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Osimertinib after definitive chemoradiotherapy in unresectable stage III epidermal growth factor receptor-mutated non-small-cell lung cancer: analyses of central nervous system efficacy and distant progression from the phase III LAURA study

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作者：
S. Lu[1,*1] * ; M.-J. Ahn[2] ; T. Reungwetwattana[3] ; M. Özgüroglu[4] ; T. Kato[5] ; J. C.-H. Yang[6] ; M. Huang[7] ; F. Fujiki[8] ; T. Inoue[9] ; L.-V. Quang[10] ; V. Sriuranpong[11] ; D. Vicente[12] ; C. Fuentes[13] ; A. A. Chaudhry[14] ; L. Poole[15] ; E. Armenteros Monterroso[16] ; Y. Rukazenkov[17] ; T. van der Gronde[18] ; S. S. Ramalingam[19] ;
机构： [1]Department of Medical Oncology, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China [2]Department of HematologyOncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea [3]Division of Medical Oncology, Department of Medicine,Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand [4]Department of Internal Medicine, Division of Medical Oncology, Clinical Trial Unit,Istanbul University-Cerrahpas¸a, Cerrahpas¸a Faculty of Medicine, Istanbul, Türkiye [5]Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan [6]Department of Oncology, National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan [7]Division of Thoracic TumorMultimodality Treatment and Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Sichuan, China [8]ICESPdInstituto do Câncerdo Estado de São Paulo, São Paulo, Brazil [9]Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka, Japan [10]Department of Oncology, HanoiMedical University, Hanoi, Vietnam [11]Division of Medical Oncology, Faculty of Medicine, Chulalongkorn University and the King Chulalongkorn Memorial Hospital,Bangkok, Thailand [12]Medical Oncology Department, Hospital Universitario Virgen de Macarena, Sevilla, Spain [13]Department of Oncology, Centro Médico Dra. DeSalvo, Buenos Aires, Argentina [14]Late-stage Development, Oncology R&D, AstraZeneca, Gaithersburg, USA [15]Biometrics, Late-stage Development, Oncology R&D,AstraZeneca, Cambridge, UK [16]Late-stage Development, Oncology R&D, AstraZeneca, Barcelona, Spain [17]Late-stage Development, Oncology R&D, AstraZeneca,Cambridge, UK [18]Late-stage Development, Oncology R&D, AstraZeneca, New York [19]Department of Hematology and Medical Oncology, Emory University School ofMedicine, Winship Cancer Institute, Atlanta, USA
出处：
DOI： 10.1016/j.annonc.2024.08.2243
ISSN：

关键词： osimertinib epidermal growth factor receptor mutation non-small-cell lung cancer locally advanced stage III central nervous system metastases distant metastases

摘要：
Distant metastases in non-small-cell lung cancer (NSCLC) are a poor prognostic factor that negatively impact quality of life. The central nervous system (CNS) is a common site of distant progression in epidermal growth factor receptor-mutated (EGFRm) NSCLC. Osimertinib is a third-generation EGFR-tyrosine kinase inhibitor recommended for advanced EGFRm NSCLC and as adjuvant treatment for resected EGFRm NSCLC. In LAURA (NCT03521154), osimertinib demonstrated statistically significant improvement in progression-free survival (PFS) versus placebo in unresectable stage III EGFRm NSCLC without progression during/following chemoradiotherapy (CRT). CNS efficacy and time to death or distant metastases (TTDM) analyses are reported here.Patients without progression during/following definitive platinum-based CRT were randomised 2 : 1 to receive osimertinib (80 mg daily) or placebo until progression [by blinded independent central review (BICR)] or discontinuation. The primary endpoint was PFS by BICR. CNS PFS by neuroradiologist BICR and TTDM by BICR were secondary endpoints.Overall, 216 patients were randomised (143 osimertinib, 73 placebo). Median CNS PFS by neuroradiologist BICR was not reached [95% confidence interval (CI) not calculable (NC)-NC] with osimertinib versus 14.9 months (95% CI 7.4 months-NC) with placebo; hazard ratio (HR) for CNS PFS: 0.17 (95% CI 0.09-0.32). CNS PFS analysis by investigator assessment was consistent with BICR assessment. The cumulative incidence of CNS progression at 12 months was 9% (95% CI 5% to 14%) with osimertinib and 36% (95% CI 24% to 47%) with placebo. There was clinically meaningful improvement in TTDM with osimertinib versus placebo; HR for TTDM: 0.21 (95% CI 0.11-0.38). The cumulative incidence of distant metastases at 12 months was 11% (95% CI 6% to 17%) with osimertinib and 37% (95% CI 26% to 48%) with placebo.Osimertinib demonstrated clinically meaningful improvements in CNS PFS and TTDM versus placebo, supporting osimertinib post-CRT as the standard of care in unresectable stage III EGFRm NSCLC.Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.

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大类 | 1 区 医学
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第一作者：
第一作者机构： [1]Department of Medical Oncology, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China [*1]Department of Medical Oncology, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
通讯作者：
通讯机构： [1]Department of Medical Oncology, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China [*1]Department of Medical Oncology, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
推荐引用方式(GB/T 7714)：
S. Lu,M.-J. Ahn,T. Reungwetwattana,et al.Osimertinib after definitive chemoradiotherapy in unresectable stage III epidermal growth factor receptor-mutated non-small-cell lung cancer: analyses of central nervous system efficacy and distant progression from the phase III LAURA study[J].Annals Of Oncology : Official Journal Of The European Society For Medical Oncology.2024,doi:10.1016/j.annonc.2024.08.2243.
APA：
S. Lu,M.-J. Ahn,T. Reungwetwattana,M. Özgüroglu,T. Kato...&S. S. Ramalingam.(2024).Osimertinib after definitive chemoradiotherapy in unresectable stage III epidermal growth factor receptor-mutated non-small-cell lung cancer: analyses of central nervous system efficacy and distant progression from the phase III LAURA study.Annals Of Oncology : Official Journal Of The European Society For Medical Oncology,,
MLA：
S. Lu,et al."Osimertinib after definitive chemoradiotherapy in unresectable stage III epidermal growth factor receptor-mutated non-small-cell lung cancer: analyses of central nervous system efficacy and distant progression from the phase III LAURA study".Annals Of Oncology : Official Journal Of The European Society For Medical Oncology .(2024)

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