用Sorafenib治疗门静脉瘤血栓的辅助性静脉外化学栓塞:一个随机临床试验
Zhenwei Peng1,2, Wenzhe Fan3, Zelong Liu1
1Department of Radiation Oncology, Cancer Center, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
JAMA surgery
|April 3, 2024
概括
术后辅助疗法将索拉费尼布与跨动脉化学栓塞结合,显著改善了肝细胞癌患者的无复发性和整体存活率,患者有门静脉瘤血栓,没有增加毒性.
科学领域:
- 肝胆道手术是肝胆道的手术.
- 手术瘤学手术瘤学
- 干预性放射学是干预性的放射学.
背景情况:
- 肝细胞癌 (HCC) 与门静脉瘤血栓 (PVTT) 构成一个重大的临床挑战.
- 手术切除为PVTT的选择性HCC患者提供了潜在的好处.
- 术后辅助治疗对于降低这些患者的瘤复发率至关重要.
研究的目的:
- 为了比较索拉费尼布加过动脉化学栓塞 (TACE) 与索拉费尼布单独作为PVTTHCC患者的术后辅助治疗的疗效和安全性.
- 评估联合治疗对无复发生存 (RFS) 和整体生存 (OS) 的影响.
主要方法:
- 一个第三阶段,多中心,随机临床试验,涉及158名HCC患者的成等级I-III PVTT.
- 患者被随机分配,接受TACE加索拉芬尼或索拉芬尼单独作为辅助疗法.
- 主要终点是RFS,操作系统和安全作为次要终点.
主要成果:
- 与单独使用索拉费尼布 (12.6个月) 相比,TACE和索拉费尼布的组合显示RFS中位数显著更长 (16.8个月) (HR,0.57;P=.002).
- 与TACE加索拉芬尼布 (30.4个月) 相比,单独索拉芬尼布 (22.5个月) (HR,0.57;P=.02) 的中位 OS 也显著改善.
- 3/4级不良事件的发生率,如手脚综合征,在各组之间是相似的,并且没有发生与治疗相关的死亡.
结论:
- 将索拉芬尼与TACE作为术后辅助疗法结合使用,可以有效地改善PVTTHCC患者的RFS和OS.
- 这种组合疗法耐受性良好,与索拉费尼布单一疗法相比,不会显著增加毒性.
- 这些发现支持TACE加索拉芬尼的使用,作为PVTTHCC的宝贵辅助治疗策略.
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