title: Tumour response and safety of cetuximab in a window pre-operative study in patients with squamous cell carcinoma of the head and neck.
abstract: BACKGROUND
  To investigate the safety and activity of cetuximab in the pre-operative treatment of squamous cell carcinoma of the head and neck (SCCHN).
  
  
  METHODS
  Cetuximab was administered for 2 weeks before surgery to 33 treatment-naïve patients selected for primary surgical treatment. Tumour biopsies, 2-[fluorine-18]-fluoro-2-deoxy-d-glucose positron emission tomography ((18)FDG-PET) and imaging were carried out at baseline and before surgery. The primary aim of the study was safety and the secondary aims included metabolical, radiological and pathological tumour response. Five untreated patients were included as controls.
  
  
  RESULTS
  Cetuximab given 24 h before surgery was safe. Ninety percent of patients had (18)FDG-PET partial response (EORTC guideline) in the cetuximab group versus 0% in the control group. Delta maximal standardized uptake values (ΔSUVmax) were correlated with tumour cellularity on the surgical specimens (P < 0.0001). For patients with ΔSUVmax less than -25% or less than -50%, Ki67 was significantly decreased by cetuximab (P = 0.01 and 0.003). Cetuximab induced down-regulation of pEGFR (P = 0.0004) and pERK (P = 0.003).
  
  
  CONCLUSIONS
  Short-course pre-operative administration of cetuximab is safe and shows a high rate of (18)FDG-PET response. (18)FDG-PET response was correlated with residual tumour cellularity suggesting that (18)FDG-PET deserves further investigation as a potential early marker of cetuximab activity in SCCHN.
authors.affiliation: Cancer Center, Department of Medical Oncology, Cliniques universitaires Saint-Luc and Institut de Recherche Clinique et Expérimentale (Pole MIRO), Université catholique de Louvain, Brussels, Belgium.
authors.forename: S
authors.initials: S
authors.lastname: Schmitz
authors.forename: M
authors.initials: M
authors.lastname: Hamoir
authors.forename: H
authors.initials: H
authors.lastname: Reychler
authors.forename: M
authors.initials: M
authors.lastname: Magremanne
authors.forename: B
authors.initials: B
authors.lastname: Weynand
authors.forename: R
authors.initials: R
authors.lastname: Lhommel
authors.forename: F-X
authors.initials: FX
authors.lastname: Hanin
authors.forename: T
authors.initials: T
authors.lastname: Duprez
authors.forename: N
authors.initials: N
authors.lastname: Michoux
authors.forename: D
authors.initials: D
authors.lastname: Rommel
authors.forename: M
authors.initials: M
authors.lastname: Lonneux
authors.forename: N
authors.initials: N
authors.lastname: Cappoen
authors.forename: A
authors.initials: A
authors.lastname: Gillain
authors.forename: J-P
authors.initials: JP
authors.lastname: Machiels
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000601:surgery; D000068818:Cetuximab; D066246:ErbB Receptors / Q000037:antagonists & inhibitors; D019788:Fluorodeoxyglucose F18; D006258:Head and Neck Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000601:surgery; D006801:Humans; D049268:Positron-Emission Tomography; D000077195:Squamous Cell Carcinoma of Head and Neck; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D019788:Fluorodeoxyglucose F18; C512478:EGFR protein, human; D066246:ErbB Receptors; D000068818:Cetuximab
keywords: cetuximab; head and neck cancer; targeted therapy