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

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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 :

Cancer [ 0008-543X ] ; 2013.

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:

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

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

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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="Jabbour, Elias J" sort="Jabbour, Elias J" uniqKey="Jabbour E" first="Elias J" last="Jabbour">Elias J. Jabbour</name>
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<author><name sortKey="Quintas Cardama, Alfonso" sort="Quintas Cardama, Alfonso" uniqKey="Quintas Cardama A" first="Alfonso" last="Quintás-Cardama">Alfonso Quintás-Cardama</name>
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<country xml:lang="fr">Japon</country>
<wicri:regionArea>Tokai University Hospital, Isehara, Kanagawa</wicri:regionArea>
</affiliation>
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<author><name sortKey="Bay, Jacques Olivier" sort="Bay, Jacques Olivier" uniqKey="Bay J" first="Jacques-Olivier" last="Bay">Jacques-Olivier Bay</name>
<affiliation wicri:level="1"><nlm:aff id="A4">Cellular Therapy and Clinic Hematology Unit for Adults, CHU Clermont-Ferrand, France</nlm:aff>
<country xml:lang="fr">France</country>
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<author><name sortKey="Wei, Andrew" sort="Wei, Andrew" uniqKey="Wei A" first="Andrew" last="Wei">Andrew Wei</name>
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<country xml:lang="fr">Australie</country>
<wicri:regionArea>Department of Clinical Hematology, The Alfred Hospital, Monash University, Melbourne</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Gropper, Stefanie" sort="Gropper, Stefanie" uniqKey="Gropper S" first="Stefanie" last="Gröpper">Stefanie Gröpper</name>
<affiliation wicri:level="1"><nlm:aff id="A6">Medizinische Klinik II, Marien Hospital, Düsseldorf, Germany</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Medizinische Klinik II, Marien Hospital, Düsseldorf</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Papayannidis, Cristina" sort="Papayannidis, Cristina" uniqKey="Papayannidis C" first="Cristina" last="Papayannidis">Cristina Papayannidis</name>
<affiliation wicri:level="1"><nlm:aff id="A2">Istituto di Ematologica ed Oncologia Medica “L. eA. Seràgnoli”, Università Degli Studi di Bologna, Bologna, Italy</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Istituto di Ematologica ed Oncologia Medica “L. eA. Seràgnoli”, Università Degli Studi di Bologna, Bologna</wicri:regionArea>
</affiliation>
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<author><name sortKey="Owen, Kate" sort="Owen, Kate" uniqKey="Owen K" first="Kate" last="Owen">Kate Owen</name>
<affiliation wicri:level="1"><nlm:aff id="A7">AstraZeneca, Alderley Park, Macclesfield, UK</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>AstraZeneca, Alderley Park, Macclesfield</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Pike, Laura" sort="Pike, Laura" uniqKey="Pike L" first="Laura" last="Pike">Laura Pike</name>
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<country xml:lang="fr">Royaume-Uni</country>
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</affiliation>
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<author><name sortKey="Schmitt, Nicola" sort="Schmitt, Nicola" uniqKey="Schmitt N" first="Nicola" last="Schmitt">Nicola Schmitt</name>
<affiliation wicri:level="1"><nlm:aff id="A7">AstraZeneca, Alderley Park, Macclesfield, UK</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>AstraZeneca, Alderley Park, Macclesfield</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Stockman, Paul K" sort="Stockman, Paul K" uniqKey="Stockman P" first="Paul K" last="Stockman">Paul K. Stockman</name>
<affiliation wicri:level="1"><nlm:aff id="A7">AstraZeneca, Alderley Park, Macclesfield, UK</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>AstraZeneca, Alderley Park, Macclesfield</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Giagounidis, Aristoteles" sort="Giagounidis, Aristoteles" uniqKey="Giagounidis A" first="Aristoteles" last="Giagounidis">Aristoteles Giagounidis</name>
<affiliation wicri:level="1"><nlm:aff id="A6">Medizinische Klinik II, Marien Hospital, Düsseldorf, Germany</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Medizinische Klinik II, Marien Hospital, Düsseldorf</wicri:regionArea>
</affiliation>
