cell lung cancer.TRANSLATIONAL LUNG CANCER RESEARCH,8,(6)
MLA：
Yang, Yunpeng,et al."Biosimilar candidate IBI305 plus paclitaxel/carboplatin for the treatment of non-squamous non-small cell lung cancer".TRANSLATIONAL LUNG CANCER RESEARCH 8..6(2019):989-+

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