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

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CheckMate 025 Randomized Phase 3 Study: Outcomes by Key Baseline Factors and Prior Therapy for Nivolumab Versus Everolimus in Advanced Renal Cell Carcinoma.

Identifieur interne : 000115 ( PubMed/Curation ); précédent : 000114; suivant : 000116

CheckMate 025 Randomized Phase 3 Study: Outcomes by Key Baseline Factors and Prior Therapy for Nivolumab Versus Everolimus in Advanced Renal Cell Carcinoma.

Auteurs : Bernard Escudier [France] ; Padmanee Sharma [États-Unis] ; David F. Mcdermott [États-Unis] ; Saby George [États-Unis] ; Hans J. Hammers [États-Unis] ; Sandhya Srinivas [États-Unis] ; Scott S. Tykodi [États-Unis] ; Jeffrey A. Sosman [États-Unis] ; Giuseppe Procopio [Italie] ; Elizabeth R. Plimack [États-Unis] ; Daniel Castellano [Espagne] ; Howard Gurney [Australie] ; Frede Donskov [Danemark] ; Katriina Peltola [Finlande] ; John Wagstaff [Royaume-Uni] ; Thomas C. Gauler [Allemagne] ; Takeshi Ueda [Japon] ; Huanyu Zhao [États-Unis] ; Ian M. Waxman [États-Unis] ; Robert J. Motzer [États-Unis]

Source :

RBID : pubmed:28262413

Abstract

The randomized, phase 3 CheckMate 025 study of nivolumab (n=410) versus everolimus (n=411) in previously treated adults (75% male; 88% white) with advanced renal cell carcinoma (aRCC) demonstrated significantly improved overall survival (OS) and objective response rate (ORR).

