title: EGFR mutation status and first-line treatment in patients with stage III/IV non-small cell lung cancer in Germany: an observational study.
abstract: BACKGROUND
  EGFR mutations confer sensitivity to EGFR tyrosine kinase inhibitors (TKI) in advanced non-small cell lung cancer (NSCLC). We investigated the clinicopathologic characteristics associated with EGFR mutations and their impact on real-world treatment decisions and outcomes in Caucasian patients with advanced NSCLC.
  
  
  METHODS
  REASON (NCT00997230) was a noninterventional multicenter study in patients (≥18 years) with stage IIIb/IV NSCLC, who were candidates for EGFR mutation testing and first-line systemic treatment, but not eligible for surgery or radiotherapy. Patients were followed up according to normal clinical practice and assessed for primary (correlation of mutation status with baseline characteristics) and secondary endpoints (first-line treatment decision).
  
  
  RESULTS
  Baseline data were obtained for 4,200 patients; 4,196 fulfilled the inclusion criteria; EGFR mutations were detected in 431 patients; no EGFR mutations were detected in 3,590 patients; mutation status was not evaluable in 175 patients. In multivariate analysis, the odds of EGFR mutations were significantly higher (P < 0.0001) in females versus males (odds ratio: 1.85; 95% confidence interval, 1.48-2.32), never-smokers versus smokers (3.64; 2.91-4.56), and patients with adenocarcinoma versus other histologic subtypes (2.94; 2.17-4.08). The most commonly prescribed first-line systemic treatments were: EGFR-TKIs in EGFR mutation-positive NSCLC (56.6%) and combination chemotherapy in EGFR mutation-negative NSCLC (78.5%).
  
  
  CONCLUSIONS
  This represents the largest dataset for EGFR mutations in Caucasian patients and shows EGFR mutations to be most prevalent in females with adenocarcinoma who had never smoked.
  
  
  CONCLUSIONS
  These findings add to our understanding of the prognostic and predictive factors of NSCLC, supporting future improved treatment selection.
authors.affiliation: Department of Internal Medicine II, Hospital Martha-Maria, Halle-Dölau, Halle, Germany. Wolfgang.Schuette@Martha-Maria.de.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Schuette
authors.affiliation: Institute of Pathology, University Hospital Heidelberg, Heidelberg, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Schirmacher
authors.affiliation: Department of Medical Oncology, West German Tumor Centre, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
authors.forename: Wilfried Ernst Erich
authors.initials: WE
authors.lastname: Eberhardt
authors.affiliation: Medical Department II Oncology, Hospital Löwenstein LLC, Löwenstein, Germany.
authors.forename: Juergen R
authors.initials: JR
authors.lastname: Fischer
authors.affiliation: Center for Health Economics Research Hannover, Leibniz University Hannover, Hannover, Germany.
authors.forename: J-Matthias Graf
authors.initials: JM
authors.lastname: von der Schulenburg
authors.affiliation: Department of Internal Medicine II, Haematology, Oncology, Immunology, St. Vincentius-Kliniken, Karlsruhe, Germany.
authors.forename: Joerg
authors.initials: J
authors.lastname: Mezger
authors.affiliation: Department of Internal Medicine II, University Hospital of Ulm, Ulm, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Schumann
authors.affiliation: Pulmonary and Thoracic Oncology, Lungenklinik Hemer, Hemer, Germany.
authors.forename: Monika
authors.initials: M
authors.lastname: Serke
authors.affiliation: Medical Affairs, AstraZeneca, Wedel, Germany.
authors.forename: Silke
authors.initials: S
authors.lastname: Zaun
authors.affiliation: Institute of Pathology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Manfred
authors.initials: M
authors.lastname: Dietel
authors.affiliation: Department of Thoracic Oncology, Thoraxklinik at the University of Heidelberg, Heidelberg, Germany. Translational Lung Research Center Heidelberg (TLRC-H), Member of the German Center for Lung Research (DZL), Heidelberg, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Thomas
mesh_terms: D002289:Carcinoma, Non-Small-Cell Lung / Q000235:genetics*; D066246:ErbB Receptors / Q000235:genetics*; D005260:Female; D005858:Germany; D006801:Humans; D008175:Lung Neoplasms / Q000235:genetics*; D008297:Male; D009367:Neoplasm Staging; D011379:Prognosis
chemical_list: D066246:ErbB Receptors