Study participants
Thirty-four patients with advanced HCC who had undergone sorafenib
treatment were enrolled in our study and distributed into two groups
(responders vs non-responders) according to modified Response Evaluation
Criteria in Solid Tumors
(mRECIST).15Among them, patients who showed partial response or stable disease (SD)
for more than 6 months were classified as responders, while patients
with a progressive disease were considered non-responders. Only two
patients showed a complete response. We classified patients from 5
medical centers: the Department of Health Promotion, Mother and Child
Care, Internal Medicine and Medical Specialties, University Hospital of
Palermo, Italy; the Oncology Unit, AOU Mater Domini, Catanzaro, Italy;
the Department of Clinical and Experimental Medicine Policlinico ”G.
Rodolico” University of Catania, Italy; the Liver Unit of ARNAS
Garibaldi-Nesima, Catania, Italy; and the Villa Sofia-Cervello Hospital,
Palermo, Italy. All patients were enrolled according to inclusion
criteria provided by the clinical study protocol. More in detail, since
the regulatory approval of the use of sorafenib as a drug for the
treatment of HCC is not amenable to locoregional therapy, all the
patients who met the inclusion criteria according to international
guidelines (AASLD and EASL)16,17 for medical therapy
and had therefore started therapy with sorafenib, were included in the
study after signing the informed consent.
The study was approved by the Ethics Committees of the University
Hospital of Palermo, and the Ethics Committees of Section Area Centro
(Region of Calabria), as spontaneous study No. 3/2017 and Prot. n. 387,
respectively. All patients gave their approval and signed informed
consent according to the recommendations of the Declaration of Helsinki
for biomedical research involving human subjects.18