TOPLINE:
METHODOLOGY:
- Recurrent intermediate-stage HCC has a poor prognosis, and TACE alone has yielded “unsatisfactory survival benefits,” the study authors explained. Retrospective studies suggest that combining sorafenib and TACE may be a better therapeutic option.
- Sorafenib, an inhibitor of vascular endothelial growth factor and platelet-derived growth factor receptors, may have a synergistic effect alongside TACE after hepatectomy in patients with positive microvascular invasion.
- To investigate further, 162 patients (median age, 55 years; 93% men) with recurrent intermediate-stage HCC and positive microvascular invasion were randomly allocated to sorafenib plus TACE or TACE alone.
- The trial was conducted at five hospitals in China from October 2019 to December 2021.
TAKEAWAY:
- Median overall survival was significantly longer with sorafenib plus TACE than with TACE alone (22.2 months vs 15.1 months; hazard ratio [HR], 0.55; P < .001).
- The overall survival rate at 24 months was 44.4% in the combination group vs 24.2% in the TACE group, and the rate at 36 months was 26.9% and 13.6%, respectively.
- The combination of sorafenib and TACE also significantly prolonged progression-free survival (median 16.2 months vs 11.8 months; HR, 0.54; P < .001) and led to a significantly better objective response rate (80.2% vs 58.0%; P = .002).
- Any-grade adverse events were more common in the combination arm, but all responded well to treatment, and no unexpected adverse events or treatment-related deaths occurred. The most common grade 3 or 4 adverse events in both arms included increased alanine aminotransferase (19.8% in both) and increased aspartate aminotransferase (23.5% in the combination group vs 18.5% in the TACE arm).
IN PRACTICE:
“These findings suggest that combined [sorafenib plus TACE] treatment should be considered for patients with recurrent intermediate-stage HCC after R0 hepatectomy with positive microvascular invasion,” the authors wrote.
SOURCE:
The study, with first author Wenzhe Fan, MD, from The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China, was published online in JAMA Oncology.
LIMITATIONS:
The open-label design may introduce potential bias, although the results were confirmed by a masked independent imaging review. The study population was primarily from an endemic region with high rates of chronic hepatitis B virus infection, which may limit generalizability to populations with different etiologies of HCC, such as hepatitis C in Western countries.
DISCLOSURES:
Funding was provided by the National Natural Science Foundation of China and the Outstanding Youth Fund of the National Natural Science Foundation of China. The authors reported no conflicts of interest.
A version of this article first appeared on Medscape.com.