Gefitinib(an EGFR tyrosine kinase inhibitor)plus anlotinib(an multikinase inhibitor)for untreated,EGFR-mutated,advanced non-small cell lung cancer(FL-ALTER):a multicenter phase III trial  

作　　者：Hua-Qiang Zhou Ya-Xiong Zhang Gang Chen Qi-Tao Yu Hua Zhang Guo-Wu Wu Di Wu Ying-Cheng Lin Jun-Fei Zhu Jian-Hua Chen Xiao-Hua Hu Bin Lan Ze-Qiang Zhou Hai-Feng Lin Zi-Bing Wang Xiao-Lin Lei Suo-Ming Pan Li-Ming Chen Jian Zhang Tian-Dong Kong Ji-Cheng Yao Xin Zheng Feng Li Li Zhang Wen-Feng Fang 

机构地区：[1]Department of Medical Oncology,Sun Yat-sen University Cancer Center,State Key Laboratory of Oncology in South China,Guangdong Provincial Clinical Research Center for Cancer,Collaborative Innovation Center for Cancer Medicine,Guangzhou 510060,China [2]Department of Medical Oncology of Respirotary,Affiliated Tumor Hospital of Guangxi Medical University,Nanning 530021,China [3]Department of Urogenital Oncology,the First People’s Hospital of Foshan,Foshan 52800,China [4]Department of Medical Oncology,Meizhou People’s Hospital(Huangtang Hospital),Meizhou 514031,China [5]Department of Respiratory and Critical Care Medicine,Shenzhen people’s Hospital,Shenzhen 518020,China [6]Department of Medical Oncology of Respirotary,Cancer Hospital of Shantou University Medical College,Shantou 515031,China [7]Department of Respiratory and Critical Care Medicine,Taizhou Central Hospital,Taizhou 318000,China [8]Department of Medical Oncology,Hunan Provincial Cancer Hospital,Changsha 410031,China [9]Department of Medical Oncology,the First Affiliated Hospital of Guangxi Medical University,Nanning 530021,China [10]Department of Cardiothoracic Surgery,Shantou Central Hospital,Shantou 515031,China [11]Department of Oncology,the 2nd People’s Hospital of Shenzhen,Shenzhen 518025,China [12]Department of Medical Oncology,the Second Affiliated Hospital of Hainan Medical University,Haikou 570216,China [13]Department of Immunotherapy,Henan Cancer Hospital,Zhengzhou 450003,China [14]Department of Oncology,Affiliated Hospital of Panzhihua University,Panzhihua 617099,China [15]Department of Radiotherapy,Yuebei People’s Hospital,Shaoguan 512099,China [16]Department of Oncology,the First Affiliated Hospital of Shantou University Medicine College,Shantou 515041,China [17]Department of Oncology,ZhuJiang Hospital of Southern Medical University(The Second Clinical Medical College),Guangzhou 510280,China [18]Department of Respiratory Oncology,the Third People’s Hospital of Zhengzhou,Zhengzhou 450001,China [19]Shanghai OrigiMed Co.,Ltd,Shang

出　　处：《Signal Transduction and Targeted Therapy》2024年第9期4091-4102,共12页信号转导与靶向治疗（英文）

基　　金：funded by the Chinese National Natural Science Foundation Project(Grant No.82173101,82373262,82241232,82272789,82102864);Guangzhou Basic and Applied Basic Research Foundation(2024A04J4082);partly funded by the 308 Clinical Research Foundation of Sun Yat-sen University Cancer Center.

摘　　要：Dual inhibition of vascular endothelial growth factor and epidermal growth factor receptor(EGFR)signaling pathways offers the prospect of improving the effectiveness of EFGR-targeted therapy.In this phase 3 study(ClinicalTrial.gov:NCT04028778),315 patients with treatment-naïve,EGFR-mutated,advanced non-small cell lung cancer(NSCLC)were randomized(1:1)to receive anlotinib or placebo plus gefitinib once daily on days 1–14 per a 3-week cycle.At the prespecified final analysis of progression-free survival(PFS),a significant improvement in PFS was observed for the anlotinib arm over the placebo arm(hazards ratio[HR]=0.64,95%CI,0.48–0.80,P=0.003).Particularly,patients with brain metastasis and those harboring EGFR amplification or high tumor mutation load gained significant more benefits in PFS from gefitinib plus anlotinib.The incidence of grade 3 or higher treatment-emergent adverse events was 49.7%of the patients receiving gefitinib plus anlotinib versus 31.0%of the patients receiving gefitinib plus placebo.Anlotinib plus gefitinib significantly improves PFS in patients with treatment-naïve,EGFR-mutated,advanced NSCLC,with a manageable safety profile.

关 键 词：cancer lung treatment 

分 类 号：R734.2[医药卫生—肿瘤]