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Camrelizumab plus carboplatin and pemetrexed as first-line therapy for advanced non-squamous non-small-cell lung cancer: 5-year outcomes of the CameL randomized phase 3 study

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作者：
Zhou Caicun[1] * ; Chen Gongyan[2] ; Huang Yunchao[3] ; Zhou Jianying[4] ; Lin LiZhu[5] ; Feng Jifeng[6] ; Wang Zhehai[7] ; Shu Yongqian[8] ; Shi Jianhua[9] ; Hu Yi[10] ; Wang QiMing[11] ; Cheng Ying[12] ; Wu Fengying[13] ; Chen Jianhua[14] ; Lin Xiaoyan[15] ; Wang Yongsheng[16] ; Huang Jianan[17] ; Cui Jiuwei[18] ; Cao Lejie[19] ; Liu Yunpeng[20] ; Zhang Yiping[21] ; Pan Yueyin[22] ; Zhao Jun[23] ; Wang LiPing[24] ; Chang Jianhua[25] ; Chen Qun[26] ; Ren Xiubao[27] ; Zhang Wei[28] ; Fan Yun[21] ; He Zhiyong[29] ; Fang Jian[30] ; Gu Kangsheng[31] ; Dong XiaoRong[32] ; Jin Faguang[33] ; Gao Hongjun[34] ; An Guangyu[35] ; Ding Cuimin[36] ; Jiang Xiaodong[37] ; Xiong Jianping[38] ; Zhou Xiangdong[39] ; Hu Sheng[40] ; Lu Ping[41] ; Liu Anwen[42] ; Guo Shuliang[43] ; Huang Jianjin[44] ; Zhu Chengchu[45] ; Zhao Jian[46] ; Gao Beili[47] ; Chen Yinglan[48] ; Hu Chengping[49] ; Zhang Jian[50] ; Zhang Hongmei[51,51] ; Zhao Hui[52] ; Wang Zhigao[53] ; Ma Xinjing[53] ; Shi Wei[53] ;
机构： [1]Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China caicunzhou_dr@163.com. [2]Department of Respiratory Medicine, Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China. [3]Department of Thoracic Surgery Oncology, Yunnan Cancer Hospital and The Third Affiliated Hospital of Kunming Medical University and Yunnan Cancer Center, Kunming, Yunnan, China. [4]Respiratory Medicine, The First Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, China. [5]Oncology Center, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China. [6]Department of Thoracic Medical Oncology, Jiangsu Cancer Hospital and Jiangsu Institute of Cancer Research and The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, Jiangsu, China. [7]Department of Respiratory, Shandong Cancer Hospital and Institute, Jinan, Shandong, China. [8]Department of Oncology, Jiangsu Province Hospital, Nanjing, Jiangsu, China. [9]Department of Medical Oncology, Linyi Cancer Hospital, Linyi, Shandong, China. [10]Oncology Department, General Hospital of Chinese People's Liberation Army, Beijing, China. [11]Respiratory Medicine, Henan Cancer Hospital, Zhengzhou, Henan, China. [12]Department of Thoracic Oncology, Jilin Cancer Hospital, Changchun, Jilin, China. [13]Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China. [14]Department of Medical Oncology-Chest, Hunan Cancer Hospital, Changsha, Hunan, China. [15]Department of Oncology, Fujian Medical University Union Hospital, Fuzhou, Fujian, China. [16]Department of Thoracic Medical Oncology, West China Hospital, Sichuan University, Chengdu, Sichuan, China. [17]Department of Respiration, First Affiliated Hospital of Suzhou University, Suzhou, Jiangsu, China. [18]Department of Medical Oncology, The First Bethune Hospital of Jilin University, Changchun, Jilin, China. [19]Pulmonary and Critical Care Medicine, The First Affiliated Hospital University of Science Technology of China, Hefei, Anhui, China. [20]Department of Medical Oncology, The First Hospital of China Medical University, Shenyang, Liaoning, China. [21]Department of Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China. [22]Department of Tumor Chemotherapy, The First Affiliated Hospital University of Science Technology of China, Hefei, Anhui, China. [23]Department of Thoracic Medical Oncology, Peking University Cancer Hospital and Institute, Beijing, China. [24]Department of Medical Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China. [25]Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. [26]Department of Oncology, Fuzhou Pulmonary Hospital of Fujian, Fuzhou, Fujian, China. [27]Department of Biotherapy, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China. [28]Pneumology Department, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China. [29]Department of Thoracic Oncology, Fujian Cancer Hospital, Fuzhou, Fujian, China. [30]Department of Thoracic Oncology II, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing, China. [31]Department of Medical Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China. [32]Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China. [33]Department of Respiratory Medicine, The Second Affiliated Hospital of Air Force Medical University, Xi'an, Shaanxi, China. [34]Department of Pulmonary Oncology, Fifth Medical Center of Chinese People's Liberation Army General Hospital, Beijing, China. [35]Department of Medical Oncology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China. [36]Department of Respiratory Medicine, The Fourth Clinical Medical College of Hebei Medical University, Shijiazhuang, Hebei, China. [37]Department of Medical Oncology, First People's Hospital of Lianyungang City, Lianyungang, Jiangsu, China. [38]Department of Medical Oncology, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China. [39]Department of Respiratory Medicine, First Affiliated Hospital of Army Medical University, Chongqing, Chongqing, China. [40]Department of Thoracic Medicine, Hubei Cancer Hospital, Wuhan, Hubei, China. [41]Department of Medical Oncology, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, Henan, China. [42]Department of Medical Oncology, The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China. [43]Department of Respiratory Medicine, First Affiliated Hospital of Chongqing Medical University, Chongqing, China. [44]Department of Medical Oncology, The Second Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, China. [45]Department of Cardiothoracic Surgery, Taizhou Hospital of Zhejiang Province, Taizhou, Zhejiang, China. [46]Department of Thoracic Surgical Oncology, Cancer Center of Guangzhou Medical University, Guangzhou, Guangdong, China. [47]Department of Respiratory Medicine, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China. [48]Department of Medical Oncology, Jiangxi Cancer Hospital, Nanchang, Jiangxi, China. [49]Department of Respiratory Medicine, Xiangya Hospital Central South University, Changsha, Hunan, China. [50]Department of Respiratory Medicine, The First Affiliated Hospital of Air Force Medical University, Xi'an, Shaanxi, China. [51]Department of Medical Oncology, The First Affiliated Hospital of Air Force Medical University, Xi'an, Shaanxi, China. [52]Department of Respiratory Medicine, Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China. [53]Clinical Research and Development, Jiangsu Hengrui Pharmaceuticals, Shanghai, China.
出处：
DOI： 10.1136/jitc-2024-009240

