A Phase II Trial of the Multitargeted Tyrosine Kinase Inhibitor Lenvatinib (E7080) in Advanced Medullary Thyroid Cancer.
Identifieur interne : 002386 ( PubMed/Curation ); précédent : 002385; suivant : 002387A Phase II Trial of the Multitargeted Tyrosine Kinase Inhibitor Lenvatinib (E7080) in Advanced Medullary Thyroid Cancer.
Auteurs : Martin Schlumberger [France] ; Barbara Jarzab [Pologne] ; Maria E. Cabanillas [États-Unis] ; Bruce Robinson [Australie] ; Furio Pacini [Italie] ; Douglas W. Ball [États-Unis] ; Judith Mccaffrey [États-Unis] ; Kate Newbold [Royaume-Uni] ; Roger Allison [Australie] ; Renato G. Martins [États-Unis] ; Lisa F. Licitra [Italie] ; Manisha H. Shah [États-Unis] ; Donald Bodenner [États-Unis] ; Rossella Elisei [Italie] ; Lynn Burmeister [États-Unis] ; Yasuhiro Funahashi [États-Unis] ; Min Ren [États-Unis] ; James P. O'Brien [États-Unis] ; Steven I. Sherman [États-Unis]Source :
- Clinical cancer research : an official journal of the American Association for Cancer Research [ 1078-0432 ] ; 2016.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Antinéoplasiques (pharmacologie), Antinéoplasiques (usage thérapeutique), Carcinome neuroendocrine (anatomopathologie), Carcinome neuroendocrine (sang), Carcinome neuroendocrine (traitement médicamenteux), Femelle, Humains, Inhibiteurs de protéines kinases (pharmacologie), Inhibiteurs de protéines kinases (usage thérapeutique), Jeune adulte, Marqueurs biologiques, Mâle, Métastase tumorale, Phénylurées (pharmacologie), Phénylurées (usage thérapeutique), Quinoléines (pharmacologie), Quinoléines (usage thérapeutique), Reprise du traitement, Résultat thérapeutique, Stade de la tumeur, Sujet âgé, Thérapie moléculaire ciblée, Tumeurs de la thyroïde (anatomopathologie), Tumeurs de la thyroïde (sang), Tumeurs de la thyroïde (traitement médicamenteux), Évolution de la maladie.
- MESH :
- anatomopathologie : Carcinome neuroendocrine, Tumeurs de la thyroïde.
- pharmacologie : Antinéoplasiques, Inhibiteurs de protéines kinases, Phénylurées, Quinoléines.
- sang : Carcinome neuroendocrine, Tumeurs de la thyroïde.
- traitement médicamenteux : Carcinome neuroendocrine, Tumeurs de la thyroïde.
- usage thérapeutique : Antinéoplasiques, Inhibiteurs de protéines kinases, Phénylurées, Quinoléines.
- Adulte, Adulte d'âge moyen, Femelle, Humains, Jeune adulte, Marqueurs biologiques, Mâle, Métastase tumorale, Reprise du traitement, Résultat thérapeutique, Stade de la tumeur, Sujet âgé, Thérapie moléculaire ciblée, Évolution de la maladie.
English descriptors
- KwdEn :
- Adult, Aged, Antineoplastic Agents (pharmacology), Antineoplastic Agents (therapeutic use), Biomarkers, Carcinoma, Neuroendocrine (blood), Carcinoma, Neuroendocrine (drug therapy), Carcinoma, Neuroendocrine (pathology), Disease Progression, Female, Humans, Male, Middle Aged, Molecular Targeted Therapy, Neoplasm Metastasis, Neoplasm Staging, Phenylurea Compounds (pharmacology), Phenylurea Compounds (therapeutic use), Protein Kinase Inhibitors (pharmacology), Protein Kinase Inhibitors (therapeutic use), Quinolines (pharmacology), Quinolines (therapeutic use), Retreatment, Thyroid Neoplasms (blood), Thyroid Neoplasms (drug therapy), Thyroid Neoplasms (pathology), Treatment Outcome, Young Adult.
- MESH :
- chemical , pharmacology : Antineoplastic Agents, Phenylurea Compounds, Protein Kinase Inhibitors, Quinolines.
- chemical , therapeutic use : Antineoplastic Agents, Phenylurea Compounds, Protein Kinase Inhibitors, Quinolines.
