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Treatment Beyond Progression in Patients with Advanced Renal Cell Carcinoma Treated with Nivolumab in CheckMate 025.

Identifieur interne : 000656 ( PubMed/Corpus ); précédent : 000655; suivant : 000657

Treatment Beyond Progression in Patients with Advanced Renal Cell Carcinoma Treated with Nivolumab in CheckMate 025.

Auteurs : Bernard Escudier ; Robert J. Motzer ; Padmanee Sharma ; John Wagstaff ; Elizabeth R. Plimack ; Hans J. Hammers ; Frede Donskov ; Howard Gurney ; Jeffrey A. Sosman ; Pawel G. Zalewski ; Ulrika Harmenberg ; David F. Mcdermott ; Toni K. Choueiri ; Martin Richardet ; Yoshihiko Tomita ; Alain Ravaud ; Justin Doan ; Huanyu Zhao ; Helene Hardy ; Saby George

Source :

RBID : pubmed:28410865

Abstract

Response patterns to nivolumab differ from those seen with other approved targeted therapies.

DOI: 10.1016/j.eururo.2017.03.037
PubMed: 28410865

Links to Exploration step

pubmed:28410865

Le document en format XML

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<name sortKey="Hardy, Helene" sort="Hardy, Helene" uniqKey="Hardy H" first="Helene" last="Hardy">Helene Hardy</name>
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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="Wagstaff, John" sort="Wagstaff, John" uniqKey="Wagstaff J" first="John" last="Wagstaff">John Wagstaff</name>
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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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<name sortKey="Hammers, Hans J" sort="Hammers, Hans J" uniqKey="Hammers H" first="Hans J" last="Hammers">Hans J. Hammers</name>
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<nlm:affiliation>Department of Medical Oncology, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA.</nlm:affiliation>
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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>Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Gurney, Howard" sort="Gurney, Howard" uniqKey="Gurney H" first="Howard" last="Gurney">Howard Gurney</name>
<affiliation>
<nlm:affiliation>Department of Medical Oncology, Westmead Hospital and Macquarie University, Sydney, Australia.</nlm:affiliation>
</affiliation>
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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>Department of Hematology, Vanderbilt University Medical Center, Nashville, TN, USA.</nlm:affiliation>
</affiliation>
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<name sortKey="Zalewski, Pawel G" sort="Zalewski, Pawel G" uniqKey="Zalewski P" first="Pawel G" last="Zalewski">Pawel G. Zalewski</name>
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<nlm:affiliation>Department of Oncology, Lakeridge Health RS McLaughlin Durham Regional Cancer Centre, Oshawa, ON, Canada.</nlm:affiliation>
</affiliation>
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<name sortKey="Harmenberg, Ulrika" sort="Harmenberg, Ulrika" uniqKey="Harmenberg U" first="Ulrika" last="Harmenberg">Ulrika Harmenberg</name>
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<nlm:affiliation>Department of Oncology, Radiumhemmet, Karolinska University Hospital, Stockholm, Sweden.</nlm:affiliation>
</affiliation>
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<author>
<name sortKey="Mcdermott, David F" sort="Mcdermott, David F" uniqKey="Mcdermott D" first="David F" last="Mcdermott">David F. Mcdermott</name>
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<nlm:affiliation>Biologic Therapy and Cutaneous Oncology Programs, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA, USA.</nlm:affiliation>
</affiliation>
</author>
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<name sortKey="Choueiri, Toni K" sort="Choueiri, Toni K" uniqKey="Choueiri T" first="Toni K" last="Choueiri">Toni K. Choueiri</name>
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<nlm:affiliation>Kidney Cancer Center, Department of Medical Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, MA, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Richardet, Martin" sort="Richardet, Martin" uniqKey="Richardet M" first="Martin" last="Richardet">Martin Richardet</name>
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<nlm:affiliation>Department of Medical Oncology, Instituto Oncologico de Cordoba, Cordoba, Argentina.</nlm:affiliation>
</affiliation>
</author>
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<name sortKey="Tomita, Yoshihiko" sort="Tomita, Yoshihiko" uniqKey="Tomita Y" first="Yoshihiko" last="Tomita">Yoshihiko Tomita</name>
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<nlm:affiliation>Department of Urology, Department of Molecular Oncology, Niigata University, Niigata, Japan.</nlm:affiliation>
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<name sortKey="Ravaud, Alain" sort="Ravaud, Alain" uniqKey="Ravaud A" first="Alain" last="Ravaud">Alain Ravaud</name>
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<nlm:affiliation>Department of Medical Oncology and Radiotherapy, Bordeaux University Hospital, Hôpital Saint André, Bordeaux, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Doan, Justin" sort="Doan, Justin" uniqKey="Doan J" first="Justin" last="Doan">Justin Doan</name>
