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 : 000022 ( Pmc/Checkpoint ); précédent : 000021; suivant : 000023Health-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 [Belgique] ; Leonard Minuk [Canada] ; Jean-Claude Eisenmann [France] ; Bertrand Arnulf [France] ; Letizia Canepa [Italie] ; Alberto Fragasso [Italie] ; Serge Leyvraz [Suisse] ; Christian Langer [Allemagne] ; Yousef Ezaydi [Royaume-Uni] ; Dan T. Vogl [États-Unis] ; Pilar Giraldo-Castellano [Espagne] ; Sung-Soo Yoon [Corée du Sud] ; Charles Zarnitsky [France] ; Martine Escoffre-Barbe [France] ; Bernard Lemieux [Canada] ; Kevin Song [Canada] ; Nizar Jacques Bahlis [Canada] ; Shien Guo [États-Unis] ; Mara Silva Monzini [États-Unis] ; Annette Ervin-Haynes [États-Unis] ; Vanessa Houck [États-Unis] ; Thierry Facon [France]Source :
- Haematologica [ 0390-6078 ] ; 2015.
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
Url:
DOI: 10.3324/haematol.2014.120121
PubMed: 25769541
PubMed Central: 4450629
Affiliations:
- Allemagne, Belgique, Canada, Corée du Sud, Espagne, France, Italie, Royaume-Uni, Suisse, États-Unis
- Alberta, Bade-Wurtemberg, Canton de Vaud, District de Tübingen, Massachusetts, New Jersey, Pennsylvanie
- Calgary, Lausanne, Le Havre, Lille, Mulhouse, Paris, Rennes, Ulm
- Université de Calgary
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Vogl</name><affiliation wicri:level="2"><nlm:aff id="af10-1000826">Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Giraldo Castellano, Pilar" sort="Giraldo Castellano, Pilar" uniqKey="Giraldo Castellano P" first="Pilar" last="Giraldo-Castellano">Pilar Giraldo-Castellano</name><affiliation wicri:level="1"><nlm:aff id="af11-1000826">CIBER Enfermedades Raras (CIBERER), Translational Research Unit, Miguel Servet University Hospital, Zaragoza, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>CIBER Enfermedades Raras (CIBERER), Translational Research Unit, Miguel Servet University Hospital, Zaragoza</wicri:regionArea><wicri:noRegion>Zaragoza</wicri:noRegion></affiliation></author><author><name sortKey="Yoon, Sung Soo" sort="Yoon, Sung Soo" uniqKey="Yoon S" first="Sung-Soo" last="Yoon">Sung-Soo Yoon</name><affiliation wicri:level="1"><nlm:aff id="af12-1000826">Seoul National University Hospital, Korea</nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>Seoul National University Hospital</wicri:regionArea></affiliation></author><author><name sortKey="Zarnitsky, Charles" sort="Zarnitsky, Charles" uniqKey="Zarnitsky C" first="Charles" last="Zarnitsky">Charles Zarnitsky</name><affiliation wicri:level="1"><nlm:aff id="af13-1000826">Rhumatologie Nord, Hôpital J. Monod, Le Havre, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Rhumatologie Nord, Hôpital J. Monod, Le Havre</wicri:regionArea><placeName><settlement type="city">Le Havre</settlement></placeName></affiliation></author><author><name sortKey="Escoffre Barbe, Martine" sort="Escoffre Barbe, Martine" uniqKey="Escoffre Barbe M" first="Martine" last="Escoffre-Barbe">Martine Escoffre-Barbe</name><affiliation wicri:level="1"><nlm:aff id="af14-1000826">CHRU Hôpital de Pontchaillou, Rennes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>CHRU Hôpital de Pontchaillou, Rennes</wicri:regionArea><placeName><settlement type="city">Rennes</settlement></placeName></affiliation></author><author><name sortKey="Lemieux, Bernard" sort="Lemieux, Bernard" uniqKey="Lemieux B" first="Bernard" last="Lemieux">Bernard Lemieux</name><affiliation wicri:level="1"><nlm:aff id="af15-1000826">CHUM Hôpital Notre-Dame, Montreal, QUE, Canada</nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>CHUM Hôpital Notre-Dame, Montreal, QUE</wicri:regionArea><wicri:noRegion>QUE</wicri:noRegion></affiliation></author><author><name sortKey="Song, Kevin" sort="Song, Kevin" uniqKey="Song K" first="Kevin" last="Song">Kevin Song</name><affiliation wicri:level="1"><nlm:aff id="af16-1000826">Vancouver General Hospital, Vancouver, BC, Canada</nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>Vancouver