在完全切除的早期非小细胞肺癌中使用辅助药杜尔瓦卢马布
Glenwood D Goss1, Gail E Darling2, Virginie Westeel3
1Division of Medical Oncology, Department of Medicine, University of Ottawa and the Ottawa Hospital Research Institute, Ottawa, Canada.
概括
助剂杜尔瓦卢马布在切除非小细胞肺癌 (NSCLC) 的患者中没有改善无病生存率. 这种免疫疗法无论在EGFR-/ALK-NSCLC中PD-L1表达如何,都没有显示出任何益处.
科学领域:
- 在瘤学瘤学.
- 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:
- 辅助免疫疗法在切除的非小细胞肺癌 (NSCLC) 中表现有前途.
- 然而,之前的试验对其有效性产生了相互矛盾的结果.
- 加拿大癌症试验小组BR.31试验专门研究辅助剂杜尔瓦卢马布.
研究的目的:
- 评估助剂杜尔瓦卢马布在完全切除早期NSCLC的患者中的疗效.
- 作为主要终点,评估无疾病生存率 (DFS).
- 分析二次结果,包括整体存活率 (OS) 和不良事件.
主要方法:
- 1,415名切除IB到IIIANSCLC阶段的患者被随机分为2:1接受杜尔瓦卢马布或安慰剂,持续12个周期.
- 分层包括阶段,节点解剖,PD-L1表达,化疗使用和中心.
- 主要分析的重点是PD-L1瘤细胞表达≥25%的患者,没有EGFR或ALK突变 (EGFR-/ALK-).
主要成果:
- 在初级 (HR 0.93; P=.64) 或二级EGFR-/ALK-群体中,在durvalumab和安慰剂组之间没有观察到DFS的显著差异.
- 随访时间中位数为60个月.
- 与安慰剂 (20%) 相比,杜尔瓦卢马布组 (26%),3-4级不良事件的发生率更高.
结论:
- 完全切除后的辅助药杜瓦卢马布在EGFR/ALK-NSCLC患者中没有改善DFS.
- 无论PD-L1表达状态如何,疗效没有得到改善.
- 该研究没有支持在这个患者群体中使用辅助药杜瓦卢马布.
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