title: Prospective Evaluation of First-Line Erlotinib in Advanced Non-Small Cell Lung Cancer (NSCLC) Carrying an Activating EGFR Mutation: A Multicenter Academic Phase II Study in Caucasian Patients (FIELT).
abstract: BACKGROUND
  Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibition is the preferred first-line treatment of advanced adenocarcinoma of the lung that harbors EGFR activating tyrosine kinase domain mutations. Most data available pertain to Asian populations in which such mutations are more prevalent. We report on the long-term results of first-line treatment with erlotinib in Caucasian patients with advanced adenocarcinoma of the lung that have a somatic EGFR mutation in their tumor.
  
  
  METHODS
  Multicenter academic prospective phase II study with erlotinib in patients with an activating EGFR tyrosine kinase (TK) domain somatic mutation (any exon encoding the kinase domain) in the tumor and no prior treatment for their advanced disease.
  
  
  RESULTS
  Phenotypic preselecting of 229 patients led to a high EGFR mutation detection rate of 24% of which 46 patients were included in the phase II study. With a progression free survival (PFS) of 81% at three months the study met its primary endpoint for presumed superiority over chemotherapy. With an overall median PFS of 11 months and a median overall survival (OS) of 23 months, the results compare favorably with results obtained in randomized studies using TKI in first line in EGFR mutation positive adenocarcinoma of the lung.
  
  
  CONCLUSIONS
  The present study reinforces the use of EGFR tyrosine kinase inhibition (TKI) as a first line treatment of choice for advanced adenocarcinoma of the lung carrying an activating EGFR mutation. The mutation rate in preselected Caucasian patients is higher than previously reported. Issues relevant for clinical practice are discussed.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00339586.
authors.affiliation: Department of Medical Oncology, Oncologisch Centrum, Universitair Ziekenhuis Brussel, Brussels, Belgium.
authors.forename: Jacques
authors.initials: J
authors.lastname: De Grève
authors.affiliation: Department of Thoracic Oncology, University Hospital, Gent, Belgium.
authors.forename: Jan
authors.initials: J
authors.lastname: Van Meerbeeck
authors.affiliation: Department of Pneumology, University Hospital KU Leuven, Leuven, Belgium.
authors.forename: Johan F
authors.initials: JF
authors.lastname: Vansteenkiste
authors.affiliation: Department of Medical Oncology, Oncologisch Centrum, Universitair Ziekenhuis Brussel, Brussels, Belgium.
authors.forename: Lore
authors.initials: L
authors.lastname: Decoster
authors.affiliation: Department of Pneumology, Institut Jules Bordet, Brussels, Belgium.
authors.forename: Anne-Pascale
authors.initials: AP
authors.lastname: Meert
authors.affiliation: Department of Medical Oncology, Clinique et Maternité Sainte-Elisabeth, Namur, Belgium.
authors.forename: Peter
authors.initials: P
authors.lastname: Vuylsteke
authors.affiliation: Department of Medical Oncology, CHC Clinique Saint Joseph, Liège, Belgium.
authors.forename: Christian
authors.initials: C
authors.lastname: Focan
authors.affiliation: Department of Medical Oncology, Grand Hôpital de Charleroi, Charleroi, Belgium.
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Canon
authors.affiliation: Department of Medical Oncology, Centre du Cancer de l'Université Catholique de Louvain, Brussels, Belgium.
authors.forename: Yves
authors.initials: Y
authors.lastname: Humblet
authors.affiliation: Department of Medical Oncology, Centre Hospitalier du Luxembourg, Luxembourg, Luxembourg.
authors.forename: Guy
authors.initials: G
authors.lastname: Berchem
authors.affiliation: Department of Medical Oncology, Grand Hôpital de Charleroi, Charleroi, Belgium.
authors.forename: Benoit
authors.initials: B
authors.lastname: Colinet
authors.affiliation: Department of Medical Oncology, ZNA Middelheim Hospital, Antwerp, Belgium.
authors.forename: Danny
authors.initials: D
authors.lastname: Galdermans
authors.affiliation: Department of Respiratory Medicine, CHU Sart-Tilman, Liège, Belgium.
authors.forename: Lionel
authors.initials: L
authors.lastname: Bosquée
authors.affiliation: Department of Medical Oncology, ZNA Jan Palfijn, Merksem, Belgium.
authors.forename: Joanna
authors.initials: J
authors.lastname: Vermeij
authors.affiliation: Department of Medical Oncology, Oncologisch Centrum, Universitair Ziekenhuis Brussel, Brussels, Belgium.
authors.forename: Alex
authors.initials: A
authors.lastname: Dewaele
authors.affiliation: Department of Medical Oncology, Oncologisch Centrum, Universitair Ziekenhuis Brussel, Brussels, Belgium.
authors.forename: Caroline
authors.initials: C
authors.lastname: Geers
authors.affiliation: Department of Medical Oncology, Oncologisch Centrum, Universitair Ziekenhuis Brussel, Brussels, Belgium.
authors.forename: Denis
authors.initials: D
authors.lastname: Schallier
authors.affiliation: Department of Medical Oncology, Oncologisch Centrum, Universitair Ziekenhuis Brussel, Brussels, Belgium.
authors.forename: Erik
authors.initials: E
authors.lastname: Teugels
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000235:genetics*; D004252:DNA Mutational Analysis; D066246:ErbB Receptors / Q000235:genetics*; D000069347:Erlotinib Hydrochloride / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009154:Mutation / Q000235:genetics*; D011446:Prospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome; D044465:White People / Q000235:genetics*
chemical_list: D000069347:Erlotinib Hydrochloride; D066246:ErbB Receptors