title: Erlotinib for advanced hepatocellular carcinoma. A systematic review of phase II/III clinical trials.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of erlotinib for the treatment of advanced hepatocellular carcinoma (HCC).
  
  
  METHODS
  A systematic literature search was undertaken in June 2015. Phase II/III trials of erlotinib for the treatment of advanced HCC were included. A descriptive analysis was applied. The study was conducted in College of Medicine, Honghui Hospital, Xi'an Jiaotong University, Xi'an, China, between June 2015 and January 2016.
  
  
  RESULTS
  Ten trials, comprising 9 phase II and one phase III trial, were included in the systematic review. The tumor response rate was 0% in 4 of the phase II trials, less than 10% in 3 of the phase II trials and the phase III trial, and greater than 20% in 2 of the phase II trials. The disease control rate was 42.5-79.6% in most studies. Three studies reported a median progression-free survival (PFS) of 6.5-9.0 months, although PFS was less than 3.5 months in most studies. Most trials reported a median overall survival of 6.25-15.65 months. The most frequent grade 3/4 toxicities were fatigue (11.9%), diarrhea (10%), increased alanine and aspartate transaminases (7.3%), and rash/desquamation (6.9%). Conclusion: Erlotinib provides efficacious and well-tolerated treatment for advanced HCC. However, more detailed investigations of HCC pathogenesis and evaluation of sensitive patient subsets are needed to improve outcomes of patients with advanced HCC. Additional well-designed, randomized, controlled trials are needed to evaluate the efficacy and safety of erlotinib as monotherapy or combination with other drugs for advanced HCC.
authors.affiliation: Department of Hepatopathy, The eighth hospital of Xi'an, Xi'an, China. E-mail. 515247334@22.com.
authors.forename: Jing
authors.initials: J
authors.lastname: Zhang
authors.forename: Yuan
authors.initials: Y
authors.lastname: Zong
authors.forename: Gang-Zhu
authors.initials: GZ
authors.lastname: Xu
authors.forename: Ke
authors.initials: K
authors.lastname: Xing
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D000069347:Erlotinib Hydrochloride / Q000627:therapeutic use*; D019317:Evidence-Based Medicine; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D009367:Neoplasm Staging; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D000069347:Erlotinib Hydrochloride