AustralieFrV1, Main, Exploration, bibRecord, 003699

Multivariate and subgroup analyses of a randomized, multinational, phase 3 trial of decitabine vs treatment choice of supportive care or cytarabine in older patients with newly diagnosed acute myeloid leukemia and poor- or intermediate-risk cytogenetics

Identifieur interne : 003699 ( Main/Exploration ); précédent : 003698; suivant : 003700

Multivariate and subgroup analyses of a randomized, multinational, phase 3 trial of decitabine vs treatment choice of supportive care or cytarabine in older patients with newly diagnosed acute myeloid leukemia and poor- or intermediate-risk cytogenetics

Auteurs : Ji Mayer [République tchèque] ; Christopher Arthur [Australie] ; Jacques Delaunay [France] ; Grzegorz Mazur [Pologne] ; Xavier G. Thomas [France] ; Agnieszka Wierzbowska [Pologne] ; Farhad Ravandi [États-Unis] ; Erhan Berrak [États-Unis] ; Mark Jones [États-Unis] ; Yuhan Li [États-Unis] ; Hagop M. Kantarjian [États-Unis]

Source :

BMC Cancer [ 1471-2407 ] ; 2014.

RBID : PMC:3928608

Abstract

Background

Compared with younger patients, older adults with acute myeloid leukemia (AML) generally have poorer survival outcomes and less benefit from clinical trials. A recent phase 3 trial demonstrated a trend toward improved overall survival (OS) with decitabine, a hypomethylating agent, compared with treatment choice of either cytarabine or supportive care (7.7 months, 95% CI: 6.2–9.2 vs 5.0 months, 95% CI: 4.3–6.3, respectively) in older adults with newly diagnosed AML. The current analyses investigated prognostic factors for outcomes in this trial and examined OS and responses in prespecified subgroups.

Methods

A multivariate Cox proportional hazards model was used to investigate effects of demographic and baseline characteristics, including age, sex, cytogenetic risk, AML type, ECOG Performance Status, geographic region, bone marrow blasts, platelets, and white blood cells on OS, based on mature data. Similar analyses were conducted with a logistic regression model to predict response rates. Prespecified subgroup analyses were performed for OS and response rates, also using mature data.

Results

Patient characteristics that appeared to negatively influence OS included more advanced age (hazard ratio [HR] 1.560 for ≥75 vs <70 years; p = 0.0010), poorer performance status at baseline (HR 0.771 for 0 or 1 vs 2; p = 0.0321), poor cytogenetics (HR 0.699 for intermediate vs poor; p = 0.0010), higher bone marrow blast counts (HR 1.355 for >50% vs ≤50%; p = 0.0045), low baseline platelet counts (HR 0.775 for each additional 100 × 10⁹/L; p = 0.0015), and high white blood cell counts (HR 1.256 for each additional 25 × 10⁹/L; p = 0.0151). Regarding geographic regions, patients from Western Europe had the longest median OS. Response rates favored decitabine for all subgroups investigated, including patients ≥75 years (odds ratio 5.94, p = 0.0006).

Conclusion

Response to decitabine in AML is associated with known prognostic factors related to both patient demographics and disease characteristics.

Trial registration

ClinicalTrials.gov identifier NCT00260832

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3928608

DOI: 10.1186/1471-2407-14-69
PubMed: 24498872
PubMed Central: 3928608

Affiliations:

Australie, France, Pologne, République tchèque, États-Unis
Auvergne-Rhône-Alpes, Moravie, New Jersey, Pays de la Loire, Rhône-Alpes, Texas
Brno, Lyon, Nantes

