1270P - Mutact: An Observational Study of EGFR Mutation Status and Management of Patients with Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma

Abstract

ABSTRACT Background Certain mutations in the EGFR gene predict sensitivity to EGFR tyrosine kinase inhibitors (TKIs) in advanced NSCLC, and are more common in adenocarcinoma than other histologies. When this study was planned, epidemiological data on EGFR mutations were mostly derived from Asian studies. MUTACT aims to determine the frequency of EGFR mutation positive (EGFR M+) cases in a cohort of French patients with NSCLC adenocarcinoma, and the clinical outcomes of patients with EGFR M+ disease. Methods All patients ≥18 years old with NSCLC adenocarcinoma and a planned EGFR mutation test were eligible for this observational study (NCT01167972, AstraZeneca sponsored). Demographics, disease characteristics and EGFR mutation status were recorded for all patients. Follow-up for treatment decisions and clinical outcomes for patients with EGFR M+ disease is ongoing. Results Between Sept 2010 and Aug 2011, 1382 patients were enrolled at 76 sites in France. Baseline characteristics were: male (57%), Caucasian (95%) and stage IV disease (79%), including more smokers (38%) than never-smokers (30%) or ex-smokers (29%). EGFR M + /M-/non-evaluable (Mx) disease rates were respectively 20.6%, 76.1% and 3.3%. Most samples were analysed by direct sequencing (69%) using primary tumour tissue (77%), with a median turnover time of 12 days. Patients with EGFR M+ disease were mostly female (67%) and never-smokers (70%). As expected, the majority of mutations were detected at exons 19 (54%) and 21 (37%), but mutations were also found at exons 18 (3%) and 20 (7%). Overall, 1% patients had mutations conferring decreased sensitivity to EGFR TKIs (exon 20). At inclusion, 633 patients (46%) were in 1st line treatment (others had surgery or were in 2nd/3rd line). Of the 283 patients with EGFR M+ disease, 186 (66%) were in 1st line treatment at inclusion; 158 (84%) of these received EGFR TKI. Conclusions MUTACT provides a large epidemiological database of predominantly Caucasian patients with NSCLC. More females and never-smokers than expected in an adenocarcinoma population were included, resulting in a high EGFR M+ rate. EGFR TKIs were the most common 1st line treatment in patients with EGFR M+ disease. Disclosure P. Souquet: P-J Souquet is currently conducting research sponsored by AstraZeneca. He has also participated in several boards with AstraZeneca and has received fundings from AstraZeneca. J.C. Sabourin: J-C Sabourin is a member of a scientific board for AstraZeneca and has received funding for research from AstraZeneca. E. Garcia: E Garcia is an employee of AstraZeneca. M. Licour: M Licour is an employee of AstraZeneca. N. Karam: N Karam is an employee of AstraZeneca. All other authors have declared no conflicts of interest.