General Hospital, Vancouver, BC</wicri:regionArea><wicri:noRegion>BC</wicri:noRegion></affiliation></author><author><name sortKey="Bahlis, Nizar Jacques" sort="Bahlis, Nizar Jacques" uniqKey="Bahlis N" first="Nizar Jacques" last="Bahlis">Nizar Jacques Bahlis</name><affiliation wicri:level="4"><nlm:aff id="af17-1000826">Tom Baker Cancer Centre – University of Calgary, Calgary, AL, Canada</nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>Tom Baker Cancer Centre – University of Calgary, Calgary, AL</wicri:regionArea><orgName type="university">Université de Calgary</orgName><placeName><settlement type="city">Calgary</settlement><region type="state">Alberta</region></placeName></affiliation></author><author><name sortKey="Guo, Shien" sort="Guo, Shien" uniqKey="Guo S" first="Shien" last="Guo">Shien Guo</name><affiliation wicri:level="2"><nlm:aff id="af18-1000826">Evidera, Lexington, MA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Evidera, Lexington, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Monzini, Mara Silva" sort="Monzini, Mara Silva" uniqKey="Monzini M" first="Mara Silva" last="Monzini">Mara Silva Monzini</name><affiliation wicri:level="2"><nlm:aff id="af19-1000826">Celgene Corporation, Summit, NJ, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Celgene Corporation, Summit, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Ervin Haynes, Annette" sort="Ervin Haynes, Annette" uniqKey="Ervin Haynes A" first="Annette" last="Ervin-Haynes">Annette Ervin-Haynes</name><affiliation wicri:level="2"><nlm:aff id="af19-1000826">Celgene Corporation, Summit, NJ, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Celgene Corporation, Summit, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Houck, Vanessa" sort="Houck, Vanessa" uniqKey="Houck V" first="Vanessa" last="Houck">Vanessa Houck</name><affiliation wicri:level="2"><nlm:aff id="af19-1000826">Celgene Corporation, Summit, NJ, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Celgene Corporation, Summit, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></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="af20-1000826">Hôpital Claude Huriez, Lille, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Hôpital Claude Huriez, Lille</wicri:regionArea><placeName><settlement type="city">Lille</settlement></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">25769541</idno><idno type="pmc">4450629</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4450629</idno><idno type="RBID">PMC:4450629</idno><idno type="doi">10.3324/haematol.2014.120121</idno><date when="2015">2015</date><idno type="wicri:Area/Pmc/Corpus">000005</idno><idno type="wicri:Area/Pmc/Curation">000005</idno><idno type="wicri:Area/Pmc/Checkpoint">000022</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">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</title><author><name sortKey="Delforge, Michel" sort="Delforge, Michel" uniqKey="Delforge M" first="Michel" last="Delforge">Michel Delforge</name><affiliation wicri:level="1"><nlm:aff id="af1-1000826">Universitair Ziekenhuis Leuven, Campus Gasthuisberg, Leuven, Belgium</nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea>Universitair Ziekenhuis Leuven, Campus Gasthuisberg, Leuven</wicri:regionArea><wicri:noRegion>Leuven</wicri:noRegion></affiliation></author><author><name sortKey="Minuk, Leonard" sort="Minuk, Leonard" uniqKey="Minuk L" first="Leonard" last="Minuk">Leonard Minuk</name><affiliation wicri:level="1"><nlm:aff id="af2-1000826">London Health Sciences Centre, London, ON, Canada</nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>London Health Sciences Centre, London, ON</wicri:regionArea><wicri:noRegion>ON</wicri:noRegion></affiliation></author><author><name sortKey="Eisenmann, Jean Claude" sort="Eisenmann, Jean Claude" uniqKey="Eisenmann J" first="Jean-Claude" last="Eisenmann">Jean-Claude Eisenmann</name><affiliation wicri:level="1"><nlm:aff id="af3-1000826">Hôpital