阿米万塔马布加拉泽提尼布在以前未经治疗的EGFR突变高级NSCLC中
Byoung C Cho1, Shun Lu1, Enriqueta Felip1
1From the Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine (B.C.C.), Samsung Medical Center, Sungkyunkwan University School of Medicine (S.-H.L.), and the Lung Cancer Center, Asan Medical Center Cancer Institute (S.-W.K.), Seoul, the Department of Hematology-Oncology, Seoul National University Bundang Hospital, Seongnam (J.-S.L.), and the Medical Department, Chungbuk National University Hospital, Cheongju (K.-H.L.) - all in South Korea; the Department of Medical Oncology, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai (S.L.), Harbin Medical University Cancer Hospital, Harbin (B.L.), the Department of Medical Oncology, Huizhou Municipal Central Hospital of Guangdong Province, Huizhou (H.X.), and Jilin Cancer Hospital, Changchun (Y.C.) - all in China; the Medical Oncology Service, Vall d'Hebron Barcelona Hospital Campus-Vall d'Hebron University Hospital, Barcelona (E. Felip), and the Medical Oncology Department, Hospital Regional Universitario de Málaga y Virgen de la Victoria, Institute of Biomedical Research of Malaga, Malaga (V.G.C.) - both in Spain; Virginia Cancer Specialists, Fairfax (A.I.S.); Institut Curie, Institut du Thorax Curie-Montsouris, Paris (N.G.), and Paris-Saclay University, Université de Versailles Saint-Quentin-en-Yvelines, Versailles (N.G.), and Paris-Saclay University and Institut Gustave Roussy, Villejuif (B.B.) - all in France; the National Cancer Institute, Kyiv, Ukraine (Y.O.); the Division of Medical Oncology, Department of Medicine, Siriraj Hospital Faculty of Medicine, Mahidol University Bangkok Noi Campus, Bangkok, Thailand (P.D.); the Clinical Oncology Unit, Faculty of Medicine, University of Malaya, Kuala Lumpur (A.A.), and the Department of Internal Medicine, Division of Respiratory Medicine, International Islamic University Malaysia Medical Specialist Center, Pahang (S.-H.H.) - both in Malaysia; British Hospital of Buenos Aires, Central British Hospital, Buenos Aires (E.K.); the Department of Medical Oncology, Barretos Cancer Hospital, São Paulo (J.M.D.); the School of Medicine and Institute of Medicine, Chung Shan Medical University, and the Division of Pulmonary Medicine, Department of Internal Medicine, Chung Shan Medical University Hospital, Taichung (G.-C.C.), and the Department of Medical Oncology, National Taiwan University Cancer Center, Taipei (J.C.-H.Y.) - both in Taiwan; the Department of Thoracic Oncology, Kansai Medical University Hospital, Hirakata (H.Y.), and the Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka (H.H.) - both in Japan; the Department of Thoracic Oncology, Thoraxklinik, Heidelberg University Hospital, and the National Center for Tumor Diseases Heidelberg, German Center for Lung Research, Heidelberg, Germany (M.T.); City of Hope National Medical Center, Duarte (D.N.), Chao Family Comprehensive Cancer Center, University of California, Irvine, School of Medicine, Orange (S.-H.I.O.), and Janssen Research and Development, San Diego (E. Fennema, D.M., S.M.S.) - all in California; St. John of God Murdoch Hospital, Murdoch, WA, Australia (S.M.); the Department of Medical Oncology, Division of Adult Solid Tumor, Tata Memorial Center and Homi Bhabha National Institute, Mumbai, India (K.P.); the Local Health Unit Authority of Romagna, Ravenna Hospital and Department of Onco-Hematology, Santa Maria delle Croci Hospital of Ravenna, Ravenna (M. D'Arcangelo), and the Division of Thoracic Oncology, European Institute of Oncology IRCCS, Milan (F.M., A.P.) - both in Italy; Health Pharma Professional Research, Mexico City (J.A.-A.), Oncología Médica, Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde," Guadalajara, and Universidad de Guadalajara, Guadalajara (J.C.V.L.) - all in Mexico; Instituto Português de Oncologia do Porto, Porto, Portugal (S.A.); Moscow City Oncology Hospital No. 62 (D.S.) and the Medical Center in Kolomenskoe (M.P.) - both in Moscow; the Department of Medical Oncology, Ankara Bilkent City Hospital and Ankara Yıldırım Beyazıt University (M.A.N.Ş.), and the Department of Medical Oncology, Gazi University Faculty of Medicine (O.Y.) - both in Ankara, Turkey; the Department of Medical Oncology, Christie NHS Foundation Trust and Division of Cancer Sciences, University of Manchester, Manchester, United Kingdom (R.C.); the Division of Hematology-Oncology, Henry Ford Cancer Institute, Henry Ford Health, Detroit (S.M.G.); Janssen Research and Development, Raritan, NJ (J.X., T.S., M.M., M. Daksh, M.B.); Janssen Research and Development, Spring House, PA (M.E., R.I., P.L., S. Shah, J.M.B., S. Sethi, R.E.K.); and Johnson and Johnson Clinical Innovation, Campus Basel, Allschwil, Switzerland (I.L.).
在EGFR突变的高级非小细胞肺癌患者中,阿米万塔马布加拉泽丁尼显著改善了无进展的存活率. 这种组合疗法与奥西默提尼布作为一线治疗选择相比,显示出更高的疗效.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
背景情况:
- 阿米万塔马布加拉泽提尼布在EGFR突变的高级非小细胞肺癌 (NSCLC) 中显示出有效性.
- 之前的治疗在以前未接受治疗或先前接受过 osimertinib 治疗的患者中显示出局限性.
研究的目的:
- 评估阿米万塔马布加拉泽提尼布与奥西默提尼布在EGFR突变高级NSCLC的第一线治疗中的疗效.
- 将无进展生存期 (PFS) 作为主要终点进行比较.
主要方法:
- 第三阶段,国际,随机试验比较amivantamab-lazertinib, osimertinib 和 lazertinib.
- 患有EGFR突变的患者 (外因子19删除或L858R) 在2:2:1比率中随机分配.
- 主要终点:通过盲目的独立中央审查评估的PFS.
主要成果:
- 艾米万他马布-拉泽提尼布 (23.7个月) 与奥西默提尼布 (16.6个月) 的中位数PFS显著更长.
- 客观响应率在两只手臂中都很高 (86%对85%),对阿米万他马布-拉泽提尼布的响应持续时间更长.
- 与治疗相关的不良事件导致10%的amivantamab-lazertinib患者和3%的 osimertinib 患者停止治疗.
结论:
- 阿米万塔马布加上拉泽提尼布的疗效优于奥西默提尼布,作为EGFR突变高级NSCLC的第一线治疗.
- 组合疗法为这种患者群体提供了一个有前途的新选择.
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