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Sintilimab versus docetaxel as second-line treatment in advanced or metastatic squamous non-small-cell lung cancer: an open-label, randomized controlled phase 3 trial (ORIENT-3)

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收录情况： ◇ SCIE

作者：
Shi, Yuankai[1,*1] * ; Wu, Lin[2] ; Yu, Xinmin[3] ; Xing, Puyuan[1] ; Wang, Yan[1] ; Zhou, Jianying[4] ; Wang, Airong[5] ; Shi, Jianhua[6] ; Hu, Yi[7] ; Wang, Ziping[8] ; An, Guangyu[9] ; Fang, Yong[10] ; Sun, Sanyuan[11] ; Zhou, Caicun[12] ; Wang, Changli[13] ; Ye, Feng[14] ; Li, Xingya[15] ; Wang, Junye[16] ; Wang, Mengzhao[17] ; Liu, Yunpeng[18] ; Zhao, Yanqiu[19] ; Yuan, Ying[20] ; Feng, Jifeng[21,*2] ; Chen, Zhendong[22] ; Shi, Jindong[23] ; Sun, Tao[24] ; Wu, Gang[25] ; Shu, Yongqian[26] ; Guo, Qisen[27] ; Zhang, Yi[28] ; Song, Yong[29] ; Zhang, Shucai[30] ; Chen, Yuan[31] ; Li, Wei[32] ; Niu, Hongrui[33] ; Hu, Wenwei[34] ; Wang, Lijun[35] ; Huang, Jianan[36] ; Zhang, Yang[37] ; Cheng, Ying[38] ; Wu, Zhengdong[39] ; Peng, Bo[40] ; Sun, Jiya[40] ; Mancao, Christoph[40] ; Wang, Yanqi[41] ; Sun, Luyao[41] ;
机构： [1]Chinese Acad Med Sci & Peking Union Med Coll, Natl Canc Ctr,Natl Clin Res Ctr Canc,Canc Hosp, Dept Med Oncol, Beijing Key Lab Clin Study Anticanc Mol Targeted, 17 Panjiayuan Nanli, Beijing 100021, Peoples R China [2]Hunan Canc Hosp, Dept Thorac Med 2, Changsha, Hunan, Peoples R China [3]Zhejiang Canc Hosp, Dept Med Oncol, Hangzhou, Zhejiang, Peoples R China [4]Zhejiang Univ, Affiliated Hosp 1, Coll Med, Dept Resp Dis, Hangzhou, Zhejiang, Peoples R China [5]Weihai Municipal Hosp, Dept Chemotherapy 3, Weihai, Shandong, Peoples R China [6]Linyi Canc Hosp, Dept Med Oncol, Linyi, Shandong, Peoples R China [7]Chinese Peoples Liberat Army, Oncol Dept, Gen Hosp, Beijing, Peoples R China [8]Beijing Canc Hosp, Dept Chest Med, Beijing, Peoples R China [9]Capital Med Univ, Beijing Chao Yang Hosp, Dept Oncol, Beijing, Peoples R China [10]Zhejiang Univ, Sir Run Run Shaw Hosp, Dept Med Oncol, Hangzhou, Zhejiang, Peoples R China [11]Xuzhou Med Univ, Xuzhou Cent Hosp, Dept Med Oncol, Xuzhou, Jiangsu, Peoples R China [12]Tongji Univ, Shanghai Pulm Hosp, Dept Med Oncol, Shanghai, Peoples R China [13]Tianjin Med Univ Canc Inst & Hosp, Dept Lung Canc, Tianjin, Peoples R China [14]Fujian Med Univ, Xiamen Univ, Affiliated Hosp 1, Canc Hosp,Dept Med Oncol, Xiamen, Fujian, Peoples R China [15]Zhengzhou Univ, Dept Med Oncol, Affiliated Hosp 1, Zhengzhou, Henan, Peoples R China [16]Jining Med Univ, Dept