Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial.
Identifieur interne : 003354 ( PubMed/Curation ); précédent : 003353; suivant : 003355Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial.
Auteurs : Caroline Robert [France] ; Antoni Ribas [États-Unis] ; Jedd D. Wolchok [États-Unis] ; F Stephen Hodi [États-Unis] ; Omid Hamid [États-Unis] ; Richard Kefford [Australie] ; Jeffrey S. Weber [États-Unis] ; Anthony M. Joshua [Canada] ; Wen-Jen Hwu [États-Unis] ; Tara C. Gangadhar [États-Unis] ; Amita Patnaik [États-Unis] ; Roxana Dronca [États-Unis] ; Hassane Zarour [États-Unis] ; Richard W. Joseph [États-Unis] ; Peter Boasberg [États-Unis] ; Bartosz Chmielowski [États-Unis] ; Christine Mateus [France] ; Michael A. Postow [États-Unis] ; Kevin Gergich [États-Unis] ; Jeroen Elassaiss-Schaap [États-Unis] ; Xiaoyun Nicole Li [États-Unis] ; Robert Iannone [États-Unis] ; Scot W. Ebbinghaus [États-Unis] ; S Peter Kang [États-Unis] ; Adil Daud [États-Unis]Source :
- Lancet (London, England) [ 1474-547X ] ; 2014.
Descripteurs français
- KwdFr :
- Adolescent, Adulte, Adulte d'âge moyen, Anticorps monoclonaux (administration et posologie), Anticorps monoclonaux (effets indésirables), Anticorps monoclonaux (usage thérapeutique), Anticorps monoclonaux humanisés, Antinéoplasiques (administration et posologie), Antinéoplasiques (effets indésirables), Fatigue (), Femelle, Humains, Jeune adulte, Mâle, Mélanome (traitement médicamenteux), Prurit (), Relation dose-effet des médicaments, Récepteur-1 de mort cellulaire programmée (antagonistes et inhibiteurs), Résistance aux médicaments antinéoplasiques, Résultat thérapeutique, Sujet âgé, Toxidermies (étiologie), Tumeurs cutanées (traitement médicamenteux).
- MESH :
- administration et posologie : Anticorps monoclonaux, Antinéoplasiques.
- antagonistes et inhibiteurs : Récepteur-1 de mort cellulaire programmée.
- effets indésirables : Anticorps monoclonaux, Antinéoplasiques.
- traitement médicamenteux : Mélanome, Tumeurs cutanées.
- usage thérapeutique : Anticorps monoclonaux.
- étiologie : Toxidermies.
- Adolescent, Adulte, Adulte d'âge moyen, Anticorps monoclonaux humanisés, Fatigue, Femelle, Humains, Jeune adulte, Mâle, Prurit, Relation dose-effet des médicaments, Résistance aux médicaments antinéoplasiques, Résultat thérapeutique, Sujet âgé.
English descriptors
- KwdEn :
- Adolescent, Adult, Aged, Antibodies, Monoclonal (administration & dosage), Antibodies, Monoclonal (adverse effects), Antibodies, Monoclonal (therapeutic use), Antibodies, Monoclonal, Humanized, Antineoplastic Agents (administration & dosage), Antineoplastic Agents (adverse effects), Dose-Response Relationship, Drug, Drug Eruptions (etiology), Drug Resistance, Neoplasm, Fatigue (chemically induced), Female, Humans, Male, Melanoma (drug therapy), Middle Aged, Programmed Cell Death 1 Receptor (antagonists & inhibitors), Pruritus (chemically induced), Skin Neoplasms (drug therapy), Treatment Outcome, Young Adult.
- MESH :
- chemical , administration & dosage : Antibodies, Monoclonal, Antineoplastic Agents.
- chemical , adverse effects : Antibodies, Monoclonal, Antineoplastic Agents.
- chemical , antagonists & inhibitors : Programmed Cell Death 1 Receptor.
- chemical , therapeutic use : Antibodies, Monoclonal.
- chemically induced : Fatigue, Pruritus.
- drug therapy : Melanoma, Skin Neoplasms.
- etiology : Drug Eruptions.