DOI: 10.1016/j.eururo.2017.02.010
PubMed: 28262413

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pubmed:28262413

Le document en format XML

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<nlm:affiliation>Gustave Roussy, Villejuif, France. Electronic address: escudier@gustaveroussy.fr.</nlm:affiliation>
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<name sortKey="Tykodi, Scott S" sort="Tykodi, Scott S" uniqKey="Tykodi S" first="Scott S" last="Tykodi">Scott S. Tykodi</name>
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<name sortKey="Procopio, Giuseppe" sort="Procopio, Giuseppe" uniqKey="Procopio G" first="Giuseppe" last="Procopio">Giuseppe Procopio</name>
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<nlm:affiliation>Fondazione Istituto Nazionale Tumori, Milan, Italy.</nlm:affiliation>
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<name sortKey="Plimack, Elizabeth R" sort="Plimack, Elizabeth R" uniqKey="Plimack E" first="Elizabeth R" last="Plimack">Elizabeth R. Plimack</name>
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<nlm:affiliation>Fox Chase Cancer Center, Philadelphia, PA, USA.</nlm:affiliation>
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<name sortKey="Castellano, Daniel" sort="Castellano, Daniel" uniqKey="Castellano D" first="Daniel" last="Castellano">Daniel Castellano</name>
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<nlm:affiliation>Hospital Universitario 12 De Octubre, Madrid, Spain.</nlm:affiliation>
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<name sortKey="Gurney, Howard" sort="Gurney, Howard" uniqKey="Gurney H" first="Howard" last="Gurney">Howard Gurney</name>
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<name sortKey="Donskov, Frede" sort="Donskov, Frede" uniqKey="Donskov F" first="Frede" last="Donskov">Frede Donskov</name>
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<nlm:affiliation>Aarhus University Hospital, Aarhus, Denmark.</nlm:affiliation>
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<wicri:regionArea>Aarhus University Hospital, Aarhus</wicri:regionArea>
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<name sortKey="Peltola, Katriina" sort="Peltola, Katriina" uniqKey="Peltola K" first="Katriina" last="Peltola">Katriina Peltola</name>
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<nlm:affiliation>Comprehensive Cancer Center, Helsinki University Central Hospital Cancer Center, Helsinki, Finland.</nlm:affiliation>
<country xml:lang="fr">Finlande</country>
<wicri:regionArea>Comprehensive Cancer Center, Helsinki University Central Hospital Cancer Center, Helsinki</wicri:regionArea>
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<name sortKey="Wagstaff, John" sort="Wagstaff, John" uniqKey="Wagstaff J" first="John" last="Wagstaff">John Wagstaff</name>
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<nlm:affiliation>South West Wales Cancer Institute and Swansea University College of Medicine, Swansea, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>South West Wales Cancer Institute and Swansea University College of Medicine, Swansea</wicri:regionArea>
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<wicri:regionArea>Chiba Cancer Center, Chiba</wicri:regionArea>
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<name sortKey="Zhao, Huanyu" sort="Zhao, Huanyu" uniqKey="Zhao H" first="Huanyu" last="Zhao">Huanyu Zhao</name>
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<name sortKey="Motzer, Robert J" sort="Motzer, Robert J" uniqKey="Motzer R" first="Robert J" last="Motzer">Robert J. Motzer</name>
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<nlm:affiliation>Memorial Sloan Kettering Cancer Center, New York, NY, USA.</nlm:affiliation>
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<nlm:affiliation>MD Anderson Cancer Center, University of Texas, Houston, TX, USA.</nlm:affiliation>
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<nlm:affiliation>Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA, USA.</nlm:affiliation>
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<name sortKey="George, Saby" sort="George, Saby" uniqKey="George S" first="Saby" last="George">Saby George</name>
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<name sortKey="Sosman, Jeffrey A" sort="Sosman, Jeffrey A" uniqKey="Sosman J" first="Jeffrey A" last="Sosman">Jeffrey A. Sosman</name>
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<nlm:affiliation>Vanderbilt University Medical Center, Nashville, TN, USA.</nlm:affiliation>
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<name sortKey="Procopio, Giuseppe" sort="Procopio, Giuseppe" uniqKey="Procopio G" first="Giuseppe" last="Procopio">Giuseppe Procopio</name>
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<nlm:affiliation>Fondazione Istituto Nazionale Tumori, Milan, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Fondazione Istituto Nazionale Tumori, Milan</wicri:regionArea>
