Article Publish Status: FREE
Abstract Title:

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

Abstract Source:

Korean J Hepatobiliary Pancreat Surg. 2015 Feb ;19(1):1-5. Epub 2015 Feb 28. PMID: 26155269

Abstract Author(s):

Dong-Hwan Jung, Shin Hwang, Gi-Won Song, Baek-Yeol Ryoo, Nayoung Kim, Eunyoung Tak, Hea-Nam Hong

Article Affiliation:

Dong-Hwan Jung


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.

Study Type : Human Study

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