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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\u003EThis article discusses the results of the Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer trial [CHAARTED; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00309985\u0026amp;atom=%2Fspmdc%2F14%2F14%2F12.atom\u0022\u003ENCT00309985\u003C\/a\u003E]. The trial demonstrated that the use of docetaxel at the beginning of androgen deprivation therapy (ADT) increases overall survival (OS) in patients with metastatic prostate cancer by \u0026gt;1 year compared with ADT alone.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EReproductive 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\u003EReproductive Cancers\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EChristopher Sweeney, MBBS, Dana-Farber Cancer Institute, Boston, Massachusetts, USA, described the results of the Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer trial [CHAARTED; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00309985\u0026amp;atom=%2Fspmdc%2F14%2F14%2F12.atom\u0022\u003ENCT00309985\u003C\/a\u003E]. The trial demonstrated that the use of docetaxel at the beginning of androgen deprivation therapy (ADT) increases overall survival (OS) in patients with metastatic prostate cancer by \u0026gt;1 year compared with ADT alone.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe knowledge that ADT can limit prostate cancer dates back to the 1940s [Huggins C et al. \u003Cem\u003ECancer Res\u003C\/em\u003E 1941]. More recently, the benefit of docetaxel in improving OS in men with metastatic, castration-resistant prostate cancer was demonstrated [Tannock IF et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2004]. Nonetheless, the combination of early chemotherapy and ADT is debatable. The randomized Phase 3 CHAARTED trial was undertaken to address this debate. The hypothesis of the trial was that docetaxel added at the start of ADT in men with hormone-na\u00efve metastatic prostate cancer would prolong OS. The design of the trial is shown 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\/14\/12\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Design of the CHAARTED Trial\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-776722705\u0022 data-figure-caption=\u0022Design of the CHAARTED Trial\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\/14\/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\/14\/14\/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\/14\/14\/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\/14547\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-4\u0022 class=\u0022first-child\u0022\u003EDesign of the CHAARTED Trial\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EADT=androgen deprivation therapy; ECOG PS=Eastern Cooperative Oncology Group performance status.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003EReproduced with permission from C. J. Sweeney, MBBS.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-5\u0022\u003EThe key eligibility criteria were the presence of metastatic prostate cancer, ADT limited to 120 days before study randomization or to adjuvant treatment within the prior 24 months with no disease progression within 12 months after completion of the treatment, Eastern Cooperative Oncology Group performance status of 0 to 2 (the latter only if due to prostate cancer), functions of select organs judged suitable for docetaxel application, and no previous use of docetaxel.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EA total of 790 men (89% Caucasian; median age, 63 years; range, 36 to 91 years) newly diagnosed with hormone-sensitive metastatic prostate cancer were recruited from June 2006 to November 2012 and randomly assigned to ADT plus docetaxel (n=397) or standard ADT alone (n=393). Docetaxel was given as a 75 mg\/m\u003Csup\u003E2\u003C\/sup\u003E dose every 3 weeks for 6 cycles within 4 months of starting ADT.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EBoth arms were similar at baseline. Patients were stratified with respect to high-volume (visceral metastases and\/or \u22654 bone metastases) or low-volume disease, androgen suppression \u0026gt;30 days, age, Eastern Cooperative Oncology Group performance status 0 or 1 versus 2, prior adjuvant ADT, and the use of an approved drug to delay skeletal-related events. Radiotherapy and prostatectomy had each been performed in 24% of the subjects.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EThe primary endpoint was OS. Secondary endpoints included the rate of prostate-specific antigen level \u0026lt;0.2 ng\/mL at 6 and 12 months, time to progressive disease (biochemical, radiographic, or symptomatic), adverse events and drug tolerability, and quality of life up to 12 months following randomization.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EThe primary endpoint of OS was met. The median OS of the ADT-plus-docetaxel arm was 57.6 months compared with 44.0 months for men who received ADT only (HR, 0.61; 95% CI, 0.47 to 0.80; p=0.0003; \u003Ca id=\u0022xref-fig-2-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F2\u0022\u003EFigure 2\u003C\/a\u003E).\u003C\/p\u003E\u003Cdiv id=\u0022F2\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\/14\/12\/F2.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Overall Survival\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-776722705\u0022 data-figure-caption=\u0022Overall Survival\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 2.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/14\/12\/F2.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\/14\/12\/F2.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 2.\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\/14\/12\/F2.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\/14549\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 2.\u003C\/span\u003E \n            \u003Cp id=\u0022p-10\u0022 class=\u0022first-child\u0022\u003EOverall Survival\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-3\u0022\u003EADT=androgen deprivation therapy; D=docetaxel; OS=overall survival.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-4\u0022\u003EReproduced with permission from C. J. Sweeney, MBBS.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-11\u0022\u003EThe 13-month difference translated to a 39% reduction in the survival hazard (HR, 0.61; 95% CI, 0.47 to 0.80; p=0.0003). Those with a high disease burden at the time of enrollment displayed an even more pronounced survival difference, with median OS of 49.2 months for ADT plus docetaxel treatment compared with 32.2 months for ADT alone (HR, 0.60; 95% CI, 0.45 to 0.81; p=0.0004). The secondary outcomes significantly favored ADT plus docetaxel treatment: prostate-specific antigen response (\u0026lt;0.2 ng\/dL at 6 months: 27.5% vs 14.0% [p\u0026lt;0.0001]; \u0026lt;0.2 ng\/mL at 12 months: 22.7% vs 11.7% [p\u0026lt;0.0001]), time to castration resistance (20.7 vs 14.7 months, p\u0026lt;0.0001), and time to clinical progression (32.7 vs 19.8 months, p\u0026lt;0.0001).\u003C\/p\u003E\u003Cp id=\u0022p-12\u0022\u003EThe trial was ended prematurely when a planned interim analysis revealed the compelling statistically significant survival difference between the treatment arms.\u003C\/p\u003E\u003Cp id=\u0022p-13\u0022\u003EAs of mid-January 2013, at a median follow-up of 29 months, there had been 237 deaths: 101 in the ADT-plus-docetaxel arm, of which 84 (83.2%) were due to prostate cancer, and 136 in the ADT-alone arm, of which 112 (83.6%) were due to prostate cancer. The adverse events in the patients treated with docetaxel were generally mild and were manageable. There were no Grade 5 adverse events, although there were 9 cases of Grade 4 neutropenia.\u003C\/p\u003E\u003Cp id=\u0022p-14\u0022\u003EThe data demonstrated that ADT and 6 cycles of docetaxel significantly improved OS compared with ADT alone in men with hormone-sensitive prostate cancer. The results are likely practice changing.\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\/14\/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?nzp4s6\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?nzp4s6\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}