</affiliation>
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<name sortKey="Plimack, Elizabeth R" sort="Plimack, Elizabeth R" uniqKey="Plimack E" first="Elizabeth R" last="Plimack">Elizabeth R. Plimack</name>
<affiliation wicri:level="1">
<nlm:affiliation>Fox Chase Cancer Center, Philadelphia, PA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Fox Chase Cancer Center, Philadelphia, PA</wicri:regionArea>
</affiliation>
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<name sortKey="Castellano, Daniel" sort="Castellano, Daniel" uniqKey="Castellano D" first="Daniel" last="Castellano">Daniel Castellano</name>
<affiliation wicri:level="1">
<nlm:affiliation>Hospital Universitario 12 De Octubre, Madrid, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Hospital Universitario 12 De Octubre, Madrid</wicri:regionArea>
</affiliation>
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<name sortKey="Gurney, Howard" sort="Gurney, Howard" uniqKey="Gurney H" first="Howard" last="Gurney">Howard Gurney</name>
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<country xml:lang="fr">Australie</country>
<wicri:regionArea>Westmead Hospital, Westmead, NSW</wicri:regionArea>
</affiliation>
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<name sortKey="Donskov, Frede" sort="Donskov, Frede" uniqKey="Donskov F" first="Frede" last="Donskov">Frede Donskov</name>
<affiliation wicri:level="1">
<nlm:affiliation>Aarhus University Hospital, Aarhus, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Aarhus University Hospital, Aarhus</wicri:regionArea>
</affiliation>
</author>
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<name sortKey="Peltola, Katriina" sort="Peltola, Katriina" uniqKey="Peltola K" first="Katriina" last="Peltola">Katriina Peltola</name>
<affiliation wicri:level="1">
<nlm:affiliation>Comprehensive Cancer Center, Helsinki University Central Hospital Cancer Center, Helsinki, Finland.</nlm:affiliation>
<country xml:lang="fr">Finlande</country>
<wicri:regionArea>Comprehensive Cancer Center, Helsinki University Central Hospital Cancer Center, Helsinki</wicri:regionArea>
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<author>
<name sortKey="Wagstaff, John" sort="Wagstaff, John" uniqKey="Wagstaff J" first="John" last="Wagstaff">John Wagstaff</name>
<affiliation wicri:level="1">
<nlm:affiliation>South West Wales Cancer Institute and Swansea University College of Medicine, Swansea, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>South West Wales Cancer Institute and Swansea University College of Medicine, Swansea</wicri:regionArea>
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<name sortKey="Gauler, Thomas C" sort="Gauler, Thomas C" uniqKey="Gauler T" first="Thomas C" last="Gauler">Thomas C. Gauler</name>
<affiliation wicri:level="1">
<nlm:affiliation>University Hospital Essen of University of Duisburg-Essen, Essen, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>University Hospital Essen of University of Duisburg-Essen, Essen</wicri:regionArea>
</affiliation>
</author>
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<name sortKey="Ueda, Takeshi" sort="Ueda, Takeshi" uniqKey="Ueda T" first="Takeshi" last="Ueda">Takeshi Ueda</name>
<affiliation wicri:level="1">
<nlm:affiliation>Chiba Cancer Center, Chiba, Japan.</nlm:affiliation>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Chiba Cancer Center, Chiba</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Zhao, Huanyu" sort="Zhao, Huanyu" uniqKey="Zhao H" first="Huanyu" last="Zhao">Huanyu Zhao</name>
<affiliation wicri:level="1">
<nlm:affiliation>Bristol-Myers Squibb, Princeton, NJ, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Bristol-Myers Squibb, Princeton, NJ</wicri:regionArea>
</affiliation>
</author>
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<name sortKey="Waxman, Ian M" sort="Waxman, Ian M" uniqKey="Waxman I" first="Ian M" last="Waxman">Ian M. Waxman</name>
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<nlm:affiliation>Bristol-Myers Squibb, Princeton, NJ, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Bristol-Myers Squibb, Princeton, NJ</wicri:regionArea>
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<name sortKey="Motzer, Robert J" sort="Motzer, Robert J" uniqKey="Motzer R" first="Robert J" last="Motzer">Robert J. Motzer</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>
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<title level="j">European urology</title>
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<date when="2017" type="published">2017</date>
