1244P - French real-life efficacy of 1st line gefitinib in EGFR mutation-positive NSCLC in the prospective EPIDAURE study: Results by EGFR exon 19 Del and...

Date 08 October 2016
Event ESMO 2016 Congress
Session Poster Display
Topics Non-Small Cell Lung Cancer
Presenter Maurice Perol
Citation Annals of Oncology (2016) 27 (6): 416-454. 10.1093/annonc/mdw383
Authors M. Perol1, J. Morère2, E. Fabre3, B. Lemaire4, I. Monnet5, E. Brambilla6, V. Rondeau7, M. Licour8, J. Cadranel9
  • 1Medical Oncology, Centre Léon Bérard, 69008 - Lyon/FR
  • 2Medical Oncology, Hopital Paul Brousse, Villejuif/FR
  • 3Medical Oncology, Hopital Europeen Georges, Paris/FR
  • 4Pneumologie, C.H.R. Orleans - La Source, Orleans/FR
  • 5Pulmonology, Respiratory Medicine, Oncology, CHI de Créteil,, Créteil/FR
  • 6Department Of Pathology, Hôpital Albert Michallon, Tronch/FR
  • 7Isped, Inserm U1219, Université de Bordeaux, Bordeaux/FR
  • 8Department Of Epidemiology And Biometry, AstraZeneca, Courbevoie/FR
  • 9Pneumology, Hôpital Tenon, 75020 - Paris/FR



The EGFR tyrosine kinase inhibitor (TKI) gefitinib (IRESSATM) received approval in France on 4 Nov 2009. At the French authority's request, the EPIDAURE study was initiated in Jan 2012 to explore real-life gefitinib use in terms of patients (pts) population, EGFR mutation testing and efficacy.


Eligible French pts had NSCLC of any stage, histology or treatment line, and started gefitinib treatment between Jan 2011-Mar 2013 prior to study entry (‘prevalent pts’) or at study entry (‘incident pts’). Efficacy, safety and quality of life with gefitinib were assessed over a 2-year follow-up period (previously reported: ELCC 2016 #327). Efficacy data (objective response rate [ORR], progression-free survival [PFS], overall survival [OS]) in pts with EGFR common mutation-positive NSCLC who received 1st line gefitinib are presented by mutation subtype.


Of 361 pts recruited across 104 sites in France (116 incident pts), 283 were EGFR mutation-positive and received 1st line gefitinib (94 incident pts); EGFR mutation subtypes data were available for 260 (82 incident pts). Median duration of follow-up: 20.8 months. In the total 1st line population: median age was 71 years, 61% were never-smokers, 73% had performance status 0-1 and 33% had brain metastases. ORR was 68.5% (95% CI 61.9, 72.9), median PFS was 11.5 months (95% CI 10.0, 13.4) and median OS from initiation of gefitinib was 25.7 months (95% CI 23.4, 27.9). Better outcomes were observed with exon 19 Del vs L858R mutations (Table), especially in incident pts.


EPIDAURE provided a large cohort of French pts with EGFR mutation-positive NSCLC treated with 1st line gefitinib. Higher ORR and prolonged OS/PFS in exon 19 Del vs L858R mutations indicate that this subtype represents distinct tumours which may be more sensitive to EGFR TKI therapy. Findings were similar to afatinib data in Caucasian pts. Funding AstraZeneca.

Incident pts (n = 82) Total pts (n = 260)
Exon 19 del L858R Exon 19 del L858R
EGFR mutation subtype, n (%) 49 (60) 29 (35) 136 (52) 106 (41)
ORR, n (%) (95% CI) 39 (83) (72.3, 93.7) 16 (59) (40.8, 77.8) 102 (78) (70.8, 85.0) 66 (64) (54.8, 73.4)
PFS, median months (95% CI) 12.2 (9.1, 18.1) 6.4 (5.3, 10.5) 12.8 (10.2, 14.9) 11.0 (7.7, 13.4)
OS, median months (95% CI) 27.2 (24.0, NC) 18.1 (10.9, 26.4) 31.4 (25.6, 34.6) 19.6 (16.9, 24.2)

CI, confidence interval; EGFR, epidermal growth factor receptor; NC, non-calculable; OS, overall survival; PFS, progression-free survival

Clinical trial identification

Legal entity responsible for the study





M. Perol, J-F. Morère, J. Cadranel: Honoraria received from Astra Zeneca (Advisory Board) M. Licour: Employee of AstraZeneca. All other authors have declared no conflicts of interest.