Observational Study
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Hepatol. Jun 28, 2015; 7(12): 1694-1700
Published online Jun 28, 2015. doi: 10.4254/wjh.v7.i12.1694
Downstaging disease in patients with hepatocellular carcinoma outside up-to-seven criteria: Strategies using degradable starch microspheres transcatheter arterial chemo-embolization
Antonio Orlacchio, Fabrizio Chegai, Stefano Merolla, Simona Francioso, Costantino Del Giudice, Mario Angelico, Giuseppe Tisone, Giovanni Simonetti
Antonio Orlacchio, Fabrizio Chegai, Stefano Merolla, Costantino Del Giudice, Giovanni Simonetti, Department of Diagnostic and Molecular Imaging, Radiation Therapy and Interventional Radiology, University Hospital Tor Vergata, 00133 Rome, Italy
Simona Francioso, Mario Angelico, Liver Unit, University Hospital Tor Vergata, 00133 Rome, Italy
Giuseppe Tisone, Organ Transplantation Unit, University Hospital Tor Vergata, 00133 Rome, Italy
Author contributions: Orlacchio A, Chegai F, Francioso S, Angelico M, Tisone G and Simonetti G designed research; Orlacchio A, Chegai F, Merolla S and Del Giudice C performed research; Orlacchio A, Chegai F, Merolla S and Francioso S contributed new reagents or analytic tools; Orlacchio A, Chegai F and Francioso S analyzed data; Orlacchio A, Chegai F and Francioso S wrote the paper.
Ethics approval: This study was approved by the Ethics Committee of our institution, No. 175/13.
Informed consent: All patients declared the informed consent.
Conflict-of-interest: All authors declare no conflict of interest.
Data sharing: Thecnical appendix, statistical code and data set available from the corresponding auhor at aorlacchio@uniroma2.it. The present data are anonymized without risk of identification.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Antonio Orlacchio, MD, Department of Diagnostic and Molecular Imaging, Radiation Therapy and Interventional Radiology, University Hospital Tor Vergata, Viale Oxford 81, 00133 Rome, Italy. aorlacchio@uniroma2.it
Telephone: +39-6-20902400 Fax: +39-6-20902404
Received: November 28, 2014
Peer-review started: November 29, 2014
First decision: January 8, 2015
Revised: January 20, 2015
Accepted: May 26, 2015
Article in press: May 27, 2015
Published online: June 28, 2015
Abstract

AIM: To evaluate the downstaging rates in hepatitis C virus-patients with hepatocellular carcinoma (HCC), treated with degradable starch microspheres transcatheter arterial chemoembolization (DSM-TACE), to reach new-Milan-criteria (nMC) for transplantation.

METHODS: This study was approved by the Ethics Committee of our institution. From September 2013 to March 2014 eight patients (5 men and 3 women) with liver cirrhosis and multinodular HCC, that did not meet nMC at baseline, were enrolled in this study. Patients who received any other type of treatment such as termal ablation or percutaneous ethanol injection were excluded. DSM-TACE was performed in all patients using EmboCept® S and doxorubicin. Baseline and follow-up computed tomography or magnetic resonance imaging was assessed measuring the longest enhancing axial dimension of each tumor according to the modified Response Evaluation Criteria In Solid Tumors measurements, and medical records were reviewed.

RESULTS: DSM-TACE was successfully performed in all patients without major complication. We treated 35 lesions (mean 4.3 per patient). Six of eight patients (75%) had their HCC downstaged to meet nMC. Every patient whose disease was downstaged eventually underwent transplantation. The six patients who received transplant were still living at the time of this writing, without recurrence of HCC. Baseline age (P = 0.25), Model for End-stage Liver Disease score (P = 0. 77), and α-fetoprotein level (P = 1.00) were similar between patients with and without downstaged HCC.

CONCLUSION: DSM-TACE represents a safely and effective treatment option with similar safety and efficacy of conventional chemoembolization and could be successfully performed also for downstaging disease in patients without nMC, allowing them to reach liver transplantation.

Keywords: Hepatocellular carcinoma, Transcatheter arterial chemoembolization, Liver transplantation, Degradable starch microspheres, New-Milan-criteria, Recurrence-free survival, Locoregional therapies

Core tip: Liver transplantation (LT) is the standard of care for select patients with hepatocellular carcinoma (HCC) and cirrhosis and recently more transplant centers use the new Milan criteria to assess the candidacy of HCC patients for LT. This manuscript reports a preliminary experience on the HCC treatment in liver transplant candidates without new-Milan-criteria, using a new technique of transcatheter arterial chemoembolization with degradable starch microspheres transcatheter arterial chemoembolization (DSM-TACE). Providing a temporary embolization DSM-TACE allows to treat more patients with an impaired liver function reducing toxicity due to standard arterial embolization. Moreover good down-staging rates after repeated DSM-TACE were successfully achieved.