Efficacy and Safety of Transarterial Chemoembolization Plus External Beam Radiotherapy vs Sorafenib in Hepatocellular Carcinoma With Macroscopic Vascular Invasion

作者：Sang Min Yoon, Baek‐Yeol Ryoo, So Jung Lee, Jong Hoon Kim, Ji Hoon Shin, Jihyun An, Han Chu Lee, Young‐Suk Lim · 发表于：JAMA Oncology · 年份：2018 · DOI：10.1001/jamaoncol.2017.5847 · 被引用次数：457 · 研究领域：Hepatocellular Carcinoma Treatment and Prognosis、Cancer Mechanisms and Therapy、Cholangiocarcinoma and Gallbladder Cancer Studies

Importance: Patients with hepatocellular carcinoma showing macroscopic vascular invasion have a poor prognosis. Sorafenib is the sole treatment option for these patients, with unsatisfactory response and survival benefit. Combined treatment with transarterial chemoembolization (TACE) plus external beam radiotherapy (RT) has shown promising results for these patients in observational studies. Objective: To evaluate the efficacy and safety of TACE plus RT compared with sorafenib for patients with hepatocellular carcinoma and macroscopic vascular invasion. Design, Setting, and Participants: In this randomized, open-label clinical trial conducted at an academic tertiary care center between July 1, 2013, and October 31, 2016, 90 treatment-naive patients with liver-confined hepatocellular carcinoma showing macroscopic vascular invasion were randomly assigned to receive sorafenib (400 mg twice daily; 45 participants [the sorafenib group]) or TACE (every 6 weeks) plus RT (within 3 weeks after the first TACE, maximum 45 Gy with the fraction size of 2.5 to 3 Gy; 45 participants [the TACE-RT group]). Main Outcomes and Measures: The primary end point was the 12-week progression-free survival rate by intention-to-treat analysis. Radiologic response was assessed by independent review according to the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1). Treatment crossover was permitted after confirming disease progression. Results: Of the 90 patients (median age, 55 years; r...