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.
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).
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
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|
|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
Legal entity responsible for the study
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 (