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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\u003ENintedanib plus docetaxel significantly improved progression-free survival independent of histology, and prolonged overall survival for non-small cell lung cancer (NSCLC) with adenocarcinoma histology. Adverse events were generally manageable with dose reductions and symptomatic treatment. This article reports on results from the BIBF 1120 Plus Docetaxel as Compared to Placebo Plus Docetaxel in Second-Line Non-Small Cell Lung Cancer study [LUME-Lung 1; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00805194\u0026amp;atom=%2Fspmdc%2F13%2F6%2F14.atom\u0022\u003ENCT00805194\u003C\/a\u003E; Reck M et al. \u003Cem\u003EJ Clin Oncol\u003C\/em\u003E 2013 (suppl; abstr LBA8011)], a placebo-controlled Phase 3 trial of nintedanib plus docetaxel in patients with locally advanced\/metastatic NSCLC progressing after first-line therapy.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECancer\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERespiratory Cancers\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECancer\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERespiratory Cancers\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003ENintedanib plus docetaxel significantly improved progression-free survival (PFS) independent of histology, and prolonged overall survival (OS) for non-small cell lung cancer (NSCLC) with adenocarcinoma histology. Adverse events (AEs) were generally manageable with dose reductions and symptomatic treatment.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003ENo targeted agent has been shown to prolong OS in combination with second-line chemotherapy in NSCLC. Inhibition of tumor-related angiogenesis has been identified as an attractive target for antitumor therapy. Nintedanib is an oral angiokinase inhibitor targeting vascular endothelial growth factor receptors, platelet-derived growth factor receptors, and fibroblast growth factors. Martin Reck, MD, PhD, Hospital Grosshandorf, Grosshansdorf, Germany, reported results from the BIBF 1120 Plus Docetaxel as Compared to Placebo Plus Docetaxel in Second-Line Non-Small Cell Lung Cancer study [LUME-Lung 1; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00805194\u0026amp;atom=%2Fspmdc%2F13%2F6%2F14.atom\u0022\u003ENCT00805194\u003C\/a\u003E; Reck M et al. \u003Cem\u003EJ Clin Oncol\u003C\/em\u003E 2013 (suppl; abstr LBA8011)], a placebo-controlled Phase 3 trial of nintedanib plus docetaxel in patients with locally advanced\/metastatic NSCLC progressing after first-line therapy.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EPatients with histologically or cytologically confirmed locally advanced (stage IIIB), metastatic stage IV or recurrent NSCLC in whom first-line chemotherapy failed, were randomized to oral nintedanib 200 mg BID on Days 2 to 21 plus intravenous docetaxel 75 mg\/m\u003Csup\u003E2\u003C\/sup\u003E Q21D (n=655) or placebo plus docetaxel (n=659). The number of docetaxel cycles was not restricted. Monotherapy was permitted after \u22654 cycles of combination therapy.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe primary study endpoint was PFS assessed by independent central review using RECIST v1.0. Imaging was performed every 6 weeks. The key secondary endpoint of OS was analyzed hierarchically first in adenocarcinoma patients \u0026lt;9 months since start of first-line therapy (T \u0026lt;9 months; identified as a prognostic\/predictive biomarker), followed by all adenocarcinoma patients, and then all patients. Additional secondary analyses included response rate, safety, and patient reported outcomes.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe study participants were mostly men (73%), with a mean age of \u223c68 years; \u223c75% of participants were current or past smokers. Approximately 50% of patients had adenocarcinoma histology and 42% had squamous cell carcinoma. At randomization \u223c90% of patients had metastatic disease and \u0026gt;90% had received platinum-based chemotherapy as first-line treatment.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003ENintedanib plus docetaxel significantly prolonged PFS versus placebo plus docetaxel (HR, 0.79; 95% CI, 0.68 to 0.92; p=0.0019; median 3.4 vs 2.7 months) regardless of histology (squamous HR, 0.77; p=0.0200; adenocarcinoma HR, 0.77; p=0.0193). The results were also consistent among all previously specified subgroups.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EThere was no difference in OS in the intention-to-treat population of all patients. OS was significantly prolonged in patients with adenocarcinoma histology (HR, 0.83; p=0.0359; median 12.6 vs 10.3 months) but not those with squamous cell carcinoma. Tumor response was comparable between both arms and between the major histologies; however, there was a significant increase in disease control rates (complete response+partial response+stable disease) with nintedanib plus docetaxel in patients with adenocarcinoma (OR, 1.93; p\u0026lt;0.0001) and squamous cell carcinoma (OR, 1.78; p\u0026lt;0.0009).\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EThere was a higher incidence of drug-related adverse events (AEs) and severe drug-related AEs in the combination-therapy group. However, there was no difference in the number of AEs leading to drug discontinuation or the incidence of serious AEs. The most common AEs associated with combination therapy were gastrointestinal (diarrhea 42.3% vs 21.8%, and nausea) and transient elevation of transaminases (28.5% vs 8.4%). The side effects were mostly low to moderate in intensity, and nearly all were reversible. Further investigations are warranted to identify molecular and clinical determinants of benefit for nintedanib in NSCLC.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2013 MD Conference Express\u00ae\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\/13\/6\/14.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?nznvn2\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}