Evidence map›Paper›PMID 39016053›Full record

Trial reportCancer communications (London, England)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).

Shun Lu, Xiaorong Dong, Hong Jian, Jianhua Chen, Gongyan Chen, Yuping Sun, Yinghua Ji, Ziping Wang, Jianhua Shi, Junguo Lu and 47 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Cancer communications (London, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03849768 (A Phase III Randomized, Controlled, Double-Blind, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of HS-10296 Versus Gefitinib as First-Line Therapy for Locally Advanced or Metastatic NSCLC With EGFR Sensitizing Mutations), which is not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03849768 phase3unknown statusnot on this map

A Phase III Randomized, Controlled, Double-Blind, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of HS-10296 Versus Gefitinib as First-Line Therapy for Locally Advanced or Metastatic NSCLC With EGFR Sensitizing Mutations

TypeinterventionalSponsorJiangsu Hansoh Pharmaceutical Co., Ltd.Ran2019 to 2023Enrolled429ConditionsNon Small Cell Lung CancerArmsHS-10296, Gefitinib
3 · Its place in the literature

Who cites it

21 citing papers in PubMed.

  1. Trial
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  3. Rezivertinib inCancer communications (London, England) · 2026
    Trial
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  5. Central nervous system efficacy of third generationJournal of thoracic disease · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

57 authors.

Shun LuDepartment of Medical Oncology, Shanghai Chest Hospital Shanghai JiaoTong University, Shanghai, P. R. China.ORCID 0000-0001-8833-7262
Xiaorong DongCancer Center, Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, P. R. China.
Hong JianDepartment of Medical Oncology, Shanghai Chest Hospital Shanghai JiaoTong University, Shanghai, P. R. China.
Jianhua ChenDepartment of Medical Oncology-Chest, Hunan Cancer Hospital & The Affiliated Cancer Hospital of Central South University Xiangya School of Medicine, Changsha, Hunan, P. R. China.
Gongyan ChenThoracic Oncology Medicine, Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, P. R. China.
Yuping SunDepartment of Oncology, Jinan Central Hospital, Jinan, Shandong, P. R. China.
Yinghua JiDepartment of Oncology, First Affiliated Hospital of Xinxiang Medical University, Xinxiang, Henan, P. R. China.
Ziping WangDepartment of Chest Medicine, Beijing Cancer Hospital, Beijing, P. R. China.
Jianhua ShiDepartment of Internal Medicine, Linyi Cancer Hospital, Linyi, Shandong, P. R. China.
Junguo LuDepartment of Respiratory Medicine, Nantong Tumor Hospital, Nantong, Jiangsu, P. R. China.
Shaoshui ChenDepartment of Oncology, Binzhou Medical University Hospital, Binzhou, Shandong, P. R. China.
Dongqing LvBreath Internal Medicine, Taizhou Hospital of Zhejiang Province, Linhai, Zhejiang, P. R. China.
Guojun ZhangDepartment of Respiration, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, P. R. China.
Chunling LiuDepartment of Lung Internal Medicine, Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, Xinjiang, P. R. China.
Juan LiDepartment of Thoracic Oncology, Sichuan Cancer Hospital, Chengdu, Sichuan, P. R. China.
Xinmin YuThoracic Medical Oncology, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, Zhejiang, P. R. China.
Zhong LinDepartment of Thoracic Oncology, The Fifth Subsidiary Sun Yat-sen University Hospital, Zhuhai, Guangdong, P. R. China.
Zhuang YuDepartment of Oncology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, P. R. China.
Zhehai WangDepartment of Oncology, Shandong Cancer Hospital, Jinan, Shandong, P. R. China.
Jiuwei CuiDepartment of Oncology, The First Bethune Hospital of Jilin University, Changchun, Jilin, P. R. China.
Xingxiang XuDepartment of Respiration, Northern Jiangsu People's Hospital Affiliated to Yangzhou University, Yangzhou, Jiangsu, P. R. China.
Jian FangDepartment of Chest Medicine, Beijing Cancer Hospital, Beijing, P. R. China.ORCID 0000-0003-3697-4563
Jifeng FengDepartment of Internal Medicine, Jiangsu Cancer Hospital, Nanjing, Jiangsu, P. R. China.
Zhi XuDepartment of Respiration, The Second Affiliated Hospital of Army Medical University, Chongqing, P. R. China.
Rui MaDepartment of Chest Internal Medicine, Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, P. R. China.
Jie HuRespiratory Medicine, Zhongshan Hospital Fudan University, Shanghai, P. R. China.
Nong YangLung & Gastrointestinal Oncology Department, Hunan Cancer Hospital & The Affiliated Cancer Hospital of Central South University Xiangya School of Medicine, Changsha, Hunan, P. R. China.
Xiangdong ZhouDepartment of Respiratory and Critical Care Medicine, The Southwest Hospital of AMU, Chongqing, P. R. China.
Xiaohong WuDepartment of Oncology, Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, P. R. China.
Chengping HuRespiratory Medicine, Xiangya Hospital Central South University, Changsha, Hunan, P. R. China.
Zhihong ZhangDepartment of Respiration Oncology, Anhui Provincial Cancer Hospital, Hefei, Anhui, P. R. China.
You LuDepartment of Thoracic Oncology, West China Hospital of Sichuan University, Chengdu, Sichuan, P. R. China.
Yanping HuDepartment of Thoracic Oncology, Hubei Cancer Hospital, Wuhan, Hubei, P. R. China.
Liyan JiangDepartment of Respiration, Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai, P. R. China.
Qiming WangDepartment of Respiration, Henan Cancer hospital, Zhengzhou, Henan, P. R. China.
Renhua GuoDepartment of Oncology, Jiangsu Province Hospital, Nanjing, Jiangsu, P. R. China.
Jianying ZhouDepartment of Respiratory Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, P. R. China.
Baolan LiDepartment of Oncology Internal Medicine, Beijing Chest Hospital, Capital Medical University, Beijing, P. R. China.
Chunhong HuDepartment of Oncology, Xiangya Second Hospital of Central South University, Changsha, Hunan, P. R. China.
Wancheng TongDepartment of Infection Internal Medicine, Nanfang Hospital, Nanfang Medical University, Guangzhou, Guangdong, P. R. China.
Helong ZhangDepartment of Oncology, The Second Affiliated Hospital of Air Force Military Medical University, Xi'an, Shanxi, P. R. China.
Lin MaDepartment of Respiration, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, P. R. China.
Yuan ChenDepartment of Oncology, Tongji Medical College Huazhong University of Science & Technology, Wuhan, Hubei, P. R. China.
Zhijun JieDepartment of Respiratory and Critical Care Medicine, Shanghai Fifth People's Hospital, Fudan University, Shanghai, P. R. China.
Yu YaoDepartment of Oncology Internal Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi, P. R. China.
Longzhen ZhangRadiotherapy Department, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, P. R. China.
Jie WengDepartment of Oncology, Yueyang Central Hospital, Yueyang, Hunan, P. R. China.
Weidong LiDepartment of Internal Medicine, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong, P. R. China.
Jianping XiongDepartment of Oncology, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, P. R. China.
Xianwei YeDepartment of Respiratory and Critical Care Medicine, Guizhou Provincial People's Hospital, Guiyang, Guizhou, P. R. China.
Jianchun DuanDepartment of Internal Medicine, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, P. R. China.
Haihua YangRadiotherapy Section, Taizhou Hospital of Zhejiang Province, Linhai, Zhejiang, P. R. China.
Meili SunDepartment of Oncology Internal Medicine, Jinan Central Hospital Affiliated to Shandong University, Jinan, Shandong, P. R. China.
Hongying WeiHansoh Pharmaceutical Group Co. Ltd., Shanghai, P. R. China.
Jiawei WeiHansoh Pharmaceutical Group Co. Ltd., Shanghai, P. R. China.
Zheyu ZhangHansoh Pharmaceutical Group Co. Ltd., Shanghai, P. R. China.ORCID 0000-0003-1907-0765
Qiong WuHansoh Pharmaceutical Group Co. Ltd., Shanghai, P. R. China.

