在III期EGFR突变NSCLC中进行化学放射治疗后,奥西默蒂尼布
Shun Lu1, Terufumi Kato1, Xiaorong Dong1
1From the Department of Medical Oncology, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai (S.L.), the Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan (X.D.), the Division of Thoracic Tumor Multimodality Treatment and Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu (M.H.), the Department of Radiotherapy, the Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), the Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou (M. Chen) - all in China; the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.), the Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka (T.I.), and the Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka (T.T.) - all in Japan; the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (M.-J.A.); the Department of Oncology, Hanoi Medical University (L.-V.Q.), and the Department of Oncology, Vietnam National Lung Hospital (D.-V.K.) - both in Hanoi; the Faculty of Medicine, Siriraj Hospital, Mahidol University (N.S.), the Division of Medical Oncology, Faculty of Medicine, Chulalongkorn University and the King Chulalongkorn Memorial Hospital (V.S.), and the Faculty of Medicine, Vajira Hospital, Navamindradhiraj University (Y.R.) - all in Bangkok, Thailand; the Division of Pulmonary Oncology and Interventional Bronchoscopy, Department of Thoracic Medicine, Linkou Chang Gung Memorial Hospital, Medical College of Chang Gung University, Taoyuan (C.-L.W.), and the Department of Oncology, National Taiwan University Hospital, and the National Taiwan University Cancer Center, Taipei (J.C.-H.Y.) - all in Taiwan; Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga, Málaga, Spain (M. Cobo); the Department of Internal Medicine, Division of Medical Oncology, Clinical Trial Unit, Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.Ö.); Servicio Oncología, Hospital Bernardo Houssay, Mar del Plata, Buenos Aires (I.C.); Centro de Pesquisa Clínica, Centro Regional Integrado de Oncologia, Fortaleza, Brazil (E.C.); Biometrics, Late-Stage Development, Oncology Research and Development, AstraZeneca, Cambridge, United Kingdom (X.H., E.G.); Late-Stage Development, Oncology Research and Development, AstraZeneca, Baar, Switzerland (D.G.); Late-Stage Development, Oncology Research and Development, AstraZeneca, New York (T.G.); and the Department of Hematology and Medical Oncology, Emory University School of Medicine, Winship Cancer Institute, Atlanta (S.S.R.).
奥西默提尼布显著改善了患有不可切除的第三阶段非小细胞肺癌 (NSCLC) 患者的无进展生存率,这些患者患有表皮生长因子受体 (EGFR) 突变. 这种向治疗在这个患者群体中比安慰剂提供了相当大的好处.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 奥西默提尼布是高级非小细胞肺癌 (NSCLC) 的关键治疗方法,具有表皮生长因子受体 (EGFR) 突变.
- EGFR氨酸激酶抑制剂已经在不可切除的第三阶段EGFR突变NSCLC中表现出初步的疗效.
- 这项研究研究了奥西默蒂尼布在化学放射治疗后不可切除的EGFR突变NSCLCIII期的疗效.
研究的目的:
- 评估与安慰剂相比,奥西默蒂尼布在患有不可切除的EGFR突变NSCLC的III期患者中的疗效.
- 评估无进展生存期 (PFS) 作为该患者组的主要终点.
主要方法:
- 进行了第三阶段,双盲,安慰剂对照试验.
- 患有无法切除的EGFR突变NSCLC的III期患者,在化疗放射治疗后没有进展,被随机分组.
- 参与者接受奥西默蒂尼布或安慰剂,直到疾病进展或停止治疗.
主要成果:
- 奥西默提尼布显示出显著的无进展生存益处:中位数PFS为39.1个月,与安慰剂组相比为5.6个月 (HR 0.16).
- 在12个月后,74%的ozimertinib患者还活着,没有进展,相比之下,安慰剂组的22%.
- 3级或更高的不良事件在 osimertinib (35%) 比安慰剂 (12%),更频繁,没有发现新的安全问题.
结论:
- 欧西默提尼布显著延长了无法切除的EGFR突变NSCLC的III期患者的无进展生存期.
- 这些发现支持奥西默蒂尼布作为这种特定NSCLC患者亚组的有价值的治疗选择.
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