Does Sorafenib Add Benefit to TACE in HCC?

Transarterial chemoembolization (TACE) for liver-confined, unresectable hepatocellular cancer (HCC) is a care standard. Trials of systemic agents combined with regional therapies such as TACE, radioembolization, and external beam radiotherapy have yielded inconsistent impact on survival.

Investigators report results of a multicenter, open-label, randomized, phase 3 trial comparing TACE alone and combined with sorafenib (400 mg twice daily; SOR-TACE) in 162 patients in China with recurrent intermediate-stage HCC (defined as multifocal disease confined to the liver without vascular invasion or extrahepatic spread) who had positive microvascular invasion after prior potentially curative surgery. Most patients had hepatitis B (91%) and cirrhosis (62%), and most had more than 3 tumors (92%) with a median size less than 5 cm (81%); 33% underwent one TACE session, 27% underwent two, and 40% underwent three or more sessions.

At a median follow-up of 37.5 months, the primary endpoint of overall survival was superior for SOR-TACE compared to TACE (median, 22.2 vs. 15.1 months; hazard ratio, 0.55; P<0.01), with superior survival at 12 months (90.1% vs. 71.6%), 24 months (44.4% vs. 24.2%), and 36 months (26.9% vs. 13.6%). Progression-free survival was also superior for SOR-TACE over TACE (median, 16.2 vs. 11.8 months; HR, 0.54; P<001). Grade 3/4 adverse events were similar in the SOR-TACE and TACE arms with the exception of hand-foot skin reaction (12.3% vs. 0) and hypertension (13.6% vs. 0).