A study led by Masafumi Ikeda, National Cancer Center Hospita, Kashiwanoha, Kashiwa Chiba, Japan, and published in the Journal of Vascular and Interventional Radiology, has investigated transcatheter arterial chemoembolization (TACE) with emulsion of lipidol and anthracycline agent and gelatin sponge particles for hepatocellular carcinoma.
The authors said that this is a widely used standard treatment in Asian countries and differed from Western implementation of TACE, which is meant to be lipodiol chemoembolization regardless of which drug or embolic agent is used. Ikeda and colleagues said that, previous to their study, there was no robust data from prospective studies.
The authors aimed to assess the safety and efficacy of TACE with emulsion of lipidol and anthracycline agent and gelatin sponge particles for the treatment of hepatocellular carcinoma in Asian countries, which was conducted in a single-arm Japan-Korea co-operative prospective study. Ikeda and others also compared their study outcomes with a similar study design by Llovet et al which explored the survival benefits of regularly repeated arterial embolization (gelatin sponge) or chemoembolization (gelatin sponge plus doxorubicin) compared with conservative treatment for unresectable hepatocellular carcinoma.
The eligibility criteria for the study, which were similar to the Llovet et al trial, included unresectable hepatocellular carcinoma; no previous treatment for hepatocellular carincoma, liver transplantation or local ablative therapy; hypervascular lesion showing enhancement on early phase computed tomography (CT) or magnetic resonance imaging (MRI); no tumour thrombosis in the first branch for main portal vein; an Eastern Cooperative Oncology Group performance status of 0 to 2; a Child-Pugh classification of A or B; adequate haemtologic, hepatic, renal and cardiac function; and 20 years or older.
The authors used 100mg/body for epirubicin, 70mg/body for doxorubicin, and 20mL for lipodol. The epriubicin or doxorubicin was dissolved in an aqueous non-ionic contract medium and was mixed with lipiodol to form an emulsion using the pumping technique.
Ikeda et al described the TACE technique as: “1) tumour enhancement and the feeding artery were confirmed using abdominal angiography 2) a catheter was inserted into the feeding artery for the hepatocellular carcinoma and the emulsion containing epriubicin or doxorubicin with lipiodol was injected 3) the feeding artery was embolized using small pieces of gelatin sponge till the disappearance of tumour stain, and 4) the therapeutic effect was confirming using contract CT or MRI after 6±2 weeks.”
TACE, was repeated on an as-need basis. The authors reported that primary endpoint was two-year survival rate and secondary endpoints were adverse events and response rate.
According to the Ikeda et al, 99 patients were included in the study and the two-year survival rate was 75.0% (95% CI, 65.2–82.8%). Of the 99 patients, 42 achieved a complete response and 31 had a partial response. The authors reported that the pattern of disease progression was locoregional recurrence in 66 patients (67%), new lesion in the liver in 53 (54%), vascular invasion in eight patients (8%) and distant metastases in eight patients (8%). At the time of analysis 33 patients had died, and the median survival times, one-year survival rate and two-year survival rate for all 99 patients were 3.1 years and 75% respectively. The two-year survival rates were 77.4% in Japan and 67% in Korea (p=0.57).
“A favourable overall survival was obtained in our study, and the result was superior to that reported in Llovet’s study (2-year survival: 63%),” said Ikeda and colleagues.
“Therefore, our results could be regarded as reference data for the usefulness of Asian TACE for hepatocellular carcinoma, and the results of Asian TACE in this study might be used as a reference arm for the development of new therapies for unresectable hepatocellular carcinoma in the future.”