Lenalidomide in combination with dexamethasone at first relapse in comparison with its use as later salvage therapy in relapsed or refractory multiple myeloma
Identifieur interne : 002774 ( Pmc/Checkpoint ); précédent : 002773; suivant : 002775Lenalidomide in combination with dexamethasone at first relapse in comparison with its use as later salvage therapy in relapsed or refractory multiple myeloma
Auteurs : Edward A. Stadtmauer [États-Unis] ; Donna M. Weber [États-Unis] ; Ruben Niesvizky [États-Unis] ; Andrew Belch [Canada] ; Miles H. Prince [Australie] ; Jesús F. San Miguel [Espagne] ; Thierry Facon [France] ; Marta Olesnyckyj [États-Unis] ; Zhinuan Yu [États-Unis] ; Jerome B. Zeldis [États-Unis] ; Robert D. Knight [États-Unis] ; Meletios A. Dimopoulos [Grèce]Source :
- European Journal of Haematology [ 0902-4441 ] ; 2009.
Abstract
This subset analysis of data from two phase III studies in patients with relapsed or refractory multiple myeloma (MM) evaluated the benefit of initiating lenalidomide plus dexamethasone at first relapse. Multivariate analysis showed that fewer prior therapies, along with β2-microglobulin (≤2.5 mg/L), predicted a better time to progression (TTP; study end-point) with lenalidomide plus dexamethasone treatment. Patients with one prior therapy showed a significant improvement in benefit after first relapse compared with those who received two or more therapies. Patients with one prior therapy had significantly prolonged median TTP (17.1 vs. 10.6 months;
Url:
DOI: 10.1111/j.1600-0609.2009.01257.x
PubMed: 19302559
PubMed Central: 2704925
Affiliations:
- Australie, Canada, Espagne, France, Grèce, États-Unis
- New Jersey, Pennsylvanie, Texas, État de New York
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Stadtmauer</name><affiliation wicri:level="2"><nlm:aff id="au1"><institution>Abramson Cancer Center, University of Pennsylvania</institution><addr-line>Philadelphia, PA, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Philadelphia, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></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="2"><nlm:aff id="au2"><institution>M. D. Anderson Cancer Center</institution><addr-line>Houston, TX, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Houston, TX</wicri:regionArea><placeName><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Niesvizky, Ruben" sort="Niesvizky, Ruben" uniqKey="Niesvizky R" first="Ruben" last="Niesvizky">Ruben Niesvizky</name><affiliation wicri:level="2"><nlm:aff id="au3"><institution>Weill Cornell Medical College</institution><addr-line>New York, NY, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>New York, NY</wicri:regionArea><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Belch, Andrew" sort="Belch, Andrew" uniqKey="Belch A" first="Andrew" last="Belch">Andrew Belch</name><affiliation wicri:level="1"><nlm:aff id="au4"><institution>Cross Cancer Institute</institution><addr-line>Edmonton, Alberta, Canada</addr-line></nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>Edmonton, Alberta</wicri:regionArea><wicri:noRegion>Alberta</wicri:noRegion></affiliation></author><author><name sortKey="Prince, Miles H" sort="Prince, Miles H" uniqKey="Prince M" first="Miles H" last="Prince">Miles H. Prince</name><affiliation wicri:level="1"><nlm:aff id="au5"><institution>Peter MacCallum Cancer Institute Division of Haematology/Medical Oncology and University of Melbourne</institution><addr-line>Melbourne, Australia</addr-line></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Melbourne</wicri:regionArea></affiliation></author><author><name sortKey="San Miguel, Jesus F" sort="San Miguel, Jesus F" uniqKey="San Miguel J" first="Jesús F" last="San Miguel">Jesús F. San Miguel</name><affiliation wicri:level="1"><nlm:aff id="au6"><institution>Servicio de Hematología, Hospital Universitario de Salamanca, CIC, IBMCC (USAL-CSIC)</institution><addr-line>Salamanca, Spain</addr-line></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Salamanca</wicri:regionArea></affiliation></author><author><name sortKey="Facon, Thierry" sort="Facon, Thierry" uniqKey="Facon T" first="Thierry" last="Facon">Thierry Facon</name><affiliation wicri:level="1"><nlm:aff id="au7"><institution>Hôpital Claude