Health-related quality of life impact in a randomised phase III study of the combination of dabrafenib and trametinib versus dabrafenib monotherapy in patients with BRAF V600 metastatic melanoma.
Identifieur interne : 002B21 ( PubMed/Checkpoint ); précédent : 002B20; suivant : 002B22Health-related quality of life impact in a randomised phase III study of the combination of dabrafenib and trametinib versus dabrafenib monotherapy in patients with BRAF V600 metastatic melanoma.
Auteurs : Dirk Schadendorf [Allemagne] ; Mayur M. Amonkar [États-Unis] ; Daniil Stroyakovskiy [Russie] ; Evgeny Levchenko [Russie] ; Helen Gogas [Grèce] ; Filippo De Braud [Italie] ; Jean-Jacques Grob [France] ; Igor Bondarenko [Ukraine] ; Claus Garbe [Allemagne] ; Celeste Lebbe [France] ; James Larkin [Royaume-Uni] ; Vanna Chiarion-Sileni [Italie] ; Michael Millward [Australie] ; Ana Arance [Espagne] ; Mario Mandalà [Italie] ; Keith T. Flaherty [États-Unis] ; Paul Nathan [Royaume-Uni] ; Antoni Ribas [États-Unis] ; Caroline Robert [France] ; Michelle Casey [États-Unis] ; Douglas J. Demarini [États-Unis] ; Jhangir G. Irani [États-Unis] ; Gursel Aktan [États-Unis] ; Georgina V. Long [Australie]Source :
- European journal of cancer (Oxford, England : 1990) [ 1879-0852 ] ; 2015.
Descripteurs français
- KwdFr :
- Humains, Imidazoles (administration et posologie), Imidazoles (effets indésirables), Mesure de la douleur, Mélanome (anatomopathologie), Mélanome (génétique), Mélanome (traitement médicamenteux), Métastase tumorale, Oximes (administration et posologie), Oximes (effets indésirables), Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique), Protéines proto-oncogènes B-raf (génétique), Pyridones (administration et posologie), Pyridones (effets indésirables), Pyrimidinones (administration et posologie), Pyrimidinones (effets indésirables), Qualité de vie, Substitution d'acide aminé, Tumeurs cutanées (anatomopathologie), Tumeurs cutanées (génétique), Tumeurs cutanées (traitement médicamenteux), Valine (génétique), État de santé.
- MESH :
- administration et posologie : Imidazoles, Oximes, Pyridones, Pyrimidinones.
- anatomopathologie : Mélanome, Tumeurs cutanées.
- effets indésirables : Imidazoles, Oximes, Pyridones, Pyrimidinones.
- génétique : Mélanome, Protéines proto-oncogènes B-raf, Tumeurs cutanées, Valine.
- traitement médicamenteux : Mélanome, Tumeurs cutanées.
- usage thérapeutique : Protocoles de polychimiothérapie antinéoplasique.
- Humains, Mesure de la douleur, Métastase tumorale, Qualité de vie, Substitution d'acide aminé, État de santé.
English descriptors
- KwdEn :
- Amino Acid Substitution, Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Health Status, Humans, Imidazoles (administration & dosage), Imidazoles (adverse effects), Melanoma (drug therapy), Melanoma (genetics), Melanoma (pathology), Neoplasm Metastasis, Oximes (administration & dosage), Oximes (adverse effects), Pain Measurement, Proto-Oncogene Proteins B-raf (genetics), Pyridones (administration & dosage), Pyridones (adverse effects), Pyrimidinones (administration & dosage), Pyrimidinones (adverse effects), Quality of Life, Skin Neoplasms (drug therapy), Skin Neoplasms (genetics), Skin Neoplasms (pathology), Valine (genetics).
- MESH :
- chemical , administration & dosage : Imidazoles, Oximes, Pyridones, Pyrimidinones.
- chemical , adverse effects : Imidazoles, Oximes, Pyridones, Pyrimidinones.
- drug therapy : Melanoma, Skin Neoplasms.
- genetics : Melanoma, Proto-Oncogene Proteins B-raf, Skin Neoplasms, Valine.
- pathology : Melanoma, Skin Neoplasms.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols.
- Amino Acid Substitution, Health Status, Humans, Neoplasm Metastasis, Pain Measurement, Quality of Life.
