title: Sorafenib in patients with Child-Pugh class A and B advanced hepatocellular carcinoma: a prospective feasibility analysis.
abstract: BACKGROUND
  Sorafenib has shown survival benefits in patients with advanced hepatocellular carcinoma (HCC) and Child-Pugh (CP) class A liver function. There are few prospective data on sorafenib in patients with HCC and CP class B.
  
  
  METHODS
  A consecutive prospective series of 300 patients with CP class A or B HCC were enrolled in a dual-phase trial to determine survival and safety data according to liver function (class A or B) in patients receiving oral sorafenib 800 mg daily. [Results of this study were presented in part at the ASCO 2012 Gastrointestinal Cancers Symposium, 19-21 January 2012. J Clin Oncol 2012; 30 (Suppl 4): abstract 306.]
  
  
  RESULTS
  Overall progression-free survival (PFS), time to progression (TTP) and overall survival (OS) were 3.9, 4.1 and 9.1 months, respectively. For patients with CP class A versus B status, PFS was 4.3 versus 2.1 months, TTP was 4.2 versus 3.8 months and OS was 10.0 versus 3. 8 months. Extrahepatic spread was associated with worse outcomes but taken together with CP class, liver function played a greater role in reducing survival. Adverse events for the two CP groups were similar.
  
  
  CONCLUSIONS
  Although patients with HCC and CP class B liver function have poorer outcomes than those with CP class A function, data suggest that patients with CP class B liver function can tolerate treatment and may still benefit from sorafenib.
authors.affiliation: Medical Oncology and Haematology Unit, Humanitas Cancer Center, Istituto Clinico Humanitas, IRCCS, Rozzano.
authors.forename: T
authors.initials: T
authors.lastname: Pressiani
authors.affiliation: Medical Oncology, Arcispedale Santa Maria Nuova, IRCCS, Reggio Emilia.
authors.forename: C
authors.initials: C
authors.lastname: Boni
authors.affiliation: Medical Oncology and Haematology Unit, Humanitas Cancer Center, Istituto Clinico Humanitas, IRCCS, Rozzano. Electronic address: lorenza.rimassa@cancercenter.humanitas.it.
authors.forename: L
authors.initials: L
authors.lastname: Rimassa
authors.affiliation: Department of Oncology and Hematology, Ospedali Riuniti di Bergamo, Bergamo.
authors.forename: R
authors.initials: R
authors.lastname: Labianca
authors.affiliation: Division of Gastroenterology and Transplant Hepatology, Department of Medicine, Ospedali Riuniti di Bergamo, Bergamo.
authors.forename: S
authors.initials: S
authors.lastname: Fagiuoli
authors.affiliation: Oncology Division, Azienda Ospedaliero-Universitaria, Parma.
authors.forename: S
authors.initials: S
authors.lastname: Salvagni
authors.affiliation: Department of Oncology, San Paolo University Hospital, Milano.
authors.forename: D
authors.initials: D
authors.lastname: Ferrari
authors.affiliation: Department of Radiology, Oncology and Human Patology, Sapienza - University of Rome, Roma.
authors.forename: E
authors.initials: E
authors.lastname: Cortesi
authors.affiliation: Medical Oncology, IRCCS San Matteo University Hospital Foundation, Pavia.
authors.forename: C
authors.initials: C
authors.lastname: Porta
authors.affiliation: Oncology Department, "Ramazzini" Hospital - Carpi.
authors.forename: C
authors.initials: C
authors.lastname: Mucciarini
authors.affiliation: Medical Oncology, Hospital of Macerata, Macerata.
authors.forename: L
authors.initials: L
authors.lastname: Latini
authors.affiliation: Medical Oncology and Haematology Unit, Humanitas Cancer Center, Istituto Clinico Humanitas, IRCCS, Rozzano.
authors.forename: C
authors.initials: C
authors.lastname: Carnaghi
authors.affiliation: Medical Oncology, Arcispedale Santa Maria Nuova, IRCCS, Reggio Emilia.
authors.forename: M
authors.initials: M
authors.lastname: Banzi
authors.affiliation: Medical Oncology, Arcispedale Santa Maria Nuova, IRCCS, Reggio Emilia.
authors.forename: S
authors.initials: S
authors.lastname: Fanello
authors.affiliation: Division of Gastroenterology and Transplant Hepatology, Department of Medicine, Ospedali Riuniti di Bergamo, Bergamo.
authors.forename: M
authors.initials: M
authors.lastname: De Giorgio
authors.affiliation: Department of Radiology, Humanitas Cancer Center, Istituto Clinico Humanitas, IRCCS, Rozzano.
authors.forename: F R
authors.initials: FR
authors.lastname: Lutman
authors.affiliation: University of Milan - School of Medicine, Liver Surgery Unit, Humanitas Cancer Center, Istituto Clinico Humanitas, IRCCS, Rozzano.
authors.forename: G
authors.initials: G
authors.lastname: Torzilli
authors.affiliation: Department of Gastroenterology, Liver Unit, Istituto Clinico Humanitas, IRCCS, Rozzano.
authors.forename: M A
authors.initials: MA
authors.lastname: Tommasini
authors.affiliation: Department of Gastroenterology, Liver Unit, Istituto Clinico Humanitas, IRCCS, Rozzano.
authors.forename: R
authors.initials: R
authors.lastname: Ceriani
authors.affiliation: Department of Gastroenterology, Liver Unit, Istituto Clinico Humanitas, IRCCS, Rozzano.
authors.forename: G
authors.initials: G
authors.lastname: Covini
authors.affiliation: Medical Oncology and Haematology Unit, Humanitas Cancer Center, Istituto Clinico Humanitas, IRCCS, Rozzano.
authors.forename: M C
authors.initials: MC
authors.lastname: Tronconi
authors.affiliation: Biostatistic Unit, Humanitas Cancer Center, Istituto Clinico Humanitas, IRCCS, Rozzano, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Giordano
authors.affiliation: Medical Oncology and Haematology Unit, Humanitas Cancer Center, Istituto Clinico Humanitas, IRCCS, Rozzano.
authors.forename: N
authors.initials: N
authors.lastname: Locopo
authors.affiliation: Medical Oncology and Haematology Unit, Humanitas Cancer Center, Istituto Clinico Humanitas, IRCCS, Rozzano.
authors.forename: S
authors.initials: S
authors.lastname: Naimo
authors.affiliation: Medical Oncology and Haematology Unit, Humanitas Cancer Center, Istituto Clinico Humanitas, IRCCS, Rozzano.
authors.forename: A
authors.initials: A
authors.lastname: Santoro
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000401:mortality; D018572:Disease-Free Survival; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008099:Liver / Q000378:metabolism / Q000473:pathology; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D009536:Niacinamide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D047428:Protein Kinase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D012720:Severity of Illness Index; D000077157:Sorafenib; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D047428:Protein Kinase Inhibitors; D009536:Niacinamide; D000077157:Sorafenib