Abstract
The study aimed to compare the tumor response to and complications of doxorubicin-eluting CalliSphere bead-transarterial chemoembolization (DEB-TACE) using small- and medium-sized beads in patients with hepatocellular carcinoma (HCC) who underwent multiple rounds of oncology therapies. Sixty patients with intermediate stage HCC who had previously received multiple oncology therapies underwent DEB-TACE with CalliSpheres of 100–300 μm (small bead group, n = 34) or 300–500 μm (medium bead group, n = 26) in diameter between October 2016 and December 2018. Adverse events and the response rate of the index tumor based on the modified Response Evaluation Criteria in Solid Tumors at 3 months post-TACE were compared between the groups. The rates of complete response, partial response, stable disease, and progressive disease were 35.4%, 29.4%, 17.6%, and 17.6%, respectively, for the small bead group and 33.1%, 23.1%, 20.8%, and 23.0%, respectively, for the medium bead group, showing no significant between-group differences (P > 0.05). Common Terminology Criteria for Adverse Events version 4.0 grade 3/4 adverse events were reported in 8 patients in the small bead group and in no patients in the medium bead group, showing a significant group difference (P < 0.01). Major complications included 8 events of ischemic hepatitis, 2 of biloma, and 2 of severe liver abscess. DEB-TACE using CalliSpheres of 300–500 μm was associated with a comparable rate of tumor response but lower rate of complications compared with that using CalliSpheres of 100–300 μm for HCC treatment in patients who had already undergone multiple rounds of oncology therapies.
Highlights
A recent meta-analysis, including data from 1990 to 2015, concluded that drug-eluting beads (DEBs)-Transarterial chemoembolization (TACE) achieved a higher complete response rate and higher overall survival rate than conventional TACE (C-TACE) in patients with hepatocellular carcinoma (HCC)
DEB-TACE was found to be safe and associated with fewer adverse events than C-TACE in the treatment of HCC9. Another meta-analysis of 30 studies were analyzed found that patients who underwent DEB-TACE had a higher complete response rate, disease control rate, and 3-year survival rate than patients who underwent C-TACE; no significant difference regarding safety was seen for patients treated with C-TACE and DEB-TACE10
The inclusion criteria were: age >18 years: HCC diagnosis based on the European Association for the Study of the Liver (EASL) Guidelines[15]; intermediate stage HCC (Barcelona Clinic Liver Cancer [BCLC] stage A or B); prior history of therapies for the disease; well compensated liver function classified as Child-Pugh Class A or B; absence of main trunk or segmental portal thrombosis; Eastern Cooperative Oncology Group (ECOG) performance status score of 0–2; and TACE treatment with
Summary
A recent meta-analysis, including data from 1990 to 2015, concluded that DEB-TACE achieved a higher complete response rate and higher overall survival rate than C-TACE in patients with HCC. DEB-TACE was found to be safe and associated with fewer adverse events than C-TACE in the treatment of HCC9 Another meta-analysis of 30 studies were analyzed found that patients who underwent DEB-TACE had a higher complete response rate, disease control rate, and 3-year survival rate than patients who underwent C-TACE; no significant difference regarding safety was seen for patients treated with C-TACE and DEB-TACE10. Small-size microspheres allow for more homogeneous intratumoral drug distribution and more distal vascular penetration[11] This theory was supported by a recent study in patients with liver malignancies in whom DEBs with small diameters achieved improved the radiological response in terms of extensive intratumoral necrosis[12]. The aim of this study was to assess and compare the safety and clinical and radiological responses achieved by DEB-TACE using CalliSpheres with diameters of [100–300] μm 300–500 μm in patients with intermediate stage HCC who had received multiple oncological treatments
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