Safety Profile and Efficacy of Chemoembolization with Doxorubicin - Loaded Polyethylene Glycol Microspheres in Patients with Hepatocellular Carcinoma

Abstract

AIM: This study was designed as a preliminary investigation of safety and efficacy of LifePearl, polyethylene glycol microspheres loaded with doxorubicin for treatment of locally untreatable (i.e., unresectable and not suitable for local thermal ablation) hepatocellular carcinoma (HCC).
 MATERIAL AND METHODS: Patients with locally untreatable HCC (mono- or bilobar disease, ECOG performance status 0-1, Chilg-Pugh score < 11) were analysed for this single arm Unicenter retrospective study. All the information were acquired through our local hospital information system. DEB-TACE was performed with 100-200 microns LifePearl loaded with 75-150 mg of doxorubicin depending on tumour size. One interventional radiologist with experience of more than 350 TACE procedures and one fellow in radiology performed all embolisations.
 RESULTS: Twenty subjects with 29 tumours were treated (mean age 66.2 years). Child-Pugh status was A for 12 pts. (60%), B for 6 pts. (30%) and C for 2 pts. (10%). Three patients had insignificant ascites. Most patients (70%) underwent < 3 DEB-TACE procedures. Average doxorubicin dose was 71.1 mg per procedure. One patient had procedure-related SAE (acute pancreatitis) within the postembolization period which was induced due to non-target embolisation of the superior pancreaticoduodenal artery. Six-month freedom from procedure-related SAE or death was 95% (one necrotizing pancreatitis). Tumor response or stable disease was achieved in 95% (19/20) of subjects. Freedom from tumor progression or death at 6 months was 95%. One-year survival rate was 90% overall.
 CONCLUSION: The results from this investigation suggest that LifePearl microspheres, Terumo loaded with doxorubicin can provide an excellent local tumour control with very few side effects in a relatively homogeneous group of patients with locally untreatable HCC.

Unresectable hepatocellular carcinoma treatment with doxorubicin-eluting polyethylene glycol microspheres: a single-center experience

“…Treatment with LifePearl™ was well tolerated in the authors' study and agreed with the findings of several previous studies, which demonstrated good procedure safety and AEs of mild intensity (e.g., postembolic syndrome and fever) [6,[17][18][19][20][21][22][23][24][25]. Liver toxicity with TACE with doxorubicin-loaded microspheres was usually reflected by increases in AST, GGT, ALT and bilirubin levels [6,23,24]. The results of this study showed that AST, ALT and GGT levels did not change significantly after TACE compared with baseline, whereas ALK levels significantly increased versus baseline (though never exceeding normal values).…”

“…Treatment with LifePearl™ was well tolerated in the authors' study and agreed with the findings of several previous studies, which demonstrated good procedure safety and AEs of mild intensity (e.g., postembolic syndrome and fever) [ 6 , 17–25 ]. Liver toxicity with TACE with doxorubicin-loaded microspheres was usually reflected by increases in AST, GGT, ALT and bilirubin levels [ 6 , 23 , 24 ].…”

“…Several liver-directed therapies are used for local disease control (DC), downstaging or palliative care in HCC patients, including radiofrequency and microwave ablation, which are mainly used in early stages of HCC (BCLC stage 0/A) [3,4]. Liver-directed therapies for BCLC stage B are lipiodol-based conventional transarterial chemoembolization (TACE), drug-eluting microsphere TACE and transarterial radioembolization, where microspheres are impregnated with 90 Y or 166 Ho [5][6][7][8].…”

“…LifePearl™ microspheres are approved for loading with doxorubicin, idarubicin and epirubicin and have good tolerability and efficacy in HCC treatment [6,[17][18][19][20][21][22][23][24]. Doxorubicin is the most frequently used drug for TACE in HCC treatment [17,23,24] and is used in the current study, which is aimed at assessing the tolerability, treatment efficacy and safety of LifePearl™ in HCC patients.…”

Technical update on transcatheter arterial chemoembolization

“…Polyethylene glycol offers a longer time in suspension than DC Bead and HepaSphere when loaded with doxorubicin and DC Bead and Tandem when loaded with irinotecan. Longer time in suspension enables a smoother embolization procedure without the need for any interruption to resuspend the microspheres [30] .…”