Le document en format XML

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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Multivariate and subgroup analyses of a randomized, multinational, phase 3 trial of decitabine vs treatment choice of supportive care or cytarabine in older patients with newly diagnosed acute myeloid leukemia and poor- or intermediate-risk cytogenetics</title>
<author><name sortKey="Mayer, Ji" sort="Mayer, Ji" uniqKey="Mayer J" first="Ji" last="Mayer">Ji Mayer</name>
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<author><name sortKey="Arthur, Christopher" sort="Arthur, Christopher" uniqKey="Arthur C" first="Christopher" last="Arthur">Christopher Arthur</name>
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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="Mazur, Grzegorz" sort="Mazur, Grzegorz" uniqKey="Mazur G" first="Grzegorz" last="Mazur">Grzegorz Mazur</name>
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<country xml:lang="fr">Pologne</country>
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<wicri:noRegion>Wroclaw</wicri:noRegion>
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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>
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<author><name sortKey="Wierzbowska, Agnieszka" sort="Wierzbowska, Agnieszka" uniqKey="Wierzbowska A" first="Agnieszka" last="Wierzbowska">Agnieszka Wierzbowska</name>
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<wicri:noRegion>Lodz</wicri:noRegion>
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<author><name sortKey="Ravandi, Farhad" sort="Ravandi, Farhad" uniqKey="Ravandi F" first="Farhad" last="Ravandi">Farhad Ravandi</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>The University of Texas MD Anderson Cancer Center, Houston, TX</wicri:regionArea>
<placeName><region type="state">Texas</region>
</placeName>
</affiliation>
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<author><name sortKey="Berrak, Erhan" sort="Berrak, Erhan" uniqKey="Berrak E" first="Erhan" last="Berrak">Erhan Berrak</name>
<affiliation wicri:level="2"><nlm:aff id="I8">Eisai Inc., Woodcliff Lake, NJ, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Eisai Inc., Woodcliff Lake, NJ</wicri:regionArea>
<placeName><region type="state">New Jersey</region>
</placeName>
</affiliation>
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<author><name sortKey="Jones, Mark" sort="Jones, Mark" uniqKey="Jones M" first="Mark" last="Jones">Mark Jones</name>
<affiliation wicri:level="2"><nlm:aff id="I8">Eisai Inc., Woodcliff Lake, NJ, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Eisai Inc., Woodcliff Lake, NJ</wicri:regionArea>
<placeName><region type="state">New Jersey</region>
</placeName>
</affiliation>
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<author><name sortKey="Li, Yuhan" sort="Li, Yuhan" uniqKey="Li Y" first="Yuhan" last="Li">Yuhan Li</name>
<affiliation wicri:level="2"><nlm:aff id="I8">Eisai Inc., Woodcliff Lake, NJ, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Eisai Inc., Woodcliff Lake, NJ</wicri:regionArea>
<placeName><region type="state">New Jersey</region>
</placeName>
</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 wicri:level="2"><nlm:aff id="I7">The University of Texas MD Anderson Cancer Center, Houston, TX, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>The University of Texas MD Anderson Cancer Center, Houston, TX</wicri:regionArea>
<placeName><region type="state">Texas</region>
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<series><title level="j">BMC Cancer</title>
<idno type="eISSN">1471-2407</idno>
<imprint><date when="2014">2014</date>
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<front><div type="abstract" xml:lang="en"><sec><title>Background</title>
<p>Compared with younger patients, older adults with acute myeloid leukemia (AML) generally have poorer survival outcomes and less benefit from clinical trials. A recent phase 3 trial demonstrated a trend toward improved overall survival (OS) with decitabine, a hypomethylating agent, compared with treatment choice of either cytarabine or supportive care (7.7 months, 95% CI: 6.2–9.2 vs 5.0 months, 95% CI: 4.3–6.3, respectively) in older adults with newly diagnosed AML. The current analyses investigated prognostic factors for outcomes in this trial and examined OS and responses in prespecified subgroups.</p>
</sec>
<sec><title>Methods</title>
<p>A multivariate Cox proportional hazards model was used to investigate effects of demographic and baseline characteristics, including age, sex, cytogenetic risk, AML type, ECOG Performance Status, geographic region, bone marrow blasts, platelets, and white blood cells on OS, based on mature data. Similar analyses were conducted with a logistic regression model to predict response rates. Prespecified subgroup analyses were performed for OS and response rates, also using mature data.</p>
</sec>
<sec><title>Results</title>
