从随机的III期CheckMate 9ER试验中对尼沃卢马布加卡博桑提尼布治疗晚期细胞癌的最终分析
R J Motzer1, B Escudier2, M Burotto3
1Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, USA.
概括
与sunitinib (SUN) 相比,Nivolumab加上cabozantinib (NIVO+CABO) 在以前未经治疗的晚期细胞癌 (RCC) 中显示出更高的长期疗效和安全性. 这些发现证实了NIVO+CABO作为高级RCC患者的护理标准.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 免疫治疗是一种免疫疗法.
背景情况:
- 检查Mate 9ER试验评估了尼沃卢马布加卡博桑提尼布 (NIVO+CABO) 与苏尼蒂尼布 (SUN) 在晚期细胞癌 (RCC) 中.
- 以前的结果显示,NIVO+CABO在无进展生存期 (PFS),总生存期 (OS) 和客观反应率 (ORR) 中具有显著的益处.
- 本报告提出了最终的疗效和安全性数据,随访时间中位数为5.6年.
研究的目的:
- 报告第三阶段CheckMate 9ER试验的最终,更新的疗效和安全结果.
- 评估与SUN相比,NIVO+CABO对先前未经治疗的晚期RCC患者的长期益处.
主要方法:
- 患有晚期RCC的患者被随机分配给接受一线NIVO+CABO或SUN.
- 治疗持续到疾病进展或不可接受的毒性.
- 主要终点是PFS,次要终点包括OS,ORR和安全性,通过盲目的独立中央审查进行评估.
主要成果:
- 随访时间中位数为5.6年.
- 与SUN相比,NIVO+CABO显著改善了PFS中位数 (16.4 vs 8.3个月) 和60个月PFS率 (13.6% vs 3.6%).
- 此外,NIVO+CABO还显示了优异的中位数 (46.5 vs 35.5 个月) 和60个月的OS率 (40.9% vs 35.4%),具有更高的ORR (55.7% vs 27.4%).
- 与治疗相关的不良事件是可以管理的,与先前的报告一致,没有新的死亡归因于毒性.
结论:
- 在以前未经治疗的高级RCC中,NIVO+CABO比SUN具有显著的长期疗效益.
- 尼沃+卡博的安全概况保持一致,加强其作为护理标准的作用.
- 这些最终结果支持NIVO+CABO在先进RCC的第一线治疗中的既定作用.
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