Emile Muller, Mulhouse, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Hôpital Emile Muller, Mulhouse</wicri:regionArea><placeName><settlement type="city">Mulhouse</settlement></placeName></affiliation></author><author><name sortKey="Arnulf, Bertrand" sort="Arnulf, Bertrand" uniqKey="Arnulf B" first="Bertrand" last="Arnulf">Bertrand Arnulf</name><affiliation wicri:level="1"><nlm:aff id="af4-1000826">Hôpital Saint-Louis, Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Hôpital Saint-Louis, Paris</wicri:regionArea><placeName><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Canepa, Letizia" sort="Canepa, Letizia" uniqKey="Canepa L" first="Letizia" last="Canepa">Letizia Canepa</name><affiliation wicri:level="1"><nlm:aff id="af5-1000826">Clinica Ematologica, A.O.U. San Martino di Genova, Italy</nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Clinica Ematologica, A.O.U. San Martino di Genova</wicri:regionArea><wicri:noRegion>A.O.U. San Martino di Genova</wicri:noRegion></affiliation></author><author><name sortKey="Fragasso, Alberto" sort="Fragasso, Alberto" uniqKey="Fragasso A" first="Alberto" last="Fragasso">Alberto Fragasso</name><affiliation wicri:level="1"><nlm:aff id="af6-1000826">Unità Operativa di Oncoematologia, Ospedale di Matera, Italy</nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Unità Operativa di Oncoematologia, Ospedale di Matera</wicri:regionArea><wicri:noRegion>Ospedale di Matera</wicri:noRegion></affiliation></author><author><name sortKey="Leyvraz, Serge" sort="Leyvraz, Serge" uniqKey="Leyvraz S" first="Serge" last="Leyvraz">Serge Leyvraz</name><affiliation wicri:level="3"><nlm:aff id="af7-1000826">Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland</nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne</wicri:regionArea><placeName><settlement type="city">Lausanne</settlement><region nuts="3" type="region">Canton de Vaud</region></placeName></affiliation></author><author><name sortKey="Langer, Christian" sort="Langer, Christian" uniqKey="Langer C" first="Christian" last="Langer">Christian Langer</name><affiliation wicri:level="3"><nlm:aff id="af8-1000826">Klinik für Innere Medizin III, Ulm, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Klinik für Innere Medizin III, Ulm</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Tübingen</region><settlement type="city">Ulm</settlement></placeName></affiliation></author><author><name sortKey="Ezaydi, Yousef" sort="Ezaydi, Yousef" uniqKey="Ezaydi Y" first="Yousef" last="Ezaydi">Yousef Ezaydi</name><affiliation wicri:level="1"><nlm:aff id="af9-1000826">Royal Hallamshire Hospital, Sheffield, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Royal Hallamshire Hospital, Sheffield</wicri:regionArea><wicri:noRegion>Sheffield</wicri:noRegion></affiliation></author><author><name sortKey="Vogl, Dan T" sort="Vogl, Dan T" uniqKey="Vogl D" first="Dan T." last="Vogl">Dan T. Vogl</name><affiliation wicri:level="2"><nlm:aff id="af10-1000826">Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Giraldo Castellano, Pilar" sort="Giraldo Castellano, Pilar" uniqKey="Giraldo Castellano P" first="Pilar" last="Giraldo-Castellano">Pilar Giraldo-Castellano</name><affiliation wicri:level="1"><nlm:aff id="af11-1000826">CIBER Enfermedades Raras (CIBERER), Translational Research Unit, Miguel Servet University Hospital, Zaragoza, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>CIBER Enfermedades Raras (CIBERER), Translational Research Unit, Miguel Servet University Hospital, Zaragoza</wicri:regionArea><wicri:noRegion>Zaragoza</wicri:noRegion></affiliation></author><author><name sortKey="Yoon, Sung Soo" sort="Yoon, Sung Soo" uniqKey="Yoon S" first="Sung-Soo" last="Yoon">Sung-Soo Yoon</name><affiliation wicri:level="1"><nlm:aff id="af12-1000826">Seoul National University Hospital, Korea</nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>Seoul National University Hospital</wicri:regionArea></affiliation></author><author><name