An interim safety analysis of hepatocellular carcinoma patients administrating oral vitamin K with or without sorafenib

한국간담췌외과학회지 2015년 19권 1호 p.1 ~ p.5

정동환(Jung Dong-Hwan) - University of Ulsan College of Medicine Department of Surgery
황신(Hwang Shin) - University of Ulsan College of Medicine Asan Medical Center Department of Surgery
송기원(Song Gi-Won) - University of Ulsan College of Medicine Asan Medical Center Department of Surgery
류백열(Ryoo Baek-Yeol) - University of Ulsan College of Medicine Asan Medical Center Department of Oncology
김나영(Kim Na-Young) - University of Ulsan College of Medicine Asan Medical Center Asan Institute for Life Sciences
탁은영(Tak Eun-Young) - University of Ulsan College of Medicine Asan Medical Center Asan Institute for Life Sciences
홍혜남(Hong Hea-Nam) - University of Ulsan College of Medicine Department of Anatomy and Cell Biology

Abstract

Backgrounds/Aims: 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 trans-plantation 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 expect-ation of synergistic therapeutic effects.

키워드

Vitamin K, Hepatocellular carcinoma, Sorafenib, Synergy, Metastasis
원문 및 링크아웃 정보
등재저널 정보
학술진흥재단(KCI) KoreaMed 대한의학회 회원 
주제코드
주제명(Target field)
연구대상(Population)
연구참여(Sample size)
대상성별(Gender)
질병특성(Condition Category)
연구환경(Setting)
연구설계(Study Design)
연구기간(Period)
중재방법(Intervention Type)
중재명칭(Intervention Name)
키워드(Keyword)
유효성결과(Recomendation)
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.
연구비지원(Fund Source)
근거수준평가(Evidence Hierarchy)
출판년도(Year)
참여저자수(Authors)
대표저자
KCD코드
ICD 03
건강보험코드