- blood : Carcinoma, Neuroendocrine, Thyroid Neoplasms.
- drug therapy : Carcinoma, Neuroendocrine, Thyroid Neoplasms.
- pathology : Carcinoma, Neuroendocrine, Thyroid Neoplasms.
- Adult, Aged, Biomarkers, Disease Progression, Female, Humans, Male, Middle Aged, Molecular Targeted Therapy, Neoplasm Metastasis, Neoplasm Staging, Retreatment, Treatment Outcome, Young Adult.
Abstract
Positive results of phase I studies evaluating lenvatinib in solid tumors, including thyroid cancer, prompted a phase II trial in advanced medullary thyroid carcinoma (MTC).
DOI: 10.1158/1078-0432.CCR-15-1127
PubMed: 26311725
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pubmed:26311725Le document en format XML
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<sourceDesc><biblStruct><analytic><title xml:lang="en">A Phase II Trial of the Multitargeted Tyrosine Kinase Inhibitor Lenvatinib (E7080) in Advanced Medullary Thyroid Cancer.</title>
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<author><name sortKey="Mccaffrey, Judith" sort="Mccaffrey, Judith" uniqKey="Mccaffrey J" first="Judith" last="Mccaffrey">Judith Mccaffrey</name>
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<author><name sortKey="Newbold, Kate" sort="Newbold, Kate" uniqKey="Newbold K" first="Kate" last="Newbold">Kate Newbold</name>
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<author><name sortKey="Licitra, Lisa F" sort="Licitra, Lisa F" uniqKey="Licitra L" first="Lisa F" last="Licitra">Lisa F. Licitra</name>
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<author><name sortKey="Shah, Manisha H" sort="Shah, Manisha H" uniqKey="Shah M" first="Manisha H" last="Shah">Manisha H. Shah</name>
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<author><name sortKey="Funahashi, Yasuhiro" sort="Funahashi, Yasuhiro" uniqKey="Funahashi Y" first="Yasuhiro" last="Funahashi">Yasuhiro Funahashi</name>
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<author><name sortKey="Ren, Min" sort="Ren, Min" uniqKey="Ren M" first="Min" last="Ren">Min Ren</name>
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<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">New Jersey</region>
</placeName>
<wicri:cityArea>Eisai Inc., Woodcliff Lake</wicri:cityArea>
</affiliation>
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<author><name sortKey="O Brien, James P" sort="O Brien, James P" uniqKey="O Brien J" first="James P" last="O'Brien">James P. O'Brien</name>
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</placeName>
<wicri:cityArea>Eisai Inc., Woodcliff Lake</wicri:cityArea>
</affiliation>
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<author><name sortKey="Sherman, Steven I" sort="Sherman, Steven I" uniqKey="Sherman S" first="Steven I" last="Sherman">Steven I. Sherman</name>
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<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Texas</region>
</placeName>
<wicri:cityArea>Department of Endocrine Neoplasia and Hormonal Disorders, The University of Texas MD Anderson Cancer Center, Houston</wicri:cityArea>
</affiliation>
</author>
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<series><title level="j">Clinical cancer research : an official journal of the American Association for Cancer Research</title>
<idno type="ISSN">1078-0432</idno>
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<term>Antineoplastic Agents (pharmacology)</term>
<term>Antineoplastic Agents (therapeutic use)</term>
<term>Biomarkers</term>
<term>Carcinoma, Neuroendocrine (blood)</term>
<term>Carcinoma, Neuroendocrine (drug therapy)</term>
<term>Carcinoma, Neuroendocrine (pathology)</term>
<term>Disease Progression</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Molecular Targeted Therapy</term>
<term>Neoplasm Metastasis</term>
<term>Neoplasm Staging</term>
<term>Phenylurea Compounds (pharmacology)</term>
<term>Phenylurea Compounds (therapeutic use)</term>
<term>Protein Kinase Inhibitors (pharmacology)</term>
<term>Protein Kinase Inhibitors (therapeutic use)</term>
<term>Quinolines (pharmacology)</term>
<term>Quinolines (therapeutic use)</term>
<term>Retreatment</term>
<term>Thyroid Neoplasms (blood)</term>
<term>Thyroid Neoplasms (drug therapy)</term>
<term>Thyroid Neoplasms (pathology)</term>
<term>Treatment Outcome</term>
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<term>Adulte d'âge moyen</term>
<term>Antinéoplasiques (pharmacologie)</term>
<term>Antinéoplasiques (usage thérapeutique)</term>
<term>Carcinome neuroendocrine (anatomopathologie)</term>
<term>Carcinome neuroendocrine (sang)</term>
