CamreliZumab Plus Carboplatin and PemetreXed as First-Line Treatment for Advanced NonsQuamous NSCLC: EXtended Follow-Up of CameL Phase 3 Trial

作者全名："Zhou, Caicun; Chen, Gongyan; Huang, Yunchao; Zhou, Jianying; Lin, LiZhu; Feng, Jifeng; Wang, Zhehai; Shu, YongQian; Shi, Jianhua; Hu, Yi; Wang, QiMing; Cheng, Ying; Wu, Fengying; Chen, Jianhua; Lin, Xiaoyan; Wang, Yongsheng; Huang, Jianan; Cui, Jiuwei; Cao, Lejie; Liu, Yunpeng; Zhang, Yiping; Pan, Yueyin; Zhao, Jun; Wang, LiPing; Chang, Jianhua; Chen, Qun; Ren, Xiubao; Zhang, Wei; Fan, Yun; He, Zhiyong; Fang, Jian; Gu, Kangsheng; Dong, XiaoRong; Jin, Faguang; Gao, Hongjun; An, Guangyu; Ding, Cuimin; Jiang, Xiaodong; Xiong, Jianping; Zhou, Xiangdong; Hu, Sheng; Lu, Ping; Liu, Anwen; Guo, Shuliang; Huang, Jianjin; Zhu, Chengchu; Zhao, Jian; Gao, Beili; Chen, Yinglan; Hu, Chengping; Zhang, Jian; Zhang, Hongmei; Zhao, Hui; Tai, Yanfei; Ma, Xinjing; Shi, Wei; CameL Study Grp"

