Transarterial Chemoembolization plus External Beam Radiotherapy Improves Survival of Patients with He patocellular Carcinoma Showing Macroscopic Vascular Invasion Compared with Sorafenib: A Randomized Trial = Transarterial Chemoembolization plus External Beam Radiotherapy Improves Survival of Patients with He patocellular Carcinoma Showing Macroscopic Vascular Invasion Compared with Sorafenib: A Randomized Trial

다국어 초록 (Multilingual Abstract)

Aims: Patients with hepatocellular carcinoma (HCC) showing macroscopic vascular invasion (MVI) bear an extremely poor prognosis. Sorafenib is the sole treatment option for advanced stage HCC with MVI with unsatisfactory response rate and survival benefit. Combined transarterial chemoembolization (TACE) plus external beam radiotherapy (RT) has shown promising results in these patients by observational studies. Here, we report the efficacy and safety of TACE plus RT compared to sorafenib in patients with advanced HCC and MVI.
Methods: This study was a randomized, open-label trial at an academic tertiary care center. Between July 2013 and October 2016, 90 treatment-naive patients with liver-confined HCC showing MVI were randomly assigned to receive sorafenib (400 mg twice-daily; n = 45; sorafenib group) or TACE (every 6 weeks) plus RT (within 3 weeks after the first TACE; n = 45; TACE+RT group). Primary endpoint was 12-week the progression-free survival (PFS) rate by intention-to-treat analysis. Radiologic response was assessed by independent review according to Response Evaluation Criteria in Solid Tumors (version 1.1). Crossover of treatment was permitted after confirming disease progression.
Results: Patients were 33 to 82 years of age, and 85.6% were male. All patients had portal vein invasion of HCC and Child- Pugh class A liver function. The median maximal tumor diameter was 9.7 cm. Most (78.9%) patients had multiple lesions. At week 12, the PFS rate was significantly higher in the TACE+RT group than the sorafenib group (86.7% vs. 34.3%; P<0.001). The TACE+RT group showed significantly higher radiologic response rate (33.3% vs. 2.2% at 24 weeks; P<0.001), significantly longer median time to disease progression (31 weeks vs. 11.7 weeks; P<0.001), and significantly longer overall survival (55 weeks vs. 43 weeks; P=0.04), compared with the sorafenib group. No patients in the TACE+RT group discontinued treatment due to hepatic decompensation.
Conclusions: In patients with advanced HCC showing MVI, first-line treatment with TACE+RT was well-tolerated and provided improved progression-free survival, objective response rate, time to disease progression, and overall survival, compared with sorafenib.