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Better quality of response to lenalidomide plus dexamethasone is associated with improved clinical outcomes in patients with relapsed or refractory multiple myeloma

Identifieur interne : 007A21 ( Main/Exploration ); précédent : 007A20; suivant : 007A22

Better quality of response to lenalidomide plus dexamethasone is associated with improved clinical outcomes in patients with relapsed or refractory multiple myeloma

Auteurs : Jean-Luc Harousseau [France] ; Meletios A. Dimopoulos [Grèce] ; Michael Wang [États-Unis] ; Alessandro Corso [Italie] ; Christine Chen [Canada] ; Michel Attal [France] ; Andrew Spencer [Australie] ; ZHINUAN YU [États-Unis] ; Marta Olesnyckyj [États-Unis] ; Jerome B. Zeldis [États-Unis] ; Robert D. Knight [États-Unis] ; Donna M. Weber [États-Unis]

Source :

RBID : Pascal:10-0503657

Descripteurs français

English descriptors

Abstract

Background This retrospective pooled analysis of two phase III trials (MM-009/MM-010) compared clinical outcomes of patients who achieved a complete response or very good partial response to treatment with lenalidomide plus dexamethasone with the outcomes of those who only achieved a partial response. Design and Methods Patients (n=353) received lenalidomide (25 mg/day for 21 days of each 28-day cycle) plus dexamethasone (40 mg on days 1-4, 9-12, and 17-20 for four cycles, and only on days 1-4 after the first four cycles). Time to response, duration of response, time-to-progression, overall survival, and adverse events were investigated for patients who had a complete or very good partial response and compared with those of patients who had a partial response. Results At the time of unblinding, 32% of patients had achieved a complete or very good partial response and 28% had a partial response. Half (50.5%) of the patients who had a partial response as their initial response achieved a complete or very good partial response with further treatment. The probability of achieving a complete or very good partial response with continued lenalidomide treatment decreased with delayed achievement of a partial response (by cycle 4 versus later); however, it remained clinically significant. With an extended follow-up of 48 months, the median response duration, time-to-progression, and overall survival were longer in patients with a complete or very good partial response than in those with a partial response (24.0 versus 8.3 months, P<0.001; 27.7 versus 12.0 months, P<0.001; not reached versus 44.2 months, P=0.021, respectively). The benefit of a complete or very good partial response was independent of when it was achieved. Conclusions Continuing treatment with lenalidomide plus dexamethasone to achieve best response, in the absence of disease progression and toxicity, provided deeper remissions and greater clinical benefit over time for patients in this study.

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Le document en format XML

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<name sortKey="Spencer, Andrew" sort="Spencer, Andrew" uniqKey="Spencer A" first="Andrew" last="Spencer">Andrew Spencer</name>
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<country>États-Unis</country>
<wicri:noRegion>Celgene Corporation</wicri:noRegion>
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<name sortKey="Olesnyckyj, Marta" sort="Olesnyckyj, Marta" uniqKey="Olesnyckyj M" first="Marta" last="Olesnyckyj">Marta Olesnyckyj</name>
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<name sortKey="Zeldis, Jerome B" sort="Zeldis, Jerome B" uniqKey="Zeldis J" first="Jerome B." last="Zeldis">Jerome B. Zeldis</name>
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<wicri:noRegion>Celgene Corporation</wicri:noRegion>
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<name sortKey="Weber, Donna M" sort="Weber, Donna M" uniqKey="Weber D" first="Donna M." last="Weber">Donna M. Weber</name>
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<s1>M.D. Anderson Cancer Center</s1>
<s2>Houston, TX</s2>
<s3>USA</s3>
<sZ>3 aut.</sZ>
<sZ>12 aut.</sZ>
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<country>États-Unis</country>
<wicri:noRegion>M.D. Anderson Cancer Center</wicri:noRegion>
</affiliation>
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<series>
<title level="j" type="main">Haematologica : (Roma)</title>
<title level="j" type="abbreviated">Haematologica : (Roma)</title>
<idno type="ISSN">0390-6078</idno>
<imprint>
<date when="2010">2010</date>
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<title level="j" type="main">Haematologica : (Roma)</title>
<title level="j" type="abbreviated">Haematologica : (Roma)</title>
<idno type="ISSN">0390-6078</idno>
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<term>Antineoplastic agent</term>
<term>Clinical benefit</term>
<term>Dexamethasone</term>
<term>Hematology</term>
<term>Human</term>
<term>Lenalidomide</term>
<term>Myeloma</term>
<term>Prognosis</term>
<term>Quality</term>
<term>Relapse</term>
<term>Treatment efficiency</term>
<term>Treatment resistance</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Lénalidomide</term>
<term>Qualité</term>
<term>Pronostic</term>
<term>Dexaméthasone</term>
<term>Homme</term>
<term>Récidive</term>
<term>Myélome</term>
<term>Résistance traitement</term>
<term>Efficacité traitement</term>
<term>Hématologie</term>
<term>Anticancéreux</term>
<term>Bénéfice clinique</term>
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<div type="abstract" xml:lang="en">Background This retrospective pooled analysis of two phase III trials (MM-009/MM-010) compared clinical outcomes of patients who achieved a complete response or very good partial response to treatment with lenalidomide plus dexamethasone with the outcomes of those who only achieved a partial response. Design and Methods Patients (n=353) received lenalidomide (25 mg/day for 21 days of each 28-day cycle) plus dexamethasone (40 mg on days 1-4, 9-12, and 17-20 for four cycles, and only on days 1-4 after the first four cycles). Time to response, duration of response, time-to-progression, overall survival, and adverse events were investigated for patients who had a complete or very good partial response and compared with those of patients who had a partial response. Results At the time of unblinding, 32% of patients had achieved a complete or very good partial response and 28% had a partial response. Half (50.5%) of the patients who had a partial response as their initial response achieved a complete or very good partial response with further treatment. The probability of achieving a complete or very good partial response with continued lenalidomide treatment decreased with delayed achievement of a partial response (by cycle 4 versus later); however, it remained clinically significant. With an extended follow-up of 48 months, the median response duration, time-to-progression, and overall survival were longer in patients with a complete or very good partial response than in those with a partial response (24.0 versus 8.3 months, P<0.001; 27.7 versus 12.0 months, P<0.001; not reached versus 44.2 months, P=0.021, respectively). The benefit of a complete or very good partial response was independent of when it was achieved. Conclusions Continuing treatment with lenalidomide plus dexamethasone to achieve best response, in the absence of disease progression and toxicity, provided deeper remissions and greater clinical benefit over time for patients in this study.</div>
</front>
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<li>Canada</li>
<li>France</li>
<li>Grèce</li>
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<li>États-Unis</li>
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<li>Midi-Pyrénées</li>
<li>Occitanie (région administrative)</li>
<li>Victoria (État)</li>
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<name sortKey="Harousseau, Jean Luc" sort="Harousseau, Jean Luc" uniqKey="Harousseau J" first="Jean-Luc" last="Harousseau">Jean-Luc Harousseau</name>
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<name sortKey="Attal, Michel" sort="Attal, Michel" uniqKey="Attal M" first="Michel" last="Attal">Michel Attal</name>
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