Lenalidomide plus dexamethasone is more effective than dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure
Identifieur interne : 008C23 ( Main/Exploration ); précédent : 008C22; suivant : 008C24Lenalidomide plus dexamethasone is more effective than dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure
Auteurs : Michael Wang [États-Unis] ; Meletios A. Dimopoulos [Grèce] ; Christine Chen [Canada] ; M. Teresa Cibeira [Espagne] ; Michel Attal [France] ; Andrew Spencer [Australie] ; S. Vincent Rajkumar [États-Unis] ; ZHINUAN YU [États-Unis] ; Marta Olesnyckyj [États-Unis] ; Jerome B. Zeldis [États-Unis] ; Robert D. Knight [États-Unis] ; Donna M. Weber [États-Unis]Source :
- Blood [ 0006-4971 ] ; 2008.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
Abstract
This analysis assessed the efficacy and safety of lenalidomide + dexamethasone in patients with relapsed or refractory multiple myeloma (MM) previously treated with thalidomide. Of 704 patients, 39% were thalidomide exposed. Thalidomide-exposed patients had more prior lines of therapy and longer duration of myeloma than thalidomide-naive patients. Lenalidomide + dexamethasone led to higher overall response rate (ORR), longer time to progression (TTP), and progression-free survival (PFS) versus placebo + dexamethasone despite prior thalidomide exposure. Among lenalidomide + dexamethasone-treated patients, ORR was higher in thalidomide-naive versus thalidomide-exposed patients (P = .04), with longer median TTP (P = .04) and PFS (P = .02). Likewise for dexamethasone alone-treated patients (P = .03 for ORR, P = .03 for TTP, P = .06 for PFS). Prior thalidomide did not affect survival in lenalidomide + dexamethasone-treated patients (36.1 vs 33.3 months, P >.05). Thalidomide-naive and thalidomide-exposed patients had similar toxicities. Lenalidomide + dexamethasone resulted in higher rates of venous thromboembolism, myelosuppression, and infections versus placebo + dexamethasone, independent of prior thalidomide exposure. Lenalidomide + dexamethasone was superior to placebo + dexamethasone, independent of prior thalidomide exposure. Although prior thalidomide may have contributed to inferior TTP and PFS compared with thalidomide-naive patients, these parameters remained superior compared with placebo + dexamethasone; similar benefits compared with placebo + dexamethasone were not evident for thalidomide-exposed patients in terms of overall survival. Studies were registered at http://www.clinicaltrials. gov under NCT00056160 and NCT00424047.
Affiliations:
- Australie, Canada, Espagne, France, Grèce, États-Unis
- Attique (région), Catalogne, Midi-Pyrénées, Occitanie (région administrative), Victoria (État)
- Athènes, Barcelone, Melbourne, Toulouse
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Dimopoulos</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Department of Clinical Therapeutics, University of Athens School of Medicine</s1><s2>Athens</s2><s3>GRC</s3><sZ>2 aut.</sZ></inist:fA14><country>Grèce</country><placeName><settlement type="city">Athènes</settlement><region nuts="2" type="region">Attique (région)</region></placeName></affiliation></author><author><name sortKey="Chen, Christine" sort="Chen, Christine" uniqKey="Chen C" first="Christine" last="Chen">Christine Chen</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Department of Medicine, Princess Margaret Hospital</s1><s2>Toronto, ON</s2><s3>CAN</s3><sZ>3 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>Toronto, ON</wicri:noRegion></affiliation></author><author><name sortKey="Cibeira, M Teresa" sort="Cibeira, M Teresa" uniqKey="Cibeira M" first="M. Teresa" last="Cibeira">M. Teresa Cibeira</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Hematology Department, Institute of Hematology and Oncology, Hospital Clinic, Institut d'lnvestigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona</s1><s2>Barcelona</s2><s3>ESP</s3><sZ>4 aut.