%0 Journal Article
%T Prospective exosome©\focused translational research for afatinib study of non©\small cell lung cancer patients expressing EGFR (EXTRA study)
%A Akihiro Bessho
%A Akira Togashi
%A Hidetoshi Itani
%A Hideyuki Nakagawa
%A Hisashi Tanaka
%A Katsuhisa Horimoto
%A Kazuma Kishi
%A Kazuya Horiuchi
%A Kei Morikawa
%A Kenzo Soejima
%A Koji Ueda
%A Nobuhiko Seki
%A Nobumasa Takahashi
%A Noriyuki Matsutani
%A Takuma Yokoyama
%A Yae Kanai
%A Yusuke Okuma
%J Archive of "Thoracic Cancer".
%D 2019
%R 10.1111/1759-7714.12923
%X Patients with EGFR©\mutated non©\small cell lung cancer (NSCLC) exhibit resistance to EGFR©\tyrosine kinase inhibitors (TKIs) within 9¨C14 months of therapy. Recently, EGFR©\mutated NSCLC has demonstrated the potential for heterogeneity; therefore, the manner of clonal heterogeneity may impact the duration of progression©\free and overall survival and other parameters affecting EGFR©\TKI treatment efficacy. However no predictive biomarker of these favorable treatment efficacies has been identified to date. The exosome©\focused translational research for afatinib (EXTRA) study aims to identify a novel predictive biomarker and a resistance marker for afatinib by analyzing data from association studies of the clinical efficacy of afatinib and four ¡°OMICs¡± (genomics, proteomics, epigenomics, and metabolomics) using peripheral blood from patients treated with afatinib. This study aims to: (i) conduct comprehensive multi©\OMIC analyses in a prospective clinical trial, and (ii) focus on both sera/plasma and exosome as a source for OMIC analyses to identify a novel predictor of the efficacy of a specific drug. To eliminate the carryover bias of prior treatment, systemic treatment©\na£¿ve patients were enrolled. The candidates to be screened for biomarkers comprise a discovery cohort of 60 patients and an independent validation cohort of 40 patients. The EXTRA study is the first trial to screen novel biomarkers of longer treatment efficacy of EGFR©\TKIs using four©\OMICs analyses, focusing on both ¡°naked or free¡± molecules and ¡°capsulated¡± exosomal components in serially collected peripheral blood
%K Afatinib
%K epidermal growth factor receptor
%K exosome
%K OMIC
%K translational research
%U https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6360199/