This is the report of a randomized trial comparing transarterial chemoembolization (TACE) plus sorafenib with TACE alone using a new TACE-specific endpoint and pre-treatment of sorafenib before initial TACE, in patients with unresectable hepatocellular carcinoma (HCC). 80 patients were randomized to TACE plus sorafenib and 76 patients to TACE alone. Patients in the combination group received sorafenib 400 mg once daily for 2-3 weeks before TACE, followed by 800 mg daily during on-demand conventional TACE sessions until time to untreatable (unTACEable) progression (TTUP). Median progression-free survival (25.2 vs 13.5 months; P=0.006) and median TTUP (26.7 vs 20.6 months; P=0.02) were significantly longer in the TACE plus sorafenib than in the TACE alone group. Overall survival at 1 year and 2 years in TACE plus sorafenib group and TACE alone group were 96.2% and 82.7% and 77.2% and 64.6%, respectively. No unexpected toxicities were observed.
(Kudo M et al. – Gut, 4 December 2019)