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<div type="abstract" xml:lang="en">The randomized, phase 3 CheckMate 025 study of nivolumab (n=410) versus everolimus (n=411) in previously treated adults (75% male; 88% white) with advanced renal cell carcinoma (aRCC) demonstrated significantly improved overall survival (OS) and objective response rate (ORR).</div>
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<DateCreated>
<Year>2017</Year>
<Month>03</Month>
<Day>06</Day>
</DateCreated>
<DateRevised>
<Year>2017</Year>
<Month>11</Month>
<Day>18</Day>
</DateRevised>
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<ISSN IssnType="Electronic">1873-7560</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>72</Volume>
<Issue>6</Issue>
<PubDate>
<Year>2017</Year>
<Month>Dec</Month>
</PubDate>
</JournalIssue>
<Title>European urology</Title>
<ISOAbbreviation>Eur. Urol.</ISOAbbreviation>
</Journal>
<ArticleTitle>CheckMate 025 Randomized Phase 3 Study: Outcomes by Key Baseline Factors and Prior Therapy for Nivolumab Versus Everolimus in Advanced Renal Cell Carcinoma.</ArticleTitle>
<Pagination>
<MedlinePgn>962-971</MedlinePgn>
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<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.eururo.2017.02.010</ELocationID>
<Abstract>
<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">The randomized, phase 3 CheckMate 025 study of nivolumab (n=410) versus everolimus (n=411) in previously treated adults (75% male; 88% white) with advanced renal cell carcinoma (aRCC) demonstrated significantly improved overall survival (OS) and objective response rate (ORR).</AbstractText>
<AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">To investigate which baseline factors were associated with OS and ORR benefit with nivolumab versus everolimus.</AbstractText>
<AbstractText Label="DESIGN, SETTING, AND PARTICIPANTS" NlmCategory="METHODS">Subgroup OS analyses were performed using Kaplan-Meier methodology. Hazard ratios were estimated using the Cox proportional hazards model.</AbstractText>
<AbstractText Label="INTERVENTION" NlmCategory="METHODS">Nivolumab 3mg/kg every 2 wk or everolimus 10mg once daily.</AbstractText>
<AbstractText Label="RESULTS AND LIMITATIONS" NlmCategory="CONCLUSIONS">The minimum follow-up was 14 mo. Baseline subgroup distributions were balanced between nivolumab and everolimus arms. Nivolumab demonstrated an OS improvement versus everolimus across subgroups, including Memorial Sloan Kettering Cancer Center (MSKCC) and International Metastatic Renal Cell Carcinoma Database Consortium risk groups; age <65 and ≥65 yr; one and two or more sites of metastases; bone, liver, and lung metastases; number of prior therapies; duration of prior therapy; and prior sunitinib, pazopanib, or interleukin-2 therapy. The benefit with nivolumab versus everolimus was noteworthy for patients with poor MSKCC risk (hazard ratio 0.48, 95% confidence interval 0.32-0.70). The mortality rate at 12 mo for all subgroups was lower with nivolumab compared with everolimus. ORR also favored nivolumab. The incidence of grade 3 or 4 treatment-related adverse events across subgroups was lower with nivolumab. Limitations include the post hoc analysis and differing sample sizes between groups.</AbstractText>
<AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">The trend for OS and ORR benefit with nivolumab for multiple subgroups, without notable safety concerns, may help to guide treatment decisions, and further supports nivolumab as the standard of care in previously treated patients with aRCC.</AbstractText>
<AbstractText Label="PATIENT SUMMARY" NlmCategory="UNASSIGNED">We investigated the impact of demographic and pretreatment features on survival benefit and tumor response with nivolumab versus everolimus in advanced renal cell carcinoma (aRCC). Survival benefit and response were observed for multiple subgroups, supporting the use of nivolumab as a new standard of care across a broad range of patients with previously treated aRCC. The trial is registered on ClinicalTrials.gov as NCT01668784.</AbstractText>
<CopyrightInformation>Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y">
<Author ValidYN="Y">
<LastName>Escudier</LastName>
<ForeName>Bernard</ForeName>
<Initials>B</Initials>
<AffiliationInfo>
<Affiliation>Gustave Roussy, Villejuif, France. Electronic address: escudier@gustaveroussy.fr.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Sharma</LastName>
<ForeName>Padmanee</ForeName>
<Initials>P</Initials>
<AffiliationInfo>
<Affiliation>MD Anderson Cancer Center, University of Texas, Houston, TX, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>McDermott</LastName>
<ForeName>David F</ForeName>
<Initials>DF</Initials>
<AffiliationInfo>
<Affiliation>Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>George</LastName>
<ForeName>Saby</ForeName>
<Initials>S</Initials>
<AffiliationInfo>
<Affiliation>Roswell Park Cancer Institute, Buffalo, NY, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Hammers</LastName>
