title: Phase II study of figitumumab in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck: clinical activity and molecular response (GORTEC 2008-02).
abstract: BACKGROUND
  Preclinical studies suggest that insulin-like growth factor-1 receptor (IGF-1R) blockage could be a promising therapeutic target in squamous cell carcinoma of the head and neck (SCCHN). Therefore, we investigated the efficacy and toxicity of figitumumab, an anti-IGF-1R monoclonal antibody, in palliative SCCHN.
  
  
  METHODS
  Patients with palliative SCCHN progressing after platinum-based therapy were treated with figitumumab i.v. 20 mg/kg, every 3 weeks. The primary end point was the disease control rate at 6-8 weeks after treatment initiation. Tumor biopsies and plasma samples were collected before and after figitumumab administration to monitor the molecular response.
  
  
  RESULTS
  Seventeen patients were included. Only two patients achieved stable disease at 6-8 weeks. Median overall survival and progression-free survival were 63 and 52 days, respectively. The main grade 3-4 adverse event was hyperglycemia (41%). Translational research showed that figitumumab downregulated IGF-1R at the surface of tumor cells with activation of the epidermal growth factor receptor (EGFR) pathway, as shown by the upregulation of p-EGFR in tumor cells (P=0.016), and an increase in the plasma level of tumor growth factor-alpha (P=0.006).
  
  
  CONCLUSIONS
  Figitumumab monotherapy has no clinically significant activity in unselected palliative SCCHN.
authors.affiliation: Cancer Center; Department of Medical Oncology, University Hospital St-Luc, Catholic University Louvain, Brussels, Belgium; Head and Neck Surgery, University Hospital St-Luc, Catholic University Louvain, Brussels, Belgium.
authors.forename: S
authors.initials: S
authors.lastname: Schmitz
authors.affiliation: Department of Medical Oncology, Center Alexis Vautrin, Nancy, France.
authors.forename: M-C
authors.initials: MC
authors.lastname: Kaminsky-Forrett
authors.affiliation: Department of Medical Oncology, Catholic University Louvain, Mont-Godinne and St-Elisabeth, Namur, Belgium.
authors.forename: S
authors.initials: S
authors.lastname: Henry
authors.affiliation: Department of Medical Oncology, Center G-F Leclerc, Dijon.
authors.forename: S
authors.initials: S
authors.lastname: Zanetta
authors.affiliation: Department of Medical Oncology, Center Alexis Vautrin, Nancy, France.
authors.forename: L
authors.initials: L
authors.lastname: Geoffrois
authors.affiliation: Department of Medical Oncology, Center René Gauducheau, Nantes.
authors.forename: E
authors.initials: E
authors.lastname: Bompas
authors.affiliation: Cancer Center; Department of Medical Oncology, University Hospital St-Luc, Catholic University Louvain, Brussels, Belgium.
authors.forename: A
authors.initials: A
authors.lastname: Moxhon
authors.affiliation: Cancer Center; Department of Medical Oncology, University Hospital St-Luc, Catholic University Louvain, Brussels, Belgium.
authors.forename: L
authors.initials: L
authors.lastname: Mignion
authors.affiliation: Department of Medical Oncology, Gustave Roussy Institut, Villejuif, France.
authors.forename: J
authors.initials: J
authors.lastname: Guigay
authors.affiliation: Cancer Center; Ludwig Institute for Cancer Research; Department of Hematology, University Hospital St-Luc, Catholic University Louvain, Brussels, Belgium.
authors.forename: L
authors.initials: L
authors.lastname: Knoops
authors.affiliation: Cancer Center; Head and Neck Surgery, University Hospital St-Luc, Catholic University Louvain, Brussels, Belgium.
authors.forename: M
authors.initials: M
authors.lastname: Hamoir
authors.affiliation: Cancer Center; Department of Medical Oncology, University Hospital St-Luc, Catholic University Louvain, Brussels, Belgium; Head and Neck Surgery, University Hospital St-Luc, Catholic University Louvain, Brussels, Belgium. Electronic address: jean-pascal.machiels@uclouvain.be.
authors.forename: J-P
authors.initials: JP
authors.lastname: Machiels
mesh_terms: D000911:Antibodies, Monoclonal; D001706:Biopsy; D002294:Carcinoma, Squamous Cell / Q000097:blood / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D020869:Gene Expression Profiling; D006258:Head and Neck Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D017526:Receptor, IGF Type 1 / Q000037:antagonists & inhibitors / Q000276:immunology; D020133:Reverse Transcriptase Polymerase Chain Reaction
chemical_list: D000911:Antibodies, Monoclonal; D016756:Immunoglobulins, Intravenous; D017526:Receptor, IGF Type 1; C525021:figitumumab