AustralieFrV1, Main, Exploration, bibRecord, 005A68

Multicenter, Randomized, Open-Label, Phase III Trial of Decitabine Versus Patient Choice, With Physician Advice, of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Identifieur interne : 005A68 ( Main/Exploration ); précédent : 005A67; suivant : 005A69

Multicenter, Randomized, Open-Label, Phase III Trial of Decitabine Versus Patient Choice, With Physician Advice, of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Auteurs : Hagop M. Kantarjian [États-Unis] ; Xavier G. Thomas [France] ; Anna Dmoszynska [Pologne] ; Agnieszka Wierzbowska [Pologne] ; Grzegorz Mazur [Pologne] ; Jiri Mayer [République tchèque] ; Jyh-Pyng Gau [Taïwan] ; Wen-Chien Chou [Taïwan] ; Rena Buckstein [Canada] ; Jaroslav Cermak [République tchèque] ; Ching-Yuan Kuo [Taïwan] ; Albert Oriol [Espagne] ; Farhad Ravandi [États-Unis] ; Stefan Faderl [États-Unis] ; Jacques Delaunay [France, Australie] ; Daniel Lysak [République tchèque] ; Mark Minden ; Christopher Arthur

Source :

Journal of clinical oncology [ 0732-183X ] ; 2012.

RBID : Pascal:12-0317309

Descripteurs français

Pascal (Inist)
- Essai clinique phase III, Etude multicentrique, Essai clinique, Décitabine, Randomisation, Etude comparative, Chimiothérapie, Homme, Choix, Soin de support, Médecin, Dose faible, Cytarabine, Age, Personne âgée, Stade précoce, Leucémie aiguë myéloblastique, Cancérologie, Anticancéreux, Antipyrimidique.
Wicri :
- topic : Homme, Médecin, Personne âgée.

English descriptors

KwdEn :
- Acute myelogenous leukemia, Age, Antineoplastic agent, Cancerology, Chemotherapy, Choice, Clinical trial, Comparative study, Cytarabine, Decitabine, Early stage, Elderly, Human, Low dose, Multicenter study, Phase III trial, Physician, Randomization, Supportive care.

Abstract

Purpose This multicenter, randomized, open-label, phase III trial compared the efficacy and safety of decitabine with treatment choice (TC) in older patients with newly diagnosed acute myeloid leukemia (AML) and poor- or intermediate-risk cytogenetics. Patients and Methods Patients (N = 485) age ≥ 65 years were randomly assigned 1:1 to receive decitabine 20 mg/m² per day as a 1-hour intravenous infusion for five consecutive days every 4 weeks or TC (supportive care or cytarabine 20 mg/m² per day as a subcutaneous injection for 10 consecutive days every 4 weeks). The primary end point was overall survival (OS); the secondary end point was the complete remission (CR) rate plus the CR rate without platelet recovery (CRp). Adverse events (AEs) were recorded. Results The primary analysis with 396 deaths (81.6%) showed a nonsignificant increase in median OS with decitabine (7.7 months; 95% CI, 6.2 to 9.2) versus TC (5.0 months; 95% CI, 4.3 to 6.3; P = .108; hazard ratio [HR], 0.85; 95% CI, 0.69 to 1.04). An unplanned analysis with 446 deaths (92%) indicated the same median OS (HR, 0.82; 95% CI, 0.68 to 0.99; nominal P = .037). The CR rate plus CRp was 17.8% with decitabine versus 7.8% with TC (odds ratio, 2.5; 95% CI, 1.4 to 4.8; P = .001). AEs were similar for decitabine and cytarabine, although patients received a median of four cycles of decitabine versus two cycles of TC. The most common drug-related AEs with decitabine were thrombocytopenia (27%) and neutropenia (24%). Conclusion In older patients with AML, decitabine improved response rates compared with standard therapies without major differences in safety. An unplanned survival analysis showed a benefit for decitabine, which was not observed at the time of the primary analysis.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4874148

Affiliations:

Australie, Canada, Espagne, France, Pologne, République tchèque, Taïwan, États-Unis
Auvergne-Rhône-Alpes, Bohême centrale, Moravie, Ontario, Pays de la Loire, Rhône-Alpes
Brno, Lyon, Nantes, Prague, Toronto
Université de Toronto

