Patient perception of the benefit of a BRAF inhibitor in metastatic melanoma: quality-of-life analyses of the BREAK-3 study comparing dabrafenib with dacarbazine
Identifieur interne : 004026 ( Main/Exploration ); précédent : 004025; suivant : 004027Patient perception of the benefit of a BRAF inhibitor in metastatic melanoma: quality-of-life analyses of the BREAK-3 study comparing dabrafenib with dacarbazine
Auteurs : J.-J. Grob [France] ; M. M. Amonkar [États-Unis] ; S. Martin-Algarra [Espagne] ; L. V. Demidov [Russie] ; V. Goodman [États-Unis] ; K. Grotzinger [États-Unis] ; P. Haney [États-Unis] ; E. K Mpgen [Allemagne] ; B. Karaszewska [Pologne] ; C. Mauch [Allemagne] ; W. H. Jr Miller [Canada] ; M. Millward [Australie] ; B. Mirakhur [États-Unis] ; P. Rutkowski [Pologne] ; V. Chiarion-Sileni [Italie] ; S. Swann [États-Unis] ; A. Hauschild [Allemagne]Source :
- Annals of oncology [ 0923-7534 ] ; 2014.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
Abstract
Background: In a randomized phase III study (BREAK-3), dabrafenib showed prolonged progression-free survival (PFS) (median 5.1 versus 2.7 months; hazard ratio = 0.30; 95% confidence interval 0.18-0.53; P<0.0001) compared with dacarbazine (DTIC) in patients with BRAF V600E metastatic melanoma. Assessing how these results are transformed into a real health benefit for patients is crucial. Methods: The EORTC QLQ-C30 questionnaire assessed quality of life (QoL) at baseline and follow-up visits. Results: For DTIC, all functional dimensions except role dimension worsened from baseline at follow-up. For dabrafenib, all functionality dimensions remained stable relative to baseline or improved at week 6; mean change in seven symptom dimensions improved from baseline, with appetite loss, insomnia, nausea and vomiting, and pain showing the greatest improvement. In the DTIC arm, symptom dimensions were unchanged or worsened from baseline for all symptoms except pain (week 6), with the greatest exacerbations observed for fatigue and nausea and vomiting. Mixed-model-repeated measures analyses showed significant (P < 0.05) and/or clinically meaningful improvements from baseline in favor of dabrafenib for emotional and social functioning, nausea and vomiting, appetite loss, diarrhea, fatigue, dyspnea, and insomnia at weeks 6 and/or 12. After crossing over to dabrafenib upon progression (n = 35), improvements in all QoL dimensions were evident after receiving dabrafenib for 6 (n = 31) to 12 (n = 25) weeks. Conclusions: This first reported QoL analysis for a BRAF inhibitor in metastatic melanoma demonstrates that the high tumor response rates and PFS superiority of dabrafenib over DTIC is not only a theoretical advantage, but also transforms in a rapid functional and symptomatic benefit for the patient.
Affiliations:
- Allemagne, Australie, Canada, Espagne, France, Italie, Pologne, Russie, États-Unis
- Bavière, District de Moyenne-Franconie, District fédéral central, Provence-Alpes-Côte d'Azur, Québec, Schleswig-Holstein
- Erlangen, Kiel, Marseille, Montréal, Moscou
- Université McGill
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Jr Miller</name><affiliation wicri:level="4"><inist:fA14 i1="08"><s1>Departments of Oncology and Medicine, Lady Davis Institute and Segal Cancer Centre, Jewish General Hospital, McGill University</s1><s2>Montreal</s2><s3>CAN</s3><sZ>11 aut.</sZ></inist:fA14><country>Canada</country><placeName><settlement type="city">Montréal</settlement><region type="state">Québec</region><settlement type="city">Montréal</settlement></placeName><orgName type="university">Université McGill</orgName></affiliation></author><author><name sortKey="Millward, M" sort="Millward, M" uniqKey="Millward M" first="M." last="Millward">M. 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Swann</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>GlaxoSmithKline</s1><s2>Collegeville</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ><sZ>13 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>GlaxoSmithKline</wicri:noRegion></affiliation></author><author><name sortKey="Hauschild, A" sort="Hauschild, A" uniqKey="Hauschild A" first="A." last="Hauschild">A. Hauschild</name><affiliation wicri:level="3"><inist:fA14 i1="12"><s1>Department of Dermatology, University Hospital Schleswig-Holstein</s1><s2>Kiel</s2><s3>DEU</s3><sZ>17 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="2">Schleswig-Holstein</region><settlement type="city">Kiel</settlement></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">14-0208382</idno><date when="2014">2014</date><idno type="stanalyst">PASCAL 14-0208382 INIST</idno><idno type="RBID">Pascal:14-0208382</idno><idno