AustralieFrV1, Main, Exploration, bibRecord, 004C54

Stage I of a Phase 2 Study Assessing the Efficacy, Safety, and Tolerability of Barasertib (AZD1152) Versus Low-Dose Cytosine Arabinoside in Elderly Patients With Acute Myeloid Leukemia

Identifieur interne : 004C54 ( Main/Exploration ); précédent : 004C53; suivant : 004C55

Stage I of a Phase 2 Study Assessing the Efficacy, Safety, and Tolerability of Barasertib (AZD1152) Versus Low-Dose Cytosine Arabinoside in Elderly Patients With Acute Myeloid Leukemia

Auteurs : Hagop M. Kantarjian [États-Unis] ; Giovanni Martinelli [Italie] ; Elias J. Jabbour [États-Unis] ; Alfonso Ouintas-Cardama [États-Unis] ; Kiyoshi Ando [Japon] ; Jacques-Olivier Bay [France] ; Andrew Wei [Australie] ; Stefanie Gröpper [Allemagne] ; Cristina Papayannidis [Italie] ; Kate Owen [Royaume-Uni] ; Laura Pike [Royaume-Uni] ; Nicola Schmitt [Royaume-Uni] ; Paul K. Stockman [Royaume-Uni] ; Aristoteles Giagounidis [Allemagne]

Source :

Cancer [ 0008-543X ] ; 2013.

RBID : Pascal:13-0237044

Descripteurs français

Pascal (Inist)
- Essai clinique phase I, Stade précoce, Traitement, Cytarabine, Efficacité traitement, Toxicité, Etude comparative, Dose faible, Personne âgée, Leucémie aiguë myéloblastique, Cancérologie, Anticancéreux, Antiviral, Antipyrimidique, Barasertib.
Wicri :
- topic : Personne âgée.

English descriptors

KwdEn :
- Acute myelogenous leukemia, Antineoplastic agent, Antiviral, Barasertib, Cancerology, Comparative study, Cytarabine, Early stage, Elderly, Low dose, Phase I trial, Toxicity, Treatment, Treatment efficiency.

Abstract

BACKGROUND: In this phase 2 study, the authors evaluated the efficacy, safety, and tolerability of the Aurora B kinase inhibitor barasertib compared with low-dose cytosine arabinoside (LDAC) in patients aged ≥60 years with acute myeloid leukemia (AML). METHODS: Patients were randomized 2:1 to receive either open-label barasertib 1200 mg (as a 7-day intravenous infusion) or LDAC 20 mg (subcutaneously twice daiiy for 10 days) in 28-day cycles. The primary endpoint was the objective complete response rate (OCRR) (complete responses [CR] plus confirmed CRs with incomplete recovery of neutrophils or platelets [CRi] according to Cheson criteria [also requiring reconfirmation of CRi ≥21 days after the first appearance and associated with partial recovery of platelets and neutrophils]). Secondary endpoints included overall survival (OS) and safety. RESULTS: In total, 74 patients (barasertib, n=48; LDAC, n=26) completed ≥1 cycle of treatment. A significant improvement in the OCRR was observed with barasertib (35.4% vs 11.5%; difference, 23.9%; 95% confidence interval, 2.7%-39.9%; P<.05). Although the study was not formally sized to compare OS data, the median OS with barasertib was 8.2 months versus 4.5 months with LDAC (hazard ratio, 0.88; 95% confidence interval, 0.49-1.58; P=663). Stomatitis and febrile neutropenia were the most common adverse events with barasertib versus LDAC (71% vs 15% and 67% vs 19%, respectively). CONCLUSIONS: Barasertib produced a significant improvement in the OCRR versus LDAC and had a more toxic but manageable safety profile, consistent with previous studies.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4132839

Affiliations:

Le document en format XML

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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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<author><name sortKey="Giagounidis, Aristoteles" sort="Giagounidis, Aristoteles" uniqKey="Giagounidis A" first="Aristoteles" last="Giagounidis">Aristoteles Giagounidis</name>
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</sourceDesc>
<seriesStmt><title level="j" type="main">Cancer</title>
<title level="j" type="abbreviated">Cancer</title>
<idno type="ISSN">0008-543X</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Acute myelogenous leukemia</term>
<term>Antineoplastic agent</term>
<term>Antiviral</term>
<term>Barasertib</term>
<term>Cancerology</term>
<term>Comparative study</term>
<term>Cytarabine</term>
<term>Early stage</term>
<term>Elderly</term>
<term>Low dose</term>
<term>Phase I trial</term>
<term>Toxicity</term>
<term>Treatment</term>
<term>Treatment efficiency</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Essai clinique phase I</term>
<term>Stade précoce</term>
<term>Traitement</term>
<term>Cytarabine</term>
<term>Efficacité traitement</term>
<term>Toxicité</term>
<term>Etude comparative</term>
<term>Dose faible</term>
<term>Personne âgée</term>
<term>Leucémie aiguë myéloblastique</term>
<term>Cancérologie</term>
<term>Anticancéreux</term>
<term>Antiviral</term>
<term>Antipyrimidique</term>
<term>Barasertib</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Personne âgée</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">BACKGROUND: In this phase 2 study, the authors evaluated the efficacy, safety, and tolerability of the Aurora B kinase inhibitor barasertib compared with low-dose cytosine arabinoside (LDAC) in patients aged ≥60 years with acute myeloid leukemia (AML). METHODS: Patients were randomized 2:1 to receive either open-label barasertib 1200 mg (as a 7-day intravenous infusion) or LDAC 20 mg (subcutaneously twice daiiy for 10 days) in 28-day cycles. The primary endpoint was the objective complete response rate (OCRR) (complete responses [CR] plus confirmed CRs with incomplete recovery of neutrophils or platelets [CRi] according to Cheson criteria [also requiring reconfirmation of CRi ≥21 days after the first appearance and associated with partial recovery of platelets and neutrophils]). Secondary endpoints included overall survival (OS) and safety. RESULTS: In total, 74 patients (barasertib, n=48; LDAC, n=26) completed ≥1 cycle of treatment. A significant improvement in the OCRR was observed with barasertib (35.4% vs 11.5%; difference, 23.9%; 95% confidence interval, 2.7%-39.9%; P<.05). Although the study was not formally sized to compare OS data, the median OS with barasertib was 8.2 months versus 4.5 months with LDAC (hazard ratio, 0.88; 95% confidence interval, 0.49-1.58; P=663). Stomatitis and febrile neutropenia were the most common adverse events with barasertib versus LDAC (71% vs 15% and 67% vs 19%, respectively). CONCLUSIONS: Barasertib produced a significant improvement in the OCRR versus LDAC and had a more toxic but manageable safety profile, consistent with previous studies.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>France</li>
<li>Italie</li>
<li>Japon</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
</country>
<region><li>Auvergne (région administrative)</li>
<li>Auvergne-Rhône-Alpes</li>
<li>District de Düsseldorf</li>
<li>Rhénanie-du-Nord-Westphalie</li>
<li>Texas</li>
<li>Victoria (État)</li>
</region>
<settlement><li>Clermont-Ferrand</li>
<li>Düsseldorf</li>
<li>Melbourne</li>
</settlement>
</list>
<tree><country name="États-Unis"><region name="Texas"><name sortKey="Kantarjian, Hagop M" sort="Kantarjian, Hagop M" uniqKey="Kantarjian H" first="Hagop M." last="Kantarjian">Hagop M. Kantarjian</name>
</region>
<name sortKey="Jabbour, Elias J" sort="Jabbour, Elias J" uniqKey="Jabbour E" first="Elias J." last="Jabbour">Elias J. Jabbour</name>
<name sortKey="Ouintas Cardama, Alfonso" sort="Ouintas Cardama, Alfonso" uniqKey="Ouintas Cardama A" first="Alfonso" last="Ouintas-Cardama">Alfonso Ouintas-Cardama</name>
</country>
<country name="Italie"><noRegion><name sortKey="Martinelli, Giovanni" sort="Martinelli, Giovanni" uniqKey="Martinelli G" first="Giovanni" last="Martinelli">Giovanni Martinelli</name>
</noRegion>
<name sortKey="Papayannidis, Cristina" sort="Papayannidis, Cristina" uniqKey="Papayannidis C" first="Cristina" last="Papayannidis">Cristina Papayannidis</name>
</country>
<country name="Japon"><noRegion><name sortKey="Ando, Kiyoshi" sort="Ando, Kiyoshi" uniqKey="Ando K" first="Kiyoshi" last="Ando">Kiyoshi Ando</name>
</noRegion>
</country>
<country name="France"><region name="Auvergne-Rhône-Alpes"><name sortKey="Bay, Jacques Olivier" sort="Bay, Jacques Olivier" uniqKey="Bay J" first="Jacques-Olivier" last="Bay">Jacques-Olivier Bay</name>
</region>
</country>
<country name="Australie"><region name="Victoria (État)"><name sortKey="Wei, Andrew" sort="Wei, Andrew" uniqKey="Wei A" first="Andrew" last="Wei">Andrew Wei</name>
</region>
</country>
<country name="Allemagne"><region name="Rhénanie-du-Nord-Westphalie"><name sortKey="Gropper, Stefanie" sort="Gropper, Stefanie" uniqKey="Gropper S" first="Stefanie" last="Gröpper">Stefanie Gröpper</name>
</region>
<name sortKey="Giagounidis, Aristoteles" sort="Giagounidis, Aristoteles" uniqKey="Giagounidis A" first="Aristoteles" last="Giagounidis">Aristoteles Giagounidis</name>
</country>
<country name="Royaume-Uni"><noRegion><name sortKey="Owen, Kate" sort="Owen, Kate" uniqKey="Owen K" first="Kate" last="Owen">Kate Owen</name>
</noRegion>
<name sortKey="Pike, Laura" sort="Pike, Laura" uniqKey="Pike L" first="Laura" last="Pike">Laura Pike</name>
<name sortKey="Schmitt, Nicola" sort="Schmitt, Nicola" uniqKey="Schmitt N" first="Nicola" last="Schmitt">Nicola Schmitt</name>
<name sortKey="Stockman, Paul K" sort="Stockman, Paul K" uniqKey="Stockman P" first="Paul K." last="Stockman">Paul K. Stockman</name>
</country>
</tree>
</affiliations>
</record>

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Stage I of a Phase 2 Study Assessing the Efficacy, Safety, and Tolerability of Barasertib (AZD1152) Versus Low-Dose Cytosine Arabinoside in Elderly Patients With Acute Myeloid Leukemia

Stage I of a Phase 2 Study Assessing the Efficacy, Safety, and Tolerability of Barasertib (AZD1152) Versus Low-Dose Cytosine Arabinoside in Elderly Patients With Acute Myeloid Leukemia

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