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TACE OF HCC WITH OCCLUSIN®50 AND DOXORUBIN: PHASE 1 RESULTS OF A NEW EMBOLIC AGENT
KW Burak1, A Stevens2, JR Kachura3, DJ Sadler1, MW Stewart2, M Sherman3
1University of Calgary, Calgary; 2Virexx Medical Corp, Edmonton; 3University Health Network, Toronto
BACKGROUND: Transarterial chemoembolization (TACE) offers a survival benefit to selected patients with hepatocellular carcinoma (HCC). Occlusin®50 is a suspension of macro-aggregated human serum albumin (MAA) particles to which human von Willebrand Factor (VWF) has been conjugated. Following intra-arterial administration, it produces platelet-dependent clot formation leading to effective arterial embolization.
OBJECTIVES: To evaluate the safety, the dose required for thrombosis, and extent of devascularization achieved with Occlusin®50.
METHODS: Twelve patients with Child A cirrhosis and HCC (4F, 8M), mean age 66.7 years (range 54-81), each received a single TACE with doxorubicin (75 mg/m2) in Lipiodol® followed by Occlusin®50. Tumor responses were assessed by CT or MRI at baseline, Day 8 and Day 43.
RESULTS: There were no clinically important safety concerns noted with Occlusin®50. There were no deaths, but 3 patients were readmitted to hospital (febrile neutropenia, presyncope, upper GI bleed) during the 9 week study period. There were no significant adverse effects on hemostatic function, although 4 patients developed thrombocytosis (platelets >400×109/L). The average volume of Occlusin®50 required to achieve thrombosis was 3.7 mL (range 1.8-5.0 mL). Devascularization at angiography was complete (>95%) in 6, extensive (>60-95%) in 2, moderate (30-60%) in 2 and slight (<30%) in 2 subjects. The 2 HCC with slight devascularization were both >10 cm. Disease was stable in 11 subjects and progressed in one. Mean (± SE) baseline longest tumour diameter was 5.7±1.0 cm, vs. 5.6±1.1 cm after TACE. Two subjects have undergone liver transplant (LT) and a 3rd is awaiting LT. The median LT-free survival following TACE was 7.5 months (range 6 – 23).
CONCLUSION: Results of this phase 1 study support further investigation of Occlusin®50 as an embolic agent for TACE in HCC patients.