title: High dose vitamin K3 infusion in advanced hepatocellular carcinoma.
abstract: OBJECTIVE
  The survival of patients with unresectable advanced hepatocellular carcinoma (HCC) with portal vein thrombosis is dismal. Current therapeutic options have limited efficacy. Vitamin K has been shown to have antitumor effect on HCC cells both in cell lines and patients with advanced HCC. The aim of this study was to assess the clinical efficacy of high dose vitamin K3 in the treatment of advanced HCC with portal vein thrombosis.
  
  
  METHODS
  Forty-two consecutive patients with advanced HCC (Stage C according to BCLC staging system) with portal vein thrombosis were randomized into two groups: (i) high dose vitamin K3 (n = 23); and (ii) placebo (n = 19). The vitamin K3 was administered by i.v. infusion of 50 mg/day with daily increase of dose by 50 mg for 6 days, followed by 20 mg i.m. twice daily for 2 weeks.
  
  
  RESULTS
  Of the 23 patients treated with vitamin K, one (4.3%) achieved complete response and three (13%) partial response, for a total of four (17.4%) objective responders overall. The overall mean survival was 8.9 +/- 8.8 months (median: 6; range 1-37 months) in the vitamin K group and 6.8 +/- 5.3 months (median: 5; range 1.5-21 months) in the placebo group (P = 0.552). The mean duration of survival was longer in patients in the vitamin K group who achieved objective response (22.5 +/- 12.2; median: 21; range 11-37 months) as compared to patients not achieving objective response (6.1 +/- 4.6; median: 5; range 1-16 months) (P = 0.0.002). Portal vein thrombosis resolved with complete patency in one (4.35%) patient.
  
  
  CONCLUSIONS
  Treatment with high dose vitamin K produces objective response in 17% patients with improved survival in patients achieving objective response; however, it does not affect the overall survival.
authors.affiliation: Department of Gastroenterology, GB Pant Hospital, New Delhi, India. sksarin@nda.vsnl.net.in
authors.forename: Shiv K
authors.initials: SK
authors.lastname: Sarin
authors.forename: Manoj
authors.initials: M
authors.lastname: Kumar
authors.forename: Sanjay
authors.initials: S
authors.lastname: Garg
authors.forename: Syed
authors.initials: S
authors.lastname: Hissar
authors.forename: Chandana
authors.initials: C
authors.lastname: Pandey
authors.forename: Barjesh C
authors.initials: BC
authors.lastname: Sharma
mesh_terms: D000328:Adult; D000933:Antifibrinolytic Agents / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008875:Middle Aged; D009367:Neoplasm Staging; D010919:Placebos; D011169:Portal Vein / Q000473:pathology; D015996:Survival Rate; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000188:drug therapy / Q000473:pathology; D024483:Vitamin K 3 / Q000627:therapeutic use*
chemical_list: D000933:Antifibrinolytic Agents; D010919:Placebos; D024483:Vitamin K 3