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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 Finland Herceptin [FinHer] trial results and concerns about cardiac toxicity with trastuzumab provided the rationale for the Trastuzumab for 6 Months or 1 Year in Treating Women with Nonmetastatic Breast Cancer That Can Be Removed by Surgery [PHARE; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00381901\u0026amp;atom=%2Fspmdc%2F12%2F15%2F12.atom\u0022\u003ENCT00381901\u003C\/a\u003E] trial. The primary objective of this noninferiority trial was to compare the effect of 6 versus 12 months of adjuvant treatment with trastuzumab on disease-free survival in patients with HER2-positive early breast cancer.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EAdjuvant\/Neoadjuvant Therapy\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EBreast Cancer\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EOne year of adjuvant treatment with trastuzumab improves survival in patients with human epidermal growth factor 2 (HER2)-positive early breast cancer [Piccart-Gebhart MJ et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2005; Romond EH et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2005]. The Finland Herceptin [FinHer] trial showed that patients treated with 9 weeks of adjuvant trastuzumab also had a similar survival benefit [Joensuu H et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2006]. The FinHer results and concerns about cardiac toxicity with trastuzumab provided the rationale for the Trastuzumab for 6 Months or 1 Year in Treating Women with Nonmetastatic Breast Cancer That Can Be Removed by Surgery [PHARE; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00381901\u0026amp;atom=%2Fspmdc%2F12%2F15%2F12.atom\u0022\u003ENCT00381901\u003C\/a\u003E] trial presented by Xavier Pivot, MD, Institut National du Cancer, Boulogne-Billancourt, France. The primary objective of this noninferiority trial was to compare the effect of 6 versus 12 months of adjuvant treatment with trastuzumab on disease-free survival (DFS) in patients with HER2-positive early breast cancer.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EA total of 3384 patients undergoing treatment with trastuzumab were randomized to continue treatment for 12 months (n=1690) or to stop treatment at 6 months (n=1690). The patients were stratified according to estrogen receptor status, and concurrent or sequential chemotherapy. Patients were evaluated with a clinical exam and left ventricular ejection fraction (LVEF) every 3 months for up to 24 months, and at 30 months. Mammography was performed every 6 months for up to 60 months. The primary endpoint was DFS; secondary endpoints were overall survival (OS) and cardiac toxicity.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EBaseline patient characteristics were well balanced between the 2 study groups. About 58% of patients in both groups received concomitant chemotherapy, while about 42% received sequential chemotherapy. The mean duration of trastuzumab therapy was 11.8 months in the 12-month group and 6.3 months in the 6-month group.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EAt median follow-up of 42.5 months, DFS events occurred in 10.4% (176 events) of patients treated for 12 months versus 13.0% (219 events) of those treated for 6 months (HR, 1.28; 95% CI, 1.05 to 1.56; p=0.29; \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). The DFS events in the 12-month versus the 6-month treatment group included local recurrence (1.1% vs 1.4%), regional recurrence (0.6% vs 0.5%), and distant recurrence (6.4% vs 8.3%). Contralateral breast cancer occurred in 0.4% of the 12-month treatment group and 0.7% of the 6-month treatment group, and a second primary malignancy was reported in 1.5% of patients in each group. There were 66 deaths in the 12-month group versus 93 deaths in the 6-month group (HR, 1.47; 95% CI, 1.07 to 2.02; no p value 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\/12\/15\/12\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Disease-Free Survival.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-437729777\u0022 data-figure-caption=\u0022Disease-Free Survival.\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\/12\/15\/12\/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\/12\/15\/12\/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\/12\/15\/12\/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\/14243\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-6\u0022 class=\u0022first-child\u0022\u003EDisease-Free Survival.\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EReproduced with permission from X Pivot, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-7\u0022\u003EThe cardiac event (composite of clinical and LVEF findings) rate was 5.7% in the 12-month group versus 1.9% in the 6-month group (p\u0026lt;0.0001). LVEF was \u0026lt;50% in 6.3% of the 12-month group versus 4.7% in the 6-month group (p=0.04); it was \u0026lt;50% and decreased by \u0026gt;10% in 4.8% of the 12-month group versus 3.6% of the 6-month group (p=0.071); it was \u0026gt;50% and decreased by \u0026gt;15% in 7.4% of the 12-month group versus 7.0% of the 6-month group (not significant).\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EThe results of the PHARE trial were inconclusive for the noninferiority hypothesis. Nevertheless, a trend favoring the standard 12 months of treatment in DFS and OS was observed.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2012 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\/15\/12.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?nzn7sq\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?nzn7sq\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}