<term>Carcinome neuroendocrine (traitement médicamenteux)</term>
<term>Femelle</term>
<term>Humains</term>
<term>Inhibiteurs de protéines kinases (pharmacologie)</term>
<term>Inhibiteurs de protéines kinases (usage thérapeutique)</term>
<term>Jeune adulte</term>
<term>Marqueurs biologiques</term>
<term>Mâle</term>
<term>Métastase tumorale</term>
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<term>Tumeurs de la thyroïde (sang)</term>
<term>Tumeurs de la thyroïde (traitement médicamenteux)</term>
<term>Évolution de la maladie</term>
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<term>Disease Progression</term>
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<term>Humans</term>
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<front><div type="abstract" xml:lang="en">Positive results of phase I studies evaluating lenvatinib in solid tumors, including thyroid cancer, prompted a phase II trial in advanced medullary thyroid carcinoma (MTC).</div>
</front>
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<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26311725</PMID>
<DateCreated><Year>2016</Year>
<Month>01</Month>
<Day>05</Day>
</DateCreated>
<DateCompleted><Year>2016</Year>
<Month>10</Month>
<Day>13</Day>
</DateCompleted>
<DateRevised><Year>2016</Year>
<Month>12</Month>
<Day>30</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Print">1078-0432</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>22</Volume>
<Issue>1</Issue>
<PubDate><Year>2016</Year>
<Month>Jan</Month>
<Day>01</Day>
</PubDate>
</JournalIssue>
<Title>Clinical cancer research : an official journal of the American Association for Cancer Research</Title>
<ISOAbbreviation>Clin. Cancer Res.</ISOAbbreviation>
</Journal>
<ArticleTitle>A Phase II Trial of the Multitargeted Tyrosine Kinase Inhibitor Lenvatinib (E7080) in Advanced Medullary Thyroid Cancer.</ArticleTitle>
<Pagination><MedlinePgn>44-53</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1158/1078-0432.CCR-15-1127</ELocationID>
<Abstract><AbstractText Label="PURPOSE" NlmCategory="OBJECTIVE">Positive results of phase I studies evaluating lenvatinib in solid tumors, including thyroid cancer, prompted a phase II trial in advanced medullary thyroid carcinoma (MTC).</AbstractText>
<AbstractText Label="EXPERIMENTAL DESIGN" NlmCategory="METHODS">Fifty-nine patients with unresectable progressive MTC per Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 within the prior 12 months received lenvatinib (24-mg daily, 28-day cycles) until disease progression, unmanageable toxicity, withdrawal, or death. Prior anti-VEGFR therapy was permitted. The primary endpoint was objective response rate (ORR) by RECIST v1.0 and independent imaging review.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">Lenvatinib ORR was 36% [95% confidence interval (CI), 24%-49%]; all partial responses. ORR was comparable between patients with (35%) or without (36%) prior anti-VEGFR therapy. Disease control rate (DCR) was 80% (95% CI, 67%-89%); 44% had stable disease. Among responders, median time to response (TTR) was 3.5 months (95% CI, 1.9-3.7). Median progression-free survival (PFS) was 9.0 months (95% CI, 7.0-not evaluable). Common toxicity criteria grade 3/4 treatment-emergent adverse events included diarrhea (14%), hypertension (7%), decreased appetite (7%), fatigue, dysphagia, and increased alanine aminotransferase levels (5% each). Ret proto-oncogene status did not correlate with outcomes. Low baseline levels of angiopoietin-2, hepatocyte growth factor, and IL8 were associated with tumor reduction and prolonged PFS. High baseline levels of VEGF, soluble VEGFR3, and platelet-derived growth factor BB, and low baseline levels of soluble Tie-2, were associated with tumor reduction.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Lenvatinib had a high ORR, high DCR, and a short TTR in patients with documented progressive MTC. Toxicities were managed with dose modifications and medications.</AbstractText>
<CopyrightInformation>©2015 American Association for Cancer Research.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Schlumberger</LastName>
<ForeName>Martin</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Department of Nuclear Medicine and Endocrine Oncology, Institut Gustave-Roussy and University Paris-Sud, Villejuif, France. martin.schlumberger@gustaveroussy.fr.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Jarzab</LastName>
<ForeName>Barbara</ForeName>
<Initials>B</Initials>
