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Final overall survival analysis for the phase II RECORD-3 study of first-line everolimus followed by sunitinib versus first-line sunitinib followed by everolimus in metastatic RCC.

Identifieur interne : 000C24 ( PubMed/Checkpoint ); précédent : 000C23; suivant : 000C25

Final overall survival analysis for the phase II RECORD-3 study of first-line everolimus followed by sunitinib versus first-line sunitinib followed by everolimus in metastatic RCC.

Auteurs : J J Knox [Canada] ; C H Barrios [Brésil] ; T M Kim [Corée du Sud] ; T. Cosgriff [États-Unis] ; V. Srimuninnimit [Thaïlande] ; K. Pittman [Australie] ; R. Sabbatini [Italie] ; S Y Rha [Corée du Sud] ; T W Flaig ; R D Page ; J T Beck [États-Unis] ; F. Cheung [République populaire de Chine] ; S. Yadav [Canada] ; P. Patel [Royaume-Uni] ; L. Geoffrois ; J. Niolat [France] ; N. Berkowitz ; M. Marker ; D. Chen ; R J Motzer [États-Unis]

Source :

RBID : pubmed:28327953

Abstract

RECORD-3 compared everolimus and sunitinib as first-line therapy, and the sequence of everolimus followed by sunitinib at progression compared with the opposite (standard) sequence in patients with metastatic renal cell carcinoma (mRCC). This final overall survival (OS) analysis evaluated mature data for secondary end points.

DOI: 10.1093/annonc/mdx075
PubMed: 28327953


Affiliations:


