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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\u003Cp id=\u0022p-1\u0022\u003EAcute myeloid leukemia, a common form of leukemia with a high mortality rate, is difficult to treat. In the SORAML trial, sorafenib, a multikinase inhibitor, prolonged event-free and relapse-free survival compared with a placebo in younger patients with acute myeloid leukemia. However, this benefit was accompanied by a higher rate of infections and bleeding.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Eoverall survival\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eevent free survival\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Erelapse free survival\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Einfection\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ebleeding\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group drug\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Esorafenib\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eplacebo\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EStudy Evaluating Sorafenib Added to Standard Primary Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia Less Than 60 Years of Age\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ESORAML\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENCT00893373\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\u003Cp id=\u0022p-2\u0022\u003EChristoph R\u00f6llig, MD, Universit\u00e4tsklinikum Dresden, Dresden, Germany, presented the results of the Study Evaluating Sorafenib Added to Standard Primary Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia Less Than 60 Years of Age [SORAML; R\u00f6llig C et al. ASH 2014 (abstr 6)]. Although overall survival (OS) was not different compared with placebo, sorafenib significantly improved event-free survival (EFS) and relapse-free survival (RFS) with a cost of higher incidence of infections and bleeding events in younger patients with acute myeloid leukemia (AML).\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EAML is the most common form of leukemia in adults [National Cancer Institute. \u003Ca href=\u0022http:\/\/www.cancer.gov\/cancertopics\/pdq\/treatment\/adultAML\/Patient\/page1\u0022\u003Ehttp:\/\/www.cancer.gov\/cancertopics\/pdq\/treatment\/adultAML\/Patient\/page1\u003C\/a\u003E. Accessed December 23, 2014]. Survival rate for this disease continues to remain unsatisfactory, particularly among patients aged\u2009\u0026gt;\u200960 years. The significant genetic diversity and abnormality in AML even within a tumor of a single individual make it difficult to treat [Cancer Genome Atlas Research Network. \u003Cem\u003EN Engl J Med.\u003C\/em\u003E 2013]. Kinase mutations are among the most frequently found genetic abnormalities. Mutations in the tyrosine kinase genes KIT and FLT3, and aberrant VEGF signaling through tyrosine kinases, play a critical role in AML biology. Sorafenib is a multikinase inhibitor with activity against several serine\/threonine kinases and receptor tyrosine kinases.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003ESORAML was a randomized, multicenter, double-blind trial comparing sorafenib with placebo as an add-on to standard induction and consolidation treatment in 276 newly diagnosed AML patients aged 18 to 60 years with Eastern Cooperative Oncology Group (ECOG) performance 0 to 2, and adequate renal and liver function [R\u00f6llig C et al. ASH 2014 (abstr 6)]. Induction therapy consisted of 2 cycles of daunorubicin (60 mg\/m\u003Csup\u003E2\u003C\/sup\u003E days 3 to 5, plus cytarabine 100 mg\/m\u003Csup\u003E2\u003C\/sup\u003E cont. inf. days 1 to 7), followed by 3 cycles of high-dose cytarabine consolidation (3 g\/m\u003Csup\u003E2\u003C\/sup\u003E BID days 1, 3, and 5). Allogeneic stem cell transplantation was scheduled in the first complete remission. Patients were randomized (1:1) to receive sorafenib (800 mg\/day) or placebo as an add-on to standard treatment. The primary end point was EFS. Secondary end points included RFS, OS, complete remission rate, and incidence of adverse events (AEs).\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EDemographic and disease characteristics were equally distributed between the two arms. The incidence of FLT3-internal tandem duplication (ITD) and NPM1 mutation was 17% and 33%, respectively. Median drug dose was approximately 16\u2009200 mg with significantly less intake in the sorafenib arm, most likely due to side effects. Complete remission was evident in 60% of sorafenib-treated patients compared with 59% of placebo-treated patients (\u003Cem\u003EP\u003C\/em\u003E\u2009=\u2009.764). EFS was 9.2 months and 20.5 months in the placebo and sorafenib groups, respectively, corresponding to a 3-year EFS of 22% vs 40% (\u003Cem\u003EP\u003C\/em\u003E\u2009=\u2009.013; \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\/55\/8.2\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Sorafenib Significantly Improves Event-Free SurvivalReproduced with permission from C R\u0026#xF6;llig, MD.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-2082856906\u0022 data-figure-caption=\u0022Sorafenib Significantly Improves Event-Free SurvivalReproduced with permission from C R\u0026#xF6;llig, MD.\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\/55\/8.2\/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\/55\/8.2\/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\/55\/8.2\/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\/11649\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\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \u003Cp id=\u0022p-6\u0022 class=\u0022first-child\u0022\u003ESorafenib Significantly Improves Event-Free Survival\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EReproduced with permission from C R\u00f6llig, MD.\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-8\u0022\u003ERFS was also significantly (\u003Cem\u003EP\u003C\/em\u003E\u2009=\u2009.017) improved with sorafenib (56% after 3 years) treatment compared with placebo (38%), with a median RFS of 23 months with placebo compared with not yet reached after sorafenib treatment. At this point, there is no clear benefit for sorafenib treatment regarding OS (\u003Cem\u003EP\u003C\/em\u003E\u2009=\u2009.382; \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\/55\/8.2\/F2.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Sorafenib Does Not Improve Overall Survival Compared With PlaceboReproduced with permission from C R\u0026#xF6;llig, MD.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-2082856906\u0022 data-figure-caption=\u0022Sorafenib Does Not Improve Overall Survival Compared With PlaceboReproduced with permission from C R\u0026#xF6;llig, MD.\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\/55\/8.2\/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\/55\/8.2\/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\/55\/8.2\/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\/11650\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\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 2.\u003C\/span\u003E \u003Cp id=\u0022p-9\u0022 class=\u0022first-child\u0022\u003ESorafenib Does Not Improve Overall Survival Compared With Placebo\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003EReproduced with permission from C R\u00f6llig, MD.\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\u003EIn the 46 FLT3-ITD-positive patients, there was no difference in EFS, but there was a trend for prolonged RFS and OS in favor of sorafenib. The relative risk for the occurrence of grade\u2009\u2265\u20093 AEs was significantly higher for hand-foot syndrome, diarrhea, bleeding, rash, liver toxicity, and fever in the sorafenib arm compared with the placebo arm.\u003C\/p\u003E\u003Cp id=\u0022p-12\u0022\u003EIn this first randomized trial, sorafenib plus chemotherapy comprise a feasible treatment strategy in younger AML patients and are associated with improved outcomes.\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\/55\/8.2.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?nzm322\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?nzm322\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}