title: Characteristics of 18 patients with hepatocellular carcinoma who obtained a complete response after treatment with sorafenib.
abstract: OBJECTIVE
  Sorafenib, a multi-targeted tyrosine kinase inhibitor, is a first-line systemic treatment for advanced hepatocellular carcinoma (HCC). However, possible predictors of the efficacy of sorafenib treatment in HCC patients remain unclear.
  
  
  METHODS
  We conducted a nationwide survey to examine the situation of patients with HCC treated with sorafenib who obtained a complete response (CR) according to the modified response evaluation criteria in solid tumors (mRECIST). The investigation was intended to collect clinical information regarding CR patients and to compare this data with an interim report examining all-patient surveillance for sorafenib use in Japan, which was released in May 2012.
  
  
  RESULTS
  Among the 3047 patients who were treated at institutions belonging to the Liver Cancer Study Group of Japan, 18 patients (0.6%) obtained a CR. Significant factors in the CR group were a female sex, a low bodyweight (<59 kg), an early clinical stage and a small initial dose of sorafenib (P < 0.05). Furthermore, specific adverse events (palmar-plantar erythrodysesthesia syndrome, hypertension, diarrhea, alopecia, fatigue, nausea and anorexia) were frequently observed in the CR group (P < 0.05).
  
  
  CONCLUSIONS
  This study identified the characteristics of CR patients during sorafenib treatment. The evaluation of patients receiving sorafenib, including the investigation of biomarkers, warrants further exploration in future clinical studies to identify a population in which sorafenib treatment is remarkably effective.
authors.affiliation: Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Shiba
authors.forename: Takuji
authors.initials: T
authors.lastname: Okusaka
authors.forename: Masafumi
authors.initials: M
authors.lastname: Ikeda
authors.forename: Hidetsugu
authors.initials: H
authors.lastname: Saito
authors.forename: Takafumi
authors.initials: T
authors.lastname: Ichida
keywords: adverse drug event; complete response; data collection; hepatocellular carcinoma; population characteristics; sorafenib