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Carfilzomib–dexamethasone vs bortezomib–dexamethasone in relapsed or refractory multiple myeloma by cytogenetic risk in the phase 3 study ENDEAVOR

Identifieur interne : 001040 ( Main/Exploration ); précédent : 001039; suivant : 001041

Carfilzomib–dexamethasone vs bortezomib–dexamethasone in relapsed or refractory multiple myeloma by cytogenetic risk in the phase 3 study ENDEAVOR

Auteurs : W-J Chng [Singapour] ; H. Goldschmidt [Allemagne] ; M A Dimopoulos [Grèce] ; P. Moreau [France] ; D. Joshua [Australie] ; A. Palumbo [Italie] ; T. Facon [France] ; H. Ludwig [Autriche] ; L. Pour [République tchèque] ; R. Niesvizky [États-Unis] ; A. Oriol [Espagne] ; L. Rosi Ol [Espagne] ; A. Suvorov [Russie] ; G. Gaidano [Italie] ; T. Pika [République tchèque] ; K. Weisel [Allemagne] ; V. Goranova-Marinova [Bulgarie] ; H H Gillenwater [États-Unis] ; N. Mohamed [États-Unis] ; S. Feng [États-Unis] ; S. Aggarwal [États-Unis] ; R. Hájek [République tchèque]

Source :

RBID : PMC:5467042

Descripteurs français

English descriptors

Abstract

The randomized phase 3 study ENDEAVOR demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for carfilzomib and dexamethasone (Kd) vs bortezomib and dexamethasone (Vd) in relapsed or refractory multiple myeloma (MM). We conducted a preplanned subgroup analysis of ENDEAVOR to evaluate Kd vs Vd by cytogenetic risk. Of 785 patients with known cytogenetics, 210 (27%) had high-risk cytogenetics (Kd, n=97 (25%); Vd, n=113 (28%)) and 575 (73%) had standard-risk cytogenetics (Kd, n=284 (75%); Vd, n=291 (72%)). Median PFS in the high-risk group was 8.8 months for Kd vs 6.0 months for Vd (hazard ratio (HR), 0.65; 95% confidence interval (CI), 0.45–0.92; P=0.0075). Median PFS in the standard-risk group was not estimable for Kd vs 10.2 months for Vd (HR, 0.44; 95% CI, 0.33–0.58; P<0.0001). Overall response rates were 72.2% (Kd) vs 58.4% (Vd) in the high-risk group and 79.2% (Kd) vs 66.0% (Vd) in the standard-risk group. In the high-risk group, 15.5% (Kd) vs 4.4% (Vd) achieved a complete response (CR) or better. In the standard-risk group, 13.0% (Kd) vs 7.9% (Vd) achieved ⩾CR. This preplanned subgroup analysis found that Kd was superior to Vd in relapsed or refractory MM, regardless of cytogenetic risk.


Url:
DOI: 10.1038/leu.2016.390
PubMed: 28025582
PubMed Central: 5467042


Affiliations:


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Le document en format XML

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<title xml:lang="en">Carfilzomib–dexamethasone vs bortezomib–dexamethasone in relapsed or refractory multiple myeloma by cytogenetic risk in the phase 3 study ENDEAVOR</title>
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<name sortKey="Chng, W J" sort="Chng, W J" uniqKey="Chng W" first="W-J" last="Chng">W-J Chng</name>
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<institution>Department of Haematology-Oncology, National University Cancer Institute, National University Health System</institution>
, Singapore,
<country>Singapore</country>
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<country xml:lang="fr">Singapour</country>
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<institution>Department of Haematology-Oncology, Cancer Science Institute of Singapore, National University of Singapore</institution>
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<country xml:lang="fr">Singapour</country>
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<name sortKey="Goldschmidt, H" sort="Goldschmidt, H" uniqKey="Goldschmidt H" first="H" last="Goldschmidt">H. Goldschmidt</name>
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<country xml:lang="fr">Allemagne</country>
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<name sortKey="Dimopoulos, M A" sort="Dimopoulos, M A" uniqKey="Dimopoulos M" first="M A" last="Dimopoulos">M A Dimopoulos</name>
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<institution>School of Medicine, National and Kapodistrian University of Athens</institution>
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<name sortKey="Moreau, P" sort="Moreau, P" uniqKey="Moreau P" first="P" last="Moreau">P. Moreau</name>
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<institution>Department of Oncology, University of Torino</institution>
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<country xml:lang="fr">Italie</country>
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<institution>Department of Haematology, CHRU Lille Hôpital Claude Huriez</institution>
, Lille,
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</nlm:aff>
<country xml:lang="fr">France</country>
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<name sortKey="Ludwig, H" sort="Ludwig, H" uniqKey="Ludwig H" first="H" last="Ludwig">H. Ludwig</name>
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<institution>Department of Medicine, Wilhelminen Cancer Research Institute, Wilhelminenspital</institution>
, Vienna,
<country>Austria</country>
</nlm:aff>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<name sortKey="Pour, L" sort="Pour, L" uniqKey="Pour L" first="L" last="Pour">L. Pour</name>
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<institution>Myeloma Group, University Hospital Brno</institution>
, Brno,
<country>Czech Republic</country>
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<country xml:lang="fr">République tchèque</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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, New York, NY,
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<country xml:lang="fr">États-Unis</country>
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<institution>Department of Clinical Haematology, Institut Català d'Oncologia, Institut Josep Carreras, Hospital Germans Trias i Pujol</institution>
, Barcelona,
<country>Spain</country>
</nlm:aff>
<country xml:lang="fr">Espagne</country>
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<name sortKey="Rosi Ol, L" sort="Rosi Ol, L" uniqKey="Rosi Ol L" first="L" last="Rosi Ol">L. Rosi Ol</name>
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<institution>Department of Haematology, Hospital Clínic de Barcelona</institution>
, Barcelona,
<country>Spain</country>
</nlm:aff>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<name sortKey="Suvorov, A" sort="Suvorov, A" uniqKey="Suvorov A" first="A" last="Suvorov">A. Suvorov</name>
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<institution>Hematological Department, First Republican Clinical Hospital of Udmurtia</institution>
, Izhevsk,
<country>Russia</country>