作者地址："[Zhou, Caicun; Wu, Fengying] Tongji Univ, Shanghai Pulm Hosp, Dept Med Oncol, Sch Med, 507 Zhengmin Rd, Shanghai 200433, Peoples R China; [Chen, Gongyan] Harbin Med Univ Canc Hosp, Dept Resp Med, Harbin, Peoples R China; [Huang, Yunchao] Kunming Med Univ, Yunnan Canc Hosp, Dept Thorac Surg Oncol, Kunming, Peoples R China; [Huang, Yunchao] Kunming Med Univ, Affiliated Hosp 3, Kunming, Peoples R China; [Huang, Yunchao] Yunnan Canc Ctr, Kunming, Peoples R China; [Zhou, Jianying] Zhejiang Univ, Affiliated Hosp 1, Resp Med, Hangzhou, Peoples R China; [Lin, LiZhu] Guangzhou Univ Chinese Med, Affiliated Hosp 1, Oncol Ctr, Guangzhou, Peoples R China; [Feng, Jifeng] Nanjing Med Univ, Jiangsu Canc Hosp, Dept Thorac Med Oncol, Nanjing, Peoples R China; [Feng, Jifeng] Nanjing Med Univ, Jiangsu Inst Canc Res, Nanjing, Peoples R China; [Feng, Jifeng] Nanjing Med Univ, Affiliated Canc Hosp, Nanjing, Peoples R China; [Wang, Zhehai] Shandong Canc Hosp & Inst, Dept Resp, Jinan, Peoples R China; [Shu, YongQian] Jiangsu Prov Hosp, Dept Oncol, Nanjing, Peoples R China; [Shi, Jianhua] Linyi Canc Hosp, Dept Med Oncol, Linyi, Peoples R China; [Hu, Yi] Gen Hosp Chinese Peoples Liberat Army, Oncol Dept, Beijing, Peoples R China; [Wang, QiMing] Henan Canc Hosp, Resp Med, Zhengzhou, Peoples R China; [Cheng, Ying] Jilin Canc Hosp, Dept Thorac Oncol, Changchun, Peoples R China; [Chen, Jianhua] Hunan Canc Hosp, Dept Med Oncol Chest, Changsha, Peoples R China; [Lin, Xiaoyan] Fujian Med Univ Union Hosp, Dept Oncol, Fuzhou, Peoples R China; [Wang, Yongsheng] Sichuan Univ, West Peoples Republ China Hosp, Dept Thorac Med Oncol, Chengdu, Peoples R China; [Huang, Jianan] Suzhou Univ, Affiliated Hosp 1, Dept Respirat, Suzhou, Peoples R China; [Cui, Jiuwei] Jilin Univ, Bethune Hosp 1, Dept Med Oncol, Changchun, Peoples R China; [Cao, Lejie] Univ Sci Technol Peoples Republ China, Affiliated Hosp 1, Pulm & Crit Care Med, Hefei, Peoples R China; [Liu, Yunpeng] First Hosp Peoples Republ China Med Univ, Dept Med Oncol, Shenyang, Peoples R China; [Zhang, Yiping; Fan, Yun] Zhejiang Canc Hosp, Dept Thorac Med Oncol, Hangzhou, Peoples R China; [Pan, Yueyin] Univ Sci Technol Peoples Republ China, Affiliated Hosp 1, Dept Tumor Chemotherapy, Hefei, Peoples R China; [Zhao, Jun] Peking Univ Canc Hosp & Inst, Dept Thorac Med Oncol, Beijing, Peoples R China; [Wang, LiPing] Zhengzhou Univ, Affiliated Hosp 1, Dept Med Oncol, Zhengzhou, Peoples R China; [Chang, Jianhua] Fudan Univ, Shanghai Canc Ctr, Dept Med Oncol, Shanghai, Peoples R China; [Chen, Qun] Fuzhou Pulm Hosp Fujian, Dept Oncol, Fuzhou, Peoples R China; [Ren, Xiubao] Tianjin Med Univ Canc Inst & Hosp, Dept Biotherapy, Tianjin, Peoples R China; [Zhang, Wei] Nanchang Univ, Affiliated Hosp 1, Pneumol Dept, Nanchang, Peoples R China; [He, Zhiyong] Fujian Canc Hosp, Dept Thorac Oncol, Fuzhou, Peoples R China; [Fang, Jian] Peking Univ Canc Hosp & Inst, Dept Thorac Oncol 2, Key Lab Carcinogenesis & Translat Res, Minist Educ Beijing, Beijing, Peoples R China; [Gu, Kangsheng] Anhui Med Univ, Affiliated Hosp 1, Dept Med Oncol, Hefei, Peoples R China; [Dong, XiaoRong] Huazhong Univ Sci & Technol, Union Hosp, Tongji Med Coll, Canc Ctr, Wuhan, Peoples R China; [Jin, Faguang] Air Force Med Univ, Affiliated Hosp 2, Dept Resp Med, Xian, Peoples R China; [Gao, Hongjun] Chinese Peoples Liberat Army Gen Hosp, Dept Pulm Oncol, Med Ctr 5, Beijing, Peoples R China; [An, Guangyu] Capital Med Univ, Beijing Chaoyang Hosp, Dept Med Oncol, Beijing, Peoples R China; [Ding, Cuimin] Hebei Med Univ, Clin Med Coll 4, Dept Resp Med, Shijiazhuang, Peoples R China; [Jiang, Xiaodong] First Peoples Hosp Lianyungang City, Dept Med Oncol, Lianyungang, Peoples R China; [Xiong, Jianping] Nanchang Univ, Affiliated Hosp 1, Dept Med Oncol, Nanchang, Peoples R China; [Zhou, Xiangdong] Army Med Univ, Affiliated Hosp 1, Dept Resp Med, Chongqing, Peoples R China; [Hu, Sheng] Hubei Canc Hosp, Dept Thorac Med, Wuhan, Peoples R China; [Lu, Ping] Xinxiang Med Univ, Affiliated Hosp 1, Dept Med Oncol, Xinxiang, Peoples R China; [Liu, Anwen] Nanchang Univ, Affiliated Hosp 2, Dept Med Oncol, Nanchang, Peoples R China; [Guo, Shuliang] Chongqing Med Univ, Affiliated Hosp 1, Dept Resp Med, Chongqing, Peoples R China; [Huang, Jianjin] Zhejiang Univ, Affiliated Hosp 2, Dept Med Oncol, Hangzhou, Peoples R China; [Zhu, Chengchu] Taizhou Hosp Zhejiang Prov, Dept Cardiothorac Surg, Taizhou, Peoples R China; [Zhao, Jian] Guangzhou Med Univ, Canc Ctr, Dept Thorac Surg Oncol, Guangzhou, Peoples R China; [Gao, Beili] Shanghai Jiao Tong Univ, Ruijin Hosp, Dept Resp Med, Sch Med, Shanghai, Peoples R China; [Chen, Yinglan] Jiangxi Canc Hosp, Dept Med Oncol, Nanchang, Peoples R China; [Hu, Chengping] Cent South Univ, Dept Resp Med, Xiangya Hosp, Changsha, Peoples R China; [Zhang, Jian] Air Force Med Univ, Affiliated Hosp 1, Dept Resp Med, Xian, Peoples R China; [Zhang, Hongmei] Air Force Med Univ, Affiliated Hosp 1, Dept Med Oncol, Xian, Peoples R China; [Zhao, Hui] Anhui Med Univ, Affiliated Hosp 2, Dept Resp Med, Hefei, Peoples R China; [Tai, Yanfei; Ma, Xinjing; Shi, Wei] Jiangsu Hengrui Pharmaceut, Clin Res & Dev, Shanghai, Peoples R China"

