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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 : 000005 ( Pmc/Corpus ); précédent : 000004; suivant : 000006

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 : PMC:4450629

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.


Url:
DOI: 10.3324/haematol.2014.120121
PubMed: 25769541
PubMed Central: 4450629

Links to Exploration step

PMC:4450629

Le document en format XML

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<name sortKey="Zarnitsky, Charles" sort="Zarnitsky, Charles" uniqKey="Zarnitsky C" first="Charles" last="Zarnitsky">Charles Zarnitsky</name>
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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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<name sortKey="Houck, Vanessa" sort="Houck, Vanessa" uniqKey="Houck V" first="Vanessa" last="Houck">Vanessa Houck</name>
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<name sortKey="Delforge, Michel" sort="Delforge, Michel" uniqKey="Delforge M" first="Michel" last="Delforge">Michel Delforge</name>
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<name sortKey="Minuk, Leonard" sort="Minuk, Leonard" uniqKey="Minuk L" first="Leonard" last="Minuk">Leonard Minuk</name>
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<name sortKey="Arnulf, Bertrand" sort="Arnulf, Bertrand" uniqKey="Arnulf B" first="Bertrand" last="Arnulf">Bertrand Arnulf</name>
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<name sortKey="Canepa, Letizia" sort="Canepa, Letizia" uniqKey="Canepa L" first="Letizia" last="Canepa">Letizia Canepa</name>
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<nlm:aff id="af5-1000826">Clinica Ematologica, A.O.U. San Martino di Genova, Italy</nlm:aff>
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<name sortKey="Fragasso, Alberto" sort="Fragasso, Alberto" uniqKey="Fragasso A" first="Alberto" last="Fragasso">Alberto Fragasso</name>
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<nlm:aff id="af6-1000826">Unità Operativa di Oncoematologia, Ospedale di Matera, Italy</nlm:aff>
</affiliation>
</author>
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<name sortKey="Leyvraz, Serge" sort="Leyvraz, Serge" uniqKey="Leyvraz S" first="Serge" last="Leyvraz">Serge Leyvraz</name>
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<nlm:aff id="af7-1000826">Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland</nlm:aff>
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<name sortKey="Langer, Christian" sort="Langer, Christian" uniqKey="Langer C" first="Christian" last="Langer">Christian Langer</name>
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<nlm:aff id="af8-1000826">Klinik für Innere Medizin III, Ulm, Germany</nlm:aff>
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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:aff id="af9-1000826">Royal Hallamshire Hospital, Sheffield, UK</nlm:aff>
</affiliation>
</author>
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<name sortKey="Vogl, Dan T" sort="Vogl, Dan T" uniqKey="Vogl D" first="Dan T." last="Vogl">Dan T. Vogl</name>
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<nlm:aff id="af10-1000826">Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA</nlm:aff>
</affiliation>
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<author>
<name sortKey="Giraldo Castellano, Pilar" sort="Giraldo Castellano, Pilar" uniqKey="Giraldo Castellano P" first="Pilar" last="Giraldo-Castellano">Pilar Giraldo-Castellano</name>
<affiliation>
<nlm:aff id="af11-1000826">CIBER Enfermedades Raras (CIBERER), Translational Research Unit, Miguel Servet University Hospital, Zaragoza, Spain</nlm:aff>
</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>
<nlm:aff id="af12-1000826">Seoul National University Hospital, Korea</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Zarnitsky, Charles" sort="Zarnitsky, Charles" uniqKey="Zarnitsky C" first="Charles" last="Zarnitsky">Charles Zarnitsky</name>
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<nlm:aff id="af13-1000826">Rhumatologie Nord, Hôpital J. Monod, Le Havre, France</nlm:aff>
</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>
<nlm:aff id="af14-1000826">CHRU Hôpital de Pontchaillou, Rennes, France</nlm:aff>
</affiliation>
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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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<nlm:aff id="af15-1000826">CHUM Hôpital Notre-Dame, Montreal, QUE, Canada</nlm:aff>
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</author>
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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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<nlm:aff id="af16-1000826">Vancouver General Hospital, Vancouver, BC, Canada</nlm:aff>
</affiliation>
</author>
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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>
<affiliation>
<nlm:aff id="af17-1000826">Tom Baker Cancer Centre – University of Calgary, Calgary, AL, Canada</nlm:aff>
</affiliation>
</author>
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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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<nlm:aff id="af18-1000826">Evidera, Lexington, MA, USA</nlm:aff>
</affiliation>
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<name sortKey="Monzini, Mara Silva" sort="Monzini, Mara Silva" uniqKey="Monzini M" first="Mara Silva" last="Monzini">Mara Silva Monzini</name>
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<nlm:aff id="af19-1000826">Celgene Corporation, Summit, NJ, USA</nlm:aff>
</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>
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<nlm:aff id="af19-1000826">Celgene Corporation, Summit, NJ, USA</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Houck, Vanessa" sort="Houck, Vanessa" uniqKey="Houck V" first="Vanessa" last="Houck">Vanessa Houck</name>
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<nlm:aff id="af19-1000826">Celgene Corporation, Summit, NJ, USA</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Facon, Thierry" sort="Facon, Thierry" uniqKey="Facon T" first="Thierry" last="Facon">Thierry Facon</name>
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<nlm:aff id="af20-1000826">Hôpital Claude Huriez, Lille, France</nlm:aff>
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<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>
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<journal-id journal-id-type="iso-abbrev">Haematologica</journal-id>
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<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>
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<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>
</record>

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