NEW findings from a randomised clinical trial provided compelling evidence that combining transarterial chemoembolisation (TACE) with sorafenib (SOR-TACE) significantly improves survival outcomes for patients with recurrent intermediate-stage hepatocellular carcinoma (HCC) and positive microvascular invasion (MVI). HCC is a common and aggressive liver cancer often treated with TACE, particularly in cases with recurrent intermediate-stage disease and positive MVI. Despite its widespread use, TACE alone has shown limited survival benefits. Previous retrospective studies suggested that adding sorafenib, an oral multikinase inhibitor, to TACE might enhance therapeutic outcomes. This study aimed to evaluate the clinical effectiveness of this combination therapy.
The phase III, open-label, multicentre trial involved 162 patients with recurrent intermediate-stage HCC and positive MVI post-R0 hepatectomy. Conducted across five hospitals in China, the trial ran from October 2019 to December 2021, with a 24-month follow-up period. Participants were randomly assigned to receive either SOR-TACE or TACE alone, with 81 patients in each group. The primary endpoint was overall survival, with secondary outcomes including progression-free survival and objective response rate.
The results were striking. Patients in the SOR-TACE group had a median overall survival of 22.2 months, compared to 15.1 months in the TACE-only group. Additionally, SOR-TACE extended median progression-free survival to 16.2 months versus 11.8 months for TACE alone. The objective response rate was also higher in the SOR-TACE group (80.2%) compared to the TACE group (58.0%). Adverse events were more frequent in the SOR-TACE group but were manageable and expected. Notably, no unexpected adverse events or treatment-related deaths occurred, indicating a favourable safety profile for the combined therapy.
These findings support the use of combined SOR-TACE therapy for patients with recurrent intermediate-stage HCC and positive MVI. The significant improvement in survival metrics underscores the potential of this approach to become a new standard of care. As a result, clinicians should consider SOR-TACE to enhance patient outcomes in this difficult-to-treat population. The clinical trial results demonstrate that integrating sorafenib with TACE offers superior survival benefits over TACE alone for HCC patients with microvascular invasion. This advancement in treatment strategy marks a significant step forward in managing recurrent intermediate-stage HCC, promising improved prognosis and quality of life for affected patients.
Reference:
Fan W et al. Survival in Patients With Recurrent Intermediate-Stage Hepatocellular Carcinoma. 2024;DOI:10.1001/jamaoncol.2024.1831.