<AffiliationInfo><Affiliation>Department of Nuclear Medicine and Endocrine Oncology, Centrum Onkologii Instytut im. M. Sklodowskiei-Curie, Gliwice, Poland.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Cabanillas</LastName>
<ForeName>Maria E</ForeName>
<Initials>ME</Initials>
<AffiliationInfo><Affiliation>Department of Endocrine Neoplasia and Hormonal Disorders, The University of Texas MD Anderson Cancer Center, Houston, Texas.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Robinson</LastName>
<ForeName>Bruce</ForeName>
<Initials>B</Initials>
<AffiliationInfo><Affiliation>Department of Endocrinology, Royal North Shore Hospital, Sydney, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Pacini</LastName>
<ForeName>Furio</ForeName>
<Initials>F</Initials>
<AffiliationInfo><Affiliation>Department of Medical, Surgical and Neurological Sciences, Azienda Ospedaliera Universitaria Senese, Siena, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ball</LastName>
<ForeName>Douglas W</ForeName>
<Initials>DW</Initials>
<AffiliationInfo><Affiliation>Division of Endocrinology and Metabolism, Johns Hopkins Medical Institute, Baltimore, Maryland.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>McCaffrey</LastName>
<ForeName>Judith</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Department of Interdisciplinary Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Newbold</LastName>
<ForeName>Kate</ForeName>
<Initials>K</Initials>
<AffiliationInfo><Affiliation>NIHR Royal Marsden Hospital and Institute of Cancer Research BRC, London, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Allison</LastName>
<ForeName>Roger</ForeName>
<Initials>R</Initials>
<AffiliationInfo><Affiliation>Cancer Care Services, The Royal Brisbane and Women's Hospital, Herston, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Martins</LastName>
<ForeName>Renato G</ForeName>
<Initials>RG</Initials>
<AffiliationInfo><Affiliation>Division of Clinical Research, Seattle Cancer Care Alliance, Seattle, Washington.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Licitra</LastName>
<ForeName>Lisa F</ForeName>
<Initials>LF</Initials>
<AffiliationInfo><Affiliation>Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Shah</LastName>
<ForeName>Manisha H</ForeName>
<Initials>MH</Initials>
<AffiliationInfo><Affiliation>Department of Medical Oncology, The Ohio State University School of Medicine, Columbus, Ohio.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Bodenner</LastName>
<ForeName>Donald</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Department of Otolaryngology-Head and Neck Surgery, University of Arkansas, Little Rock, Arkansas.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Elisei</LastName>
<ForeName>Rossella</ForeName>
<Initials>R</Initials>
<AffiliationInfo><Affiliation>Endocrine Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Burmeister</LastName>
<ForeName>Lynn</ForeName>
<Initials>L</Initials>
<AffiliationInfo><Affiliation>Department of Medicine, University of Minnesota, Minneapolis, Minnesota.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Funahashi</LastName>
<ForeName>Yasuhiro</ForeName>
<Initials>Y</Initials>
<AffiliationInfo><Affiliation>Eisai, Andover, Massachusetts.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ren</LastName>
<ForeName>Min</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Eisai Inc., Woodcliff Lake, New Jersey.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>O'Brien</LastName>
<ForeName>James P</ForeName>
<Initials>JP</Initials>
<AffiliationInfo><Affiliation>Eisai Inc., Woodcliff Lake, New Jersey.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Sherman</LastName>
<ForeName>Steven I</ForeName>
<Initials>SI</Initials>
<AffiliationInfo><Affiliation>Department of Endocrine Neoplasia and Hormonal Disorders, The University of Texas MD Anderson Cancer Center, Houston, Texas.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<GrantList CompleteYN="Y"><Grant><GrantID>P30 CA016672</GrantID>
<Acronym>CA</Acronym>
<Agency>NCI NIH HHS</Agency>
<Country>United States</Country>
</Grant>
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<PublicationType UI="D016428">Journal Article</PublicationType>
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<PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType>
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<ArticleDate DateType="Electronic"><Year>2015</Year>
<Month>08</Month>
<Day>26</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>United States</Country>
<MedlineTA>Clin Cancer Res</MedlineTA>
<NlmUniqueID>9502500</NlmUniqueID>
<ISSNLinking>1078-0432</ISSNLinking>
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