Serveur d'exploration sur les relations entre la France et l'Australie

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Nivolumab for Patients With Advanced Melanoma Treated Beyond Progression: Analysis of 2 Phase 3 Clinical Trials.

Identifieur interne : 004A55 ( Ncbi/Merge ); précédent : 004A54; suivant : 004A56

Nivolumab for Patients With Advanced Melanoma Treated Beyond Progression: Analysis of 2 Phase 3 Clinical Trials.

Auteurs : Georgina V. Long [Australie] ; Jeffrey S. Weber [États-Unis] ; James Larkin [Royaume-Uni] ; Victoria Atkinson [Australie] ; Jean-Jacques Grob [France] ; Dirk Schadendorf [Allemagne] ; Reinhard Dummer [Suisse] ; Caroline Robert [France] ; Ivan Márquez-Rodas [Espagne] ; Catriona Mcneil [Australie] ; Henrik Schmidt [Danemark] ; Karen Briscoe [Australie] ; Jean-François Baurain [Belgique] ; F Stephen Hodi [États-Unis] ; Jedd D. Wolchok [États-Unis]

Source :

RBID : pubmed:28662232

Abstract

Immune checkpoint inhibitors have demonstrated atypical response patterns, which may not be fully captured by conventional response criteria. There is a need to better understand the potential benefit of continued immune checkpoint inhibition beyond progression.

DOI: 10.1001/jamaoncol.2017.1588
PubMed: 28662232

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pubmed:28662232

Le document en format XML

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<title xml:lang="en">Nivolumab for Patients With Advanced Melanoma Treated Beyond Progression: Analysis of 2 Phase 3 Clinical Trials.</title>
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<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, University of Sydney, Sydney, New South Wales, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Melanoma Institute Australia, University of Sydney, Sydney, New South Wales</wicri:regionArea>
<orgName type="university">Université de Sydney</orgName>
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<settlement type="city">Sydney</settlement>
<region type="état">Nouvelle-Galles du Sud</region>
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<name sortKey="Weber, Jeffrey S" sort="Weber, Jeffrey S" uniqKey="Weber J" first="Jeffrey S" last="Weber">Jeffrey S. Weber</name>
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<nlm:affiliation>Department of Medical Oncology, Moffitt Cancer Center, Tampa, Florida.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Floride</region>
</placeName>
<wicri:cityArea>Department of Medical Oncology, Moffitt Cancer Center, Tampa</wicri:cityArea>
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<name sortKey="Larkin, James" sort="Larkin, James" uniqKey="Larkin J" first="James" last="Larkin">James Larkin</name>
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<nlm:affiliation>Department of Oncology, Royal Marsden Hospital, London, United Kingdom.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Department of Oncology, Royal Marsden Hospital, London</wicri:regionArea>
<placeName>
<settlement type="city">Londres</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Grand Londres</region>
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<name sortKey="Atkinson, Victoria" sort="Atkinson, Victoria" uniqKey="Atkinson V" first="Victoria" last="Atkinson">Victoria Atkinson</name>
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<nlm:affiliation>Gallipoli Medical Research Foundation and Princess Alexandra Hospital, and University of Queensland, Queensland, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Gallipoli Medical Research Foundation and Princess Alexandra Hospital, and University of Queensland, Queensland</wicri:regionArea>
<wicri:noRegion>Queensland</wicri:noRegion>
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<name sortKey="Grob, Jean Jacques" sort="Grob, Jean Jacques" uniqKey="Grob J" first="Jean-Jacques" last="Grob">Jean-Jacques Grob</name>
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<nlm:affiliation>Department of Dermatology and Skin Cancer, Hospital Timone APHM, Aix-Marseille University, Marseille, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Dermatology and Skin Cancer, Hospital Timone APHM, Aix-Marseille University, Marseille</wicri:regionArea>
<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>
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<name sortKey="Schadendorf, Dirk" sort="Schadendorf, Dirk" uniqKey="Schadendorf D" first="Dirk" last="Schadendorf">Dirk Schadendorf</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Skin, University Hospital Essen, Essen, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Skin, University Hospital Essen, Essen</wicri:regionArea>
<wicri:noRegion>Essen</wicri:noRegion>
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<name sortKey="Dummer, Reinhard" sort="Dummer, Reinhard" uniqKey="Dummer R" first="Reinhard" last="Dummer">Reinhard Dummer</name>
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<nlm:affiliation>Department of Dermatology, UniversitaetsSpital, Zurich, Switzerland.</nlm:affiliation>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Department of Dermatology, UniversitaetsSpital, Zurich</wicri:regionArea>
<wicri:noRegion>Zurich</wicri:noRegion>
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<author>
<name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Medicine Institute Gustave Roussy, Gustave Roussy and Paris-Sud University, Villejuif Paris-Sud, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Medicine Institute Gustave Roussy, Gustave Roussy and Paris-Sud University, Villejuif Paris-Sud</wicri:regionArea>
<wicri:noRegion>Villejuif Paris-Sud</wicri:noRegion>
<wicri:noRegion>Villejuif Paris-Sud</wicri:noRegion>
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<name sortKey="Marquez Rodas, Ivan" sort="Marquez Rodas, Ivan" uniqKey="Marquez Rodas I" first="Ivan" last="Márquez-Rodas">Ivan Márquez-Rodas</name>
<affiliation wicri:level="3">
<nlm:affiliation>Servicio de Oncología Médica, Hospital General Universitario Gregorio Marañón, Madrid, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
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<region nuts="2" type="region">Communauté de Madrid</region>
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<name sortKey="Mcneil, Catriona" sort="Mcneil, Catriona" uniqKey="Mcneil C" first="Catriona" last="Mcneil">Catriona Mcneil</name>
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<nlm:affiliation>Chris O'Brien Lifehouse, Melanoma Institute Australia, Camperdown, New South Wales, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Chris O'Brien Lifehouse, Melanoma Institute Australia, Camperdown, New South Wales</wicri:regionArea>
<wicri:noRegion>New South Wales</wicri:noRegion>
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<name sortKey="Schmidt, Henrik" sort="Schmidt, Henrik" uniqKey="Schmidt H" first="Henrik" last="Schmidt">Henrik Schmidt</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Oncology, Aarhus University Hospital, Aarhus</wicri:regionArea>
<wicri:noRegion>Aarhus</wicri:noRegion>
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<name sortKey="Briscoe, Karen" sort="Briscoe, Karen" uniqKey="Briscoe K" first="Karen" last="Briscoe">Karen Briscoe</name>
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<nlm:affiliation>Department of Medical Oncology, Coffs Harbour Health Campus, New South Wales, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Department of Medical Oncology, Coffs Harbour Health Campus, New South Wales</wicri:regionArea>
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<name sortKey="Baurain, Jean Francois" sort="Baurain, Jean Francois" uniqKey="Baurain J" first="Jean-François" last="Baurain">Jean-François Baurain</name>
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<nlm:affiliation>Melanoma Clinic at King Albert II Cancer Institute, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Bruxelles, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>Melanoma Clinic at King Albert II Cancer Institute, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Bruxelles</wicri:regionArea>
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<settlement type="city">Bruxelles</settlement>
<region nuts="2">Région de Bruxelles-Capitale</region>
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<name sortKey="Hodi, F Stephen" sort="Hodi, F Stephen" uniqKey="Hodi F" first="F Stephen" last="Hodi">F Stephen Hodi</name>
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<nlm:affiliation>Melanoma Center and Center for Immuno-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Massachusetts</region>
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<wicri:cityArea>Melanoma Center and Center for Immuno-Oncology, Dana-Farber Cancer Institute, Boston</wicri:cityArea>
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<name sortKey="Wolchok, Jedd D" sort="Wolchok, Jedd D" uniqKey="Wolchok J" first="Jedd D" last="Wolchok">Jedd D. Wolchok</name>
<affiliation wicri:level="2">
<nlm:affiliation>Ludwig Center for Cancer Immunotherapy at Memorial Sloan Kettering Cancer Center, New York, New York.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">État de New York</region>
</placeName>
<wicri:cityArea>Ludwig Center for Cancer Immunotherapy at Memorial Sloan Kettering Cancer Center, New York</wicri:cityArea>
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<name sortKey="Long, Georgina V" sort="Long, Georgina V" uniqKey="Long G" first="Georgina V" last="Long">Georgina V. Long</name>
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<nlm:affiliation>Melanoma Institute Australia, University of Sydney, Sydney, New South Wales, Australia.</nlm:affiliation>
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<name sortKey="Weber, Jeffrey S" sort="Weber, Jeffrey S" uniqKey="Weber J" first="Jeffrey S" last="Weber">Jeffrey S. Weber</name>
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<nlm:affiliation>Department of Medical Oncology, Moffitt Cancer Center, Tampa, Florida.</nlm:affiliation>
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<region type="state">Floride</region>
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<wicri:cityArea>Department of Medical Oncology, Moffitt Cancer Center, Tampa</wicri:cityArea>
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<name sortKey="Larkin, James" sort="Larkin, James" uniqKey="Larkin J" first="James" last="Larkin">James Larkin</name>
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<nlm:affiliation>Department of Oncology, Royal Marsden Hospital, London, United Kingdom.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Department of Oncology, Royal Marsden Hospital, London</wicri:regionArea>
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<name sortKey="Atkinson, Victoria" sort="Atkinson, Victoria" uniqKey="Atkinson V" first="Victoria" last="Atkinson">Victoria Atkinson</name>
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<nlm:affiliation>Gallipoli Medical Research Foundation and Princess Alexandra Hospital, and University of Queensland, Queensland, Australia.</nlm:affiliation>
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<name sortKey="Grob, Jean Jacques" sort="Grob, Jean Jacques" uniqKey="Grob J" first="Jean-Jacques" last="Grob">Jean-Jacques Grob</name>
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<nlm:affiliation>Department of Dermatology and Skin Cancer, Hospital Timone APHM, Aix-Marseille University, Marseille, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Dermatology and Skin Cancer, Hospital Timone APHM, Aix-Marseille University, Marseille</wicri:regionArea>
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<region type="old region">Provence-Alpes-Côte d'Azur</region>
<settlement type="city">Marseille</settlement>
</placeName>
</affiliation>