Huriez</institution><addr-line>Lille, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Lille</wicri:regionArea></affiliation></author><author><name sortKey="Olesnyckyj, Marta" sort="Olesnyckyj, Marta" uniqKey="Olesnyckyj M" first="Marta" last="Olesnyckyj">Marta Olesnyckyj</name><affiliation wicri:level="2"><nlm:aff id="au8"><institution>Celgene Corporation</institution><addr-line>Summit, NJ, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Summit, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Yu, Zhinuan" sort="Yu, Zhinuan" uniqKey="Yu Z" first="Zhinuan" last="Yu">Zhinuan Yu</name><affiliation wicri:level="2"><nlm:aff id="au8"><institution>Celgene Corporation</institution><addr-line>Summit, NJ, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Summit, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></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="2"><nlm:aff id="au8"><institution>Celgene Corporation</institution><addr-line>Summit, NJ, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Summit, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></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="2"><nlm:aff id="au8"><institution>Celgene Corporation</institution><addr-line>Summit, NJ, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Summit, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></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="1"><nlm:aff id="au9"><institution>University of Athens School of Medicine</institution><addr-line>Athens, Greece</addr-line></nlm:aff><country xml:lang="fr">Grèce</country><wicri:regionArea>Athens</wicri:regionArea></affiliation></author></analytic><series><title level="j">European Journal of Haematology</title><idno type="ISSN">0902-4441</idno><idno type="eISSN">1600-0609</idno><imprint><date when="2009">2009</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>This subset analysis of data from two phase III studies in patients with relapsed or refractory multiple myeloma (MM) evaluated the benefit of initiating lenalidomide plus dexamethasone at first relapse. Multivariate analysis showed that fewer prior therapies, along with β<sub>2</sub>-microglobulin (≤2.5 mg/L), predicted a better time to progression (TTP; study end-point) with lenalidomide plus dexamethasone treatment. Patients with one prior therapy showed a significant improvement in benefit after first relapse compared with those who received two or more therapies. Patients with one prior therapy had significantly prolonged median TTP (17.1 vs. 10.6 months; <italic>P</italic>=0.026) and progression-free survival (14.1 vs. 9.5 months, <italic>P</italic>=0.047) compared with patients treated in later lines. Overall response rates were higher (66.9% vs. 56.8%, <italic>P</italic>=0.06), and the complete response plus very good partial response rate was significantly higher in first relapse (39.8% vs. 27.7%, <italic>P</italic>=0.025). Importantly, overall survival was significantly prolonged for patients treated with lenalidomide plus dexamethasone with one prior therapy, compared with patients treated later in salvage (median of 42.0 vs. 35.8 months, <italic>P</italic>=0.041), with no differences in toxicity, dose reductions, or discontinuations despite longer treatment. Therefore, lenalidomide plus dexamethasone is both effective and tolerable for second-line MM therapy and the data suggest that the greatest benefit occurs with earlier use.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Terpos, E" uniqKey="Terpos E">E Terpos</name></author><author><name sortKey="Rahemtulla, A" uniqKey="Rahemtulla A">A Rahemtulla</name></author><author><name sortKey="Dimopoulos, Ma" uniqKey="Dimopoulos M">MA Dimopoulos</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Weber, Dm" uniqKey="Weber D">DM Weber</name></author><author><name sortKey="Chen, C" uniqKey="Chen C">C Chen</name></author><author><name sortKey="Niesvizky, R" uniqKey="Niesvizky R">R Niesvizky</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Dimopoulos, M" uniqKey="Dimopoulos M">M Dimopoulos</name></author><author><name sortKey="Spencer, A" uniqKey="Spencer A">A 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Eur J Haematol</journal-id><journal-id journal-id-type="publisher-id">ejh</journal-id><journal-title-group><journal-title>European Journal of Haematology</journal-title></journal-title-group><issn