Degradable starch microspheres transarterial chemoembolization (DSMs-TACE) in patients with unresectable hepatocellular carcinoma (HCC): long-term results from a single-center 137-patient cohort prospective study.

Abstract

To evaluate safety and efficacy of degradable starch microspheres (DSMs) TACE in a large clinical cohort of patients with unresectable HCC. This is a single-center consecutive patients cohort study. The study was approved by local institutional ethics committee. Written informed consent was obtained. From December 2013 to March 2018, 137 cirrhotic patients with unresectable HCC were enrolled. For DSMs-TACE, a mixture of 4mL of DSMs, 6mL of non-ionic contrast and doxorubicin at a dose of 50mg/m2 were used. Primary end point was long-term outcome, in terms of time to progression (TTP) and overall survival (OS). Secondary endpoints were: safety, liver toxicity, 1-month percentage of tumor necrosis according to the modified RECIST criteria. Two hundred and sixty-seven DSMs-TACE were performed in 137 HCC patients (33 patients in BCLC stage A, 84 patients in BCLC stage B, and 20 in stage C). Patients had a mean nodule number of 3.5 ± 1.2 (SD). Major complications were observed in 6.8% of cases. Post-embolization syndrome was common (101 patients 73.7%). According to mRecist criteria, a high objective response rate was obtained even after just one treatment (84.3% of patients showed complete response or partial response). The median TTP and OS after DSMs-TACE were 12months and 36months, respectively. OS at 6months, 1year, 2 and 3years was 98%, 81.3%, 57.9%, 34.9%, respectively. DSMs-TACE is a safe and effective therapy for patients with HCC, allowing to obtain a good rate of OS with excellent local tumor control.