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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\u003ENew data from the RICMAC trial showed similar rates of non-relapse mortality, incidence of relapse, and relapse-free survival in patients with myelodysplastic syndrome or secondary acute myeloid leukemia after conditioning with reduced-dose busulfan plus fludarabine vs standard-dose busulfan plus cyclophosphamide prior to allogeneic stem cell transplantation. Overall survival was higher with the reduced dose, but results were not statistically significant.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Eallogenic stem cell transplantation\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Emyelodysplastic syndrome\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Esecondary acute myeloid leukemia\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Enonrelapse mortality\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Erelapse\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group drug\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Ebusalfan\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecyclophosphamide\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Efludarabine\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EDose-Reduced Versus Standard Conditioning in MDS\/sAML\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERICMAC\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENCT01203228\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\u003Cp id=\u0022p-2\u0022\u003EReduced-dose conditioning prior to allogenic stem cell transplantation (ASCT) in patients with myelodysplastic syndrome (MDS) or secondary acute myeloid leukemia (sAML) resulted in similar outcomes including nonrelapse mortality, incidence of relapse, and relapse-free survival compared with standard-dose conditioning. Nicolaus Kr\u00f6ger, MD, University Cancer Center Hamburg, Hamburg, Germany, presented data from the Dose-Reduced Versus Standard Conditioning in MDS\/sAML trial [RICMAC; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01203228\u0026amp;atom=%2Fspmdc%2F14%2F55%2F20.atom\u0022\u003ENCT01203228\u003C\/a\u003E].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003ECurrently, the most effective, potentially curative, treatment for MDS is ASCT. In favor of reducing toxicity, dose-reduced conditioning is being increasingly used; however, some retrospective data suggest that dose-reduced conditioning may lead to higher rates of relapse. The purpose of the RICMAC trial was to evaluate the effect of reduced-dose conditioning on the outcomes of patients with MDS or sAML after ASCT.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EIn the prospective, open-label, phase 3 RICMAC trial, patients (n\u003Cem\u003E\u2009\u003C\/em\u003E=\u003Cem\u003E\u2009\u003C\/em\u003E129) with MDS or sAML were randomly assigned to receive standard-dose busulfan (12.8 mg\/kg ideal body weight [IBW] intravenously [IV] or 16 mg\/kg body weight [BW] orally) plus cyclophosphamide (120 mg\/kg BW IV) or reduced-dose busulfan (6.4 mg\/kg IBW IV or 8 mg\/kg BW orally) plus fludarabine (5 \u00d7 30 mg\/m\u003Csup\u003E2\u003C\/sup\u003E IV). Patients were considered to have cytologically proven MDS based on refractory anemia or refractory anemia with ring sideroblasts, excess blasts, or excess of blast in transformation. Patients with chronic myelomonocytic leukemia and sAML were also included. All patients had a blast count \u0026lt;\u003Cem\u003E\u2009\u003C\/em\u003E20% regardless of chemotherapy at the time of ASCT. Other eligibility criteria included human leukocyte antigen (HLA)\u2013matched related donors aged 18 to 65 years or unrelated donors aged 18 to 60 years and no major organ dysfunction. One HLA antigen mismatch was also allowed. Patients were excluded if there was central nervous system involvement, a life expectancy \u0026lt;\u003Cem\u003E\u2009\u003C\/em\u003E6 months owing to comorbidities, serious psychiatric or psychological disorder, pregnancy or lactation, or positive serology for HIV.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe primary end point of the study was nonrelapse mortality at 1 year after ASCT. Secondary end points included incidence of acute and chronic graft-vs-host disease, overall survival (OS) at 2 years, event-free survival at 2 years, and incidence of relapse at 2 years. Slow recruitment led to early termination of the study.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThere was no significant difference in nonrelapse mortality at 24 months (\u003Cem\u003EP\u2009\u003C\/em\u003E=\u003Cem\u003E\u2009\u003C\/em\u003E.17). Similarly, there was no significant difference in relapse incidence or relapse-free survival in both arms. There was a higher percentage in survival in the reduced-dose arm compared with the standard-dose arm, but results did not achieve significance (\u003Cem\u003EP\u2009\u003C\/em\u003E=\u003Cem\u003E\u2009\u003C\/em\u003E.06).\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EIn a subanalysis, patients aged \u0026gt;\u003Cem\u003E\u2009\u003C\/em\u003E51 years had significantly lower rates of relapse-free survival compared with younger patients (HR, 1.93; \u003Cem\u003EP\u2009\u003C\/em\u003E=\u003Cem\u003E\u2009\u003C\/em\u003E.03). In addition, prior chemotherapy increased the risk of relapse (HR, 3.36; \u003Cem\u003EP\u2009\u003C\/em\u003E=\u003Cem\u003E\u2009\u003C\/em\u003E.01) and OS was significantly lower in patients with a performance status of 1 to 3 compared with 0 (HR, 2.58; \u003Cem\u003EP\u2009\u003C\/em\u003E=\u2009.04). Interestingly, patients with a low cytogenetic risk who receive reduced-dose conditioning had significantly higher rates of OS compared with patients who received standard-dose conditioning (HR, 0.14; \u003Cem\u003EP\u2009\u003C\/em\u003E=\u003Cem\u003E\u2009\u003C\/em\u003E.002). However, there was no benefit in patients with intermediate risk and patients with high risk demonstrated greater rates of OS when treated with standard-dose conditioning (HR, 1.70; \u003Cem\u003EP\u2009\u003C\/em\u003E=\u003Cem\u003E\u2009\u003C\/em\u003E.39).\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EIn conclusion, Dr Kr\u00f6ger indicated that the data from the RICMAC trial suggest that reduced-dose conditioning results in similar outcomes as standard-dose conditioning; however, he indicated that a longer follow-up period is required to confirm these results.\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\/20.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?nzoa82\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}