pub-type="ppub">0902-4441</issn><issn pub-type="epub">1600-0609</issn><publisher><publisher-name>Blackwell Publishing Ltd</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">19302559</article-id><article-id pub-id-type="pmc">2704925</article-id><article-id pub-id-type="doi">10.1111/j.1600-0609.2009.01257.x</article-id><article-categories><subj-group subj-group-type="heading"><subject>Original Articles</subject></subj-group></article-categories><title-group><article-title>Lenalidomide in combination with dexamethasone at first relapse in comparison with its use as later salvage therapy in relapsed or refractory multiple myeloma</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Stadtmauer</surname><given-names>Edward A</given-names></name><xref ref-type="aff" rid="au1">1</xref></contrib><contrib contrib-type="author"><name><surname>Weber</surname><given-names>Donna M</given-names></name><xref ref-type="aff" rid="au2">2</xref></contrib><contrib contrib-type="author"><name><surname>Niesvizky</surname><given-names>Ruben</given-names></name><xref ref-type="aff" rid="au3">3</xref></contrib><contrib contrib-type="author"><name><surname>Belch</surname><given-names>Andrew</given-names></name><xref ref-type="aff" rid="au4">4</xref></contrib><contrib contrib-type="author"><name><surname>Prince</surname><given-names>Miles H</given-names></name><xref ref-type="aff" rid="au5">5</xref></contrib><contrib contrib-type="author"><name><surname>San Miguel</surname><given-names>Jesús F</given-names></name><xref ref-type="aff" rid="au6">6</xref></contrib><contrib contrib-type="author"><name><surname>Facon</surname><given-names>Thierry</given-names></name><xref ref-type="aff" rid="au7">7</xref></contrib><contrib contrib-type="author"><name><surname>Olesnyckyj</surname><given-names>Marta</given-names></name><xref ref-type="aff" rid="au8">8</xref></contrib><contrib contrib-type="author"><name><surname>Yu</surname><given-names>Zhinuan</given-names></name><xref ref-type="aff" rid="au8">8</xref></contrib><contrib contrib-type="author"><name><surname>Zeldis</surname><given-names>Jerome B</given-names></name><xref ref-type="aff" rid="au8">8</xref></contrib><contrib contrib-type="author"><name><surname>Knight</surname><given-names>Robert D</given-names></name><xref ref-type="aff" rid="au8">8</xref></contrib><contrib contrib-type="author"><name><surname>Dimopoulos</surname><given-names>Meletios A</given-names></name><xref ref-type="aff" rid="au9">9</xref></contrib><aff id="au1"><label>1</label><institution>Abramson Cancer Center, University of Pennsylvania</institution><addr-line>Philadelphia, PA, USA</addr-line></aff><aff id="au2"><label>2</label><institution>M. D. Anderson Cancer Center</institution><addr-line>Houston, TX, USA</addr-line></aff><aff id="au3"><label>3</label><institution>Weill Cornell Medical College</institution><addr-line>New York, NY, USA</addr-line></aff><aff id="au4"><label>4</label><institution>Cross Cancer Institute</institution><addr-line>Edmonton, Alberta, Canada</addr-line></aff><aff id="au5"><label>5</label><institution>Peter MacCallum Cancer Institute Division of Haematology/Medical Oncology and University of Melbourne</institution><addr-line>Melbourne, Australia</addr-line></aff><aff id="au6"><label>6</label><institution>Servicio de Hematología, Hospital Universitario de Salamanca, CIC, IBMCC (USAL-CSIC)</institution><addr-line>Salamanca, Spain</addr-line></aff><aff id="au7"><label>7</label><institution>Hôpital Claude Huriez</institution><addr-line>Lille, France</addr-line></aff><aff id="au8"><label>8</label><institution>Celgene Corporation</institution><addr-line>Summit, NJ, USA</addr-line></aff><aff id="au9"><label>9</label><institution>University of Athens School of Medicine</institution><addr-line>Athens, Greece</addr-line></aff></contrib-group><author-notes><corresp id="cor1">Correspondence Dr Edward A. Stadtmauer, Abramson Cancer Center, University of Pennsylvania School of Medicine, 16 Penn Tower, 34th and Civic Center Blvd, Philadelphia, PA 19104, USA. Tel: + 1 215 662 7910; Fax: +1 215 662 4064; e-mail: <email>edward.stadtmauer@uphs.upenn.edu</email></corresp></author-notes><pub-date pub-type="ppub"><month>6</month><year>2009</year></pub-date><volume>82</volume><issue>6</issue><fpage>426</fpage><lpage>432</lpage><history><date date-type="accepted"><day>09</day><month>3</month><year>2009</year></date></history><permissions><copyright-statement>© 2009 John Wiley & Sons A/S</copyright-statement><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by/2.5/"><license-p>Re-use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2.5, which does not permit commercial exploitation.