Le document en format XML

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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Multicenter, Randomized, Open-Label, Phase III Trial of Decitabine Versus Patient Choice, With Physician Advice, of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia</title>
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</affiliation>
</author>
<author><name sortKey="Ravandi, Farhad" sort="Ravandi, Farhad" uniqKey="Ravandi F" first="Farhad" last="Ravandi">Farhad Ravandi</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>University of Texas MD Anderson Cancer Center</s1>
<s2>Houston, TX</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>University of Texas MD Anderson Cancer Center</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Faderl, Stefan" sort="Faderl, Stefan" uniqKey="Faderl S" first="Stefan" last="Faderl">Stefan Faderl</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>University of Texas MD Anderson Cancer Center</s1>
<s2>Houston, TX</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>University of Texas MD Anderson Cancer Center</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Delaunay, Jacques" sort="Delaunay, Jacques" uniqKey="Delaunay J" first="Jacques" last="Delaunay">Jacques Delaunay</name>
<affiliation wicri:level="3"><inist:fA14 i1="15"><s1>Nantes University Hospital</s1>
<s2>Nantes</s2>
<s3>FRA</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Pays de la Loire</region>
<region type="old region">Pays de la Loire</region>
<settlement type="city">Nantes</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Christopher Arthur, Royal North Shore Hospital</s1>
<s2>St Leonards, New South Wales</s2>
<s3>AUS</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<wicri:noRegion>St Leonards, New South Wales</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Lysak, Daniel" sort="Lysak, Daniel" uniqKey="Lysak D" first="Daniel" last="Lysak">Daniel Lysak</name>
<affiliation wicri:level="1"><inist:fA14 i1="08"><s1>University Hospital Plzeň</s1>
<s2>Plzeň</s2>
<s3>CZE</s3>
<sZ>16 aut.</sZ>
</inist:fA14>
<country>République tchèque</country>
<wicri:noRegion>University Hospital Plzeň</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Minden, Mark" sort="Minden, Mark" uniqKey="Minden M" first="Mark" last="Minden">Mark Minden</name>
</author>
<author><name sortKey="Arthur, Christopher" sort="Arthur, Christopher" uniqKey="Arthur C" first="Christopher" last="Arthur">Christopher Arthur</name>
</author>
</analytic>
<series><title level="j" type="main">Journal of clinical oncology</title>
<title level="j" type="abbreviated">J. clin. oncol.</title>
<idno type="ISSN">0732-183X</idno>
<imprint><date when="2012">2012</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">Journal of clinical oncology</title>
<title level="j" type="abbreviated">J. clin. oncol.</title>
<idno type="ISSN">0732-183X</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Acute myelogenous leukemia</term>
<term>Age</term>
<term>Antineoplastic agent</term>
<term>Cancerology</term>
<term>Chemotherapy</term>
<term>Choice</term>
<term>Clinical trial</term>
<term>Comparative study</term>
<term>Cytarabine</term>
<term>Decitabine</term>
<term>Early stage</term>
<term>Elderly</term>
<term>Human</term>
<term>Low dose</term>
<term>Multicenter study</term>
<term>Phase III trial</term>
<term>Physician</term>
<term>Randomization</term>
<term>Supportive care</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Essai clinique phase III</term>
<term>Etude multicentrique</term>
<term>Essai clinique</term>
<term>Décitabine</term>
<term>Randomisation</term>
<term>Etude comparative</term>
<term>Chimiothérapie</term>
<term>Homme</term>
<term>Choix</term>
<term>Soin de support</term>
<term>Médecin</term>
<term>Dose faible</term>
<term>Cytarabine</term>
<term>Age</term>
<term>Personne âgée</term>
<term>Stade précoce</term>
<term>Leucémie aiguë myéloblastique</term>
<term>Cancérologie</term>
<term>Anticancéreux</term>
<term>Antipyrimidique</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
<term>Médecin</term>
<term>Personne âgée</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Purpose This multicenter, randomized, open-label, phase III trial compared the efficacy and safety of decitabine with treatment choice (TC) in older patients with newly diagnosed acute myeloid leukemia (AML) and poor- or intermediate-risk cytogenetics. Patients and Methods Patients (N = 485) age ≥ 65 years were randomly assigned 1:1 to receive decitabine 20 mg/m<sup>2</sup>
 per day as a 1-hour intravenous infusion for five consecutive days every 4 weeks or TC (supportive care or cytarabine 20 mg/m<sup>2</sup>