type="wicri:Area/PascalFrancis/Corpus">000287</idno><idno type="wicri:Area/PascalFrancis/Curation">005B75</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">000162</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">000162</idno><idno type="wicri:doubleKey">0923-7534:2014:Grob J:patient:perception:of</idno><idno type="wicri:Area/Main/Merge">004086</idno><idno type="wicri:Area/Main/Curation">004026</idno><idno type="wicri:Area/Main/Exploration">004026</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Patient perception of the benefit of a BRAF inhibitor in metastatic melanoma: quality-of-life analyses of the BREAK-3 study comparing dabrafenib with dacarbazine</title><author><name sortKey="Grob, J J" sort="Grob, J J" uniqKey="Grob J" first="J.-J." last="Grob">J.-J. Grob</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Aix-Marseille University, APHM, Hôpital Timone</s1><s2>Marseille</s2><s3>FRA</s3><sZ>1 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Provence-Alpes-Côte d'Azur</region><region type="old region">Provence-Alpes-Côte d'Azur</region><settlement type="city">Marseille</settlement></placeName></affiliation></author><author><name sortKey="Amonkar, M M" sort="Amonkar, M M" uniqKey="Amonkar M" first="M. M." last="Amonkar">M. M. Amonkar</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>GlaxoSmithKline</s1><s2>Collegeville</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ><sZ>13 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>GlaxoSmithKline</wicri:noRegion></affiliation></author><author><name sortKey="Martin Algarra, S" sort="Martin Algarra, S" uniqKey="Martin Algarra S" first="S." last="Martin-Algarra">S. Martin-Algarra</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Department of Medical Oncology, Clínica Universidad de Navarra</s1><s2>Pamplona</s2><s3>ESP</s3><sZ>3 aut.</sZ></inist:fA14><country>Espagne</country><wicri:noRegion>Pamplona</wicri:noRegion></affiliation></author><author><name sortKey="Demidov, L V" sort="Demidov, L V" uniqKey="Demidov L" first="L. V." last="Demidov">L. V. Demidov</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Department of Tumor Biotherapy, N.N. Blokhin Russian Cancer Research Center</s1><s2>Moscow</s2><s3>RUS</s3><sZ>4 aut.</sZ></inist:fA14><country>Russie</country><placeName><settlement type="city">Moscou</settlement><region>District fédéral central</region></placeName></affiliation></author><author><name sortKey="Goodman, V" sort="Goodman, V" uniqKey="Goodman V" first="V." last="Goodman">V. Goodman</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>GlaxoSmithKline</s1><s2>Collegeville</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ><sZ>13 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>GlaxoSmithKline</wicri:noRegion></affiliation></author><author><name sortKey="Grotzinger, K" sort="Grotzinger, K" uniqKey="Grotzinger K" first="K." last="Grotzinger">K. Grotzinger</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>GlaxoSmithKline</s1><s2>Collegeville</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ><sZ>13 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>GlaxoSmithKline</wicri:noRegion></affiliation></author><author><name sortKey="Haney, P" sort="Haney, P" uniqKey="Haney P" first="P." last="Haney">P. Haney</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>GlaxoSmithKline</s1><s2>Collegeville</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ><sZ>13 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>GlaxoSmithKline</wicri:noRegion></affiliation></author><author><name sortKey="K Mpgen, E" sort="K Mpgen, E" uniqKey="K Mpgen E" first="E." last="K Mpgen">E. K Mpgen</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Department of Dermatology, Skin Cancer Center, University Hospital Erlangen</s1><s2>Erlangen</s2><s3>DEU</s3><sZ>8 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><settlement type="city">Erlangen</settlement><region type="land" nuts="1">Bavière</region><region type="district" nuts="2">District de Moyenne-Franconie</region></placeName></affiliation></author><author><name sortKey="Karaszewska, B" sort="Karaszewska, B" uniqKey="Karaszewska B" first="B." last="Karaszewska">B. Karaszewska</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Przychodnia Lekarska KOMED</s1><s2>Konin</s2><s3>POL</s3><sZ>9 aut.