</sZ></inist:fA14><country>Espagne</country><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Attal, Michel" sort="Attal, Michel" uniqKey="Attal M" first="Michel" last="Attal">Michel Attal</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Division of Hematology, Centre Hospitalier Université de Purpan</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>5 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Spencer, Andrew" sort="Spencer, Andrew" uniqKey="Spencer A" first="Andrew" last="Spencer">Andrew Spencer</name><affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Department of Malignant Hematology and Stem Cell Transplantation Service, The Alfred Hospital</s1><s2>Melbourne</s2><s3>AUS</s3><sZ>6 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Rajkumar, S Vincent" sort="Rajkumar, S Vincent" uniqKey="Rajkumar S" first="S. Vincent" last="Rajkumar">S. Vincent Rajkumar</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Mayo Clinic Cancer Center</s1><s2>Rochester, MN</s2><s3>USA</s3><sZ>7 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Mayo Clinic Cancer Center</wicri:noRegion></affiliation></author><author><name sortKey="Zhinuan Yu" sort="Zhinuan Yu" uniqKey="Zhinuan Yu" last="Zhinuan Yu">ZHINUAN YU</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Celgene</s1><s2>Summit, NJ</s2><s3>USA</s3><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Celgene</wicri:noRegion></affiliation></author><author><name sortKey="Olesnyckyj, Marta" sort="Olesnyckyj, Marta" uniqKey="Olesnyckyj M" first="Marta" last="Olesnyckyj">Marta Olesnyckyj</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Celgene</s1><s2>Summit, NJ</s2><s3>USA</s3><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Celgene</wicri:noRegion></affiliation></author><author><name sortKey="Zeldis, Jerome B" sort="Zeldis, Jerome B" uniqKey="Zeldis J" first="Jerome B." last="Zeldis">Jerome B. Zeldis</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Celgene</s1><s2>Summit, NJ</s2><s3>USA</s3><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Celgene</wicri:noRegion></affiliation></author><author><name sortKey="Knight, Robert D" sort="Knight, Robert D" uniqKey="Knight R" first="Robert D." last="Knight">Robert D. Knight</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Celgene</s1><s2>Summit, NJ</s2><s3>USA</s3><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Celgene</wicri:noRegion></affiliation></author><author><name sortKey="Weber, Donna M" sort="Weber, Donna M" uniqKey="Weber D" first="Donna M." last="Weber">Donna M. Weber</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Lymphoma and Myeloma, M. D. Anderson Cancer Center</s1><s2>Houston, TX</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Houston, TX</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">09-0094441</idno><date when="2008">2008</date><idno type="stanalyst">PASCAL 09-0094441 INIST</idno><idno type="RBID">Pascal:09-0094441</idno><idno type="wicri:Area/PascalFrancis/Corpus">003009</idno><idno type="wicri:Area/PascalFrancis/Curation">003009</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">003108</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">003108</idno><idno type="wicri:doubleKey">0006-4971:2008:Wang M:lenalidomide:plus:dexamethasone</idno><idno type="wicri:Area/Main/Merge">009522</idno><idno type="wicri:Area/Main/Curation">008C23</idno><idno type="wicri:Area/Main/Exploration">008C23</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Lenalidomide plus dexamethasone is more effective than dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure</title><author><name sortKey="Wang, Michael" sort="Wang, Michael" uniqKey="Wang M" first="Michael" last="Wang">Michael Wang</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Lymphoma and Myeloma, M. D. Anderson Cancer Center</s1><s2>Houston, TX</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Houston, TX</wicri:noRegion></affiliation></author><author><name sortKey="Dimopoulos, Meletios A" sort="Dimopoulos, Meletios A" uniqKey="Dimopoulos M" first="Meletios A." last="Dimopoulos">Meletios A. Dimopoulos</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Department of Clinical Therapeutics, University of Athens School of Medicine</s1><s2>Athens</s2><s3>GRC</s3><sZ>2 aut.