title: Downstaging disease in patients with hepatocellular carcinoma outside up-to-seven criteria: Strategies using degradable starch microspheres transcatheter arterial chemo-embolization.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: 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.
authors.forename: Antonio
authors.initials: A
authors.lastname: Orlacchio
authors.affiliation: 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.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Chegai
authors.affiliation: 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.
authors.forename: Stefano
authors.initials: S
authors.lastname: Merolla
authors.affiliation: 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.
authors.forename: Simona
authors.initials: S
authors.lastname: Francioso
authors.affiliation: 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.
authors.forename: Costantino Del
authors.initials: CD
authors.lastname: Giudice
authors.affiliation: 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.
authors.forename: Mario
authors.initials: M
authors.lastname: Angelico
authors.affiliation: 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.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Tisone
authors.affiliation: 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.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Simonetti
keywords: Degradable starch microspheres; Hepatocellular carcinoma; Liver transplantation; Locoregional therapies; New-Milan-criteria; Recurrence-free survival; Transcatheter arterial chemoembolization