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pubmed:28327953

Le document en format XML

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<div type="abstract" xml:lang="en">RECORD-3 compared everolimus and sunitinib as first-line therapy, and the sequence of everolimus followed by sunitinib at progression compared with the opposite (standard) sequence in patients with metastatic renal cell carcinoma (mRCC). This final overall survival (OS) analysis evaluated mature data for secondary end points.</div>
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<ELocationID EIdType="doi" ValidYN="Y">10.1093/annonc/mdx075</ELocationID>
<Abstract>
<AbstractText Label="Background" NlmCategory="UNASSIGNED">RECORD-3 compared everolimus and sunitinib as first-line therapy, and the sequence of everolimus followed by sunitinib at progression compared with the opposite (standard) sequence in patients with metastatic renal cell carcinoma (mRCC). This final overall survival (OS) analysis evaluated mature data for secondary end points.</AbstractText>
<AbstractText Label="Patients and methods" NlmCategory="UNASSIGNED">Patients received either first-line everolimus followed by second-line sunitinib at progression (n = 238) or first-line sunitinib followed by second-line everolimus (n = 233). Secondary end points were combined first- and second-line progression-free survival (PFS), OS, and safety. The impacts of neutrophil lymphocyte ratio (NLR) and baseline levels of soluble biomarkers on OS were explored.</AbstractText>
<AbstractText Label="Results" NlmCategory="UNASSIGNED">At final analysis, median duration of exposure was 5.6 months for everolimus and 8.3 months for sunitinib. Median combined PFS was 21.7 months [95% confidence interval (CI) 15.1-26.7] with everolimus-sunitinib and 22.2 months (95% CI 16.0-29.8) with sunitinib-everolimus [hazard ratio (HR)EVE-SUN/SUN-EVE, 1.2; 95% CI 0.9-1.6]. Median OS was 22.4 months (95% CI 18.6-33.3) for everolimus-sunitinib and 29.5 months (95% CI 22.8-33.1) for sunitinib-everolimus (HREVE-SUN/SUN-EVE, 1.1; 95% CI 0.9-1.4). The rates of grade 3 and 4 adverse events suspected to be related to second-line therapy were 47% with everolimus and 57% with sunitinib. Higher NLR and 12 soluble biomarker levels were identified as prognostic markers for poor OS with the association being largely independent of treatment sequences.</AbstractText>
<AbstractText Label="Conclusions" NlmCategory="UNASSIGNED">Results of this final OS analysis support the sequence of sunitinib followed by everolimus at progression in patients with mRCC. The safety profiles of everolimus and sunitinib were consistent with those previously reported, and there were no unexpected safety signals.</AbstractText>
<AbstractText Label="Clinical Trials number" NlmCategory="UNASSIGNED">ClinicalTrials.gov identifier, NCT00903175.</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y">
<Author ValidYN="Y">
<LastName>Knox</LastName>
<ForeName>J J</ForeName>
<Initials>JJ</Initials>
<AffiliationInfo>
<Affiliation>Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Barrios</LastName>
<ForeName>C H</ForeName>
<Initials>CH</Initials>
<AffiliationInfo>
<Affiliation>PUCRS School of Medicine, Porto Alegre, Brazil.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Kim</LastName>
<ForeName>T M</ForeName>
<Initials>TM</Initials>
<AffiliationInfo>
<Affiliation>Internal Medicine, Seoul National University Hospital, Seoul, South Korea.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Cosgriff</LastName>
<ForeName>T</ForeName>
<Initials>T</Initials>
<AffiliationInfo>
<Affiliation>Crescent City Research Consortium, Marrero, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Srimuninnimit</LastName>
<ForeName>V</ForeName>
<Initials>V</Initials>
<AffiliationInfo>
<Affiliation>Internal Medicine, Siriraj Hospital, Mahidol University, Mahidol, Thailand.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Pittman</LastName>
<ForeName>K</ForeName>
<Initials>K</Initials>
<AffiliationInfo>
<Affiliation>Medical Oncology, The Queen Elizabeth Hospital, Woodville, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Sabbatini</LastName>
<ForeName>R</ForeName>
<Initials>R</Initials>
<AffiliationInfo>
<Affiliation>AOU Policlinico di Modena, Modena, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Rha</LastName>
<ForeName>S Y</ForeName>
<Initials>SY</Initials>
<AffiliationInfo>
<Affiliation>Yonsei Cancer Center, Seoul, South Korea.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Flaig</LastName>
<ForeName>T W</ForeName>
<Initials>TW</Initials>
<AffiliationInfo>
<Affiliation>University of Colorado School of Medicine, Aurora.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Page</LastName>
<ForeName>R D</ForeName>
<Initials>RD</Initials>
<AffiliationInfo>
<Affiliation>The Center for Cancer and Blood Disorders, Fort Worth.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Beck</LastName>
<ForeName>J T</ForeName>
<Initials>JT</Initials>
<AffiliationInfo>
<Affiliation>Highlands Oncology Group, Fayetteville, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Cheung</LastName>
<ForeName>F</ForeName>
<Initials>F</Initials>
<AffiliationInfo>
<Affiliation>Department of Oncology, Queen Elizabeth Hospital, Hong Kong, China.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Yadav</LastName>
<ForeName>S</ForeName>
<Initials>S</Initials>
<AffiliationInfo>
<Affiliation>Saskatoon Cancer Center, University of Saskatchewan, Saskatoon, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Patel</LastName>
<ForeName>P</ForeName>
<Initials>P</Initials>
<AffiliationInfo>
<Affiliation>Academic Division of Clinical Oncology, University of Nottingham, Nottingham, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Geoffrois</LastName>
<ForeName>L</ForeName>
<Initials>L</Initials>
<AffiliationInfo>
<Affiliation>Department of Oncology, Institut de Cancérologie de Lorraine, Vandoeuvre Lès Nancy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Niolat</LastName>
<ForeName>J</ForeName>
<Initials>J</Initials>
<AffiliationInfo>
<Affiliation>Novartis Pharma SAS, Rueil-Malmaison, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Berkowitz</LastName>
<ForeName>N</ForeName>
<Initials>N</Initials>
<AffiliationInfo>
<Affiliation>Novartis Oncology, East Hanover.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Marker</LastName>
<ForeName>M</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>Novartis Oncology, East Hanover.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Chen</LastName>
<ForeName>D</ForeName>
<Initials>D</Initials>
<AffiliationInfo>
<Affiliation>Novartis Oncology, East Hanover.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Motzer</LastName>
<ForeName>R J</ForeName>
<Initials>RJ</Initials>
<AffiliationInfo>
<Affiliation>Genitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, USA.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList>
<PublicationType UI="D016428">Journal Article</PublicationType>
</PublicationTypeList>
</Article>
<MedlineJournalInfo>
<Country>England</Country>
<MedlineTA>Ann Oncol</MedlineTA>
<NlmUniqueID>9007735</NlmUniqueID>
<ISSNLinking>0923-7534</ISSNLinking>
</MedlineJournalInfo>
<KeywordList Owner="NOTNLM">
<Keyword MajorTopicYN="N">everolimus</Keyword>
<Keyword MajorTopicYN="N">renal cell carcinoma</Keyword>
<Keyword MajorTopicYN="N">sequential targeted therapy</Keyword>
<Keyword MajorTopicYN="N">sunitinib</Keyword>
</KeywordList>
</MedlineCitation>
<PubmedData>
<History>
<PubMedPubDate PubStatus="pubmed">
<Year>2017</Year>
<Month>3</Month>
<Day>23</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="medline">
<Year>2017</Year>
<Month>3</Month>
<Day>23</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="entrez">
<Year>2017</Year>
<Month>3</Month>
<Day>23</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
</History>
<PublicationStatus>ppublish</PublicationStatus>
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<ArticleId IdType="pii">3040903</ArticleId>
<ArticleId IdType="doi">10.1093/annonc/mdx075</ArticleId>
<ArticleId IdType="pmc">PMC5452072</ArticleId>
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<li>Australie</li>
<li>Brésil</li>
<li>Canada</li>
<li>Corée du Sud</li>
<li>France</li>
<li>Italie</li>
<li>Royaume-Uni</li>
<li>République populaire de Chine</li>
<li>Thaïlande</li>
<li>États-Unis</li>
</country>
<region>
<li>Angleterre</li>
<li>Nottinghamshire</li>
<li>Ontario</li>
<li>Rio Grande do Sul</li>
<li>Région capitale de Séoul</li>
<li>État de New York</li>
</region>
<settlement>
<li>Nottingham</li>
<li>Porto Alegre</li>
<li>Séoul</li>
<li>Toronto</li>
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<orgName>
<li>Université de Nottingham</li>
<li>Université de Toronto</li>
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