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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\u003Cp id=\u0022p-1\u0022\u003EPrevious studies suggested that elderly patients with early moderate- to high-risk breast cancer might benefit from adjuvant combination capecitabine plus ibandronate. The phase 3 ICE study showed no difference in invasive disease-free survival or overall survival at 3 or 5 years between those receiving capecitabine plus ibandronate vs ibandronate alone.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Eelderly patients\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eadjuvant\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecombination treatment\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Edisease-free survival\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group drug\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Ecapecitabine\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eibandronate\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EStudy in Elderly Patients With Early Breast Cancer\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EICE\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENCT00196859\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\u003Cp id=\u0022p-2\u0022\u003EElderly individuals are underrepresented in clinical trials. Standard anthracycline or taxane-based adjuvant regimens for breast cancer (BC) are often considered to be intolerable in frail elderly patients, whereas capecitabine has an acceptable toxicity profile and relevant single-agent activity in metastatic BC [O\u2019Shaughnessy JA et al. \u003Cem\u003EOncologist\u003C\/em\u003E. 2012]. Elderly patients have a high incidence of treatment-induced osteopenia\/osteoporosis, fractures, and bone surgery, especially from aromatase inhibitors [Chen JS et al. \u003Cem\u003EOsteoporos Int\u003C\/em\u003E. 2009]. Adjuvant bisphosphonates reduce distant recurrence and increase overall survival (OS) in postmenopausal patients [Coleman R et al. SABCS 2013 (abstr S4-07)]. Therefore, the effects of adjuvant ibandronate with and without capecitabine was investigated in elderly patients.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EResults of the phase 3 Study in Elderly Patients With Early Breast Cancer [ICE; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00196859\u0026amp;atom=%2Fspmdc%2F14%2F56%2F9.atom\u0022\u003ENCT00196859\u003C\/a\u003E] were reported by Gunter von Minckwitz, MD, PhD, University of Frankfurt, Frankfurt, and Chairman of the German Breast Group (GBG), Germany. This study enrolled 1358 women aged\u2009\u2265\u200965 years with moderate- to high-risk early BC who did not have extensive comorbidities. Patients were randomly assigned to capecitabine 2000 mg\/m\u003Csup\u003E2\u003C\/sup\u003E daily on day 1 to 14 every 3 weeks for 6 cycles plus oral ibandronate 50 mg daily or 6 mg IV every 4 weeks (route of administration chosen by patients) for 2 years, or to ibandronate monotherapy for 2 years. Anastrozole and\/or tamoxifen treatment in hormone receptor\u2013positive disease and\/or radiotherapy was started after capecitabine. Trastuzumab was not given.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe primary end point was invasive disease\u2013free survival (IDFS). Secondary end points were OS, bone-related events (fractures, surgery, or new osteoporosis; bone metastases were excluded), preference of oral or IV administration of ibandronate, and safety.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EPatient and tumor characteristics were well balanced between the combination (n\u2009=\u2009677) and monotherapy (n\u2009=\u2009681) intent-to-treat arms. Median age was 71 years, with about 25% aged\u2009\u2265\u200975 years. About half of patients had node-positive disease; 81% were hormone-receptor positive, and almost three-quarters received aromatase inhibitors only; 75.8% in each arm completed ibandronate treatment, and 83.3% completed 6 cycles of capecitabine with 7.8% discontinuations due to toxicity. Of the 65.4% who started oral ibandronate, 2.4% switched from oral to IV; of the 34.6% who started with IV, 3.6% switched to oral; and the median duration of ibandronate was similar in the 2 treatment arms.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EToxicities in the capecitabine arm were as expected, including 31.0% of patients experiencing any grade 3 or 4 adverse events; fewer experienced skin disorders, especially hand-foot syndrome (14.6%). Bone-related events occurred in 25.0% of the capecitabine arm and 24.7% of the ibandronate-only arm (\u003Cem\u003EP\u003C\/em\u003E\u2009=\u2009.65).\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EIDFS and OS are shown in \u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E. Neither treatment was favored in a subgroup analysis. Prof von Minckwitz suggested that given the high OS rate, patient life expectancy in this elderly population should be taken into account when treatment decisions are made.\u003C\/p\u003E\u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/11639\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/11639\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/11639\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\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \u003Cp id=\u0022p-8\u0022 class=\u0022first-child\u0022\u003EInvasive Disease\u2013Free and Overall Survival, Median Follow-Up 61.3 Months\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-11\u0022\u003EThe ICE study failed to show that adjuvant capecitabine improved IDFS in patients receiving ibandronate. The outcome of elderly patients with moderate- or high-risk early BC receiving ibandronate alone is favorable, although bone-related events were frequent (25%). Longer follow-up may be needed to observe any potential late effects of capecitabine.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 SAGE Publications\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\/56\/9.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?nzo7oe\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_tables.js?nzo7oe\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}