在患有晚期非小细胞肺癌 (FLEX) 的患者中,塞图西马布加化疗:一个开放式随机的第三期试验
Robert Pirker1, Jose R Pereira, Aleksandra Szczesna
1Medical University of Vienna, Vienna, Austria.
Lancet (London, England)
|May 5, 2009
概括
在晚期非小细胞肺癌患者中,将塞图西马布添加到化疗中改善了存活率. 这种向治疗为EGFR阳性肺癌提供了一个新的选择,尽管有皮疹等副作用.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
背景情况:
- 晚期非小细胞肺癌 (NSCLC) 带来了重大的生存挑战.
- 表皮生长因子受体 (EGFR) 是NSCLC治疗的关键标.
- 塞图西马布是一种向EGFR的单克隆抗体,在NSCLC治疗中显示出潜力.
研究的目的:
- 为了比较化疗加塞图西马布和单独化疗在晚期EGFR阳性NSCLC患者中的疗效.
- 为了评估添加 cetuximab 对这一患者群体的整体存活时间的影响.
主要方法:
- 一项跨国,开放标签的III期试验随机选择了1125名先前未接受化疗的患有晚期NSCLC的患者.
- 患者接受了西斯普拉丁/维诺雷尔宾化学疗法加塞图西马布或单独化学疗法.
- 治疗包括多达六轮化疗,然后是塞图西马布,直到疾病进展或毒性.
主要成果:
- 接受化疗加塞图西马布治疗的患者的整体存活时间更长 (中位数为11.3个月与10.1个月).
- 组合组中的死亡危险比率为0.871 (p=0.044).
- 与 cetuximab 相关的最常见的不良事件是状皮疹 (10% 的患者患有 3 级).
结论:
- 将 cetuximab 添加到以为基础的化疗中,对于晚期的 NSCLC 是一种可行的新治疗选择.
- 这种组合疗法为表达EGFR的高级NSCLC的患者提供了生存益处.
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