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<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<name sortKey="Gaidano, G" sort="Gaidano, G" uniqKey="Gaidano G" first="G" last="Gaidano">G. Gaidano</name>
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<institution>Division of Hematology, Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont</institution>
, Novara,
<country>Italy</country>
</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<name sortKey="Pika, T" sort="Pika, T" uniqKey="Pika T" first="T" last="Pika">T. Pika</name>
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<institution>Department of Hematooncology, University Hospital Olomouc</institution>
, Olomouc,
<country>Czech Republic</country>
</nlm:aff>
<country xml:lang="fr">République tchèque</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<name sortKey="Weisel, K" sort="Weisel, K" uniqKey="Weisel K" first="K" last="Weisel">K. Weisel</name>
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<institution>Myeloma Clinic, Universitatsklinikum Tubingen</institution>
, Tubingen,
<country>Germany</country>
</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
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<author>
<name sortKey="Goranova Marinova, V" sort="Goranova Marinova, V" uniqKey="Goranova Marinova V" first="V" last="Goranova-Marinova">V. Goranova-Marinova</name>
<affiliation wicri:level="1">
<nlm:aff id="aff18">
<institution>Haematooncology Clinic, University Multiprofile Hospital for Active Treatment ‘Sveti Georgi' and Medical University</institution>
, Plovdiv,
<country>Bulgaria</country>
</nlm:aff>
<country xml:lang="fr">Bulgarie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
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<name sortKey="Gillenwater, H H" sort="Gillenwater, H H" uniqKey="Gillenwater H" first="H H" last="Gillenwater">H H Gillenwater</name>
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<nlm:aff id="aff19">
<institution>Onyx Pharmaceuticals, Inc., an Amgen subsidiary</institution>
, South San Francisco, CA,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<author>
<name sortKey="Mohamed, N" sort="Mohamed, N" uniqKey="Mohamed N" first="N" last="Mohamed">N. Mohamed</name>
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<nlm:aff id="aff19">
<institution>Onyx Pharmaceuticals, Inc., an Amgen subsidiary</institution>
, South San Francisco, CA,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<name sortKey="Feng, S" sort="Feng, S" uniqKey="Feng S" first="S" last="Feng">S. Feng</name>
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<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<name sortKey="Aggarwal, S" sort="Aggarwal, S" uniqKey="Aggarwal S" first="S" last="Aggarwal">S. Aggarwal</name>
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, South San Francisco, CA,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
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<name sortKey="Hajek, R" sort="Hajek, R" uniqKey="Hajek R" first="R" last="Hájek">R. Hájek</name>
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<nlm:aff id="aff20">
<institution>Department of Haematooncology, University Hospital Ostrava, Faculty of Medicine, University of Ostrava</institution>
, Ostrava,
<country>Czech Republic</country>
</nlm:aff>
<country xml:lang="fr">République tchèque</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<title xml:lang="en" level="a" type="main">Carfilzomib–dexamethasone vs bortezomib–dexamethasone in relapsed or refractory multiple myeloma by cytogenetic risk in the phase 3 study ENDEAVOR</title>
<author>
<name sortKey="Chng, W J" sort="Chng, W J" uniqKey="Chng W" first="W-J" last="Chng">W-J Chng</name>
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<nlm:aff id="aff1">
<institution>Department of Haematology-Oncology, National University Cancer Institute, National University Health System</institution>
, Singapore,
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</nlm:aff>
<country xml:lang="fr">Singapour</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1">
<nlm:aff id="aff2">
<institution>Department of Haematology-Oncology, Cancer Science Institute of Singapore, National University of Singapore</institution>
, Singapore,
<country>Singapore</country>
</nlm:aff>
<country xml:lang="fr">Singapour</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