Abstract
To present the impact of treatments on health-related quality of life (HRQoL) from the double-blind, randomised phase III COMBI-d study that investigated the combination of dabrafenib and trametinib versus dabrafenib monotherapy in patients with BRAF V600E/K-mutant metastatic melanoma. COMBI-d showed significantly prolonged progression-free survival for the combination.
DOI: 10.1016/j.ejca.2015.03.004
PubMed: 25794603
Affiliations:
- Allemagne, Australie, Espagne, France, Grèce, Italie, Royaume-Uni, Russie, Ukraine, États-Unis
- Attique (région), Californie, Catalogne, District fédéral central, Lombardie, Massachusetts, Nouvelle-Galles du Sud, Pennsylvanie, Provence-Alpes-Côte d'Azur, Île-de-France
- Athènes, Barcelone, Milan, Moscou, Paris, Sydney
- Université de Sydney
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pubmed:25794603Le document en format XML
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<author><name sortKey="Gogas, Helen" sort="Gogas, Helen" uniqKey="Gogas H" first="Helen" last="Gogas">Helen Gogas</name>
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<author><name sortKey="Bondarenko, Igor" sort="Bondarenko, Igor" uniqKey="Bondarenko I" first="Igor" last="Bondarenko">Igor Bondarenko</name>
<affiliation wicri:level="1"><nlm:affiliation>Dnepropetrovsk State Medical Academy, Dzerzhyns'koho Street 9, Dnepropetrovsk 49044, Ukraine. Electronic address: oncology@dsma.dp.ua.</nlm:affiliation>
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<author><name sortKey="Garbe, Claus" sort="Garbe, Claus" uniqKey="Garbe C" first="Claus" last="Garbe">Claus Garbe</name>
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<author><name sortKey="Chiarion Sileni, Vanna" sort="Chiarion Sileni, Vanna" uniqKey="Chiarion Sileni V" first="Vanna" last="Chiarion-Sileni">Vanna Chiarion-Sileni</name>
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<wicri:regionArea>Mount Vernon Cancer Centre, Rickmansworth Road, Northwood HA6 2RN</wicri:regionArea>
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<author><name sortKey="Ribas, Antoni" sort="Ribas, Antoni" uniqKey="Ribas A" first="Antoni" last="Ribas">Antoni Ribas</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>David Geffen School of Medicine, UCLA, 10833 Le Conte Avenue, Los Angeles 90095, CA</wicri:regionArea>
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</author>
<author><name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name>
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<country xml:lang="fr">France</country>
<wicri:regionArea>Gustave Roussy and Paris 11 University, 114 Rue Edouard Vaillant, Villejuif-Paris-Sud 94805</wicri:regionArea>
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<author><name sortKey="Casey, Michelle" sort="Casey, Michelle" uniqKey="Casey M" first="Michelle" last="Casey">Michelle Casey</name>
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<author><name sortKey="Demarini, Douglas J" sort="Demarini, Douglas J" uniqKey="Demarini D" first="Douglas J" last="Demarini">Douglas J. Demarini</name>
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<country xml:lang="fr">États-Unis</country>
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<placeName><region type="state">Pennsylvanie</region>
</placeName>
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<author><name sortKey="Irani, Jhangir G" sort="Irani, Jhangir G" uniqKey="Irani J" first="Jhangir G" last="Irani">Jhangir G. Irani</name>
<affiliation wicri:level="2"><nlm:affiliation>GlaxoSmithKline, 1250 S Collegeville Rd, Collegeville, PA 19426, United States. Electronic address: jhangir.g.irani@gsk.com.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>GlaxoSmithKline, 1250 S Collegeville Rd, Collegeville, PA 19426</wicri:regionArea>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
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<author><name sortKey="Aktan, Gursel" sort="Aktan, Gursel" uniqKey="Aktan G" first="Gursel" last="Aktan">Gursel Aktan</name>
<affiliation wicri:level="2"><nlm:affiliation>GlaxoSmithKline, 1250 S Collegeville Rd, Collegeville, PA 19426, United States. Electronic address: gursel.aktan@gmail.com.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>GlaxoSmithKline, 1250 S Collegeville Rd, Collegeville, PA 19426</wicri:regionArea>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Long, Georgina V" sort="Long, Georgina V" uniqKey="Long G" first="Georgina V" last="Long">Georgina V. Long</name>
