Real-world data on ALK rearrangement test in Chinese advanced non-small cell lung cancer(RATICAL):a nationwide multicenter retrospective study
作者机构：Department of PathologyNational Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking UnionMedical CollegeBeijingP.R.China Department of Pathologythe First Affiliated Hospital of Zhengzhou UniversityZhengzhouHenanP.R.China Department of PathologyShanghai Pulmonary HospitalSchool of MedicineTongji UniversityShanghaiP.R.China Department of PathologyCancer Hospital Affiliated to Shanxi Medical UniversityShanxi Province Cancer HospitalShanxi Hospital Affiliated to Cancer HospitalChinese Academy of Medical SciencesTaiyuanShanxiP.R.China Department of PathologyZhongshan HospitalFudan UniversityShanghaiP.R.China Department of PathologyWest China Hospital of Sichuan UniversityChengduSichuanP.R.China Department of PathologyPeking Union Medical College HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijingP.R.China Department of PathologySun Yat-sen University Cancer CenterState Key Laboratory of Oncology in South ChinaCollaborative Innovation Center for Cancer MedicineGuangzhouGuangdongP.R.China Department of PathologyFujian Cancer HospitalFujian Medical University Cancer HospitalFuzhouFujianP.R.China Department of PathologyDepartment of OncologyFudan University Cancer CenterShanghaiMedical College of Fudan UniversityShanghaiP.R.China Department of PathologyThe Fourth Hospital of Hebei Medical UniversityShijiazhuangHebeiP.R.China Department of PathologyShandong Cancer HospitalJinanShandongP.R.China Department of PathologyShanghai Chest HospitalShanghai Jiao Tong UniversityShanghaiP.R.China Department of PathologyTianjin Medical University Cancer Institute and HospitalTianjinP.R.China Department of Pathologythe Affiliated Cancer Hospital of Zhengzhou UniversityHenan Provincial Cancer HospitalZhengzhouHenanP.R.China Department of Pathologythe First Affiliated HospitalCollege of MedicineZhejiang UniversityHangzhouZhejiangP.R.China Department of PathologyBeijing Chest HospitalCapital Medical UniversityBeijing Tuberculosis and Thoracic Tumor Research InstituteBeijingP.R.China Department of PathologyCancer Hospital of the University of Chinese Academy of Sciences(Zhejiang Cancer Hospital)HangzhouZhejiangP.R.China Department of Pathologythe First Hospital of China Medical UniversityShenyangLiaoningP.R.China Department of PathologyGuangdong Provincial People’s HospitalGuangdong Academy of Medical SciencesGuangzhouGuangdongP.R.China Institute of PathologySouthwest HospitalThird Military Medical University(Army Medical University)ChongqingP.R.China Department of Pathologythe Second Xiangya Hospital of Central South UniversityChangshaHunanP.R.China Department of Pathologythe First Affiliated Hospital of Nanjing Medical UniversityNanjingJiangsuP.R.China Department of PathologyXijing HospitalFourth Military Medical UniversityXi’anShaanxiP.R.China Department of PathologytheAffiliated Hospital ofQingdao UniversityQingdaoShandongP.R.China Department of PathologyBeijing HospitalNational Center of GerontologyBeijingP.R.China Department of Pathologythe First Affiliated Hospital of Soochow UniversitySuzhouJiangsuP.R.China Department of PathologyUnion HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhanHubeiP.R.China Department of PathologyHarbin Medical University Cancer HospitalHarbinHeilongjiangP.R.China Department of PathologyXiangya HospitalCentral South UniversityChangshaHunanP.R.China
出 版 物：《Cancer Communications》 (癌症通讯（英文）)
年 卷 期：2024年第44卷第9期
页 面：992-1004页
核心收录：
学科分类：1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学]
基 金：CAMS Innovation Fund for Medical Sciences,Grant/Award Numbers:2021-1-I2M-012,2022-I2M-C&T-B-078 Beijing Hope Run Special Fund of Cancer Foundation of the People’s Republic of China,Grant/Award Number:LC2019L04 National Key Research and Development Program,Grant/Award Number:2022YFC2409902 Capital’s Funds for Health Improvement and Research,Grant/Award Number:2020-2Z-4028
主 题：anaplastic lymphoma kinase diagnosis gene fusion non-small cell lung cancer
摘 要：Background:Anaplastic lymphoma kinase(ALK)test in advanced non-small cell lung cancer(NSCLC)can help physicians provide target therapies for patients harboring ALK gene *** study aimed to investigate the real-world test patterns and positive rates of ALK gene rearrangements in advanced ***:In this real-world study(ChiCTR2000030266),patientswith advanced NSCLC who underwent an ALK rearrangement test in 30 medical centers in China between October 1,2018 and December 31,2019 were retrospectively *** training was conducted before the study was *** controls were performed at participating centers using immunohistochemistry(IHC)-*** positive ALK gene rearrangement rate and consistency rate were *** associated clinicopathological characteristics of ALK gene rearrangement were investigated as ***:The overall ALK gene rearrangement rate was 6.7%in 23,689 patients with advanced NSCLC and 8.2%in 17,436 patients with advanced lung *** quality control analysis of IHC-VENTANA-D5F3 revealed an intrahospital consistency rate of 98.2%(879/895)and an inter-hospital consistency rate of 99.2%(646/651).IHC-VENTANA-D5F3 was used in 53.6%,real-time polymerase chain reaction(RT-PCR)in 25.4%,next-generation sequencing(NGS)in 18.3%,and fluorescence in-situ hybridization(FISH)in 15.9%in the adenocarcinoma *** specimens tested with multiple methods,the consistency rates confirmed by IHC-VENTANA-D5F3 were 98.0%(822/839)for FISH,98.7%(1,222/1,238)forNGS,and 91.3%(146/160)for *** overall ALK gene rearrangement rateswere higher in females,patients of≤35 years old,never smokers,tumor cellularity of50,and metastatic specimens used for testing in the total NSCLC population and adenocarcinoma subgroup(all P0.05).Conclusions:This study highlights the real-world variability and challenges of ALK test in advanced NSCLC,demonstrating a predominant use of IHCVENTANA-D5F3 with high co
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