Oncol, Affiliated Hosp, Jining, Shandong, Peoples R China [17]Chinese Acad Med Sci & Peking Union Med Coll, Peking Union Med Coll Hosp, Dept Resp & Crit Care Med, Beijing, Peoples R China [18]China Med Univ, Dept Med Oncol, Key Lab Anticanc Drugs & Biotherapy Liaoning Prov, Hosp 1, Shenyang, Liaoning, Peoples R China [19]Zhengzhou Univ, Henan Canc Hosp, Dept Internal Med, Affiliated Canc Hosp, Zhengzhou, Henan, Peoples R China [20]Zhejiang Univ, Dept Med Oncol, Affiliated Hosp 2, Sch Med, Hangzhou, Zhejiang, Peoples R China [21]Nanjing Med Univ, Affiliated Canc Hosp, Jiangsu Inst Canc Res, Dept Med Oncol,Jiangsu Canc Hosp, 42 Baiziting, Nanjing 210009, Jiangsu, Peoples R China [22]Anhui Med Univ, Dept Oncol, Hosp 2, Hefei, Anhui, Peoples R China [23]Fudan Univ, Shanghai Peoples Hosp 5, Dept Resp Med, Shanghai, Peoples R China [24]China Med Univ, Liaoning Canc Hosp & Inst, Dept Med Oncol, Canc Hosp, Shenyang, Liaoning, Peoples R China [25]Huazhong Univ Sci & Technol, Union Hosp, Tongji Med Coll, Canc Ctr, Wuhan, Hubei, Peoples R China [26]Nanjing Med Univ, Dept Oncol, Affiliated Hosp 1, Nanjing, Jiangsu, Peoples R China [27]Shandong Univ, Shandong Canc Hosp, Dept Oncol, Shandong Acad Med Sci,Shandong Canc Hosp & Inst, Jinan, Shandong, Peoples R China [28]Capital Med Univ, Xuanwu Hosp, Dept Thorac Surg, Beijing, Peoples R China [29]Eastern Theater Command PLA, Dept Resp & Crit Care Med, Gen Hosp, Nanjing, Jiangsu, Peoples R China [30]Capital Med Univ, Beijing Chest Hosp, Beijing TB & Thorac Tumor Res Inst, Dept Oncol, Beijing, Peoples R China [31]Huazhong Univ Sci & Technol, Tongji Hosp, Tongji Med Coll, Dept Oncol, Wuhan, Hubei, Peoples R China [32]First Hosp Jilin Univ, Canc Ctr, Changchun, Jilin, Peoples R China [33]Xinxiang Med Univ, Dept Oncol, Affiliated Hosp 1, Xinxiang, Henan, Peoples R China [34]First Peoples Hosp Changzhou, Dept Oncol, Changzhou, Jiangsu, Peoples R China [35]Xingtai Med Coll, Dept Tumor Radiotherapy, Affiliated Hosp 2, Xingtai, Hebei, Peoples R China [36]Soochow Univ, Dept Resp Med, Affiliated Hosp 1, Suzhou, Jiangsu, Peoples R China [37]Dalian Med Univ, Dept Oncol, Hosp 2, Dalian, Liaoning, Peoples R China [38]Jilin Canc Hosp, Dept Thorac Oncol, Changchun, Jilin, Peoples R China [39]Jiangsu Taizhou Peoples Hosp, Dept Oncol, Taizhou, Jiangsu, Peoples R China [40]Innovent Biol Inc, New Drug Biol & Translat Med, Suzhou, Jiangsu, Peoples R China [41]Innovent Biol Inc, Med Sci & Strategy Oncol, Suzhou, Jiangsu, Peoples R China
出处：
DOI： 10.1002/cac2.12385
ISSN：

