Transarterial Hepatic Chemoembolization with 70–150 µm Drug-Eluting Beads: Assessment of Clinical Safety and Liver Toxicity Profile

Abstract

Purpose To assess the incidence and severity of adverse events (AEs) in the form clinical symptoms and liver/biliary injuries (LBI) in patients with hepatic malignancies treated with transarterial chemoembolization using 70–150 μm drug-eluting beads (DEBs). Materials and Methods A single-institution retrospective analysis was performed in 37 patients (25 patients with hepatocellular carcinoma and 12 patients with metastatic disease) who underwent 43 sessions of segmental/subsegmental 70–150 μm DEB transarterial chemoembolization with doxorubicin (38 sessions) or irinotecan (5 sessions). Patient inclusion criteria included the presence of the following lesion features: small diameter (≤ 3 cm), hypovascular, or with areas of residual disease after other locoregional therapies. Mean tumor diameter was 3.4 cm. Mean imaging and clinical follow-up periods were 171 days and 373 days, respectively. Clinical, laboratory, and imaging data were used to identify and classify clinically symptomatic AEs per session and LBI per patient according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03. Predictors for the occurrence of LBI were evaluated by logistic regression analysis. Results No grade 4 or 5 AEs were recorded. Clinically symptomatic AEs occurred in 29 (67.4%) sessions (grade 1–2, 28 sessions; grade 3, 1 session), all constituting postembolization syndrome. Asymptomatic LBI occurred in 11 (29.7%) patients (grade 1, 8 patients; grade 2, 3 patients). The mean time between 70–150 μm DEB transarterial chemoembolization session and appearance of LBI was 71 days (range, 21–223 d). No predictive factors for the development of LBI were identified. Conclusions Transarterial chemoembolization with 70–150 μm DEBs was considered safe in the present study population given the acceptably low incidence and severity of AEs.

Risk Factors for the Development of Postembolization Syndrome after Transarterial Chemoembolization for Hepatocellular Carcinoma Treatment

“…12,13 A study from Odisio et al, 14 where they used 70 -150 μm drug-eluting beads, pointed out an incidence of PES of 67.4%, which is also in the described range of 60% -80%. However, a study from Padia et al 15 that compared the safety of small (100 -300 μm) and mediumsize (300 -500 μm) particles, showed that the incidence of postembolization syndrome was lower in the first group and corresponded to 8%.…”

Transarterial chemoembolization with medium-sized doxorubicin-eluting Callisphere is safe and effective for patients with hepatocellular carcinoma

“…DEB-TACE was effective and tolerable in Chinese HCC patients with portal vein invasion, and previous C-TACE treatment appeared to be an important predictor of worse clinical outcome 18 . Moreover, the optimal particle size of DEBs for HCC patients receiving DEB-TACE treatment remains uncertain and not well studied 11,[19][20][21][22] . Lencioni et al 23 recommended that, in order to embolize the tumor thoroughly, a particle size range of 300-500 um is needed for tumors >5 cm.…”

“…Continuous efforts have been directed toward reducing the particle size of DEBs based on the hypothesis that microspheres of smaller size can penetrate more deeply into the arterioles of tumor tissues. Theoretically, 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 .…”

Selective embolization with magnetized microbeads using magnetic resonance navigation in a controlled‐flow liver model

“…Currently available DEB size ranges between 70 and 300 lm which can be chosen depending on the target tumor vascularity. 16,21 Another limitation was the use of magnetic gradient coil inserts 14,18,20 which are more powerful than built-in imaging gradient coils but are not usable clinically due to their limited bore size. Prior studies also lack anatomical and physiological realism; they were either performed in nonbifurcating arteries, 17 in vitro in small animal models 14 or in nontubular channels with slow flow, which maximize steering efficiency due to the weakness of the magnetic force but that are not representative of physiologic rheological conditions.…”

“…One technical limitation of those studies was the use of large beads, which possess higher magnetization but are not optimal for hepatic embolization. Currently available DEB size ranges between 70 and 300 μm which can be chosen depending on the target tumor vascularity . Another limitation was the use of magnetic gradient coil inserts which are more powerful than built‐in imaging gradient coils but are not usable clinically due to their limited bore size.…”