在当前的现实世界中治疗晚期肝细胞癌的拉穆齐鲁马布:REACH-2 (R-evolution研究) 后的一项日本单臂研究
Kazufumi Kobayashi1, Sadahisa Ogasawara2, Ei Itobayashi3
1Department of Gastroenterology, Graduate School of Medicine, Chiba University, Chiba, Japan.
Investigational new drugs
|June 6, 2024
概括
拉慕西鲁马布在现实环境中对晚期肝细胞癌 (HCC) 的疗效与REACH-2研究相提并论. 然而,与临床试验相比,这项现实研究观察到不良事件 (AE) 的发生率更高.
科学领域:
- 肝胆道癌症 肝胆道癌症
- 医学瘤学 医学瘤学
- 临床药理学 临床药理学
背景情况:
- 晚期肝细胞癌 (HCC) 存在重大治疗挑战.
- 之前的研究,如REACH-2,评估了ramucirumab在HCC中的疗效.
- 在日常临床实践中,了解治疗结果至关重要.
研究的目的:
- 在现实日本环境中,前性地评估拉慕西鲁马布在晚期HCC患者的安全性和有效性.
- 为了补充REACH-2临床试验的发现.
- 评估ramucirumab作为第二线或第三线治疗,后 atezolizumab加 bevacizumab (Atez/Bev) 或 lenvatinib.
主要方法:
- 这是一项在日本进行的开放标签,非随机,多中心,前性研究.
- 包括17名患有晚期HCC的Child-Pugh A级患者,他们接受了ramucirumab.
- 在Atez/Bev或lenvatinib等先前疗法之后,Ramucirumab作为二线或三线治疗进行.
主要成果:
- 6个月无进展生存率 (PFS) 为14.3%.
- 平均PFS和总生存时间分别为3.7个月和12.0个月.
- 常见的≥3级不良事件包括高血压 (23.5%),蛋白尿 (17.6%) 和中性质减退 (11.8%),由于AE的中止率为29.4%.
结论:
- 在这个真实世界的HCC队列中,拉穆西鲁马布的疗效与REACH-2研究的疗效相当.
- 与REACH-2相比,在现实环境中不良事件的发生率更高.
- 由于患者数量有限和观察到更高的AE率,需要进一步调查.
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