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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\u003EA phase 3 dose escalation study of radiation therapy (RT) in patients with localized prostate cancer was terminated early and did not find an improvement in the primary outcome of overall survival. The Radiation Therapy Oncology Group 0126 study found significant improvements in the rates of local control, distant metastases, and biochemical disease-free survival as discussed in this article.\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\u003ERadiology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EReproductive Cancers\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERadiation Therapy\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERadiology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EReproductive Cancers\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERadiation Therapy\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EA phase 3 dose escalation study of radiation therapy (RT) in patients with localized prostate cancer was terminated early and did not find an improvement in the primary outcome of overall survival (OS). The Radiation Therapy Oncology Group 0126 study, presented by Jeff Michalski, MD, Washington University School of Medicine, St Louis, Missouri, USA, found significant improvements in the rates of local control, distant metastases, and biochemical disease-free survival.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe intermediate-risk patients were randomized to a high or low dose of RT (79.2 Gy in 44 fractions, n = 748; 70.2 Gy in 39 fractions, n = 751). They were stratified by Gleason score (GS; 6 vs 7), prostate-specific antigen level (PSA; between 10 and 20 ng\/mL vs \u0026lt; 15 ng\/mL), and treatment (3D conformal radiation therapy vs intensity-modulated radiotherapy). At baseline, the median age was 71 years, and the tumor stage was T1 and T2 in 57% and 43% of each group, respectively. Most patients (83% of low dose and 85% of high dose) had a GS of 7, and most (70%) had a PSA \u0026lt; 10 ng\/mL. Of the low- and high-dose groups, 85% and 83% had a GS 7 and a PSA \u0026lt; 15 ng\/mL. The median follow-up was 7.0 years in all patients.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe OS was 66.7% and 65.6% in the high- and low-dose groups, respectively (HR, 0.98; 95% CI, 0.79 to 1.21; log-rank \u003Cem\u003EP\u003C\/em\u003E = .87). Death due to prostate cancer was uncommon, at 13%, while death from other cancer was 22% and other causes, 46%, based on a blinded review. Time to prostate cancer death was similar, at 3.5% and 5.6% in the high- and low-dose groups, respectively (HR, 0.61; 95% CI, 0.33 to 1.11; Gray test, \u003Cem\u003EP\u003C\/em\u003E = .11).\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EAn important and significant difference was seen in biochemical failure at 10 years. Based on the ASTRO consensus definition, it was 30% and 45% in the high- and low-dose groups, respectively (HR, 0.59; 95% CI, 0.49 to 0.70; Gray test, \u003Cem\u003EP\u003C\/em\u003E \u0026lt; .0001), and based on the Phoenix definition, it was 26% and 43%, respectively (HR, 0.59; 95% CI, 0.48 to 0.72; Gray test, \u003Cem\u003EP\u003C\/em\u003E \u0026lt; .0001).\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EA significant improvement in the rates of local progression and distant metastases was seen at 10 years. With high- versus low-dose RT, the local progression rates were 4% and 8% (HR, 0.42; 95% CI, 0.24 to 0.73; Gray test, \u003Cem\u003EP\u003C\/em\u003E = .0059), and the distant metastasis rates were 5% and 8% (HR, 0.60; 95% CI, 0.37 to 0.98; Gray test, \u003Cem\u003EP\u003C\/em\u003E = .026). Salvage therapy was more common in the low-dose group (20.6% vs 13.5% in the high-dose group; \u003Cem\u003EP\u003C\/em\u003E = .0002).\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EThe rate of acute adverse events was similar in both groups. The incidence of genitourinary (GU) and gastrointestinal (GI) grade 2+ toxicity in the high- and low-dose groups was 2.4% and 2.8% (\u003Cem\u003EP\u003C\/em\u003E = .64) and 11.1% and 12.8% (\u003Cem\u003EP\u003C\/em\u003E = .31), respectively. The incidence of GU plus GI toxicity was 12.3% and 13.7% (\u003Cem\u003EP\u003C\/em\u003E = .42). The rate of late-phase toxicity was higher at 10 years in the high- versus low-dose group (\u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E).\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\/11913\/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\/11913\/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\/11913\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 \n            \u003Cp id=\u0022p-8\u0022 class=\u0022first-child\u0022\u003ELate-Phase Adverse Events in the Radiation Therapy Oncology Group 0126 Study\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-11\u0022\u003EDr Michalski stated that, compared with the other published trials of dose escalation of RT in patients with prostate cancer, the present trial was the largest by about 2-fold. In all 6 trials, there was no improvement in OS, while there was an improvement in biochemical disease-free survival. The rates of grade 2+ GI toxicity were similar in the late phase in 6 trials, but the rate of GU toxicity was slightly higher in the present study.\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\/31\/17.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?nzm1o1\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?nzm1o1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}