AustralieFrV1, PascalFrancis, Corpus, bibRecord, 000396

Results of a Randomized, Double-Blind Study of Romiplostim Versus Placebo in Patients With Low/Intermediate-1-Risk Myelodysplastic Syndrome and Thrombocytopenia

Identifieur interne : 000396 ( PascalFrancis/Corpus ); précédent : 000395; suivant : 000397

Results of a Randomized, Double-Blind Study of Romiplostim Versus Placebo in Patients With Low/Intermediate-1-Risk Myelodysplastic Syndrome and Thrombocytopenia

Auteurs : Aristoteles Giagounidis ; Ghulam J. Mufti ; Pierre Fenaux ; Mikkael A. Sekeres ; Jeffrey Szer ; Uwe Platzbecker ; Andrea Kuendgen ; Gianluca Gaidano ; Wieslaw Wiktor-Jedrzejczak ; KUOLUNG HU ; Paul Woodard ; Allen S. Yang ; Hagop M. Kantarjian

Source :

Cancer [ 0008-543X ] ; 2014.

RBID : Pascal:14-0154010

Descripteurs français

Pascal (Inist)
- Romiplostim, Randomisation, Etude double insu, Syndrome myélodysplasique, Etude comparative, Placebo, Thrombopénie, Homme, Pharmacothérapie, Chimiothérapie, Cancérologie, Thrombocyte, Risque faible, Essai randomisé contrôlé.

English descriptors

KwdEn :
- Cancerology, Chemotherapy, Comparative study, Double blind study, Human, Low risk, Myelodysplastic syndrome, Pharmacotherapy, Placebo, Platelet, Randomization, Randomized controlled trial, Romiplostim, Thrombocytopenia.

Abstract

BACKGROUND: Thrombocytopenia in patients with myelodysplastic syndrome (MDS) is associated with shortened survival and an increased risk of evolution to acute myeloid leukemia (AML). In this study, the authors evaluated the efficacy of romiplostim in patients who had thrombocytopenia with low-risk/intermediate-1-risk MDS. METHODS: Patients who had thrombocytopenia with low-risk/intermediate-1-risk MDS (N=250) were randomized 2:1 to receive romiplostim or placebo weekly for 58 weeks. RESULTS: The primary endpoint- the number of clinically significant bleeding events (CSBEs) per patient-had a hazard ratio for romiplostim:-placebo of 0.83 (95% confidence interval, 0.66-1.05; P=.13). CSBEs were reduced significantly in the romiplostim group for patients who had baseline platelet counts ≥2:20 × 10⁹/L (P<.0001). For patients who had baseline platelet counts <20 × 10⁹/L, there was no difference in the number of CSBEs, but the platelet transfusion rates were higher in the placebo group (P<.0001), which may have affected the overall CSBE results in this group with severe thrombocytopenia. The incidence of bleeding events was reduced significantly in the romiplostim group (relative risk, 0.92), as were protocol-defined platelet transfusions (relative risk, 0.77). Platelet response rates according to 2006 International Working Group criteria were higher for the group that received romiplostim (odds ratio, 15.6). On the basis of interim data, an independent data monitoring committee advised halting study drug because of concerns regarding excess blasts and AML rates with romiplostim (interim hazard ratio, 2.51). At 58 weeks, the AML rates were 6% in the romiplostim group and 4.9% in the placebo group (hazard ratio, 1.20; 95% confidence interval, 0.38-3.84), and the overall survival rates were similar. CONCLUSIONS: Romiplostim treatment in patients with low-risk/intermediate-1-risk MDS increased platelet counts and decreased the number of bleeding events and platelet transfusions. Although study drug was discontinued because of an initial concern of AML risk, survival and AML rates were similar with romiplostim and placebo.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

