Conventional transarterial chemoembolisation in combination with sorafenib for patients with hepatocellular carcinoma: a pilot study

Objectives To investigate the safety of transarterial chemoembolisation (TACE) in combination with sorafenib in patients with hepatocellular carcinoma (HCC). Methods Patients with Child-Pugh A/B liver function, ECOG performance status 0-2 and HCC treatable with TACE received continuous sorafenib 800 mg/day, and TACE with doxorubicin (75, 50 and 25 mg/m(2) according to serum bilirubin: < 1.5, 1.5-3, and > 3 mg/dL) and lipiodol 2 weeks after sorafenib initiation and repeated every 4 weeks. Results Fifteen patients were included (Child-Pugh A/B, = 12/3; Barcelona Clinic Liver Cancer-A/B/C, = 1/9/5; ECOG 0/2, = 14/1). Median time on sorafenib was 5.2 months (2.6-7.4 months); median number of TACE sessions was 3. Common adverse events were abdominal pain ( = 14), weight loss ( = 13), alopecia ( = 12), fatigue ( = 12) and hyperbilirubinaemia ( = 11). There were 32 serious adverse events (grade >= 3); 9/10-unscheduled hospital admissions and 4/5 deaths were considered TACE-related. The study was stopped prematurely because of safety concerns. At 6 months, 2 and 5 patients had complete or partial responses; 1 had stable disease. Median overall survival was 10.6 months (95% CI: 5.2-16 months). Conclusion These findings do not support use of an intensive, high-dose doxorubicin-based TACE regimen in combination with sorafenib in this study population. Key Points Transarterial chemoembolisation (TACE) is widely used in patients with hepatocellular carcinoma (HCC) Various antiangiogenic and other agents have been used to augment this treatment We tested lipiodol-TACE with bilirubin-adjusted doxorubicin dosing in combination with sorafenib This trial was stopped prematurely because of safety reasons Our safety results do not support the combination of sorafenib with this TACE regimen