- Adolescent, Adult, Aged, Antibodies, Monoclonal, Humanized, Dose-Response Relationship, Drug, Drug Resistance, Neoplasm, Female, Humans, Male, Middle Aged, Treatment Outcome, Young Adult.
Abstract
The anti-programmed-death-receptor-1 (PD-1) antibody pembrolizumab has shown potent antitumour activity at different doses and schedules in patients with melanoma. We compared the efficacy and safety of pembrolizumab at doses of 2 mg/kg and 10 mg/kg every 3 weeks in patients with ipilimumab-refractory advanced melanoma.
DOI: 10.1016/S0140-6736(14)60958-2
PubMed: 25034862
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Joshua</name><affiliation wicri:level="1"><nlm:affiliation>Princess Margaret Cancer Centre, Toronto, ON, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Princess Margaret Cancer Centre, Toronto, ON</wicri:regionArea></affiliation></author><author><name sortKey="Hwu, Wen Jen" sort="Hwu, Wen Jen" uniqKey="Hwu W" first="Wen-Jen" last="Hwu">Wen-Jen Hwu</name><affiliation wicri:level="1"><nlm:affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Texas MD Anderson Cancer Center, Houston, TX</wicri:regionArea></affiliation></author><author><name sortKey="Gangadhar, Tara C" sort="Gangadhar, Tara C" uniqKey="Gangadhar T" first="Tara C" last="Gangadhar">Tara C. Gangadhar</name><affiliation wicri:level="1"><nlm:affiliation>Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA</wicri:regionArea></affiliation></author><author><name sortKey="Patnaik, Amita" sort="Patnaik, Amita" uniqKey="Patnaik A" first="Amita" last="Patnaik">Amita Patnaik</name><affiliation wicri:level="1"><nlm:affiliation>South Texas Accelerated Research Therapeutics, San Antonio, TX, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>South Texas Accelerated Research Therapeutics, San Antonio, TX</wicri:regionArea></affiliation></author><author><name sortKey="Dronca, Roxana" sort="Dronca, Roxana" uniqKey="Dronca R" first="Roxana" last="Dronca">Roxana Dronca</name><affiliation wicri:level="1"><nlm:affiliation>Mayo Clinic, Rochester, MN, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Mayo Clinic, Rochester, MN</wicri:regionArea></affiliation></author><author><name sortKey="Zarour, Hassane" sort="Zarour, Hassane" uniqKey="Zarour H" first="Hassane" last="Zarour">Hassane Zarour</name><affiliation wicri:level="1"><nlm:affiliation>University of Pittsburgh, Pittsburgh, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Pittsburgh, Pittsburgh, PA</wicri:regionArea></affiliation></author><author><name sortKey="Joseph, Richard W" sort="Joseph, Richard W" uniqKey="Joseph R" first="Richard W" last="Joseph">Richard W. Joseph</name><affiliation wicri:level="1"><nlm:affiliation>Mayo Clinic, Jacksonville, FL, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Mayo Clinic, Jacksonville, FL</wicri:regionArea></affiliation></author><author><name sortKey="Boasberg, Peter" sort="Boasberg, Peter" uniqKey="Boasberg P" first="Peter" last="Boasberg">Peter Boasberg</name><affiliation wicri:level="1"><nlm:affiliation>Angeles Clinic and Research Institute, Los Angeles, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Angeles Clinic and Research Institute, Los Angeles, CA</wicri:regionArea></affiliation></author><author><name sortKey="Chmielowski, Bartosz" sort="Chmielowski, Bartosz" uniqKey="Chmielowski B" first="Bartosz" last="Chmielowski">Bartosz Chmielowski</name><affiliation wicri:level="1"><nlm:affiliation>University of California Los Angeles, Los Angeles, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of California Los Angeles, Los Angeles, CA</wicri:regionArea></affiliation></author><author><name sortKey="Mateus, Christine" sort="Mateus, Christine" uniqKey="Mateus C" first="Christine" last="Mateus">Christine Mateus</name><affiliation wicri:level="1"><nlm:affiliation>Gustave Roussy and INSERM U981, Paris-Sud, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Gustave Roussy and INSERM U981, Paris-Sud</wicri:regionArea></affiliation></author><author><name sortKey="Postow, Michael A" sort="Postow, Michael A" uniqKey="Postow M" first="Michael A" last="Postow">Michael A. Postow</name><affiliation wicri:level="1"><nlm:affiliation>Memorial Sloan-Kettering Cancer Center, New York, NY, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Memorial Sloan-Kettering Cancer Center, New York, NY</wicri:regionArea></affiliation></author><author><name sortKey="Gergich, Kevin" sort="Gergich, Kevin" uniqKey="Gergich