A01	`01`	`1`		`@0 0008-543X`
A02	`01`			`@0 CANCAR`
A03		`1`		`@0 Cancer`
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A06				`@2 12`
A08	`01`	`1`	`ENG`	`@1 Results of a Randomized, Double-Blind Study of Romiplostim Versus Placebo in Patients With Low/Intermediate-1-Risk Myelodysplastic Syndrome and Thrombocytopenia`
A11	`01`	`1`		`@1 GIAGOUNIDIS (Aristoteles)`
A11	`02`	`1`		`@1 MUFTI (Ghulam J.)`
A11	`03`	`1`		`@1 FENAUX (Pierre)`
A11	`04`	`1`		`@1 SEKERES (Mikkael A.)`
A11	`05`	`1`		`@1 SZER (Jeffrey)`
A11	`06`	`1`		`@1 PLATZBECKER (Uwe)`
A11	`07`	`1`		`@1 KUENDGEN (Andrea)`
A11	`08`	`1`		`@1 GAIDANO (Gianluca)`
A11	`09`	`1`		`@1 WIKTOR-JEDRZEJCZAK (Wieslaw)`
A11	`10`	`1`		`@1 KUOLUNG HU`
A11	`11`	`1`		`@1 WOODARD (Paul)`
A11	`12`	`1`		`@1 YANG (Allen S.)`
A11	`13`	`1`		`@1 KANTARJIAN (Hagop M.)`
A14	`01`			`@1 Clinic for Oncology, Hematology, and Palliative Medicine, Marien Hospital Dusseldorf @2 Dusseldorf @3 DEU @Z 1 aut.`
A14	`02`			`@1 Department of Haemato-Oncology, King's College London @2 London @3 GBR @Z 2 aut.`
A14	`03`			`@1 Clinical Hematology Service, Avicenne Hospital, University of Paris XIII @2 Bobigny @3 FRA @Z 3 aut.`
A14	`04`			`@1 Leukemia Program, Cleveland Clinic Taussig Cancer Institute @2 Cleveland, Ohio @3 USA @Z 4 aut.`
A14	`05`			`@1 Clinical Hematology, Royal Melbourne Hospital @2 Melbourne @3 AUS @Z 5 aut.`
A14	`06`			`@1 Medical Clinic and Polyclinic I, University Hospital Carl Gustav Carus Dresden @2 Dresden @3 DEU @Z 6 aut.`
A14	`07`			`@1 Medical Clinic and Polyclinic A, University Hospital, Heinrich-Heine University of Dusseldorf @2 Dusseldorf @3 DEU @Z 7 aut.`
A14	`08`			`@1 Division of Hematology, Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont @2 Novara @3 ITA @Z 8 aut.`
A14	`09`			`@1 Independent Public Central Hospital Clinic, Medical University of Warsaw @2 Warsaw @3 POL @Z 9 aut.`
A14	`10`			`@1 Amgen Inc. @2 Thousand Oaks, California @3 USA @Z 10 aut. @Z 11 aut. @Z 12 aut.`
A14	`11`			`@1 Department of Leukemia, The University of Texas MD Anderson Cancer Center @2 Houston, Texas @3 USA @Z 13 aut.`
A20				`@1 1838-1846`
A21				`@1 2014`
A23	`01`			`@0 ENG`
A43	`01`			`@1 INIST @2 2701 @5 354000502739460110`
A44				`@0 0000 @1 © 2014 INIST-CNRS. All rights reserved.`
A45				`@0 28 ref.`
A47	`01`	`1`		`@0 14-0154010`
A60				`@1 P`
A61				`@0 A`
A64	`01`	`1`		`@0 Cancer`
A66	`01`			`@0 USA`
C01	`01`		`ENG`	@0 BACKGROUND: Thrombocytopenia in patients with myelodysplastic syndrome (MDS) is associated with shortened survival and an increased risk of evolution to acute myeloid leukemia (AML). In this study, the authors evaluated the efficacy of romiplostim in patients who had thrombocytopenia with low-risk/intermediate-1-risk MDS. METHODS: Patients who had thrombocytopenia with low-risk/intermediate-1-risk MDS (N=250) were randomized 2:1 to receive romiplostim or placebo weekly for 58 weeks. RESULTS: The primary endpoint- the number of clinically significant bleeding events (CSBEs) per patient-had a hazard ratio for romiplostim:-placebo of 0.83 (95% confidence interval, 0.66-1.05; P=.13). CSBEs were reduced significantly in the romiplostim group for patients who had baseline platelet counts ≥2:20 × 10⁹/L (P<.0001). For patients who had baseline platelet counts <20 × 10⁹/L, there was no difference in the number of CSBEs, but the platelet transfusion rates were higher in the placebo group (P<.0001), which may have affected the overall CSBE results in this group with severe thrombocytopenia. The incidence of bleeding events was reduced significantly in