Effects of azacitidine compared with conventional care regimens in elderly (≥75 years) patients with higher-risk myelodysplastic syndromes☆
Identifieur interne : 001F15 ( Pmc/Curation ); précédent : 001F14; suivant : 001F16Effects of azacitidine compared with conventional care regimens in elderly (≥75 years) patients with higher-risk myelodysplastic syndromes☆
Auteurs : John F. Seymour [Australie] ; Pierre Fenaux [France] ; Lewis R. Silverman [États-Unis] ; Ghulam J. Mufti [Royaume-Uni] ; Eva Hellström-Lindberg [Suède] ; Valeria Santini [Italie] ; Alan F. List [États-Unis] ; Steven D. Gore [États-Unis] ; Jay Backstrom [États-Unis] ; David Mckenzie [États-Unis] ; C. L. Beach [États-Unis]Source :
- Critical reviews in oncology/hematology [ 1040-8428 ] ; 2010.
Abstract
This analysis compared azacitidine (AZA) to conventional care regimens (CCR) and their associated overall survival (OS) and tolerability in the subset of 87 elderly (≥75 years) patients with higher-risk MDS (FAB: RAEB, RAEB-t, CMML and IPSS: Int-2 or High) from the AZA-001 trial. Patients were randomized to AZA (75 mg/m2/day subcutaneously×7 days every 28 days) (
Url:
DOI: 10.1016/j.critrevonc.2010.04.005
PubMed: 20451404
PubMed Central: 4000027
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<series><title level="j">Critical reviews in oncology/hematology</title>
<idno type="ISSN">1040-8428</idno>
<idno type="eISSN">1879-0461</idno>
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<front><div type="abstract" xml:lang="en"><p id="P1">This analysis compared azacitidine (AZA) to conventional care regimens (CCR) and their associated overall survival (OS) and tolerability in the subset of 87 elderly (≥75 years) patients with higher-risk MDS (FAB: RAEB, RAEB-t, CMML and IPSS: Int-2 or High) from the AZA-001 trial. Patients were randomized to AZA (75 mg/m<sup>2</sup>
/day subcutaneously×7 days every 28 days) (<italic>n</italic>
= 38) or CCR (<italic>n</italic>
= 49) and had median ages of 78 and 77 years, respectively. AZA significantly improved OS vs CCR (HR: 0.48 [95%CI: 0.26, 0.89]; <italic>p</italic>
= 0.0193) and 2-year OS rates were 55% vs 15% (<italic>p</italic>
< 0.001), respectively. AZA was generally well tolerated compared with CCR, which was primarily best supportive care (67%). Grade 3–4 anemia, neutropenia, and thrombocytopenia with AZA vs CCR were 13% vs 4%, 61% vs 17%, and 50% vs 30%, respectively. Given this efficacy and tolerability, AZA should be considered the treatment of choice in patients aged ≥75 years with good performance status and higher-risk MDS.</p>
</div>
</front>
</TEI>
<pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<pmc-dir>properties manuscript</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-journal-id">8916049</journal-id>
<journal-id journal-id-type="pubmed-jr-id">1454</journal-id>
<journal-id journal-id-type="nlm-ta">Crit Rev Oncol Hematol</journal-id>
<journal-id journal-id-type="iso-abbrev">Crit. Rev. Oncol. Hematol.</journal-id>
<journal-title-group><journal-title>Critical reviews in oncology/hematology</journal-title>
</journal-title-group>
<issn pub-type="ppub">1040-8428</issn>
<issn pub-type="epub">1879-0461</issn>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">20451404</article-id>
<article-id pub-id-type="pmc">4000027</article-id>
<article-id pub-id-type="doi">10.1016/j.critrevonc.2010.04.005</article-id>
<article-id pub-id-type="manuscript">NIHMS490287</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Article</subject>
</subj-group>
</article-categories>
<title-group><article-title>Effects of azacitidine compared with conventional care regimens in elderly (≥75 years) patients with higher-risk myelodysplastic syndromes<xref ref-type="fn" rid="FN1">☆</xref>
</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Seymour</surname>
<given-names>John F.</given-names>
</name>
<xref ref-type="aff" rid="A1">a</xref>
<xref ref-type="corresp" rid="cor1">*</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Fenaux</surname>
<given-names>Pierre</given-names>
</name>
<xref ref-type="aff" rid="A2">b</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Silverman</surname>
<given-names>Lewis R.</given-names>
</name>
<xref ref-type="aff" rid="A3">c</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Mufti</surname>
