title: Clinical course of sorafenib treatment in patients with hepatocellular carcinoma.
abstract: OBJECTIVE
  Sorafenib has been shown to improve survival of patients with advanced hepatocellular carcinoma (HCC). However, its tolerance in clinical practice has not been well evaluated, and whether sorafenib should be continued in cases of tumor progression or intolerance has not been established. The authors retrospectively assessed sorafenib tolerability, and evaluated the clinical course in patients who showed progression during sorafenib treatment.
  
  
  METHODS
  Between March 2008 and July 2010, 80 patients with advanced HCC were treated with sorafenib.
  
  
  RESULTS
  With a median of 78.5 days of treatment, 15% discontinued sorafenib due to adverse events. The duration was significantly longer in patients with Child-Pugh class A liver function (233 ± 240 days) than in those with Child-Pugh class B (100 ± 136 days; p = 0.006). The overall progression rate was 53% (43/80), with a median time to progression of 105 days (95% confidence interval, 59-150 days). After progression, 14 patients received conservative care only (group 1), 14 continued sorafenib monotherapy (group 2), 6 changed to treatment without sorafenib (group 3) and 9 underwent additional treatment with concomitant sorafenib (group 4). Survival after progression was significantly better in groups 2, 3 and 4 than in group 1 (p = 0.001).
  
  
  CONCLUSIONS
  Sorafenib was tolerable for most patients in clinical practice and may be continued in patients who show progression during sorafenib therapy. However, it was less well tolerated in patients with Child-Pugh class B liver function and should be used with caution in these patients.
authors.affiliation: Department of Internal Medicine, Pusan National University School of Medicine Division of Gastroenterology and Hepatology, Busan, Republic of Korea.
authors.forename: Hyun Young
authors.initials: HY
authors.lastname: Woo
authors.forename: Jeong
authors.initials: J
authors.lastname: Heo
authors.forename: Ki Tae
authors.initials: KT
authors.lastname: Yoon
authors.forename: Gwang Ha
authors.initials: GH
authors.lastname: Kim
authors.forename: Dae Hwan
authors.initials: DH
authors.lastname: Kang
authors.forename: Geun Am
authors.initials: GA
authors.lastname: Song
authors.forename: Mong
authors.initials: M
authors.lastname: Cho
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001557:Benzenesulfonates / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D003967:Diarrhea / Q000139:chemically induced; D018450:Disease Progression; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D060831:Hand-Foot Syndrome / Q000209:etiology; D006801:Humans; D053208:Kaplan-Meier Estimate; D017093:Liver Failure / Q000139:chemically induced; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009536:Niacinamide / Q000031:analogs & derivatives; D010671:Phenylurea Compounds; D016016:Proportional Hazards Models; D011725:Pyridines / Q000009:adverse effects / Q000627:therapeutic use*; D012189:Retrospective Studies; D000077157:Sorafenib; D013997:Time Factors
chemical_list: D000970:Antineoplastic Agents; D001557:Benzenesulfonates; D010671:Phenylurea Compounds; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib