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2026年8月14日星期五
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Mefatinib对比吉非替尼一线治疗EGFR突变非小细胞肺癌：一项随机、双盲、多中心III期研究

Mefatinib versus gefitinib as a first-line treatment for EGFR-mutated non-small cell lung cancer: a randomized, double-blind, multicenter phase III study.

期刊
Signal Transduction and Targeted Therapy
PMID
42586967
原文
PubMed ↗
发布日期

作者

  • Jia Yu — Department of Medical Oncology, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, China.
  • Anwen Xiong — Department of Medical Oncology, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, China.
  • Qiming Wang — Department of Respiratory Medicine, Henan Cancer Hospital, Zhengzhou, China.
  • Jianhua Chen — Department of Medical Oncology, Hunan Cancer Hospital, Changsha, China.
  • Hongrui Niu — Department of Oncology, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China.
  • Chengzhi Zhou — State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, Department of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
  • Panwen Tian — Department of Respiratory and Critical Care Medicine, West China School of Medicine/West China Hospital of Sichuan University, Chengdu, China.
  • Wu Zhuang — Department of Thoracic Oncology, Fujian Cancer Hospital & Fujian Medical University Cancer Hospital, Fuzhou, China.
  • Jie Li — Department of Respiratory Medicine, First Affiliated Hospital of Gannan Medical University, Ganzhou, China.
  • Jing Wang — Department of Respiratory Medicine, First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
  • Junguo Lu — Department of Respiratory Medicine, Nantong Tumor Hospital, Nantong, China.
  • Kangsheng Gu — Medical Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.
  • Jinsheng Shi — Department of Oncology, Cangzhou People's Hospital, Cangzhou, China.
  • Jun Guo — Department of Medical Oncology, Xingtai People's Hospital, Hebei, China.
  • Yonghui Di — Department of Thoracic Surgery, Xingtai People's Hospital, Xingtai, China.
  • Dongqing Lv — Department of Respiratory Medicine, Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University, Taizhou, China.
  • Debin Sun — Respiratory Department, Lishui Central Hospital, Lishui, China.
  • Liming Cao — Department of Respiratory Medicine, Xiangya Hospital Central South University, Changsha, China.
  • Zhixiong Yang — Department of Oncology, Affiliated Hospital of Guangdong Medical University, Zhanjiang, China.
  • Jingxun Wu — Department of Medical Oncology, The First Affiliated Hospital of Xiamen University, Xiamen, China.
  • Liyun Miao — Department of Respiratory and Critical Care Medicine, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, China.
  • Yueyin Pan — Division of Life Sciences and Medicine, Department of Medical Oncology, The First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei, China.
  • Chong Li — Department of Respiration, First People's Hospital of Changzhou, Third Affiliated Hospital of Soochow University, Changzhou, China.
  • Xiaohong Wu — Department of Medical Oncology, The Affiliated Hospital of Jiangnan University (The Fourth People's Hospital in Wuxi City), Wuxi, China.
  • Jie Yin — Department of Respiratory and Critical Care Medicine, General Hospital of the Eastern Theatre of the Chinese People's Liberation Army, Nanjing, China.
  • Xiang Wang — Department of Oncology, Xuzhou Central Hospital, Xuzhou, China.
  • Meili Sun — Department of Oncology, Jinan Central Hospital, Jinan, China.
  • Miao He — Oncology Department, Deyang People's Hospital, Deyang, China.
  • Shundong Cang — Department of Oncology, Henan Provincial People's Hospital, Zhengzhou, China.
  • Haohui Fang — Department of Respiratory Medicine, Anhui Chest Hospital, Hefei, China.
  • Ping Chen — Department of Oncology, Yancheng NO.1 People's Hospital, Yancheng, China.
  • Min Zhang — Department of Pulmonary and Critical Care Medicine, Ganzhou People's Hospital, Ganzhou, China.
  • Xinmei Yang — Department of Radiation Oncology, The First Hospital of Jiaxing, Jiaxing, China.
  • Hui Zhao — Department of Respiratory Medicine, Second Affiliated Hospital of Anhui Medical University, Hefei, China.
  • Jian Feng — Department of Respiratory and Critical Care Medicine, Affiliated Hospital and Medical School of Nantong University, Nantong, China.
  • Xuezhen Ma — Department of Oncology, Affiliated Qingdao Central Hospital of Qingdao University, Qingdao Cancer Hospital, Qingdao, China.
  • Sheng Hu — Department of Thoracic Oncology, Hubei Cancer Hospital, Wuhan, China.
  • Jian Lu — Department of Oncology, The Affiliated Hospital of Qingdao University, Qingdao, China.
  • Xin Zhao — Department of Respiratory and Critical Care Medicine, Jiangsu Province Hospital and The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.
  • Zhixiang Zhuang — Department of Oncology, The Second Affiliated Hospital of Soochow University, Suzhou, China.
  • Yilan Sun — Department of Pulmonary and Critical Care Medicine, Zhejiang Provincial People's Hospital, Hangzhou, China.
  • Xu Sun — Hangzhou Zhongmei Huadong Pharmaceutical Company, Hangzhou, China.
  • Bing Yu — Hangzhou Zhongmei Huadong Pharmaceutical Company, Hangzhou, China.
  • Chaonan Zhu — Hangzhou Zhongmei Huadong Pharmaceutical Company, Hangzhou, China.
  • Jianghua Chen — Hangzhou Zhongmei Huadong Pharmaceutical Company, Hangzhou, China.
  • June Xu — Hangzhou Zhongmei Huadong Pharmaceutical Company, Hangzhou, China.
  • Kai Wang — Department of Respiratory Medicine, The Second Affiliated Hospital of Medical College of Zhejiang University, Hangzhou, China. doctorhuxi@163.com.
  • Caicun Zhou — Department of Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China. caicunzhoudr@163.com.

