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
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">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.</title><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></affiliation></author><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></affiliation></author><author><name sortKey="Delaunay, Jacques" sort="Delaunay, Jacques" uniqKey="Delaunay J" first="Jacques" last="Delaunay">Jacques Delaunay</name><affiliation><nlm:affiliation>Department of Haematology, Nantes University Hospital, Nantes, France.</nlm:affiliation></affiliation></author><author><name sortKey="Jones, Mark" sort="Jones, Mark" uniqKey="Jones M" first="Mark" last="Jones">Mark Jones</name><affiliation><nlm:affiliation>Department of Oncology, Eisai Inc, Woodcliff Lake, NJ.</nlm:affiliation></affiliation></author><author><name sortKey="Berrak, Erhan" sort="Berrak, Erhan" uniqKey="Berrak E" first="Erhan" last="Berrak">Erhan Berrak</name><affiliation><nlm:affiliation>Department of Oncology, Eisai Inc, Woodcliff Lake, NJ.</nlm:affiliation></affiliation></author><author><name sortKey="Kantarjian, Hagop M" sort="Kantarjian, Hagop M" uniqKey="Kantarjian H" first="Hagop M" last="Kantarjian">Hagop M. Kantarjian</name><affiliation><nlm:affiliation>Department of Leukemia, The University of Texas M.D. Anderson Cancer Center, Houston, TX.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2014">2014</date><idno type="RBID">pubmed:24220616</idno><idno type="pmid">24220616</idno><idno type="doi">10.1016/j.clml.2013.09.007</idno><idno type="wicri:Area/PubMed/Corpus">003974</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">003974</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">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.</title><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></affiliation></author><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></affiliation></author><author><name sortKey="Delaunay, Jacques" sort="Delaunay, Jacques" uniqKey="Delaunay J" first="Jacques" last="Delaunay">Jacques Delaunay</name><affiliation><nlm:affiliation>Department of Haematology, Nantes University Hospital, Nantes, France.</nlm:affiliation></affiliation></author><author><name sortKey="Jones, Mark" sort="Jones, Mark" uniqKey="Jones M" first="Mark" last="Jones">Mark Jones</name><affiliation><nlm:affiliation>Department of Oncology, Eisai Inc, Woodcliff Lake, NJ.</nlm:affiliation></affiliation></author><author><name sortKey="Berrak, Erhan" sort="Berrak, Erhan" uniqKey="Berrak E" first="Erhan" last="Berrak">Erhan Berrak</name><affiliation><nlm:affiliation>Department of Oncology, Eisai Inc, Woodcliff Lake, NJ.</nlm:affiliation></affiliation></author><author><name sortKey="Kantarjian, Hagop M" sort="Kantarjian, Hagop M" uniqKey="Kantarjian H" first="Hagop M" last="Kantarjian">Hagop M. Kantarjian</name><affiliation><nlm:affiliation>Department of Leukemia, The University of Texas M.D. Anderson Cancer Center, Houston, TX.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Clinical lymphoma, myeloma & leukemia</title><idno type="eISSN">2152-2669</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Aged, 80 and over</term><term>Antimetabolites, Antineoplastic (therapeutic use)</term><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></keywords><keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en"><term>Azacitidine</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antimetabolites, Antineoplastic</term><term>Azacitidine</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Leukemia, Myeloid, Acute</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Leukemia, Myeloid, Acute</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Aged, 80 and over</term><term>Drug Administration Schedule</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Prognosis</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><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></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">24220616</PMID><DateCreated><Year>2014</Year><Month>01</Month><Day>27</Day></DateCreated><DateCompleted><Year>2014</Year><Month>10</Month><Day>31</Day></DateCompleted><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><ELocationID EIdType="pii" ValidYN="Y">S2152-2650(13)00428-X</ELocationID><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></Author><Author ValidYN="Y"><LastName>Arthur</LastName><ForeName>Christopher</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Department of Haematology, Royal North Shore Hospital, St Leonards, New South Wales, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Delaunay</LastName><ForeName>Jacques</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Haematology, Nantes University Hospital, Nantes, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jones</LastName><ForeName>Mark</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Oncology, Eisai Inc, Woodcliff Lake, NJ.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Berrak</LastName><ForeName>Erhan</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Department of Oncology, Eisai Inc, Woodcliff Lake, NJ.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kantarjian</LastName><ForeName>Hagop M</ForeName><Initials>HM</Initials><AffiliationInfo><Affiliation>Department of Leukemia, The University of Texas M.D. Anderson Cancer Center, Houston, TX.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2013</Year><Month>10</Month><Day>01</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Clin Lymphoma Myeloma Leuk</MedlineTA><NlmUniqueID>101525386</NlmUniqueID><ISSNLinking>2152-2669</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000964">Antimetabolites, Antineoplastic</NameOfSubstance></Chemical><Chemical><RegistryNumber>776B62CQ27</RegistryNumber><NameOfSubstance UI="C014347">decitabine</NameOfSubstance></Chemical><Chemical><RegistryNumber>M801H13NRU</RegistryNumber><NameOfSubstance UI="D001374">Azacitidine</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000964" MajorTopicYN="N">Antimetabolites, Antineoplastic</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D001374" MajorTopicYN="N">Azacitidine</DescriptorName><QualifierName UI="Q000031" MajorTopicYN="Y">analogs & derivatives</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004334" MajorTopicYN="N">Drug Administration Schedule</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015470" MajorTopicYN="N">Leukemia, Myeloid, Acute</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011379" MajorTopicYN="N">Prognosis</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Age factors</Keyword><Keyword MajorTopicYN="N">Chemotherapy</Keyword><Keyword MajorTopicYN="N">Cytarabine</Keyword><Keyword MajorTopicYN="N">Dacogen</Keyword><Keyword MajorTopicYN="N">Treatment outcome</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2013</Year><Month>06</Month><Day>14</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2013</Year><Month>09</Month><Day>11</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2013</Year><Month>09</Month><Day>24</Day></PubMedPubDate><PubMedPubDate 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