TACE Plus Sorafenib Boosts OS, PFS in Intermediate Recurrent HCC With Positive MVI

By Emily Menendez - Last Updated: March 19, 2025

A recent study by Wenzhe Fan, MD, and colleagues compared the use of sorafenib in combination with transarterial chemoembolization (TACE) with TACE alone to determine if the combination improves survival in patients with recurrent intermediate-stage hepatocellular carcinoma (HCC) after R0 hepatectomy with positive microvascular invasion (MVI).

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While TACE is a common treatment for patients with recurrent intermediate-stage HCC with positive MVI, the procedure alone is associated with unsatisfactory survival benefits. Previous studies have pointed to the potential benefit of TACE in combination with sorafenib for this patient population.

The phase 3, open-label, multicenter trial included 162 patients who were randomized to receive TACE with sorafenib (n=81) or TACE alone (n=81). The primary end point was overall survival (OS) by intention-to-treat analysis. Safety was also assessed in patients who received at least 1 dose of the study treatment.

The median OS rate was significantly longer in patients who received TACE with sorafenib over TACE alone (22.2 months vs 15.1 months; hazard ratio [HR], 0.55; P<.001). TACE with sorafenib also prolonged progression-free survival (16.2 months vs 11.8 months; HR, 0.54; P<.001) and improved the objective response rate when compared with TACE alone based on the modified Response Evaluation Criteria in Solid Tumors v1.1 criteria (80.2% vs 58.0%; P=.002).

Any grade adverse events (AEs) were more common in patients who received TACE with sorafenib, but all responded well to treatment. No unexpected AEs or treatment-related deaths occurred in the study.

TACE in combination with sorafenib can provide better clinical outcomes in patients with HCC than TACE alone. The combined treatment can be beneficial for patients with recurrent intermediate-stage HCC after R0 hepatectomy with positive MVI.

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