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Bruce Brockstein, Mario Lacouture, and Mark Agulnik

Edited by Kerrin G. Robinson

Cancer Institute of Canada Clinical Trials Group . Invest New Drugs 2005 ; 23 : 147 – 155 . 45. Wolf M Swaisland H Averbuch S . Development of the novel biologically targeted anticancer agent gefitinib: determining the optimum dose for

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Barbara Burtness, Milan Anadkat, Surendra Basti, Miranda Hughes, Mario E. Lacouture, Joan S. McClure, Patricia L. Myskowski, Jennifer Paul, Clifford S. Perlis, Leonard Saltz, and Sharon Spencer

Clin Oncol 2008 ; 26 ( Suppl 1 ): Abstract 4000 . 14 Riely GJ Pao W Pham D . Clinical course of patients with non-small cell lung cancer and epidermal growth factor receptor exon 19 and exon 21 mutations treated with gefitinib or

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Helena A. Yu and Gregory J. Riely

. First-Generation EGFR Tyrosine Kinase Inhibitors Gefitinib and erlotinib were the first EGFR tyrosine kinase inhibitors (TKIs) that were approved for the treatment of patients with non–small cell lung cancer (NSCLC). These drugs inhibit kinase activity

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Rogerio A. Lilenbaum and Leora A. Horn

to 4 weeks. Dr. Lilenbaum noted that patients with an EGFR mutation have better outcomes with gefitinib compared with chemotherapy, based on the results of the IPASS trial 1 , and that patients without the mutation experience a poor response on

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David S. Ettinger, Douglas E. Wood, Dara L. Aisner, Wallace Akerley, Jessica Bauman, Lucian R. Chirieac, Thomas A. D'Amico, Malcolm M. DeCamp, Thomas J. Dilling, Michael Dobelbower, Robert C. Doebele, Ramaswamy Govindan, Matthew A. Gubens, Mark Hennon, Leora Horn, Ritsuko Komaki, Rudy P. Lackner, Michael Lanuti, Ticiana A. Leal, Leah J. Leisch, Rogerio Lilenbaum, Jules Lin, Billy W. Loo Jr, Renato Martins, Gregory A. Otterson, Karen Reckamp, Gregory J. Riely, Steven E. Schild, Theresa A. Shapiro, James Stevenson, Scott J. Swanson, Kurt Tauer, Stephen C. Yang, Kristina Gregory, and Miranda Hughes

in exon 21 (L858R in 40%). Both mutations result in activation of the tyrosine kinase domain, and both are associated with sensitivity to the small molecule tyrosine kinase inhibitors (TKIs), such as erlotinib, gefitinib, and afatinib (see “EGFR TKIs

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Leora Horn by Vanderbilt University. Used with permission. disease responded to gefitinib than to chemotherapy (71% vs 47%). Conversely, more patients with EGFR mutation–negative disease responded to chemotherapy than to gefitinib

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Leora Horn

mutation (Asians with adenocarcinoma histology who were never or light former smokers). 5 , 6 The presence of an EGFR mutation was a strong predictor of better outcomes with gefitinib. Of those with EGFR mutation-positive disease, more patients

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Karen L. Reckamp

mutations discovered prior to first-line therapy, which includes erlotinib, afatinib, gefitinib (all category 1), and osimertinib (recently FDA-approved for the first line). Dacomitinib, a second-generation EGFR TKI, is not FDA-approved but has encouraging

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Charu Aggarwal, Neeta Somaiah, and George R. Simon

cohort of patients with KRAS wild-type tumors will have a subset with EGFR mutations. EGFR mutations are intricately linked to sensitivity to erlotinib or gefitinib, and therefore KRAS -mutated tumors may be perceived to predict for erlotinib

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Kevin S. Scher, Juan-Sebastian Saldivar, Michael Fishbein, Alberto Marchevsky, and Karen L. Reckamp

/Former Employee. Kristina M. Gregory, RN, MSN, OCN, Vice President, Clinical Information Operations Ms. Gregory has disclosed that she has no relevant financial relationships. References 1. Mok TS Wu YL Thongprasert S . Gefitinib or