<affiliation wicri:level="4"><nlm:affiliation>Melanoma Institute Australia & The University of Sydney, 40 Rocklands Road, Sydney 2060, Australia. Electronic address: georgina.long@sydney.edu.au.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Melanoma Institute Australia & The University of Sydney, 40 Rocklands Road, Sydney 2060</wicri:regionArea>
<placeName><settlement type="city">Sydney</settlement>
<region type="état">Nouvelle-Galles du Sud</region>
<settlement type="city">Sydney</settlement>
</placeName>
<orgName type="university">Université de Sydney</orgName>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Health-related quality of life impact in a randomised phase III study of the combination of dabrafenib and trametinib versus dabrafenib monotherapy in patients with BRAF V600 metastatic melanoma.</title>
<author><name sortKey="Schadendorf, Dirk" sort="Schadendorf, Dirk" uniqKey="Schadendorf D" first="Dirk" last="Schadendorf">Dirk Schadendorf</name>
<affiliation wicri:level="1"><nlm:affiliation>Universitätsklinikum Essen, Hufelandstr. 55, Essen 45147, Germany. Electronic address: Dirk.Schadendorf@uk-essen.de.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Universitätsklinikum Essen, Hufelandstr. 55, Essen 45147</wicri:regionArea>
<wicri:noRegion>45147</wicri:noRegion>
<wicri:noRegion>45147</wicri:noRegion>
<wicri:noRegion>Essen 45147</wicri:noRegion>
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<author><name sortKey="Amonkar, Mayur M" sort="Amonkar, Mayur M" uniqKey="Amonkar M" first="Mayur M" last="Amonkar">Mayur M. Amonkar</name>
<affiliation wicri:level="2"><nlm:affiliation>GlaxoSmithKline, 1250 S Collegeville Rd, Collegeville, PA 19426, United States. Electronic address: mayur.m.amonkar@gsk.com.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>GlaxoSmithKline, 1250 S Collegeville Rd, Collegeville, PA 19426</wicri:regionArea>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Stroyakovskiy, Daniil" sort="Stroyakovskiy, Daniil" uniqKey="Stroyakovskiy D" first="Daniil" last="Stroyakovskiy">Daniil Stroyakovskiy</name>
<affiliation wicri:level="1"><nlm:affiliation>Moscow City Oncology Hospital #62, Moscow 143423, Russia. Electronic address: sdaniel@mail.ru.</nlm:affiliation>
<country xml:lang="fr">Russie</country>
<wicri:regionArea>Moscow City Oncology Hospital #62, Moscow 143423</wicri:regionArea>
<placeName><settlement type="city">Moscou</settlement>
<region>District fédéral central</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Levchenko, Evgeny" sort="Levchenko, Evgeny" uniqKey="Levchenko E" first="Evgeny" last="Levchenko">Evgeny Levchenko</name>
<affiliation wicri:level="1"><nlm:affiliation>Petrov Research Institute of Oncology, 68 Leningradskaya Street, Saint Petersburg 197758, Russia. Electronic address: levchenko@newmail.ru.</nlm:affiliation>
<country xml:lang="fr">Russie</country>
<wicri:regionArea>Petrov Research Institute of Oncology, 68 Leningradskaya Street, Saint Petersburg 197758</wicri:regionArea>
<wicri:noRegion>Saint Petersburg 197758</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Gogas, Helen" sort="Gogas, Helen" uniqKey="Gogas H" first="Helen" last="Gogas">Helen Gogas</name>
<affiliation wicri:level="1"><nlm:affiliation>University of Athens, Aghiou Thoma 17, Athens 11527, Greece. Electronic address: hgogas@hol.gr.</nlm:affiliation>
<country xml:lang="fr">Grèce</country>
<wicri:regionArea>University of Athens, Aghiou Thoma 17, Athens 11527</wicri:regionArea>
<placeName><settlement type="city">Athènes</settlement>
<region nuts="2" type="region">Attique (région)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="De Braud, Filippo" sort="De Braud, Filippo" uniqKey="De Braud F" first="Filippo" last="De Braud">Filippo De Braud</name>
<affiliation wicri:level="3"><nlm:affiliation>Fondazione IRCCS Istituto Nazionale Tumori, via Giacomo Venezian, 1, Milan, Italy. Electronic address: filippo.debraud@istitutotumori.mi.it.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Fondazione IRCCS Istituto Nazionale Tumori, via Giacomo Venezian, 1, Milan</wicri:regionArea>
<placeName><settlement type="city">Milan</settlement>
<region nuts="2">Lombardie</region>
</placeName>
</affiliation>
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<author><name sortKey="Grob, Jean Jacques" sort="Grob, Jean Jacques" uniqKey="Grob J" first="Jean-Jacques" last="Grob">Jean-Jacques Grob</name>
<affiliation wicri:level="3"><nlm:affiliation>Service de Dermatologie, Centre Hospitalo-Universitaire Sainte-Marguerite, 270 Boulevard de Sainte-Marguerite, Marseille 13009, France. Electronic address: jean-jacques.grob@ap-hm.fr.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Service de Dermatologie, Centre Hospitalo-Universitaire Sainte-Marguerite, 270 Boulevard de Sainte-Marguerite, Marseille 13009</wicri:regionArea>
<placeName><region type="region" nuts="2">Provence-Alpes-Côte d'Azur</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Bondarenko, Igor" sort="Bondarenko, Igor" uniqKey="Bondarenko I" first="Igor" last="Bondarenko">Igor Bondarenko</name>
<affiliation wicri:level="1"><nlm:affiliation>Dnepropetrovsk State Medical Academy, Dzerzhyns'koho Street 9, Dnepropetrovsk 49044, Ukraine. Electronic address: oncology@dsma.dp.ua.</nlm:affiliation>
<country xml:lang="fr">Ukraine</country>
<wicri:regionArea>Dnepropetrovsk State Medical Academy, Dzerzhyns'koho Street 9, Dnepropetrovsk 49044</wicri:regionArea>
<wicri:noRegion>Dnepropetrovsk 49044</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Garbe, Claus" sort="Garbe, Claus" uniqKey="Garbe C" first="Claus" last="Garbe">Claus Garbe</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Dermatology, University Hospital Tuebingen, Liebermeisterstraße 25, Tuebingen 72076, Germany. Electronic address: claus.garbe@med.uni-tuebingen.de.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Dermatology, University Hospital Tuebingen, Liebermeisterstraße 25, Tuebingen 72076</wicri:regionArea>
<wicri:noRegion>72076</wicri:noRegion>
<wicri:noRegion>72076</wicri:noRegion>
<wicri:noRegion>Tuebingen 72076</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Lebbe, Celeste" sort="Lebbe, Celeste" uniqKey="Lebbe C" first="Celeste" last="Lebbe">Celeste Lebbe</name>
<affiliation wicri:level="1"><nlm:affiliation>APHP Dermatology CIC Hôpital Saint Louis, University Paris Diderot, INSERM U976, Avenue Claude Vellefaux, Paris 75010, France. Electronic address: celeste.lebbe@sls.aphp.fr.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>APHP Dermatology CIC Hôpital Saint Louis, University Paris Diderot, INSERM U976, Avenue Claude Vellefaux, Paris 75010</wicri:regionArea>
<wicri:noRegion>75010</wicri:noRegion>
<placeName><settlement type="city">Paris</settlement>
<region type="région" nuts="2">Île-de-France</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Larkin, James" sort="Larkin, James" uniqKey="Larkin J" first="James" last="Larkin">James Larkin</name>
<affiliation wicri:level="1"><nlm:affiliation>Royal Marsden Hospital, Fulham Road, London SW3 6JJ, United Kingdom. Electronic address: james.larkin@rmh.nhs.uk.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Royal Marsden Hospital, Fulham Road, London SW3 6JJ</wicri:regionArea>
<wicri:noRegion>London SW3 6JJ</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Chiarion Sileni, Vanna" sort="Chiarion Sileni, Vanna" uniqKey="Chiarion Sileni V" first="Vanna" last="Chiarion-Sileni">Vanna Chiarion-Sileni</name>
<affiliation wicri:level="1"><nlm:affiliation>Melanoma and Esophageal Oncology Unit, Veneto Oncology Institute-IRCCS, via Gattamelata, 64, Padua 35128, Italy. Electronic address: mgaliz@tiscali.it.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Melanoma and Esophageal Oncology Unit, Veneto Oncology Institute-IRCCS, via Gattamelata, 64, Padua 35128</wicri:regionArea>
<wicri:noRegion>Padua 35128</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Millward, Michael" sort="Millward, Michael" uniqKey="Millward M" first="Michael" last="Millward">Michael Millward</name>
<affiliation wicri:level="1"><nlm:affiliation>Sir Charles Gairdner Hospital, Hospital Avenue, Perth, WA 6009, Australia. Electronic address: michael.millward@uwa.edu.au.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Sir Charles Gairdner Hospital, Hospital Avenue, Perth, WA 6009</wicri:regionArea>
<wicri:noRegion>WA 6009</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Arance, Ana" sort="Arance, Ana" uniqKey="Arance A" first="Ana" last="Arance">Ana Arance</name>