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<name sortKey="Goldschmidt, H" sort="Goldschmidt, H" uniqKey="Goldschmidt H" first="H" last="Goldschmidt">H. Goldschmidt</name>
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<nlm:aff id="aff3">
<institution>Department of Internal Medicine, Heidelberg Medical University</institution>
, Heidelberg,
<country>Germany</country>
</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Dimopoulos, M A" sort="Dimopoulos, M A" uniqKey="Dimopoulos M" first="M A" last="Dimopoulos">M A Dimopoulos</name>
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<nlm:aff id="aff4">
<institution>School of Medicine, National and Kapodistrian University of Athens</institution>
, Athens,
<country>Greece</country>
</nlm:aff>
<country xml:lang="fr">Grèce</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Moreau, P" sort="Moreau, P" uniqKey="Moreau P" first="P" last="Moreau">P. Moreau</name>
<affiliation wicri:level="1">
<nlm:aff id="aff5">
<institution>Department of Haematology, University of Nantes</institution>
, Nantes,
<country>France</country>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
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<author>
<name sortKey="Joshua, D" sort="Joshua, D" uniqKey="Joshua D" first="D" last="Joshua">D. Joshua</name>
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<institution>Department of Haematology, Royal Prince Alfred Hospital</institution>
, Camperdown, New South Wales,
<country>Australia</country>
</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Palumbo, A" sort="Palumbo, A" uniqKey="Palumbo A" first="A" last="Palumbo">A. Palumbo</name>
<affiliation wicri:level="1">
<nlm:aff id="aff7">
<institution>Department of Oncology, University of Torino</institution>
, Torino,
<country>Italy</country>
</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Facon, T" sort="Facon, T" uniqKey="Facon T" first="T" last="Facon">T. Facon</name>
<affiliation wicri:level="1">
<nlm:aff id="aff8">
<institution>Department of Haematology, CHRU Lille Hôpital Claude Huriez</institution>
, Lille,
<country>France</country>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Ludwig, H" sort="Ludwig, H" uniqKey="Ludwig H" first="H" last="Ludwig">H. Ludwig</name>
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<nlm:aff id="aff9">
<institution>Department of Medicine, Wilhelminen Cancer Research Institute, Wilhelminenspital</institution>
, Vienna,
<country>Austria</country>
</nlm:aff>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Pour, L" sort="Pour, L" uniqKey="Pour L" first="L" last="Pour">L. Pour</name>
<affiliation wicri:level="1">
<nlm:aff id="aff10">
<institution>Myeloma Group, University Hospital Brno</institution>
, Brno,
<country>Czech Republic</country>
</nlm:aff>
<country xml:lang="fr">République tchèque</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Niesvizky, R" sort="Niesvizky, R" uniqKey="Niesvizky R" first="R" last="Niesvizky">R. Niesvizky</name>
<affiliation wicri:level="1">
<nlm:aff id="aff11">
<institution>Multiple Myeloma Center, Weill Cornell Medical College, New York Presbyterian Hospital</institution>
, New York, NY,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Oriol, A" sort="Oriol, A" uniqKey="Oriol A" first="A" last="Oriol">A. Oriol</name>
<affiliation wicri:level="1">
<nlm:aff id="aff12">
<institution>Department of Clinical Haematology, Institut Català d'Oncologia, Institut Josep Carreras, Hospital Germans Trias i Pujol</institution>
, Barcelona,
<country>Spain</country>
</nlm:aff>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Rosi Ol, L" sort="Rosi Ol, L" uniqKey="Rosi Ol L" first="L" last="Rosi Ol">L. Rosi Ol</name>
<affiliation wicri:level="1">
<nlm:aff id="aff13">
<institution>Department of Haematology, Hospital Clínic de Barcelona</institution>
, Barcelona,
<country>Spain</country>
</nlm:aff>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Suvorov, A" sort="Suvorov, A" uniqKey="Suvorov A" first="A" last="Suvorov">A. Suvorov</name>
<affiliation wicri:level="1">
<nlm:aff id="aff14">
<institution>Hematological Department, First Republican Clinical Hospital of Udmurtia</institution>
, Izhevsk,
<country>Russia</country>
</nlm:aff>
