Adding sorafenib to transarterial chemoembolization (TACE) improves outcomes in patients with recurrent, intermediate-stage hepatocellular carcinoma (HCC), according to research published in JAMA Oncology.

This phase 3 trial showed that patients who received sorafenib plus TACE has longer progression-free survival (PFS) and overall survival (OS) than patients who received TACE alone.

The trial (NCT04103398) included 162 patients with recurrent, intermediate-stage HCC and positive microvascular invasion. At baseline, the median age was 55 years, 93.2% of patients were men, 91.4% had hepatitis B, 62.3% had cirrhosis, 92.0% had more than 3 tumors, and 60.5% had recurrence within 1 year of hepatectomy.

The patients were randomly assigned to receive sorafenib at 400 mg twice daily plus TACE (n=81) or TACE alone (n=81). Baseline characteristics were similar between the arms. The median follow-up was 37.5 months in the sorafenib arm and 36.9 months in the TACE-alone arm.

The objective response rate (ORR) based on RECIST v1.1 was 77.8% with sorafenib and 53.1% without it (P =.001). The ORR based on modified RECIST was 80.2% and 58.0%, respectively (P =.002).

The median PFS was 16.2 months in the sorafenib arm and 11.8 months in the TACE-alone arm (hazard ratio [HR], 0.54; 95% CI, 0.39-0.76; P <.001). The 12-month PFS rate was 74.1% in the sorafenib arm and 48.0% in the TACE arm. The 24-month PFS rates were 27.2% and 11.4%, respectively.

The median OS was 22.2 months in the sorafenib arm and 15.1 months in the TACE-alone arm (HR, 0.55; 95% CI, 0.39-0.78; P <.001). The 12-month OS rate was 90.1% in the sorafenib arm and 71.6% in the TACE-alone arm. The 36-month OS rates were 26.9% and 13.6%, respectively.

The researchers noted that the improved outcomes with sorafenib were consistent across most of the clinical subgroups. They also found that outcomes were similar between patients who received conventional TACE and those who received TACE via drug-eluting beads.

Adverse events (AEs) of any grade were more common among patients who received sorafenib. AEs that were more common in the sorafenib arm than in the TACE-alone arm included:

• Hand-foot skin reaction (53.1% and 0%, respectively; P <.001)
• Diarrhea (46.9% vs 13.6%; P <.001)
• Hypertension (38.3% vs 3.7%; P <.001)
• Dysphonia (14.8% vs 0%; P <.001)
• Anemia (46.9% vs 8.6%; P <.001)
• Rash (24.7% vs 0%; P <.001).

Grade 3-4 AEs that were more common in the sorafenib arm than in the TACE-alone arm were hand-foot skin reaction (12.3% and 0%, respectively; P =.001) and hypertension (13.6% and 0%, respectively; P <.001).

Disclosures: This research was supported by National Natural Science Foundation of China. The study authors reported having no conflicts of interest. Please see the original reference for complete disclosures.