title: Sorafenib for the treatment of recurrent hepatocellular carcinoma after liver transplantation?
abstract: BACKGROUND
  There are scarce data on the use of sorafenib for the treatment of recurrent hepatocellular carcinoma (HCC) after orthotopic liver transplantation (OLT).
  
  
  METHODS
  Ten patients were treated with sorafenib after OLT following the Italian Drug Agency guidelines: they had well-compensated liver function (Child-Pugh class A in the case of cirrhosis), intermediate-or advanced-stage HCC, good general condition (performance status 0), and not suitable for loco-regional therapies. Patients with HCC recurrence after OLT were treated with sorafenib (400 mg twice daily). Adverse events (AEs) were assessed using National Cancer Institute Common Toxicity Criteria of Adverse Events (NCI-CTCAE) v3.0 with tumor responses evaluated acording to modified Response Evaluation Criteria in Select Tumors) criteria.
  
  
  RESULTS
  Median duration of treatment was 10 months (range, 2-18). Seven patients (70%) received an additionally targeted therapy with mTOR inhibitors as part of their immunosuppressive regimen. Most common grade 3 AEs included diarrhea (50%), hand-foot skin reaction (30%), and fatigue (20%). Sorafenib had to be discontinued in 3 patients (30%) due to AEs and 4 additional patients (40%) required a dose adjustment. No deterioration of liver graft function occurred. Three patients (30%) stopped treatment due to radiological progression of HCC, whereas 3 are still using the drug. Median time to progression was 8 months (range, 2-16). Median survival from start of therapy was 18 months (range, 4- 36).
  
  
  CONCLUSIONS
  Our preliminary results suggest that sorafenib is a safe effective therapy for recurrent HCC after OLT.
authors.affiliation: Unità di Chirurgia Epatobiliare e Trapianto Epatico, Azienda - Università di Padova, Padova, Italy. alessandro.vitale@unipd.it
authors.forename: A
authors.initials: A
authors.lastname: Vitale
authors.forename: P
authors.initials: P
authors.lastname: Boccagni
authors.forename: X
authors.initials: X
authors.lastname: Kertusha
authors.forename: G
authors.initials: G
authors.lastname: Zanus
authors.forename: F
authors.initials: F
authors.lastname: D'Amico
authors.forename: E
authors.initials: E
authors.lastname: Lodo
authors.forename: D
authors.initials: D
authors.lastname: Pastorelli
authors.forename: R
authors.initials: R
authors.lastname: Ramirez Morales
authors.forename: G
authors.initials: G
authors.lastname: Lombardi
authors.forename: M
authors.initials: M
authors.lastname: Senzolo
authors.forename: P
authors.initials: P
authors.lastname: Burra
authors.forename: U
authors.initials: U
authors.lastname: Cillo
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001557:Benzenesulfonates / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy*; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy*; D016031:Liver Transplantation; D009536:Niacinamide / Q000031:analogs & derivatives; D010671:Phenylurea Compounds; D011725:Pyridines / Q000627:therapeutic use*; D012008:Recurrence; D000077157:Sorafenib
chemical_list: D000970:Antineoplastic Agents; D001557:Benzenesulfonates; D010671:Phenylurea Compounds; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib