Dabrafenib plus trametinib in patients with BRAF(V600)-mutant melanoma brain metastases (COMBI-MB): a multicentre, multicohort, open-label, phase 2 trial.
Identifieur interne : 000972 ( PubMed/Curation ); précédent : 000971; suivant : 000973Dabrafenib plus trametinib in patients with BRAF(V600)-mutant melanoma brain metastases (COMBI-MB): a multicentre, multicohort, open-label, phase 2 trial.
Auteurs : Michael A. Davies [États-Unis] ; Philippe Saiag [France] ; Caroline Robert [France] ; Jean-Jacques Grob [France] ; Keith T. Flaherty [États-Unis] ; Ana Arance [Espagne] ; Vanna Chiarion-Sileni [Italie] ; Luc Thomas [France] ; Thierry Lesimple [France] ; Laurent Mortier [France] ; Stergios J. Moschos [États-Unis] ; David Hogg [Canada] ; Iván Márquez-Rodas [Espagne] ; Michele Del Vecchio [Italie] ; Céleste Lebbé [France] ; Nicolas Meyer [France] ; Ying Zhang [États-Unis] ; Yingjie Huang [États-Unis] ; Bijoyesh Mookerjee [États-Unis] ; Georgina V. Long [Australie]Source :
- The Lancet. Oncology [ 1474-5488 ] ; 2017.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Céphalée (), Débit systolique (), Femelle, Fièvre (), Humains, Imagerie par résonance magnétique, Imidazoles (administration et posologie), Imidazoles (effets indésirables), Jeune adulte, Mutation, Mâle, Mélanome (génétique), Mélanome (imagerie diagnostique), Mélanome (secondaire), Mélanome (traitement médicamenteux), Oximes (administration et posologie), Oximes (effets indésirables), Protocoles de polychimiothérapie antinéoplasique (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), Sujet âgé, Sujet âgé de 80 ans ou plus, Tumeurs du cerveau (génétique), Tumeurs du cerveau (imagerie diagnostique), Tumeurs du cerveau (secondaire), Tumeurs du cerveau (traitement médicamenteux), Études prospectives.
- MESH :
- administration et posologie : Imidazoles, Oximes, Pyridones, Pyrimidinones.
- effets indésirables : Imidazoles, Oximes, Protocoles de polychimiothérapie antinéoplasique, Pyridones, Pyrimidinones.
- génétique : Mélanome, Protéines proto-oncogènes B-raf, Tumeurs du cerveau.
- imagerie diagnostique : Mélanome, Tumeurs du cerveau.
- secondaire : Mélanome, Tumeurs du cerveau.
- traitement médicamenteux : Mélanome, Tumeurs du cerveau.
- usage thérapeutique : Protocoles de polychimiothérapie antinéoplasique.
- Adulte, Adulte d'âge moyen, Céphalée, Débit systolique, Femelle, Fièvre, Humains, Imagerie par résonance magnétique, Jeune adulte, Mutation, Mâle, Sujet âgé, Sujet âgé de 80 ans ou plus, Études prospectives.
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols (adverse effects), Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Brain Neoplasms (diagnostic imaging), Brain Neoplasms (drug therapy), Brain Neoplasms (genetics), Brain Neoplasms (secondary), Female, Fever (chemically induced), Headache (chemically induced), Humans, Imidazoles (administration & dosage), Imidazoles (adverse effects), Magnetic Resonance Imaging, Male, Melanoma (diagnostic imaging), Melanoma (drug therapy), Melanoma (genetics), Melanoma (secondary), Middle Aged, Mutation, Oximes (administration & dosage), Oximes (adverse effects), Prospective Studies, Proto-Oncogene Proteins B-raf (genetics), Pyridones (administration & dosage), Pyridones (adverse effects), Pyrimidinones (administration & dosage), Pyrimidinones (adverse effects), Stroke Volume (drug effects), Young Adult.
- MESH :
- chemical , administration & dosage : Imidazoles, Oximes, Pyridones, Pyrimidinones.
- adverse effects : Antineoplastic Combined Chemotherapy Protocols, Imidazoles, Oximes, Pyridones, Pyrimidinones.
- chemically induced : Fever, Headache.
- diagnostic imaging : Brain Neoplasms, Melanoma.
- drug effects : Stroke Volume.
- drug therapy : Brain Neoplasms, Melanoma.
- genetics : Brain Neoplasms, Melanoma, Proto-Oncogene Proteins B-raf.
- secondary : Brain Neoplasms, Melanoma.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols.
- Adult, Aged, Aged, 80 and over, Female, Humans, Magnetic Resonance Imaging, Male, Middle Aged, Mutation, Prospective Studies, Young Adult.
Abstract
Dabrafenib plus trametinib improves clinical outcomes in BRAF(V600)-mutant metastatic melanoma without brain metastases; however, the activity of dabrafenib plus trametinib has not been studied in active melanoma brain metastases. Here, we report results from the phase 2 COMBI-MB trial. Our aim was to build on the current body of evidence of targeted therapy in melanoma brain metastases through an evaluation of dabrafenib plus trametinib in patients with BRAF(V600)-mutant melanoma brain metastases.
DOI: 10.1016/S1470-2045(17)30429-1
PubMed: 28592387
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Electronic address: mdavies@mdanderson.org.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Melanoma Medical Oncology and Systems Biology, The University of Texas MD Anderson Cancer Center, Houston, TX</wicri:regionArea></affiliation></author><author><name sortKey="Saiag, Philippe" sort="Saiag, Philippe" uniqKey="Saiag P" first="Philippe" last="Saiag">Philippe Saiag</name><affiliation wicri:level="1"><nlm:affiliation>Service de Dermatologie Générale et Oncologique, Hôpital A Paré, Assistance Publique-Hôpitaux de Paris, Boulogne Billancourt, France; EA 4340, Université Versailles Saint-Quentin-en-Yvelines, Boulogne Billancourt, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Service de Dermatologie Générale et Oncologique, Hôpital A Paré, Assistance Publique-Hôpitaux de Paris, Boulogne Billancourt, France; EA 4340, Université Versailles Saint-Quentin-en-Yvelines, Boulogne Billancourt</wicri:regionArea></affiliation></author><author><name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name><affiliation wicri:level="1"><nlm:affiliation>Gustave Roussy, Département de Médecine Oncologique, Service de Dermatologie et Université Paris-Sud, Faculté de Médecine, Villejuif, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Gustave Roussy, Département de Médecine Oncologique, Service de Dermatologie et Université Paris-Sud, Faculté de Médecine, Villejuif</wicri:regionArea></affiliation></author><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="1"><nlm:affiliation>Service de Dermatologie, Centre Hospitalo-Universitaire Timone, Aix Marseille University, Marseille, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Service de Dermatologie, Centre Hospitalo-Universitaire Timone, Aix Marseille University, Marseille</wicri:regionArea></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="1"><nlm:affiliation>Developmental Therapeutics and Melanoma Programs, Massachusetts General Hospital Cancer Center, Boston, MA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Developmental Therapeutics and Melanoma Programs, Massachusetts General Hospital Cancer Center, Boston, MA</wicri:regionArea></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>Department of Medical Oncology, Hospital Clinic of Barcelona, Carrer de Villarroel, Barcelona, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Department of Medical Oncology, Hospital Clinic of Barcelona, Carrer de Villarroel, Barcelona</wicri:regionArea></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 Oesophageal Oncology Unit, Veneto Oncology Institute-IRCCS, Padova, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Melanoma and Oesophageal Oncology Unit, Veneto Oncology Institute-IRCCS, Padova</wicri:regionArea></affiliation></author><author><name sortKey="Thomas, Luc" sort="Thomas, Luc" uniqKey="Thomas L" first="Luc" last="Thomas">Luc Thomas</name><affiliation wicri:level="1"><nlm:affiliation>Service de Dermatologie, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Service de Dermatologie, Centre Hospitalier Lyon-Sud, Pierre-Bénite</wicri:regionArea></affiliation></author><author><name sortKey="Lesimple, Thierry" sort="Lesimple, Thierry" uniqKey="Lesimple T" first="Thierry" last="Lesimple">Thierry Lesimple</name><affiliation wicri:level="1"><nlm:affiliation>Oncologie Dermatologique, Centre Eugène Marquis, Rennes, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Oncologie Dermatologique, Centre Eugène Marquis, Rennes</wicri:regionArea></affiliation></author><author><name sortKey="Mortier, Laurent" sort="Mortier, Laurent" uniqKey="Mortier L" first="Laurent" last="Mortier">Laurent Mortier</name><affiliation wicri:level="1"><nlm:affiliation>Clinique de Dermatologie, Unité d'Onco-Dermatologie, Le Centre Hospitalier Régional Universitaire de Lille, University Lille 2, Lille, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Clinique de Dermatologie, Unité d'Onco-Dermatologie, Le Centre Hospitalier Régional Universitaire de Lille, University Lille 2, Lille</wicri:regionArea></affiliation></author><author><name sortKey="Moschos, Stergios J" sort="Moschos, Stergios J" uniqKey="Moschos S" first="Stergios J" last="Moschos">Stergios J. Moschos</name><affiliation wicri:level="1"><nlm:affiliation>Melanoma Program, Medical Oncology, UNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Melanoma Program, Medical Oncology, UNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC</wicri:regionArea></affiliation></author><author><name sortKey="Hogg, David" sort="Hogg, David" uniqKey="Hogg D" first="David" last="Hogg">David Hogg</name><affiliation wicri:level="1"><nlm:affiliation>Clinical Cancer Research Unit, Princess Margaret Cancer Centre, Toronto, ON, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Clinical Cancer Research Unit, Princess Margaret Cancer Centre, Toronto, ON</wicri:regionArea></affiliation></author><author><name sortKey="Marquez Rodas, Ivan" sort="Marquez Rodas, Ivan" uniqKey="Marquez Rodas I" first="Iván" last="Márquez-Rodas">Iván Márquez-Rodas</name><affiliation wicri:level="1"><nlm:affiliation>Servicio de Oncología Médica; Hospital General Universitario Gregorio Marañon, Madrid, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Servicio de Oncología Médica; Hospital General Universitario Gregorio Marañon, Madrid</wicri:regionArea></affiliation></author><author><name sortKey="Del Vecchio, Michele" sort="Del Vecchio, Michele" uniqKey="Del Vecchio M" first="Michele" last="Del Vecchio">Michele Del Vecchio</name><affiliation wicri:level="1"><nlm:affiliation>Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Fondazione IRCCS Istituto Nazionale dei Tumori, Milan</wicri:regionArea></affiliation></author><author><name sortKey="Lebbe, Celeste" sort="Lebbe, Celeste" uniqKey="Lebbe C" first="Céleste" last="Lebbé">Céleste Lebbé</name><affiliation wicri:level="1"><nlm:affiliation>APHP Dermatology and CIC Departments, INSERM U976, University Paris Diderot, Hôpital Saint Louis Paris, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>APHP Dermatology and CIC Departments, INSERM U976, University Paris Diderot, Hôpital Saint Louis Paris, Paris</wicri:regionArea></affiliation></author><author><name sortKey="Meyer, Nicolas" sort="Meyer, Nicolas" uniqKey="Meyer N" first="Nicolas" last="Meyer">Nicolas Meyer</name><affiliation wicri:level="1"><nlm:affiliation>Medical Oncology, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Medical Oncology, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse</wicri:regionArea></affiliation></author><author><name sortKey="Zhang, Ying" sort="Zhang, Ying" uniqKey="Zhang Y" first="Ying" last="Zhang">Ying Zhang</name><affiliation wicri:level="1"><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Pharmaceuticals Corporation, East Hanover, NJ</wicri:regionArea></affiliation></author><author><name sortKey="Huang, Yingjie" sort="Huang, Yingjie" uniqKey="Huang Y" first="Yingjie" last="Huang">Yingjie Huang</name><affiliation wicri:level="1"><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Pharmaceuticals Corporation, East Hanover, NJ</wicri:regionArea></affiliation></author><author><name sortKey="Mookerjee, Bijoyesh" sort="Mookerjee, Bijoyesh" uniqKey="Mookerjee B" first="Bijoyesh" last="Mookerjee">Bijoyesh Mookerjee</name><affiliation wicri:level="1"><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Pharmaceuticals Corporation, East Hanover, NJ</wicri:regionArea></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="1"><nlm:affiliation>Melanoma Institute Australia, The University of Sydney, Royal North Shore and Mater Hospitals, Sydney, NSW, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Melanoma Institute Australia, The University of Sydney, Royal North Shore and Mater Hospitals, Sydney, NSW</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28592387</idno><idno type="pmid">28592387</idno><idno type="doi">10.1016/S1470-2045(17)30429-1</idno><idno type="wicri:Area/PubMed/Corpus">000975</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000975</idno><idno type="wicri:Area/PubMed/Curation">000972</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000972</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Dabrafenib plus trametinib in patients with BRAF(V600)-mutant melanoma brain metastases (COMBI-MB): a multicentre, multicohort, open-label, phase 2 trial.</title><author><name sortKey="Davies, Michael A" sort="Davies, Michael A" uniqKey="Davies M" first="Michael A" last="Davies">Michael A. Davies</name><affiliation wicri:level="1"><nlm:affiliation>Melanoma Medical Oncology and Systems Biology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: mdavies@mdanderson.org.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Melanoma Medical Oncology and Systems Biology, The University of Texas MD Anderson Cancer Center, Houston, TX</wicri:regionArea></affiliation></author><author><name sortKey="Saiag, Philippe" sort="Saiag, Philippe" uniqKey="Saiag P" first="Philippe" last="Saiag">Philippe Saiag</name><affiliation wicri:level="1"><nlm:affiliation>Service de Dermatologie Générale et Oncologique, Hôpital A Paré, Assistance Publique-Hôpitaux de Paris, Boulogne Billancourt, France; EA 4340, Université Versailles Saint-Quentin-en-Yvelines, Boulogne Billancourt, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Service de Dermatologie Générale et Oncologique, Hôpital A Paré, Assistance Publique-Hôpitaux de Paris, Boulogne Billancourt, France; EA 4340, Université Versailles Saint-Quentin-en-Yvelines, Boulogne Billancourt</wicri:regionArea></affiliation></author><author><name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name><affiliation wicri:level="1"><nlm:affiliation>Gustave Roussy, Département de Médecine Oncologique, Service de Dermatologie et Université Paris-Sud, Faculté de Médecine, Villejuif, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Gustave Roussy, Département de Médecine Oncologique, Service de Dermatologie et Université Paris-Sud, Faculté de Médecine, Villejuif</wicri:regionArea></affiliation></author><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="1"><nlm:affiliation>Service de Dermatologie, Centre Hospitalo-Universitaire Timone, Aix Marseille University, Marseille, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Service de Dermatologie, Centre Hospitalo-Universitaire Timone, Aix Marseille University, Marseille</wicri:regionArea></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="1"><nlm:affiliation>Developmental Therapeutics and Melanoma Programs, Massachusetts General Hospital Cancer Center, Boston, MA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Developmental Therapeutics and Melanoma Programs, Massachusetts General Hospital Cancer Center, Boston, MA</wicri:regionArea></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>Department of Medical Oncology, Hospital Clinic of Barcelona, Carrer de Villarroel, Barcelona, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Department of Medical Oncology, Hospital Clinic of Barcelona, Carrer de Villarroel, Barcelona</wicri:regionArea></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 Oesophageal Oncology Unit, Veneto Oncology Institute-IRCCS, Padova, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Melanoma and Oesophageal Oncology Unit, Veneto Oncology Institute-IRCCS, Padova</wicri:regionArea></affiliation></author><author><name sortKey="Thomas, Luc" sort="Thomas, Luc" uniqKey="Thomas L" first="Luc" last="Thomas">Luc Thomas</name><affiliation wicri:level="1"><nlm:affiliation>Service de Dermatologie, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Service de Dermatologie, Centre Hospitalier Lyon-Sud, Pierre-Bénite</wicri:regionArea></affiliation></author><author><name sortKey="Lesimple, Thierry" sort="Lesimple, Thierry" uniqKey="Lesimple T" first="Thierry" last="Lesimple">Thierry Lesimple</name><affiliation wicri:level="1"><nlm:affiliation>Oncologie Dermatologique, Centre Eugène Marquis, Rennes, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Oncologie Dermatologique, Centre Eugène Marquis, Rennes</wicri:regionArea></affiliation></author><author><name sortKey="Mortier, Laurent" sort="Mortier, Laurent" uniqKey="Mortier L" first="Laurent" last="Mortier">Laurent Mortier</name><affiliation wicri:level="1"><nlm:affiliation>Clinique de Dermatologie, Unité d'Onco-Dermatologie, Le Centre Hospitalier Régional Universitaire de Lille, University Lille 2, Lille, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Clinique de Dermatologie, Unité d'Onco-Dermatologie, Le Centre Hospitalier Régional Universitaire de Lille, University Lille 2, Lille</wicri:regionArea></affiliation></author><author><name sortKey="Moschos, Stergios J" sort="Moschos, Stergios J" uniqKey="Moschos S" first="Stergios J" last="Moschos">Stergios J. Moschos</name><affiliation wicri:level="1"><nlm:affiliation>Melanoma Program, Medical Oncology, UNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Melanoma Program, Medical Oncology, UNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC</wicri:regionArea></affiliation></author><author><name sortKey="Hogg, David" sort="Hogg, David" uniqKey="Hogg D" first="David" last="Hogg">David Hogg</name><affiliation wicri:level="1"><nlm:affiliation>Clinical Cancer Research Unit, Princess Margaret Cancer Centre, Toronto, ON, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Clinical Cancer Research Unit, Princess Margaret Cancer Centre, Toronto, ON</wicri:regionArea></affiliation></author><author><name sortKey="Marquez Rodas, Ivan" sort="Marquez Rodas, Ivan" uniqKey="Marquez Rodas I" first="Iván" last="Márquez-Rodas">Iván Márquez-Rodas</name><affiliation wicri:level="1"><nlm:affiliation>Servicio de Oncología Médica; Hospital General Universitario Gregorio Marañon, Madrid, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Servicio de Oncología Médica; Hospital General Universitario Gregorio Marañon, Madrid</wicri:regionArea></affiliation></author><author><name sortKey="Del Vecchio, Michele" sort="Del Vecchio, Michele" uniqKey="Del Vecchio M" first="Michele" last="Del Vecchio">Michele Del Vecchio</name><affiliation wicri:level="1"><nlm:affiliation>Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Fondazione IRCCS Istituto Nazionale dei Tumori, Milan</wicri:regionArea></affiliation></author><author><name sortKey="Lebbe, Celeste" sort="Lebbe, Celeste" uniqKey="Lebbe C" first="Céleste" last="Lebbé">Céleste Lebbé</name><affiliation wicri:level="1"><nlm:affiliation>APHP Dermatology and CIC Departments, INSERM U976, University Paris Diderot, Hôpital Saint Louis Paris, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>APHP Dermatology and CIC Departments, INSERM U976, University Paris Diderot, Hôpital Saint Louis Paris, Paris</wicri:regionArea></affiliation></author><author><name sortKey="Meyer, Nicolas" sort="Meyer, Nicolas" uniqKey="Meyer N" first="Nicolas" last="Meyer">Nicolas Meyer</name><affiliation wicri:level="1"><nlm:affiliation>Medical Oncology, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Medical Oncology, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse</wicri:regionArea></affiliation></author><author><name sortKey="Zhang, Ying" sort="Zhang, Ying" uniqKey="Zhang Y" first="Ying" last="Zhang">Ying Zhang</name><affiliation wicri:level="1"><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Pharmaceuticals Corporation, East Hanover, NJ</wicri:regionArea></affiliation></author><author><name sortKey="Huang, Yingjie" sort="Huang, Yingjie" uniqKey="Huang Y" first="Yingjie" last="Huang">Yingjie Huang</name><affiliation wicri:level="1"><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Pharmaceuticals Corporation, East Hanover, NJ</wicri:regionArea></affiliation></author><author><name sortKey="Mookerjee, Bijoyesh" sort="Mookerjee, Bijoyesh" uniqKey="Mookerjee B" first="Bijoyesh" last="Mookerjee">Bijoyesh Mookerjee</name><affiliation wicri:level="1"><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Pharmaceuticals Corporation, East Hanover, NJ</wicri:regionArea></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="1"><nlm:affiliation>Melanoma Institute Australia, The University of Sydney, Royal North Shore and Mater Hospitals, Sydney, NSW, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Melanoma Institute Australia, The University of Sydney, Royal North Shore and Mater Hospitals, Sydney, NSW</wicri:regionArea></affiliation></author></analytic><series><title level="j">The Lancet. Oncology</title><idno type="eISSN">1474-5488</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Antineoplastic Combined Chemotherapy Protocols (adverse effects)</term><term>Antineoplastic Combined Chemotherapy Protocols (therapeutic use)</term><term>Brain Neoplasms (diagnostic imaging)</term><term>Brain Neoplasms (drug therapy)</term><term>Brain Neoplasms (genetics)</term><term>Brain Neoplasms (secondary)</term><term>Female</term><term>Fever (chemically induced)</term><term>Headache (chemically induced)</term><term>Humans</term><term>Imidazoles (administration & dosage)</term><term>Imidazoles (adverse effects)</term><term>Magnetic Resonance Imaging</term><term>Male</term><term>Melanoma (diagnostic imaging)</term><term>Melanoma (drug therapy)</term><term>Melanoma (genetics)</term><term>Melanoma (secondary)</term><term>Middle Aged</term><term>Mutation</term><term>Oximes (administration & dosage)</term><term>Oximes (adverse effects)</term><term>Prospective Studies</term><term>Proto-Oncogene Proteins B-raf (genetics)</term><term>Pyridones (administration & dosage)</term><term>Pyridones (adverse effects)</term><term>Pyrimidinones (administration & dosage)</term><term>Pyrimidinones (adverse effects)</term><term>Stroke Volume (drug effects)</term><term>Young Adult</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Céphalée ()</term><term>Débit systolique ()</term><term>Femelle</term><term>Fièvre ()</term><term>Humains</term><term>Imagerie par résonance magnétique</term><term>Imidazoles (administration et posologie)</term><term>Imidazoles (effets indésirables)</term><term>Jeune adulte</term><term>Mutation</term><term>Mâle</term><term>Mélanome (génétique)</term><term>Mélanome (imagerie diagnostique)</term><term>Mélanome (secondaire)</term><term>Mélanome (traitement médicamenteux)</term><term>Oximes (administration et posologie)</term><term>Oximes (effets indésirables)</term><term>Protocoles de polychimiothérapie antinéoplasique (effets indésirables)</term><term>Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique)</term><term>Protéines proto-oncogènes B-raf (génétique)</term><term>Pyridones (administration et posologie)</term><term>Pyridones (effets indésirables)</term><term>Pyrimidinones (administration et posologie)</term><term>Pyrimidinones (effets indésirables)</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Tumeurs du cerveau (génétique)</term><term>Tumeurs du cerveau (imagerie diagnostique)</term><term>Tumeurs du cerveau (secondaire)</term><term>Tumeurs du cerveau (traitement médicamenteux)</term><term>Études prospectives</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Imidazoles</term><term>Oximes</term><term>Pyridones</term><term>Pyrimidinones</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Imidazoles</term><term>Oximes</term><term>Pyridones</term><term>Pyrimidinones</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term><term>Imidazoles</term><term>Oximes</term><term>Pyridones</term><term>Pyrimidinones</term></keywords><keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Fever</term><term>Headache</term></keywords><keywords scheme="MESH" qualifier="diagnostic imaging" xml:lang="en"><term>Brain Neoplasms</term><term>Melanoma</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Stroke Volume</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Brain Neoplasms</term><term>Melanoma</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Imidazoles</term><term>Oximes</term><term>Protocoles de polychimiothérapie antinéoplasique</term><term>Pyridones</term><term>Pyrimidinones</term></keywords><keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Brain Neoplasms</term><term>Melanoma</term><term>Proto-Oncogene Proteins B-raf</term></keywords><keywords scheme="MESH" qualifier="génétique" xml:lang="fr"><term>Mélanome</term><term>Protéines proto-oncogènes B-raf</term><term>Tumeurs du cerveau</term></keywords><keywords scheme="MESH" qualifier="imagerie diagnostique" xml:lang="fr"><term>Mélanome</term><term>Tumeurs du cerveau</term></keywords><keywords scheme="MESH" qualifier="secondaire" xml:lang="fr"><term>Mélanome</term><term>Tumeurs du cerveau</term></keywords><keywords scheme="MESH" qualifier="secondary" xml:lang="en"><term>Brain Neoplasms</term><term>Melanoma</term></keywords><keywords scheme="MESH" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Mélanome</term><term>Tumeurs du cerveau</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Protocoles de polychimiothérapie antinéoplasique</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Female</term><term>Humans</term><term>Magnetic Resonance Imaging</term><term>Male</term><term>Middle Aged</term><term>Mutation</term><term>Prospective Studies</term><term>Young Adult</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Céphalée</term><term>Débit systolique</term><term>Femelle</term><term>Fièvre</term><term>Humains</term><term>Imagerie par résonance magnétique</term><term>Jeune adulte</term><term>Mutation</term><term>Mâle</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Études prospectives</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Dabrafenib plus trametinib improves clinical outcomes in BRAF(V600)-mutant metastatic melanoma without brain metastases; however, the activity of dabrafenib plus trametinib has not been studied in active melanoma brain metastases. Here, we report results from the phase 2 COMBI-MB trial. Our aim was to build on the current body of evidence of targeted therapy in melanoma brain metastases through an evaluation of dabrafenib plus trametinib in patients with BRAF(V600)-mutant melanoma brain metastases.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">28592387</PMID><DateCreated><Year>2017</Year><Month>06</Month><Day>08</Day></DateCreated><DateCompleted><Year>2017</Year><Month>09</Month><Day>11</Day></DateCompleted><DateRevised><Year>2017</Year><Month>09</Month><Day>11</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1474-5488</ISSN><JournalIssue CitedMedium="Internet"><Volume>18</Volume><Issue>7</Issue><PubDate><Year>2017</Year><Month>Jul</Month></PubDate></JournalIssue><Title>The Lancet. Oncology</Title><ISOAbbreviation>Lancet Oncol.</ISOAbbreviation></Journal><ArticleTitle>Dabrafenib plus trametinib in patients with BRAF(V600)-mutant melanoma brain metastases (COMBI-MB): a multicentre, multicohort, open-label, phase 2 trial.</ArticleTitle><Pagination><MedlinePgn>863-873</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S1470-2045(17)30429-1</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/S1470-2045(17)30429-1</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Dabrafenib plus trametinib improves clinical outcomes in BRAF(V600)-mutant metastatic melanoma without brain metastases; however, the activity of dabrafenib plus trametinib has not been studied in active melanoma brain metastases. Here, we report results from the phase 2 COMBI-MB trial. Our aim was to build on the current body of evidence of targeted therapy in melanoma brain metastases through an evaluation of dabrafenib plus trametinib in patients with BRAF(V600)-mutant melanoma brain metastases.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">This ongoing, multicentre, multicohort, open-label, phase 2 study evaluated oral dabrafenib (150 mg twice per day) plus oral trametinib (2 mg once per day) in four patient cohorts with melanoma brain metastases enrolled from 32 hospitals and institutions in Europe, North America, and Australia: (A) BRAF(V600E)-positive, asymptomatic melanoma brain metastases, with no previous local brain therapy, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; (B) BRAF(V600E)-positive, asymptomatic melanoma brain metastases, with previous local brain therapy, and an ECOG performance status of 0 or 1; (C) BRAF(V600D/K/R)-positive, asymptomatic melanoma brain metastases, with or without previous local brain therapy, and an ECOG performance status of 0 or 1; and (D) BRAF(V600D/E/K/R)-positive, symptomatic melanoma brain metastases, with or without previous local brain therapy, and an ECOG performance status of 0, 1, or 2. The primary endpoint was investigator-assessed intracranial response in cohort A in the all-treated-patients population. Secondary endpoints included intracranial response in cohorts B, C, and D. This study is registered with ClinicalTrials.gov, number NCT02039947.</AbstractText><AbstractText Label="FINDINGS" NlmCategory="RESULTS">Between Feb 28, 2014, and Aug 5, 2016, 125 patients were enrolled in the study: 76 patients in cohort A; 16 patients in cohort B; 16 patients in cohort C; and 17 patients in cohort D. At the data cutoff (Nov 28, 2016) after a median follow-up of 8·5 months (IQR 5·5-14·0), 44 (58%; 95% CI 46-69) of 76 patients in cohort A achieved an intracranial response. Intracranial response by investigator assessment was also achieved in nine (56%; 95% CI 30-80) of 16 patients in cohort B, seven (44%; 20-70) of 16 patients in cohort C, and ten (59%; 33-82) of 17 patients in cohort D. The most common serious adverse events related to study treatment were pyrexia for dabrafenib (eight [6%] of 125 patients) and decreased ejection fraction (five [4%]) for trametinib. The most common grade 3 or worse adverse events, regardless of study drug relationship, were pyrexia (four [3%] of 125) and headache (three [2%]).</AbstractText><AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">Dabrafenib plus trametinib was active with a manageable safety profile in this melanoma population that was consistent with previous dabrafenib plus trametinib studies in patients with BRAF(V600)-mutant melanoma without brain metastases, but the median duration of response was relatively short. These results provide evidence of clinical benefit with dabrafenib plus trametinib and support the need for additional research to further improve outcomes in patients with melanoma brain metastases.</AbstractText><AbstractText Label="FUNDING" NlmCategory="BACKGROUND">Novartis.</AbstractText><CopyrightInformation>Copyright © 2017 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Davies</LastName><ForeName>Michael A</ForeName><Initials>MA</Initials><AffiliationInfo><Affiliation>Melanoma Medical Oncology and Systems Biology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: mdavies@mdanderson.org.