60P - Circulating free tumour-derived DNA (ctDNA) to detect EGFR mutation in patients (pts) with advanced NSCLC (aNSCLC): French subset analysis of the A...

Date 10 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Biomarkers
Presenter Marc Denis
Citation Annals of Oncology (2016) 27 (6): 15-42. 10.1093/annonc/mdw363
Authors M.G. Denis1, M.P. Lafourcade2, G. Le Garff3, C. Dayen4, L. Falchero5, P. Thomas6, C. Locher7, G. Fraboulet8, G. Oliviero9, M. Licour10, N. Normanno11, M. Reck12, O. Molinier13
  • 1Department Of Biochemistry, CHU de Nantes, 44093 - Nantes/FR
  • 2Department Of Pneumology, CH d'Angoulême, Angouleme/FR
  • 3Department Of Pneumology, Hopital Yves Le Foll, St. Brieuc/FR
  • 4Department Of Pneumology, Centre Hospitalier St. Quentin, St Quentin/FR
  • 5Pneumologie Et Cancérologie Thoracique, CH Villefranche-Sur-Saône, Villefranche-sur-Saône Cedex/FR
  • 6Department Of Pneumology, CHI Alpes du Sud - Site de Gap, Gap/FR
  • 7Department Of Pneumology, Centre hospitalier général Meaux, Meaux/FR
  • 8Department Of Oncology, Hopital René Dubos, Pontoise/FR
  • 9Department Of Pneumology, CH de Longjumeau, Longjumeau/FR
  • 10Department Of Epidemiology And Biometry, AstraZeneca, Courbevoie/FR
  • 11Cell Biology And Biotherapy Unit, Istituto Nazionale Tumori – I.R.C.C.S - Fondazione Pascale, Napoli/IT
  • 12Department Of Thoracic Oncology, LungenClinic Grosshansdorf GmbH, Grosshansdorf/DE
  • 13Centre De Coordination En Cancérologie, Centre Hospitalier Du Mans, Le Mans/FR

Abstract

Background

ASSESS (non-interventional diagnostic study NCT01785888) assessed the concordance of EGFR mutation status in tumour samples and plasma ctDNA in pts with aNSCLC in Europe and Japan. Subset data for pts from France are presented.

Methods

Pts: stage IIIA/B/IV chemo-/TKI-naïve NSCLC. Primary endpoint: EGFR mutation status concordance between matched plasma and tumour samples. Tumour testing was performed locally as per local practice; plasma testing was centralised. ctDNA was extracted using the PureLink Virus Kit on an iPrep Purification Instrument (Life Technologies) and EGFR mutations detected via the approved Therascreen EGFR RGQ kit (Qiagen).

Results

Of 1311 enrolled pts, 145 were from France (mean age 64 years, 64% male, 83% ever-smokers). Most samples were collected from primary tumours (81%); collection was mostly via bronchoscopy (38%) and image-guided core biopsy (19%). Of 130 pts with available tissue, 126 were evaluable for EGFR; activating mutations were found in 13 (EGFR mutation frequency 10%). 10 pts tested positive for EGFR mutations in plasma (EGFR mutation frequency 7%). Mutation rate was significantly higher in never- vs ever-smokers (stepwise logistic regression: tumour p 

Conclusions

These real-world data confirm ctDNA as a powerful alternative sample for EGFR mutation analysis in aNSCLC.

Matched tissue/cytology samples (N = 126)

Unadjusted parameters n/N % Exact 95% confidence interval
Concordance 120/126 95.2 89.9, 98.2
Sensitivity 8/13 61.5 31.6, 86.1
Specificity 112/113 99.1 95.2, 100.0
Positive-predictive value 8/9 88.9 51.8, 99.7
Negative-predictive value 112/117 95.7 90.3, 98.6

Clinical trial identification

NCT01785888

Legal entity responsible for the study

AstraZeneca

Funding

AstraZeneca

Disclosure

M.G. Denis: Grants/Research support/consultant: AstraZeneca, Qiagen, Roche Pharma, and Boehringer Ingelheim. G. Le Garff: Clin. Trial: Lilly, Roche, AstraZeneca. All financial contributions except MUTACT study (AZ) paid by clinical research unit. Board: Novartis. Inv. to Congress: AZ (