<affiliation wicri:level="1"><nlm:affiliation>Hospital Clinic, Carrer Villarroel 170, Barcelona 08036, Spain. Electronic address: amarance@clinic.ub.es.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Hospital Clinic, Carrer Villarroel 170, Barcelona 08036</wicri:regionArea>
<placeName><settlement type="city">Barcelone</settlement>
<region nuts="2" type="region">Catalogne</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Mandala, Mario" sort="Mandala, Mario" uniqKey="Mandala M" first="Mario" last="Mandalà">Mario Mandalà</name>
<affiliation wicri:level="1"><nlm:affiliation>Papa Giovanni XIII Hospital, Piazza OMS 1, Bergamo 24127, Italy. Electronic address: mmandala@hpg23.it.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Papa Giovanni XIII Hospital, Piazza OMS 1, Bergamo 24127</wicri:regionArea>
<wicri:noRegion>Bergamo 24127</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Flaherty, Keith T" sort="Flaherty, Keith T" uniqKey="Flaherty K" first="Keith T" last="Flaherty">Keith T. Flaherty</name>
<affiliation wicri:level="2"><nlm:affiliation>Massachusetts General Hospital Cancer Center, 55 Fruit St, Boston 02114, MA, United States. Electronic address: kflaherty@partners.org.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Massachusetts General Hospital Cancer Center, 55 Fruit St, Boston 02114, MA</wicri:regionArea>
<placeName><region type="state">Massachusetts</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Nathan, Paul" sort="Nathan, Paul" uniqKey="Nathan P" first="Paul" last="Nathan">Paul Nathan</name>
<affiliation wicri:level="1"><nlm:affiliation>Mount Vernon Cancer Centre, Rickmansworth Road, Northwood HA6 2RN, United Kingdom. Electronic address: p.nathan@nhs.net.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Mount Vernon Cancer Centre, Rickmansworth Road, Northwood HA6 2RN</wicri:regionArea>
<wicri:noRegion>Northwood HA6 2RN</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Ribas, Antoni" sort="Ribas, Antoni" uniqKey="Ribas A" first="Antoni" last="Ribas">Antoni Ribas</name>
<affiliation wicri:level="2"><nlm:affiliation>David Geffen School of Medicine, UCLA, 10833 Le Conte Avenue, Los Angeles 90095, CA, United States. Electronic address: aribas@mednet.ucla.edu.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>David Geffen School of Medicine, UCLA, 10833 Le Conte Avenue, Los Angeles 90095, CA</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name>
<affiliation wicri:level="3"><nlm:affiliation>Gustave Roussy and Paris 11 University, 114 Rue Edouard Vaillant, Villejuif-Paris-Sud 94805, France. Electronic address: Caroline.Robert@igr.fr.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Gustave Roussy and Paris 11 University, 114 Rue Edouard Vaillant, Villejuif-Paris-Sud 94805</wicri:regionArea>
<placeName><region type="region" nuts="2">Île-de-France</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Casey, Michelle" sort="Casey, Michelle" uniqKey="Casey M" first="Michelle" last="Casey">Michelle Casey</name>
<affiliation wicri:level="2"><nlm:affiliation>GlaxoSmithKline, 1250 S Collegeville Rd, Collegeville, PA 19426, United States. Electronic address: meshellcasey@yahoo.com.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>GlaxoSmithKline, 1250 S Collegeville Rd, Collegeville, PA 19426</wicri:regionArea>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
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<author><name sortKey="Demarini, Douglas J" sort="Demarini, Douglas J" uniqKey="Demarini D" first="Douglas J" last="Demarini">Douglas J. Demarini</name>
<affiliation wicri:level="2"><nlm:affiliation>GlaxoSmithKline, 1250 S Collegeville Rd, Collegeville, PA 19426, United States. Electronic address: douglas.j.demarini@gsk.com.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>GlaxoSmithKline, 1250 S Collegeville Rd, Collegeville, PA 19426</wicri:regionArea>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Irani, Jhangir G" sort="Irani, Jhangir G" uniqKey="Irani J" first="Jhangir G" last="Irani">Jhangir G. Irani</name>