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<nlm:affiliation>Bristol-Myers Squibb, Princeton, NJ, USA.</nlm:affiliation>
</affiliation>
</author>
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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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<nlm:affiliation>Bristol-Myers Squibb, Princeton, NJ, USA.</nlm:affiliation>
</affiliation>
</author>
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<name sortKey="Hardy, Helene" sort="Hardy, Helene" uniqKey="Hardy H" first="Helene" last="Hardy">Helene Hardy</name>
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<nlm:affiliation>Bristol-Myers Squibb, Princeton, NJ, USA.</nlm:affiliation>
</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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<nlm:affiliation>Department of Medicine, Roswell Park Cancer Institute, Buffalo, NY, USA.</nlm:affiliation>
</affiliation>
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<series>
<title level="j">European urology</title>
<idno type="eISSN">1873-7560</idno>
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<date when="2017" type="published">2017</date>
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<front>
<div type="abstract" xml:lang="en">Response patterns to nivolumab differ from those seen with other approved targeted therapies.</div>
</front>
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<PMID Version="1">28410865</PMID>
<DateCreated>
<Year>2017</Year>
<Month>04</Month>
<Day>15</Day>
</DateCreated>
<DateRevised>
<Year>2017</Year>
<Month>08</Month>
<Day>19</Day>
</DateRevised>
<Article PubModel="Print-Electronic">
<Journal>
<ISSN IssnType="Electronic">1873-7560</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>72</Volume>
<Issue>3</Issue>
<PubDate>
<Year>2017</Year>
<Month>Sep</Month>
</PubDate>
</JournalIssue>
<Title>European urology</Title>
<ISOAbbreviation>Eur. Urol.</ISOAbbreviation>
</Journal>
<ArticleTitle>Treatment Beyond Progression in Patients with Advanced Renal Cell Carcinoma Treated with Nivolumab in CheckMate 025.</ArticleTitle>
<Pagination>
<MedlinePgn>368-376</MedlinePgn>
</Pagination>
<ELocationID EIdType="pii" ValidYN="Y">S0302-2838(17)30265-8</ELocationID>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.eururo.2017.03.037</ELocationID>
<Abstract>
<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Response patterns to nivolumab differ from those seen with other approved targeted therapies.</AbstractText>
<AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">To investigate the efficacy of nivolumab in previously treated patients with advanced renal cell carcinoma who were treated beyond (Response Evaluation Criteria In Solid Tumors) RECIST progression.</AbstractText>
<AbstractText Label="DESIGN, SETTING, AND PARTICIPANTS" NlmCategory="METHODS">This was a subgroup analysis of patients treated with nivolumab in the phase 3 CheckMate 025 study. Patients continuing to tolerate therapy and exhibiting investigator-assessed clinical benefit were eligible to be treated beyond RECIST progression (TBP) and received therapy for ≥4 wk after first progression; patients not treated beyond RECIST progression (NTBP) received 0 wk to <4 wk of therapy after progression.</AbstractText>
<AbstractText Label="INTERVENTIONS" NlmCategory="METHODS">Nivolumab 3mg/kg intravenously every 2 wk.</AbstractText>
<AbstractText Label="RESULTS AND LIMITATIONS" NlmCategory="CONCLUSIONS">Of 406 nivolumab-treated patients, 316 (78%) progressed by RECIST criteria. Of those who progressed, 48% were TBP, 52% were NTBP. Before being TBP, objective response rate (95% confidence interval) was 20% (14-28) and 14% (9-21) in patients TBP and NTBP, respectively. Differences in clinical characteristics assessed at first progression between patients TBP versus NTBP included better Karnofsky performance status, less deterioration in Karnofsky performance status, shorter time to response, lower incidence of new bone lesions, and improved quality of life. Postprogression, 13% of all patients TBP (20/153) had ≥30% tumor burden reduction including patients with preprogression and postprogression tumor measurements (n=142) and complete/partial response (28%, 8/29), stable disease (6%, 3/47), and progressive disease (14%, 9/66) as their best response before being TBP. Incidence of treatment-related adverse events in patients TBP was lower after (59%) versus before (71%) progression. Limitations included potential bias from the nonrandomized nature of the analysis.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">A subset of patients with advanced renal cell carcinoma and RECIST progression experienced tumor reduction postprogression with nivolumab, and had an acceptable safety profile. Clinical judgment remains essential when switching therapy. ClinicalTrials.gov Identifier: NCT01668784.</AbstractText>
