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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\u003EThe updated safety results of the RADIANT-2 and \u22123 Trials have demonstrated a favorable benefit-to-risk profile of everolimus for progressive advanced neuroendocrine tumors. The findings are consistent with those of the initial safety analyses and the known safety profile of the drug in patients with cancer.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EDiabetes \u0026amp; Endocrinology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENeuroendocrine Tumors\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EThe updated safety results of two studies have demonstrated a favorable benefit-to-risk profile of everolimus for progressive advanced neuroendocrine tumors. The findings are consistent with those of the initial safety analyses and the known safety profile of the drug in patients with cancer.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EEverolimus is a mammalian target of rapamycin (mTOR) inhibitor that was studied in the RADIANT-2 and RADIANT-3 trials, two international, multicenter Phase 3 trials. In RADIANT-2, 429 adult patients with advanced neuroendocrine tumors with carcinoid syndrome were randomly assigned to treatment with octreotide LAR with either everolimus or placebo. In RADIANT-3, 410 patients with advanced neuroendocrine tumors of pancreatic origin were randomly assigned to best supportive care with either everolimus or placebo. The primary efficacy endpoint for both trials was progression-free survival (PFS). The results of the studies, which were reported in 2010, showed that the addition of everolimus led to significant increases in median PFS compared with placebo (16.4 months vs 11.3 months; p=0.026 in RADIANT-2; 11.0 months vs 4.6 months; p\u0026lt;0.0001 in RADIANT-3).\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe updated safety analysis in each study represented an additional 3.1 months of follow-up compared with the initial analysis (median of 31.1 months [compared with 28 months] in RADIANT-2 and median of 20.1 months [compared with 17 months] in RADIANT-3). The safety population included 426 patients in RADIANT-2 (215 who received everolimus and 211 who received placebo) and 407 in RADIANT-3 (204 who received everolimus and 203 who received placebo).\u003C\/p\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003ESafety Analysis in RADIANT-2\u003C\/h2\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EDavid Gross, MD, Hadassah-Hebrew University Medical Center, Jerusalem, Israel, reported that the majority of treatment-related adverse events (AEs) in RADIANT-2 were grade 1 or 2. When considering AEs of all grades, stomatitis was the most common event (61.9%), followed by rash (37.2%) and fatigue (31.6%; \u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E). Other AEs included diarrhea (27.4%) and infections (20%). Pneumonitis was relatively infrequent, occurring in 9.3% in the everolimus + octreotide LAR group; 3 of these patients (1.4%) had grade 3 pneumonitis\u2014this was modest compared with that reported in association with traditional cytotoxic chemotherapy.\u003C\/p\u003E\n         \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\/12281\/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\/12281\/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\/12281\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-6\u0022 class=\u0022first-child\u0022\u003EUpdated Treatment-Related AEs (All Grades) in RADIANT-2 and RADIANT-3.\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-8\u0022\u003EThe rate of grade 3 and 4 AEs was 40% and 5%, respectively, in the everolimus + octreotide LAR group, compared with 15% and 1% in the placebo + octreotide LAR group. The most common grade 3 AEs that were associated with everolimus were fatigue and stomatitis, each occurring in 7% (compared with 3% and 0% in the placebo groups). Diarrhea, infections, hyperglycemia, and thrombocytopenia also occurred in more than 3% of the everolimus + octreotide LAR group (\u003Ca id=\u0022xref-table-wrap-2-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T2\u0022\u003ETable 2\u003C\/a\u003E).\u003C\/p\u003E\n         \u003Cdiv id=\u0022T2\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\/12282\/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\/12282\/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\/12282\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 2.\u003C\/span\u003E \n               \u003Cp id=\u0022p-9\u0022 class=\u0022first-child\u0022\u003EUpdated Treatment-Related Grade 3 and 4 AEs Occurring in More than 3% of Patients in RADIANT-2.\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-11\u0022\u003EOverall, the AEs were modest compared with that reported in association with traditional cytotoxic chemotherapy. Most AEs were easily managed with dose modification or treatment interruptions, concomitant medication, or dietary interventions. Disease progression was the primary reason for treatment discontinuation in both groups. The rate of treatment-related AEs that led to discontinuation was 19.5% for the everolimus+octreotide LAR group compared with 3.8% for the placebo+octreotide LAR group.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-2\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003ESafety Analysis in RADIANT-3\u003C\/h2\u003E\n         \u003Cp id=\u0022p-12\u0022\u003EDieter H\u00f6rsch, MD, Klinik f\u00fcr Innere Medizin, ENETS Center of Excellence, Bad Berka, Germany, reported similar rates of treatment-related AEs in RADIANT-3. As in RADIANT-2, stomatitis, rash, fatigue, diarrhea, and infections were the most common events in RADIANT-3, although the rates of some events differed from those in RADIANT-2 (\u003Ca id=\u0022xref-table-wrap-1-2\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E). Also similar was the infrequent occurrence of pneumonitis, which developed in 12.3% of patients who were treated with everolimus, 3 (1.4%) of whom had grade 3 pneumonitis.\u003C\/p\u003E\n         \u003Cp id=\u0022p-13\u0022\u003EMost AEs were manageable, resolving with dose modification or treatment interruptions or concomitant medication. The rate of treatment-related AEs that led to discontinuation was 13.7% for the everolimus group compared with 2.0% for the placebo group. Disease progression was the primary reason for treatment discontinuation in both groups.\u003C\/p\u003E\n         \u003Cp id=\u0022p-14\u0022\u003EThe overall rate of grade 3 or 4 AEs in RADIANT-3 was also similar to that in RADIANT-2, affecting 41% and 5% of patients, respectively (\u003Ca id=\u0022xref-table-wrap-3-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T3\u0022\u003ETable 3\u003C\/a\u003E). In addition, the rates of most AEs were similar to those in the other study, but the grade 3 events that occurred most frequently were different, with hyperglycemia being the most common (6%). Anemia was the second most common event (5%), followed by stomatitis (5%), thrombocytopenia (3%), and diarrhea (3%). The overall frequency of all treatment-related events (all grades) remained the same as in the initial safety analysis.\u003C\/p\u003E\n         \u003Cdiv id=\u0022T3\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\/12283\/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\/12283\/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\/12283\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 3.\u003C\/span\u003E \n               \u003Cp id=\u0022p-15\u0022 class=\u0022first-child\u0022\u003EUpdated Treatment-Related Grade 3 and 4 AEs Occurring in More than 3% of Patients in RADIANT-3.\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-17\u0022\u003EBoth Prof. Gross and Prof. H\u00f6rsch noted that the findings provide further evidence of the favorable risk-benefit profile of everolimus in patients with advanced neuroendocrine tumors and support the use of the drug as standard therapy in this setting. The findings of RADIANT-3 led to the United States Food and Drug Administration approval for the use of everolimus as treatment for progressive unresectable, locally advanced, or metastatic pancreatic neuroendocrine tumors in May 2010.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2011 MD Conference Express\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\/11\/5\/16.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?nzn28q\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?nzn28q\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}