尼沃卢马布加上伊皮利穆马布与伦瓦提尼布或索拉费尼布作为不可切除的肝细胞癌的第一线治疗 (CheckMate 9DW):一个开放的,随机的,第三阶段的试验
Thomas Yau1, Peter R Galle2, Thomas Decaens3
1Centre of Cancer Medicine and University Department of Medicine, The University of Hong Kong, Hong Kong.
Lancet (London, England)
|May 11, 2025
概括
与伦瓦丁尼布或索拉芬尼布相比,尼沃卢马布加上伊皮利穆马布显著改善了不可切除的肝细胞癌患者的整体存活率. 这种组合疗法提供了一种新的一线治疗方案,具有可控的安全性.
科学领域:
- 肝细胞癌研究
- 在瘤学中的免疫治疗
- 临床试验分析
背景情况:
- 不切除的肝细胞癌 (HCC) 预后不佳,需要长期有效的治疗.
- 在CheckMate 9DW试验中,研究了nivolumab加上ipilimumab作为不可切割的HCC的第一线治疗方法.
研究的目的:
- 与伦瓦提尼布或索拉芬尼布相比,评估尼沃卢马布加上伊皮利穆马布在不可切除的肝细胞癌的第一线治疗中的疗效和安全性.
主要方法:
- 一个开放的,随机的,第三阶段试验 (NCT04039607) 招募了668名无法切除的HCC患者.
- 患者接受了尼沃卢马布加上伊皮利穆马布或研究人员选择的伦瓦提尼布或索拉费尼布.
- 主要终点是整体存活率,安全性是一个探索性终点.
主要成果:
- 尼沃卢马布加上伊皮利穆马布显著改善了总生存时间的中位数 (23. 7 vs 20. 6 个月; HR 0. 79; p=0. 018).
- 在24个月 (49% vs. 39%) 和36个月 (38% vs. 24%) 的生存率有利于nivolumab和ipilimumab组.
- 在两组之间,与治疗相关的3 - 4级不良事件相似 (41%与42%),在nivolumab和ipilimumab组中,与治疗相关的死亡人数较多 (12与3).
结论:
- 在未经治疗的不可切除的HCC中,nivolumab加上ipilimumab提供了显著的整体生存益处和可控的安全性.
- 这些发现支持尼沃卢马布加上伊皮利穆马布作为不可切除的肝细胞癌患者的首选治疗方案.
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