title: Development of hypertension within 2 weeks of initiation of sorafenib for advanced hepatocellular carcinoma is a predictor of efficacy.
abstract: BACKGROUND
  Sorafenib is an agent that inhibits vascular endothelial growth factor and is associated with onset or worsening of hypertension in some patients. We conducted a retrospective analysis of whether the development of hypertension during sorafenib treatment of advanced hepatocellular carcinoma could be a predictor of anti-cancer efficacy.
  
  
  METHODS
  The study included 38 patients with advanced hepatocellular carcinoma who had received sorafenib for at least 1 month between January 2010 and December 2012. A retrospective analysis of the efficacy of sorafenib was conducted by dividing the patients into two groups-a hypertension group, presenting with grade 2 or higher hypertension according to the Common Terminology Criteria for Adverse Events (CTCTE) version 4.0; and a non-hypertension group, which included all other patients. This study evaluated the occurrence of hypertension within 2 weeks of initiation of therapy in order to avoid any treatment duration bias. Images were evaluated using the modified Response Evaluation Criteria in Solid Tumors. The response rate, time to progression, and overall survival were assessed.
  
  
  RESULTS
  Twenty-two patients (58 %) developed grade 2 or higher hypertension within 2 weeks of initiation of therapy. The response rate was significantly higher in the hypertension group. Median time to progression was 153 days in the hypertension group versus 50.5 days in the non-hypertension group, which was significantly longer in the hypertension group. Moreover, median overall survival was 1,329 days in the hypertension group versus 302 days in the non-hypertension group, which was significantly longer in the hypertension group.
  
  
  CONCLUSIONS
  Hypertension within 2 weeks of initiation of therapy may be a predictor of the anti-cancer efficacy of sorafenib when used for the treatment of advanced hepatocellular carcinoma.
authors.affiliation: Department of Gastroenterology, Rheumatology, and Clinical Immunology, Sapporo Medical University, S-1, W-16, Chuo-ku, Sapporo, 060-8543, Japan, akutsu@sapmed.ac.jp.
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Akutsu
authors.forename: Shigeru
authors.initials: S
authors.lastname: Sasaki
authors.forename: Hideyasu
authors.initials: H
authors.lastname: Takagi
authors.forename: Masayo
authors.initials: M
authors.lastname: Motoya
authors.forename: Masahiro
authors.initials: M
authors.lastname: Shitani
authors.forename: Mai
authors.initials: M
authors.lastname: Igarashi
authors.forename: Daisuke
authors.initials: D
authors.lastname: Hirayama
authors.forename: Hideki
authors.initials: H
authors.lastname: Wakasugi
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Yamamoto
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Kaneto
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Yonezawa
authors.forename: Atsushi
authors.initials: A
authors.lastname: Yawata
authors.forename: Takeya
authors.initials: T
authors.lastname: Adachi
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Hamamoto
authors.forename: Yasuhisa
authors.initials: Y
authors.lastname: Shinomura
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D005260:Female; D006801:Humans; D006973:Hypertension / Q000139:chemically induced*; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000009:adverse effects* / Q000627:therapeutic use*; D012189:Retrospective Studies; D000077157:Sorafenib
chemical_list: D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D009536:Niacinamide; D000077157:Sorafenib
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