title: Systemic cytotoxic chemotherapy of patients with advanced hepatocellular carcinoma in the era of sorafenib nonavailability.
abstract: OBJECTIVE
  The goal of the study was to compare the efficacy and safety of sorafenib with those of systemic cytotoxic chemotherapy.
  
  
  BACKGROUND
  Sorafenib treatment has shown to improve the survival in patients with advanced hepatocellular carcinoma (HCC) when compared with placebo. However, whether sorafenib controls advanced-stage HCC better than systemic cytotoxic chemotherapy has not been elucidated.
  
  
  METHODS
  We retrospectively reviewed the medical records of 220 patients with measurable advanced HCC who had not received systemic treatment previously between January 2007 and April 2012. Among these patients, 78 had been treated with sorafenib. Another 14 patients who were treated with a 4-weekly regimen of adriamycin, cisplatin, and capecitabine were included as the historical control group for comparison. The median overall survival, the progression-free survival, response rates, and safety profiles were evaluated.
  
  
  RESULTS
  Baseline characteristics were similar between the treatment groups. The median overall survival was 7.2 months [95% confidence interval (CI), 5.6-8.8] in the sorafenib group and 11.2 months (95% CI, 8.1-14.2) in the cytotoxic chemotherapy group (P=0.10). The median progression-free survival was 3.2 months (95% CI, 2.2-4.3) in the sorafenib group and 5.9 months (95% CI, 3.6-8.2) in the cytotoxic chemotherapy group (P=0.07). The deterioration of liver function and neutropenia were the most frequent serious adverse events in the sorafenib and the systemic chemotherapy group.
  
  
  CONCLUSIONS
  Although a direct head-to-head comparison could not be done, there were some patients who showed a good response to systemic cytotoxic chemotherapy. Further assessment is necessary to study the role of chemotherapy in patients who are intolerant or intractable to sorafenib.
authors.affiliation: Department of Internal Medicine, Division of Gastroenterology and Hepatology, Korea University College of Medicine, Seoul, Korea.
authors.forename: Eileen L
authors.initials: EL
authors.lastname: Yoon
authors.forename: Jong Eun
authors.initials: JE
authors.lastname: Yeon
authors.forename: Hyun Jung
authors.initials: HJ
authors.lastname: Lee
authors.forename: Sang Jun
authors.initials: SJ
authors.lastname: Suh
authors.forename: Sun Jae
authors.initials: SJ
authors.lastname: Lee
authors.forename: Seong Hee
authors.initials: SH
authors.lastname: Kang
authors.forename: Keunhee
authors.initials: K
authors.lastname: Kang
authors.forename: Yang Jae
authors.initials: YJ
authors.lastname: Yoo
authors.forename: Ji Hoon
authors.initials: JH
authors.lastname: Kim
authors.forename: Hyung Joon
authors.initials: HJ
authors.lastname: Yim
authors.forename: Kwan Soo
authors.initials: KS
authors.lastname: Byun
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000201:enzymology / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018450:Disease Progression; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D053208:Kaplan-Meier Estimate; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000201:enzymology / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D058990:Molecular Targeted Therapy; D009536:Niacinamide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D016016:Proportional Hazards Models; D047428:Protein Kinase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D012189:Retrospective Studies; D012307:Risk Factors; D015398:Signal Transduction / Q000187:drug effects; D000077157:Sorafenib; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D010671:Phenylurea Compounds; D047428:Protein Kinase Inhibitors; D003841:Deoxycytidine; D009536:Niacinamide; D000069287:Capecitabine; D004317:Doxorubicin; D000077157:Sorafenib; D002945:Cisplatin; D005472:Fluorouracil