sortKey="Zarnitsky, Charles" sort="Zarnitsky, Charles" uniqKey="Zarnitsky C" first="Charles" last="Zarnitsky">Charles Zarnitsky</name><affiliation wicri:level="1"><nlm:aff id="af13-1000826">Rhumatologie Nord, Hôpital J. Monod, Le Havre, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Rhumatologie Nord, Hôpital J. Monod, Le Havre</wicri:regionArea><placeName><settlement type="city">Le Havre</settlement></placeName></affiliation></author><author><name sortKey="Escoffre Barbe, Martine" sort="Escoffre Barbe, Martine" uniqKey="Escoffre Barbe M" first="Martine" last="Escoffre-Barbe">Martine Escoffre-Barbe</name><affiliation wicri:level="1"><nlm:aff id="af14-1000826">CHRU Hôpital de Pontchaillou, Rennes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>CHRU Hôpital de Pontchaillou, Rennes</wicri:regionArea><placeName><settlement type="city">Rennes</settlement></placeName></affiliation></author><author><name sortKey="Lemieux, Bernard" sort="Lemieux, Bernard" uniqKey="Lemieux B" first="Bernard" last="Lemieux">Bernard Lemieux</name><affiliation wicri:level="1"><nlm:aff id="af15-1000826">CHUM Hôpital Notre-Dame, Montreal, QUE, Canada</nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>CHUM Hôpital Notre-Dame, Montreal, QUE</wicri:regionArea><wicri:noRegion>QUE</wicri:noRegion></affiliation></author><author><name sortKey="Song, Kevin" sort="Song, Kevin" uniqKey="Song K" first="Kevin" last="Song">Kevin Song</name><affiliation wicri:level="1"><nlm:aff id="af16-1000826">Vancouver General Hospital, Vancouver, BC, Canada</nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>Vancouver General Hospital, Vancouver, BC</wicri:regionArea><wicri:noRegion>BC</wicri:noRegion></affiliation></author><author><name sortKey="Bahlis, Nizar Jacques" sort="Bahlis, Nizar Jacques" uniqKey="Bahlis N" first="Nizar Jacques" last="Bahlis">Nizar Jacques Bahlis</name><affiliation wicri:level="4"><nlm:aff id="af17-1000826">Tom Baker Cancer Centre – University of Calgary, Calgary, AL, Canada</nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>Tom Baker Cancer Centre – University of Calgary, Calgary, AL</wicri:regionArea><orgName type="university">Université de Calgary</orgName><placeName><settlement type="city">Calgary</settlement><region type="state">Alberta</region></placeName></affiliation></author><author><name sortKey="Guo, Shien" sort="Guo, Shien" uniqKey="Guo S" first="Shien" last="Guo">Shien Guo</name><affiliation wicri:level="2"><nlm:aff id="af18-1000826">Evidera, Lexington, MA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Evidera, Lexington, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Monzini, Mara Silva" sort="Monzini, Mara Silva" uniqKey="Monzini M" first="Mara Silva" last="Monzini">Mara Silva Monzini</name><affiliation wicri:level="2"><nlm:aff id="af19-1000826">Celgene Corporation, Summit, NJ, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Celgene Corporation, Summit, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Ervin Haynes, Annette" sort="Ervin Haynes, Annette" uniqKey="Ervin Haynes A" first="Annette" last="Ervin-Haynes">Annette Ervin-Haynes</name><affiliation wicri:level="2"><nlm:aff id="af19-1000826">Celgene Corporation, Summit, NJ, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Celgene Corporation, Summit, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Houck, Vanessa" sort="Houck, Vanessa" uniqKey="Houck V" first="Vanessa" last="Houck">Vanessa Houck</name><affiliation wicri:level="2"><nlm:aff id="af19-1000826">Celgene Corporation, Summit, NJ, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Celgene Corporation, Summit, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></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="af20-1000826">Hôpital Claude Huriez, Lille, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Hôpital Claude Huriez, Lille</wicri:regionArea><placeName><settlement type="city">Lille</settlement></placeName></affiliation></author></analytic><series><title level="j">Haematologica</title><idno type="ISSN">0390-6078</idno><idno type="eISSN">1592-8721</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>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 <italic>versus</italic> 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.