K" first="Kevin" last="Gergich">Kevin Gergich</name><affiliation wicri:level="1"><nlm:affiliation>Merck, Whitehouse Station, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck, Whitehouse Station, NJ</wicri:regionArea></affiliation></author><author><name sortKey="Elassaiss Schaap, Jeroen" sort="Elassaiss Schaap, Jeroen" uniqKey="Elassaiss Schaap J" first="Jeroen" last="Elassaiss-Schaap">Jeroen Elassaiss-Schaap</name><affiliation wicri:level="1"><nlm:affiliation>Merck, Whitehouse Station, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck, Whitehouse Station, NJ</wicri:regionArea></affiliation></author><author><name sortKey="Li, Xiaoyun Nicole" sort="Li, Xiaoyun Nicole" uniqKey="Li X" first="Xiaoyun Nicole" last="Li">Xiaoyun Nicole Li</name><affiliation wicri:level="1"><nlm:affiliation>Merck, Whitehouse Station, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck, Whitehouse Station, NJ</wicri:regionArea></affiliation></author><author><name sortKey="Iannone, Robert" sort="Iannone, Robert" uniqKey="Iannone R" first="Robert" last="Iannone">Robert Iannone</name><affiliation wicri:level="1"><nlm:affiliation>Merck, Whitehouse Station, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck, Whitehouse Station, NJ</wicri:regionArea></affiliation></author><author><name sortKey="Ebbinghaus, Scot W" sort="Ebbinghaus, Scot W" uniqKey="Ebbinghaus S" first="Scot W" last="Ebbinghaus">Scot W. Ebbinghaus</name><affiliation wicri:level="1"><nlm:affiliation>Merck, Whitehouse Station, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck, Whitehouse Station, NJ</wicri:regionArea></affiliation></author><author><name sortKey="Kang, S Peter" sort="Kang, S Peter" uniqKey="Kang S" first="S Peter" last="Kang">S Peter Kang</name><affiliation wicri:level="1"><nlm:affiliation>Merck, Whitehouse Station, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck, Whitehouse Station, NJ</wicri:regionArea></affiliation></author><author><name sortKey="Daud, Adil" sort="Daud, Adil" uniqKey="Daud A" first="Adil" last="Daud">Adil Daud</name><affiliation wicri:level="1"><nlm:affiliation>University of California San Francisco, San Francisco, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of California San Francisco, San Francisco, CA</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2014">2014</date><idno type="RBID">pubmed:25034862</idno><idno type="pmid">25034862</idno><idno type="doi">10.1016/S0140-6736(14)60958-2</idno><idno type="wicri:Area/PubMed/Corpus">003467</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">003467</idno><idno type="wicri:Area/PubMed/Curation">003354</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">003354</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial.</title><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 and INSERM U981, Paris-Sud, France. Electronic address: caroline.robert@gustaveroussy.fr.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Gustave Roussy and INSERM U981, Paris-Sud</wicri:regionArea></affiliation></author><author><name sortKey="Ribas, Antoni" sort="Ribas, Antoni" uniqKey="Ribas A" first="Antoni" last="Ribas">Antoni Ribas</name><affiliation wicri:level="1"><nlm:affiliation>University of California Los Angeles, Los Angeles, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of California Los Angeles, Los Angeles, CA</wicri:regionArea></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="1"><nlm:affiliation>Memorial Sloan-Kettering Cancer Center, New York, NY, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Memorial Sloan-Kettering Cancer Center, New York, NY</wicri:regionArea></affiliation></author><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="1"><nlm:affiliation>Dana-Farber Cancer Institute, Boston, MA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Dana-Farber Cancer Institute, Boston, MA</wicri:regionArea></affiliation></author><author><name sortKey="Hamid, Omid" sort="Hamid, Omid" uniqKey="Hamid O" first="Omid" last="Hamid">Omid Hamid</name><affiliation wicri:level="1"><nlm:affiliation>Angeles Clinic and Research Institute, Los Angeles, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Angeles Clinic and Research Institute, Los Angeles, CA</wicri:regionArea></affiliation></author><author><name sortKey="Kefford, Richard" sort="Kefford, Richard" uniqKey="Kefford R" first="Richard" last="Kefford">Richard Kefford</name><affiliation wicri:level="1"><nlm:affiliation>Crown Princess Mary Cancer Centre, Westmead Hospital