Masatoshi Kudo, MD, PhD, Department of Gastroenterology and Hepatology, Kindai University, discusses the randomized phase II trial comparing transarterial chemoradiation (TACE) plus sorafenib (Nexavar) with TACE alone in patients with hepatocellular carcinoma (HCC).

A total of 156 patients participated in this trial. Median PFS reached 13.5 months with TACE and 25.2 months with TACE plus sorafenib, translating into a 41% reduction in the risk of progression with the addition of the targeted therapy (HR, 0.59, 95% CI 0.41, 0.87; 

 = .006). The overall survival data are not yet mature since only 74% of the targeted number of events have been observed.

According to Kudo, RECIST is measured for systemic therapy. In clinical practice, TACE was given to patients, and if new lesions formed in a different site, TACE was continued. The new lesion is not progressive disease, it is a natural biology of HCC, explains Kudo. For the TACE combination trial, the RECIST criteria is not a good measurement.

Masatoshi Kudo, MD, PhD

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Dr. Kudo Discusses TACE Plus Sorafenib in HCC