Transarterial Chemoembolisation (TACE) with Degradable Starch Microspheres (DSM) and Anthracycline in Patients with Locally Extensive Hepatocellular Carcinoma (HCC): Safety and Efficacy.

Objective: To evalutate safety and efficacy of degradable starch microspheres (DSM) as embolic agent in transarterial chemoembolisation (TACE) of unresectable, locally extensive hepatocellular carcinoma (HCC).

Methods: In this retrospective study, 37 patients with intermediate to advanced HCC treated with ≥ 3 chemoembolisations with doxorubicin/epirubicin and DSM were analysed. Patients were treated with three consecutive chemoembolisations in 4-weekly intervals. Clinical parameters and laboratory findings were obtained from patient records before and after each intervention. Tumour response was assessed after every 3 embolisations by CT/MRI according to modified response evaluation criteria in solid tumours.

Results: Thirty-seven patients with HCC were treated with 177 DSM-TACEs (3-12/patient, mean 4.8). Disease stages according to the Barcelona Clinic Liver Cancer (BCLC) staging system were: 27 × B, 9 × C, 1 × D. Five patients had uninodular, 32 multinodular (23 bilobar) disease. Three patients had portal vein invasion. Apart from one possibly procedure-related grade 3 complication, only grade 1 adverse events occurred. These were pain reacting to analgesics (23%), transient nausea (11%), vomiting (3%) and post-embolisation syndrome (4%). Transient laboratory changes were bone marrow toxicity (29%) and increase in INR (14%), creatinine (8%) or bilirubin (38%). Tumour response was objective response rate 49%, disease control rate 83%. Median survival was 19 months: 22 months for BCLC stage B and 6.7 months for BCLC stages C + D. Responders had a significantly better prognosis than non-responders.

Conclusions: DSM-TACE of HCC is safe even in patients with advanced disease stages. Tumour response and survival rates were encouraging in our series of patients with locally extensive disease.