and Melanoma Institute Australia, Westmead, NSW, Australia; University of Sydney, Sydney, NSW, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Crown Princess Mary Cancer Centre, Westmead Hospital and Melanoma Institute Australia, Westmead, NSW, Australia; University of Sydney, Sydney, NSW</wicri:regionArea></affiliation></author><author><name sortKey="Weber, Jeffrey S" sort="Weber, Jeffrey S" uniqKey="Weber J" first="Jeffrey S" last="Weber">Jeffrey S. Weber</name><affiliation wicri:level="1"><nlm:affiliation>H Lee Moffitt Cancer Center, Tampa, FL, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>H Lee Moffitt Cancer Center, Tampa, FL</wicri:regionArea></affiliation></author><author><name sortKey="Joshua, Anthony M" sort="Joshua, Anthony M" uniqKey="Joshua A" first="Anthony M" last="Joshua">Anthony M. Joshua</name><affiliation wicri:level="1"><nlm:affiliation>Princess Margaret Cancer Centre, Toronto, ON, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Princess Margaret Cancer Centre, Toronto, ON</wicri:regionArea></affiliation></author><author><name sortKey="Hwu, Wen Jen" sort="Hwu, Wen Jen" uniqKey="Hwu W" first="Wen-Jen" last="Hwu">Wen-Jen Hwu</name><affiliation wicri:level="1"><nlm:affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Texas MD Anderson Cancer Center, Houston, TX</wicri:regionArea></affiliation></author><author><name sortKey="Gangadhar, Tara C" sort="Gangadhar, Tara C" uniqKey="Gangadhar T" first="Tara C" last="Gangadhar">Tara C. Gangadhar</name><affiliation wicri:level="1"><nlm:affiliation>Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA</wicri:regionArea></affiliation></author><author><name sortKey="Patnaik, Amita" sort="Patnaik, Amita" uniqKey="Patnaik A" first="Amita" last="Patnaik">Amita Patnaik</name><affiliation wicri:level="1"><nlm:affiliation>South Texas Accelerated Research Therapeutics, San Antonio, TX, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>South Texas Accelerated Research Therapeutics, San Antonio, TX</wicri:regionArea></affiliation></author><author><name sortKey="Dronca, Roxana" sort="Dronca, Roxana" uniqKey="Dronca R" first="Roxana" last="Dronca">Roxana Dronca</name><affiliation wicri:level="1"><nlm:affiliation>Mayo Clinic, Rochester, MN, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Mayo Clinic, Rochester, MN</wicri:regionArea></affiliation></author><author><name sortKey="Zarour, Hassane" sort="Zarour, Hassane" uniqKey="Zarour H" first="Hassane" last="Zarour">Hassane Zarour</name><affiliation wicri:level="1"><nlm:affiliation>University of Pittsburgh, Pittsburgh, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Pittsburgh, Pittsburgh, PA</wicri:regionArea></affiliation></author><author><name sortKey="Joseph, Richard W" sort="Joseph, Richard W" uniqKey="Joseph R" first="Richard W" last="Joseph">Richard W. Joseph</name><affiliation wicri:level="1"><nlm:affiliation>Mayo Clinic, Jacksonville, FL, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Mayo Clinic, Jacksonville, FL</wicri:regionArea></affiliation></author><author><name sortKey="Boasberg, Peter" sort="Boasberg, Peter" uniqKey="Boasberg P" first="Peter" last="Boasberg">Peter Boasberg</name><affiliation wicri:level="1"><nlm:affiliation>Angeles Clinic and Research Institute, Los Angeles, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Angeles Clinic and Research Institute, Los Angeles, CA</wicri:regionArea></affiliation></author><author><name sortKey="Chmielowski, Bartosz" sort="Chmielowski, Bartosz" uniqKey="Chmielowski B" first="Bartosz" last="Chmielowski">Bartosz Chmielowski</name><affiliation wicri:level="1"><nlm:affiliation>University of California Los Angeles, Los Angeles, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of California Los Angeles, Los Angeles, CA</wicri:regionArea></affiliation></author><author><name sortKey="Mateus, Christine" sort="Mateus, Christine" uniqKey="Mateus C" first="Christine" last="Mateus">Christine Mateus</name><affiliation wicri:level="1"><nlm:affiliation>Gustave Roussy and INSERM U981, Paris-Sud, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Gustave Roussy and INSERM U981, Paris-Sud</wicri:regionArea></affiliation></author><author><name sortKey="Postow, Michael A" sort="Postow, Michael A" uniqKey="Postow M" first="Michael A" last="Postow">Michael A. Postow</name><affiliation wicri:level="1"><nlm:affiliation>Memorial Sloan-Kettering Cancer Center, New York, NY, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Memorial