</sZ></inist:fA14><country>Grèce</country><placeName><settlement type="city">Athènes</settlement><region nuts="2" type="region">Attique (région)</region></placeName></affiliation></author><author><name sortKey="Chen, Christine" sort="Chen, Christine" uniqKey="Chen C" first="Christine" last="Chen">Christine Chen</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Department of Medicine, Princess Margaret Hospital</s1><s2>Toronto, ON</s2><s3>CAN</s3><sZ>3 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>Toronto, ON</wicri:noRegion></affiliation></author><author><name sortKey="Cibeira, M Teresa" sort="Cibeira, M Teresa" uniqKey="Cibeira M" first="M. Teresa" last="Cibeira">M. Teresa Cibeira</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Hematology Department, Institute of Hematology and Oncology, Hospital Clinic, Institut d'lnvestigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona</s1><s2>Barcelona</s2><s3>ESP</s3><sZ>4 aut.</sZ></inist:fA14><country>Espagne</country><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Attal, Michel" sort="Attal, Michel" uniqKey="Attal M" first="Michel" last="Attal">Michel Attal</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Division of Hematology, Centre Hospitalier Université de Purpan</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>5 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Spencer, Andrew" sort="Spencer, Andrew" uniqKey="Spencer A" first="Andrew" last="Spencer">Andrew Spencer</name><affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Department of Malignant Hematology and Stem Cell Transplantation Service, The Alfred Hospital</s1><s2>Melbourne</s2><s3>AUS</s3><sZ>6 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Rajkumar, S Vincent" sort="Rajkumar, S Vincent" uniqKey="Rajkumar S" first="S. Vincent" last="Rajkumar">S. Vincent Rajkumar</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Mayo Clinic Cancer Center</s1><s2>Rochester, MN</s2><s3>USA</s3><sZ>7 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Mayo Clinic Cancer Center</wicri:noRegion></affiliation></author><author><name sortKey="Zhinuan Yu" sort="Zhinuan Yu" uniqKey="Zhinuan Yu" last="Zhinuan Yu">ZHINUAN YU</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Celgene</s1><s2>Summit, NJ</s2><s3>USA</s3><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Celgene</wicri:noRegion></affiliation></author><author><name sortKey="Olesnyckyj, Marta" sort="Olesnyckyj, Marta" uniqKey="Olesnyckyj M" first="Marta" last="Olesnyckyj">Marta Olesnyckyj</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Celgene</s1><s2>Summit, NJ</s2><s3>USA</s3><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Celgene</wicri:noRegion></affiliation></author><author><name sortKey="Zeldis, Jerome B" sort="Zeldis, Jerome B" uniqKey="Zeldis J" first="Jerome B." last="Zeldis">Jerome B. Zeldis</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Celgene</s1><s2>Summit, NJ</s2><s3>USA</s3><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Celgene</wicri:noRegion></affiliation></author><author><name sortKey="Knight, Robert D" sort="Knight, Robert D" uniqKey="Knight R" first="Robert D." last="Knight">Robert D. Knight</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Celgene</s1><s2>Summit, NJ</s2><s3>USA</s3><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Celgene</wicri:noRegion></affiliation></author><author><name sortKey="Weber, Donna M" sort="Weber, Donna M" uniqKey="Weber D" first="Donna M." last="Weber">Donna M. Weber</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Lymphoma and Myeloma, M. D. Anderson Cancer Center</s1><s2>Houston, TX</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Houston, TX</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">Blood</title><title level="j" type="abbreviated">Blood</title><idno type="ISSN">0006-4971</idno><imprint><date when="2008">2008</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Blood</title><title level="j" type="abbreviated">Blood</title><idno type="ISSN">0006-4971</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiangiogenic agent</term><term>Antineoplastic agent</term><term>Dexamethasone</term><term>Efficiency</term><term>Exposure</term><term>Hematology</term><term>Human</term><term>Lenalidomide</term><term>Myeloma</term><term>Relapse</term><term>Thalidomide</term><term>Treatment resistance</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Lénalidomide</term><term>Efficacité</term><term>Homme</term><term>Dexaméthasone</term><term>Récidive</term><term>Résistance traitement</term><term>Myélome</term><term>Exposition</term><term>Hématologie</term><term>Thalidomide</term><term>Anticancéreux</term><term>Antiangiogénique</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">This