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Saiag</LastName><ForeName>Philippe</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Service de Dermatologie Générale et Oncologique, Hôpital A Paré, Assistance Publique-Hôpitaux de Paris, Boulogne Billancourt, France; EA 4340, Université Versailles Saint-Quentin-en-Yvelines, Boulogne Billancourt, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Robert</LastName><ForeName>Caroline</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Gustave Roussy, Département de Médecine Oncologique, Service de Dermatologie et Université Paris-Sud, Faculté de Médecine, Villejuif, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Grob</LastName><ForeName>Jean-Jacques</ForeName><Initials>JJ</Initials><AffiliationInfo><Affiliation>Service de Dermatologie, Centre Hospitalo-Universitaire Timone, Aix Marseille University, Marseille, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Flaherty</LastName><ForeName>Keith T</ForeName><Initials>KT</Initials><AffiliationInfo><Affiliation>Developmental Therapeutics and Melanoma Programs, Massachusetts General Hospital Cancer Center, Boston, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Arance</LastName><ForeName>Ana</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Medical Oncology, Hospital Clinic of Barcelona, Carrer de Villarroel, Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chiarion-Sileni</LastName><ForeName>Vanna</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Melanoma and Oesophageal Oncology Unit, Veneto Oncology Institute-IRCCS, Padova, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Thomas</LastName><ForeName>Luc</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Service de Dermatologie, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lesimple</LastName><ForeName>Thierry</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Oncologie Dermatologique, Centre Eugène Marquis, Rennes, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mortier</LastName><ForeName>Laurent</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Clinique de Dermatologie, Unité d'Onco-Dermatologie, Le Centre Hospitalier Régional Universitaire de Lille, University Lille 2, Lille, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Moschos</LastName><ForeName>Stergios J</ForeName><Initials>SJ</Initials><AffiliationInfo><Affiliation>Melanoma Program, Medical Oncology, UNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hogg</LastName><ForeName>David</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Clinical Cancer Research Unit, Princess Margaret Cancer Centre, Toronto, ON, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Márquez-Rodas</LastName><ForeName>Iván</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>Servicio de Oncología Médica; Hospital General Universitario Gregorio Marañon, Madrid, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Del Vecchio</LastName><ForeName>Michele</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lebbé</LastName><ForeName>Céleste</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>APHP Dermatology and CIC Departments, INSERM U976, University Paris Diderot, Hôpital Saint Louis Paris, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Meyer</LastName><ForeName>Nicolas</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Medical Oncology, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zhang</LastName><ForeName>Ying</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Huang</LastName><ForeName>Yingjie</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mookerjee</LastName><ForeName>Bijoyesh</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Long</LastName><ForeName>Georgina V</ForeName><Initials>GV</Initials><AffiliationInfo><Affiliation>Melanoma Institute Australia, The University of Sydney, Royal North Shore and Mater Hospitals, Sydney, NSW, Australia.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D017427">Clinical Trial, Phase II</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>06</Month><Day>04</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Lancet Oncol</MedlineTA><NlmUniqueID>100957246</NlmUniqueID><ISSNLinking>1470-2045</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance 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Resonance Imaging</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008545" MajorTopicYN="N">Melanoma</DescriptorName><QualifierName UI="Q000000981" MajorTopicYN="N">diagnostic imaging</QualifierName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000235" MajorTopicYN="N">genetics</QualifierName><QualifierName UI="Q000556" MajorTopicYN="N">secondary</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009154" MajorTopicYN="N">Mutation</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D010091" MajorTopicYN="N">Oximes</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse 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