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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 2005, data from 3 large randomized trials demonstrated that 1 year of trastuzumab treatment provided a statistically significant disease-free survival benefit compared with no trastuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer [Piccart-Gebhart MJ et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2005]. One of these studies, the Trastuzumab in Treating Women with Primary Breast Cancer [HERceptin Adjuvant (HERA); \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00045032\u0026amp;atom=%2Fspmdc%2F12%2F20%2F9.2.atom\u0022\u003ENCT00045032\u003C\/a\u003E] trial, continued trastuzumab therapy to assess whether 2 years of treatment was superior to 1 year. This article provides an update of the HERA trial after 8 years of median follow-up.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology Genomics\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EBreast Cancer\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EIn 2005, data from 3 large randomized trials demonstrated that 1 year of trastuzumab treatment provided a statistically significant disease-free survival (DFS) benefit compared with no trastuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer [Piccart-Gebhart MJ et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2005]. One of these studies, the Trastuzumab in Treating Women with Primary Breast Cancer [HERceptin Adjuvant (HERA); \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00045032\u0026amp;atom=%2Fspmdc%2F12%2F20%2F9.2.atom\u0022\u003ENCT00045032\u003C\/a\u003E] trial, continued trastuzumab therapy to assess whether 2 years of treatment was superior to 1 year. Martine J. Piccart-Gebhart, MD, PhD, Jules Bordet Institute, Brussels, Belgium, provided an update of the HERA trial after 8 years of median follow-up.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EWomen with locally determined and centrally confirmed early HER2-positive invasive breast cancer who had undergone surgery and neoadjuvant chemotherapy with or without radiation therapy were recruited globally except in the United States (n=5102). Patients were randomized to observation, 1 year of trastuzumab every 3 weeks, or 2 years of trastuzumab every 3 weeks. Patients in the observation arm were given the option of crossing over after the release of first results in 2005.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003ENo significant difference was found in DFS or overall survival (OS) between the 2- and 1-year trastuzumab arms at 8 years median follow-up. When patients were stratified by receptor status, DFS and OS were still similar between the 2- and 1-year groups. At the interim point of 4 years median follow-up, a transient DFS advantage was reported for patients with hormone receptor (HR)-negative breast cancer who received 2 years of trastuzumab compared with 1 year of treatment in patients with HR-negative breast cancer. However, this benefit was not sustained at 8 years median follow-up.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EAlthough no differences in DFS and OS were observed between 2 years of trastuzumab and 1 year, secondary cardiac endpoints and other grade 3 or 4 adverse events were increased in the arm treated with trastuzumab for 2 years. Nonetheless, most cardiac endpoints were reversible and occurred during the treatment administration period.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EProf. Piccart-Gebhart said, \u201cThere is no evidence of long-term benefit of 2 years compared with 1 year trastuzumab when administered as sequential treatment following chemotherapy.\u201d She added that \u201ctransient DFS advantage for the 2-year arm in the hormone receptor-negative cohort [at 4 years follow-up] highlights the need for long-term follow-up in trials investigating different durations of adjuvant trastuzumab.\u201d\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EAfter disclosure of the first results in 2005, 885 of the 1698 patients (52.1%) crossed over to receive trastuzumab, which complicates long-term follow-up results. For the analysis of DFS and OS for 1 year trastuzumab versus observation at 8 years median follow-up, the HERA results show sustained statistically significant benefit for DFS and OS compared with observation in intention-to-treat analyses despite selective crossover. In addition, benefit was shown across HR-positive and HR-negative cohorts at 8 years median follow-up.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EProf. Piccart-Gebhart concluded, \u201cOne year of trastuzumab remains the standard of care as part of an adjuvant therapy for patients with HER2-positive early breast cancer.\u201d\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\/12\/20\/9.2.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_openurl.js?nzo4e1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}