Safety Profile and Efficacy of Chemoembolization with Doxorubicin - Loaded Polyethylene Glycol Microspheres in Patients with Hepatocellular Carcinoma
DOI:
https://doi.org/10.3889/oamjms.2019.179Keywords:
Chemoembolization, Doxorubicin, Hepatocellular carcinoma, MicrospheresAbstract
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.
Downloads
Metrics
Plum Analytics Artifact Widget Block
References
Bruix J, Sherman M. Management of hepatocellular carcinoma: an update. Hepatology. 2011; 53:1020–2. https://doi.org/10.1002/hep.24199 PMid:21374666 PMCid:PMC3084991
Llovet JM, Ricci S, Mazzaferro V, et al. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008; 359:378–90. https://doi.org/10.1056/NEJMoa0708857 PMid:18650514
Hui Y, Ruihua T, Jing L, et al. Meta-analysis of doxorubicineluting beads via transcatheter arterial chemoembolization in the treatment of unresectable hepatocellular carcinoma. Hepatogastroenterology. 2015; 62:1002–6. PMid:26902045
Zou J, Zhang L, Ren Z, Ye SL. Efficacy and safety of cTACE versus DEB-TACE in patients with hepatocellular carcinoma: a meta-analysis. J Dig Dis. 2016; 17(8):510–7. https://doi.org/10.1111/1751-2980.12380 PMid:27384075
Malagari K, Kiakidis T, Pomoni M, et al. Pharmacokinetics, safety, and efficacy of chemoembolization with doxorubicinloaded tightly calibrated small microspheres in patients with hepatocellular carcinoma. Cardiovasc Intervent Radiol. 2016; 39:1379–91. https://doi.org/10.1007/s00270-016-1382-6 PMid:27393274
EASL-EORTC clinical practice guidelines. Management of hepatocellular carcinoma. J Hepatol. 2012; 56:908–43. https://doi.org/10.1016/j.jhep.2011.12.001 PMid:22424438
Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern cooperative oncology group. Am J Clin Oncol. 1982; 5:649–55. https://doi.org/10.1097/00000421-198212000-00014 PMid:7165009
Pugh RN, Murray-Lyon IM, Dawson JL, Pietroni MC, Williams R. Transection of the oesophagus for bleeding oesophageal varices. Br J Surg. 1973; 60:646–9. https://doi.org/10.1002/bjs.1800600817 PMid:4541913
de Baere T, Plotkin S, Yu R, Sutter A, Wu Y, Cruise GM. An In vitro evaluation of four types of drug-eluting microspheres loaded with doxorubicin. J Vasc Interv Radiol. 2016; 27:1425–31. https://doi.org/10.1016/j.jvir.2016.05.015 PMid:27402527
Tanaka T, Nishiofuku H, Hukuoka Y, Sato T, Masada T, Takano M, Gilbert CW, Obayashi C, Kichikawa K. Pharmacokinetics and antitumor efficacy of chemoembolization using 40 µm irinotecan-loaded microspheres in a rabbit liver tumor model. Journal of Vascular and Interventional Radiology. 2014; 25(7):1037-44. https://doi.org/10.1016/j.jvir.2014.04.005 PMid:24861663
Gnutzmann DM, Mechel J, Schmitz A, et al. Evaluation of the plasmatic and parenchymal elution kinetics in a domestic pig model using irinotecan-loaded drug-eluting beads. J Vasc Intervent Radiol. 2015; 26:746–52. https://doi.org/10.1016/j.jvir.2014.12.016 PMid:25704223
Lencioni R, Llovet JM. Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. Semin Liver Dis. 2010; 30:52–60. https://doi.org/10.1055/s-0030-1247132 PMid:20175033
Prajapati HJ, Dhanasekaran R, El-Rayes BF, et al. Safety and efficacy of doxorubicin drug-eluting bead transarterial chemoembolization in patients with advanced hepatocellular carcinoma. J Vasc Interv Radiol. 2013; 24:307–15. https://doi.org/10.1016/j.jvir.2012.11.026 PMid:23375519
Lammer J, Malagari K, Vogl T, et al. Prospective randomized study of doxorubicin-eluting-bead embolization in the treatment of hepatocellular carcinoma: results of the PRECISION V study. Cardiovasc Intervent Radiol. 2010; 33:41–52. https://doi.org/10.1007/s00270-009-9711-7 PMid:19908093 PMCid:PMC2816794
Reyes DK, Vossen JA, Kamel IR, et al. Single-center phase II trial of transarterial chemoembolization with drug-eluting beads for patients with unresectable hepatocellular carcinoma: initial experience in the United States. Cancer J. 2009; 15:526–32. https://doi.org/10.1097/PPO.0b013e3181c5214b PMid:20010173 PMCid:PMC4390059
Malagari K, Chatzimichael K, Alexopoulou E, et al. Transarterial chemoembolization of unresectable hepatocellular carcinoma with drug eluting beads: results of an open-label study of 62 patients. Cardiovasc Intervent Radiol. 2008; 31:269–80. https://doi.org/10.1007/s00270-007-9226-z PMid:17999110
Malagari K, Pomoni M, Spyridopoulos TN, et al. Safety profile of sequential transcatheter chemoembolization with DC Bead: results of 237 hepatocellular carcinoma (HCC) patients. Cardiovasc Intervent Radiol. 2011; 34:774–85. https://doi.org/10.1007/s00270-010-0044-3 PMid:21184228
Dhanasekaran R, Kooby DA, Staley CA, Kauh JS, Khanna V, Kim HS. Comparison of conventional transarterial chemoembolization (TACE) and chemoembolization with doxorubicin drug eluting beads (DEB) for unresectable hepatocelluar carcinoma (HCC). J Surg Oncol. 2010; 101:476–80. https://doi.org/10.1002/jso.21522
Hsin IF, Hsu CY, Huang HC, et al. Liver failure after transarterial chemoembolization for patients with hepatocellular carcinoma and ascites: incidence, risk factors, and prognostic prediction. J Clin Gastroenterol. 2011; 45:556–62. https://doi.org/10.1097/MCG.0b013e318210ff17 PMid:21666547
Richter G, Radeleff B, Stroszczynski C, Pereira P, Helmberger T, Barakat M, Huppert P. Safety and feasibility of chemoembolization with doxorubicin-loaded small calibrated microspheres in patients with hepatocellular carcinoma: results of the MIRACLE I prospective multicenter study. Cardiovascular and interventional radiology. 2018; 41(4):587-93. https://doi.org/10.1007/s00270-017-1839-2 PMid:29167967 PMCid:PMC5838148
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2019 Aleksandar Gjoreski, Rozalinda Popova-Jovanovska, Irena Eftimovska-Rogac, Jusuf Vejseli
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
http://creativecommons.org/licenses/by-nc/4.0