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Central nervous system efficacy of aumolertinib versus gefitinib in patients with untreated, EGFR-mutated, advanced non-small cell lung cancer: data from a randomized phase III trial (AENEAS)

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作者：
Lu, Shun[1,*1] ; Dong, Xiaorong[2] ; Jian, Hong[1] ; Chen, Jianhua[3,4] ; Chen, Gongyan[5] ; Sun, Yuping[6] ; Ji, Yinghua[7] ; Wang, Ziping[8] ; Shi, Jianhua[9] ; Lu, Junguo[10] ; Chen, Shaoshui[11] ; Lv, Dongqing[12] ; Zhang, Guojun[13] ; Liu, Chunling[14] ; Li, Juan[15] ; Yu, Xinmin[16] ; Lin, Zhong[17] ; Yu, Zhuang[18] ; Wang, Zhehai[19] ; Cui, Jiuwei[20] ; Xu, Xingxiang[21] ; Fang, Jian[8] ; Feng, Jifeng[22] ; Xu, Zhi[23] ; Ma, Rui[24] ; Hu, Jie[25] ; Yang, Nong[26,4] ; Zhou, Xiangdong[27] ; Wu, Xiaohong[28] ; Hu, Chengping[29] ; Zhang, Zhihong[30] ; Lu, You[31] ; Hu, Yanping[32] ; Jiang, Liyan[33] ; Wang, Qiming[34] ; Guo, Renhua[35] ; Zhou, Jianying[36] ; Li, Baolan[37] ; Hu, Chunhong[38] ; Tong, Wancheng[39] ; Zhang, Helong[40] ; Ma, Lin[41] ; Chen, Yuan[42] ; Jie, Zhijun[43] ; Yao, Yu[44] ; Zhang, Longzhen[45] ; Weng, Jie[46] ; Li, Weidong[47] ; Xiong, Jianping[48] ; Ye, Xianwei[49] ; Duan, Jianchun[50] ; Yang, Haihua[51] ; Sun, Meili[52] ; Wei, Hongying[53] ; Wei, Jiawei[53] ; Zhang, Zheyu[53] ; Wu, Qiong[53] ;
机构： [1]Shanghai Jiao Tong Univ, Dept Med Oncol, Shanghai Chest Hosp, Shanghai 200030, Peoples R China [2]Huazhong Univ Sci & Technol, Union Hosp, Tongji Med Coll, Canc Ctr, Wuhan, Hubei, Peoples R China [3]Cent South Univ, Dept Med Oncol Chest, Xiangya Sch Med, Changsha, Hunan, Peoples R China [4]Cent South Univ, Affiliated Canc Hosp, Xiangya Sch Med, Changsha, Hunan, Peoples R China [5]Harbin Med Univ, Thorac Oncol Med, Canc Hosp, Harbin, Heilongjiang, Peoples R China [6]Jinan Cent Hosp, Dept Oncol, Jinan, Shandong, Peoples R China [7]Xinxiang Med Univ, Affiliated Hosp 1, Dept Oncol, Xinxiang, Henan, Peoples R China [8]Beijing Canc Hosp, Dept Chest Med, Beijing, Peoples R China [9]Linyi Canc Hosp, Dept Internal Med, Linyi, Shandong, Peoples R China [10]Nantong Tumor Hosp, Dept Resp Med, Nantong, Jiangsu, Peoples R China [11]Binzhou Med Univ Hosp, Dept Oncol, Binzhou, Shandong, Peoples R China [12]Taizhou Hosp Zhejiang Prov, Breath Internal Med, Linhai, Zhejiang, Peoples R China [13]Zhengzhou Univ, Dept Respirat, Affiliated Hosp 1, Zhengzhou, Henan, Peoples R China [14]Xinjiang Med Univ, Dept Lung Internal Med, Affiliated Tumor Hosp, Urumqi, Xinjiang, Peoples R China [15]Sichuan Canc Hosp, Dept Thorac Oncol, Chengdu, Sichuan, Peoples R China [16]Univ Chinese Acad Sci, Zhejiang Canc Hosp, Thorac Med Oncol, Canc Hosp, Hangzhou, Zhejiang, Peoples R China [17]Sun Yat sen Univ Hosp, Dept Thorac Oncol, Fifth Subsidiary, Zhuhai, Guangdong, Peoples R China [18]Qingdao Univ, Dept Oncol, Affiliated Hosp, Qingdao, Shandong, Peoples R China [19]Shandong Canc Hosp, Dept Oncol, Jinan, Shandong, Peoples R China [20]Jilin Univ, Dept Oncol, First Bethune Hosp, Changchun, Jilin, Peoples R China [21]Yangzhou Univ, Dept Respirat, Northern Jiangsu Peoples Hosp, Yangzhou, Jiangsu, Peoples R China [22]Jiangsu Canc Hosp, Dept Internal Med, Nanjing, Jiangsu, Peoples R China [23]Army Med Univ, Dept Respirat, Affiliated Hosp 2, Chongqing, Peoples R China [24]Liaoning Canc Hosp & Inst, Dept Chest Internal Med, Shenyang, Liaoning, Peoples R China [25]Fudan Univ, Resp Med, Zhongshan Hosp, Shanghai, Peoples R China [26]Cent South Univ, Hunan Canc Hosp, Lung & Gastrointestinal Oncol Dept, Xiangya Sch Med, Changsha, Hunan, Peoples R China [27]Southwest Hosp AMU, Dept Resp & Crit Care Med, Chongqing, Peoples R China [28]Jiangnan Univ, Affiliated Hosp, Dept Oncol, Wuxi, Jiangsu, Peoples R China [29]Cent South Univ, Xiangya Hosp, Resp Med, Changsha, Hunan, Peoples R China [30]Anhui Prov Canc Hosp, Dept Respirat Oncol, Hefei, Anhui, Peoples R China [31]Sichuan Univ, Dept Thorac Oncol, West China Hosp, Chengdu, Sichuan, Peoples R China [32]Hubei Canc Hosp, Dept Thorac Oncol, Wuhan, Hubei, Peoples R China [33]Shanghai Jiao Tong Univ, Shanghai Chest Hosp, Dept Respirat, Shanghai, Peoples R China [34]Henan Canc Hosp, Dept Respirat, Zhengzhou, Henan, Peoples R China [35]Jiangsu Prov Hosp, Dept Oncol, Nanjing 210029, Jiangsu, Peoples R China [36]Zhejiang Univ, Dept Resp Med, Affiliated Hosp 1, Sch Med, Hangzhou, Zhejiang, Peoples R China [37]Capital Med Univ, Beijing Chest Hosp, Dept Oncol Internal Med, Beijing, Peoples R China [38]Cent South Univ, Xiangya Second Hosp, Dept Oncol, Changsha, Hunan, Peoples R China [39]Nanfang Med Univ, Nanfang Hosp, Dept Infect Internal Med, Guangzhou, Guangdong, Peoples R China [40]Air Force Mil Med Univ, Dept Oncol, Affiliated Hosp 2, Xian, Shanxi, Peoples R China [41]Nanchang Univ, Dept Respirat, Affiliated Hosp 1, Nanchang, Jiangxi, Peoples R China [42]Huazhong Univ Sci & Technol, Dept Oncol, Tongji Med Coll, Wuhan, Hubei, Peoples R China [43]Fudan Univ, Shanghai Fifth Peoples Hosp, Dept Resp & Crit Care Med, Shanghai, Peoples R China [44]Xi An Jiao Tong Univ, Dept Oncol Internal Med, Affiliated Hosp 1, Xian, Shanxi, Peoples R China [45]Xuzhou Med Univ, Radiotherapy Dept, Affiliated Hosp, Xuzhou, Jiangsu, Peoples R China [46]Yueyang Cent Hosp, Dept Oncol, Yueyang, Hunan, Peoples R China [47]Guangzhou Med Univ, Affiliated Canc Hosp & Inst, Dept Internal Med, Guangzhou, Guangdong, Peoples R China [48]Nanchang Univ, Dept Oncol, Affiliated Hosp 1, Nanchang, Jiangxi, Peoples R China [49]Guizhou Prov Peoples Hosp, Dept Resp & Crit Care Med, Guiyang, Guizhou, Peoples R China [50]Chinese Acad Med Sci, Canc Hosp, Dept Internal Med, Beijing, Peoples R China [51]Taizhou Hosp Zhejiang Prov, Radiotherapy Sect, Linhai, Zhejiang, Peoples R China [52]Shandong Univ, Dept Oncol Internal Med, Jinan Cent Hosp, Jinan, Shandong, Peoples R China [53]Hansoh Pharmaceut Grp Co Ltd, Shanghai, Peoples R China
出处：
DOI： 10.1002/cac2.12594
ISSN：

