147P - Level of concordance between EGFR mutation status obtained from tissue/cytology and blood (plasma) for advanced non-small-cell lung cancer in Spain...

Date 15 April 2016
Event European Lung Cancer Conference 2016 (ELCC) 2016
Session Poster lunch
Topics Non-Small-Cell Lung Cancer, Metastatic
Translational Research
Presenter Edurne Arriola
Citation Journal of Thoracic Oncology (2016) 11 (supplement 4): S57-S166. S1556-0864(16)X0004-4
Authors E. Arriola1, A. Paredes2, R. García Gomez3, P. Diz4, M. Constenla5, C. García Girón6, M. Amador7, M. Reck8, G. López Vivanco9
  • 1Cancer Sciences Unit, Southampton General Hospital Southampton University Hospitals NHS Trust, SO16 6YD - Southampton/GB
  • 2Servicio De Oncología Médica, Hospital Donostia, San Sebastian/ES
  • 3Servicio De Oncología Médica, Hospital General Universitario Gregorio Marañon, Madrid/ES
  • 4Servicio De Oncología Médica, Complejo Asistencial Universitario de León, Leon/ES
  • 5Servicio De Oncología Médica, Complejo Hospitalario de Pontevedra, Pontevedra/ES
  • 6Servicio De Oncología Médica, Hospital Universitario de Burgos, Burgos/ES
  • 7Medical Department, AstraZeneca, Madrid/ES
  • 8Department Of Thoracic Oncology, LungenClinic Grosshansdorf, Grosshansdorf/DE
  • 9Servicio De Oncología Médica, Hospital Universitario Cruces, Barakaldo/ES

Abstract

Background

ASSESS, a large, multicenter, non-interventional, diagnostic study (NCT01785888) evaluated local diagnostic practices for EGFR mutation testing in patients (pts) with advanced non-small-cell lung cancer (aNSCLC) in Europe/Japan. Results from the Spanish cohort are presented.

Methods

Eligible pts had newly diagnosed chemotherapy/EGFR TKI-naïve aNSCLC, and provided diagnostic tissue/cytology and blood (plasma) samples upon inclusion. DNA extracted from tissue/cytology samples underwent EGFR mutation testing according to local practices; DNA extraction from blood samples and subsequent mutation testing was performed at designated laboratories. Demographic, diagnostic and treatment data were recorded. The level of concordance between EGFR mutation status obtained from tissue/cytology and blood (plasma) samples was evaluated.

Results

158 pts were enrolled in Spain (1311 total). The majority were men (72.7%) and Caucasian (100%). Median age was 64.4 years. EGFR mutation could not be performed on tumor samples from 15 pts, most commonly due to insufficient specimen (62.5% of cases where a reason was given). Median turnaround time for EGFR mutation test in tumor tissue was 10 days. Mutation test success (i.e., providing a mutation result) rate was 97.9% and 100%, for tumor and plasma samples, respectively. EGFR mutations were detected in 15.4%/11% in tumor/plasma of evaluable pts (18.5%/12.5% of pts with adenocarcinoma vs 5.9%/7.5% of pts with non-adenocarcinoma, 10.6%/9.6% of male pts vs 28.2%/15.4% of female pts and 55.6%/22.2% never vs 3.9%/5.7% current smokers); 86.4% of the EGFR mutant pts went on to receive EGFR-TKIs. Concordance rate between detection methods (tumor vs plasma) was 89%. Plasma sensitivity was 45.5% and specificity 96.7%. Positive predictive value was 71% and negative predictive value was 91%.

Conclusions

86.4% of EGFR mutated pts received treatment with EGFR-TKI confirming the importance of performing the EGFR mutation testing at diagnosis. EGFR mutation testing in plasma is a good alternative to tumor testing when tissue is not available with high specificity. However, currently, tumor testing remains the preferred option.

Clinical trial identification

NCT01785888

Legal entity responsible for the study

AstraZeneca

Funding

AstraZeneca

Disclosure

M. Amador: AstraZaeneca employee. M. Reck: Advisory Board and honoraria for lectures: Hoffmann-La Roche, Lilly, MSD, BMS, AstraZeneca, Boehringer-Ingelheim, Pfizer, Novartis. All other authors have declared no conflicts of interest.