<country xml:lang="fr">Russie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Gaidano, G" sort="Gaidano, G" uniqKey="Gaidano G" first="G" last="Gaidano">G. Gaidano</name>
<affiliation wicri:level="1">
<nlm:aff id="aff15">
<institution>Division of Hematology, Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont</institution>
, Novara,
<country>Italy</country>
</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Pika, T" sort="Pika, T" uniqKey="Pika T" first="T" last="Pika">T. Pika</name>
<affiliation wicri:level="1">
<nlm:aff id="aff16">
<institution>Department of Hematooncology, University Hospital Olomouc</institution>
, Olomouc,
<country>Czech Republic</country>
</nlm:aff>
<country xml:lang="fr">République tchèque</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Weisel, K" sort="Weisel, K" uniqKey="Weisel K" first="K" last="Weisel">K. Weisel</name>
<affiliation wicri:level="1">
<nlm:aff id="aff17">
<institution>Myeloma Clinic, Universitatsklinikum Tubingen</institution>
, Tubingen,
<country>Germany</country>
</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Goranova Marinova, V" sort="Goranova Marinova, V" uniqKey="Goranova Marinova V" first="V" last="Goranova-Marinova">V. Goranova-Marinova</name>
<affiliation wicri:level="1">
<nlm:aff id="aff18">
<institution>Haematooncology Clinic, University Multiprofile Hospital for Active Treatment ‘Sveti Georgi' and Medical University</institution>
, Plovdiv,
<country>Bulgaria</country>
</nlm:aff>
<country xml:lang="fr">Bulgarie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Gillenwater, H H" sort="Gillenwater, H H" uniqKey="Gillenwater H" first="H H" last="Gillenwater">H H Gillenwater</name>
<affiliation wicri:level="1">
<nlm:aff id="aff19">
<institution>Onyx Pharmaceuticals, Inc., an Amgen subsidiary</institution>
, South San Francisco, CA,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Mohamed, N" sort="Mohamed, N" uniqKey="Mohamed N" first="N" last="Mohamed">N. Mohamed</name>
<affiliation wicri:level="1">
<nlm:aff id="aff19">
<institution>Onyx Pharmaceuticals, Inc., an Amgen subsidiary</institution>
, South San Francisco, CA,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Feng, S" sort="Feng, S" uniqKey="Feng S" first="S" last="Feng">S. Feng</name>
<affiliation wicri:level="1">
<nlm:aff id="aff19">
<institution>Onyx Pharmaceuticals, Inc., an Amgen subsidiary</institution>
, South San Francisco, CA,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Aggarwal, S" sort="Aggarwal, S" uniqKey="Aggarwal S" first="S" last="Aggarwal">S. Aggarwal</name>
<affiliation wicri:level="1">
<nlm:aff id="aff19">
<institution>Onyx Pharmaceuticals, Inc., an Amgen subsidiary</institution>
, South San Francisco, CA,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Hajek, R" sort="Hajek, R" uniqKey="Hajek R" first="R" last="Hájek">R. Hájek</name>
<affiliation wicri:level="1">
<nlm:aff id="aff20">
<institution>Department of Haematooncology, University Hospital Ostrava, Faculty of Medicine, University of Ostrava</institution>
, Ostrava,
<country>Czech Republic</country>
</nlm:aff>
<country xml:lang="fr">République tchèque</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
</analytic>
<series>
<title level="j">Leukemia</title>
<idno type="ISSN">0887-6924</idno>
<idno type="eISSN">1476-5551</idno>
<imprint>
<date when="2017">2017</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc>
<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Adult</term>
<term>Antineoplastic Combined Chemotherapy Protocols (therapeutic use)</term>
<term>Biomarkers, Tumor</term>
<term>Bortezomib (administration & dosage)</term>
<term>Chromosome Aberrations</term>
<term>Cytogenetic Analysis</term>
<term>Dexamethasone (administration & dosage)</term>
<term>Drug Resistance, Neoplasm (drug effects)</term>
<term>Drug Resistance, Neoplasm (genetics)</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Male</term>
<term>Multiple Myeloma (drug therapy)</term>
<term>Multiple Myeloma (genetics)</term>
<term>Multiple Myeloma (pathology)</term>
<term>Neoplasm Grading</term>
<term>Neoplasm Recurrence, Local (drug therapy)</term>
<term>Neoplasm Recurrence, Local (genetics)</term>
<term>Neoplasm Recurrence, Local (pathology)</term>
<term>Oligopeptides (administration & dosage)</term>
<term>Prognosis</term>
<term>Remission Induction</term>
<term>Salvage Therapy</term>
<term>Survival Rate</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr">
