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Stage I of Phase II study assessing efficacy, safety and tolerability of barasertib (AZD1152) versus LDAC in elderly AML patients

Identifieur interne : 001225 ( Ncbi/Curation ); précédent : 001224; suivant : 001226

Stage I of Phase II study assessing efficacy, safety and tolerability of barasertib (AZD1152) versus LDAC in elderly AML patients

Auteurs : Hagop M. Kantarjian [États-Unis] ; Giovanni Martinelli [Italie] ; Elias J. Jabbour [États-Unis] ; Alfonso Quintás-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 :

RBID : PMC:4132839

Abstract

Background

This Phase II study 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 open-label barasertib 1200 mg (7-day iv infusion) or LDAC 20 mg (sc twice-daily for 10 days) in 28-day cycles. The primary endpoint was objective complete response rate (OCRR: CR + CRi [Cheson criteria, additionally requiring CRi reconfirmation ≥21 days after first appearance and associated with partial recovery of platelets and neutrophils]). Secondary endpoints included overall survival (OS) and safety.

Results

74 patients (barasertib, n=48; LDAC, n=26) completed ≥1 cycle. A significant improvement in OCRR was observed with barasertib (35.4% vs 11.5%; difference, 23.9% [95% CI, 2.7–39.9]; P<0.05). Although not formally sized to compare OS data, the median OS with barasertib was 8.2 months versus 4.5 months with LDAC. (HR=0.88, 95% CI, 0.49-1.58; P=0.663;). Stomatitis and febrile neutropenia were the most common adverse events with barasertib versus LDAC (71% vs 15%; 67% vs 19%, respectively).

Conclusions

Barasertib showed a significant improvement in OCRR versus LDAC, with a more toxic but manageable safety profile that was consistent with previous studies. Clinicaltrials.gov, NCT00952588.


Url:
DOI: 10.1002/cncr.28113
PubMed: 23605952
PubMed Central: 4132839

Links toward previous steps (curation, corpus...)

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PMC:4132839

Le document en format XML

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<name sortKey="Papayannidis, Cristina" sort="Papayannidis, Cristina" uniqKey="Papayannidis C" first="Cristina" last="Papayannidis">Cristina Papayannidis</name>
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<name sortKey="Schmitt, Nicola" sort="Schmitt, Nicola" uniqKey="Schmitt N" first="Nicola" last="Schmitt">Nicola Schmitt</name>
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<name sortKey="Giagounidis, Aristoteles" sort="Giagounidis, Aristoteles" uniqKey="Giagounidis A" first="Aristoteles" last="Giagounidis">Aristoteles Giagounidis</name>
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<nlm:aff id="A6">Medizinische Klinik II, Marien Hospital, Düsseldorf, Germany</nlm:aff>
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<series>
<title level="j">Cancer</title>
<idno type="ISSN">0008-543X</idno>
<idno type="eISSN">1097-0142</idno>
<imprint>
<date when="2013">2013</date>
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<div type="abstract" xml:lang="en">
<sec id="S1">
<title>Background</title>
<p id="P1">This Phase II study 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).</p>
</sec>
<sec id="S2">
<title>Methods</title>
<p id="P2">Patients were randomized 2:1 to open-label barasertib 1200 mg (7-day iv infusion) or LDAC 20 mg (sc twice-daily for 10 days) in 28-day cycles. The primary endpoint was objective complete response rate (OCRR: CR + CRi [Cheson criteria, additionally requiring CRi reconfirmation ≥21 days after first appearance and associated with partial recovery of platelets and neutrophils]). Secondary endpoints included overall survival (OS) and safety.</p>
</sec>
<sec id="S3">
<title>Results</title>
<p id="P3">74 patients (barasertib, n=48; LDAC, n=26) completed ≥1 cycle. A significant improvement in OCRR was observed with barasertib (35.4% vs 11.5%; difference, 23.9% [95% CI, 2.7–39.9];
<italic>P</italic>
<0.05). Although not formally sized to compare OS data, the median OS with barasertib was 8.2 months versus 4.5 months with LDAC. (HR=0.88, 95% CI, 0.49-1.58;
<italic>P</italic>
=0.663;). Stomatitis and febrile neutropenia were the most common adverse events with barasertib versus LDAC (71% vs 15%; 67% vs 19%, respectively).</p>
</sec>
<sec id="S4">
<title>Conclusions</title>
<p id="P4">Barasertib showed a significant improvement in OCRR versus LDAC, with a more toxic but manageable safety profile that was consistent with previous studies. Clinicaltrials.gov, NCT00952588.</p>
</sec>
</div>
</front>
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   |étape=   Curation
   |type=    RBID
   |clé=     PMC:4132839
   |texte=   Stage I of Phase II study assessing efficacy, safety and tolerability of barasertib (AZD1152) versus LDAC in elderly AML patients
}}

Pour générer des pages wiki

HfdIndexSelect -h $EXPLOR_AREA/Data/Ncbi/Curation/RBID.i   -Sk "pubmed:23605952" \
       | HfdSelect -Kh $EXPLOR_AREA/Data/Ncbi/Curation/biblio.hfd   \
       | NlmPubMed2Wicri -a AustralieFrV1
Wicri

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