摘要：
CameL phase 3 study demonstrated the superiority of camrelizumab plus chemotherapy over chemotherapy alone for progression-free survival in patients with previously untreated advanced non-squamous non-small-cell lung cancer (NSCLC) without EGFR/ALK alterations. Here, we present the 5-year outcomes.Patients were randomized (1:1) and received 4-6 cycles of camrelizumab plus carboplatin and pemetrexed (n=205) or carboplatin and pemetrexed (n=207) every 3 weeks, followed by maintenance camrelizumab plus pemetrexed or pemetrexed only. Crossover from chemotherapy group to camrelizumab monotherapy was permitted after disease progression.Median time from randomization to data cut-off was 65.2 months (range, 59.7-72.2). HR for overall survival (OS) was 0.74 (95% CI 0.58 to 0.93; one-sided p=0.0043), and was 0.62 (95% CI 0.49 to 0.79; one-sided p<0.0001) after adjustment for crossover. Five-year OS rates were 31.2% (95% CI 24.7% to 37.9%) with camrelizumab plus chemotherapy versus 19.3% (95% CI 13.9% to 25.3%) with chemotherapy alone. Among the 33 patients who completed 2 years of camrelizumab, 5-year OS rate was 84.3% (95% CI 66.4% to 93.2%), and 5-year duration of response rate was 46.5% (95% CI 24.9% to 65.6%) in the 32 responders. No new safety signals were noted.Camrelizumab plus carboplatin and pemetrexed as first-line therapy continued to demonstrate long-term OS benefit over carboplatin and pemetrexed, with manageable toxicity. Patients who completed 2 years of camrelizumab had enduring response and impressive OS. Current 5-year updated analysis further supports camrelizumab plus carboplatin and pemetrexed as a standard-of-care for previously untreated advanced non-squamous NSCLC without EGFR/ALK alterations.NCT03134872.© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

基金：
This study was funded by Jiangsu Hengrui Pharmaceuticals, which participated in study design, data collection, and data interpretation. We are grateful to all patients and their families and all members of the collaborative group. We would also like to acknowledge PAREXEL International for statistical analyses (funded by Hengrui) and Dr Hui Dong for medical writing support (Medical Writer at Hengrui).
语种：
外文
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出版当年[2024]版：
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最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 免疫学 2 区 肿瘤学
JCR分区：
出版当年[2024]版：
无
最新[2023]版：
Q1 ONCOLOGY Q1 IMMUNOLOGY

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

第一作者：
第一作者机构： [1]Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China caicunzhou_dr@163.com.
通讯作者：
推荐引用方式(GB/T 7714)：
Zhou Caicun,Chen Gongyan,Huang Yunchao,et al.Camrelizumab plus carboplatin and pemetrexed as first-line therapy for advanced non-squamous non-small-cell lung cancer: 5-year outcomes of the CameL randomized phase 3 study[J].Journal For Immunotherapy Of Cancer.2024,12(11):doi:10.1136/jitc-2024-009240.
APA：
Zhou Caicun,Chen Gongyan,Huang Yunchao,Zhou Jianying,Lin LiZhu...&Shi Wei.(2024).Camrelizumab plus carboplatin and pemetrexed as first-line therapy for advanced non-squamous non-small-cell lung cancer: 5-year outcomes of the CameL randomized phase 3 study.Journal For Immunotherapy Of Cancer,12,(11)
MLA：
Zhou Caicun,et al."Camrelizumab plus carboplatin and pemetrexed as first-line therapy for advanced non-squamous non-small-cell lung cancer: 5-year outcomes of the CameL randomized phase 3 study".Journal For Immunotherapy Of Cancer 12..11(2024)

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