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Health-related quality-of-life in patients with newly diagnosed multiple myeloma in the FIRST trial: lenalidomide plus low-dose dexamethasone versus melphalan, prednisone, thalidomide.

Identifieur interne : 000087 ( PubMed/Corpus ); précédent : 000086; suivant : 000088

Health-related quality-of-life in patients with newly diagnosed multiple myeloma in the FIRST trial: lenalidomide plus low-dose dexamethasone versus melphalan, prednisone, thalidomide.

Auteurs : Michel Delforge ; Leonard Minuk ; Jean-Claude Eisenmann ; Bertrand Arnulf ; Letizia Canepa ; Alberto Fragasso ; Serge Leyvraz ; Christian Langer ; Yousef Ezaydi ; Dan T. Vogl ; Pilar Giraldo-Castellano ; Sung-Soo Yoon ; Charles Zarnitsky ; Martine Escoffre-Barbe ; Bernard Lemieux ; Kevin Song ; Nizar Jacques Bahlis ; Shien Guo ; Mara Silva Monzini ; Annette Ervin-Haynes ; Vanessa Houck ; Thierry Facon

Source :

RBID : pubmed:25769541

English descriptors

Abstract

We compared the health-related quality-of-life of patients with newly diagnosed multiple myeloma aged over 65 years or transplant-ineligible in the pivotal, phase III FIRST trial. Patients received: i) continuous lenalidomide and low-dose dexamethasone until disease progression; ii) fixed cycles of lenalidomide and low-dose dexamethasone for 18 months; or iii) fixed cycles of melphalan, prednisone, thalidomide for 18 months. Data were collected using the validated questionnaires (QLQ-MY20, QLQ-C30, and EQ-5D). The analysis focused on the EQ-5D utility value and six domains pre-selected for their perceived clinical relevance. Lenalidomide and low-dose dexamethasone, and melphalan, prednisone, thalidomide improved patients' health-related quality-of-life from baseline over the duration of the study across all pre-selected domains of the QLQ-C30 and EQ-5D. In the QLQ-MY20, lenalidomide and low-dose dexamethasone demonstrated a significantly greater reduction in the Disease Symptoms domain compared with melphalan, prednisone, thalidomide at Month 3, and significantly lower scores for QLQ-MY20 Side Effects of Treatment at all post-baseline assessments except Month 18. Linear mixed-model repeated-measures analyses confirmed the results observed in the cross-sectional analysis. Continuous lenalidomide and low-dose dexamethasone delays disease progression versus melphalan, prednisone, thalidomide and has been associated with a clinically meaningful improvement in health-related quality-of-life. These results further establish continuous lenalidomide and low-dose dexamethasone as a new standard of care for initial therapy of myeloma by demonstrating superior health-related quality-of-life during treatment, compared with melphalan, prednisone, thalidomide.

