A post hoc sensitivity analysis of survival probabilities in a multinational phase III trial of decitabine in older patients with newly diagnosed acute myeloid leukemia.
Identifieur interne : 003974 ( PubMed/Corpus ); précédent : 003973; suivant : 003975A post hoc sensitivity analysis of survival probabilities in a multinational phase III trial of decitabine in older patients with newly diagnosed acute myeloid leukemia.
Auteurs : Xavier G. Thomas ; Christopher Arthur ; Jacques Delaunay ; Mark Jones ; Erhan Berrak ; Hagop M. KantarjianSource :
- Clinical lymphoma, myeloma & leukemia [ 2152-2669 ] ; 2014.
English descriptors
- KwdEn :
- Aged, Aged, 80 and over, Antimetabolites, Antineoplastic (therapeutic use), Azacitidine (analogs & derivatives), Azacitidine (therapeutic use), Drug Administration Schedule, Female, Humans, Leukemia, Myeloid, Acute (drug therapy), Leukemia, Myeloid, Acute (pathology), Male, Middle Aged, Prognosis, Treatment Outcome.
- MESH :
- chemical , analogs & derivatives : Azacitidine.
- chemical , therapeutic use : Antimetabolites, Antineoplastic, Azacitidine.
- drug therapy : Leukemia, Myeloid, Acute.
- pathology : Leukemia, Myeloid, Acute.
- Aged, Aged, 80 and over, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Prognosis, Treatment Outcome.
Abstract
In a multicenter, randomized, open-label phase III study, patients ≥ 65 years with newly diagnosed AML received decitabine 20 mg/m(2) once daily for 5 days every 4 weeks (n = 242) or treatment choice (supportive care or cytarabine 20 mg/m(2) once daily for 10 days every 4 weeks; n = 243). Decitabine use demonstrated greater response rates (P = .001) and OS data favored decitabine.
DOI: 10.1016/j.clml.2013.09.007
PubMed: 24220616
Links to Exploration step
pubmed:24220616Le document en format XML
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<author><name sortKey="Thomas, Xavier G" sort="Thomas, Xavier G" uniqKey="Thomas X" first="Xavier G" last="Thomas">Xavier G. Thomas</name>
<affiliation><nlm:affiliation>Department of Haematology, Lyon-Sud Hospital, Lyon, France. Electronic address: xavier.thomas@chu-lyon.fr.</nlm:affiliation>
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<author><name sortKey="Arthur, Christopher" sort="Arthur, Christopher" uniqKey="Arthur C" first="Christopher" last="Arthur">Christopher Arthur</name>
<affiliation><nlm:affiliation>Department of Haematology, Royal North Shore Hospital, St Leonards, New South Wales, Australia.</nlm:affiliation>
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<author><name sortKey="Delaunay, Jacques" sort="Delaunay, Jacques" uniqKey="Delaunay J" first="Jacques" last="Delaunay">Jacques Delaunay</name>
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<author><name sortKey="Berrak, Erhan" sort="Berrak, Erhan" uniqKey="Berrak E" first="Erhan" last="Berrak">Erhan Berrak</name>
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<author><name sortKey="Kantarjian, Hagop M" sort="Kantarjian, Hagop M" uniqKey="Kantarjian H" first="Hagop M" last="Kantarjian">Hagop M. Kantarjian</name>
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<series><title level="j">Clinical lymphoma, myeloma & leukemia</title>
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<term>Azacitidine (analogs & derivatives)</term>
<term>Azacitidine (therapeutic use)</term>
<term>Drug Administration Schedule</term>
<term>Female</term>
<term>Humans</term>
<term>Leukemia, Myeloid, Acute (drug therapy)</term>
<term>Leukemia, Myeloid, Acute (pathology)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Prognosis</term>
<term>Treatment Outcome</term>
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<front><div type="abstract" xml:lang="en">In a multicenter, randomized, open-label phase III study, patients ≥ 65 years with newly diagnosed AML received decitabine 20 mg/m(2) once daily for 5 days every 4 weeks (n = 242) or treatment choice (supportive care or cytarabine 20 mg/m(2) once daily for 10 days every 4 weeks; n = 243). Decitabine use demonstrated greater response rates (P = .001) and OS data favored decitabine.</div>
</front>
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<DateCreated><Year>2014</Year>
<Month>01</Month>
<Day>27</Day>
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<DateCompleted><Year>2014</Year>
<Month>10</Month>
<Day>31</Day>
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<DateRevised><Year>2017</Year>
<Month>09</Month>
<Day>30</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">2152-2669</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>14</Volume>
<Issue>1</Issue>
<PubDate><Year>2014</Year>
<Month>Feb</Month>
</PubDate>
</JournalIssue>
<Title>Clinical lymphoma, myeloma & leukemia</Title>
<ISOAbbreviation>Clin Lymphoma Myeloma Leuk</ISOAbbreviation>
</Journal>
<ArticleTitle>A post hoc sensitivity analysis of survival probabilities in a multinational phase III trial of decitabine in older patients with newly diagnosed acute myeloid leukemia.</ArticleTitle>
<Pagination><MedlinePgn>68-72</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.clml.2013.09.007</ELocationID>
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<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">In a multicenter, randomized, open-label phase III study, patients ≥ 65 years with newly diagnosed AML received decitabine 20 mg/m(2) once daily for 5 days every 4 weeks (n = 242) or treatment choice (supportive care or cytarabine 20 mg/m(2) once daily for 10 days every 4 weeks; n = 243). Decitabine use demonstrated greater response rates (P = .001) and OS data favored decitabine.</AbstractText>
<AbstractText Label="PATIENTS AND METHODS" NlmCategory="METHODS">In a post hoc sensitivity analysis of mature data of patients in the intent-to-treat population (N = 485), OS at 3, 6, 12, 18, and 24 months after randomization was estimated for each arm using Kaplan-Meier methods. Age, cytogenetic risk, and Eastern Cooperative Oncology Group performance status were used as stratification factors in the Cox regression model to estimate the hazard ratio.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">A survival advantage was seen with decitabine at each cutoff time point; hazard ratios for OS for decitabine vs. treatment choice were 0.83, 0.71, 0.83, 0.80, and 0.79 at 3, 6, 12, 18, and 24 months, respectively. A trend toward improved OS with decitabine was observed at fixed time points over 2 years.</AbstractText>
<AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">Decitabine should be considered as a treatment option for older patients with AML and poor prognostic risk factors.</AbstractText>
<CopyrightInformation>Copyright © 2014 Elsevier Inc. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Thomas</LastName>
<ForeName>Xavier G</ForeName>
<Initials>XG</Initials>
<AffiliationInfo><Affiliation>Department of Haematology, Lyon-Sud Hospital, Lyon, France. Electronic address: xavier.thomas@chu-lyon.fr.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Arthur</LastName>
<ForeName>Christopher</ForeName>
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<AffiliationInfo><Affiliation>Department of Haematology, Royal North Shore Hospital, St Leonards, New South Wales, Australia.</Affiliation>
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<Author ValidYN="Y"><LastName>Kantarjian</LastName>
<ForeName>Hagop M</ForeName>
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<AffiliationInfo><Affiliation>Department of Leukemia, The University of Texas M.D. Anderson Cancer Center, Houston, TX.</Affiliation>
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<Keyword MajorTopicYN="N">Chemotherapy</Keyword>
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