Sloan-Kettering Cancer Center, New York, NY</wicri:regionArea></affiliation></author><author><name sortKey="Gergich, Kevin" sort="Gergich, Kevin" uniqKey="Gergich K" first="Kevin" last="Gergich">Kevin Gergich</name><affiliation wicri:level="1"><nlm:affiliation>Merck, Whitehouse Station, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck, Whitehouse Station, NJ</wicri:regionArea></affiliation></author><author><name sortKey="Elassaiss Schaap, Jeroen" sort="Elassaiss Schaap, Jeroen" uniqKey="Elassaiss Schaap J" first="Jeroen" last="Elassaiss-Schaap">Jeroen Elassaiss-Schaap</name><affiliation wicri:level="1"><nlm:affiliation>Merck, Whitehouse Station, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck, Whitehouse Station, NJ</wicri:regionArea></affiliation></author><author><name sortKey="Li, Xiaoyun Nicole" sort="Li, Xiaoyun Nicole" uniqKey="Li X" first="Xiaoyun Nicole" last="Li">Xiaoyun Nicole Li</name><affiliation wicri:level="1"><nlm:affiliation>Merck, Whitehouse Station, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck, Whitehouse Station, NJ</wicri:regionArea></affiliation></author><author><name sortKey="Iannone, Robert" sort="Iannone, Robert" uniqKey="Iannone R" first="Robert" last="Iannone">Robert Iannone</name><affiliation wicri:level="1"><nlm:affiliation>Merck, Whitehouse Station, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck, Whitehouse Station, NJ</wicri:regionArea></affiliation></author><author><name sortKey="Ebbinghaus, Scot W" sort="Ebbinghaus, Scot W" uniqKey="Ebbinghaus S" first="Scot W" last="Ebbinghaus">Scot W. Ebbinghaus</name><affiliation wicri:level="1"><nlm:affiliation>Merck, Whitehouse Station, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck, Whitehouse Station, NJ</wicri:regionArea></affiliation></author><author><name sortKey="Kang, S Peter" sort="Kang, S Peter" uniqKey="Kang S" first="S Peter" last="Kang">S Peter Kang</name><affiliation wicri:level="1"><nlm:affiliation>Merck, Whitehouse Station, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merck, Whitehouse Station, NJ</wicri:regionArea></affiliation></author><author><name sortKey="Daud, Adil" sort="Daud, Adil" uniqKey="Daud A" first="Adil" last="Daud">Adil Daud</name><affiliation wicri:level="1"><nlm:affiliation>University of California San Francisco, San Francisco, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of California San Francisco, San Francisco, CA</wicri:regionArea></affiliation></author></analytic><series><title level="j">Lancet (London, England)</title><idno type="eISSN">1474-547X</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Antibodies, Monoclonal (administration & dosage)</term><term>Antibodies, Monoclonal (adverse effects)</term><term>Antibodies, Monoclonal (therapeutic use)</term><term>Antibodies, Monoclonal, Humanized</term><term>Antineoplastic Agents (administration & dosage)</term><term>Antineoplastic Agents (adverse effects)</term><term>Dose-Response Relationship, Drug</term><term>Drug Eruptions (etiology)</term><term>Drug Resistance, Neoplasm</term><term>Fatigue (chemically induced)</term><term>Female</term><term>Humans</term><term>Male</term><term>Melanoma (drug therapy)</term><term>Middle Aged</term><term>Programmed Cell Death 1 Receptor (antagonists & inhibitors)</term><term>Pruritus (chemically induced)</term><term>Skin Neoplasms (drug therapy)</term><term>Treatment Outcome</term><term>Young Adult</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Anticorps monoclonaux (administration et posologie)</term><term>Anticorps monoclonaux (effets indésirables)</term><term>Anticorps monoclonaux (usage thérapeutique)</term><term>Anticorps monoclonaux humanisés</term><term>Antinéoplasiques (administration et posologie)</term><term>Antinéoplasiques (effets indésirables)</term><term>Fatigue ()</term><term>Femelle</term><term>Humains</term><term>Jeune adulte</term><term>Mâle</term><term>Mélanome (traitement médicamenteux)</term><term>Prurit ()</term><term>Relation dose-effet des médicaments</term><term>Récepteur-1 de mort cellulaire programmée (antagonistes et inhibiteurs)</term><term>Résistance aux médicaments antinéoplasiques</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Toxidermies (étiologie)</term><term>Tumeurs cutanées (traitement médicamenteux)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antibodies, Monoclonal</term><term>Antineoplastic Agents</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antibodies, Monoclonal</term><term>Antineoplastic