An interim safety analysis of hepatocellular carcinoma patients administrating oral vitamin K with or without sorafenib
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Á¤µ¿È¯(Jung Dong-Hwan) - University of Ulsan College of Medicine Department of Surgery
Ȳ½Å(Hwang Shin) - University of Ulsan College of Medicine Asan Medical Center Department of Surgery
¼Û±â¿ø(Song Gi-Won) - University of Ulsan College of Medicine Asan Medical Center Department of Surgery
·ù¹é¿(Ryoo Baek-Yeol) - University of Ulsan College of Medicine Asan Medical Center Department of Oncology
±è³ª¿µ(Kim Na-Young) - University of Ulsan College of Medicine Asan Medical Center Asan Institute for Life Sciences
ŹÀº¿µ(Tak Eun-Young) - University of Ulsan College of Medicine Asan Medical Center Asan Institute for Life Sciences
È«Çý³²(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¡¾10.6 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.
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Vitamin K, Hepatocellular carcinoma, Sorafenib, Synergy, Metastasis
KMID :
0870420150190010001
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À¯È¿¼º°á°ú(Recomendation)
Administration of vitamin K2 analog 45 mg/day did not show any noticeable adverse side-effect during vitamin K therapy of 23.3¡¾10.6 months.