尼沃卢马布加上伊皮利穆马布与尼沃卢马布单独治疗黑色素瘤以外的晚期癌症:一个元分析
Anthony V Serritella1,2, Niraj K Shenoy1,2
1Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, Illinois.
JAMA oncology
|August 31, 2023
概括
在超越黑色素瘤的晚期癌症中,Nivolumab加Ipilimumab联合治疗没有显著改善整体存活率或无进展存活率. 组合疗法导致严重不良事件和停止治疗的发生率大幅增加.
科学领域:
- 免疫治疗是一种免疫疗法.
- 在瘤学瘤学.
- 临床试验 临床试验
背景情况:
- 尼沃卢马布和伊皮利穆马布的组合显示在晚期黑色素瘤中具有益处.
- 在其他晚期癌症中,仅有有限的数据比较这种组合与尼沃卢马布单一治疗.
研究的目的:
- 评估尼沃卢马布加上伊皮利穆马布与尼沃卢马布单一治疗在黑色素瘤以外的晚期癌症中的安全性和疗效.
- 为了确定是否添加伊皮利穆马布 (ipilimumab) 与尼沃卢穆马布 (nivolumab) 在这个患者群体中改善了临床结果.
主要方法:
- 对相关研究进行电子数据库的系统文献搜索.
- 包括8项涉及1727名患者的研究,涉及各种晚期癌症.
- 对总生存 (OS),无进展生存 (PFS) 和与治疗相关的不良事件的元分析.
主要成果:
- 与单独使用nivolumab相比,nivolumab加上ipilimumab并没有显著改善OS (HR,0.95;95%CI,0.85-1.06).
- 随着组合的使用,观察到PFS的边际,但没有临床意义的改善 (HR,0.88;95% CI,0.79-0.98).
- 组合疗法与3-4级不良事件 (OR,1.84) 和停药 (OR,1.96) 的显著更高率有关.
结论:
- 将伊皮利穆马布添加到尼沃卢马布中,对黑色素瘤以外的晚期癌症的OS或PFS没有提供临床意义上的好处.
- 组合疗法显著增加了毒性和治疗中止.
- 未来的研究应该仔细评估添加抗CTLA-4 抗PD1 治疗的净益处,以避免不必要的毒性和成本.
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