Details

Autor(en) / Beteiligte

• Sieghart, Wolfgang
• Pinter, Matthias
• Reisegger, Michael
• Müller, Christian
• Ba-Ssalamah, Ahmed
• Lammer, Johannes
• Peck-Radosavljevic, Markus

Titel

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

Ist Teil von

• European radiology, 2012-06, Vol.22 (6), p.1214-1223

Ort / Verlag

Berlin/Heidelberg: Springer-Verlag

Erscheinungsjahr

2012

Quelle

MEDLINE

Beschreibungen/Notizen

• 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