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在先进的非脂肪细胞软组织肉瘤患者的第一线基于多克索鲁比的化疗后,作为维护疗法的雷戈拉费尼布:双盲随机试验

N Penel¹, A Italiano², J Wallet³

¹Department of Medical Oncology, Centre Oscar-Lambret, Lille, France; ULR 2694 - Metrics : Evaluation des technologies de santé et des pratiques médicales, CHU of Lille, University of Lille, Lille, France.

Annals of oncology : official journal of the European Society for Medical Oncology

|April 10, 2025

概括

在一线化疗后,regorafenib显著延迟了先进的非脂肪细胞软组织肉瘤 (STS) 的疾病进展. 这种维持疗法显示了整体存活率的积极趋势,符合研究结果.

科学领域:

在瘤学瘤学.
医学瘤学医学瘤学
临床试验临床试验

背景情况:

先进的非脂肪细胞软组织肉瘤 (STS) 缺乏经批准的维持疗法.
调查regorafenib作为一线治疗后的潜在维持策略至关重要.

研究的目的:

评估regorafenib作为高级非脂肪细胞性STS的维持疗法的疗效和安全性.
评估regorafenib对初始化疗后无进展生存期 (PFS) 的影响.

主要方法:

这是一项双盲,安慰剂控制,随机的II期试验 (EREMISS),涉及126名患者.
患者接受了regorafenib (120毫克/天,3周在/1周休息) 或安慰剂在基于多克索鲁比的化疗后.
主要终点:通过使用RECIST 1.1标准的盲目中央审查评估PFS.

主要成果:

在regorafenib治疗中,PFS的中位数为5.6个月,而在安慰剂治疗中为3.5个月 (HR=0.53,P=0.001).
总生存时间的中位数显示出有利于regorafenib (27.6 vs 20.5个月) 的非显著趋势.
3级以上的不良事件发生在56.3%的regorafenib患者中,与4.8%的安慰剂患者相比.

结论:

在先进的非脂肪细胞性STS患者中,regorafenib显著改善了PFS,在第一线治疗后.
该试验实现了其主要目标,证明了regorafenib作为维持治疗的潜力.
对整体生存效益和毒性管理的进一步调查是有必要的.

关键词:

维护疗法维护疗法与安慰剂控制的试验试验.随机化试验是指随机化的试验.雷戈拉芬尼布的使用情况软组织肉瘤 (软组织肉瘤)

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