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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\u003EAspirin may be an effective adjuvant treatment for patients with cancer; this has been suggested by long-term follow-up of randomized trials that were originally designed to determine the vascular effects of aspirin. This article discusses Add-Aspirin, a Phase 3 double-blind multicenter trial that will determine whether taking low-dose aspirin on a regular basis will improve the prognosis of patients who have recently undergone primary curative treatment for nonmetastatic colorectal, gastroesophageal, breast, or prostate cancer.\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\u003EGastrointestinal 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\u003EGastrointestinal Cancers\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EAspirin may be an effective adjuvant treatment for patients with cancer; this has been suggested by long-term follow-up of randomized trials that were originally designed to determine the vascular effects of aspirin. Low-dose aspirin, taken daily for 5 years, was associated with a decreased risk of cancer, particularly that of gastrointestinal tumors [Rothwell PM et al. \u003Cem\u003ELancet\u003C\/em\u003E. 2011]. Aspirin may also reduce the risk of developing BRAF wild-type colorectal cancer [Nishihara R et al. \u003Cem\u003EJAMA\u003C\/em\u003E. 2013]. Other studies have suggested that mutations in the PIK3CA gene (phosphatidylinositol-4, 5-bisphosphate 3-kinase, catalytic subunit alpha) may identify patients with colorectal cancer who would derive even greater benefit from adjuvant aspirin therapy [Liao X et al. \u003Cem\u003EN Engl J Med.\u003C\/em\u003E 2012; Domingo E et al. \u003Cem\u003EJ Clin Oncol.\u003C\/em\u003E 2013; Kothari N et al. \u003Cem\u003EJ Clin Oncol.\u003C\/em\u003E 2014]. Another study showed no benefit from aspirin in patients with wild-type PIK3CA, although the study was inadequately powered [Reimers MS et al. \u003Cem\u003EJAMA Intern Med\u003C\/em\u003E. 2014]. Therefore, the hypothesis that aspirin might improve prognosis in patients with colorectal cancer with PIK3CA mutations requires prospective evaluation in randomized trials. Add-Aspirin is a Phase 3 double-blind multicenter trial that will determine whether taking low-dose aspirin on a regular basis will improve the prognosis of patients who have recently undergone primary curative treatment for nonmetastatic colorectal, gastroesophageal, breast, or prostate cancer. Ruth E. Langley, MD, Medical Research Council Clinical Trials Unit at University College London, London, United Kingdom, described the Add-Aspirin trial in the presentation \u201cAre the Benefits of Aspirin in Colorectal Cancer Limited to PIK3CA Mutated Cancers?\u201d Add-Aspirin provides an opportunity to investigate the potential association between PIK3CA mutations and benefit from aspirin after a colorectal cancer diagnosis. The Add-Aspirin study plan is presented in \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E.\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\/8\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Add-Aspirin Study Plan\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-636456358\u0022 data-figure-caption=\u0022Add-Aspirin Study Plan\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/22\/8\/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\/8\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\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\/8\/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\/14868\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 attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-3\u0022 class=\u0022first-child\u0022\u003EAdd-Aspirin Study Plan\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EOGJ=esophagogastric junction; RFS=relapse-free survival; RT=radiation therapy\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003EReproduced with permission from R Langley, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-4\u0022\u003EThe Add-Aspirin study is aiming to register approximately 11,000 potential participants and randomize 9920, including 2600 patients with colorectal cancer. The study design includes an active run-in period prior to randomization during which participants take 100 mg of aspirin daily for about 8 weeks. During the run-in period, the toxicity of and adherence to the aspirin therapy will be determined. If funding is available, the PIK3CA mutation status in patients with colorectal cancer will be determined and used as a stratification factor as part of the random assignment to treatment. After the run-in period, patients will be randomly assigned within each tumor-type cohort, 1:1:1, to aspirin\u2013100 mg daily, aspirin\u2013300 mg daily, or matching placebo for at least 5 years. Patients aged at least 75 years will be randomly assigned 2:1 to 100 mg of aspirin or placebo. Each tumor-specific cohort is individually powered with separate co\u2014primary outcome measures, incorporating overall survival alongside a tumor-specific measure.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EFor patients in the colorectal cohort, there is a planned subgroup analysis for disease-free survival (DFS) in the PIK3CA-mutated group (approximately n = 390 or 15% of randomized patients). This analysis is powered at 90% to detect a hazard ratio of .5 in favor of aspirin versus placebo in DFS.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EAdd-Aspirin is designed to determine if long-term low-dose aspirin therapy will improve prognosis in patients with successfully treated colorectal, gastroesophageal, breast, or prostate cancer. Different signaling pathways may influence the development of primary tumors and the development and spread of tumor metastases. Add-Aspirin may determine if aspirin can inhibit one or more of these pathways. Add-Aspirin also offers the opportunity to address the role of PIK3CA mutation status in the colorectal patient cohort and determine whether the benefits of aspirin after a colorectal cancer diagnosis are influenced by PIK3CA mutation status.\u003C\/p\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\/8.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?nzoxlp\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?nzoxlp\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}