关键词： aumolertinib brain metastasis non-small cell lung cancer third-generation EGFR-TKI

摘要：
Background: The initial randomized, double-blinded, actively controlled, phase III ANEAS study (NCT03849768) demonstrated that aumolertinib showed superior efficacy relative to gefitinib as first-line therapy in epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer (NSCLC). Metastatic disease in the central nervous system (CNS) remains a challenge in the management of NSCLC. This study aimed to compare the efficacy of aumolertinib versus gefitinib among patients with baseline CNS metastases in the ANEAS study. Methods: Eligible patients were enrolled and randomly assigned in a 1:1 ratio to orally receive either aumolertinib or gefitinib in a double-blinded fashion. Patients with asymptomatic, stable CNS metastases were included. Follow-up imaging of the same modality as the initial CNS imaging was performed every 6 weeks for 15 months, then every 12 weeks. CNS response was assessed by a neuroradiological blinded, independent central review (neuroradiological-BICR). The primary endpoint for this subgroup analysis was CNS progression-free survival (PFS). Results: Of the 429 patients enrolled and randomized in the ANEAS study, 106 patients were found to have CNS metastases (CNS Full Analysis Set, cFAS) at baseline by neuroradiological-BICR, and 60 of them had CNS target lesions (CNS Evaluable for Response, cEFR). Treatment with aumolertinib significantly prolonged median CNS PFS compared with gefitinib in both cFAS (29.0 vs. 8.3 months; hazard ratio [HR] = 0.31; 95% confidence interval [CI], 0.17-0.56; P < 0.001) and cEFR (29.0 vs. 8.3 months; HR = 0.26; 95% CI, 0.11-0.57; P < 0.001). The confirmed CNS overall response rate in cEFR was 85.7% and 75.0% in patients treated with aumolertinib and gefitinib, respectively. Competing risk analysis showed that the estimated probability of CNS progression without prior non-CNS progression or death was consistently lower with aumolertinib than with gefitinib in patients with and without CNS metastases at baseline. No new safety findings were observed. Conclusions: These results indicate a potential advantage of aumolertinib over gefitinib in terms of CNS PFS and the risk of CNS progression in patients with EGFR-mutated advanced NSCLC with baseline CNS metastases.

基金：
Hansoh Pharmaceutical Group Co. Ltd [22PJ1420700]; Hansoh Pharmaceutical Group Co. Ltd, Pujiang Program [82030045, 82241227]; National Natural Science Foundation of China [2020NMDTP]; National Multi-disciplinary Treatment Project for Major Diseases [CCTS-202204, CCTS-202304]; Collaborative Innovation Center for Clinical and Translational Science by Ministry of Education Shanghai [2023YNKT-1]
语种：
外文
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出版当年[2023]版：
大类 | 1 区 医学
小类 | 2 区 肿瘤学
最新[2023]版：
大类 | 1 区 医学
小类 | 2 区 肿瘤学
JCR分区：
出版当年[2023]版：
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[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]Shanghai Jiao Tong Univ, Dept Med Oncol, Shanghai Chest Hosp, Shanghai 200030, Peoples R China [*1]Department ofMedical Oncology, Shanghai ChestHospital, Shanghai JiaoTong University,Shanghai, 200030, China
通讯机构： [*1]Department ofMedical Oncology, Shanghai ChestHospital, Shanghai JiaoTong University,Shanghai, 200030, China
推荐引用方式(GB/T 7714)：
Lu Shun,Dong Xiaorong,Jian Hong,et al.Central nervous system efficacy of aumolertinib versus gefitinib in patients with untreated, EGFR-mutated, advanced non-small cell lung cancer: data from a randomized phase III trial (AENEAS)[J].CANCER COMMUNICATIONS.2024,doi:10.1002/cac2.12594.
APA：
Lu, Shun,Dong, Xiaorong,Jian, Hong,Chen, Jianhua,Chen, Gongyan...&Wu, Qiong.(2024).Central nervous system efficacy of aumolertinib versus gefitinib in patients with untreated, EGFR-mutated, advanced non-small cell lung cancer: data from a randomized phase III trial (AENEAS).CANCER COMMUNICATIONS,,
MLA：
Lu, Shun,et al."Central nervous system efficacy of aumolertinib versus gefitinib in patients with untreated, EGFR-mutated, advanced non-small cell lung cancer: data from a randomized phase III trial (AENEAS)".CANCER COMMUNICATIONS .(2024)

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