</p></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Haematologica</journal-id><journal-id journal-id-type="iso-abbrev">Haematologica</journal-id><journal-id journal-id-type="hwp">haematol</journal-id><journal-id journal-id-type="publisher-id">Haematologica</journal-id><journal-title-group><journal-title>Haematologica</journal-title></journal-title-group><issn pub-type="ppub">0390-6078</issn><issn pub-type="epub">1592-8721</issn><publisher><publisher-name>Ferrata Storti Foundation</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">25769541</article-id><article-id pub-id-type="pmc">4450629</article-id><article-id pub-id-type="doi">10.3324/haematol.2014.120121</article-id><article-id pub-id-type="publisher-id">1000826</article-id><article-categories><subj-group subj-group-type="heading"><subject>Articles</subject><subj-group subj-group-type="heading"><subject>Plasma Cell Disorders</subject></subj-group></subj-group></article-categories><title-group><article-title>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</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Delforge</surname><given-names>Michel</given-names></name><xref ref-type="aff" rid="af1-1000826">1</xref><xref ref-type="corresp" rid="c1-1000826"></xref></contrib><contrib contrib-type="author"><name><surname>Minuk</surname><given-names>Leonard</given-names></name><xref ref-type="aff" rid="af2-1000826">2</xref></contrib><contrib contrib-type="author"><name><surname>Eisenmann</surname><given-names>Jean-Claude</given-names></name><xref ref-type="aff" rid="af3-1000826">3</xref></contrib><contrib contrib-type="author"><name><surname>Arnulf</surname><given-names>Bertrand</given-names></name><xref ref-type="aff" rid="af4-1000826">4</xref></contrib><contrib contrib-type="author"><name><surname>Canepa</surname><given-names>Letizia</given-names></name><xref ref-type="aff" rid="af5-1000826">5</xref></contrib><contrib contrib-type="author"><name><surname>Fragasso</surname><given-names>Alberto</given-names></name><xref ref-type="aff" rid="af6-1000826">6</xref></contrib><contrib contrib-type="author"><name><surname>Leyvraz</surname><given-names>Serge</given-names></name><xref ref-type="aff" rid="af7-1000826">7</xref></contrib><contrib contrib-type="author"><name><surname>Langer</surname><given-names>Christian</given-names></name><xref ref-type="aff" rid="af8-1000826">8</xref></contrib><contrib contrib-type="author"><name><surname>Ezaydi</surname><given-names>Yousef</given-names></name><xref ref-type="aff" rid="af9-1000826">9</xref></contrib><contrib contrib-type="author"><name><surname>Vogl</surname><given-names>Dan T.</given-names></name><xref ref-type="aff" rid="af10-1000826">10</xref></contrib><contrib contrib-type="author"><name><surname>Giraldo-Castellano</surname><given-names>Pilar</given-names></name><xref ref-type="aff" rid="af11-1000826">11</xref></contrib><contrib contrib-type="author"><name><surname>Yoon</surname><given-names>Sung-Soo</given-names></name><xref ref-type="aff" rid="af12-1000826">12</xref></contrib><contrib contrib-type="author"><name><surname>Zarnitsky</surname><given-names>Charles</given-names></name><xref ref-type="aff" rid="af13-1000826">13</xref></contrib><contrib contrib-type="author"><name><surname>Escoffre-Barbe</surname><given-names>Martine</given-names></name><xref ref-type="aff" rid="af14-1000826">14</xref></contrib><contrib contrib-type="author"><name><surname>Lemieux</surname><given-names>Bernard</given-names></name><xref ref-type="aff" rid="af15-1000826">15</xref></contrib><contrib contrib-type="author"><name><surname>Song</surname><given-names>Kevin</given-names></name><xref ref-type="aff" rid="af16-1000826">16</xref></contrib><contrib