Agents</term></keywords><keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en"><term>Programmed Cell Death 1 Receptor</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antibodies, Monoclonal</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Anticorps monoclonaux</term><term>Antinéoplasiques</term></keywords><keywords scheme="MESH" qualifier="antagonistes et inhibiteurs" xml:lang="fr"><term>Récepteur-1 de mort cellulaire programmée</term></keywords><keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Fatigue</term><term>Pruritus</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Melanoma</term><term>Skin Neoplasms</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Anticorps monoclonaux</term><term>Antinéoplasiques</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Drug Eruptions</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Mélanome</term><term>Tumeurs cutanées</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Anticorps monoclonaux</term></keywords><keywords scheme="MESH" qualifier="étiologie" xml:lang="fr"><term>Toxidermies</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Antibodies, Monoclonal, Humanized</term><term>Dose-Response Relationship, Drug</term><term>Drug Resistance, Neoplasm</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Treatment Outcome</term><term>Young Adult</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Anticorps monoclonaux humanisés</term><term>Fatigue</term><term>Femelle</term><term>Humains</term><term>Jeune adulte</term><term>Mâle</term><term>Prurit</term><term>Relation dose-effet des médicaments</term><term>Résistance aux médicaments antinéoplasiques</term><term>Résultat thérapeutique</term><term>Sujet âgé</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The anti-programmed-death-receptor-1 (PD-1) antibody pembrolizumab has shown potent antitumour activity at different doses and schedules in patients with melanoma. We compared the efficacy and safety of pembrolizumab at doses of 2 mg/kg and 10 mg/kg every 3 weeks in patients with ipilimumab-refractory advanced melanoma.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">25034862</PMID><DateCreated><Year>2014</Year><Month>09</Month><Day>22</Day></DateCreated><DateCompleted><Year>2014</Year><Month>12</Month><Day>10</Day></DateCompleted><DateRevised><Year>2017</Year><Month>11</Month><Day>16</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1474-547X</ISSN><JournalIssue CitedMedium="Internet"><Volume>384</Volume><Issue>9948</Issue><PubDate><Year>2014</Year><Month>Sep</Month><Day>20</Day></PubDate></JournalIssue><Title>Lancet (London, England)</Title><ISOAbbreviation>Lancet</ISOAbbreviation></Journal><ArticleTitle>Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial.</ArticleTitle><Pagination><MedlinePgn>1109-17</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/S0140-6736(14)60958-2</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S0140-6736(14)60958-2</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">The anti-programmed-death-receptor-1 (PD-1) antibody pembrolizumab has shown potent antitumour activity at different doses and schedules in patients with melanoma. We compared the efficacy and safety of pembrolizumab at doses of 2 mg/kg and 10 mg/kg every 3 weeks in patients with ipilimumab-refractory advanced melanoma.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">In an open-label, international, multicentre expansion cohort of a phase 1 trial, patients (aged ≥18 years) with advanced melanoma whose disease had progressed after at least two ipilimumab doses were randomly assigned with a computer-generated allocation schedule (1:1 final ratio) to intravenous pembrolizumab at 2 mg/kg every 3 weeks or 10 mg/kg every 3 weeks until disease progression, intolerable toxicity, or consent withdrawal. Primary endpoint was overall response rate (ORR) assessed with the Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) by independent central review. Analysis was done on the full-analysis set (all treated patients with measurable disease at baseline). This study is registered with ClinicalTrials.gov, number NCT01295827.