在EGFR-突变高级NSCLC中使用化学治疗或不使用Osimertinib
David Planchard1, Pasi A Jänne1, Ying Cheng1
1From the Department of Medical Oncology, Institut Gustave Roussy, Thoracic Group and International Center for Thoracic Cancers, Villejuif, and the Faculty of Medicine, Paris-Saclay University, Paris - both in France (D.P.); the Department of Medical Oncology, Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, Boston (P.A.J.); the Department of Thoracic Oncology, Jilin Cancer Hospital, Changchun (Y.C.), the Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin (Y.Y.), and the Department of Medical Oncology, Zhejiang Cancer Hospital, Hangzhou (Y.F.) - all in China; the Department of Oncology, National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei (J.C.-H.Y.); the Department of Thoracic Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo (N.Y.), the Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai (S.S.), and the Department of Respiratory Medicine, Saitama Medical University International Medical Center, Hidaka (K.K.) - all in Japan; the Department of Oncology, Asan Medical Center, Seoul, South Korea (S.-W.K.); the Department of Internal Medicine, Prince of Songkla University, Songkhla, Thailand (S.L.G.); the Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" of the Ministry of Health of the Russian Federation, Moscow (K.L.); the Department of Medical Oncology, Cancer Care Centre, St. George Hospital, Kogarah, NSW, Australia (C.K.L.); the Department of Oncology, Instituto Nacional de Enfermedades Neoplásicas, Surquillo, Peru (N.V.); the Department of Medical Oncology, University Hospitals of Leicester, Leicester (S.A.), and Oncology Research and Development (D.G., Y.R.) and Oncology Biometrics (A.T.), AstraZeneca, Cambridge - both in the United Kingdom; the Department of Clinical Oncology, Rondebosch Oncology Centre, Cape Town, South Africa (J.-M.M.); the Department of Radiotherapy and Oncology, Východoslovenský Onkologický Ústav, Košice, Slovakia (I.A.); and the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.G.).
将化疗添加到 osimertinib 显著改善了 EGFR 突变高级非小细胞肺癌患者的无进展生存率. 这种组合疗法提供了一种新的一线治疗选择,提高了患者的治疗结果.
科学领域:
- 在瘤学瘤学.
- 医学研究 医学研究
- 临床试验 临床试验
背景情况:
- 奥西默提尼布是一种第三代EGFR-TKI,向特定的EGFR突变.
- 化学疗法与EGFR-TKI疗法相结合可能会改善治疗效益.
- EGFR突变是非小细胞肺癌 (NSCLC) 的关键驱动因素.
研究的目的:
- 评估一线奥西默蒂尼布加化疗与奥西默蒂尼布单疗的疗效和安全性,在患有EGFR突变的晚期NSCLC患者中.
- 将无进展生存期 (PFS) 作为主要终点进行比较.
- 评估客观的响应率和安全概况.
主要方法:
- 一个第三阶段,国际,开放标签,随机化试验 (FLAURA2).
- 557名患有EGFR突变晚期NSCLC的患者被随机分配为1:1组.
- 治疗臂:奥西默蒂尼布加化疗 (佩米特雷克斯和西斯/碳) 与奥西默蒂尼布单一治疗.
主要成果:
- 奥西默提尼布加化疗显著改善了研究人员评估的PFS (HR 0.62,P<0.001).
- 24个月的PFS在组合治疗中为57%,单一治疗为41%.
- 客观反应率为83% (组合治疗) 与76% (单一治疗);在组合治疗中观察到更严重的不良事件.
结论:
- 在先进的EGFR突变NSCLC中,一线 osimertinib加化学疗法显示PFS比osimertinib单一疗法要长得多.
- 组合疗法为这种患者群体提供了优越的第一线治疗选择.
- 安全性概况与单个药物的已知不良事件一致.
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