<p>Patient characteristics that appeared to negatively influence OS included more advanced age (hazard ratio [HR] 1.560 for ≥75 vs <70 years; p = 0.0010), poorer performance status at baseline (HR 0.771 for 0 or 1 vs 2; p = 0.0321), poor cytogenetics (HR 0.699 for intermediate vs poor; p = 0.0010), higher bone marrow blast counts (HR 1.355 for >50% vs ≤50%; p = 0.0045), low baseline platelet counts (HR 0.775 for each additional 100 × 10<sup>9</sup>
/L; p = 0.0015), and high white blood cell counts (HR 1.256 for each additional 25 × 10<sup>9</sup>
/L; p = 0.0151). Regarding geographic regions, patients from Western Europe had the longest median OS. Response rates favored decitabine for all subgroups investigated, including patients ≥75 years (odds ratio 5.94, p = 0.0006).</p>
</sec>
<sec><title>Conclusion</title>
<p>Response to decitabine in AML is associated with known prognostic factors related to both patient demographics and disease characteristics.</p>
</sec>
<sec><title>Trial registration</title>
<p>ClinicalTrials.gov identifier <ext-link ext-link-type="uri" xlink:href="http://clinicaltrials.gov/show/NCT00260832">NCT00260832</ext-link>
</p>
</sec>
</div>
</front>
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<author><name sortKey="Kopecky, Kj" uniqKey="Kopecky K">KJ Kopecky</name>
</author>
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<author><name sortKey="Hellstrom Lindberg, E" uniqKey="Hellstrom Lindberg E">E Hellstrom-Lindberg</name>
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<author><name sortKey="Santini, V" uniqKey="Santini V">V Santini</name>
</author>
<author><name sortKey="Gattermann, N" uniqKey="Gattermann N">N Gattermann</name>
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<author><name sortKey="List, Af" uniqKey="List A">AF List</name>
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<author><name sortKey="Gore, S" uniqKey="Gore S">S Gore</name>
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<affiliations><list><country><li>Australie</li>
<li>France</li>
<li>Pologne</li>
<li>République tchèque</li>
<li>États-Unis</li>
</country>
<region><li>Auvergne-Rhône-Alpes</li>
<li>Moravie</li>
<li>New Jersey</li>
<li>Pays de la Loire</li>
<li>Rhône-Alpes</li>
<li>Texas</li>
</region>
<settlement><li>Brno</li>
<li>Lyon</li>
<li>Nantes</li>
</settlement>
</list>
<tree><country name="République tchèque"><region name="Moravie"><name sortKey="Mayer, Ji" sort="Mayer, Ji" uniqKey="Mayer J" first="Ji" last="Mayer">Ji Mayer</name>
</region>
</country>
<country name="Australie"><noRegion><name sortKey="Arthur, Christopher" sort="Arthur, Christopher" uniqKey="Arthur C" first="Christopher" last="Arthur">Christopher Arthur</name>
</noRegion>
</country>
<country name="France"><region name="Pays de la Loire"><name sortKey="Delaunay, Jacques" sort="Delaunay, Jacques" uniqKey="Delaunay J" first="Jacques" last="Delaunay">Jacques Delaunay</name>
</region>
<name sortKey="Thomas, Xavier G" sort="Thomas, Xavier G" uniqKey="Thomas X" first="Xavier G" last="Thomas">Xavier G. Thomas</name>
<name sortKey="Thomas, Xavier G" sort="Thomas, Xavier G" uniqKey="Thomas X" first="Xavier G" last="Thomas">Xavier G. Thomas</name>
</country>
<country name="Pologne"><noRegion><name sortKey="Mazur, Grzegorz" sort="Mazur, Grzegorz" uniqKey="Mazur G" first="Grzegorz" last="Mazur">Grzegorz Mazur</name>
</noRegion>
<name sortKey="Wierzbowska, Agnieszka" sort="Wierzbowska, Agnieszka" uniqKey="Wierzbowska A" first="Agnieszka" last="Wierzbowska">Agnieszka Wierzbowska</name>
</country>
<country name="États-Unis"><region name="Texas"><name sortKey="Ravandi, Farhad" sort="Ravandi, Farhad" uniqKey="Ravandi F" first="Farhad" last="Ravandi">Farhad Ravandi</name>
</region>
<name sortKey="Berrak, Erhan" sort="Berrak, Erhan" uniqKey="Berrak E" first="Erhan" last="Berrak">Erhan Berrak</name>
<name sortKey="Jones, Mark" sort="Jones, Mark" uniqKey="Jones M" first="Mark" last="Jones">Mark Jones</name>
<name sortKey="Kantarjian, Hagop M" sort="Kantarjian, Hagop M" uniqKey="Kantarjian H" first="Hagop M" last="Kantarjian">Hagop M. Kantarjian</name>
<name sortKey="Li, Yuhan" sort="Li, Yuhan" uniqKey="Li Y" first="Yuhan" last="Li">Yuhan Li</name>
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</record>

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   |texte=   Multivariate and subgroup analyses of a randomized, multinational, phase 3 trial of decitabine vs treatment choice of supportive care or cytarabine in older patients with newly diagnosed acute myeloid leukemia and poor- or intermediate-risk cytogenetics
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Serveur d'exploration sur les relations entre la France et l'Australie

Multivariate and subgroup analyses of a randomized, multinational, phase 3 trial of decitabine vs treatment choice of supportive care or cytarabine in older patients with newly diagnosed acute myeloid leukemia and poor- or intermediate-risk cytogenetics

Multivariate and subgroup analyses of a randomized, multinational, phase 3 trial of decitabine vs treatment choice of supportive care or cytarabine in older patients with newly diagnosed acute myeloid leukemia and poor- or intermediate-risk cytogenetics

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