<affiliation wicri:level="2"><nlm:affiliation>GlaxoSmithKline, 1250 S Collegeville Rd, Collegeville, PA 19426, United States. Electronic address: jhangir.g.irani@gsk.com.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>GlaxoSmithKline, 1250 S Collegeville Rd, Collegeville, PA 19426</wicri:regionArea>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Aktan, Gursel" sort="Aktan, Gursel" uniqKey="Aktan G" first="Gursel" last="Aktan">Gursel Aktan</name>
<affiliation wicri:level="2"><nlm:affiliation>GlaxoSmithKline, 1250 S Collegeville Rd, Collegeville, PA 19426, United States. Electronic address: gursel.aktan@gmail.com.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>GlaxoSmithKline, 1250 S Collegeville Rd, Collegeville, PA 19426</wicri:regionArea>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Long, Georgina V" sort="Long, Georgina V" uniqKey="Long G" first="Georgina V" last="Long">Georgina V. Long</name>
<affiliation wicri:level="4"><nlm:affiliation>Melanoma Institute Australia & The University of Sydney, 40 Rocklands Road, Sydney 2060, Australia. Electronic address: georgina.long@sydney.edu.au.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Melanoma Institute Australia & The University of Sydney, 40 Rocklands Road, Sydney 2060</wicri:regionArea>
<placeName><settlement type="city">Sydney</settlement>
<region type="état">Nouvelle-Galles du Sud</region>
<settlement type="city">Sydney</settlement>
</placeName>
<orgName type="university">Université de Sydney</orgName>
</affiliation>
</author>
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<idno type="eISSN">1879-0852</idno>
<imprint><date when="2015" type="published">2015</date>
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<term>Imidazoles (administration & dosage)</term>
<term>Imidazoles (adverse effects)</term>
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<term>Melanoma (genetics)</term>
<term>Melanoma (pathology)</term>
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<term>Oximes (adverse effects)</term>
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<term>Proto-Oncogene Proteins B-raf (genetics)</term>
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<front><div type="abstract" xml:lang="en">To present the impact of treatments on health-related quality of life (HRQoL) from the double-blind, randomised phase III COMBI-d study that investigated the combination of dabrafenib and trametinib versus dabrafenib monotherapy in patients with BRAF V600E/K-mutant metastatic melanoma. COMBI-d showed significantly prolonged progression-free survival for the combination.</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">25794603</PMID>
<DateCreated><Year>2015</Year>
<Month>04</Month>
<Day>17</Day>
</DateCreated>
<DateCompleted><Year>2015</Year>
<Month>08</Month>
<Day>03</Day>
</DateCompleted>
<DateRevised><Year>2015</Year>
<Month>04</Month>
<Day>17</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1879-0852</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>51</Volume>
<Issue>7</Issue>
<PubDate><Year>2015</Year>
<Month>May</Month>
</PubDate>
</JournalIssue>
<Title>European journal of cancer (Oxford, England : 1990)</Title>
<ISOAbbreviation>Eur. J. Cancer</ISOAbbreviation>
</Journal>
<ArticleTitle>Health-related quality of life impact in a randomised phase III study of the combination of dabrafenib and trametinib versus dabrafenib monotherapy in patients with BRAF V600 metastatic melanoma.</ArticleTitle>
<Pagination><MedlinePgn>833-40</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.ejca.2015.03.004</ELocationID>
<ELocationID EIdType="pii" ValidYN="Y">S0959-8049(15)00220-8</ELocationID>
<Abstract><AbstractText Label="AIM" NlmCategory="OBJECTIVE">To present the impact of treatments on health-related quality of life (HRQoL) from the double-blind, randomised phase III COMBI-d study that investigated the combination of dabrafenib and trametinib versus dabrafenib monotherapy in patients with BRAF V600E/K-mutant metastatic melanoma. COMBI-d showed significantly prolonged progression-free survival for the combination.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">HRQoL was evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30, a generic cancer questionnaire (completed at baseline, during study treatment, at progression and post progression) assessing various dimensions (global health/QoL, functional status, and symptom impact). A mixed-model, repeated-measures analyses of covariance evaluated differences between arms.