the romiplostim group (relative risk, 0.92), as were protocol-defined platelet transfusions (relative risk, 0.77). Platelet response rates according to 2006 International Working Group criteria were higher for the group that received romiplostim (odds ratio, 15.6). On the basis of interim data, an independent data monitoring committee advised halting study drug because of concerns regarding excess blasts and AML rates with romiplostim (interim hazard ratio, 2.51). At 58 weeks, the AML rates were 6% in the romiplostim group and 4.9% in the placebo group (hazard ratio, 1.20; 95% confidence interval, 0.38-3.84), and the overall survival rates were similar. CONCLUSIONS: Romiplostim treatment in patients with low-risk/intermediate-1-risk MDS increased platelet counts and decreased the number of bleeding events and platelet transfusions. Although study drug was discontinued because of an initial concern of AML risk, survival and AML rates were similar with romiplostim and placebo.
C02	`01`	`X`		`@0 002B04`
C02	`02`	`X`		`@0 002B19B`
C03	`01`	`X`	`FRE`	`@0 Romiplostim @2 FR @5 01`
C03	`01`	`X`	`ENG`	`@0 Romiplostim @2 FR @5 01`
C03	`01`	`X`	`SPA`	`@0 Romiplostim @2 FR @5 01`
C03	`02`	`X`	`FRE`	`@0 Randomisation @5 02`
C03	`02`	`X`	`ENG`	`@0 Randomization @5 02`
C03	`02`	`X`	`SPA`	`@0 Aleatorización @5 02`
C03	`03`	`X`	`FRE`	`@0 Etude double insu @5 03`
C03	`03`	`X`	`ENG`	`@0 Double blind study @5 03`
C03	`03`	`X`	`SPA`	`@0 Estudio doble ciego @5 03`
C03	`04`	`X`	`FRE`	`@0 Syndrome myélodysplasique @5 04`
C03	`04`	`X`	`ENG`	`@0 Myelodysplastic syndrome @5 04`
C03	`04`	`X`	`SPA`	`@0 Mielodisplastico síndrome @5 04`
C03	`05`	`X`	`FRE`	`@0 Etude comparative @5 05`
C03	`05`	`X`	`ENG`	`@0 Comparative study @5 05`
C03	`05`	`X`	`SPA`	`@0 Estudio comparativo @5 05`
C03	`06`	`X`	`FRE`	`@0 Placebo @5 06`
C03	`06`	`X`	`ENG`	`@0 Placebo @5 06`
C03	`06`	`X`	`SPA`	`@0 Placebo @5 06`
C03	`07`	`X`	`FRE`	`@0 Thrombopénie @2 NM @5 07`
C03	`07`	`X`	`ENG`	`@0 Thrombocytopenia @2 NM @5 07`
C03	`07`	`X`	`SPA`	`@0 Trombopenia @2 NM @5 07`
C03	`08`	`X`	`FRE`	`@0 Homme @5 08`
C03	`08`	`X`	`ENG`	`@0 Human @5 08`
C03	`08`	`X`	`SPA`	`@0 Hombre @5 08`
C03	`09`	`X`	`FRE`	`@0 Pharmacothérapie @5 09`
C03	`09`	`X`	`ENG`	`@0 Pharmacotherapy @5 09`
C03	`09`	`X`	`SPA`	`@0 Farmacoterapia @5 09`
C03	`10`	`X`	`FRE`	`@0 Chimiothérapie @5 10`
C03	`10`	`X`	`ENG`	`@0 Chemotherapy @5 10`
C03	`10`	`X`	`SPA`	`@0 Quimioterapia @5 10`
C03	`11`	`X`	`FRE`	`@0 Cancérologie @5 11`
C03	`11`	`X`	`ENG`	`@0 Cancerology @5 11`
C03	`11`	`X`	`SPA`	`@0 Cancerología @5 11`
C03	`12`	`X`	`FRE`	`@0 Thrombocyte @5 25`
C03	`12`	`X`	`ENG`	`@0 Platelet @5 25`
C03	`12`	`X`	`SPA`	`@0 Trombocito @5 25`
C03	`13`	`X`	`FRE`	`@0 Risque faible @4 CD @5 96`
C03	`13`	`X`	`ENG`	`@0 Low risk @4 CD @5 96`
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C03	`14`	`X`	`ENG`	`@0 Randomized controlled trial @4 CD @5 97`
C03	`14`	`X`	`SPA`	`@0 Ensayo aleatorio controlado @4 CD @5 97`
C07	`01`	`X`	`FRE`	`@0 Traitement`
C07	`01`	`X`	`ENG`	`@0 Treatment`
C07	`01`	`X`	`SPA`	`@0 Tratamiento`
C07	`02`	`X`	`FRE`	`@0 Agoniste @5 37`
C07	`02`	`X`	`ENG`	`@0 Agonist @5 37`
C07	`02`	`X`	`SPA`	`@0 Agonista @5 37`
C07	`03`	`X`	`FRE`	`@0 Hémopathie maligne @2 NM @5 38`
C07	`03`	`X`	`ENG`	`@0 Malignant hemopathy @2 NM @5 38`
C07	`03`	`X`	`SPA`	`@0 Hemopatía maligna @2 NM @5 38`
C07	`04`	`X`	`FRE`	`@0 Cancer @2 NM`
C07	`04`	`X`	`ENG`	`@0 Cancer @2 NM`
C07	`04`	`X`	`SPA`	`@0 Cáncer @2 NM`
C07	`05`	`X`	`FRE`	`@0 Récepteur de la thrombopoïétine @4 INC @5 86`
N21				`@1 195`
N44	`01`			`@1 OTO`
N82				`@1 OTO`

