AustralieFrV1, PascalFrancis, Corpus, bibRecord, 000950

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 : 000950 ( PascalFrancis/Corpus ); précédent : 000949; suivant : 000951

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 ; Giovanni Martinelli ; Elias J. Jabbour ; Alfonso Ouintas-Cardama ; Kiyoshi Ando ; Jacques-Olivier Bay ; Andrew Wei ; Stefanie Gröpper ; Cristina Papayannidis ; Kate Owen ; Laura Pike ; Nicola Schmitt ; Paul K. Stockman ; Aristoteles Giagounidis

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.

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.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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C01	`01`		`ENG`	@0 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.
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C03	`08`	`X`	`FRE`	`@0 Dose faible @5 09`
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Format Inist (serveur)

NO :	PASCAL 13-0237044 INIST
ET :	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
AU :	KANTARJIAN (Hagop M.); MARTINELLI (Giovanni); JABBOUR (Elias J.); OUINTAS-CARDAMA (Alfonso); ANDO (Kiyoshi); BAY (Jacques-Olivier); WEI (Andrew); GRÖPPER (Stefanie); PAPAYANNIDIS (Cristina); OWEN (Kate); PIKE (Laura); SCHMITT (Nicola); STOCKMAN (Paul K.); GIAGOUNIDIS (Aristoteles)
AF :	The University of Texas MD Anderson Cancer Center/Houston, Texas/Etats-Unis (1 aut., 3 aut., 4 aut.); L. eA. Seragnoli" Institute of Hematology and Medical Oncology, University of Bologna/Bologna/Italie (2 aut., 9 aut.); Department of Hematology and Oncology, Tokai University Hospital/Isehara, Kanagawa/Japon (5 aut.); Cellular Therapy and Clinic Hematology Unit for Adults, University Hospital Center, Clermont-Ferrand/France (6 aut.); Department of Clinical Hematology, The Alfred Hospital, Monash University/Melbourne/Australie (7 aut.); Medical Clinic II, Marien Hospital/Dusseldorf/Allemagne (8 aut., 14 aut.); AstraZeneca, Alderley Park/Macclesfield/Royaume-Uni (10 aut., 11 aut., 12 aut., 13 aut.)
DT :	Publication en série; Niveau analytique
SO :	Cancer; ISSN 0008-543X; Coden CANCAR; Etats-Unis; Da. 2013; Vol. 119; No. 14; Pp. 2611-2619; Bibl. 30 ref.
LA :	Anglais
EA :	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.
CC :	002B04; 002B19B
FD :	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
FG :	Homme; Dérivé de la quinazoline; Antimétabolite; Pyrimidine nucléoside; Hémopathie maligne; Cancer
ED :	Phase I trial; Early stage; Treatment; Cytarabine; Treatment efficiency; Toxicity; Comparative study; Low dose; Elderly; Acute myelogenous leukemia; Cancerology; Antineoplastic agent; Antiviral; Barasertib
EG :	Human; Quinazoline derivatives; Antimetabolic; Pyrimidine nucleoside; Malignant hemopathy; Cancer
SD :	Ensayo clínico fase I; Estadio precoz; Tratamiento; Citarabina; Eficacia tratamiento; Toxicidad; Estudio comparativo; Dosis débil; Anciano; Leucemia aguda mieloblástica; Cancerología; Anticanceroso; Antiviral; Barasertib
LO :	INIST-2701.354000503876880120
ID :	13-0237044

