title: Sorafenib for hepatocellular carcinoma patients beyond Milan criteria after orthotopic liver transplantation: a case control study.
abstract: BACKGROUND
  Orthotopic liver transplantation (OLT) is one of the most effective treatments for patients with hepatocellular carcinoma (HCC) within the Milan criteria. However, for patients beyond these criteria, the recurrence rate is higher and the prognosis is worse. Sorafenib is the only drug showing survival benefits in advanced HCC patients; however, its role in patients beyond the Milan criteria after OLT remains unclear and requires further investigation.
  
  
  METHODS
  As a case-control study, we retrospectively analyzed 17 Chinese patients beyond Milan criteria undergoing OLT for HCC. These patients were stratified into adjuvant (n = 5), palliative (n = 6), and control groups (n = 6).
  
  
  RESULTS
  Nine of 11 patients who received sorafenib after OLT needed dose reduction due to more than grade 2 side effects. The disease-free survival rates for patients with or without adjuvant sorafenib were 100% versus 37.5% (p = 0.034) at 6 months, 66.7% versus 9.4% (p = 0.026) at 12 months, and 66.7% versus 0.0% (p = 0.011) at 18 months, respectively. The overall survival rates for patients in palliative and control groups were 66.7% versus 40.0% (p = 0.248) at 6 months, 66.7% versus 40.0% (p = 0.248) at 12 months, and 50.0% versus 20.0% (p = 0.17) at 18 months, respectively. Patients in the adjuvant group had better overall survival rates than those in the palliative and control groups (p = 0.031) at 24-month follow-up.
  
  
  CONCLUSIONS
  Adjuvant sorafenib could possibly extend both disease-free and overall survival for HCC patients beyond Milan criteria after OLT.
authors.affiliation: Division of Hematology/Oncology, Department of Medicine, Taichung Veterans General Hospital, 160 Section 3, Chungkang Road, Taichung 407, Taiwan.
authors.forename: Chieh-Lin
authors.initials: CL
authors.lastname: Teng
authors.forename: Wen-Li
authors.initials: WL
authors.lastname: Hwang
authors.forename: Yi-Ju
authors.initials: YJ
authors.lastname: Chen
authors.forename: Kuang-Hsi
authors.initials: KH
authors.lastname: Chang
authors.forename: Shao-Bin
authors.initials: SB
authors.lastname: Cheng
mesh_terms: D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001557:Benzenesulfonates / Q000008:administration & dosage / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000401:mortality; D016022:Case-Control Studies; D017024:Chemotherapy, Adjuvant; D002681:China; D005260:Female; D006305:Health Status Indicators; D006801:Humans; D053208:Kaplan-Meier Estimate; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality; D016031:Liver Transplantation / Q000379:methods* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000031:analogs & derivatives; D010671:Phenylurea Compounds; D011725:Pyridines / Q000008:administration & dosage / Q000627:therapeutic use*; D012189:Retrospective Studies; D000077157:Sorafenib; D013223:Statistics as Topic; D013997:Time Factors
chemical_list: D000970:Antineoplastic Agents; D001557:Benzenesulfonates; D010671:Phenylurea Compounds; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib