在切除的肺癌中,经手术时使用尼沃卢马布
Tina Cascone1, Mark M Awad1, Jonathan D Spicer1
1From the University of Texas M.D. Anderson Cancer Center, Houston (T.C., B.S.); Dana-Farber Cancer Institute, Boston (M.M.A.); McGill University Health Centre, Montreal (J.D.S.); the National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai (S.L.), and Hunan Cancer Hospital (L.W.) and Xiangya Hospital, Central South University (Y.G.), Changsha - all in China; the University of Occupational and Environmental Health, Kitakyushu (F.T.), Kanagawa Cancer Center, Yokohama (H.I.), and Saitama Cancer Center, Saitama (Y.W.) - all in Japan; Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore (J.M.T.); Erasmus MC Cancer Institute, Rotterdam, the Netherlands (R.C.); Thomayer Hospital (L.H.) and Charles University (L.B.P.) - both in Prague, Czech Republic; St. Petersburg State Budgetary Healthcare Institution, Clinical Oncology Dispensary (N.K.), and St. Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (F.V.M.) - both in St. Petersburg, Russia; Jagiellonian University Collegium Medicum, John Paul II Hospital, Krakow, Poland (J.K.); Montpellier Regional University Hospital, Montpellier, France (J.-L.P.); Prof. Dr. Ion Chiricuta and Universitatea de Medicina si Farmacie Iuliu Hatieganu, Cluj-Napoca (T.-E.C.), and Institutul Oncologic București Prof. Dr. Alexandru Trestioreanu, Bucharest (A.A.) - both in Romania; Hospital Israelita Albert Einstein, São Paulo (L.O.M.K.); Antwerp University Hospital, Edegem, Belgium (A.J.); Universitätsklinikum Schleswig-Holstein, Lübeck, Germany (S.B.); Bristol Myers Squibb, Princeton, NJ (C.C.E., P.S., S.M.-S., S.I.B.); and Hospital Universitario Puerta de Hierro, Madrid (M.P.P.).
与单独的化疗相比,术后的尼沃卢马布加上化疗显著改善了可切除非小细胞肺癌 (NSCLC) 患者的无事件生存率. 这种方法显示了更高的病理反应率,没有新的安全问题.
科学领域:
- 医学瘤学 医学瘤学
- 免疫治疗是一种免疫疗法.
- 胸部外科手术 胸部外科手术
背景情况:
- 新辅助药尼沃卢马布与化疗相结合,为可切除的非小细胞肺癌 (NSCLC) 提供了改善的结果.
- 正在探索整合新辅助和辅助疗法的外科手术治疗策略,以进一步增强NSCLC的临床益处.
研究的目的:
- 评估术后尼沃卢马布加化疗与单独新辅助化疗在切除性NSCLC患者的疗效和安全性.
- 评估术后nivolumab对无事件生存,病理反应和整体生存的影响.
主要方法:
- 一个第三阶段的随机双盲试验,涉及患有可切除IIA至IIIB期NSCLC的成年人.
- 患者接受了新辅助尼沃卢马布加化疗或新辅助化疗加安慰剂4个周期,随后进行手术和1年的辅助尼沃卢马布或安慰剂.
- 主要终点是无事件生存;次要终点包括病理完整反应,主要病理反应,整体生存和安全.
主要成果:
- 经手术治疗的尼沃卢马布显著改善了18个月无事件生存率 (70.2%vs.50.0%),降低了疾病进展,复发或死亡的风险 (HR,0.58).
- 尼沃卢马布组的病理完整反应率较高 (25.3%对4.7%),主要病理反应率也更高 (35.4%对12.1%).
- 与治疗相关的3级或4级不良事件发生在32.5%的尼沃卢马布组,而化疗组的不良事件为25.2%.
结论:
- 与单独的化疗相比,经外科治疗的nivolumab加上化疗显著提高了可切除NSCLC患者的无事件生存率.
- 该研究没有发现与外科手术期间的nivolumab治疗方案相关的新的安全问题.
- 这些发现支持使用外科手术期间的nivolumab作为可切除NSCLC的标准治疗方法.
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