</sZ></inist:fA14><country>Pologne</country><wicri:noRegion>Przychodnia Lekarska KOMED</wicri:noRegion></affiliation></author><author><name sortKey="Mauch, C" sort="Mauch, C" uniqKey="Mauch C" first="C." last="Mauch">C. Mauch</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Department for Dermatology and Venereology and CIO KölnBonn, University Hospital Cologne</s1><s2>Cologne</s2><s3>DEU</s3><sZ>10 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Cologne</wicri:noRegion><wicri:noRegion>University Hospital Cologne</wicri:noRegion><wicri:noRegion>Cologne</wicri:noRegion></affiliation></author><author><name sortKey="Miller, W H Jr" sort="Miller, W H Jr" uniqKey="Miller W" first="W. H. Jr" last="Miller">W. H. Jr Miller</name><affiliation wicri:level="4"><inist:fA14 i1="08"><s1>Departments of Oncology and Medicine, Lady Davis Institute and Segal Cancer Centre, Jewish General Hospital, McGill University</s1><s2>Montreal</s2><s3>CAN</s3><sZ>11 aut.</sZ></inist:fA14><country>Canada</country><placeName><settlement type="city">Montréal</settlement><region type="state">Québec</region><settlement type="city">Montréal</settlement></placeName><orgName type="university">Université McGill</orgName></affiliation></author><author><name sortKey="Millward, M" sort="Millward, M" uniqKey="Millward M" first="M." last="Millward">M. Millward</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Department of Medical Oncology, Sir Charles Gairdner Hospital and School of Medicine and Physiology, University of Western Australia</s1><s2>Perth</s2><s3>AUS</s3><sZ>12 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Perth</wicri:noRegion></affiliation></author><author><name sortKey="Mirakhur, B" sort="Mirakhur, B" uniqKey="Mirakhur B" first="B." last="Mirakhur">B. Mirakhur</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>GlaxoSmithKline</s1><s2>Collegeville</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ><sZ>13 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>GlaxoSmithKline</wicri:noRegion></affiliation></author><author><name sortKey="Rutkowski, P" sort="Rutkowski, P" uniqKey="Rutkowski P" first="P." last="Rutkowski">P. Rutkowski</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology</s1><s2>Warsaw</s2><s3>POL</s3><sZ>14 aut.</sZ></inist:fA14><country>Pologne</country><wicri:noRegion>Warsaw</wicri:noRegion></affiliation></author><author><name sortKey="Chiarion Sileni, V" sort="Chiarion Sileni, V" uniqKey="Chiarion Sileni V" first="V." last="Chiarion-Sileni">V. Chiarion-Sileni</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Melanoma Cancer Unit, Veneto Oncology Institute-IRCCS</s1><s2>Padova</s2><s3>ITA</s3><sZ>15 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Padova</wicri:noRegion></affiliation></author><author><name sortKey="Swann, S" sort="Swann, S" uniqKey="Swann S" first="S." last="Swann">S. Swann</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>GlaxoSmithKline</s1><s2>Collegeville</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ><sZ>13 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>GlaxoSmithKline</wicri:noRegion></affiliation></author><author><name sortKey="Hauschild, A" sort="Hauschild, A" uniqKey="Hauschild A" first="A." last="Hauschild">A. Hauschild</name><affiliation wicri:level="3"><inist:fA14 i1="12"><s1>Department of Dermatology, University Hospital Schleswig-Holstein</s1><s2>Kiel</s2><s3>DEU</s3><sZ>17 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="2">Schleswig-Holstein</region><settlement type="city">Kiel</settlement></placeName></affiliation></author></analytic><series><title level="j" type="main">Annals of oncology</title><title level="j" type="abbreviated">Ann. oncol.</title><idno type="ISSN">0923-7534</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Annals of oncology</title><title level="j" type="abbreviated">Ann. oncol.</title><idno type="ISSN">0923-7534</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Advanced stage</term><term>Antineoplastic agent</term><term>BRAF Gene</term><term>C-Onc gene</term><term>Chemotherapy</term><term>Comparative study</term><term>Dabrafenib</term><term>Dacarbazine</term><term>Human</term><term>Inhibitor</term><term>Malignant melanoma</term><term>Metastasis</term><term>Perception</term><term>Protooncogene</term><term>Quality of life</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Homme</term><term>Perception</term><term>Protooncogène</term><term>Gène onc cellulaire</term><term>Inhibiteur</term><term>Stade avancé</term><term>Métastase</term><term>Mélanome malin</term><term>Qualité de vie</term><term>Etude comparative</term><term>Dacarbazine</term><term>Chimiothérapie</term><term>Anticancéreux</term><term>Gène BRAF</term><term>Dabrafénib</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background: In a randomized phase III study (BREAK-3), dabrafenib showed prolonged progression-free survival (PFS) (median 5.1 versus 2.7 months; hazard ratio = 0.30; 95% confidence interval 0.18-0.53; P<0.0001) compared with dacarbazine (DTIC) in patients with BRAF V600E