Funding

Collaborative Innovation Center for Clinical and Translational Science by Ministry of Education & Shanghai CCTS-202204Collaborative Innovation Center for Clinical and Translational Science by Ministry of Education & Shanghai CCTS-202304Hansoh Pharmaceutical Group Co. LtdNational Multi-disciplinary Treatment Project for Major Diseases 2020NMDTPNational Natural Science Foundation of China 82030045National Natural Science Foundation of China 82241227Pujiang Program 22PJ1420700Shanghai Chest Hospital Basic Research Project 2023YNKT-1
6 · The paper itself

Abstract

backgroundThe 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.

methodsEligible 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).

resultsOf 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.

conclusionsThese 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.

trial registrationClinicalTrials.gov number, NCT03849768.

Indexed as

AcrylamidesCarcinoma, Non-Small-Cell LungErbB ReceptorsGefitinibLung NeoplasmsMutationAdultAgedAged, 80 and overAnilidesAntineoplastic AgentsCentral Nervous System NeoplasmsDouble-Blind MethodFemaleHumansMaleAcrylamidesAnilidesAntineoplastic AgentsEGFR protein, humanErbB ReceptorsGefitinibGSK 1363089Protein Kinase InhibitorsQuinolinesaumolertinibbrain metastasisnon‐small cell lung cancerthird‐generation EGFR‐TKI

Identifiers

PMID39016053
PMCPMC11492357

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