Links to Exploration step

Pascal:13-0237044

Le document en format XML

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<author><name sortKey="Schmitt, Nicola" sort="Schmitt, Nicola" uniqKey="Schmitt N" first="Nicola" last="Schmitt">Nicola Schmitt</name>
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<author><name sortKey="Stockman, Paul K" sort="Stockman, Paul K" uniqKey="Stockman P" first="Paul K." last="Stockman">Paul K. Stockman</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><biblStruct><analytic><title xml:lang="en" level="a">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</title>
<author><name sortKey="Kantarjian, Hagop M" sort="Kantarjian, Hagop M" uniqKey="Kantarjian H" first="Hagop M." last="Kantarjian">Hagop M. Kantarjian</name>
<affiliation><inist:fA14 i1="01"><s1>The University of Texas MD Anderson Cancer Center</s1>
<s2>Houston, Texas</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>3 aut.</sZ>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Martinelli, Giovanni" sort="Martinelli, Giovanni" uniqKey="Martinelli G" first="Giovanni" last="Martinelli">Giovanni Martinelli</name>
<affiliation><inist:fA14 i1="02"><s1>L. eA. Seragnoli" Institute of Hematology and Medical Oncology, University of Bologna</s1>
<s2>Bologna</s2>
<s3>ITA</s3>
<sZ>2 aut.</sZ>
<sZ>9 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Jabbour, Elias J" sort="Jabbour, Elias J" uniqKey="Jabbour E" first="Elias J." last="Jabbour">Elias J. Jabbour</name>
<affiliation><inist:fA14 i1="01"><s1>The University of Texas MD Anderson Cancer Center</s1>
<s2>Houston, Texas</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>3 aut.</sZ>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Ouintas Cardama, Alfonso" sort="Ouintas Cardama, Alfonso" uniqKey="Ouintas Cardama A" first="Alfonso" last="Ouintas-Cardama">Alfonso Ouintas-Cardama</name>
<affiliation><inist:fA14 i1="01"><s1>The University of Texas MD Anderson Cancer Center</s1>
<s2>Houston, Texas</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>3 aut.</sZ>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Ando, Kiyoshi" sort="Ando, Kiyoshi" uniqKey="Ando K" first="Kiyoshi" last="Ando">Kiyoshi Ando</name>
<affiliation><inist:fA14 i1="03"><s1>Department of Hematology and Oncology, Tokai University Hospital</s1>
<s2>Isehara, Kanagawa</s2>
<s3>JPN</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Bay, Jacques Olivier" sort="Bay, Jacques Olivier" uniqKey="Bay J" first="Jacques-Olivier" last="Bay">Jacques-Olivier Bay</name>
<affiliation><inist:fA14 i1="04"><s1>Cellular Therapy and Clinic Hematology Unit for Adults, University Hospital Center, Clermont-Ferrand</s1>
<s3>FRA</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Wei, Andrew" sort="Wei, Andrew" uniqKey="Wei A" first="Andrew" last="Wei">Andrew Wei</name>
<affiliation><inist:fA14 i1="05"><s1>Department of Clinical Hematology, The Alfred Hospital, Monash University</s1>
<s2>Melbourne</s2>
<s3>AUS</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Gropper, Stefanie" sort="Gropper, Stefanie" uniqKey="Gropper S" first="Stefanie" last="Gröpper">Stefanie Gröpper</name>
<affiliation><inist:fA14 i1="06"><s1>Medical Clinic II, Marien Hospital</s1>
<s2>Dusseldorf</s2>
<s3>DEU</s3>
<sZ>8 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Papayannidis, Cristina" sort="Papayannidis, Cristina" uniqKey="Papayannidis C" first="Cristina" last="Papayannidis">Cristina Papayannidis</name>
<affiliation><inist:fA14 i1="02"><s1>L. eA. Seragnoli" Institute of Hematology and Medical Oncology, University of Bologna</s1>
<s2>Bologna</s2>
<s3>ITA</s3>
<sZ>2 aut.</sZ>
<sZ>9 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Owen, Kate" sort="Owen, Kate" uniqKey="Owen K" first="Kate" last="Owen">Kate Owen</name>
<affiliation><inist:fA14 i1="07"><s1>AstraZeneca, Alderley Park</s1>
<s2>Macclesfield</s2>
<s3>GBR</s3>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