关键词： Non-small cell lung cancer Carcinoma squamous cell Sintilimab Immunotherapy Survival Randomized controlled trial

摘要：
Background Treatment options for Chinese patients with locally advanced or metastatic squamous-cell non-small-cell lung cancer (sqNSCLC) after failure of first-line chemotherapy are limited. This study (ORIENT-3) aimed to evaluate the efficacy and safety of sintilimab versus docetaxel as second-line treatment in patients with locally advanced or metastatic sqNSCLC. Methods ORIENT-3 was an open-label, multicenter, randomized controlled phase 3 trial that recruited patients with stage IIIB/IIIC/IV sqNSCLC after failure with first-line platinum-based chemotherapy. Patients were randomized in a 1:1 ratio to receive either 200 mg of sintilimab or 75 mg/m(2) of docetaxel intravenously every 3 weeks, stratified by the Eastern Cooperative Oncology Group performance status. The primary endpoint was overall survival (OS) in the full analysis set (FAS). Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), duration of response (DoR) and safety. Results Between August 25, 2017, and November 7, 2018, 290 patients were randomized. For FAS, 10 patients from the docetaxel arm were excluded. The median OS was 11.79 (n = 145; 95% confidence interval [CI], 10.28-15.57) months with sintilimab versus 8.25 (n = 135; 95% CI, 6.47-9.82) months with docetaxel (hazard ratio [HR]: 0.74; 95% CI, 0.56-0.96; P = 0.025). Sintilimab treatment significantly prolonged PFS (median 4.30 vs. 2.79 months; HR: 0.52; 95% CI, 0.39-0.68; P < 0.001) and showed higher ORR (25.50% vs. 2.20%, P < 0.001) and DCR (65.50% vs. 37.80%, P < 0.001) than the docetaxel arm. The median DoR was 12.45 (95% CI, 4.86-25.33) months in the sintilimab arm and 4.14 (95% CI, 1.41-7.23) months in the docetaxel arm (P = 0.045). Treatment-related adverse events of grade >= 3 were reported in 26 (18.1%) patients in the sintilimab arm and 47 (36.2%) patients in the docetaxel arm. Exploratory biomarker analysis showed potential predictive values of expression levels of two transcription factors, including OVOL2 (HR: 0.35; P < 0.001) and CTCF (HR: 3.50; P < 0.001)?for sintilimab treatment. Conclusions Compared with docetaxel, sintilimab significantly improved the OS, PFS, and ORR of Chinese patients with previously treated locally advanced or metastatic sqNSCLC.

基金：
Innovent biologics, Inc.; Eli Lilly and Company; China National Major Project for New Drug Innovation [2017ZX09304015]
语种：
外文
被引次数：
WOS：
PubmedID：
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]Chinese Acad Med Sci & Peking Union Med Coll, Natl Canc Ctr,Natl Clin Res Ctr Canc,Canc Hosp, Dept Med Oncol, Beijing Key Lab Clin Study Anticanc Mol Targeted, 17 Panjiayuan Nanli, Beijing 100021, Peoples R China [*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, No. 17 Panjiayuan Nanli, Chaoyang District, Beijing 100021, P. R. China.
通讯作者：
通讯机构： [1]Chinese Acad Med Sci & Peking Union Med Coll, Natl Canc Ctr,Natl Clin Res Ctr Canc,Canc Hosp, Dept Med Oncol, Beijing Key Lab Clin Study Anticanc Mol Targeted, 17 Panjiayuan Nanli, Beijing 100021, Peoples R China [21]Nanjing Med Univ, Affiliated Canc Hosp, Jiangsu Inst Canc Res, Dept Med Oncol,Jiangsu Canc Hosp, 42 Baiziting, Nanjing 210009, Jiangsu, Peoples R China [*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, No. 17 Panjiayuan Nanli, Chaoyang District, Beijing 100021, P. R. China. [*2]Department of Medical Oncology, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, Nanjing Medical University Affiliated Cancer Hospital, 42 Baiziting, Xuanwu District, Nanjing, Jiangsu 210009, P. R. China
推荐引用方式(GB/T 7714)：
Shi Yuankai,Wu Lin,Yu Xinmin,et al.Sintilimab versus docetaxel as second-line treatment in advanced or metastatic squamous non-small-cell lung cancer: an open-label, randomized controlled phase 3 trial (ORIENT-3)[J].CANCER COMMUNICATIONS.2022,42(12):1314-1330.doi:10.1002/cac2.12385.
APA：
Shi, Yuankai,Wu, Lin,Yu, Xinmin,Xing, Puyuan,Wang, Yan...&Sun, Luyao.(2022).Sintilimab versus docetaxel as second-line treatment in advanced or metastatic squamous non-small-cell lung cancer: an open-label, randomized controlled phase 3 trial (ORIENT-3).CANCER COMMUNICATIONS,42,(12)
MLA：
Shi, Yuankai,et al."Sintilimab versus docetaxel as second-line treatment in advanced or metastatic squamous non-small-cell lung cancer: an open-label, randomized controlled phase 3 trial (ORIENT-3)".CANCER COMMUNICATIONS 42..12(2022):1314-1330

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