Format Inist (serveur)

NO :	PASCAL 14-0154010 INIST
ET :	Results of a Randomized, Double-Blind Study of Romiplostim Versus Placebo in Patients With Low/Intermediate-1-Risk Myelodysplastic Syndrome and Thrombocytopenia
AU :	GIAGOUNIDIS (Aristoteles); MUFTI (Ghulam J.); FENAUX (Pierre); SEKERES (Mikkael A.); SZER (Jeffrey); PLATZBECKER (Uwe); KUENDGEN (Andrea); GAIDANO (Gianluca); WIKTOR-JEDRZEJCZAK (Wieslaw); KUOLUNG HU; WOODARD (Paul); YANG (Allen S.); KANTARJIAN (Hagop M.)
AF :	Clinic for Oncology, Hematology, and Palliative Medicine, Marien Hospital Dusseldorf/Dusseldorf/Allemagne (1 aut.); Department of Haemato-Oncology, King's College London/London/Royaume-Uni (2 aut.); Clinical Hematology Service, Avicenne Hospital, University of Paris XIII/Bobigny/France (3 aut.); Leukemia Program, Cleveland Clinic Taussig Cancer Institute/Cleveland, Ohio/Etats-Unis (4 aut.); Clinical Hematology, Royal Melbourne Hospital/Melbourne/Australie (5 aut.); Medical Clinic and Polyclinic I, University Hospital Carl Gustav Carus Dresden/Dresden/Allemagne (6 aut.); Medical Clinic and Polyclinic A, University Hospital, Heinrich-Heine University of Dusseldorf/Dusseldorf/Allemagne (7 aut.); Division of Hematology, Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont/Novara/Italie (8 aut.); Independent Public Central Hospital Clinic, Medical University of Warsaw/Warsaw/Pologne (9 aut.); Amgen Inc./Thousand Oaks, California/Etats-Unis (10 aut., 11 aut., 12 aut.); Department of Leukemia, The University of Texas MD Anderson Cancer Center/Houston, Texas/Etats-Unis (13 aut.)
DT :	Publication en série; Niveau analytique
SO :	Cancer; ISSN 0008-543X; Coden CANCAR; Etats-Unis; Da. 2014; Vol. 120; No. 12; Pp. 1838-1846; Bibl. 28 ref.
LA :	Anglais
EA :	BACKGROUND: Thrombocytopenia in patients with myelodysplastic syndrome (MDS) is associated with shortened survival and an increased risk of evolution to acute myeloid leukemia (AML). In this study, the authors evaluated the efficacy of romiplostim in patients who had thrombocytopenia with low-risk/intermediate-1-risk MDS. METHODS: Patients who had thrombocytopenia with low-risk/intermediate-1-risk MDS (N=250) were randomized 2:1 to receive romiplostim or placebo weekly for 58 weeks. RESULTS: The primary endpoint- the number of clinically significant bleeding events (CSBEs) per patient-had a hazard ratio for romiplostim:-placebo of 0.83 (95% confidence interval, 0.66-1.05; P=.13). CSBEs were reduced significantly in the romiplostim group for patients who had baseline platelet counts ≥2:20 × 10⁹/L (P<.0001). For patients who had baseline platelet counts <20 × 10⁹/L, there was no difference in the number of CSBEs, but the platelet transfusion rates were higher in the placebo group (P<.0001), which may have affected the overall CSBE results in this group with severe thrombocytopenia. The incidence of bleeding events was reduced significantly in the romiplostim group (relative risk, 0.92), as were protocol-defined platelet transfusions (relative risk, 0.77). Platelet response rates according to 2006 International Working Group criteria were higher for the group that received romiplostim (odds ratio, 15.6). On the basis of interim data, an independent data monitoring committee advised halting study drug because of concerns regarding excess blasts and AML rates with romiplostim (interim hazard ratio, 2.51). At 58 weeks, the AML rates were 6% in the romiplostim group and 4.9% in the placebo group (hazard ratio, 1.20; 95% confidence interval, 0.38-3.84), and the overall survival rates were similar. CONCLUSIONS: Romiplostim treatment in patients with low-risk/intermediate-1-risk MDS increased platelet counts and decreased the number of bleeding events and platelet transfusions. Although study drug was discontinued because of an initial concern of AML risk, survival and AML rates were similar with romiplostim and placebo.
CC :	002B04; 002B19B
FD :	Romiplostim; Randomisation; Etude double insu; Syndrome myélodysplasique; Etude comparative; Placebo; Thrombopénie; Homme; Pharmacothérapie; Chimiothérapie; Cancérologie; Thrombocyte; Risque faible; Essai randomisé contrôlé
FG :	Traitement; Agoniste; Hémopathie maligne; Cancer; Récepteur de la thrombopoïétine
ED :	Romiplostim; Randomization; Double blind study; Myelodysplastic syndrome; Comparative study; Placebo; Thrombocytopenia; Human; Pharmacotherapy; Chemotherapy; Cancerology; Platelet; Low risk; Randomized controlled trial
EG :	Treatment; Agonist; Malignant hemopathy; Cancer
SD :	Romiplostim; Aleatorización; Estudio doble ciego; Mielodisplastico síndrome; Estudio comparativo; Placebo; Trombopenia; Hombre; Farmacoterapia; Quimioterapia; Cancerología; Trombocito; Ensayo aleatorio controlado
LO :	INIST-2701.354000502739460110
ID :	14-0154010

