Objective: To assess safety, feasibility and effectiveness of transarterial chemoembolization with degradable-starch-microspheres (DSM-TACE) in the treatment of patients with advanced hepatocellular carcinoma (HCC) dismissing or ineligible for multikinase-inhibitor chemotherapy administration (Sorafenib) due to unbearable side effects or clinical contraindications.
Patients and methods: Six consecutive advanced HCC patients dismissing Sorafenib because of unbearable side effects or worsened clinical conditions were enrolled in our prospective single-center pilot study. DSM-TACE was performed via a lobar approach, based on extent and distribution of the disease (1 treatment session for every lobe involved, with a 2-week interval in case of bilobar disease). Tumor response based on mRECIST criteria was evaluated on MD-CT performed at 1 month after "complete treatment" and every 3 months thereafter.
Results: Eleven treatments were performed, and technical success was achieved in all patients. No intra/peri-procedural death/major complications occurred. No signs of liver failure or systemic toxicity were detected. At one month follow-up, 5 partial responses (83.3%) and 1 progression disease (16.6%) with an overall disease control (ODC) of 83.3% were observed. In two patients with ODC and residual viable tumor higher than 50%, a repeated DSM-TACE treatment was performed. During the mean follow-up of 11 months (range: 4-14 months), an ODC of 66.6% was obtained. Progression-free survival was 5.5 months with a cumulative 6-month and 1-year overall survival rates of 83.3% and 66.6%, respectively.
Conclusions: DSM-TACE seems to be a promising option for advanced HCC patients ineligible for Sorafenib administration or dismissing it due to progressive disease or unbearable side effects.