An interim safety analysis of hepatocellular carcinoma patients administrating oral vitamin K with or without sorafenib.
10.14701/kjhbps.2015.19.1.1
- Author:
Dong Hwan JUNG
1
;
Shin HWANG
;
Gi Won SONG
;
Baek Yeol RYOO
;
Nayoung KIM
;
Eunyoung TAK
;
Hea Nam HONG
Author Information
1. Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. shwang@amc.seoul.kr
- Publication Type:Clinical Trial ; Original Article
- Keywords:
Vitamin K;
Hepatocellular carcinoma;
Sorafenib;
Synergy;
Metastasis
- MeSH:
Carcinoma, Hepatocellular*;
Cross-Sectional Studies;
Exanthema;
Humans;
Liver;
Neoplasm Metastasis;
Vitamin K 2;
Vitamin K*
- From:Korean Journal of Hepato-Biliary-Pancreatic Surgery
2015;19(1):1-5
- CountryRepublic of Korea
- Language:English
-
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 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.
