title: Biomarker Analysis in a Phase II Study of Sunitinib in Patients with Advanced Melanoma.
abstract: OBJECTIVE
  To investigate the efficacy of sunitinib in patients with advanced melanoma and to correlate angiogenic biomarkers with response and survival.
  
  
  METHODS
  We performed a phase II study in patients with advanced pre-treated melanoma. The primary endpoint was tumor response. Blood samples for biomarker analysis including vascular endothelial growth factor (VEGF), and its receptors VEGFR1 and -2, placental growth factor (PlGF) and circulating endothelial cells (CEC) were collected at baseline and during the first cycle.
  
  
  RESULTS
  Four out of 39 patients (13%) achieved a partial response and eight (26%) stable disease. Time to progression was at least six months in seven patients. High baseline VEGFR1 levels and high baseline PlGF levels were both associated with a non-significant worse survival (p=0.08 for both).
  
  
  CONCLUSIONS
  Sunitinib demonstrates limited activity in unselected patients with refractory advanced melanoma, but a minority of patients experienced long-term disease control. Identification of these patients remains a challenge.
authors.affiliation: Department of Medical Oncology, Oncology Centre, University Hospital Brussel, Brussels, Belgium lore.decoster@uzbrussel.be.
authors.forename: Lore
authors.initials: L
authors.lastname: Decoster
authors.affiliation: Iridium Cancer Network, AZ Nikolaas, Sint Niklaas, Belgium.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Vande Broek
authors.affiliation: Department of Medical Oncology, Oncology Centre, University Hospital Brussel, Brussels, Belgium.
authors.forename: Bart
authors.initials: B
authors.lastname: Neyns
authors.affiliation: Department of Medical Oncology, Jolimont Hospital, Haine Saint Paul, Belgium.
authors.forename: Françoise
authors.initials: F
authors.lastname: Majois
authors.affiliation: Department of Medical Oncology, St. Luc University Hospital, Brussels, Belgium.
authors.forename: Jean François
authors.initials: JF
authors.lastname: Baurain
authors.affiliation: Department of Medical Oncology, University Hospital Gent, Gent, Belgium.
authors.forename: Sylvie
authors.initials: S
authors.lastname: Rottey
authors.affiliation: Department of Medical Oncology, University Hospital Sart Tilman, Liège, Belgium.
authors.forename: Andrée
authors.initials: A
authors.lastname: Rorive
authors.affiliation: Department of Clinical Chemistry and Radioimmunology, University Hospital Brussel, Brussels, Belgium.
authors.forename: Ellen
authors.initials: E
authors.lastname: Anckaert
authors.affiliation: Department of Radiology, University Hospital Brussel, Brussels, Belgium.
authors.forename: Johan
authors.initials: J
authors.lastname: De Mey
authors.affiliation: Laboratory of Molecular and Medical Oncology, University Hospital Brussel, Brussels, Belgium.
authors.forename: Sylvia
authors.initials: S
authors.lastname: De Brakeleer
authors.affiliation: Department of Medical Oncology, Oncology Centre, University Hospital Brussel, Brussels, Belgium.
authors.forename: Jacques
authors.initials: J
authors.lastname: De Grève
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000097:blood*; D042783:Endothelial Cells / Q000473:pathology; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D008297:Male; D008545:Melanoma / Q000098:blood supply / Q000188:drug therapy* / Q000401:mortality; D008875:Middle Aged; D009154:Mutation; D009389:Neovascularization, Pathologic / Q000175:diagnosis*; D000072483:Placenta Growth Factor; D011257:Pregnancy Proteins / Q000097:blood; D019009:Proto-Oncogene Proteins c-kit / Q000235:genetics; D011758:Pyrroles / Q000627:therapeutic use*; D012878:Skin Neoplasms / Q000098:blood supply / Q000188:drug therapy* / Q000401:mortality; D000077210:Sunitinib; D016019:Survival Analysis; D042461:Vascular Endothelial Growth Factor A / Q000097:blood; D040281:Vascular Endothelial Growth Factor Receptor-1 / Q000097:blood; D040301:Vascular Endothelial Growth Factor Receptor-2 / Q000097:blood
chemical_list: D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor; D007211:Indoles; C000608036:PGF protein, human; D011257:Pregnancy Proteins; D011758:Pyrroles; D042461:Vascular Endothelial Growth Factor A; D000072483:Placenta Growth Factor; D019009:Proto-Oncogene Proteins c-kit; D040281:Vascular Endothelial Growth Factor Receptor-1; D040301:Vascular Endothelial Growth Factor Receptor-2; D000077210:Sunitinib
keywords: Malignant melanoma; PlGF; biomarkers; phase II study; sunitinib