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Pascal:14-0154010

Le document en format XML

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<author><name sortKey="Woodard, Paul" sort="Woodard, Paul" uniqKey="Woodard P" first="Paul" last="Woodard">Paul Woodard</name>
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<author><name sortKey="Yang, Allen S" sort="Yang, Allen S" uniqKey="Yang A" first="Allen S." last="Yang">Allen S. Yang</name>
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<idno type="RBID">Pascal:14-0154010</idno>
<idno type="wicri:Area/PascalFrancis/Corpus">000396</idno>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Results of a Randomized, Double-Blind Study of Romiplostim Versus Placebo in Patients With Low/Intermediate-1-Risk Myelodysplastic Syndrome and Thrombocytopenia</title>
<author><name sortKey="Giagounidis, Aristoteles" sort="Giagounidis, Aristoteles" uniqKey="Giagounidis A" first="Aristoteles" last="Giagounidis">Aristoteles Giagounidis</name>
<affiliation><inist:fA14 i1="01"><s1>Clinic for Oncology, Hematology, and Palliative Medicine, Marien Hospital Dusseldorf</s1>
<s2>Dusseldorf</s2>
<s3>DEU</s3>
<sZ>1 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Mufti, Ghulam J" sort="Mufti, Ghulam J" uniqKey="Mufti G" first="Ghulam J." last="Mufti">Ghulam J. Mufti</name>
<affiliation><inist:fA14 i1="02"><s1>Department of Haemato-Oncology, King's College London</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>2 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Fenaux, Pierre" sort="Fenaux, Pierre" uniqKey="Fenaux P" first="Pierre" last="Fenaux">Pierre Fenaux</name>
<affiliation><inist:fA14 i1="03"><s1>Clinical Hematology Service, Avicenne Hospital, University of Paris XIII</s1>
<s2>Bobigny</s2>
<s3>FRA</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Sekeres, Mikkael A" sort="Sekeres, Mikkael A" uniqKey="Sekeres M" first="Mikkael A." last="Sekeres">Mikkael A. Sekeres</name>
<affiliation><inist:fA14 i1="04"><s1>Leukemia Program, Cleveland Clinic Taussig Cancer Institute</s1>
<s2>Cleveland, Ohio</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Szer, Jeffrey" sort="Szer, Jeffrey" uniqKey="Szer J" first="Jeffrey" last="Szer">Jeffrey Szer</name>
<affiliation><inist:fA14 i1="05"><s1>Clinical Hematology, Royal Melbourne Hospital</s1>
<s2>Melbourne</s2>
<s3>AUS</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Platzbecker, Uwe" sort="Platzbecker, Uwe" uniqKey="Platzbecker U" first="Uwe" last="Platzbecker">Uwe Platzbecker</name>
<affiliation><inist:fA14 i1="06"><s1>Medical Clinic and Polyclinic I, University Hospital Carl Gustav Carus Dresden</s1>
<s2>Dresden</s2>
<s3>DEU</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Kuendgen, Andrea" sort="Kuendgen, Andrea" uniqKey="Kuendgen A" first="Andrea" last="Kuendgen">Andrea Kuendgen</name>
<affiliation><inist:fA14 i1="07"><s1>Medical Clinic and Polyclinic A, University Hospital, Heinrich-Heine University of Dusseldorf</s1>
<s2>Dusseldorf</s2>
<s3>DEU</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Gaidano, Gianluca" sort="Gaidano, Gianluca" uniqKey="Gaidano G" first="Gianluca" last="Gaidano">Gianluca Gaidano</name>
<affiliation><inist:fA14 i1="08"><s1>Division of Hematology, Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont</s1>
<s2>Novara</s2>
<s3>ITA</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Wiktor Jedrzejczak, Wieslaw" sort="Wiktor Jedrzejczak, Wieslaw" uniqKey="Wiktor Jedrzejczak W" first="Wieslaw" last="Wiktor-Jedrzejczak">Wieslaw Wiktor-Jedrzejczak</name>
<affiliation><inist:fA14 i1="09"><s1>Independent Public Central Hospital Clinic, Medical University of Warsaw</s1>
<s2>Warsaw</s2>
<s3>POL</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Kuolung Hu" sort="Kuolung Hu" uniqKey="Kuolung Hu" last="Kuolung Hu">KUOLUNG HU</name>
<affiliation><inist:fA14 i1="10"><s1>Amgen Inc.</s1>
<s2>Thousand Oaks, California</s2>
<s3>USA</s3>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Woodard, Paul" sort="Woodard, Paul" uniqKey="Woodard P" first="Paul" last="Woodard">Paul Woodard</name>
<affiliation><inist:fA14 i1="10"><s1>Amgen Inc.</s1>
<s2>Thousand Oaks, California</s2>
<s3>USA</s3>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Yang, Allen S" sort="Yang, Allen S" uniqKey="Yang A" first="Allen S." last="Yang">Allen S. Yang</name>
<affiliation><inist:fA14 i1="10"><s1>Amgen Inc.</s1>
<s2>Thousand Oaks, California</s2>
<s3>USA</s3>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<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="11"><s1>Department of Leukemia, The University of Texas MD Anderson Cancer Center</s1>