 per day as a subcutaneous injection for 10 consecutive days every 4 weeks). The primary end point was overall survival (OS); the secondary end point was the complete remission (CR) rate plus the CR rate without platelet recovery (CRp). Adverse events (AEs) were recorded. Results The primary analysis with 396 deaths (81.6%) showed a nonsignificant increase in median OS with decitabine (7.7 months; 95% CI, 6.2 to 9.2) versus TC (5.0 months; 95% CI, 4.3 to 6.3; P = .108; hazard ratio [HR], 0.85; 95% CI, 0.69 to 1.04). An unplanned analysis with 446 deaths (92%) indicated the same median OS (HR, 0.82; 95% CI, 0.68 to 0.99; nominal P = .037). The CR rate plus CRp was 17.8% with decitabine versus 7.8% with TC (odds ratio, 2.5; 95% CI, 1.4 to 4.8; P = .001). AEs were similar for decitabine and cytarabine, although patients received a median of four cycles of decitabine versus two cycles of TC. The most common drug-related AEs with decitabine were thrombocytopenia (27%) and neutropenia (24%). Conclusion In older patients with AML, decitabine improved response rates compared with standard therapies without major differences in safety. An unplanned survival analysis showed a benefit for decitabine, which was not observed at the time of the primary analysis.</div>
</front>
</TEI>
<affiliations><list><country><li>Australie</li>
<li>Canada</li>
<li>Espagne</li>
<li>France</li>
<li>Pologne</li>
<li>République tchèque</li>
<li>Taïwan</li>
<li>États-Unis</li>
</country>
<region><li>Auvergne-Rhône-Alpes</li>
<li>Bohême centrale</li>
<li>Moravie</li>
<li>Ontario</li>
<li>Pays de la Loire</li>
<li>Rhône-Alpes</li>
</region>
<settlement><li>Brno</li>
<li>Lyon</li>
<li>Nantes</li>
<li>Prague</li>
<li>Toronto</li>
</settlement>
<orgName><li>Université de Toronto</li>
</orgName>
</list>
<tree><noCountry><name sortKey="Arthur, Christopher" sort="Arthur, Christopher" uniqKey="Arthur C" first="Christopher" last="Arthur">Christopher Arthur</name>
<name sortKey="Minden, Mark" sort="Minden, Mark" uniqKey="Minden M" first="Mark" last="Minden">Mark Minden</name>
</noCountry>
<country name="États-Unis"><noRegion><name sortKey="Kantarjian, Hagop M" sort="Kantarjian, Hagop M" uniqKey="Kantarjian H" first="Hagop M." last="Kantarjian">Hagop M. Kantarjian</name>
</noRegion>
<name sortKey="Faderl, Stefan" sort="Faderl, Stefan" uniqKey="Faderl S" first="Stefan" last="Faderl">Stefan Faderl</name>
<name sortKey="Ravandi, Farhad" sort="Ravandi, Farhad" uniqKey="Ravandi F" first="Farhad" last="Ravandi">Farhad Ravandi</name>
</country>
<country name="France"><region name="Auvergne-Rhône-Alpes"><name sortKey="Thomas, Xavier G" sort="Thomas, Xavier G" uniqKey="Thomas X" first="Xavier G." last="Thomas">Xavier G. Thomas</name>
</region>
<name sortKey="Delaunay, Jacques" sort="Delaunay, Jacques" uniqKey="Delaunay J" first="Jacques" last="Delaunay">Jacques Delaunay</name>
</country>
<country name="Pologne"><noRegion><name sortKey="Dmoszynska, Anna" sort="Dmoszynska, Anna" uniqKey="Dmoszynska A" first="Anna" last="Dmoszynska">Anna Dmoszynska</name>
</noRegion>
<name sortKey="Mazur, Grzegorz" sort="Mazur, Grzegorz" uniqKey="Mazur G" first="Grzegorz" last="Mazur">Grzegorz Mazur</name>
<name sortKey="Wierzbowska, Agnieszka" sort="Wierzbowska, Agnieszka" uniqKey="Wierzbowska A" first="Agnieszka" last="Wierzbowska">Agnieszka Wierzbowska</name>
</country>
<country name="République tchèque"><noRegion><name sortKey="Mayer, Jiri" sort="Mayer, Jiri" uniqKey="Mayer J" first="Jiri" last="Mayer">Jiri Mayer</name>
</noRegion>
<name sortKey="Cermak, Jaroslav" sort="Cermak, Jaroslav" uniqKey="Cermak J" first="Jaroslav" last="Cermak">Jaroslav Cermak</name>
<name sortKey="Lysak, Daniel" sort="Lysak, Daniel" uniqKey="Lysak D" first="Daniel" last="Lysak">Daniel Lysak</name>
<name sortKey="Mayer, Jiri" sort="Mayer, Jiri" uniqKey="Mayer J" first="Jiri" last="Mayer">Jiri Mayer</name>
</country>
<country name="Taïwan"><noRegion><name sortKey="Gau, Jyh Pyng" sort="Gau, Jyh Pyng" uniqKey="Gau J" first="Jyh-Pyng" last="Gau">Jyh-Pyng Gau</name>
</noRegion>
<name sortKey="Chou, Wen Chien" sort="Chou, Wen Chien" uniqKey="Chou W" first="Wen-Chien" last="Chou">Wen-Chien Chou</name>
<name sortKey="Kuo, Ching Yuan" sort="Kuo, Ching Yuan" uniqKey="Kuo C" first="Ching-Yuan" last="Kuo">Ching-Yuan Kuo</name>
</country>
<country name="Canada"><region name="Ontario"><name sortKey="Buckstein, Rena" sort="Buckstein, Rena" uniqKey="Buckstein R" first="Rena" last="Buckstein">Rena Buckstein</name>
</region>
</country>
<country name="Espagne"><noRegion><name sortKey="Oriol, Albert" sort="Oriol, Albert" uniqKey="Oriol A" first="Albert" last="Oriol">Albert Oriol</name>
</noRegion>
</country>
<country name="Australie"><noRegion><name sortKey="Delaunay, Jacques" sort="Delaunay, Jacques" uniqKey="Delaunay J" first="Jacques" last="Delaunay">Jacques Delaunay</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

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Multicenter, Randomized, Open-Label, Phase III Trial of Decitabine Versus Patient Choice, With Physician Advice, of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Multicenter, Randomized, Open-Label, Phase III Trial of Decitabine Versus Patient Choice, With Physician Advice, of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia

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