title: Sorafenib in combination with transarterial chemoembolization in Chinese patients with hepatocellular carcinoma: a subgroup interim analysis of the START trial.
abstract: OBJECTIVE
  The third interim results of the START trial showed encouraging safety and efficacy profiles, with a median time to progression of 9 months. This subgroup analysis presents results in Chinese patients enrolled in the START trial.
  
  
  METHODS
  Sixty two Chinese patients (median age 52 years) with unresectable hepatocellular carcinoma had transarterial chemoembolization (TACE) performed with an emulsion of Lipiodol(®) (Guerbet, Paris, France) and doxorubicin (30-60 mg) followed by embolization with absorbable particles. Sorafenib (400 mg twice-daily) was administered continuously with dose holidays 4 days prior to and post TACE procedures. TACE was performed every 6-8 weeks and responses were assessed after 4-6 weeks and then every 3 months if no further TACE was indicated. Patients continued receiving sorafenib until disease progression or unacceptable toxicity occurred.
  
  
  RESULTS
  Thirty seven patients (59.68%) received no more than two TACE procedures. During sorafenib treatment (median duration 6.4 months; mean daily dose 787.6 mg), 75.8% of patients experienced adverse events, most commonly pyrexia (37.1%), diarrhea (27.4%), skin reactions (22.6%), alopecia (19.4%) and abnormal hepatic function (16.1%). The most common grade 3-4 adverse events were abnormal hepatic function (6.5%) and diarrhea (3.2%). The median time to progression and overall survival were 10.6 and 16.5 months, respectively, and the objective response and stable disease rates were 44.3 and 42.6%, respectively.
  
  
  CONCLUSIONS
  The combination of the TACE and sorafenib proved both safe and effective in the treatment of Chinese patients with unresectable hepatocellular carcinoma.
authors.affiliation: Xijing Hospital, the Fourth Military Medical University, Xi'an, China.
authors.forename: Guohong
authors.initials: G
authors.lastname: Han
authors.forename: Jijin
authors.initials: J
authors.lastname: Yang
authors.forename: Guoliang
authors.initials: G
authors.lastname: Shao
authors.forename: Gaojun
authors.initials: G
authors.lastname: Teng
authors.forename: Maoqiang
authors.initials: M
authors.lastname: Wang
authors.forename: Jianyong
authors.initials: J
authors.lastname: Yang
authors.forename: Zhaoyu
authors.initials: Z
authors.lastname: Liu
authors.forename: Gansheng
authors.initials: G
authors.lastname: Feng
authors.forename: Renjie
authors.initials: R
authors.lastname: Yang
authors.forename: Ligong
authors.initials: L
authors.lastname: Lu
authors.forename: Yee
authors.initials: Y
authors.lastname: Chao
authors.forename: Jianhua
authors.initials: J
authors.lastname: Wang
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D044466:Asian People; D006528:Carcinoma, Hepatocellular / Q000401:mortality / Q000628:therapy*; D016461:Chemoembolization, Therapeutic; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D010671:Phenylurea Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D000077157:Sorafenib; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D009536:Niacinamide; D000077157:Sorafenib