<ForeName>Hans J</ForeName>
<Initials>HJ</Initials>
<AffiliationInfo>
<Affiliation>Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Srinivas</LastName>
<ForeName>Sandhya</ForeName>
<Initials>S</Initials>
<AffiliationInfo>
<Affiliation>Stanford Cancer Institute, Stanford, CA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Tykodi</LastName>
<ForeName>Scott S</ForeName>
<Initials>SS</Initials>
<AffiliationInfo>
<Affiliation>University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Sosman</LastName>
<ForeName>Jeffrey A</ForeName>
<Initials>JA</Initials>
<AffiliationInfo>
<Affiliation>Vanderbilt University Medical Center, Nashville, TN, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Procopio</LastName>
<ForeName>Giuseppe</ForeName>
<Initials>G</Initials>
<AffiliationInfo>
<Affiliation>Fondazione Istituto Nazionale Tumori, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Plimack</LastName>
<ForeName>Elizabeth R</ForeName>
<Initials>ER</Initials>
<AffiliationInfo>
<Affiliation>Fox Chase Cancer Center, Philadelphia, PA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Castellano</LastName>
<ForeName>Daniel</ForeName>
<Initials>D</Initials>
<AffiliationInfo>
<Affiliation>Hospital Universitario 12 De Octubre, Madrid, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Gurney</LastName>
<ForeName>Howard</ForeName>
<Initials>H</Initials>
<AffiliationInfo>
<Affiliation>Westmead Hospital, Westmead, NSW, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Donskov</LastName>
<ForeName>Frede</ForeName>
<Initials>F</Initials>
<AffiliationInfo>
<Affiliation>Aarhus University Hospital, Aarhus, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Peltola</LastName>
<ForeName>Katriina</ForeName>
<Initials>K</Initials>
<AffiliationInfo>
<Affiliation>Comprehensive Cancer Center, Helsinki University Central Hospital Cancer Center, Helsinki, Finland.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Wagstaff</LastName>
<ForeName>John</ForeName>
<Initials>J</Initials>
<AffiliationInfo>
<Affiliation>South West Wales Cancer Institute and Swansea University College of Medicine, Swansea, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Gauler</LastName>
<ForeName>Thomas C</ForeName>
<Initials>TC</Initials>
<AffiliationInfo>
<Affiliation>University Hospital Essen of University of Duisburg-Essen, Essen, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Ueda</LastName>
<ForeName>Takeshi</ForeName>
<Initials>T</Initials>
<AffiliationInfo>
<Affiliation>Chiba Cancer Center, Chiba, Japan.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Zhao</LastName>
<ForeName>Huanyu</ForeName>
<Initials>H</Initials>
<AffiliationInfo>
<Affiliation>Bristol-Myers Squibb, Princeton, NJ, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Waxman</LastName>
<ForeName>Ian M</ForeName>
<Initials>IM</Initials>
<AffiliationInfo>
<Affiliation>Bristol-Myers Squibb, Princeton, NJ, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Motzer</LastName>
<ForeName>Robert J</ForeName>
<Initials>RJ</Initials>
<AffiliationInfo>
<Affiliation>Memorial Sloan Kettering Cancer Center, New York, NY, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<CollectiveName>CheckMate 025 investigators</CollectiveName>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList>
<PublicationType UI="D016428">Journal Article</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic">
<Year>2017</Year>
<Month>03</Month>
<Day>03</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo>
<Country>Switzerland</Country>
<MedlineTA>Eur Urol</MedlineTA>
<NlmUniqueID>7512719</NlmUniqueID>
<ISSNLinking>0302-2838</ISSNLinking>
</MedlineJournalInfo>
<KeywordList Owner="NOTNLM">
<Keyword MajorTopicYN="N">Everolimus</Keyword>
<Keyword MajorTopicYN="N">Immune checkpoint inhibitor</Keyword>
<Keyword MajorTopicYN="N">Nivolumab</Keyword>
<Keyword MajorTopicYN="N">Phase 3</Keyword>
<Keyword MajorTopicYN="N">Renal cell carcinoma</Keyword>
</KeywordList>
</MedlineCitation>
<PubmedData>
<History>
<PubMedPubDate PubStatus="received">
<Year>2016</Year>
<Month>09</Month>
<Day>21</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted">
<Year>2017</Year>
<Month>02</Month>
<Day>07</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="pubmed">
<Year>2017</Year>
<Month>3</Month>
<Day>7</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="medline">
<Year>2017</Year>
<Month>3</Month>
<Day>7</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="entrez">
<Year>2017</Year>
<Month>3</Month>
<Day>7</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
</History>
<PublicationStatus>ppublish</PublicationStatus>
<ArticleIdList>
<ArticleId IdType="pubmed">28262413</ArticleId>
<ArticleId IdType="pii">S0302-2838(17)30099-4</ArticleId>
<ArticleId IdType="doi">10.1016/j.eururo.2017.02.010</ArticleId>
</ArticleIdList>
</PubmedData>
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