1. BACKGROUND METHODS RESULTS Table 1: Baseline Characteristics CONCLUSIONS BIBLIOGRAPHY  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 between baseline and disease progression could not be done because no obtional tumor samples were obtained at progression. Table 2: Sample source and type Figure 2: EGFR Mutation Rates by Clinical features 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) Sergio Vázquez Estévez 1, Joaquín Casal Rubio 2, Javier Afonso Afonso 3, José Luis Fírvida Pérez 4, Lucía Santomé Couto 5, Francisco Barón Duarte 6, Martín Lázaro Quintela 7, Carolina Pena Álvarez 8, Margarita Amenedo Gancedo 9, Ihab Abdulkader Nallib 6, Carmen González Arenas 10, Laura Fachal 11, Ana Vega 11 1 Hospital Universitario Lucus Augusti (Lugo); 2 Complexo Hospitalario Universitario de Vigo (Pontevedra); 3 Hospital Arquitecto Marcide de Ferrol (A Coruña); 4 Complexo Hospitalario Universitario de Ourense; 5 Hospital Povisa de Vigo (Pontevedra); 6 Complexo Hospitalario Universitario de Santiago (A Coruña); 7 Complexo Hospitalario Universitario de Vigo (Pontevedra); 8 Complexo Hospitalario de Pontevedra; 9 Centro Oncolóxico de Galicia (A Coruña); 10 AstraZeneca, Madrid, Spain; 11 Fundación Pública Galega de Medicina Xenómica-SERGAS, Santiago de Compostela, Spain 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 Spain 5, however the mutation rate and the clinical management of aNSCLC patients carrying EGFR mutations in Galicia are still unknown. 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.  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 Figure 1: Flowchart CharacteristicTotal Patients N=198 SexMale151 (76.3%) Female47 (23.7%) AgeMedian65.5 years HistologySquamous43 (21.7%) Adenocarcinoma136 (68.7%) Large cells Carc.16 (8.1%) Adenosquamous2 (1.0%) NOS1 (0.5%)  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%) CharacteristicTotal Patients N=198 Smoking statusNever smoked43(21.7%) Ex-smoker90(45.5%) Smoker65 (32.8%) WHO PS027 (13.6%) 1106 (53.5%) 249 (24.7%) ≥ 316 (8.1%) Table 3: Turn Around Time (TAT) Median: 8 Working days Average: 10.3 days Table 4: Mutation frequency by sample type EGFR StatusTotal N=184 (%) Biopsy N=108 Cytology N=76 EGFR +25 (13.6%)15 (13.9%)10(13.2%) EGFR -159 (86.4%)93 (86.1%)66 (86.8%) Patients EGFR M+N=2513.6% 1 Exon 1800% 2 Exon 191144% 2 Del 1911 Exón 2028% 2 Exon 20 insertions1 Not specificed1 Exon 211248% 2 L858R11 L681Q1 Table 5: Types of Mutation (1)Percentage calculated considering n=184 samples evaluable for EGFR Status; (2)Percentage according to Patients EGFR M+ Figures 3 & 4: Line of Treatment for 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 Figures 6 and 7: PFS & OS For Patients EGFR M+ (n= 20 ) #1695  Mutation testing was performed on available tumour and serum samples, through a central laboratory using the EGFR RGQ PCR Kit TM (Qiagen)  Pre-planned exploratory objectives included comparison of EGFR mutation status between matched baseline tumour and plasma samples 95% CI Median (months) 17.807.31-28.28 1,0 0,8 0,6 0,4 0,2 0,0 0510152025 Time from first linetreatment (months) Estimated probality of overall survival Overall survival (OS) Progression free survival (PFS) 1,0 0,8 0,6 0,4 0,2 0,0 05101520 Estimated probability of PFS Median (months) 95% CI 9.744.02-15.50 12-month PFS: 37% (95% CI: 15.3-58.8) Time from first line treatment (months) 1.Mok TS et al. N Engl J Med 2009;361:947-957. 2.Maemondo M et al. N Engl J Med 2010;362:2380-2388. 3.Mitsudomi T et al. Lancet Oncol 2010;11:121-128. 4.Rosell R et al. N Engl J Med 2009;13: 239-246. 5.Massuti B et al. J Thorac Oncol 2011; 5 (Suppl 2): S329-S330, Abs.O12.07 6.Rekhtman N, et al. J Thorac Oncol 2011; 6: 451–458. ACKNOWLEDGEMENTS Patients and families, investigators, data managers, lab staff. Poster presented at 15 th WCLC, October 27-30 October, 2013. Sydney, AustraliaThis study was supported by AztraZeneca through the Investigators Sposored Studies programme EGFR status at baseline Serum mutation status EGFR +EGFR -Total Tumor mutation status EGFR +101525 EGFR -1148149 Total11163174* Table 6: Comparison of baseline tumour EGFR mutation status with evaluable results from baseline serum Concordance rate90.8% Sensitivity40% Specificity99.3% Positive predictive value (PPV)90.9% Negative predictive value (NPV)90.8% *Summary of EGFR status for tumour and serum samples from patients who are evaluable for both samples.