168P - Real life practice of gefitinib in patients (pts) with non-small-cell lung cancer (NSCLC) depending on epidermal growth factor receptor (EGFR) muta...

Date 15 April 2016
Event European Lung Cancer Conference 2016 (ELCC) 2016
Session Poster lunch
Topics Anticancer agents
Non-Small Cell Lung Cancer
Biological Therapy
Presenter Jacques Cadranel
Citation Journal of Thoracic Oncology (2016) 11 (supplement 4): S57-S166. S1556-0864(16)X0004-4
Authors J. Cadranel1, E. Brambilla2, J.F. Morere3, V. Rondeau4, E. Fabre5, B. Lemaire6, I. Monnet7, M. Licour8, M. Perol9
  • 1Service De Pneumologie, Hôpital Tenon, 75020 - Paris/FR
  • 2Département D'anatomie Et Cytologie Pathologiques, Hopital Albert Michallon, la Tronche/FR
  • 3Service Oncologie, Hopital Paul Brousse, Villejuif/FR
  • 4Isped, Inserm U897, Universite Victor Segalen, Bordeaux/FR
  • 5Service Medical Oncologie, Hopital European George Pompidou, Paris/FR
  • 6Service De Pneumologie-oncologie Thoracique, CHR Orleans, La Source/FR
  • 7Service De Pneumologie, CH Intercommunal de Créteil, Créteil/FR
  • 8Département Médical, AstraZeneca, 92844 - Rueil-Malmaison/FR
  • 9Service Medical Oncologie, Centre Léon Bérard, 69008 - Lyon/FR



Gefitinib (IRESSA®) was granted marketing authorisation in France on 4 November 2009. At the French authority's request, the EPIDAURE study was conducted in 2011 to explore the use of gefitinib in real life practice in terms of target population, EGFR mutation testing and effectiveness.


Eligible pts were French with NSCLC of any stage, histology or treatment line, who started treatment with gefitinib during the period between January 2011 and March 2013. The study started in January 2012 and included pts who started treatment with gefitinib prior to study entry or at study entry (referred to as ‘new pts’). Efficacy, safety and quality of life with gefitinib were assessed over a two-year follow up period.


A total of 361 pts were recruited across 104 sites up to March 2013, including 116 (32%) ‘new’ pts. Pt characteristics are presented in the table. Objective response rate (ORR), based on clinician assessment, was 66.8% (95% confidence interval [CI] 60.3; 70.3) in the overall population and 68.8% (95% CI 59.1; 76.7) in ‘new’ pts. Median duration of follow up was 20.6 months. Median progression-free survival (PFS) was 11.1 months (95% [CI 10.0, 11.9) in the overall population and 10.0 months (95% CI 7.7, 11.8) for ‘new’ pts. Median overall survival (OS) from initiation of gefitinib was 24.6 months (95% CI 21.4, 26.7) and 24.0 months (95% CI 20.5, 27.5) in the overall population and ‘new’ pts, respectively. Most frequently reported treatment-related adverse events were skin (24.6%) and GI (19.6%) disorders. 168PT1

 Overall population (N = 361)‘New’ a patients (N = 116)
Median age, years (range)70 (34–94)69 (41–94)
Female, %72.668.1
Caucasian, %93.691.4
Adenocarcinoma histology, %96.393.9
Never-smoker, %59.256.6
Stage IIIB/IV at treatment initiation, %96.998.3


EPIDAURE provided a real life observational cohort of French pts with NSCLC and showed that gefitinib was most frequently prescribed as first-line treatment of pts with advanced EGFR mutated adenocarcinoma. ORR, PFS and OS were similar to that observed in randomised clinical trials and with the same tolerability profile.

Clinical trial identification

NCT01448187 (March 2016)

Legal entity responsible for the study





J. Cadranel, J.F. Morere, M. Perol: Honoraria from AstraZeneca for Advisory Boards. M. Licour: Employee at AstraZeneca. All other authors have declared no conflicts of interest.