<AbstractText Label="PATIENT SUMMARY" NlmCategory="UNASSIGNED">A subset of patients with advanced renal cell carcinoma and disease progression may continue to benefit from nivolumab treatment beyond progression as evidenced by tumor reduction postprogression and an acceptable safety profile.</AbstractText>
<CopyrightInformation>Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.</CopyrightInformation>
</Abstract>
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<LastName>Escudier</LastName>
<ForeName>Bernard</ForeName>
<Initials>B</Initials>
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<Affiliation>Department of Medical Oncology, Gustave Roussy, Villejuif, France. Electronic address: escudier@gustaveroussy.fr.</Affiliation>
</AffiliationInfo>
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<LastName>Motzer</LastName>
<ForeName>Robert J</ForeName>
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<Affiliation>Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.</Affiliation>
</AffiliationInfo>
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<LastName>Sharma</LastName>
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</AffiliationInfo>
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<LastName>Wagstaff</LastName>
<ForeName>John</ForeName>
<Initials>J</Initials>
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<Affiliation>Department of Medical Oncology, South West Wales Cancer Institute and Swansea University College of Medicine, Swansea, UK.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Plimack</LastName>
<ForeName>Elizabeth R</ForeName>
<Initials>ER</Initials>
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<Affiliation>Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.</Affiliation>
</AffiliationInfo>
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<LastName>Hammers</LastName>
<ForeName>Hans J</ForeName>
<Initials>HJ</Initials>
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<Affiliation>Department of Medical Oncology, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA.</Affiliation>
</AffiliationInfo>
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<LastName>Donskov</LastName>
<ForeName>Frede</ForeName>
<Initials>F</Initials>
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<Affiliation>Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Gurney</LastName>
<ForeName>Howard</ForeName>
<Initials>H</Initials>
<AffiliationInfo>
<Affiliation>Department of Medical Oncology, Westmead Hospital and Macquarie University, Sydney, Australia.</Affiliation>
</AffiliationInfo>
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<LastName>Sosman</LastName>
<ForeName>Jeffrey A</ForeName>
<Initials>JA</Initials>
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<Affiliation>Department of Hematology, Vanderbilt University Medical Center, Nashville, TN, USA.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Zalewski</LastName>
<ForeName>Pawel G</ForeName>
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<AffiliationInfo>
<Affiliation>Department of Oncology, Lakeridge Health RS McLaughlin Durham Regional Cancer Centre, Oshawa, ON, Canada.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Harmenberg</LastName>
<ForeName>Ulrika</ForeName>
<Initials>U</Initials>
<AffiliationInfo>
<Affiliation>Department of Oncology, Radiumhemmet, Karolinska University Hospital, Stockholm, Sweden.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>McDermott</LastName>
<ForeName>David F</ForeName>
<Initials>DF</Initials>
<AffiliationInfo>
<Affiliation>Biologic Therapy and Cutaneous Oncology Programs, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Choueiri</LastName>
<ForeName>Toni K</ForeName>
<Initials>TK</Initials>
<AffiliationInfo>
<Affiliation>Kidney Cancer Center, Department of Medical Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, MA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Richardet</LastName>
<ForeName>Martin</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>Department of Medical Oncology, Instituto Oncologico de Cordoba, Cordoba, Argentina.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Tomita</LastName>
<ForeName>Yoshihiko</ForeName>
<Initials>Y</Initials>
<AffiliationInfo>
<Affiliation>Department of Urology, Department of Molecular Oncology, Niigata University, Niigata, Japan.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Ravaud</LastName>
<ForeName>Alain</ForeName>
<Initials>A</Initials>
<AffiliationInfo>
<Affiliation>Department of Medical Oncology and Radiotherapy, Bordeaux University Hospital, Hôpital Saint André, Bordeaux, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Doan</LastName>
<ForeName>Justin</ForeName>
<Initials>J</Initials>
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<Affiliation>Bristol-Myers Squibb, Princeton, NJ, USA.</Affiliation>
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<LastName>Zhao</LastName>
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<Author ValidYN="Y">
<LastName>George</LastName>
<ForeName>Saby</ForeName>
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<AffiliationInfo>
<Affiliation>Department of Medicine, Roswell Park Cancer Institute, Buffalo, NY, USA.</Affiliation>
</AffiliationInfo>
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