contrib-type="author"><name><surname>Bahlis</surname><given-names>Nizar Jacques</given-names></name><xref ref-type="aff" rid="af17-1000826">17</xref></contrib><contrib contrib-type="author"><name><surname>Guo</surname><given-names>Shien</given-names></name><xref ref-type="aff" rid="af18-1000826">18</xref></contrib><contrib contrib-type="author"><name><surname>Monzini</surname><given-names>Mara Silva</given-names></name><xref ref-type="aff" rid="af19-1000826">19</xref></contrib><contrib contrib-type="author"><name><surname>Ervin-Haynes</surname><given-names>Annette</given-names></name><xref ref-type="aff" rid="af19-1000826">19</xref></contrib><contrib contrib-type="author"><name><surname>Houck</surname><given-names>Vanessa</given-names></name><xref ref-type="aff" rid="af19-1000826">19</xref></contrib><contrib contrib-type="author"><name><surname>Facon</surname><given-names>Thierry</given-names></name><xref ref-type="aff" rid="af20-1000826">20</xref></contrib></contrib-group><aff id="af1-1000826"><label>1</label>Universitair Ziekenhuis Leuven, Campus Gasthuisberg, Leuven, Belgium</aff><aff id="af2-1000826"><label>2</label>London Health Sciences Centre, London, ON, Canada</aff><aff id="af3-1000826"><label>3</label>Hôpital Emile Muller, Mulhouse, France</aff><aff id="af4-1000826"><label>4</label>Hôpital Saint-Louis, Paris, France</aff><aff id="af5-1000826"><label>5</label>Clinica Ematologica, A.O.U. San Martino di Genova, Italy</aff><aff id="af6-1000826"><label>6</label>Unità Operativa di Oncoematologia, Ospedale di Matera, Italy</aff><aff id="af7-1000826"><label>7</label>Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland</aff><aff id="af8-1000826"><label>8</label>Klinik für Innere Medizin III, Ulm, Germany</aff><aff id="af9-1000826"><label>9</label>Royal Hallamshire Hospital, Sheffield, UK</aff><aff id="af10-1000826"><label>10</label>Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA</aff><aff id="af11-1000826"><label>11</label>CIBER Enfermedades Raras (CIBERER), Translational Research Unit, Miguel Servet University Hospital, Zaragoza, Spain</aff><aff id="af12-1000826"><label>12</label>Seoul National University Hospital, Korea</aff><aff id="af13-1000826"><label>13</label>Rhumatologie Nord, Hôpital J. Monod, Le Havre, France</aff><aff id="af14-1000826"><label>14</label>CHRU Hôpital de Pontchaillou, Rennes, France</aff><aff id="af15-1000826"><label>15</label>CHUM Hôpital Notre-Dame, Montreal, QUE, Canada</aff><aff id="af16-1000826"><label>16</label>Vancouver General Hospital, Vancouver, BC, Canada</aff><aff id="af17-1000826"><label>17</label>Tom Baker Cancer Centre – University of Calgary, Calgary, AL, Canada</aff><aff id="af18-1000826"><label>18</label>Evidera, Lexington, MA, USA</aff><aff id="af19-1000826"><label>19</label>Celgene Corporation, Summit, NJ, USA</aff><aff id="af20-1000826"><label>20</label>Hôpital Claude Huriez, Lille, France</aff><author-notes><corresp id="c1-1000826">Correspondence: <email>michel.delforge@uzleuven.be</email></corresp></author-notes><pub-date pub-type="ppub"><month>6</month><year>2015</year></pub-date><volume>100</volume><issue>6</issue><fpage>826</fpage><lpage>833</lpage><history><date date-type="received"><day>14</day><month>11</month><year>2014</year></date><date date-type="accepted"><day>06</day><month>3</month><year>2015</year></date></history><permissions><copyright-statement>Copyright© Ferrata Storti Foundation</copyright-statement><copyright-year>2015</copyright-year></permissions><self-uri content-type="pdf" xlink:type="simple" xlink:href="100826.pdf"></self-uri><abstract><p>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 <italic>versus</italic> 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.