Source

Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.

Abstract

Transarterial chemoembolization (TACE) represents a first-line non-curative therapy for HCC. Sorafenib, a multikinase inhibitor, has been shown to be effective and safe monotherapy in patients with advanced HCC and the current study reports the interim results of a prospective Phase II, open label, trial investigating the safety and efficacy of the combination of sorafenib and conventional TACE in patients from the Asia-Pacific region with intermediate HCC. Patients with histologically or clinically diagnosed HCC were treated with conventional TACE followed by sorafenib 4 to 7 days later. TACE was performed by selective transarterial chemotherapy in the vessels feeding the tumor with an emulsion of lipiodol (5-20 mL) and doxorubicin (30-60 mg) followed by embolisation with absorbable particles (gel foam). TACE/sorafenib cycles were repeated every 6-8 weeks. Primary objectives were to evaluate the safety and tolerability, in addition to the efficacy of TACE combined with sorafenib for HCC. A total of 147 patients were included in the intention to treat analysis and received at least one dose of sorafenib. 62.6% of patients reported gastrointestinal AEs and 57.8% reported skin AEs although most were mild to moderate. The mean number of cycles undertaken was 2.1 and 63.3% of patients achieved either partial response or stable disease. Clinically the disease control rate was 91.2% while the overall response rate (ORR) was calculated as 52.4%. This study shows that concurrent sorafenib and TACE therapy is safe and effective with no unexpected side effects.