<s2>Houston, Texas</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
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<series><title level="j" type="main">Cancer</title>
<title level="j" type="abbreviated">Cancer</title>
<idno type="ISSN">0008-543X</idno>
<imprint><date when="2014">2014</date>
</imprint>
</series>
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<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>Cancerology</term>
<term>Chemotherapy</term>
<term>Comparative study</term>
<term>Double blind study</term>
<term>Human</term>
<term>Low risk</term>
<term>Myelodysplastic syndrome</term>
<term>Pharmacotherapy</term>
<term>Placebo</term>
<term>Platelet</term>
<term>Randomization</term>
<term>Randomized controlled trial</term>
<term>Romiplostim</term>
<term>Thrombocytopenia</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Romiplostim</term>
<term>Randomisation</term>
<term>Etude double insu</term>
<term>Syndrome myélodysplasique</term>
<term>Etude comparative</term>
<term>Placebo</term>
<term>Thrombopénie</term>
<term>Homme</term>
<term>Pharmacothérapie</term>
<term>Chimiothérapie</term>
<term>Cancérologie</term>
<term>Thrombocyte</term>
<term>Risque faible</term>
<term>Essai randomisé contrôlé</term>
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<front><div type="abstract" xml:lang="en">BACKGROUND: Thrombocytopenia in patients with myelodysplastic syndrome (MDS) is associated with shortened survival and an increased risk of evolution to acute myeloid leukemia (AML). In this study, the authors evaluated the efficacy of romiplostim in patients who had thrombocytopenia with low-risk/intermediate-1-risk MDS. METHODS: Patients who had thrombocytopenia with low-risk/intermediate-1-risk MDS (N=250) were randomized 2:1 to receive romiplostim or placebo weekly for 58 weeks. RESULTS: The primary endpoint- the number of clinically significant bleeding events (CSBEs) per patient-had a hazard ratio for romiplostim:-placebo of 0.83 (95% confidence interval, 0.66-1.05; P=.13). CSBEs were reduced significantly in the romiplostim group for patients who had baseline platelet counts ≥2:20 × 10<sup>9</sup>
/L (P<.0001). For patients who had baseline platelet counts <20 × 10<sup>9</sup>
/L, there was no difference in the number of CSBEs, but the platelet transfusion rates were higher in the placebo group (P<.0001), which may have affected the overall CSBE results in this group with severe thrombocytopenia. The incidence of bleeding events was reduced significantly in the romiplostim group (relative risk, 0.92), as were protocol-defined platelet transfusions (relative risk, 0.77). Platelet response rates according to 2006 International Working Group criteria were higher for the group that received romiplostim (odds ratio, 15.6). On the basis of interim data, an independent data monitoring committee advised halting study drug because of concerns regarding excess blasts and AML rates with romiplostim (interim hazard ratio, 2.51). At 58 weeks, the AML rates were 6% in the romiplostim group and 4.9% in the placebo group (hazard ratio, 1.20; 95% confidence interval, 0.38-3.84), and the overall survival rates were similar. CONCLUSIONS: Romiplostim treatment in patients with low-risk/intermediate-1-risk MDS increased platelet counts and decreased the number of bleeding events and platelet transfusions. Although study drug was discontinued because of an initial concern of AML risk, survival and AML rates were similar with romiplostim and placebo.</div>
</front>
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<fA08 i1="01" i2="1" l="ENG"><s1>Results of a Randomized, Double-Blind Study of Romiplostim Versus Placebo in Patients With Low/Intermediate-1-Risk Myelodysplastic Syndrome and Thrombocytopenia</s1>
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<fA14 i1="01"><s1>Clinic for Oncology, Hematology, and Palliative Medicine, Marien Hospital Dusseldorf</s1>
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<sZ>1 aut.</sZ>
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<fA14 i1="04"><s1>Leukemia Program, Cleveland Clinic Taussig Cancer Institute</s1>
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<fA14 i1="05"><s1>Clinical Hematology, Royal Melbourne Hospital</s1>
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<sZ>5 aut.</sZ>
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<fA14 i1="06"><s1>Medical Clinic and Polyclinic I, University Hospital Carl Gustav Carus Dresden</s1>
<s2>Dresden</s2>
<s3>DEU</s3>
<sZ>6 aut.</sZ>
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<fA14 i1="07"><s1>Medical Clinic and Polyclinic A, University Hospital, Heinrich-Heine University of Dusseldorf</s1>