<given-names>Ghulam J.</given-names>
</name>
<xref ref-type="aff" rid="A4">d</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Hellström-Lindberg</surname>
<given-names>Eva</given-names>
</name>
<xref ref-type="aff" rid="A5">e</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Santini</surname>
<given-names>Valeria</given-names>
</name>
<xref ref-type="aff" rid="A6">f</xref>
</contrib>
<contrib contrib-type="author"><name><surname>List</surname>
<given-names>Alan F.</given-names>
</name>
<xref ref-type="aff" rid="A7">g</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Gore</surname>
<given-names>Steven D.</given-names>
</name>
<xref ref-type="aff" rid="A8">h</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Backstrom</surname>
<given-names>Jay</given-names>
</name>
<xref ref-type="aff" rid="A9">i</xref>
</contrib>
<contrib contrib-type="author"><name><surname>McKenzie</surname>
<given-names>David</given-names>
</name>
<xref ref-type="aff" rid="A9">i</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Beach</surname>
<given-names>C.L.</given-names>
</name>
<xref ref-type="aff" rid="A9">i</xref>
</contrib>
</contrib-group>
<aff id="A1"><label>a</label>
Peter MacCallum Cancer Centre and University of Melbourne, Victoria 3002, Australia</aff>
<aff id="A2"><label>b</label>
Hôpital Avicenne, Assistance Publique-Hôpitaux de Paris (AP-HP) and Paris 13 University, France</aff>
<aff id="A3"><label>c</label>
Mount Sinai School of Medicine, New York, NY, USA</aff>
<aff id="A4"><label>d</label>
Department of Haematological Medicine, Kings College London, Denmark Hill, London, UK</aff>
<aff id="A5"><label>e</label>
Karolinska University Hospital, Stockholm, Sweden</aff>
<aff id="A6"><label>f</label>
Hematology, Azienda Ospedaliera Careggi, Firenze, Italy</aff>
<aff id="A7"><label>g</label>
H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA</aff>
<aff id="A8"><label>h</label>
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA</aff>
<aff id="A9"><label>i</label>
Celgene Corporation, Summit, NJ, USA</aff>
<author-notes><corresp id="cor1"><label>*</label>
Corresponding author. Tel.: +61 3 9656 1076; fax: +61 3 9656 1408. <email>john.seymour@petermac.org</email>
(J.F. Seymour)</corresp>
</author-notes>
<pub-date pub-type="nihms-submitted"><day>10</day>
<month>7</month>
<year>2013</year>
</pub-date>
<pub-date pub-type="epub"><day>06</day>
<month>5</month>
<year>2010</year>
</pub-date>
<pub-date pub-type="ppub"><month>12</month>
<year>2010</year>
</pub-date>
<pub-date pub-type="pmc-release"><day>25</day>
<month>4</month>
<year>2014</year>
</pub-date>
<volume>76</volume>
<issue>3</issue>
<fpage>218</fpage>
<lpage>227</lpage>
<pmc-comment>elocation-id from pubmed: 10.1016/j.critrevonc.2010.04.005</pmc-comment>
<permissions><copyright-statement>© 2010 Elsevier Ireland Ltd. All rights reserved.</copyright-statement>
<copyright-year>2010</copyright-year>
</permissions>
<abstract><p id="P1">This analysis compared azacitidine (AZA) to conventional care regimens (CCR) and their associated overall survival (OS) and tolerability in the subset of 87 elderly (≥75 years) patients with higher-risk MDS (FAB: RAEB, RAEB-t, CMML and IPSS: Int-2 or High) from the AZA-001 trial. Patients were randomized to AZA (75 mg/m<sup>2</sup>
/day subcutaneously×7 days every 28 days) (<italic>n</italic>
= 38) or CCR (<italic>n</italic>
= 49) and had median ages of 78 and 77 years, respectively. AZA significantly improved OS vs CCR (HR: 0.48 [95%CI: 0.26, 0.89]; <italic>p</italic>
= 0.0193) and 2-year OS rates were 55% vs 15% (<italic>p</italic>
< 0.001), respectively. AZA was generally well tolerated compared with CCR, which was primarily best supportive care (67%). Grade 3–4 anemia, neutropenia, and thrombocytopenia with AZA vs CCR were 13% vs 4%, 61% vs 17%, and 50% vs 30%, respectively. Given this efficacy and tolerability, AZA should be considered the treatment of choice in patients aged ≥75 years with good performance status and higher-risk MDS.</p>
</abstract>
<kwd-group><kwd>Azacitidine</kwd>
<kwd>Low-dose ara-C</kwd>
<kwd>Elderly</kwd>
<kwd>Myelodysplastic syndromes</kwd>
<kwd>MDS</kwd>
<kwd>Acute myeloid leukemia</kwd>
<kwd>AML</kwd>
<kwd>Survival</kwd>
</kwd-group>
</article-meta>
</front>
</pmc>
</record>
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