DOI: 10.3324/haematol.2014.120121
PubMed: 25769541

Links to Exploration step

pubmed:25769541

Le document en format XML

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<name sortKey="Escoffre Barbe, Martine" sort="Escoffre Barbe, Martine" uniqKey="Escoffre Barbe M" first="Martine" last="Escoffre-Barbe">Martine Escoffre-Barbe</name>
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<name sortKey="Bahlis, Nizar Jacques" sort="Bahlis, Nizar Jacques" uniqKey="Bahlis N" first="Nizar Jacques" last="Bahlis">Nizar Jacques Bahlis</name>
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<name sortKey="Guo, Shien" sort="Guo, Shien" uniqKey="Guo S" first="Shien" last="Guo">Shien Guo</name>
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<name sortKey="Houck, Vanessa" sort="Houck, Vanessa" uniqKey="Houck V" first="Vanessa" last="Houck">Vanessa Houck</name>
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<name sortKey="Ezaydi, Yousef" sort="Ezaydi, Yousef" uniqKey="Ezaydi Y" first="Yousef" last="Ezaydi">Yousef Ezaydi</name>
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<nlm:affiliation>CIBER Enfermedades Raras (CIBERER), Translational Research Unit, Miguel Servet University Hospital, Zaragoza, Spain.</nlm:affiliation>
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<name sortKey="Yoon, Sung Soo" sort="Yoon, Sung Soo" uniqKey="Yoon S" first="Sung-Soo" last="Yoon">Sung-Soo Yoon</name>
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<nlm:affiliation>Seoul National University Hospital, Korea.</nlm:affiliation>
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<name sortKey="Escoffre Barbe, Martine" sort="Escoffre Barbe, Martine" uniqKey="Escoffre Barbe M" first="Martine" last="Escoffre-Barbe">Martine Escoffre-Barbe</name>
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<name sortKey="Lemieux, Bernard" sort="Lemieux, Bernard" uniqKey="Lemieux B" first="Bernard" last="Lemieux">Bernard Lemieux</name>
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<name sortKey="Song, Kevin" sort="Song, Kevin" uniqKey="Song K" first="Kevin" last="Song">Kevin Song</name>
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<name sortKey="Bahlis, Nizar Jacques" sort="Bahlis, Nizar Jacques" uniqKey="Bahlis N" first="Nizar Jacques" last="Bahlis">Nizar Jacques Bahlis</name>
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<nlm:affiliation>Tom Baker Cancer Centre - University of Calgary, Calgary, AL, Canada.</nlm:affiliation>
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<name sortKey="Guo, Shien" sort="Guo, Shien" uniqKey="Guo S" first="Shien" last="Guo">Shien Guo</name>
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</affiliation>
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<name sortKey="Ervin Haynes, Annette" sort="Ervin Haynes, Annette" uniqKey="Ervin Haynes A" first="Annette" last="Ervin-Haynes">Annette Ervin-Haynes</name>
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<nlm:affiliation>Celgene Corporation, Summit, NJ, USA.</nlm:affiliation>
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<nlm:affiliation>Celgene Corporation, Summit, NJ, USA.</nlm:affiliation>
</affiliation>
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<name sortKey="Facon, Thierry" sort="Facon, Thierry" uniqKey="Facon T" first="Thierry" last="Facon">Thierry Facon</name>
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<title level="j">Haematologica</title>
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<term>Cross-Sectional Studies</term>
<term>Dexamethasone (administration & dosage)</term>
<term>Female</term>
<term>Health Status</term>
<term>Humans</term>
<term>Male</term>
<term>Melphalan (administration & dosage)</term>
<term>Multiple Myeloma (diagnosis)</term>
<term>Multiple Myeloma (drug therapy)</term>
<term>Multiple Myeloma (psychology)</term>
<term>Prednisone (administration & dosage)</term>
<term>Quality of Life (psychology)</term>
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<term>Thalidomide (analogs & derivatives)</term>
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<term>Multiple Myeloma</term>
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<term>Multiple Myeloma</term>
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<div type="abstract" xml:lang="en">We compared the health-related quality-of-life of patients with newly diagnosed multiple myeloma aged over 65 years or transplant-ineligible in the pivotal, phase III FIRST trial. Patients received: i) continuous lenalidomide and low-dose dexamethasone until disease progression; ii) fixed cycles of lenalidomide and low-dose dexamethasone for 18 months; or iii) fixed cycles of melphalan, prednisone, thalidomide for 18 months. Data were collected using the validated questionnaires (QLQ-MY20, QLQ-C30, and EQ-5D). The analysis focused on the EQ-5D utility value and six domains pre-selected for their perceived clinical relevance. Lenalidomide and low-dose dexamethasone, and melphalan, prednisone, thalidomide improved patients' health-related quality-of-life from baseline over the duration of the study across all pre-selected domains of the QLQ-C30 and EQ-5D. In the QLQ-MY20, lenalidomide and low-dose dexamethasone demonstrated a significantly greater reduction in the Disease Symptoms domain compared with melphalan, prednisone, thalidomide at Month 3, and significantly lower scores for QLQ-MY20 Side Effects of Treatment at all post-baseline assessments except Month 18. Linear mixed-model repeated-measures analyses confirmed the results observed in the cross-sectional analysis. Continuous lenalidomide and low-dose dexamethasone delays disease progression versus melphalan, prednisone, thalidomide and has been associated with a clinically meaningful improvement in health-related quality-of-life. These results further establish continuous lenalidomide and low-dose dexamethasone as a new standard of care for initial therapy of myeloma by demonstrating superior health-related quality-of-life during treatment, compared with melphalan, prednisone, thalidomide.</div>
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<AbstractText>We compared the health-related quality-of-life of patients with newly diagnosed multiple myeloma aged over 65 years or transplant-ineligible in the pivotal, phase III FIRST trial. Patients received: i) continuous lenalidomide and low-dose dexamethasone until disease progression; ii) fixed cycles of lenalidomide and low-dose dexamethasone for 18 months; or iii) fixed cycles of melphalan, prednisone, thalidomide for 18 months. Data were collected using the validated questionnaires (QLQ-MY20, QLQ-C30, and EQ-5D). The analysis focused on the EQ-5D utility value and six domains pre-selected for their perceived clinical relevance. Lenalidomide and low-dose dexamethasone, and melphalan, prednisone, thalidomide improved patients' health-related quality-of-life from baseline over the duration of the study across all pre-selected domains of the QLQ-C30 and EQ-5D. In the QLQ-MY20, lenalidomide and low-dose dexamethasone demonstrated a significantly greater reduction in the Disease Symptoms domain compared with melphalan, prednisone, thalidomide at Month 3, and significantly lower scores for QLQ-MY20 Side Effects of Treatment at all post-baseline assessments except Month 18. Linear mixed-model repeated-measures analyses confirmed the results observed in the cross-sectional analysis. Continuous lenalidomide and low-dose dexamethasone delays disease progression versus melphalan, prednisone, thalidomide and has been associated with a clinically meaningful improvement in health-related quality-of-life. These results further establish continuous lenalidomide and low-dose dexamethasone as a new standard of care for initial therapy of myeloma by demonstrating superior health-related quality-of-life during treatment, compared with melphalan, prednisone, thalidomide.</AbstractText>
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<LastName>Delforge</LastName>
<ForeName>Michel</ForeName>
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<LastName>Minuk</LastName>
<ForeName>Leonard</ForeName>
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<Affiliation>London Health Sciences Centre, London, ON, Canada.</Affiliation>
</AffiliationInfo>
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<Affiliation>Hôpital Emile Muller, Mulhouse, France.</Affiliation>
</AffiliationInfo>
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<LastName>Canepa</LastName>
<ForeName>Letizia</ForeName>
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<Affiliation>Clinica Ematologica, A.O.U. San Martino di Genova, Italy.</Affiliation>
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