</p></abstract></article-meta></front></pmc><affiliations><list><country><li>Allemagne</li><li>Belgique</li><li>Canada</li><li>Corée du Sud</li><li>Espagne</li><li>France</li><li>Italie</li><li>Royaume-Uni</li><li>Suisse</li><li>États-Unis</li></country><region><li>Alberta</li><li>Bade-Wurtemberg</li><li>Canton de Vaud</li><li>District de Tübingen</li><li>Massachusetts</li><li>New Jersey</li><li>Pennsylvanie</li></region><settlement><li>Calgary</li><li>Lausanne</li><li>Le Havre</li><li>Lille</li><li>Mulhouse</li><li>Paris</li><li>Rennes</li><li>Ulm</li></settlement><orgName><li>Université de Calgary</li></orgName></list><tree><country name="Belgique"><noRegion><name sortKey="Delforge, Michel" sort="Delforge, Michel" uniqKey="Delforge M" first="Michel" last="Delforge">Michel Delforge</name></noRegion></country><country name="Canada"><noRegion><name sortKey="Minuk, Leonard" sort="Minuk, Leonard" uniqKey="Minuk L" first="Leonard" last="Minuk">Leonard Minuk</name></noRegion><name sortKey="Bahlis, Nizar Jacques" sort="Bahlis, Nizar Jacques" uniqKey="Bahlis N" first="Nizar Jacques" last="Bahlis">Nizar Jacques Bahlis</name><name sortKey="Lemieux, Bernard" sort="Lemieux, Bernard" uniqKey="Lemieux B" first="Bernard" last="Lemieux">Bernard Lemieux</name><name sortKey="Song, Kevin" sort="Song, Kevin" uniqKey="Song K" first="Kevin" last="Song">Kevin Song</name></country><country name="France"><noRegion><name sortKey="Eisenmann, Jean Claude" sort="Eisenmann, Jean Claude" uniqKey="Eisenmann J" first="Jean-Claude" last="Eisenmann">Jean-Claude Eisenmann</name></noRegion><name sortKey="Arnulf, Bertrand" sort="Arnulf, Bertrand" uniqKey="Arnulf B" first="Bertrand" last="Arnulf">Bertrand Arnulf</name><name sortKey="Escoffre Barbe, Martine" sort="Escoffre Barbe, Martine" uniqKey="Escoffre Barbe M" first="Martine" last="Escoffre-Barbe">Martine Escoffre-Barbe</name><name sortKey="Facon, Thierry" sort="Facon, Thierry" uniqKey="Facon T" first="Thierry" last="Facon">Thierry Facon</name><name sortKey="Zarnitsky, Charles" sort="Zarnitsky, Charles" uniqKey="Zarnitsky C" first="Charles" last="Zarnitsky">Charles Zarnitsky</name></country><country name="Italie"><noRegion><name sortKey="Canepa, Letizia" sort="Canepa, Letizia" uniqKey="Canepa L" first="Letizia" last="Canepa">Letizia Canepa</name></noRegion><name sortKey="Fragasso, Alberto" sort="Fragasso, Alberto" uniqKey="Fragasso A" first="Alberto" last="Fragasso">Alberto Fragasso</name></country><country name="Suisse"><region name="Canton de Vaud"><name sortKey="Leyvraz, Serge" sort="Leyvraz, Serge" uniqKey="Leyvraz S" first="Serge" last="Leyvraz">Serge Leyvraz</name></region></country><country name="Allemagne"><region name="Bade-Wurtemberg"><name sortKey="Langer, Christian" sort="Langer, Christian" uniqKey="Langer C" first="Christian" last="Langer">Christian Langer</name></region></country><country name="Royaume-Uni"><noRegion><name sortKey="Ezaydi, Yousef" sort="Ezaydi, Yousef" uniqKey="Ezaydi Y" first="Yousef" last="Ezaydi">Yousef Ezaydi</name></noRegion></country><country name="États-Unis"><region name="Pennsylvanie"><name sortKey="Vogl, Dan T" sort="Vogl, Dan T" uniqKey="Vogl D" first="Dan T." last="Vogl">Dan T. Vogl</name></region><name sortKey="Ervin Haynes, Annette" sort="Ervin Haynes, Annette" uniqKey="Ervin Haynes A" first="Annette" last="Ervin-Haynes">Annette Ervin-Haynes</name><name sortKey="Guo, Shien" sort="Guo, Shien" uniqKey="Guo S" first="Shien" last="Guo">Shien Guo</name><name sortKey="Houck, Vanessa" sort="Houck, Vanessa" uniqKey="Houck V" first="Vanessa" last="Houck">Vanessa Houck</name><name sortKey="Monzini, Mara Silva" sort="Monzini, Mara Silva" uniqKey="Monzini M" first="Mara Silva" last="Monzini">Mara Silva Monzini</name></country><country name="Espagne"><noRegion><name sortKey="Giraldo Castellano, Pilar" sort="Giraldo Castellano, Pilar" uniqKey="Giraldo Castellano P" first="Pilar" last="Giraldo-Castellano">Pilar Giraldo-Castellano</name></noRegion></country><country name="Corée du Sud"><noRegion><name sortKey="Yoon, Sung Soo" sort="Yoon, Sung Soo" uniqKey="Yoon S" first="Sung-Soo" last="Yoon">Sung-Soo Yoon</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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