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<series><title level="j">Cancer</title>
<idno type="ISSN">0008-543X</idno>
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<front><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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<title-group><article-title>Stage I of Phase II study assessing efficacy, safety and tolerability of barasertib (AZD1152) versus LDAC in elderly AML patients</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Kantarjian</surname>
<given-names>Hagop M</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Martinelli</surname>
<given-names>Giovanni</given-names>
</name>
<degrees>MD, PhD</degrees>
<xref ref-type="aff" rid="A2">2</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Jabbour</surname>
<given-names>Elias J</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Quintás-Cardama</surname>
<given-names>Alfonso</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Ando</surname>
<given-names>Kiyoshi</given-names>
</name>
<degrees>MD, PhD</degrees>
<xref ref-type="aff" rid="A3">3</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Bay</surname>
<given-names>Jacques-Olivier</given-names>
</name>
<degrees>MD, PhD</degrees>
<xref ref-type="aff" rid="A4">4</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Wei</surname>
<given-names>Andrew</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="A5">5</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Gröpper</surname>
<given-names>Stefanie</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A6">6</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Papayannidis</surname>
<given-names>Cristina</given-names>
</name>
<xref ref-type="aff" rid="A2">2</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Owen</surname>
<given-names>Kate</given-names>
</name>
<degrees>MD, FFPM</degrees>
<xref ref-type="aff" rid="A7">7</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Pike</surname>
<given-names>Laura</given-names>
</name>
<degrees>MSc</degrees>
<xref ref-type="aff" rid="A7">7</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Schmitt</surname>
<given-names>Nicola</given-names>
</name>
<degrees>MPhil</degrees>
<xref ref-type="aff" rid="A7">7</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Stockman</surname>
<given-names>Paul K</given-names>
</name>
<degrees>MBChB, PhD</degrees>
<xref ref-type="aff" rid="A7">7</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Giagounidis</surname>
<given-names>Aristoteles</given-names>
</name>
<degrees>MD, PhD</degrees>
<xref ref-type="aff" rid="A6">6</xref>
</contrib>
<on-behalf-of>on behalf of the SPARK-AML1 investigators</on-behalf-of>
</contrib-group>
<aff id="A1"><label>1</label>
MD Anderson Cancer Center, The University of Texas, Houston, Texas, USA</aff>
<aff id="A2"><label>2</label>
Istituto di Ematologica ed Oncologia Medica “L. eA. Seràgnoli”, Università Degli Studi di Bologna, Bologna, Italy</aff>
<aff id="A3"><label>3</label>
Tokai University Hospital, Isehara, Kanagawa, Japan</aff>
<aff id="A4"><label>4</label>
Cellular Therapy and Clinic Hematology Unit for Adults, CHU Clermont-Ferrand, France</aff>
<aff id="A5"><label>5</label>
Department of Clinical Hematology, The Alfred Hospital, Monash University, Melbourne, Australia</aff>
<aff id="A6"><label>6</label>
Medizinische Klinik II, Marien Hospital, Düsseldorf, Germany</aff>
<aff id="A7"><label>7</label>
AstraZeneca, Alderley Park, Macclesfield, UK</aff>
<author-notes><corresp id="FN1">Corresponding author: Hagop Kantarjian, MD PhD, MD Anderson Cancer Center, The University of Texas, 1515 Holcombe Blvd, Box 428, Houston, Texas 77030, Tel: 713-792-7026, Fax: 713-794-4297, <email>hkantarjian@mdanderson.org</email>
</corresp>
</author-notes>
<pub-date pub-type="nihms-submitted"><day>10</day>
<month>5</month>
<year>2013</year>
</pub-date>
<pub-date pub-type="epub"><day>19</day>
<month>4</month>
<year>2013</year>
</pub-date>
<pub-date pub-type="ppub"><day>15</day>
<month>7</month>
<year>2013</year>
</pub-date>
<pub-date pub-type="pmc-release"><day>14</day>
<month>8</month>
<year>2014</year>
</pub-date>
<volume>119</volume>
<issue>14</issue>
<fpage>2611</fpage>
<lpage>2619</lpage>
<pmc-comment>elocation-id from pubmed: 10.1002/cncr.28113</pmc-comment>
      <abstract><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>
</abstract>
</article-meta>
</front>
</pmc>
</record>

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

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

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