BACKGROUND

1. OBSERVATIONAL POST-AUTHORIZATION PROSPECTIVE STUDY TO CHARACTERIZE THE INCIDENCE OF EGFR POSITIVE MUTATION (M+) IN ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (aNSCLC) PATIENTS (P) AND THEIR CLINICAL MANAGEMENT IN GALICIA (NCT01717105): A GALICIAN LUNG CANCER GROUP STUDY (GGCP 048-10) #1695 Progression free survival (PFS) Overallsurvival (OS) 1,0 1,0 95% CI Median (months) 95% CI Median (months) 0,8 0,8 9.74 4.02-15.50 17.80 7.31-28.28 Sergio Vázquez Estévez1, Joaquín Casal Rubio2, Javier Afonso Afonso3, José Luis Fírvida Pérez4, LucíaSantomé Couto5, Francisco Barón Duarte6, Martín Lázaro Quintela7, Carolina Pena Álvarez8, Margarita Amenedo Gancedo9, Ihab Abdulkader Nallib6, Carmen González Arenas10, Laura Fachal11, Ana Vega11 12-month PFS: 37% (95% CI: 15.3-58.8) 0,6 0,6 Estimatedprobability of PFS Estimatedprobality of overallsurvival 1 Hospital UniversitarioLucusAugusti (Lugo); 2 ComplexoHospitalarioUniversitario de Vigo (Pontevedra); 3 Hospital ArquitectoMarcide de Ferrol (A Coruña); 4 ComplexoHospitalarioUniversitario de Ourense; 5 Hospital Povisa de Vigo (Pontevedra); 6 ComplexoHospitalarioUniversitario de Santiago (A Coruña); 7 ComplexoHospitalarioUniversitario de Vigo (Pontevedra); 8 ComplexoHospitalario de Pontevedra; 9 Centro Oncolóxico de Galicia (A Coruña); 10 AstraZeneca, Madrid, Spain; 11 FundaciónPúblicaGalega de MedicinaXenómica-SERGAS, Santiago de Compostela, Spain 0,4 0,4 BACKGROUND RESULTS 0,2 0,2 • From February 2011 to March 2012 a total of 198 patients were enrolled • Mutation analysis in tissue samples was feasible in 184 P (92.93%) Table 5: Types of Mutation The presence of mutations in the gene encoding the Epidermal Growth Factor Receptor (EGFR) predicts that P with aNSCLC may respond better to Tyrosine Kinase Inhibitors (TKIs)1-4. Recently, the Spanish study REASON has reported that the rate of EGFR mutations is 11.6% in Spain5, however the mutation rate and the clinical management of aNSCLC patients carrying EGFR mutations in Galicia are still unknown. Figures 3 & 4: Line of Treatment for Patients EGFR M+ 0,0 0,0 Table 1: Baseline Characteristics 0 5 10 15 20 25 0 5 10 15 20 Time fromfirstlinetreatment (months) Time fromfirst line treatment (months) OBJECTIVES • Primary Objective: • To characterize the number of patients with epidermal growth factor receptor (EGFR) positive mutations among advanced or metastatic non-small cell lung cancer (NSCLC) patients in Galicia • Secondary Objective: • To describe the type of mutations among NSCL EGFR M+ patients. • To describe the clinical management of EFGR M+ patients. • To describe patterns of EGFR mutations after progression of EGFR M+ patients. • To correlate EGFR mutational status in tumour and serum samples. • To compare EGFR mutational status between baseline and disease progression of EGFR M+ patients. Table 2: Sample source and type Percentage calculated considering n=184 samples evaluable for EGFR Status; Percentage according to Patients EGFR M+ Figure 5: First Line Treatment Response rate Out of the 23 patients that underwent treatment 3 were excluded due to lost of follow up and only 20 were evaluated Figure 2: EGFR Mutation Rates by Clinical features METHODS Figure 1: Flowchart • All newly diagnosed aNSCLC patients in 9 Galician centres were prospectively included for a 13-month period. • Patients with M+ disease were followed from inclusion until disease progression, death or until 9 months from the inclusion of the last patient in the study have elapsed, whichever is earlier, for the characterization of their clinical management Table 3: Turn Around Time (TAT) Figures 6 and 7: PFS & OS For Patients EGFR M+ (n= 20 ) Table 6: Comparison of baseline tumour EGFR mutation status with evaluable results from baseline serum Table 4: Mutation frequency by sample type *Summary of EGFR status fortumour and serumsamplesfrompatientswho are evaluable forbothsamples. CONCLUSIONS • The estimated prevalence of EGFR mutations in a representative sample of newly diagnosed advanced NSCLC patients in Galicia is consistent with previous data obtained in the rest of Spain • EGFR mutation testing was possible in more than 90% of patients. • Given the similar adequacy for molecular analysis and mutation rates observed in cytological vs. tissue samples, cytologies should be considered suitable for mutation analysis. • The median TAT of 8 days to establish the EGFR mutation status allows the customization of treatment based on molecular criteria • EGFR testing in serum has a low sensitivity and therefore should not substitute tissue testing although it could be an alternative for those patients without tissue samples. • More than 90% of patients receive first line treatment, most of them received a TKI • Comparison EGFR mutational status betweenbaseline and diseaseprogressioncouldnotbe done because no obtional tumor sampleswereobtained at progression. BIBLIOGRAPHY Mok TS et al. N Engl J Med 2009;361:947-957. Maemondo M et al. N Engl J Med 2010;362:2380-2388. Mitsudomi T et al. Lancet Oncol 2010;11:121-128. Rosell R et al. N Engl J Med 2009;13: 239-246. Massuti B et al. J ThoracOncol 2011; 5 (Suppl 2): S329-S330, Abs.O12.07 Rekhtman N, et al. J ThoracOncol 2011; 6: 451–458. • Mutation testing was performed on available tumour and serum samples, through a central laboratory using the EGFR RGQ PCR KitTM (Qiagen) • Pre-planned exploratory objectives included comparison of EGFR mutation status between matched baseline tumour and plasma samples ACKNOWLEDGEMENTS Patients and families, investigators, data managers, lab staff. This study was supported by AztraZeneca through the Investigators Sposored Studies programme Poster presented at 15th WCLC , October 27-30 October , 2013. Sydney, Australia