Incidence and timing of common adverse events in Lenvatinib-treated patients from the SELECT trial and their association with survival outcomes
Identifieur interne : 000B57 ( Pmc/Curation ); précédent : 000B56; suivant : 000B58Incidence and timing of common adverse events in Lenvatinib-treated patients from the SELECT trial and their association with survival outcomes
Auteurs : Robert I. Haddad [États-Unis] ; Martin Schlumberger [France] ; Lori J. Wirth [États-Unis] ; Eric J. Sherman [États-Unis] ; Manisha H. Shah [États-Unis] ; Bruce Robinson [Australie] ; Corina E. Dutcus [États-Unis] ; Angela Teng [États-Unis] ; Andrew G. Gianoukakis [États-Unis] ; Steven I. Sherman [États-Unis]Source :
- Endocrine [ 1355-008X ] ; 2017.
Abstract
In the study of (E7080) lenvatinib in differentiated cancer of the thyroid, most patients experienced an adverse event. In this report, we examine common lenvatinib-emergent adverse events in this phase three, randomized, double-blind study.
Adverse events were graded per Common Terminology Criteria for Adverse Events v4.0. 392 patients were enrolled (lenvatinib: 261, placebo: 131) and received lenvatinib 24 mg/day or placebo. The main outcome measures were: associations with progression-free survival and overall survival in exploratory univariate and multivariate analyses along with additional variables.
The most common any-grade adverse events (any grade; grade 3) in lenvatinib-treated patients included proteinuria (32%; 10%), diarrhea (67%; 9%), fatigue/asthenia/malaise (67%; 10%), rash (23%; 0.4%), and palmar-plantar erythrodysesthesia syndrome (33%; 3%). There were no grade 4 events for these adverse events. They generally occurred early (median time to first onset [weeks]: proteinuria [6.1], diarrhea [12.1], fatigue/asthenia/malaise [3.0], rash [7.3], and palmar-plantar erythrodysesthesia syndrome [5.9]), and were resolved primarily with dose modifications (median time to resolution [weeks]: proteinuria [8.8], diarrhea [18.1], fatigue/asthenia/malaise [16.3], rash [5.9], and palmar-plantar erythrodysesthesia syndrome [20.0]). Discontinuation due to these adverse events occurred in 2 (1%) patients with proteinuria and 4 (2%) with fatigue. Progression-free survival was not associated with any of the adverse events. Eastern Cooperative Oncology Group performance status (
In the study of (E7080) lenvatinib in differentiated cancer of the thyroid, the most common adverse events typically occurred early and were primarily managed with dose modifications. Overall survival was significantly associated with diarrhea.
Url:
DOI: 10.1007/s12020-017-1233-5
PubMed: 28155175
PubMed Central: 5368192
Links toward previous steps (curation, corpus...)
- to stream Pmc, to step Corpus: Pour aller vers cette notice dans l'étape Curation :000B80
Links to Exploration step
PMC:5368192Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Incidence and timing of common adverse events in
Lenvatinib-treated patients from the SELECT trial and
their association with survival outcomes</title><author><name sortKey="Haddad, Robert I" sort="Haddad, Robert I" uniqKey="Haddad R" first="Robert I." last="Haddad">Robert I. Haddad</name><affiliation wicri:level="2"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0378 8294</institution-id><institution-id institution-id-type="GRID">grid.62560.37</institution-id><institution>Head and Neck Oncology Program, Dana Farber Cancer Institute,</institution><institution>Brigham and Women’s Hospital,</institution></institution-wrap>Boston, MA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Boston</wicri:cityArea></affiliation></author><author><name sortKey="Schlumberger, Martin" sort="Schlumberger, Martin" uniqKey="Schlumberger M" first="Martin" last="Schlumberger">Martin Schlumberger</name><affiliation wicri:level="1"><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2284 9388</institution-id><institution-id institution-id-type="GRID">grid.14925.3b</institution-id><institution>Department of Nuclear Medicine and Endocrine Oncology,</institution><institution>Gustave Roussy and University Paris-Sud,</institution></institution-wrap>Villejuif, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Villejuif</wicri:regionArea></affiliation></author><author><name sortKey="Wirth, Lori J" sort="Wirth, Lori J" uniqKey="Wirth L" first="Lori J." last="Wirth">Lori J. Wirth</name><affiliation wicri:level="2"><nlm:aff id="Aff3"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0386 9924</institution-id><institution-id institution-id-type="GRID">grid.32224.35</institution-id><institution>Department of Medicine,</institution><institution>Massachusetts General Hospital,</institution></institution-wrap>Boston, MA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Boston</wicri:cityArea></affiliation></author><author><name sortKey="Sherman, Eric J" sort="Sherman, Eric J" uniqKey="Sherman E" first="Eric J." last="Sherman">Eric J. Sherman</name><affiliation wicri:level="2"><nlm:aff id="Aff4"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2171 9952</institution-id><institution-id institution-id-type="GRID">grid.51462.34</institution-id><institution>Department of Medicine,</institution><institution>Memorial Sloan Kettering Cancer Center,</institution></institution-wrap>New York, NY USA</nlm:aff><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea>New York</wicri:cityArea></affiliation></author><author><name sortKey="Shah, Manisha H" sort="Shah, Manisha H" uniqKey="Shah M" first="Manisha H." last="Shah">Manisha H. Shah</name><affiliation wicri:level="2"><nlm:aff id="Aff5"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2285 7943</institution-id><institution-id institution-id-type="GRID">grid.261331.4</institution-id><institution>Department of Internal Medicine,</institution><institution>The Ohio State University Comprehensive Cancer