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<name sortKey="Schadendorf, Dirk" sort="Schadendorf, Dirk" uniqKey="Schadendorf D" first="Dirk" last="Schadendorf">Dirk Schadendorf</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Skin, University Hospital Essen, Essen, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Skin, University Hospital Essen, Essen</wicri:regionArea>
<wicri:noRegion>Essen</wicri:noRegion>
<wicri:noRegion>Essen</wicri:noRegion>
<wicri:noRegion>Essen</wicri:noRegion>
</affiliation>
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<name sortKey="Dummer, Reinhard" sort="Dummer, Reinhard" uniqKey="Dummer R" first="Reinhard" last="Dummer">Reinhard Dummer</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Dermatology, UniversitaetsSpital, Zurich, Switzerland.</nlm:affiliation>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Department of Dermatology, UniversitaetsSpital, Zurich</wicri:regionArea>
<wicri:noRegion>Zurich</wicri:noRegion>
</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>Department of Medicine Institute Gustave Roussy, Gustave Roussy and Paris-Sud University, Villejuif Paris-Sud, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Medicine Institute Gustave Roussy, Gustave Roussy and Paris-Sud University, Villejuif Paris-Sud</wicri:regionArea>
<wicri:noRegion>Villejuif Paris-Sud</wicri:noRegion>
<wicri:noRegion>Villejuif Paris-Sud</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Marquez Rodas, Ivan" sort="Marquez Rodas, Ivan" uniqKey="Marquez Rodas I" first="Ivan" last="Márquez-Rodas">Ivan Márquez-Rodas</name>
<affiliation wicri:level="3">
<nlm:affiliation>Servicio de Oncología Médica, Hospital General Universitario Gregorio Marañón, Madrid, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Servicio de Oncología Médica, Hospital General Universitario Gregorio Marañón, Madrid</wicri:regionArea>
<placeName>
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<name sortKey="Mcneil, Catriona" sort="Mcneil, Catriona" uniqKey="Mcneil C" first="Catriona" last="Mcneil">Catriona Mcneil</name>
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<nlm:affiliation>Chris O'Brien Lifehouse, Melanoma Institute Australia, Camperdown, New South Wales, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Chris O'Brien Lifehouse, Melanoma Institute Australia, Camperdown, New South Wales</wicri:regionArea>
<wicri:noRegion>New South Wales</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Schmidt, Henrik" sort="Schmidt, Henrik" uniqKey="Schmidt H" first="Henrik" last="Schmidt">Henrik Schmidt</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Oncology, Aarhus University Hospital, Aarhus</wicri:regionArea>
<wicri:noRegion>Aarhus</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Briscoe, Karen" sort="Briscoe, Karen" uniqKey="Briscoe K" first="Karen" last="Briscoe">Karen Briscoe</name>
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<nlm:affiliation>Department of Medical Oncology, Coffs Harbour Health Campus, New South Wales, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Department of Medical Oncology, Coffs Harbour Health Campus, New South Wales</wicri:regionArea>
<wicri:noRegion>New South Wales</wicri:noRegion>
</affiliation>
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<author>
<name sortKey="Baurain, Jean Francois" sort="Baurain, Jean Francois" uniqKey="Baurain J" first="Jean-François" last="Baurain">Jean-François Baurain</name>
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<nlm:affiliation>Melanoma Clinic at King Albert II Cancer Institute, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Bruxelles, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>Melanoma Clinic at King Albert II Cancer Institute, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Bruxelles</wicri:regionArea>
<placeName>
<settlement type="city">Bruxelles</settlement>
<region nuts="2">Région de Bruxelles-Capitale</region>
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</affiliation>
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<author>
<name sortKey="Hodi, F Stephen" sort="Hodi, F Stephen" uniqKey="Hodi F" first="F Stephen" last="Hodi">F Stephen Hodi</name>
<affiliation wicri:level="2">
<nlm:affiliation>Melanoma Center and Center for Immuno-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
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<region type="state">Massachusetts</region>
</placeName>
<wicri:cityArea>Melanoma Center and Center for Immuno-Oncology, Dana-Farber Cancer Institute, Boston</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Wolchok, Jedd D" sort="Wolchok, Jedd D" uniqKey="Wolchok J" first="Jedd D" last="Wolchok">Jedd D. Wolchok</name>
<affiliation wicri:level="2">
<nlm:affiliation>Ludwig Center for Cancer Immunotherapy at Memorial Sloan Kettering Cancer Center, New York, New York.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">État de New York</region>
</placeName>
<wicri:cityArea>Ludwig Center for Cancer Immunotherapy at Memorial Sloan Kettering Cancer Center, New York</wicri:cityArea>
</affiliation>
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<series>
<title level="j">JAMA oncology</title>
<idno type="eISSN">2374-2445</idno>
<imprint>
<date when="2017" type="published">2017</date>
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<div type="abstract" xml:lang="en">Immune checkpoint inhibitors have demonstrated atypical response patterns, which may not be fully captured by conventional response criteria. There is a need to better understand the potential benefit of continued immune checkpoint inhibition beyond progression.</div>
