title: Stratified phase II trial of cetuximab in patients with recurrent high-grade glioma.
abstract: BACKGROUND
  To evaluate the antitumor activity and toxicity of single-agent cetuximab in patients with recurrent high-grade glioma (HGG) after failure of surgery, radiation therapy, and chemotherapy.
  
  
  METHODS
  In this two-arm, open-label, phase II study patients were stratified according to their epidermal growth factor receptor (EGFR) gene amplification status. Cetuximab was administered intravenously at a dose of 400 mg/m(2) on week 1 followed by weekly dose of 250 mg/m(2). The primary end point for this study was the response rate in both study arms separately.
  
  
  RESULTS
  Fifty-five eligible patients (28 with and 27 without EGFR amplification) tolerated cetuximab well. Three patients (5.5%) had a partial response and 16 patients (29.6%) had stable disease. The median time to progression was 1.9 months [95% confidence interval (CI) 1.6-2.2 months]. Whereas the progression-free survival (PFS) was <6 months in the majority (n = 50/55) of patients, five patients (9.2%) had a PFS on cetuximab of >9 months. Median overall survival was 5.0 months (95% CI 4.2-5.9 months). No significant correlation was found between response, survival and EGFR amplification.
  
  
  CONCLUSIONS
  Cetuximab was well tolerated but had limited activity in this patient population with progressive HGG. A minority of patients may derive a more durable benefit but were not prospectively identified by EGFR gene copy number.
authors.affiliation: Department of Medical Oncology, UZ Brussel, Brussels. Electronic address: bart.neyns@uzbrussel.be.
authors.forename: B
authors.initials: B
authors.lastname: Neyns
authors.affiliation: Department of Medical Oncology, UZ Brussel, Brussels.
authors.forename: J
authors.initials: J
authors.lastname: Sadones
authors.affiliation: Department of Medical Oncology, ZNA Middelheim, Antwerp.
authors.forename: E
authors.initials: E
authors.lastname: Joosens
authors.affiliation: Department of Radiation therapy, AZ St Lucas, Ghent.
authors.forename: F
authors.initials: F
authors.lastname: Bouttens
authors.affiliation: Department of Radiation therapy, OLV Aalst, Aalst.
authors.forename: L
authors.initials: L
authors.lastname: Verbeke
authors.affiliation: Department of Medical Oncology, Cliniques Universitaires St Luc, Brussels.
authors.forename: J-F
authors.initials: JF
authors.lastname: Baurain
authors.affiliation: Department of Medical Oncology, Centre Hospitalier Notre-Dame et Reine Fabiola, Charleroi.
authors.forename: L
authors.initials: L
authors.lastname: D'Hondt
authors.affiliation: Department of Neurology, Sint-Augustinus, Antwerp.
authors.forename: T
authors.initials: T
authors.lastname: Strauven
authors.affiliation: Department of Neurosurgery.
authors.forename: C
authors.initials: C
authors.lastname: Chaskis
authors.affiliation: Department of Experimental pathology.
authors.forename: P
authors.initials: P
authors.lastname: In't Veld
authors.affiliation: Department of Neurology; Department of Neuropathology, UZ Brussel, Brussels, Belgium.
authors.forename: A
authors.initials: A
authors.lastname: Michotte
authors.affiliation: Department of Medical Oncology, UZ Brussel, Brussels.
authors.forename: J
authors.initials: J
authors.lastname: De Greve
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D000068818:Cetuximab; D018572:Disease-Free Survival; D066246:ErbB Receptors / Q000235:genetics; D005260:Female; D005910:Glioma / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D066246:ErbB Receptors; D000068818:Cetuximab