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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\u003EThe addition of vosaroxin to cytarabine improves overall survival and complete remission rates in patients with relapsed, refractory acute myeloid leukemia. This combination is not associated with increased early mortality. Patients at least age 60 years seemed to benefit more than younger patients.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Erelapse\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Erefractory\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eacute myeloid leukemia\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecombination treatment\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eoverall survival\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group drug\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Evosaroxin\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecytarabine\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EStudy of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia (AML)\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EVALOR\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENCT01191801\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\u003Cp id=\u0022p-2\u0022\u003ENew safe and effective treatments are urgently needed for patients with relapsed or refractory (RR) acute myeloid leukemia (AML). Vosaroxin, a first-in-class anticancer quinolone derivative, plus cytarabine has been previously investigated in a phase 1\/2 trial in patients (n\u2009=\u200969) with first relapsed or primary refractory AML [Lancet JE et al. \u003Cem\u003EHaematologica\u003C\/em\u003E. 2014]. Median overall survival (OS) was 6.9 months, the complete remission (CR) rate was 25%, the median leukemia-free survival (LFS) was 25.2 months, and 60-day all-cause mortality was 8.7%.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EFarhad Ravandi, MD, University of Texas MD Anderson Cancer Center, Houston, Texas, USA, presented results of the Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia [VALOR; Ravandi F et al. ASH 2014 (abstr LBA-6)]. VALOR was a phase 3, double-blind, randomized, placebo-controlled study. Patients with first RR AML were randomly assigned to vosaroxin (n\u2009=\u2009356) 90 mg\/m\u003Csup\u003E2\u003C\/sup\u003E days 1 and 4 of the first cycle and 70 mg\/m\u003Csup\u003E2\u003C\/sup\u003E for the second cycle plus cytarabine 1 g\/m\u003Csup\u003E2\u003C\/sup\u003E days 1 through 5 or to placebo (n\u2009=\u2009355) days 1 and 4 plus cytarabine for 1 to 2 cycles of induction.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EIf the response was CR or complete remission with incomplete platelet recovery (CRp) patients received consolidation with 1 to 2 cycles. For complete remission with insufficient hematologic recovery (CRi), partial remission (PR), or treatment failure, there was no further treatment. The primary end point was OS; secondary end points were CR, safety, and tolerability. Tertiary end points included CR\u2009+\u2009CRp\u2009+\u2009CRi, event-free survival (EFS), LFS, and stem cell transplant (SCT) rate.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EPatients in both groups were well matched for characteristics. The median age was 63 years; 42% had refractory AML, 36% were in early relapse, and 22% were in late relapse.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EOS was 7.5 months for the combination vs 6.1 months for cytarabine monotherapy (\u003Cem\u003EP\u003C\/em\u003E\u2009=\u2009.06; HR 0.87; 95% CI, 0.73 to 1.02); by stratified log-rank analysis \u003Cem\u003EP\u003C\/em\u003E\u2009=\u2009.02. CR rates are shown in \u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E, and rates of CR\u2009+\u2009CRp\u2009+\u2009CRi are shown in \u003Ca id=\u0022xref-table-wrap-2-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T2\u0022\u003ETable 2\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\/11640\/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\/11640\/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\/11640\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-7\u0022 class=\u0022first-child\u0022\u003EComplete Remission Rates\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\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\/11559\/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\/11559\/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\/11559\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 \u003Cp id=\u0022p-8\u0022 class=\u0022first-child\u0022\u003ERates of CR\u2009+\u2009CRp\u2009+\u2009CRi\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-10\u0022\u003EOverall, 30.1% of patients in the combination group had allogeneic SCT vs 29% in the placebo group. The percentages of patients aged \u0026lt;\u200960 years receiving SCT were higher (46.2% vs 45.4% for the combination and control arms, respectively) than those of patients aged \u2265\u200960 years (20.8% vs 19.6% for the combination and control arms, respectively). A higher proportion of patients in the vosaroxin arm underwent an allogeneic SCT after achieving CR on the initial prescribed therapy. In a preplanned analysis of OS censored for allogeneic SCT, OS in the vosaroxin arm was a median 6.7 months vs 5.3 months in the placebo arm (HR, 0.83; \u003Cem\u003EP\u003C\/em\u003E\u2009=\u2009.02). In an analysis of OS by subgroup, the vosaroxin combination was favored in patients aged \u2265\u200960 years and with early relapse. EFS was significantly better for patients treated with vosaroxin and cytarabine (\u003Cem\u003EP\u003C\/em\u003E\u2009\u0026lt;\u2009.0001). LFS was not significantly different between groups.\u003C\/p\u003E\u003Cp id=\u0022p-11\u0022\u003EThe clinical benefit of vosaroxin combination therapy may be underestimated in younger patients due to the high rate of SCT. All-cause mortality was similar for both groups at 30 and 60 days. The most common serious adverse events were febrile neutropenia, sepsis, pneumonia, bacteremia, and stomatitis, and were higher in the vosaroxin group but these did not translate to excess mortality. Serious and nonserious cardiac, renal, neurologic, and hepatic adverse events were comparable between treatment groups. Vosaroxin plus cytarabine provides patients with relapsed, refractory AML with a new option for salvage therapy.\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\/15.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?nzm2tp\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?nzm2tp\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}