</front>
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<Day>29</Day>
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<Year>2017</Year>
<Month>11</Month>
<Day>09</Day>
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<Issue>11</Issue>
<PubDate>
<Year>2017</Year>
<Month>Nov</Month>
<Day>01</Day>
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<Title>JAMA oncology</Title>
<ISOAbbreviation>JAMA Oncol</ISOAbbreviation>
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<ArticleTitle>Nivolumab for Patients With Advanced Melanoma Treated Beyond Progression: Analysis of 2 Phase 3 Clinical Trials.</ArticleTitle>
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<MedlinePgn>1511-1519</MedlinePgn>
</Pagination>
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<Abstract>
<AbstractText Label="Importance" NlmCategory="UNASSIGNED">Immune checkpoint inhibitors have demonstrated atypical response patterns, which may not be fully captured by conventional response criteria. There is a need to better understand the potential benefit of continued immune checkpoint inhibition beyond progression.</AbstractText>
<AbstractText Label="Objective" NlmCategory="UNASSIGNED">To evaluate the safety and potential benefit of nivolumab (anti-programmed cell death receptor 1) monotherapy beyond Response Evaluation Criteria in Solid Tumors (RECIST) v1.1-defined progression.</AbstractText>
<AbstractText Label="Design, Setting, and Participants" NlmCategory="UNASSIGNED">Pooled, retrospective analysis of data from phase 3 trials of nivolumab in treatment-naive patients with advanced melanoma (CheckMate 066 or CheckMate 067) conducted at academic and clinical cancer centers. Participants were patients treated beyond first disease progression, defined as those who received their last dose of nivolumab more than 6 weeks after progression (TBP group); and patients not treated beyond progression, who discontinued nivolumab therapy before or at progression (non-TBP group). Data analyses were conducted from November 6, 2015, to January 11, 2017.</AbstractText>
<AbstractText Label="Interventions" NlmCategory="UNASSIGNED">Nivolumab (3 mg/kg every 2 weeks) administered until progression or unacceptable toxic effects. Patients could be treated beyond progression if deriving apparent clinical benefit and tolerating study drug, at the investigator's discretion.</AbstractText>
<AbstractText Label="Main Outcomes and Measures" NlmCategory="UNASSIGNED">Tumor response and safety in TBP and non-TBP patients.</AbstractText>
<AbstractText Label="Results" NlmCategory="UNASSIGNED">Among 526 randomized patients (39% [n = 203] female; median age, 62 years [range, 18-90 years]), 306 (58%) experienced disease progression, including 85 (28%) TBP patients and 221 (72%) non-TBP patients. Twenty-four (28%) of the TBP patients had a target lesion reduction of greater than 30% after progression compared with baseline (TBP>30% group). At the time of this analysis, 65 (76%) TBP patients and 21 (87%) TBP>30% patients were still alive; 27 (32%) and 11 (46%), respectively, continued to receive treatment. Median (range) time from progression to last dose of treatment was 4.7 (1.4-25.8) months for TBP patients and 7.6 (2.4-19.4) months for TBP>30% patients. Median (range) time from progression to greater than 30% tumor reduction was 1.4 (0.2-7.0) months. Treatment-related select grade 3 to 4 adverse events were similar in the TBP and non-TBP groups (5 [6%] and 9 [4%], respectively).</AbstractText>
<AbstractText Label="Conclusions and Relevance" NlmCategory="UNASSIGNED">A substantial proportion of selected patients treated with frontline nivolumab who were clinically stable and judged to be eligible for treatment beyond RECIST v1.1-defined progression by the treating investigators derived apparent clinical benefit without compromising safety. Further analysis will help define the potential benefit of continued nivolumab treatment beyond progression.</AbstractText>
<AbstractText Label="Trial Registration" NlmCategory="UNASSIGNED">clinicaltrials.gov Identifiers: NCT01721772 (CheckMate 066) and NCT01844505 (CheckMate 067).</AbstractText>
</Abstract>
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<LastName>Long</LastName>
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<Affiliation>Melanoma Institute Australia, University of Sydney, Sydney, New South Wales, Australia.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Mater Hospital, North Sydney, New South Wales, Australia.</Affiliation>
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<Affiliation>Department of Medical Oncology, Moffitt Cancer Center, Tampa, Florida.</Affiliation>
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<AffiliationInfo>
<Affiliation>now with Department of Medical Oncology, Laura and Isaac Perlmutter Cancer Center, New York University Langone Medical Center, New York.</Affiliation>
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<Affiliation>Department of Urology, University Hospital Essen, Essen, Germany.</Affiliation>
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<name sortKey="Baurain, Jean Francois" sort="Baurain, Jean Francois" uniqKey="Baurain J" first="Jean-François" last="Baurain">Jean-François Baurain</name>
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