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BackgroundActivating mutations in the epidermal growth factor receptor gene (EGFR) confer hypersensitivity to the tyrosine kinase inhibitors gefitinib and erlotinib in patients with advanced non-small-cell lung cancer. We evaluated the feasibility of large-scale screening for EGFR mutations in such patients and analyzed the association between the mutations and the outcome of erlotinib treatment.MethodsFrom April 2005 through November 2008, lung cancers from 2105 patients in 129 institutions in Spain were screened for EGFR mutations. The analysis was performed in a central laboratory. Patients with tumors carrying EGFR mutations were eligible for erlotinib treatment.ResultsEGFR mutations were found in 350 of 2105 patients (16.6%). Mutations were more frequent in women (69.7%), in patients who had never smoked (66.6%), and in those with adenocarcinomas (80.9%) (P<0.001 for all comparisons). The mutations were deletions in exon 19 (62.2%) and L858R (37.8%). Median progression-free survival and overall survival for 217 patients who received erlotinib were 14 months and 27 months, respectively. The adjusted hazard ratios for the duration of progression-free survival were 2.94 for men (P<0.001); 1.92 for the presence of the L858R mutation, as compared with a deletion in exon 19 (P=0.02); and 1.68 for the presence of the L858R mutation in paired serum DNA, as compared with the absence of the mutation (P=0.02). The most common adverse events were mild rashes and diarrhea; grade 3 cutaneous toxic effects were recorded in 16 patients (7.4%) and grade 3 diarrhea in 8 patients (3.7%).ConclusionsLarge-scale screening of patients with lung cancer for EGFR mutations is feasible and can have a role in decisions about treatment.

Original publication

DOI

10.1056/nejmoa0904554

Type

Journal article

Journal

The New England journal of medicine

Publication Date

09/2009

Volume

361

Pages

958 - 967

Addresses

Catalan Institute of Oncology and Autonomous University of Barcelona, Hospital Germans Trias i Pujol, Barcelona, Spain.

Keywords

Spanish Lung Cancer Group, Humans, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Exanthema, Diarrhea, Quinazolines, Protein Kinase Inhibitors, Multivariate Analysis, Survival Analysis, Prospective Studies, Sex Distribution, Mutation, Adult, Aged, Aged, 80 and over, Middle Aged, Female, Male, Young Adult, Kaplan-Meier Estimate, ErbB Receptors, Erlotinib Hydrochloride