</AbstractText><AbstractText Label="FINDINGS" NlmCategory="RESULTS">173 patients received pembrolizumab 2 mg/kg (n=89) or 10 mg/kg (n=84). Median follow-up duration was 8 months. ORR was 26% at both doses--21 of 81 patients in the 2 mg/kg group and 20 of 76 in the 10 mg/kg group (difference 0%, 95% CI -14 to 13; p=0·96). Treatment was well tolerated, with similar safety profiles in the 2 mg/kg and 10 mg/kg groups and no drug-related deaths. The most common drug-related adverse events of any grade in the 2 mg/kg and 10 mg/kg groups were fatigue (29 [33%] vs 31 [37%]), pruritus (23 [26%] vs 16 [19%]), and rash (16 [18%] vs 15 [18%]). Grade 3 fatigue, reported in five (3%) patients in the 2 mg/kg pembrolizumab group, was the only drug-related grade 3 to 4 adverse event reported in more than one patient.</AbstractText><AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">The results suggest that pembrolizumab at a dose of 2 mg/kg or 10 mg/kg every 3 weeks might be an effective treatment in patients for whom there are few effective treatment options.</AbstractText><AbstractText Label="FUNDING" NlmCategory="BACKGROUND">Merck Sharp and Dohme.</AbstractText><CopyrightInformation>Copyright © 2014 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Robert</LastName><ForeName>Caroline</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Gustave Roussy and INSERM U981, Paris-Sud, France. Electronic address: caroline.robert@gustaveroussy.fr.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ribas</LastName><ForeName>Antoni</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>University of California Los Angeles, Los Angeles, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wolchok</LastName><ForeName>Jedd D</ForeName><Initials>JD</Initials><AffiliationInfo><Affiliation>Memorial Sloan-Kettering Cancer Center, New York, NY, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hodi</LastName><ForeName>F Stephen</ForeName><Initials>FS</Initials><AffiliationInfo><Affiliation>Dana-Farber Cancer Institute, Boston, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hamid</LastName><ForeName>Omid</ForeName><Initials>O</Initials><AffiliationInfo><Affiliation>Angeles Clinic and Research Institute, Los Angeles, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kefford</LastName><ForeName>Richard</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Crown Princess Mary Cancer Centre, Westmead Hospital and Melanoma Institute Australia, Westmead, NSW, Australia; University of Sydney, Sydney, NSW, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Weber</LastName><ForeName>Jeffrey S</ForeName><Initials>JS</Initials><AffiliationInfo><Affiliation>H Lee Moffitt Cancer Center, Tampa, FL, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Joshua</LastName><ForeName>Anthony M</ForeName><Initials>AM</Initials><AffiliationInfo><Affiliation>Princess Margaret Cancer Centre, Toronto, ON, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hwu</LastName><ForeName>Wen-Jen</ForeName><Initials>WJ</Initials><AffiliationInfo><Affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gangadhar</LastName><ForeName>Tara C</ForeName><Initials>TC</Initials><AffiliationInfo><Affiliation>Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Patnaik</LastName><ForeName>Amita</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>South Texas Accelerated Research Therapeutics, San Antonio, TX, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dronca</LastName><ForeName>Roxana</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Mayo Clinic, Rochester, MN, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zarour</LastName><ForeName>Hassane</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>University of Pittsburgh, Pittsburgh, PA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Joseph</LastName><ForeName>Richard W</ForeName><Initials>RW</Initials><AffiliationInfo><Affiliation>Mayo Clinic, Jacksonville, FL, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Boasberg</LastName><ForeName>Peter</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Angeles Clinic and Research Institute, Los Angeles, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chmielowski</LastName><ForeName>Bartosz</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>University of California Los Angeles, Los Angeles, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mateus</LastName><ForeName>Christine</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Gustave Roussy and INSERM U981, Paris-Sud, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Postow</LastName><ForeName>Michael A</ForeName><Initials>MA</Initials><AffiliationInfo><Affiliation>Memorial Sloan-Kettering Cancer Center, New