通信作者："Zhou, CC (通讯作者)，Tongji Univ, Shanghai Pulm Hosp, Dept Med Oncol, Sch Med, 507 Zhengmin Rd, Shanghai 200433, Peoples R China."

来源：JOURNAL OF THORACIC ONCOLOGY

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:001031382000001

JCR分区：Q1

影响因子：20.4

年份：2023

卷号：18

期号：5

开始页：628

结束页：639

文献类型：Article

关键词：Immunotherapy; PD-1; Camrelizumab; Chemo-therapy; Nonsquamous non-small cell lung cancer

摘要："Introduction: In CameL phase 3 study (ClinicalTrials.gov: NCT03134872), addition of camrelizumab to first-line chemotherapy significantly improved the progression-free survival in patients with stages IIIB to IV nonsquamous NSCLC. Here, we present outcomes after a minimum followup of 43.9 months since last patient randomization.Methods: Eligible patients were randomized 1:1 to 4 to 6 cycles of camrelizumab plus carboplatin and pemetrexed or chemotherapy alone every 3 weeks, followed by maintenance camrelizumab plus pemetrexed or pemetrexed only (n = 205 and 207, respectively). Total camrelizumab exposure was up to 2 years.Results: As of January 31, 2022, camrelizumab plus chemotherapy exhibited substantially improved overall survival over chemotherapy alone (median, 27.1 versus 19.8 mo; hazard ratio = 0.72 [95% confidence interval: 0.57-0.92]). In the chemotherapy-alone group, 95 patients (45.9%) crossed over to camrelizumab monotherapy. After adjustment for crossover, the survival benefit with camre-lizumab plus chemotherapy was more pronounced (adjusted hazard ratio = 0.55 [95% confidence interval: 0.42-0.71]). In camrelizumab plus chemotherapy group, 33 patients completed 2 years of camrelizumab. Objective response rate was 97.0%, with ongoing responses in 17 of the 32 responses (53.1%), and 93.9% (31 of 33) of the patients were alive at data cutoff. Safety profiles were consistent with the previous report, and no obvious evi-dence of cumulative toxicity was found with long exposure to camrelizumab.Conclusions: Camrelizumab plus carboplatin and peme-trexed provides long-term survival benefit over chemo-therapy, with manageable toxicity and remarkable and durable response in patients receiving 2 years of camreli-zumab, further supporting camrelizumab combination as first-line treatment for advanced nonsquamous NSCLC.& COPY; 2023 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved."

基金机构：Shanghai Municipal Health Commission Collaborative Innovation Cluster Program [2020CXJQ02]; National Natural Science Foundation of China [82141101]

基金资助正文："This study was funded by Jiangsu Hengrui Pharmaceuticals, which participated in study design, data collection, and data interpretation. This study was also supported, in part, by grants from the Shanghai Municipal Health Commission Collaborative Innovation Cluster Program (No. 2020CXJQ02) and the National Natural Science Foundation of China (No. 82141101) . We are grateful to all patients and their families and all members of the collaborative group. We acknowledge PAREXEL Inter- national for statistical analyses (funded by Hengrui) and Dr. Hui Dong for medical writing support (medical writer at Hengrui) ."