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