<sZ>13 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Pike, Laura" sort="Pike, Laura" uniqKey="Pike L" first="Laura" last="Pike">Laura Pike</name>
<affiliation><inist:fA14 i1="07"><s1>AstraZeneca, Alderley Park</s1>
<s2>Macclesfield</s2>
<s3>GBR</s3>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
<sZ>13 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Schmitt, Nicola" sort="Schmitt, Nicola" uniqKey="Schmitt N" first="Nicola" last="Schmitt">Nicola Schmitt</name>
<affiliation><inist:fA14 i1="07"><s1>AstraZeneca, Alderley Park</s1>
<s2>Macclesfield</s2>
<s3>GBR</s3>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
<sZ>13 aut.</sZ>
</inist:fA14>
</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><inist:fA14 i1="07"><s1>AstraZeneca, Alderley Park</s1>
<s2>Macclesfield</s2>
<s3>GBR</s3>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
<sZ>13 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Giagounidis, Aristoteles" sort="Giagounidis, Aristoteles" uniqKey="Giagounidis A" first="Aristoteles" last="Giagounidis">Aristoteles Giagounidis</name>
<affiliation><inist:fA14 i1="06"><s1>Medical Clinic II, Marien Hospital</s1>
<s2>Dusseldorf</s2>
<s3>DEU</s3>
<sZ>8 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">Cancer</title>
<title level="j" type="abbreviated">Cancer</title>
<idno type="ISSN">0008-543X</idno>
<imprint><date when="2013">2013</date>
</imprint>
</series>
</biblStruct>
</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>
</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>
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<fA06><s2>14</s2>
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<fA08 i1="01" i2="1" l="ENG"><s1>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</s1>
</fA08>
<fA11 i1="01" i2="1"><s1>KANTARJIAN (Hagop M.)</s1>
</fA11>
<fA11 i1="02" i2="1"><s1>MARTINELLI (Giovanni)</s1>
</fA11>
<fA11 i1="03" i2="1"><s1>JABBOUR (Elias J.)</s1>
</fA11>
<fA11 i1="04" i2="1"><s1>OUINTAS-CARDAMA (Alfonso)</s1>
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<fA11 i1="05" i2="1"><s1>ANDO (Kiyoshi)</s1>
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<fA11 i1="06" i2="1"><s1>BAY (Jacques-Olivier)</s1>
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<fA11 i1="07" i2="1"><s1>WEI (Andrew)</s1>
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<fA11 i1="08" i2="1"><s1>GRÖPPER (Stefanie)</s1>
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<fA11 i1="09" i2="1"><s1>PAPAYANNIDIS (Cristina)</s1>
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<fA11 i1="10" i2="1"><s1>OWEN (Kate)</s1>
</fA11>
<fA11 i1="11" i2="1"><s1>PIKE (Laura)</s1>
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<fA11 i1="12" i2="1"><s1>SCHMITT (Nicola)</s1>
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<fA11 i1="13" i2="1"><s1>STOCKMAN (Paul K.)</s1>
</fA11>
<fA11 i1="14" i2="1"><s1>GIAGOUNIDIS (Aristoteles)</s1>
</fA11>
<fA14 i1="01"><s1>The University of Texas MD Anderson Cancer Center</s1>
<s2>Houston, Texas</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>3 aut.</sZ>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>L. eA. Seragnoli" Institute of Hematology and Medical Oncology, University of Bologna</s1>
<s2>Bologna</s2>
<s3>ITA</s3>
<sZ>2 aut.</sZ>
<sZ>9 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>Department of Hematology and Oncology, Tokai University Hospital</s1>
<s2>Isehara, Kanagawa</s2>
<s3>JPN</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>Cellular Therapy and Clinic Hematology Unit for Adults, University Hospital Center, Clermont-Ferrand</s1>
<s3>FRA</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>Department of Clinical Hematology, The Alfred Hospital, Monash University</s1>
<s2>Melbourne</s2>
<s3>AUS</s3>
<sZ>7 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>Medical Clinic II, Marien Hospital</s1>
