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Adebrelimab or placebo plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer (CAPSTONE-1): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.

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作者：
Wang Jie[1] * ; Zhou Caicun[2] ; Yao Wenxiu[3] ; Wang Qiming[4] ; Min Xuhong[5] ; Chen Gongyan[6] ; Xu Xingxiang[7] ; Li Xingya[8] ; Xu Fei[9] ; Fang Yong[10] ; Yang Runxiang[11] ; Yu Guohua[12] ; Gong Youling[13] ; Zhao Jun[14] ; Fan Yun[15] ; Liu Quan[16] ; Cao Lejie[17] ; Yao Yu[18] ; Liu Yunpeng[19] ; Li Xiaoling[20] ; Wu Jingxun[21] ; He Zhiyong[22] ; Lu Kaihua[23] ; Jiang Liyan[24] ; Hu Chengping[25] ; Zhao Wenhua[26] ; Zhang Ben[27] ; Shi Wei[27] ; Zhang Xiaojing[27] ; Cheng Ying[28,*1] ;
机构： [1]Department of Medical Oncology, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences &amp [2]Peking Union Medical College, Beijing, China. [2]Department of Medical Oncology, Shanghai Pulmonary Hospital, Shanghai, China. [3]Department of Thoracic Oncology, Sichuan Cancer Hospital &amp [5]Institute, Chengdu, China. [4]Department of Internal Medicine, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China. [5]Department of Tumor Radiotherapy, Anhui Chest Hospital, Hefei, China. [6]Department of Respiratory Medicine, Harbin Medical University Cancer Hospital, Harbin, China. [7]Department of Respiratory Medicine, Northern Jiangsu People's Hospital, Yangzhou, China. [8]Department of Medical Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. [9]Department of Respiratory Medicine, The First Affiliated Hospital of Nanchang University, Nanchang, China. [10]Department of Medical Oncology, Sir Run Run Shaw Hospital Zhejiang University School of Medicine, Hangzhou, China. [11]Department of Internal Medicine, Yunnan Cancer Hospital, Kunming, China. [12]Department of Medical Oncology, Weifang People's Hospital, Weifang, China. [13]Department of Thoracic Oncology, West China Hospital, Sichuan University, Chengdu, China. [14]Department of Thoracic Oncology, Beijing Cancer Hospital, Beijing, China. [15]Department of Thoracic Oncology, Zhejiang Cancer Hospital, Hangzhou, China. [16]Department of Oncology, Affiliated Hospital of Jiangnan University, Wuxi, China. [17]Department of Respiratory Medicine, Affiliated Hospital of University of Science and Technology of China, Anhui Provincial Hospital, Hefei, China. [18]Department of Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. [19]Department of Oncology, The First Hospital of China Medical University, Shenyang, China. [20]Department of Thoracic Surgery, Liaoning Cancer Hospital &amp [23]Institute, Shenyang, China. [21]Department of Oncology, The First Affiliated Hospital of Xiamen University, Xiamen, China. [22]Department of Thoracic Medical Oncology, Fujian Medical University Cancer Hospital/Fujian Cancer Hospital, Fuzhou, China. [23]Department of Oncology, Jiangsu Province Hospital, Nanjing, China. [24]Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai, China. [25]Department of Respiratory Medicine, Xiangya Hospital of Central South University, Changsha, China. [26]Department of Respiratory Oncology, Guangxi Medical University Affiliated Tumour Hospital, Nanning, China. [27]Jiangsu Hengrui Pharmaceuticals, Shanghai, China. [28]Department of Thoracic Oncology, Jilin Cancer Hospital, Changchun, China. Electronic address: jl.cheng@163.com.
出处：
DOI： 10.1016/S1470-2045(22)00224-8
ISSN：