metastatic melanoma. Assessing how these results are transformed into a real health benefit for patients is crucial. Methods: The EORTC QLQ-C30 questionnaire assessed quality of life (QoL) at baseline and follow-up visits. Results: For DTIC, all functional dimensions except role dimension worsened from baseline at follow-up. For dabrafenib, all functionality dimensions remained stable relative to baseline or improved at week 6; mean change in seven symptom dimensions improved from baseline, with appetite loss, insomnia, nausea and vomiting, and pain showing the greatest improvement. In the DTIC arm, symptom dimensions were unchanged or worsened from baseline for all symptoms except pain (week 6), with the greatest exacerbations observed for fatigue and nausea and vomiting. Mixed-model-repeated measures analyses showed significant (P < 0.05) and/or clinically meaningful improvements from baseline in favor of dabrafenib for emotional and social functioning, nausea and vomiting, appetite loss, diarrhea, fatigue, dyspnea, and insomnia at weeks 6 and/or 12. After crossing over to dabrafenib upon progression (n = 35), improvements in all QoL dimensions were evident after receiving dabrafenib for 6 (n = 31) to 12 (n = 25) weeks. Conclusions: This first reported QoL analysis for a BRAF inhibitor in metastatic melanoma demonstrates that the high tumor response rates and PFS superiority of dabrafenib over DTIC is not only a theoretical advantage, but also transforms in a rapid functional and symptomatic benefit for the patient.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Canada</li><li>Espagne</li><li>France</li><li>Italie</li><li>Pologne</li><li>Russie</li><li>États-Unis</li></country><region><li>Bavière</li><li>District de Moyenne-Franconie</li><li>District fédéral central</li><li>Provence-Alpes-Côte d'Azur</li><li>Québec</li><li>Schleswig-Holstein</li></region><settlement><li>Erlangen</li><li>Kiel</li><li>Marseille</li><li>Montréal</li><li>Moscou</li></settlement><orgName><li>Université McGill</li></orgName></list><tree><country name="France"><region name="Provence-Alpes-Côte d'Azur"><name sortKey="Grob, J J" sort="Grob, J J" uniqKey="Grob J" first="J.-J." last="Grob">J.-J. Grob</name></region></country><country name="États-Unis"><noRegion><name sortKey="Amonkar, M M" sort="Amonkar, M M" uniqKey="Amonkar M" first="M. M." last="Amonkar">M. M. Amonkar</name></noRegion><name sortKey="Goodman, V" sort="Goodman, V" uniqKey="Goodman V" first="V." last="Goodman">V. Goodman</name><name sortKey="Grotzinger, K" sort="Grotzinger, K" uniqKey="Grotzinger K" first="K." last="Grotzinger">K. Grotzinger</name><name sortKey="Haney, P" sort="Haney, P" uniqKey="Haney P" first="P." last="Haney">P. Haney</name><name sortKey="Mirakhur, B" sort="Mirakhur, B" uniqKey="Mirakhur B" first="B." last="Mirakhur">B. Mirakhur</name><name sortKey="Swann, S" sort="Swann, S" uniqKey="Swann S" first="S." last="Swann">S. Swann</name></country><country name="Espagne"><noRegion><name sortKey="Martin Algarra, S" sort="Martin Algarra, S" uniqKey="Martin Algarra S" first="S." last="Martin-Algarra">S. Martin-Algarra</name></noRegion></country><country name="Russie"><region name="District fédéral central"><name sortKey="Demidov, L V" sort="Demidov, L V" uniqKey="Demidov L" first="L. V." last="Demidov">L. V. Demidov</name></region></country><country name="Allemagne"><region name="Bavière"><name sortKey="K Mpgen, E" sort="K Mpgen, E" uniqKey="K Mpgen E" first="E." last="K Mpgen">E. K Mpgen</name></region><name sortKey="Hauschild, A" sort="Hauschild, A" uniqKey="Hauschild A" first="A." last="Hauschild">A. Hauschild</name><name sortKey="Mauch, C" sort="Mauch, C" uniqKey="Mauch C" first="C." last="Mauch">C. Mauch</name></country><country name="Pologne"><noRegion><name sortKey="Karaszewska, B" sort="Karaszewska, B" uniqKey="Karaszewska B" first="B." last="Karaszewska">B. Karaszewska</name></noRegion><name sortKey="Rutkowski, P" sort="Rutkowski, P" uniqKey="Rutkowski P" first="P." last="Rutkowski">P. Rutkowski</name></country><country name="Canada"><region name="Québec"><name sortKey="Miller, W H Jr" sort="Miller, W H Jr" uniqKey="Miller W" first="W. H. Jr" last="Miller">W. H. Jr Miller</name></region></country><country name="Australie"><noRegion><name sortKey="Millward, M" sort="Millward, M" uniqKey="Millward M" first="M." last="Millward">M. Millward</name></noRegion></country><country name="Italie"><noRegion><name sortKey="Chiarion Sileni, V" sort="Chiarion Sileni, V" uniqKey="Chiarion Sileni V" first="V." last="Chiarion-Sileni">V. Chiarion-Sileni</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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