阿莱克提尼布在切除的ALK阳性非小细胞肺癌中
Yi-Long Wu1, Rafal Dziadziuszko1, Jin Seok Ahn1
1From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou (Y.-L.W., W.Z.), the Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou (W.M.), and the Department of Medical Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine (S.L.), the Department of Thoracic Surgery, Zhongshan Hospital, Fudan University (Q.W.), and the Department of Clinical Science, Roche (China) Holding (T.X.), Shanghai - all in China; the Department of Oncology and Radiotherapy and the Early Phase Clinical Trials Center, Medical University of Gdansk, Gdansk, Poland (R.D.); the Department of Hematology and Oncology, Samsung Medical Center (J.S.A.), and Asan Medical Center (D.H.L.), Seoul, and Seoul National University Bundang Hospital, Seongnam (J.-S.L.) - all in South Korea; the Department of Medical Oncology, International Center for Thoracic Cancers, Gustave Roussy, Villejuif, and Paris-Saclay University, Faculty of Medicine, Le Kremlin-Bicêtre - both in France (F.B.); the Cancer Institute Hospital, Japanese Foundation for Cancer Research (M.N.), and the Department of Thoracic Oncology, National Cancer Center Hospital (H.H.) - both in Tokyo; the Department of Respiratory and Critical Care Medicine, Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Vienna (M.H.); the Thoracic Oncology Division, European Institute of Oncology, IRCCS, Milan (F.M.); the Pneumo-Oncology Unit, San Camillo Forlanini Hospital, Rome (M.R.M.); the Oncology and Medical Radiology Department, Dnipropetrovsk State Medical Academy, Dnipro, Ukraine (I.B.); PD Oncology (T.O.L.), Data and Statistical Sciences (A.C.), PD Safety Risk Management (T.R.), and Translational Medicine (J.N.), F. Hoffmann-La Roche, Basel, Switzerland; and the Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (B.J.S.).
与化疗相比,辅助性alectinib在切除ALK阳性非小细胞肺癌 (NSCLC) 患者中显著改善了无病生存率. 这一发现为早期NSCLC患者提供了新的护理标准.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 药理学 药理学是指药理学的学科.
背景情况:
- 基于的化疗是可切除ALK阳性非小细胞肺癌 (NSCLC) 的标准辅助治疗方法.
- 在这种患者群体中,对辅助性alectinib与化疗的疗效和安全性的数据有限.
研究的目的:
- 为了比较辅助性alectinib与基于的化疗在切除ALK阳性NSCLC的患者的疗效和安全性.
- 评估无疾病生存率 (DFS),中枢神经系统 (CNS) DFS,整体生存率 (OS) 和安全性.
主要方法:
- 全球,第三期,开放标签,随机试验 (ALINA) 招募了完全切除,ALK阳性NSCLC (IB,II,IIIA阶段) 的患者.
- 患者被随机分配1:1接受口服alectinib (600毫克每天两次24个月) 或静脉注射基于的化疗 (四个21天周期).
- 主要终点是DFS,在II阶段/IIIA患者中进行了分层测试,然后是治疗意图 (ITT) 人群.
主要成果:
- 257名患者被随机分配:有130人接受了alectinib,127人接受了化疗.
- 在2年后,DFS为alectinib的93.8%,与II / IIIA阶段化疗的63.0% (HR 0.24,P<0.001) 和ITT人群中的93.6%与63.7% (HR 0.24,P<0.001) 相比.
- 阿列克提尼布在中枢神经系统DFS中显示出显著的益处 (HR 0.22),没有意外的安全问题.
结论:
- 与基于的化疗相比,辅助性alectinib显著改善了切除ALK阳性NSCLC (IB,II,IIIA阶段) 的患者的无病生存率.
- 阿列克提尼布代表了这个患者群体更有效的辅助治疗选择.
- 这项研究提供了强有力的证据,支持alectinib作为一种新的护理标准.
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