在有限阶段小细胞肺癌中进行化学放射治疗后的杜尔瓦卢马布
Ying Cheng1, David R Spigel1, Byoung Chul Cho1
1From Jilin Cancer Hospital, Changchun (Y. Cheng), Department II of Thoracic Oncology (J.F.) and the Department of Radiation Oncology (A.S.), Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing, and the Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou (Q.W.) - all in China; Sarah Cannon Research Institute (D.R.S.) and Tennessee Oncology (D.B.D.) - both in Nashville; Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (B.C.C.), and Chungbuk National University Hospital, Cheongju (K.H.L.) - both in South Korea; Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" of the Ministry of Health of the Russian Federation, Moscow (K.K.L.); Cancer and Hematology Centers of Western Michigan, Grand Rapids (Y. Chen); National Cancer Center Hospital East, Kashiwa (Y.Z.), and Kyushu University Hospital, Fukuoka (Y.S.) - both in Japan; Hospital Vall d'Hebron and Vall d'Hebron Institute of Oncology, Barcelona (A.N.), and Hospital Universitario Virgen del Rocio, Seville (R.B.) - both in Spain; Hospitals of the City of Cologne, Cologne, Germany (E.L.B.); Chang Gung Medical Foundation-Linkou Branch, Taoyuan, Taiwan (J.W.-C.C.); Akdeniz University Medical Faculty, Antalya, Turkey (S.S.G.); Medical University of Gdansk, Gdansk, Poland (A.B.); National Cancer Hospital, Hanoi, Vietnam (N.T.T.H.); First Faculty of Medicine, Charles University, and General University Hospital, Prague, Czech Republic (M.Z.); AstraZeneca, Cambridge, United Kingdom (H.M.); AstraZeneca, Gaithersburg, MD (H.G., H.J.); and the Department of Radiation Oncology, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam (S.S.).
辅助药杜瓦卢马布显著改善了化学放射治疗后的有限阶段小细胞肺癌患者的整体存活率和无进展存活率. 这种免疫疗法为这些患者提供了新的护理标准.
科学领域:
- 医学瘤学 医学瘤学
- 免疫治疗是一种免疫疗法.
- 临床试验 临床试验
背景情况:
- 局限阶段小细胞肺癌 (LS-SCLC) 提出了治疗挑战.
- 基于的标准并发化学放射治疗是当前的方法.
- 正在探索辅助疗法选择以改善结果.
研究的目的:
- 为了评估辅助剂杜尔瓦卢马布 (durvalumab) 与或没有特梅利卢马布 (tremelimumab) 在LS-SCLC患者的疗效.
- 为了比较杜尔瓦卢马布加化学放射治疗与安慰剂.
- 评估总生存率 (OS) 和无进展生存率 (PFS) 作为主要终点.
主要方法:
- 第三阶段,双盲,随机,安慰剂对照试验 (ADRIATIC).
- 患者每4周接受杜尔瓦卢马布,杜尔瓦卢马布加上特梅利卢马布或安慰剂,长达24个月.
- 根据疾病阶段的分层和预防性头骨辐射.
主要成果:
- 与安慰剂相比,杜尔瓦卢马布显著改善了OS (中位数为55.9个月与33.4个月) 和PFS (中位数为16.6个月与9.2个月).
- 死亡的风险比为0.73 (P=0.01) 和进展/死亡的风险比为0.76 (P=0.02).
- 达尔瓦卢马布和安慰剂组之间的不良事件发生率相似.
结论:
- 辅助药杜瓦卢马布在LS-SCLC患者中显示出显著的生存益处.
- 杜尔瓦卢马布为这种患者群体提供了一个有前途的新治疗方案.
- 该研究满足了其主要终点,支持杜尔瓦卢马布在LS-SCLC治疗中的作用.
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