<s2>Dusseldorf</s2>
<s3>DEU</s3>
<sZ>7 aut.</sZ>
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<fA14 i1="08"><s1>Division of Hematology, Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont</s1>
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<s3>ITA</s3>
<sZ>8 aut.</sZ>
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<fA14 i1="09"><s1>Independent Public Central Hospital Clinic, Medical University of Warsaw</s1>
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<sZ>9 aut.</sZ>
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<fA14 i1="10"><s1>Amgen Inc.</s1>
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<s3>USA</s3>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</fA14>
<fA14 i1="11"><s1>Department of Leukemia, The University of Texas MD Anderson Cancer Center</s1>
<s2>Houston, Texas</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
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<fA20><s1>1838-1846</s1>
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<fC01 i1="01" l="ENG"><s0>BACKGROUND: Thrombocytopenia in patients with myelodysplastic syndrome (MDS) is associated with shortened survival and an increased risk of evolution to acute myeloid leukemia (AML). In this study, the authors evaluated the efficacy of romiplostim in patients who had thrombocytopenia with low-risk/intermediate-1-risk MDS. METHODS: Patients who had thrombocytopenia with low-risk/intermediate-1-risk MDS (N=250) were randomized 2:1 to receive romiplostim or placebo weekly for 58 weeks. RESULTS: The primary endpoint- the number of clinically significant bleeding events (CSBEs) per patient-had a hazard ratio for romiplostim:-placebo of 0.83 (95% confidence interval, 0.66-1.05; P=.13). CSBEs were reduced significantly in the romiplostim group for patients who had baseline platelet counts ≥2:20 × 10<sup>9</sup>
/L (P<.0001). For patients who had baseline platelet counts <20 × 10<sup>9</sup>
/L, there was no difference in the number of CSBEs, but the platelet transfusion rates were higher in the placebo group (P<.0001), which may have affected the overall CSBE results in this group with severe thrombocytopenia. The incidence of bleeding events was reduced significantly in the romiplostim group (relative risk, 0.92), as were protocol-defined platelet transfusions (relative risk, 0.77). Platelet response rates according to 2006 International Working Group criteria were higher for the group that received romiplostim (odds ratio, 15.6). On the basis of interim data, an independent data monitoring committee advised halting study drug because of concerns regarding excess blasts and AML rates with romiplostim (interim hazard ratio, 2.51). At 58 weeks, the AML rates were 6% in the romiplostim group and 4.9% in the placebo group (hazard ratio, 1.20; 95% confidence interval, 0.38-3.84), and the overall survival rates were similar. CONCLUSIONS: Romiplostim treatment in patients with low-risk/intermediate-1-risk MDS increased platelet counts and decreased the number of bleeding events and platelet transfusions. Although study drug was discontinued because of an initial concern of AML risk, survival and AML rates were similar with romiplostim and placebo.</s0>
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<fC07 i1="03" i2="X" l="ENG"><s0>Malignant hemopathy</s0>
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<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Hemopatía maligna</s0>
<s2>NM</s2>
<s5>38</s5>
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<fC07 i1="04" i2="X" l="FRE"><s0>Cancer</s0>
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<fC07 i1="04" i2="X" l="ENG"><s0>Cancer</s0>
<s2>NM</s2>
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<fC07 i1="04" i2="X" l="SPA"><s0>Cáncer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="05" i2="X" l="FRE"><s0>Récepteur de la thrombopoïétine</s0>
<s4>INC</s4>
<s5>86</s5>
</fC07>
<fN21><s1>195</s1>
</fN21>
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<server><NO>PASCAL 14-0154010 INIST</NO>
<ET>Results of a Randomized, Double-Blind Study of Romiplostim Versus Placebo in Patients With Low/Intermediate-1-Risk Myelodysplastic Syndrome and Thrombocytopenia</ET>
<AU>GIAGOUNIDIS (Aristoteles); MUFTI (Ghulam J.); FENAUX (Pierre); SEKERES (Mikkael A.); SZER (Jeffrey); PLATZBECKER (Uwe); KUENDGEN (Andrea); GAIDANO (Gianluca); WIKTOR-JEDRZEJCZAK (Wieslaw); KUOLUNG HU; WOODARD (Paul); YANG (Allen S.); KANTARJIAN (Hagop M.)</AU>
