title: An interim safety analysis of hepatocellular carcinoma patients administrating oral vitamin K with or without sorafenib.
abstract: OBJECTIVE
  Vitamin K may plays a role in controlling hepatocellular carcinoma (HCC) cell growth. In this study, we intended to present 5-year experience of 72 patients receiving oral vitamin K with or without sorafenib. Its end-point was to evaluate the safety of combination therapy using sorafenib and vitamin K.
  
  
  METHODS
  An interim analysis was performed as a single-arm cross-sectional study, including 72 HCC patients who underwent liver resection or transplantation and administered oral vitamin K2 alone (n=47) or with sorafenib (n=25).
  
  
  RESULTS
  In all patients, administration of vitamin K2 analog 45 mg/day did not show any noticeable adverse side-effect during vitamin K therapy of 23.3±10.6 months, except for one patient who experienced skin rash at the third day of vitamin K therapy. In 25 patients receiving sorafenib and vitamin K for 6 months or longer, any noticeable adverse side-effect suspected of vitamin K origin was not identified yet. A small proportion of patients showed unexpectedly favorable anti-tumor effects after use of vitamin K with or without sorafenib.
  
  
  CONCLUSIONS
  Because add-on of oral vitamin K did not increase the adverse side-effects of sorafenib, a combination therapy with these two agents appears to be worthy of further clinical trial with an expectation of synergistic therapeutic effects.
authors.affiliation: Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Dong-Hwan
authors.initials: DH
authors.lastname: Jung
authors.affiliation: Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Shin
authors.initials: S
authors.lastname: Hwang
authors.affiliation: Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Gi-Won
authors.initials: GW
authors.lastname: Song
authors.affiliation: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Baek-Yeol
authors.initials: BY
authors.lastname: Ryoo
authors.affiliation: Asan Institute for Life Sciences, Asan Medical Center, Seoul, Korea.
authors.forename: Nayoung
authors.initials: N
authors.lastname: Kim
authors.affiliation: Asan Institute for Life Sciences, Asan Medical Center, Seoul, Korea.
authors.forename: Eunyoung
authors.initials: E
authors.lastname: Tak
authors.affiliation: Department of Anatomy and Cell Biology, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Hea-Nam
authors.initials: HN
authors.lastname: Hong
keywords: Hepatocellular carcinoma; Metastasis; Sorafenib; Synergy; Vitamin K