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

Jung DH, Hwang S, Song GW, Ryoo BY, Kim N, Tak E, Hong HN - Korean J Hepatobiliary Pancreat Surg (2015)

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.

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.

No MeSH data available.


Related in: MedlinePlus

A liver resection patient demonstrating vitamin K-associated anti-tumor effect on multiple HCC metastasis. A 50 year-old female patient showed lumbar spine metastasis 4 months after resection of two small HCC lesions. (A) Despite radiotherapy, bone metastasis aggravated. Multiple lung and intrahepatic metastases occurred with high rise of HCC tumor markers (AFP 2070 ng/ml and DCP 610 mAU/ml). (B, C) Transarterial chemoembolization was performed to the intrahepatic recurrence. (D) After oral vitamin K was administered for 6 month, intrahepatic metastasis disappeared, lung metastasis were regressed and bone metastasis was stationary, with normalization of all tumor markers.
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Figure 1: A liver resection patient demonstrating vitamin K-associated anti-tumor effect on multiple HCC metastasis. A 50 year-old female patient showed lumbar spine metastasis 4 months after resection of two small HCC lesions. (A) Despite radiotherapy, bone metastasis aggravated. Multiple lung and intrahepatic metastases occurred with high rise of HCC tumor markers (AFP 2070 ng/ml and DCP 610 mAU/ml). (B, C) Transarterial chemoembolization was performed to the intrahepatic recurrence. (D) After oral vitamin K was administered for 6 month, intrahepatic metastasis disappeared, lung metastasis were regressed and bone metastasis was stationary, with normalization of all tumor markers.

Mentions: As being an interim analysis focused on only vitamin K-associated side-effects, the HCC recurrence and survival outcomes of these patients were not analyzed yet; instead we briefly presented two selected patients demonstrating definite anti-tumor effect of vitamin K alone (Fig. 1) and with sorafenib (Fig. 2).


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

Jung DH, Hwang S, Song GW, Ryoo BY, Kim N, Tak E, Hong HN - Korean J Hepatobiliary Pancreat Surg (2015)

A liver resection patient demonstrating vitamin K-associated anti-tumor effect on multiple HCC metastasis. A 50 year-old female patient showed lumbar spine metastasis 4 months after resection of two small HCC lesions. (A) Despite radiotherapy, bone metastasis aggravated. Multiple lung and intrahepatic metastases occurred with high rise of HCC tumor markers (AFP 2070 ng/ml and DCP 610 mAU/ml). (B, C) Transarterial chemoembolization was performed to the intrahepatic recurrence. (D) After oral vitamin K was administered for 6 month, intrahepatic metastasis disappeared, lung metastasis were regressed and bone metastasis was stationary, with normalization of all tumor markers.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4494089&req=5

Figure 1: A liver resection patient demonstrating vitamin K-associated anti-tumor effect on multiple HCC metastasis. A 50 year-old female patient showed lumbar spine metastasis 4 months after resection of two small HCC lesions. (A) Despite radiotherapy, bone metastasis aggravated. Multiple lung and intrahepatic metastases occurred with high rise of HCC tumor markers (AFP 2070 ng/ml and DCP 610 mAU/ml). (B, C) Transarterial chemoembolization was performed to the intrahepatic recurrence. (D) After oral vitamin K was administered for 6 month, intrahepatic metastasis disappeared, lung metastasis were regressed and bone metastasis was stationary, with normalization of all tumor markers.
Mentions: As being an interim analysis focused on only vitamin K-associated side-effects, the HCC recurrence and survival outcomes of these patients were not analyzed yet; instead we briefly presented two selected patients demonstrating definite anti-tumor effect of vitamin K alone (Fig. 1) and with sorafenib (Fig. 2).

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.

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.

No MeSH data available.


Related in: MedlinePlus