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">Questionnaire completion rates were >95% at baseline, >85% to week 40 and >70% at disease progression. Baseline scores across both arms were comparable for all dimensions. Global health dimension scores were significantly better at weeks 8, 16 and 24 for patients receiving the combination during treatment and at progression. The majority of functional dimension scores (physical, social, role, emotional and cognitive functioning) trended in favour of the combination. Pain scores were significantly improved and clinically meaningful (6-13 point difference) for patients receiving the combination for all follow-up assessments versus those receiving dabrafenib monotherapy. For other symptom dimensions (nausea and vomiting, diarrhoea, dyspnoea, and constipation), scores trended in favour of dabrafenib monotherapy.</AbstractText>
<AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">This analysis demonstrates that the combination of dabrafenib and trametinib provides better preservation of HRQoL and pain improvements versus dabrafenib monotherapy while also delaying progression. (Clinicaltrials.gov registration number: NCT01584648).</AbstractText>
<CopyrightInformation>Copyright © 2015 Elsevier Ltd. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Schadendorf</LastName>
<ForeName>Dirk</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Universitätsklinikum Essen, Hufelandstr. 55, Essen 45147, Germany. Electronic address: Dirk.Schadendorf@uk-essen.de.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Amonkar</LastName>
<ForeName>Mayur M</ForeName>
<Initials>MM</Initials>
<AffiliationInfo><Affiliation>GlaxoSmithKline, 1250 S Collegeville Rd, Collegeville, PA 19426, United States. Electronic address: mayur.m.amonkar@gsk.com.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Stroyakovskiy</LastName>
<ForeName>Daniil</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Moscow City Oncology Hospital #62, Moscow 143423, Russia. Electronic address: sdaniel@mail.ru.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Levchenko</LastName>
<ForeName>Evgeny</ForeName>
<Initials>E</Initials>
<AffiliationInfo><Affiliation>Petrov Research Institute of Oncology, 68 Leningradskaya Street, Saint Petersburg 197758, Russia. Electronic address: levchenko@newmail.ru.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Gogas</LastName>
<ForeName>Helen</ForeName>
<Initials>H</Initials>
<AffiliationInfo><Affiliation>University of Athens, Aghiou Thoma 17, Athens 11527, Greece. Electronic address: hgogas@hol.gr.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>de Braud</LastName>
<ForeName>Filippo</ForeName>
<Initials>F</Initials>
<AffiliationInfo><Affiliation>Fondazione IRCCS Istituto Nazionale Tumori, via Giacomo Venezian, 1, Milan, Italy. Electronic address: filippo.debraud@istitutotumori.mi.it.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Grob</LastName>
<ForeName>Jean-Jacques</ForeName>
<Initials>JJ</Initials>
<AffiliationInfo><Affiliation>Service de Dermatologie, Centre Hospitalo-Universitaire Sainte-Marguerite, 270 Boulevard de Sainte-Marguerite, Marseille 13009, France. Electronic address: jean-jacques.grob@ap-hm.fr.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Bondarenko</LastName>
<ForeName>Igor</ForeName>
<Initials>I</Initials>
<AffiliationInfo><Affiliation>Dnepropetrovsk State Medical Academy, Dzerzhyns'koho Street 9, Dnepropetrovsk 49044, Ukraine. Electronic address: oncology@dsma.dp.ua.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Garbe</LastName>
<ForeName>Claus</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>Department of Dermatology, University Hospital Tuebingen, Liebermeisterstraße 25, Tuebingen 72076, Germany. Electronic address: claus.garbe@med.uni-tuebingen.de.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Lebbe</LastName>
<ForeName>Celeste</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>APHP Dermatology CIC Hôpital Saint Louis, University Paris Diderot, INSERM U976, Avenue Claude Vellefaux, Paris 75010, France. Electronic address: celeste.lebbe@sls.aphp.fr.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Larkin</LastName>
<ForeName>James</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Royal Marsden Hospital, Fulham Road, London SW3 6JJ, United Kingdom. Electronic address: james.larkin@rmh.nhs.uk.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Chiarion-Sileni</LastName>