作者单位

  • Department of Medical Oncology, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, China.
  • Department of Respiratory Medicine, Henan Cancer Hospital, Zhengzhou, China.
  • Department of Medical Oncology, Hunan Cancer Hospital, Changsha, China.
  • Department of Oncology, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China.
  • State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, Department of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
  • Department of Respiratory and Critical Care Medicine, West China School of Medicine/West China Hospital of Sichuan University, Chengdu, China.
  • Department of Thoracic Oncology, Fujian Cancer Hospital & Fujian Medical University Cancer Hospital, Fuzhou, China.
  • Department of Respiratory Medicine, First Affiliated Hospital of Gannan Medical University, Ganzhou, China.
  • Department of Respiratory Medicine, First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
  • Department of Respiratory Medicine, Nantong Tumor Hospital, Nantong, China.
  • Medical Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.
  • Department of Oncology, Cangzhou People's Hospital, Cangzhou, China.
  • Department of Medical Oncology, Xingtai People's Hospital, Hebei, China.
  • Department of Thoracic Surgery, Xingtai People's Hospital, Xingtai, China.
  • Department of Respiratory Medicine, Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University, Taizhou, China.
  • Respiratory Department, Lishui Central Hospital, Lishui, China.
  • Department of Respiratory Medicine, Xiangya Hospital Central South University, Changsha, China.
  • Department of Oncology, Affiliated Hospital of Guangdong Medical University, Zhanjiang, China.
  • Department of Medical Oncology, The First Affiliated Hospital of Xiamen University, Xiamen, China.
  • Department of Respiratory and Critical Care Medicine, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, China.
  • Division of Life Sciences and Medicine, Department of Medical Oncology, The First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei, China.
  • Department of Respiration, First People's Hospital of Changzhou, Third Affiliated Hospital of Soochow University, Changzhou, China.
  • Department of Medical Oncology, The Affiliated Hospital of Jiangnan University (The Fourth People's Hospital in Wuxi City), Wuxi, China.
  • Department of Respiratory and Critical Care Medicine, General Hospital of the Eastern Theatre of the Chinese People's Liberation Army, Nanjing, China.
  • Department of Oncology, Xuzhou Central Hospital, Xuzhou, China.
  • Department of Oncology, Jinan Central Hospital, Jinan, China.
  • Oncology Department, Deyang People's Hospital, Deyang, China.
  • Department of Oncology, Henan Provincial People's Hospital, Zhengzhou, China.
  • Department of Respiratory Medicine, Anhui Chest Hospital, Hefei, China.
  • Department of Oncology, Yancheng NO.1 People's Hospital, Yancheng, China.
  • Department of Pulmonary and Critical Care Medicine, Ganzhou People's Hospital, Ganzhou, China.
  • Department of Radiation Oncology, The First Hospital of Jiaxing, Jiaxing, China.
  • Department of Respiratory Medicine, Second Affiliated Hospital of Anhui Medical University, Hefei, China.
  • Department of Respiratory and Critical Care Medicine, Affiliated Hospital and Medical School of Nantong University, Nantong, China.
  • Department of Oncology, Affiliated Qingdao Central Hospital of Qingdao University, Qingdao Cancer Hospital, Qingdao, China.
  • Department of Thoracic Oncology, Hubei Cancer Hospital, Wuhan, China.
  • Department of Oncology, The Affiliated Hospital of Qingdao University, Qingdao, China.
  • Department of Respiratory and Critical Care Medicine, Jiangsu Province Hospital and The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.
  • Department of Oncology, The Second Affiliated Hospital of Soochow University, Suzhou, China.
  • Department of Pulmonary and Critical Care Medicine, Zhejiang Provincial People's Hospital, Hangzhou, China.
  • Hangzhou Zhongmei Huadong Pharmaceutical Company, Hangzhou, China.
  • Department of Respiratory Medicine, The Second Affiliated Hospital of Medical College of Zhejiang University, Hangzhou, China. doctorhuxi@163.com.
  • Department of Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China. caicunzhoudr@163.com.

