title: A phase II study of sunitinib in advanced hepatocellular carcinoma.
abstract: BACKGROUND
  In 2007, sorafenib was the first drug able to improve overall survival in patients with advanced hepatocellular carcinoma.
  
  
  OBJECTIVE
  In 2005 we designed a phase II study to assess safety and efficacy of sunitinib.
  
  
  METHODS
  This is a single arm, open-label, single-centre phase II trial. Eligibility criteria were advanced hepatocellular carcinoma; no prior chemotherapy, performance status 0-1; and Child≤B8. The treatment schedule was 50mg each day orally, 4 weeks on, 2 weeks off.
  
  
  RESULTS
  Between 10/2007 and 10/2010, 34 patients were enrolled. A significant worsening of liver functional reserve after sunitinib was observed. Grade 3/4 adverse effects occurred in 80% of patients and included fatigue (47%), nausea (15%), liver failure (15%), encephalopathy (12%) and upper gastrointestinal bleeding (12%). Six patients (18%) died within 60 days of enrolment. A partial response was observed in 4 patients (12%). Median time to tumour progression was 2.8 months and median overall survival was 5.8 months.
  
  
  CONCLUSIONS
  A dose of 50mg/d induces a high rate of severe adverse events. Toxicity remains a key concern also at the dose of 37.5mg/d. However, sunitinib is able to induce a prolonged response in some patients. Positron Emission Tomography/Computed Tomography scans may select good responders.
authors: Medical Oncology, Università Cattolica del Sacro Cuore, Rome, Italy. carlobarone@rm.unicatt.it
authors: Carlo
authors: C
authors: Barone
authors: Michele
authors: M
authors: Basso
authors: Marco
authors: M
authors: Biolato
authors: Maurizio
authors: M
authors: Pompili
authors: Vittoria
authors: V
authors: Rufini
authors: Luca
authors: L
authors: Miele
authors: Maria
authors: M
authors: Basso
authors: Anna Maria
authors: AM
authors: De Gaetano
authors: Paola
authors: P
authors: Castaldi
authors: Alessandro
authors: A
authors: Iaculli
authors: Lucia
authors: L
authors: Leccisotti
authors: Laura
authors: L
authors: Riccardi
authors: Antonio
authors: A
authors: Grieco
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D005260:Female; D006801:Humans; D007211:Indoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009367:Neoplasm Staging; D011758:Pyrroles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018570:Risk Assessment; D012307:Risk Factors; D000077210:Sunitinib; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib
keywords: Alpha-fetoprotein; Aminopyrine; Methacetin; PET