<term>Aberrations des chromosomes</term>
<term>Adulte</term>
<term>Analyse cytogénétique</term>
<term>Bortézomib (administration et posologie)</term>
<term>Dexaméthasone (administration et posologie)</term>
<term>Femelle</term>
<term>Grading des tumeurs</term>
<term>Humains</term>
<term>Induction de rémission</term>
<term>Marqueurs biologiques tumoraux</term>
<term>Myélome multiple (anatomopathologie)</term>
<term>Myélome multiple (génétique)</term>
<term>Myélome multiple (traitement médicamenteux)</term>
<term>Mâle</term>
<term>Oligopeptides (administration et posologie)</term>
<term>Pronostic</term>
<term>Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique)</term>
<term>Récidive tumorale locale (anatomopathologie)</term>
<term>Récidive tumorale locale (génétique)</term>
<term>Récidive tumorale locale (traitement médicamenteux)</term>
<term>Résistance aux médicaments antinéoplasiques ()</term>
<term>Résistance aux médicaments antinéoplasiques (génétique)</term>
<term>Taux de survie</term>
<term>Thérapie de rattrapage</term>
<term>Études de suivi</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en">
<term>Bortezomib</term>
<term>Dexamethasone</term>
<term>Oligopeptides</term>
</keywords>
<keywords scheme="MESH" type="chemical" xml:lang="en">
<term>Biomarkers, Tumor</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr">
<term>Bortézomib</term>
<term>Dexaméthasone</term>
<term>Oligopeptides</term>
</keywords>
<keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr">
<term>Myélome multiple</term>
<term>Récidive tumorale locale</term>
</keywords>
<keywords scheme="MESH" qualifier="drug effects" xml:lang="en">
<term>Drug Resistance, Neoplasm</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en">
<term>Multiple Myeloma</term>
<term>Neoplasm Recurrence, Local</term>
</keywords>
<keywords scheme="MESH" qualifier="genetics" xml:lang="en">
<term>Drug Resistance, Neoplasm</term>
<term>Multiple Myeloma</term>
<term>Neoplasm Recurrence, Local</term>
</keywords>
<keywords scheme="MESH" qualifier="génétique" xml:lang="fr">
<term>Myélome multiple</term>
<term>Récidive tumorale locale</term>
<term>Résistance aux médicaments antinéoplasiques</term>
</keywords>
<keywords scheme="MESH" qualifier="pathology" xml:lang="en">
<term>Multiple Myeloma</term>
<term>Neoplasm Recurrence, Local</term>
</keywords>
<keywords scheme="MESH" qualifier="therapeutic use" xml:lang="en">
<term>Antineoplastic Combined Chemotherapy Protocols</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr">
<term>Myélome multiple</term>
<term>Récidive tumorale locale</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr">
<term>Protocoles de polychimiothérapie antinéoplasique</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Adult</term>
<term>Chromosome Aberrations</term>
<term>Cytogenetic Analysis</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Male</term>
<term>Neoplasm Grading</term>
<term>Prognosis</term>
<term>Remission Induction</term>
<term>Salvage Therapy</term>
<term>Survival Rate</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr">
<term>Aberrations des chromosomes</term>
<term>Adulte</term>
<term>Analyse cytogénétique</term>
<term>Femelle</term>
<term>Grading des tumeurs</term>
<term>Humains</term>
<term>Induction de rémission</term>
<term>Marqueurs biologiques tumoraux</term>
<term>Mâle</term>
<term>Pronostic</term>
<term>Résistance aux médicaments antinéoplasiques</term>
<term>Taux de survie</term>
<term>Thérapie de rattrapage</term>
<term>Études de suivi</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">
<p>The randomized phase 3 study ENDEAVOR demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for carfilzomib and dexamethasone (Kd) vs bortezomib and dexamethasone (Vd) in relapsed or refractory multiple myeloma (MM). We conducted a preplanned subgroup analysis of ENDEAVOR to evaluate Kd vs Vd by cytogenetic risk. Of 785 patients with known cytogenetics, 210 (27%) had high-risk cytogenetics (Kd,
<italic>n</italic>
=97 (25%); Vd,
<italic>n</italic>
=113 (28%)) and 575 (73%) had standard-risk cytogenetics (Kd,
<italic>n</italic>
=284 (75%); Vd,
<italic>n</italic>
=291 (72%)). Median PFS in the high-risk group was 8.8 months for Kd vs 6.0 months for Vd (hazard ratio (HR), 0.65; 95% confidence interval (CI), 0.45–0.92;