摘要：
Extensive-stage small-cell lung cancer (ES-SCLC) is associated with poor prognosis and treatment options are scarce. Immunotherapy has shown robust clinical activity in ES-SCLC in previous phase 3 trials. We aimed to assess the efficacy and safety of adebrelimab (SHR-1316), a novel anti-PD-L1 antibody, with standard chemotherapy as a first-line treatment for ES-SCLC.The CAPSTONE-1 study was a randomised, double-blind, placebo-controlled, phase 3 trial, done in 47 tertiary hospitals in China. Key inclusion criteria were patients aged 18-75 years, with previously untreated histologically or cytologically confirmed ES-SCLC and an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Eligible patients were randomly assigned (1:1) to receive four to six cycles of carboplatin (area under the curve of 5 mg/mL per min, day 1 of each cycle) and etoposide (100 mg/m2 of body-surface area, on days 1-3 of each cycle) with either adebrelimab (20 mg/kg, day 1 of each cycle) or matching placebo, followed by maintenance therapy with adebrelimab or placebo. All treatments were given intravenously in 21-day cycles. Randomisation was done using a centralised interactive web response system with a block size of four, stratified by liver metastases, brain metastases, and lactate dehydrogenase concentration. The primary endpoint was overall survival in patients who received at least one dose of study medication. Safety was analysed in the as-treated population. This study is complete and registered with ClinicalTrials.gov, NCT03711305.Between Dec 26, 2018, and Sept 4, 2020, 462 eligible patients were enrolled and randomly assigned: 230 (50%) patients received adebrelimab plus chemotherapy (adebrelimab group) and 232 (50%) patients received placebo plus chemotherapy (placebo group). At data cutoff (Oct 8, 2021), median follow-up was 13·5 months (IQR 8·9-20·1). Median overall survival was significantly improved in the adebrelimab group (median 15·3 months [95% CI 13·2-17·5]) compared with the placebo group (12·8 months [11·3-13·7]; hazard ratio 0·72 [95% CI 0·58-0·90]; one-sided p=0·0017). The most common treatment-related grade 3 or 4 adverse events were decreased neutrophil count (174 [76%] patients in the adebrelimab group and 175 [75%] patients in the placebo group), decreased white blood cell count (106 [46%] and 88 [38%]), decreased platelet count (88 [38%] and 78 [34%]), and anaemia (64 [28%] and 66 [28%]). Treatment-related serious adverse events occurred in 89 (39%) patients in the adebrelimab group and 66 (28%) patients in the placebo group. Four treatment-related deaths were reported: two each in the adebrelimab group (respiratory failure and interstitial lung disease and pneumonia) and placebo group (multiple organ dysfunction and unknown cause of death).Adding adebrelimab to chemotherapy significantly improved overall survival with an acceptable safety profile in patients with ES-SCLC, supporting this combination as a new first-line treatment option for this population.Jiangsu Hengrui Pharmaceuticals.Copyright © 2022 Elsevier Ltd. All rights reserved.

基金：
This study was funded by Jiangsu Hengrui Pharmaceuticals. We are grateful to all patients and their families and all members of the collaborative group participating the study
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出版当年[2022]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 | 1 区 肿瘤学
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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[2021版] 出版当年五年平均 出版前一年[2020版] 出版后一年[2022版]

第一作者：
第一作者机构： [1]Department of Medical Oncology, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences &amp
通讯作者：
通讯机构： [28]Department of Thoracic Oncology, Jilin Cancer Hospital, Changchun, China. Electronic address: jl.cheng@163.com. [*1]Department of Thoracic Oncology, Jilin Cancer Hospital, Changchun 130012, China
推荐引用方式(GB/T 7714)：
Wang Jie,Zhou Caicun,Yao Wenxiu,et al.Adebrelimab or placebo plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer (CAPSTONE-1): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.[J].LANCET ONCOLOGY.2022,23(6):739-747.doi:10.1016/S1470-2045(22)00224-8.
APA：
Wang Jie,Zhou Caicun,Yao Wenxiu,Wang Qiming,Min Xuhong...&Cheng Ying.(2022).Adebrelimab or placebo plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer (CAPSTONE-1): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial..LANCET ONCOLOGY,23,(6)
MLA：
Wang Jie,et al."Adebrelimab or placebo plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer (CAPSTONE-1): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.".LANCET ONCOLOGY 23..6(2022):739-747

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