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Camrelizumab plus carboplatin and paclitaxel as first-line treatment for advanced squamous non-small-cell lung cancer (CameL-sq): a phase 3 trial.

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作者：
Ren Shengxiang[1] * ; Chen Jianhua[2] ; Xu Xingxiang[3] ; Jiang Tao[1] ; Cheng Ying[4] ; Chen Gongyan[5] ; Pan Yueyin[6] ; Fang Yong[7] ; Wang Qiming[8] ; Huang Yunchao[9] ; Yao Wenxiu[10] ; Wang Rui[11] ; Li Xingya[12] ; Zhang Wei[13] ; Zhang Yanjun[14] ; Hu Sheng[15] ; Guo Renhua[16] ; Shi Jianhua[17] ; Wang Zhiwu[18] ; Cao Peiguo[19] ; Wang Donglin[20] ; Fang Jian[21] ; Luo Hui[22] ; Geng Yi[23] ; Xing Chunyan[24] ; Lv Dongqing[25] ; Zhang Yiping[26] ; Yu Junyan[27] ; Cang Shundong[28] ; Yang Zeyu[29] ; Shi Wei[29] ; Zou Jianjun[29] ; Zhou Caicun[1] ;
机构： [1]Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China. [2]Hunan Cancer Hospital, Changsha, China. [3]Northern Jiangsu People's Hospital, Yangzhou, China. [4]Jilin Cancer Hospital, Changchun, China. [5]Harbin Medical University Cancer Hospital, Harbin, China. [6]Anhui Provincial Hospital, Hefei, China. [7]Sir Run Run Shaw Hospital Zhejiang University School of Medicine, Hangzhou, China. [8]Henan Cancer Hospital, Zhengzhou, China. [9]Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Centre, Kunming, China. [10]Sichuan Provincial Cancer Hospital, Chengdu, China. [11]Anhui Chest Hospital, Hefei, China. [12]The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. [13]The First Affiliated Hospital of Nanchang University, Nanchang, China. [14]Shaanxi Provincial Cancer Hospital, Xi'an, China. [15]Hubei Cancer Hospital, Wuhan, China. [16]Jiangsu Province Hospital, Nanjing, China. [17]LinYi Cancer Hospital, Linyi, China. [18]Tangshan People's Hospital, Tangshan, China. [19]The Third Xiangya Hospital of Central South University, Changsha, China. [20]Chongqing University Cancer Hospital, Chongqing, China. [21]Beijing Cancer Hospital, Beijing, China. [22]Jiangxi Cancer Hospital, Nanchang, China. [23]Baoji Central Hospital, Baoji, China. [24]Jinan Central Hospital, Jinan, China. [25]Taizhou Hospital of Zhejiang Province, Taizhou, China. [26]Zhejiang Cancer Hospital, Hangzhou, China. [27]Heping Hospital Affiliated to Changzhi Medical College, Changzhi, China. [28]Henan Provincial People's Hospital, Zhengzhou, China. [29]Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China
出处：
DOI： 10.1016/j.jtho.2021.11.018
ISSN：

摘要：
Camrelizumab, a humanized IgG4-κ monoclonal antibody against PD-1, has demonstrated anti-tumor activity and tolerability across various tumors, including lung cancers. We conducted this double-blind, randomized phase 3 trial to investigate the efficacy and safety of camrelizumab or placebo plus chemotherapy as first-line treatment for patients with advanced squamous non-small-cell lung cancer (NSCLC). The predictive value of circulating tumor DNA (ctDNA) dynamics was also analyzed.CameL-sq, a double-blind, randomized phase 3 trial (NCT03668496), was conducted in 53 centers in China. 389 patients with stage IIIB-IV squamous NSCLC were randomized (1:1) to receive 4-6 cycles of carboplatin plus paclitaxel with camrelizumab or placebo (q3w), followed by maintenance therapy with camrelizumab or placebo. Peripheral blood ctDNA samples were collected at the baseline and the time after two cycles of treatment.Of 389 eligible patients, 193 patients allocated camrelizumab plus chemotherapy and 196 patients allocated placebo plus chemotherapy were included in the efficacy and safety analysis. The results showed significantly prolonged progression-free survival (PFS, median, 8·5 vs 4.9 months; p<0.0001) and overall survival (OS, median, not reached vs 14.5 months; p<0.0001) with camrelizumab-chemotherapy versus placebo-chemotherapy. No unexpected treatment/immune-related adverse events were observed in both two groups. Biomarker analysis revealed that ctDNA clearance after two cycles treatment was independently associated with dramatically longer PFS (p<0.0001) and OS (p<0.0001) in camrelizumab plus chemotherapy group.Our findings support camrelizumab plus chemotherapy as a first-line treatment option in advanced squamous NSCLC. On-treatment ctDNA dynamics showed the potent to predict the efficacy of camrelizumab plus chemotherapy.Copyright © 2021 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.

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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[2023]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学 1 区 呼吸系统
第一作者：
第一作者机构： [1]Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.
通讯作者：
推荐引用方式(GB/T 7714)：
Ren Shengxiang,Chen Jianhua,Xu Xingxiang,et al.Camrelizumab plus carboplatin and paclitaxel as first-line treatment for advanced squamous non-small-cell lung cancer (CameL-sq): a phase 3 trial.[J].Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.2021,doi:10.1016/j.jtho.2021.11.018.
APA：
Ren Shengxiang,Chen Jianhua,Xu Xingxiang,Jiang Tao,Cheng Ying...&Zhou Caicun.(2021).Camrelizumab plus carboplatin and paclitaxel as first-line treatment for advanced squamous non-small-cell lung cancer (CameL-sq): a phase 3 trial..Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,,
MLA：
Ren Shengxiang,et al."Camrelizumab plus carboplatin and paclitaxel as first-line treatment for advanced squamous non-small-cell lung cancer (CameL-sq): a phase 3 trial.".Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer .(2021)

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