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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.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\u003EThe oral multikinase inhibitor regorafenib targets multiple pathways involved in tumor development and progression. In the CORRECT study [Grothey A et al. \u003Cem\u003ELancet\u003C\/em\u003E. 2013], treatment with regorafenib improved overall survival (OS) in patients with metastatic colorectal cancer (mCRC) disease progression after standard therapies (HR, 0.77; 95% CI, 0.64 to 0.94; 1-sided p?=?.0052). This article presents the results from the Asian Subjects With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy study [CONCUR; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01584830\u0026amp;atom=%2Fspmdc%2F14%2F22%2F17.2.atom\u0022\u003ENCT01584830\u003C\/a\u003E], a trial examining the efficacy and safety of regorafenib in a larger group of Asian patients with mCRC.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EGastrointestinal Cancers\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EGastrointestinal Cancers\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EThe oral multikinase inhibitor regorafenib targets multiple pathways involved in tumor development and progression. In the CORRECT study [Grothey A et al. \u003Cem\u003ELancet.\u003C\/em\u003E 2013], treatment with regorafenib improved overall survival (OS) in patients with metastatic colorectal cancer (mCRC) disease progression after standard therapies (HR, 0.77; 95% CI, 0.64 to 0.94; 1-sided p = .0052). The CORRECT study population included 15% Asian patients, primarily from Japan. Jin Li, MD, PhD, Fudan University Cancer Hospital, Shanghai, China, presented the results from the Asian Subjects With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy study [CONCUR; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01584830\u0026amp;atom=%2Fspmdc%2F14%2F22%2F17.2.atom\u0022\u003ENCT01584830\u003C\/a\u003E], a trial examining the efficacy and safety of regorafenib in a larger group of Asian patients with mCRC.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EConducted at 25 clinical centers in mainland China, Hong Kong, Taiwan, the Republic of Korea, and Vietnam, the CONCUR study enrolled eligible patients who had stage IV adenocarcinoma of the colon or rectum that had progressed within 3 months after receiving standard therapy and an ECOG Performance Status (PS) \u2264 1. A minimum of 2 prior treatments, including fluoropyrimidine, oxaliplatin, and irinotecan, was a requirement for participation. Previous treatment with anti\u2014vascular endothelial growth factor (VEGF) or anti\u2014epidermal growth factor receptor (EGFR) targeted therapies was permitted.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EPatients were randomized in a 2:1 ratio to best supportive care plus regorafenib (160 mg\/d) or best supportive care plus placebo for the first 3 weeks of each 4-week cycle [Li J et al. \u003Cem\u003EAnn Oncol.\u003C\/em\u003E 2014 (abstr O-0023)]. The randomization was stratified by the number of single versus multiple metastatic sites and time from diagnosis of metastatic disease to randomization (\u0026lt; 18 vs \u2264 18 months). Patients received treatment until disease progression, unacceptable toxicity, or withdrawal of consent. OS was the primary end point, and progression-free survival (PFS), tumor response, disease control rate (DCR), and safety variables were secondary end points. A stratified log-rank test (1-sided \u03b1, 0.2) was used to analyze survival.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EA total of 204 patients were randomized in the study between May 2012 and January 2013 to receive regorafenib (n = 136) or placebo (n = 68). The overall median age was 57 years, and the baseline and demographic characteristics were similar between treatment arms. Seventy-five percent of patients had an ECOG PS of 1, and 25% had an ECOG PS of 0. Approximately half of the patients had received \u2264 3 treatment lines for mCRC, and 41% had not received treatment with either an anti-VEGF or anti-EGFR agent.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EAs of the data analysis cutoff date (November 29, 2013), regorafenib significantly improved OS as compared with placebo (HR, 0.550; 95% CI, 0.395 to 0.765; 1-sided p = .0002). The median OS was 8.8 months for regorafenib-treated patients versus 6.3 months for placebo. The median PFS was 3.2 months for regorafenib and 1.7 months for placebo (HR, 0.311; 95% CI, 0.222 to 0.435; 1-sided p \u0026lt; .0001). The DCR was also greater in regorafenib-treated patients (52% vs 7% for placebo).\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EAdverse events in the study were consistent with the regorafenib safety profile in Asian patients. In regorafenib-treated patients, the most frequently reported treatment-emergent grade \u2265 3 adverse events were hand-foot skin reaction (16%), hypertension (12%), hyperbilirubinemia (12%), elevated liver enzymes (aspartate aminotransferase 10%, alanine aminotransferase 8%), hypophosphatemia (9%), anemia (7%), and hyperlipasemia (7%). No events of liver failure or pancreatitis were reported.\u003C\/p\u003E\u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/22\/17.2\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022The editors would like to thank the many members of the 16th World Congress on Gastrointestinal Cancer and the European Society for Medical Oncology presenting faculty who generously gave their time to ensure the accuracy and quality of the articles in this publication.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-988321592\u0022 data-figure-caption=\u0022The editors would like to thank the many members of the 16th World Congress on Gastrointestinal Cancer and the European Society for Medical Oncology presenting faculty who generously gave their time to ensure the accuracy and quality of the articles in this publication.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure1\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/22\/17.2\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/22\/17.2\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure1\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/22\/17.2\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/14854\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\n            \u003Cp id=\u0022p-8\u0022 class=\u0022first-child\u0022\u003EThe editors would like to thank the many members of the 16th World Congress on Gastrointestinal Cancer and the European Society for Medical Oncology presenting faculty who generously gave their time to ensure the accuracy and quality of the articles in this publication.\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 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\/14\/22\/17.2.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_figures.js?nzl602\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzl602\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}