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Erlotinib versus chemotherapy (CT) in advanced non-small cell lung cancer (NSCLC) patients (p) with epidermal growth factor receptor (EGFR) mutations: Interim results of the European Erlotinib Versus Chemotherapy (EURTAC) phase III randomized trial. Authors:R. Rosell, R. Gervais, A. Vergnenegre, B. Massuti, E. Felip, F. Cardenal, R. Garcia Gomez, C. Pallares, J. Sanchez, R. Porta, M. Cobo, M. Di Seri, P. Garrido Lopez, A. Insa, F. De Marinis, R. Corre, M. Carreras, E. Carcereny, M. Taron, L. G. Paz-Ares, Spanish Lung Cancer Group J Clin Oncol 29: 2011 (suppl; abstr 7503) Reviewed by: Charles Butts Date posted: June 2011 www.OncologyEducation.ca Thank you for downloading this update. Please feel free to use it for educational purposes. Please acknowledge OncologyEducation.ca and Dr. Charles Butts when using these slides. www.OncologyEducation.ca Study Design Study Question – In a randomized, prospective, Phase III study comparing erlotinib to Platinum based doublet chemo as first line therapy EGFR mutation positive Endpoints – Primary Endpoint • Progression free survival (PFS) – Secondary Endpoints • Overall survival (OS) • Objective Response Rate (ORR) Study Population – Stage IIIB/IV NSCLC, ECOG 0-2, chemo-naïve, EGFR mutation positive (exon 19/21) www.OncologyEducation.ca Study Design N= 174 Primary Outcome: PFS Erlotinib 150 mg daily until PD R •Stage IIIB/V •Chemo-naïve •Exon 19 del •Exon 21 L858R •ECOG 0-2 Platinum doublet X 4 cycles Population www.OncologyEducation.ca Patient Characteristics Erlotinib (n=86) Chemo (n=88) Median age 65(24-82) 65 (29-82) Gender Male Female 33 67 22 78 Smoking % Current Former Never 31 55 14 34 52 14 Mutation Ex 19del Ex 21 sub 66 34 67 33 www.OncologyEducation.ca RESULTS Treatment A Erlotinib Treatment B Chemo p-value Response Rate (%) 58 15 NA PFS (median, mos) 9.7 5.2 <0.0001 OS (median, mos) NA NA www.OncologyEducation.ca Study Commentary • 21% of patient samples tested were EGFR mutation positive • Overall survival no different but majority of patients crossed over at progression • No relevant safety concerns • First trial in western population to show erlotinib superior to chemo in terms of ORR and PFS in EGFR mutation positive patients. www.OncologyEducation.ca Bottom Line for Canadian Medical Oncologists This is the first study in Caucasian population of EGFR TKI versus chemo as first line therapy Further support for EGFR mutation analysis in appropriate patients Those with activating mutations should be considered for first line GFR TKI therapy www.OncologyEducation.ca