<ForeName>Vanna</ForeName>
<Initials>V</Initials>
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<Initials>M</Initials>
<AffiliationInfo><Affiliation>Papa Giovanni XIII Hospital, Piazza OMS 1, Bergamo 24127, Italy. Electronic address: mmandala@hpg23.it.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Flaherty</LastName>
<ForeName>Keith T</ForeName>
<Initials>KT</Initials>
<AffiliationInfo><Affiliation>Massachusetts General Hospital Cancer Center, 55 Fruit St, Boston 02114, MA, United States. Electronic address: kflaherty@partners.org.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Nathan</LastName>
<ForeName>Paul</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Mount Vernon Cancer Centre, Rickmansworth Road, Northwood HA6 2RN, United Kingdom. Electronic address: p.nathan@nhs.net.</Affiliation>
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</Author>
<Author ValidYN="Y"><LastName>Ribas</LastName>
<ForeName>Antoni</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>David Geffen School of Medicine, UCLA, 10833 Le Conte Avenue, Los Angeles 90095, CA, United States. Electronic address: aribas@mednet.ucla.edu.</Affiliation>
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</Author>
<Author ValidYN="Y"><LastName>Robert</LastName>
<ForeName>Caroline</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>Gustave Roussy and Paris 11 University, 114 Rue Edouard Vaillant, Villejuif-Paris-Sud 94805, France. Electronic address: Caroline.Robert@igr.fr.</Affiliation>
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<Initials>M</Initials>
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<ForeName>Jhangir G</ForeName>
<Initials>JG</Initials>
<AffiliationInfo><Affiliation>GlaxoSmithKline, 1250 S Collegeville Rd, Collegeville, PA 19426, United States. Electronic address: jhangir.g.irani@gsk.com.</Affiliation>
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</Author>
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<ForeName>Gursel</ForeName>
<Initials>G</Initials>
<AffiliationInfo><Affiliation>GlaxoSmithKline, 1250 S Collegeville Rd, Collegeville, PA 19426, United States. Electronic address: gursel.aktan@gmail.com.</Affiliation>
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</Author>
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<ForeName>Georgina V</ForeName>
<Initials>GV</Initials>
<AffiliationInfo><Affiliation>Melanoma Institute Australia & The University of Sydney, 40 Rocklands Road, Sydney 2060, Australia. Electronic address: georgina.long@sydney.edu.au.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
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<ArticleDate DateType="Electronic"><Year>2015</Year>
<Month>03</Month>
<Day>17</Day>
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<NameOfSubstance UI="C482119">BRAF protein, human</NameOfSubstance>
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<Chemical><RegistryNumber>EC 2.7.11.1</RegistryNumber>
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<MeshHeadingList><MeshHeading><DescriptorName UI="D019943" MajorTopicYN="N">Amino Acid Substitution</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000971" MajorTopicYN="N">Antineoplastic Combined Chemotherapy Protocols</DescriptorName>
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<MeshHeading><DescriptorName UI="D011788" MajorTopicYN="Y">Quality of Life</DescriptorName>
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<MeshHeading><DescriptorName UI="D014633" MajorTopicYN="N">Valine</DescriptorName>
<QualifierName UI="Q000235" MajorTopicYN="N">genetics</QualifierName>
</MeshHeading>
</MeshHeadingList>
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<Keyword MajorTopicYN="N">Melanoma</Keyword>
<Keyword MajorTopicYN="N">Molecular targeted therapy</Keyword>
<Keyword MajorTopicYN="N">Protein kinase inhibitors</Keyword>
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<Keyword MajorTopicYN="N">Trametinib</Keyword>
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<Month>02</Month>
<Day>26</Day>
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<Month>03</Month>
<Day>04</Day>
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