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, n = 12/3; Barcelona Clinic Liver Cancer-A/B/C, n = 1/9/5; ECOG 0/2, n = 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 (n = 14), weight loss (n = 13), alopecia (n = 12), fatigue (n = 12) and hyperbilirubinaemia (n = 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.