Adjuvant Transarterial Chemoembolization With Sorafenib for Portal Vein Tumor Thrombus

作者：Zhenwei Peng, Wenzhe Fan, Zelong Liu, Han Xiao, Jian Wu, Rong Tang, Jianfei Tu, Liangliang Qiao, Fuxi Huang, Wenxuan Xie, Wenquan Zhuang, Wenbo Guo, Shaoqiang Li, Yunpeng Hua, Shunli Shen, Qiang He, Dongming Li, Jiaping Li, Ming Kuang · 发表于：JAMA Surgery · 年份：2024 · DOI：10.1001/jamasurg.2024.0506 · 被引用次数：15 · 研究领域：Hepatocellular Carcinoma Treatment and Prognosis、Cholangiocarcinoma and Gallbladder Cancer Studies、Liver Disease and Transplantation

Importance: Certain patients with hepatocellular carcinoma with portal vein tumor thrombus could benefit from surgical resection, and postoperative adjuvant therapy may lower the incidence of tumor recurrence. Objective: To compare the efficacy and safety of sorafenib plus transarterial chemoembolization vs sorafenib alone as postoperative adjuvant therapy for patients with hepatocellular carcinoma with portal vein tumor thrombus. Design, Setting, and Participants: This was a phase 3, multicenter, randomized clinical trial conducted in 5 hospitals in China. A total of 158 patients were enrolled and randomized from October 2019 to March 2022, with a median follow-up of 28.4 months. Portal vein tumor thrombus was graded by the Cheng classification. Eligible patients with hepatocellular carcinoma with Cheng grade I to III portal vein tumor thrombus (ie, involving segmental or sectoral branches, right- or left-side branch, or main trunk of portal vein) were included. Interventions: Patients were randomly assigned 1:1 to receive transarterial chemoembolization with sorafenib or sorafenib alone as postoperative adjuvant therapy. Sorafenib treatment was started within 3 days after randomization, with an initial dose of 400 mg orally twice a day. In the transarterial chemoembolization with sorafenib group, transarterial chemoembolization was performed 1 day after the first administration of sorafenib. Main Outcomes and Measures: The primary end point was recurrence-free survival. Eff...