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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EIn this small phase 2 study, 60% of patients with stage IIIA non\u2013small cell lung cancer with known \u003Cem\u003EEGFR\u003C\/em\u003E mutations (exon 19 or exon 21) were able to proceed to radical resection. The ultimate long-term outcomes associated with this strategy are still undetermined.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Ephase 2\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Esingle-arm\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Enon\u2013small cell lung cancer\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eneoadjuvant erlotinib\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eradical resection\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecarcinoembryonic antigen\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EEGFR mutation\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eexon 19\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eexon 21\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENCT01217619\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eoncology clinical trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eadjuvant\/neoadjuvant therapy\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003ENeoadjuvant erlotinib treatment showed promise in a phase 2 trial of patients with advanced-stage non\u2013small cell lung cancer (NSCLC) with \u003Cem\u003EEGFR\u003C\/em\u003E mutations. A poster [Han B et al. \u003Cem\u003EAnn Oncol\u003C\/em\u003E. 2015] was presented on behalf of Baohui Han, MD, PhD, Shanghai Chest Hospital, Shanghai, China, that detailed findings from the single-arm ESTERN study [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01217619\u0026amp;atom=%2Fspmdc%2F15%2F8%2F10.atom\u0022\u003ENCT01217619\u003C\/a\u003E].\u003C\/p\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EOut of 155 patients with previously untreated NSCLC screened at the hospital between October 2010 and June 2014, 44 had stage IIIA-N2 tumors confirmed by endobronchial ultrasound. Twenty-five of these patients with exon 19 or 21 \u003Cem\u003EEGFR\u003C\/em\u003E mutations ultimately enrolled in the study.\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003EAll participants had adenocarcinoma and an ECOG performance status of 1. Overall median age was 59 years. Of 25 participants, 13 were men and 12 were current or former smokers. Sixteen (64%) had an exon 19 deletion, and 10 (40%) had an exon 21 \u003Cem\u003EL858R\u003C\/em\u003E mutation (1 patient had both).\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EThe primary end point was radical resection rate. Secondary end points were pathologic complete response rate, objective response rate, disease-free survival (DFS), overall survival (OS), quality of life, safety profile, and exploratory biomarkers.\u003C\/p\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EOn days 1-28, patients received 150 mg\/d of erlotinib, a tyrosine kinase inhibitor effective in first-line therapy for advanced NSCLC patients with EGFR mutations. After evaluation for disease progression, participants received the same dose regimen on days 29-56.\u003C\/p\u003E\n         \u003Cp id=\u0022p-7\u0022\u003ENine patients did not proceed to radical resection surgery because of disease progression (n\u2005=\u20055), severe adverse events (SAE; n\u2005=\u20052), or unsuitability for surgery (n\u2005=\u20052, surgery not feasible due to either tumor shrinkage or surgery history in other lung). Sixteen reaped sufficient benefit from erlotinib to have the surgery. Most were women (n\u2005=\u200510) and never-smokers (n\u2005=\u200511).\u003C\/p\u003E\n         \u003Cp id=\u0022p-8\u0022\u003EThe primary end point of radical resection rate was reached in 15 patients (60%) in the intention-to-treat (ITT) analysis and in 15 of 16 (93.8%) patients in the surgery group. One patient in the ITT group (4.0%) and 1 patient in the surgery group (6.3%) had a pathologic complete response. An objective response rate was seen in 8 patients (32.0%) and 7 patients (43.8%) in the ITT and surgery groups, respectively, and progressive disease was seen in 6 patients (24.0%) and 1 (6.3%) patient, respectively.\u003C\/p\u003E\n         \u003Cp id=\u0022p-9\u0022\u003EData for OS were not yet available. Median progression free survival in all patients was 7.9 months (95% CI, 5.6 to 10.2 months). From the start of study treatment, median DFS was 12.2 months (95% CI, 7.3 to 17.1 months). Median DFS after surgery was 10.4 months (95% CI, 5.4 to 15.4 months).\u003C\/p\u003E\n         \u003Cp id=\u0022p-10\u0022\u003EMost patients received adjuvant therapy after surgery. Median time from surgery to discharge was 8 days. Rash occurred in 28% of patients; 4% experienced diarrhea. Three patients had grade 3\/4 AEs (4% leukocytopenia; 4% abnormal liver function; 4% cerebral infarction, considered unrelated to treatment). The investigators concluded toxicity was well tolerated.\u003C\/p\u003E\n         \u003Cp id=\u0022p-11\u0022\u003EIn 3 patients with EGFR mutations detected in preoperative biopsies, surgical samples were subsequently tested and found to be EGFR wild-type. Tumor marker carcinoembryonic antigen, which helps track several cancers, was considerably lower following neoadjuvant erlotinib therapy in patients who went on to surgery (n\u2005=\u200516) compared with those who did not (n\u2005=\u20059). The baseline levels of 54.2 and 120.8 \u00b5g\/L were reduced to 10.6 and 106.8 \u00b5g\/L, respectively, at 7 weeks. In the ITT group (n\u2005=\u200525), the carcinoembryonic antigen level was 33.2\u2005\u00b5g\/L at 7 weeks, reduced from 78.2 \u00b5g\/L at baseline.\u003C\/p\u003E\n         \u003Cp id=\u0022p-12\u0022\u003ELimitations were the small sample size, single-arm design, and lack of OS data. Although findings must be confirmed in randomized studies, treatment toxicity was largely well tolerated and neoadjuvant erlotinib followed by radical resection appeared promising for some advanced-stage NSCLC patients with specific \u003Cem\u003EEGFR\u003C\/em\u003E mutations.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2015 SAGE Publications\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/15\/8\/10.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzl6vp\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}