摘要

中文

Mefatinib是一种新型第二代表皮生长因子受体（EGFR）酪氨酸激酶抑制剂，在靶向具有常见和罕见EGFR激活突变的非小细胞肺癌（NSCLC）中显示出有前景的抗肿瘤活性。在这项在中国进行的III期随机、双盲试验中，336名携带EGFR L858R或外显子19缺失（ex19del）的晚期非鳞状NSCLC患者按2:1分配，分别接受mefatinib（60 mg每日，n=223）或吉非替尼（250 mg每日，n=113）。主要终点为独立审查委员会（IRC）评估的无进展生存期（PFS）。该试验在chinadrugtrials.org.cn（CTR20192297）注册。mefatinib和吉非替尼的中位随访时间分别为15.9个月和18.5个月，mefatinib的IRC评估中位PFS显著长于吉非替尼（13.7个月 vs. 9.7个月；风险比[HR]=0.68；95%置信区间[CI]：0.53-0.87；p=0.002）。mefatinib和吉非替尼的30个月总生存率分别为60.2%和54.3%。EGFR ex19del患者两组的PFS相当（p>0.100），而EGFR L858R患者接受mefatinib治疗的中位PFS显著长于吉非替尼（13.7个月 vs. 8.3个月；HR=0.55 [95% CI: 0.38-0.78]；p=0.001）。EGFR L858R患者接受mefatinib和吉非替尼的30个月总生存率分别为56.6%和43.7%。mefatinib组和吉非替尼组≥3级治疗相关不良事件发生率分别为45.7%和24.8%。未观察到mefatinib的新的安全性信号。在EGFR突变晚期NSCLC的一线治疗中，mefatinib显示出优于吉非替尼的疗效，且耐受性相似。

English

Mefatinib, a novel second-generation epidermal growth factor (EGFR) tyrosine kinase inhibitor that has shown promising antitumor activity in targeting non-small cell lung cancer (NSCLC) with common and uncommon EGFR-activating mutations. In this phase III, randomized, double-blind trial in China, 336 eligible patients with advanced nonsquamous NSCLC harboring EGFR L858R or exon 19 deletion (ex19del) were assigned (2:1) to receive either mefatinib (60 mg daily, n = 223) or gefitinib (250 mg daily, n = 113). The primary endpoint was progression-free survival (PFS), assessed by an independent review committee (IRC). The trial is registered with chinadrugtrials.org.cn (CTR20192297). After a median follow-up of 15.9 months for mefatinib and 18.5 months for gefitinib, mefatinib demonstrated a significantly longer median IRC-assessed PFS compared to gefitinib (13.7 vs. 9.7 months; hazard ratio [HR] = 0.68; 95% confidence intervals [CI]: 0.53-0.87; p = 0.002). The 30-month overall survival rate was 60.2% for mefatinib and 54.3% for gefitinib. Patients with EGFR ex19del had comparable PFS for both treatment arms (p > 0.100), whereas patients with EGFR L858R had significantly longer median PFS when treated with mefatinib than gefitinib (13.7 vs 8.3 months HR = 0.55 [95% CI: 0.38-0.78]; p = 0.001). Patients with EGFR L858R had a 30-month overall survival rate of 56.6% with mefatinib and 43.7% with gefitinib. Treatment-related adverse events ≥grade 3 were reported in 45.7% of the mefatinib group and 24.8% of the gefitinib group. No new safety signals were observed for mefatinib. Mefatinib demonstrated superior efficacy to gefitinib with a similar tolerability profile in the first-line treatment of EGFR-mutated advanced NSCLC.

分类与指标

研究类型
临床研究
病种
肺癌
JCR 分区
Q1
影响因子
81.2
新锐分区
1区