<AF>Clinic for Oncology, Hematology, and Palliative Medicine, Marien Hospital Dusseldorf/Dusseldorf/Allemagne (1 aut.); Department of Haemato-Oncology, King's College London/London/Royaume-Uni (2 aut.); Clinical Hematology Service, Avicenne Hospital, University of Paris XIII/Bobigny/France (3 aut.); Leukemia Program, Cleveland Clinic Taussig Cancer Institute/Cleveland, Ohio/Etats-Unis (4 aut.); Clinical Hematology, Royal Melbourne Hospital/Melbourne/Australie (5 aut.); Medical Clinic and Polyclinic I, University Hospital Carl Gustav Carus Dresden/Dresden/Allemagne (6 aut.); Medical Clinic and Polyclinic A, University Hospital, Heinrich-Heine University of Dusseldorf/Dusseldorf/Allemagne (7 aut.); Division of Hematology, Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont/Novara/Italie (8 aut.); Independent Public Central Hospital Clinic, Medical University of Warsaw/Warsaw/Pologne (9 aut.); Amgen Inc./Thousand Oaks, California/Etats-Unis (10 aut., 11 aut., 12 aut.); Department of Leukemia, The University of Texas MD Anderson Cancer Center/Houston, Texas/Etats-Unis (13 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Cancer; ISSN 0008-543X; Coden CANCAR; Etats-Unis; Da. 2014; Vol. 120; No. 12; Pp. 1838-1846; Bibl. 28 ref.</SO>
<LA>Anglais</LA>
<EA>BACKGROUND: Thrombocytopenia in patients with myelodysplastic syndrome (MDS) is associated with shortened survival and an increased risk of evolution to acute myeloid leukemia (AML). In this study, the authors evaluated the efficacy of romiplostim in patients who had thrombocytopenia with low-risk/intermediate-1-risk MDS. METHODS: Patients who had thrombocytopenia with low-risk/intermediate-1-risk MDS (N=250) were randomized 2:1 to receive romiplostim or placebo weekly for 58 weeks. RESULTS: The primary endpoint- the number of clinically significant bleeding events (CSBEs) per patient-had a hazard ratio for romiplostim:-placebo of 0.83 (95% confidence interval, 0.66-1.05; P=.13). CSBEs were reduced significantly in the romiplostim group for patients who had baseline platelet counts ≥2:20 × 10<sup>9</sup>
/L (P<.0001). For patients who had baseline platelet counts <20 × 10<sup>9</sup>
/L, there was no difference in the number of CSBEs, but the platelet transfusion rates were higher in the placebo group (P<.0001), which may have affected the overall CSBE results in this group with severe thrombocytopenia. The incidence of bleeding events was reduced significantly in the romiplostim group (relative risk, 0.92), as were protocol-defined platelet transfusions (relative risk, 0.77). Platelet response rates according to 2006 International Working Group criteria were higher for the group that received romiplostim (odds ratio, 15.6). On the basis of interim data, an independent data monitoring committee advised halting study drug because of concerns regarding excess blasts and AML rates with romiplostim (interim hazard ratio, 2.51). At 58 weeks, the AML rates were 6% in the romiplostim group and 4.9% in the placebo group (hazard ratio, 1.20; 95% confidence interval, 0.38-3.84), and the overall survival rates were similar. CONCLUSIONS: Romiplostim treatment in patients with low-risk/intermediate-1-risk MDS increased platelet counts and decreased the number of bleeding events and platelet transfusions. Although study drug was discontinued because of an initial concern of AML risk, survival and AML rates were similar with romiplostim and placebo.</EA>
<CC>002B04; 002B19B</CC>
<FD>Romiplostim; Randomisation; Etude double insu; Syndrome myélodysplasique; Etude comparative; Placebo; Thrombopénie; Homme; Pharmacothérapie; Chimiothérapie; Cancérologie; Thrombocyte; Risque faible; Essai randomisé contrôlé</FD>
<FG>Traitement; Agoniste; Hémopathie maligne; Cancer; Récepteur de la thrombopoïétine</FG>
<ED>Romiplostim; Randomization; Double blind study; Myelodysplastic syndrome; Comparative study; Placebo; Thrombocytopenia; Human; Pharmacotherapy; Chemotherapy; Cancerology; Platelet; Low risk; Randomized controlled trial</ED>
<EG>Treatment; Agonist; Malignant hemopathy; Cancer</EG>
<SD>Romiplostim; Aleatorización; Estudio doble ciego; Mielodisplastico síndrome; Estudio comparativo; Placebo; Trombopenia; Hombre; Farmacoterapia; Quimioterapia; Cancerología; Trombocito; Ensayo aleatorio controlado</SD>
<LO>INIST-2701.354000502739460110</LO>
<ID>14-0154010</ID>
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Results of a Randomized, Double-Blind Study of Romiplostim Versus Placebo in Patients With Low/Intermediate-1-Risk Myelodysplastic Syndrome and Thrombocytopenia

Results of a Randomized, Double-Blind Study of Romiplostim Versus Placebo in Patients With Low/Intermediate-1-Risk Myelodysplastic Syndrome and Thrombocytopenia

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