<s2>Dusseldorf</s2>
<s3>DEU</s3>
<sZ>8 aut.</sZ>
<sZ>14 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>AstraZeneca, Alderley Park</s1>
<s2>Macclesfield</s2>
<s3>GBR</s3>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
<sZ>13 aut.</sZ>
</fA14>
<fA17 i1="01" i2="1"><s1>SPARK-AML1 Investigators</s1>
<s3>INC</s3>
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</fA66>
<fC01 i1="01" l="ENG"><s0>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.</s0>
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<fC07 i1="03" i2="X" l="FRE"><s0>Antimétabolite</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Antimetabolic</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Antimetabólito</s0>
<s5>38</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Pyrimidine nucléoside</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>Pyrimidine nucleoside</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Pirimidina nucleósido</s0>
<s5>39</s5>
</fC07>
<fC07 i1="05" i2="X" l="FRE"><s0>Hémopathie maligne</s0>
<s2>NM</s2>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG"><s0>Malignant hemopathy</s0>
<s2>NM</s2>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA"><s0>Hemopatía maligna</s0>
<s2>NM</s2>
<s5>40</s5>
</fC07>
<fC07 i1="06" i2="X" l="FRE"><s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="06" i2="X" l="ENG"><s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="06" i2="X" l="SPA"><s0>Cáncer</s0>
<s2>NM</s2>
</fC07>
<fN21><s1>224</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
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<server><NO>PASCAL 13-0237044 INIST</NO>
<ET>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</ET>
<AU>KANTARJIAN (Hagop M.); MARTINELLI (Giovanni); JABBOUR (Elias J.); OUINTAS-CARDAMA (Alfonso); ANDO (Kiyoshi); BAY (Jacques-Olivier); WEI (Andrew); GRÖPPER (Stefanie); PAPAYANNIDIS (Cristina); OWEN (Kate); PIKE (Laura); SCHMITT (Nicola); STOCKMAN (Paul K.); GIAGOUNIDIS (Aristoteles)</AU>
<AF>The University of Texas MD Anderson Cancer Center/Houston, Texas/Etats-Unis (1 aut., 3 aut., 4 aut.); L. eA. Seragnoli" Institute of Hematology and Medical Oncology, University of Bologna/Bologna/Italie (2 aut., 9 aut.); Department of Hematology and Oncology, Tokai University Hospital/Isehara, Kanagawa/Japon (5 aut.); Cellular Therapy and Clinic Hematology Unit for Adults, University Hospital Center, Clermont-Ferrand/France (6 aut.); Department of Clinical Hematology, The Alfred Hospital, Monash University/Melbourne/Australie (7 aut.); Medical Clinic II, Marien Hospital/Dusseldorf/Allemagne (8 aut., 14 aut.); AstraZeneca, Alderley Park/Macclesfield/Royaume-Uni (10 aut., 11 aut., 12 aut., 13 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Cancer; ISSN 0008-543X; Coden CANCAR; Etats-Unis; Da. 2013; Vol. 119; No. 14; Pp. 2611-2619; Bibl. 30 ref.</SO>
<LA>Anglais</LA>
<EA>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.</EA>
<CC>002B04; 002B19B</CC>
<FD>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</FD>
<FG>Homme; Dérivé de la quinazoline; Antimétabolite; Pyrimidine nucléoside; Hémopathie maligne; Cancer</FG>
<ED>Phase I trial; Early stage; Treatment; Cytarabine; Treatment efficiency; Toxicity; Comparative study; Low dose; Elderly; Acute myelogenous leukemia; Cancerology; Antineoplastic agent; Antiviral; Barasertib</ED>
<EG>Human; Quinazoline derivatives; Antimetabolic; Pyrimidine nucleoside; Malignant hemopathy; Cancer</EG>
<SD>Ensayo clínico fase I; Estadio precoz; Tratamiento; Citarabina; Eficacia tratamiento; Toxicidad; Estudio comparativo; Dosis débil; Anciano; Leucemia aguda mieloblástica; Cancerología; Anticanceroso; Antiviral; Barasertib</SD>
<LO>INIST-2701.354000503876880120</LO>
<ID>13-0237044</ID>
</server>
</inist>
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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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