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| 1 | 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)显示文摘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 fromthe docetaxel armwere excluded.Themedian 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 DoRwas 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≥3were 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. | Yuankai Shi Lin Wu Xinmin Yu Puyuan Xing Yan Wang Jianying Zhou Airong Wang Jianhua Shi Yi Hu Ziping Wang Guangyu An Yong Fang Sanyuan Sun Caicun Zhou Changli Wang Feng Ye Xingya Li Junye Wang Mengzhao Wang Yunpeng Liu Yanqiu Zhao Ying Yuan Jifeng Feng Zhendong Chen Jindong Shi Tao Sun Gang Wu Yongqian Shu Qisen Guo Yi Zhang Yong Song Shucai Zhang Yuan Chen Wei Li Hongrui Niu Wenwei Hu Lijun Wang Jianan Huang Yang Zhang Ying Cheng Zhengdong Wu Bo Peng Jiya Sun Christoph Mancao Yanqi Wang Luyao Sun | 2022 | Cancer Communications2022，42，12： | 8 |
| 2 | Clevidipine effec- tively and rapidly controls blood pressure preoperatively incardiac surgery patients : the results of the randomized, placebo- controlled efficacy study of clevidipine assessing its preoperative hypertensive effect in cardiac surgery-l显示文摘 | LEVY JH MANCAO MY GITTER R | 2007 | Anesth Analg2007，105，4： | 1 |
| 3 | Clevidipine effectively and rapidly controls blood pressure preoperatively in cardiac surgery patients: the results of the randomized, placebo-controlled efficacy study of clevidipine assessing its preoperative antihypertensive effect in cardiac surgery-1 显示文摘 | Levy JH Mancao MY Gitter R | 2007 | Anesthesia and Analgesia2007，105，4： | 1 |
| 4 | Cerebrospinal fluid shunt in-fetions in infants and children in mobile,Alabama显示文摘 | Mancao M MillerC Cochrane B | | 0，，06： | 1 |
| 5 | Power Quality Monitoring of a Distribution System 显示文摘 | Mancao R T | 1994 | IEEE Trans on Power Delivery1994，9，2： | 1 |
| 6 | Clevidipine effectively and rapidly controls blood pressure preoperatively in cardiac surgery patients:the results of the randomized, placebo-controlled efficacy study of clevidipine assessing its preoperative antihypertensive effect in cardiac surgery-l显示文摘 | Levy JH Mancao MY Gitter R | 2007 | Anesth Analg2007，105，： | 1 |
| 7 | Epstein-Barr virus latent membrane protein 2A is a B-cell receptor mimic and essential for B-cell survival显示文摘 | Mancao C Hammersehmidt W | 2007 | Blood2007，110，10： | 1 |
| 8 | Clevidipine effectively andrapidly controls blood pressure preoperatively in cardiac surgery pa-tients: The results of the randomized, placebo-controlled efficacystudy of clevidipine assessing its preoperative antihypertensive effectin cardiac surgery-1显示文摘 | Levy JH Mancao MY Gitter R | 2007 | Anesth Analg2007，105，： | 1 |
| 9 | Cerebrospinal fluid shunt infection in infants and children in mobile,Alabama显示文摘 | Mancao M Miller C Coehrane B | 1998 | Acta Pedliatr1998，87，6： | 1 |
| 10 | Rescue of“crippled”germinal center B cells from apoptosis by epstein-barr virus显示文摘 | MANCAO C ALTMANN M JUNGNICKEL B | 2005 | Blood2005，106，13： | 1 |
| 11 | Cerebrospinal fluid shunt infections in infants and children in mobile,alabama显示文摘 | Miller C Cochrane B | 1998 | Acta Pediatr1998，87，6： | 1 |
| 12 | Clevidipine effectively and rapidly controls blood pressure preoperatively in cardiac surgery patients: the results of the randomized, placebo-controlled efficacy study of clevidipine assessing its preoperative antihypertensive effect in cardiac surgery-1 显示文摘 | LEVY JH MANCAO MY GITTER R | 2007 | Anesth Analg2007，105，4： | 1 |
| 13 | Characteristics of lightning surges measured at metal oxide distribution arresters显示文摘 | Barker P P Mancao R T Kvaltine D J | 1993 | IEEE Transactions on Power Delivery1993，8，1： | 1 |
| 14 | Cerebrospinal fluid shunt infections in infants and children in mobile 显示文摘 | Mancao M Miller C Cochrane B | 1998 | Acta Pae- diatr1998，87，6： | 1 |
| 15 | Rescue of 'crippled' germinal center B ceils from apoptosis by Epstein-Barr virus 显示文摘 | Mancao C Altmann M Jungnickel B | 2005 | Blood2005，106，13： | 1 |
| 16 | Application of MOVs in the distribution environment 显示文摘 | Short T A Burke J J Mancao R T | 1994 | IEEE T-PWRD1994，9，1： | 1 |
| 17 | Cerebrospinal fluid shunt infections in infants and children in Mobile, Alabama 显示文摘 | Mancao M Miller C Cochrane B | 1998 | Acta Paediatr1998，87，6： | 1 |
| 18 | Cerebrospinal fluid shunt infections in infants and children in mobile, Alabama 显示文摘 | Mancao M Miller C Cochrane B | 1998 | ActaPacdiatr1998，87，6： | 1 |
| 19 | Generation of EBV-specific cytotoxic T cells that are resistant to calcineurin inhibitors for the treatment of posttransplantation lymphoproliferative disease 显示文摘 | Brewin J Mancao C Straathof K | 2009 | Blood2009，114，23： | 1 |
| 20 | Cerebrospinal fluid shunt infections in infants and children in mobile,alabama显示文摘 | Mancao M Miller C Cochrane B | 1998 | Acta Pacdiatr1998，87，6： | 1 |
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