<italic>P</italic>
=0.0075). Median PFS in the standard-risk group was not estimable for Kd vs 10.2 months for Vd (HR, 0.44; 95% CI, 0.33–0.58;
<italic>P</italic>
<0.0001). Overall response rates were 72.2% (Kd) vs 58.4% (Vd) in the high-risk group and 79.2% (Kd) vs 66.0% (Vd) in the standard-risk group. In the high-risk group, 15.5% (Kd) vs 4.4% (Vd) achieved a complete response (CR) or better. In the standard-risk group, 13.0% (Kd) vs 7.9% (Vd) achieved ⩾CR. This preplanned subgroup analysis found that Kd was superior to Vd in relapsed or refractory MM, regardless of cytogenetic risk.</p>
</div>
</front>
<back>
<div1 type="bibliography">
<listBibl>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
</listBibl>
</div1>
</back>
</TEI>
<affiliations>
<list>
<country>
<li>Allemagne</li>
<li>Australie</li>
<li>Autriche</li>
<li>Bulgarie</li>
<li>Espagne</li>
<li>France</li>
<li>Grèce</li>
<li>Italie</li>
<li>Russie</li>
<li>République tchèque</li>
<li>Singapour</li>
<li>États-Unis</li>
</country>
</list>
<tree>
<country name="Singapour">
<noRegion>
<name sortKey="Chng, W J" sort="Chng, W J" uniqKey="Chng W" first="W-J" last="Chng">W-J Chng</name>
</noRegion>
<name sortKey="Chng, W J" sort="Chng, W J" uniqKey="Chng W" first="W-J" last="Chng">W-J Chng</name>
</country>
<country name="Allemagne">
<noRegion>
<name sortKey="Goldschmidt, H" sort="Goldschmidt, H" uniqKey="Goldschmidt H" first="H" last="Goldschmidt">H. Goldschmidt</name>
</noRegion>
<name sortKey="Weisel, K" sort="Weisel, K" uniqKey="Weisel K" first="K" last="Weisel">K. Weisel</name>
</country>
<country name="Grèce">
<noRegion>
<name sortKey="Dimopoulos, M A" sort="Dimopoulos, M A" uniqKey="Dimopoulos M" first="M A" last="Dimopoulos">M A Dimopoulos</name>
</noRegion>
</country>
<country name="France">
<noRegion>
<name sortKey="Moreau, P" sort="Moreau, P" uniqKey="Moreau P" first="P" last="Moreau">P. Moreau</name>
</noRegion>
<name sortKey="Facon, T" sort="Facon, T" uniqKey="Facon T" first="T" last="Facon">T. Facon</name>
</country>
<country name="Australie">
<noRegion>
<name sortKey="Joshua, D" sort="Joshua, D" uniqKey="Joshua D" first="D" last="Joshua">D. Joshua</name>
</noRegion>
</country>
<country name="Italie">
<noRegion>
<name sortKey="Palumbo, A" sort="Palumbo, A" uniqKey="Palumbo A" first="A" last="Palumbo">A. Palumbo</name>
</noRegion>
<name sortKey="Gaidano, G" sort="Gaidano, G" uniqKey="Gaidano G" first="G" last="Gaidano">G. Gaidano</name>
</country>
<country name="Autriche">
<noRegion>
<name sortKey="Ludwig, H" sort="Ludwig, H" uniqKey="Ludwig H" first="H" last="Ludwig">H. Ludwig</name>
</noRegion>
</country>
<country name="République tchèque">
<noRegion>
<name sortKey="Pour, L" sort="Pour, L" uniqKey="Pour L" first="L" last="Pour">L. Pour</name>
</noRegion>
<name sortKey="Hajek, R" sort="Hajek, R" uniqKey="Hajek R" first="R" last="Hájek">R. Hájek</name>
<name sortKey="Pika, T" sort="Pika, T" uniqKey="Pika T" first="T" last="Pika">T. Pika</name>
</country>
<country name="États-Unis">
<noRegion>
<name sortKey="Niesvizky, R" sort="Niesvizky, R" uniqKey="Niesvizky R" first="R" last="Niesvizky">R. Niesvizky</name>
</noRegion>
<name sortKey="Aggarwal, S" sort="Aggarwal, S" uniqKey="Aggarwal S" first="S" last="Aggarwal">S. Aggarwal</name>
<name sortKey="Feng, S" sort="Feng, S" uniqKey="Feng S" first="S" last="Feng">S. Feng</name>
<name sortKey="Gillenwater, H H" sort="Gillenwater, H H" uniqKey="Gillenwater H" first="H H" last="Gillenwater">H H Gillenwater</name>
<name sortKey="Mohamed, N" sort="Mohamed, N" uniqKey="Mohamed N" first="N" last="Mohamed">N. Mohamed</name>
</country>
<country name="Espagne">
<noRegion>
<name sortKey="Oriol, A" sort="Oriol, A" uniqKey="Oriol A" first="A" last="Oriol">A. Oriol</name>
</noRegion>
<name sortKey="Rosi Ol, L" sort="Rosi Ol, L" uniqKey="Rosi Ol L" first="L" last="Rosi Ol">L. Rosi Ol</name>
</country>
<country name="Russie">
<noRegion>
<name sortKey="Suvorov, A" sort="Suvorov, A" uniqKey="Suvorov A" first="A" last="Suvorov">A. Suvorov</name>
</noRegion>
</country>
<country name="Bulgarie">
<noRegion>
<name sortKey="Goranova Marinova, V" sort="Goranova Marinova, V" uniqKey="Goranova Marinova V" first="V" last="Goranova-Marinova">V. Goranova-Marinova</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

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