York, NY, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gergich</LastName><ForeName>Kevin</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Merck, Whitehouse Station, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Elassaiss-Schaap</LastName><ForeName>Jeroen</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Merck, Whitehouse Station, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Li</LastName><ForeName>Xiaoyun Nicole</ForeName><Initials>XN</Initials><AffiliationInfo><Affiliation>Merck, Whitehouse Station, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Iannone</LastName><ForeName>Robert</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Merck, Whitehouse Station, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ebbinghaus</LastName><ForeName>Scot W</ForeName><Initials>SW</Initials><AffiliationInfo><Affiliation>Merck, Whitehouse Station, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kang</LastName><ForeName>S Peter</ForeName><Initials>SP</Initials><AffiliationInfo><Affiliation>Merck, Whitehouse Station, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Daud</LastName><ForeName>Adil</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>University of California San Francisco, San Francisco, CA, USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT01295827</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D017426">Clinical Trial, Phase I</PublicationType><PublicationType UI="D003160">Comparative Study</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2014</Year><Month>07</Month><Day>15</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Lancet</MedlineTA><NlmUniqueID>2985213R</NlmUniqueID><ISSNLinking>0140-6736</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000911">Antibodies, Monoclonal</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D061067">Antibodies, Monoclonal, Humanized</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000970">Antineoplastic Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D061026">Programmed Cell Death 1 Receptor</NameOfSubstance></Chemical><Chemical><RegistryNumber>6T8C155666</RegistryNumber><NameOfSubstance UI="C508317">ipilimumab</NameOfSubstance></Chemical><Chemical><RegistryNumber>DPT0O3T46P</RegistryNumber><NameOfSubstance UI="C582435">pembrolizumab</NameOfSubstance></Chemical></ChemicalList><CitationSubset>AIM</CitationSubset><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="CommentIn"><RefSource>Nat Rev Clin Oncol. 2014 Sep;11(9):502</RefSource><PMID Version="1">25091612</PMID></CommentsCorrections><CommentsCorrections RefType="CommentIn"><RefSource>Lancet. 2014 Sep 20;384(9948):1078-9</RefSource><PMID Version="1">25034863</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000911" MajorTopicYN="N">Antibodies, Monoclonal</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D061067" MajorTopicYN="N">Antibodies, Monoclonal, Humanized</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000970" MajorTopicYN="N">Antineoplastic Agents</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004305" MajorTopicYN="N">Dose-Response Relationship, Drug</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D003875" MajorTopicYN="N">Drug Eruptions</DescriptorName><QualifierName UI="Q000209" MajorTopicYN="N">etiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D019008" MajorTopicYN="N">Drug Resistance, Neoplasm</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005221" MajorTopicYN="N">Fatigue</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008545" MajorTopicYN="N">Melanoma</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D061026" MajorTopicYN="N">Programmed Cell Death 1 Receptor</DescriptorName><QualifierName UI="Q000037" MajorTopicYN="Y">antagonists & inhibitors</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011537" MajorTopicYN="N">Pruritus</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012878" MajorTopicYN="N">Skin Neoplasms</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2014</Year><Month>7</Month><Day>19</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2014</Year><Month>7</Month><Day>19</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2014</Year><Month>12</Month><Day>15</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">25034862</ArticleId><ArticleId IdType="pii">S0140-6736(14)60958-2</ArticleId><ArticleId IdType="doi">10.1016/S0140-6736(14)60958-2</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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