</license-p></license></permissions><abstract><p>This subset analysis of data from two phase III studies in patients with relapsed or refractory multiple myeloma (MM) evaluated the benefit of initiating lenalidomide plus dexamethasone at first relapse. Multivariate analysis showed that fewer prior therapies, along with β<sub>2</sub>-microglobulin (≤2.5 mg/L), predicted a better time to progression (TTP; study end-point) with lenalidomide plus dexamethasone treatment. Patients with one prior therapy showed a significant improvement in benefit after first relapse compared with those who received two or more therapies. Patients with one prior therapy had significantly prolonged median TTP (17.1 vs. 10.6 months; <italic>P</italic>=0.026) and progression-free survival (14.1 vs. 9.5 months, <italic>P</italic>=0.047) compared with patients treated in later lines. Overall response rates were higher (66.9% vs. 56.8%, <italic>P</italic>=0.06), and the complete response plus very good partial response rate was significantly higher in first relapse (39.8% vs. 27.7%, <italic>P</italic>=0.025). Importantly, overall survival was significantly prolonged for patients treated with lenalidomide plus dexamethasone with one prior therapy, compared with patients treated later in salvage (median of 42.0 vs. 35.8 months, <italic>P</italic>=0.041), with no differences in toxicity, dose reductions, or discontinuations despite longer treatment. Therefore, lenalidomide plus dexamethasone is both effective and tolerable for second-line MM therapy and the data suggest that the greatest benefit occurs with earlier use.</p></abstract><kwd-group><kwd>lenalidomide</kwd><kwd>multiple myeloma</kwd><kwd>relapse</kwd><kwd>time to progression</kwd><kwd>survival</kwd></kwd-group></article-meta></front></pmc><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>New Jersey</li><li>Pennsylvanie</li><li>Texas</li><li>État de New York</li></region></list><tree><country name="États-Unis"><region name="Pennsylvanie"><name sortKey="Stadtmauer, Edward A" sort="Stadtmauer, Edward A" uniqKey="Stadtmauer E" first="Edward A" last="Stadtmauer">Edward A. Stadtmauer</name></region><name sortKey="Knight, Robert D" sort="Knight, Robert D" uniqKey="Knight R" first="Robert D" last="Knight">Robert D. Knight</name><name sortKey="Niesvizky, Ruben" sort="Niesvizky, Ruben" uniqKey="Niesvizky R" first="Ruben" last="Niesvizky">Ruben Niesvizky</name><name sortKey="Olesnyckyj, Marta" sort="Olesnyckyj, Marta" uniqKey="Olesnyckyj M" first="Marta" last="Olesnyckyj">Marta Olesnyckyj</name><name sortKey="Weber, Donna M" sort="Weber, Donna M" uniqKey="Weber D" first="Donna M" last="Weber">Donna M. Weber</name><name sortKey="Yu, Zhinuan" sort="Yu, Zhinuan" uniqKey="Yu Z" first="Zhinuan" last="Yu">Zhinuan Yu</name><name sortKey="Zeldis, Jerome B" sort="Zeldis, Jerome B" uniqKey="Zeldis J" first="Jerome B" last="Zeldis">Jerome B. Zeldis</name></country><country name="Canada"><noRegion><name sortKey="Belch, Andrew" sort="Belch, Andrew" uniqKey="Belch A" first="Andrew" last="Belch">Andrew Belch</name></noRegion></country><country name="Australie"><noRegion><name sortKey="Prince, Miles H" sort="Prince, Miles H" uniqKey="Prince M" first="Miles H" last="Prince">Miles H. Prince</name></noRegion></country><country name="Espagne"><noRegion><name sortKey="San Miguel, Jesus F" sort="San Miguel, Jesus F" uniqKey="San Miguel J" first="Jesús F" last="San Miguel">Jesús F. San Miguel</name></noRegion></country><country name="France"><noRegion><name sortKey="Facon, Thierry" sort="Facon, Thierry" uniqKey="Facon T" first="Thierry" last="Facon">Thierry Facon</name></noRegion></country><country name="Grèce"><noRegion><name sortKey="Dimopoulos, Meletios A" sort="Dimopoulos, Meletios A" uniqKey="Dimopoulos M" first="Meletios A" last="Dimopoulos">Meletios A. Dimopoulos</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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