analysis assessed the efficacy and safety of lenalidomide + dexamethasone in patients with relapsed or refractory multiple myeloma (MM) previously treated with thalidomide. Of 704 patients, 39% were thalidomide exposed. Thalidomide-exposed patients had more prior lines of therapy and longer duration of myeloma than thalidomide-naive patients. Lenalidomide + dexamethasone led to higher overall response rate (ORR), longer time to progression (TTP), and progression-free survival (PFS) versus placebo + dexamethasone despite prior thalidomide exposure. Among lenalidomide + dexamethasone-treated patients, ORR was higher in thalidomide-naive versus thalidomide-exposed patients (P = .04), with longer median TTP (P = .04) and PFS (P = .02). Likewise for dexamethasone alone-treated patients (P = .03 for ORR, P = .03 for TTP, P = .06 for PFS). Prior thalidomide did not affect survival in lenalidomide + dexamethasone-treated patients (36.1 vs 33.3 months, P >.05). Thalidomide-naive and thalidomide-exposed patients had similar toxicities. Lenalidomide + dexamethasone resulted in higher rates of venous thromboembolism, myelosuppression, and infections versus placebo + dexamethasone, independent of prior thalidomide exposure. Lenalidomide + dexamethasone was superior to placebo + dexamethasone, independent of prior thalidomide exposure. Although prior thalidomide may have contributed to inferior TTP and PFS compared with thalidomide-naive patients, these parameters remained superior compared with placebo + dexamethasone; similar benefits compared with placebo + dexamethasone were not evident for thalidomide-exposed patients in terms of overall survival. Studies were registered at http://www.clinicaltrials. gov under NCT00056160 and NCT00424047.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Canada</li><li>Espagne</li><li>France</li><li>Grèce</li><li>États-Unis</li></country><region><li>Attique (région)</li><li>Catalogne</li><li>Midi-Pyrénées</li><li>Occitanie (région administrative)</li><li>Victoria (État)</li></region><settlement><li>Athènes</li><li>Barcelone</li><li>Melbourne</li><li>Toulouse</li></settlement></list><tree><country name="États-Unis"><noRegion><name sortKey="Wang, Michael" sort="Wang, Michael" uniqKey="Wang M" first="Michael" last="Wang">Michael Wang</name></noRegion><name sortKey="Knight, Robert D" sort="Knight, Robert D" uniqKey="Knight R" first="Robert D." last="Knight">Robert D. Knight</name><name sortKey="Olesnyckyj, Marta" sort="Olesnyckyj, Marta" uniqKey="Olesnyckyj M" first="Marta" last="Olesnyckyj">Marta Olesnyckyj</name><name sortKey="Rajkumar, S Vincent" sort="Rajkumar, S Vincent" uniqKey="Rajkumar S" first="S. Vincent" last="Rajkumar">S. Vincent Rajkumar</name><name sortKey="Weber, Donna M" sort="Weber, Donna M" uniqKey="Weber D" first="Donna M." last="Weber">Donna M. Weber</name><name sortKey="Zeldis, Jerome B" sort="Zeldis, Jerome B" uniqKey="Zeldis J" first="Jerome B." last="Zeldis">Jerome B. Zeldis</name><name sortKey="Zhinuan Yu" sort="Zhinuan Yu" uniqKey="Zhinuan Yu" last="Zhinuan Yu">ZHINUAN YU</name></country><country name="Grèce"><region name="Attique (région)"><name sortKey="Dimopoulos, Meletios A" sort="Dimopoulos, Meletios A" uniqKey="Dimopoulos M" first="Meletios A." last="Dimopoulos">Meletios A. Dimopoulos</name></region></country><country name="Canada"><noRegion><name sortKey="Chen, Christine" sort="Chen, Christine" uniqKey="Chen C" first="Christine" last="Chen">Christine Chen</name></noRegion></country><country name="Espagne"><region name="Catalogne"><name sortKey="Cibeira, M Teresa" sort="Cibeira, M Teresa" uniqKey="Cibeira M" first="M. Teresa" last="Cibeira">M. Teresa Cibeira</name></region></country><country name="France"><region name="Occitanie (région administrative)"><name sortKey="Attal, Michel" sort="Attal, Michel" uniqKey="Attal M" first="Michel" last="Attal">Michel Attal</name></region></country><country name="Australie"><region name="Victoria (État)"><name sortKey="Spencer, Andrew" sort="Spencer, Andrew" uniqKey="Spencer A" first="Andrew" last="Spencer">Andrew Spencer</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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