Center,</institution></institution-wrap>Columbus, OH USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Ohio</region></placeName><wicri:cityArea>Columbus</wicri:cityArea></affiliation></author><author><name sortKey="Robinson, Bruce" sort="Robinson, Bruce" uniqKey="Robinson B" first="Bruce" last="Robinson">Bruce Robinson</name><affiliation wicri:level="1"><nlm:aff id="Aff6"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1936 834X</institution-id><institution-id institution-id-type="GRID">grid.1013.3</institution-id><institution>Kolling Institute of Medical Research,</institution><institution>University of Sydney,</institution></institution-wrap>New South Wales, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>New South Wales</wicri:regionArea></affiliation></author><author><name sortKey="Dutcus, Corina E" sort="Dutcus, Corina E" uniqKey="Dutcus C" first="Corina E." last="Dutcus">Corina E. Dutcus</name><affiliation wicri:level="2"><nlm:aff id="Aff7"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0599 8842</institution-id><institution-id institution-id-type="GRID">grid.418767.b</institution-id><institution>Clinical Development,</institution><institution>Oncology Business Group, Eisai Inc.,</institution></institution-wrap>Woodcliff Lake, NJ USA</nlm:aff><country>États-Unis</country><placeName><region type="state">New Jersey</region></placeName><wicri:cityArea>Woodcliff Lake</wicri:cityArea></affiliation></author><author><name sortKey="Teng, Angela" sort="Teng, Angela" uniqKey="Teng A" first="Angela" last="Teng">Angela Teng</name><affiliation wicri:level="2"><nlm:aff id="Aff7"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0599 8842</institution-id><institution-id institution-id-type="GRID">grid.418767.b</institution-id><institution>Clinical Development,</institution><institution>Oncology Business Group, Eisai Inc.,</institution></institution-wrap>Woodcliff Lake, NJ USA</nlm:aff><country>États-Unis</country><placeName><region type="state">New Jersey</region></placeName><wicri:cityArea>Woodcliff Lake</wicri:cityArea></affiliation></author><author><name sortKey="Gianoukakis, Andrew G" sort="Gianoukakis, Andrew G" uniqKey="Gianoukakis A" first="Andrew G." last="Gianoukakis">Andrew G. Gianoukakis</name><affiliation wicri:level="2"><nlm:aff id="Aff8"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 0157 6501</institution-id><institution-id institution-id-type="GRID">grid.239844.0</institution-id><institution>Division of Endocrinology and Metabolism,</institution><institution>Harbor-UCLA Medical Center,</institution></institution-wrap>Torrance, CA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Torrance</wicri:cityArea></affiliation></author><author><name sortKey="Sherman, Steven I" sort="Sherman, Steven I" uniqKey="Sherman S" first="Steven I." last="Sherman">Steven I. Sherman</name><affiliation wicri:level="2"><nlm:aff id="Aff9"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2291 4776</institution-id><institution-id institution-id-type="GRID">grid.240145.6</institution-id><institution>Department of Endocrine Neoplasia and Hormonal Disorders, Division of Internal Medicine,</institution><institution>The University of Texas MD Anderson Cancer Center,</institution></institution-wrap>Houston, TX USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Houston</wicri:cityArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">28155175</idno><idno type="pmc">5368192</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5368192</idno><idno type="RBID">PMC:5368192</idno><idno type="doi">10.1007/s12020-017-1233-5</idno><date when="2017">2017</date><idno type="wicri:Area/Pmc/Corpus">000B80</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000B80</idno><idno type="wicri:Area/Pmc/Curation">000B57</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000B57</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Incidence and timing of common adverse events in
Lenvatinib-treated patients from the SELECT trial and
their association with survival outcomes</title><author><name sortKey="Haddad, Robert I" sort="Haddad, Robert I" uniqKey="Haddad R" first="Robert I." last="Haddad">Robert I. Haddad</name><affiliation wicri:level="2"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0378 8294</institution-id><institution-id institution-id-type="GRID">grid.62560.37</institution-id><institution>Head and Neck Oncology Program, Dana Farber Cancer Institute,</institution><institution>Brigham and Women’s Hospital,</institution></institution-wrap>Boston, MA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Boston</wicri:cityArea></affiliation></author><author><name sortKey="Schlumberger, Martin" sort="Schlumberger, Martin" uniqKey="Schlumberger M" first="Martin" last="Schlumberger">Martin Schlumberger</name><affiliation wicri:level="1"><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2284 9388</institution-id><institution-id institution-id-type="GRID">grid.14925.3b</institution-id><institution>Department of Nuclear Medicine and Endocrine Oncology,</institution><institution>Gustave Roussy and University Paris-Sud,</institution></institution-wrap>Villejuif, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Villejuif</wicri:regionArea></affiliation></author><author><name sortKey="Wirth, Lori J" sort="Wirth, Lori J" uniqKey="Wirth L" first="Lori J." last="Wirth">Lori J. Wirth</name><affiliation wicri:level="2"><nlm:aff id="Aff3"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0386 9924</institution-id><institution-id institution-id-type="GRID">grid.32224.35</institution-id><institution>Department of Medicine,</institution><institution>Massachusetts General Hospital,</institution></institution-wrap>Boston, MA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Boston</wicri:cityArea></affiliation></author><author><name sortKey="Sherman, Eric J" sort="Sherman, Eric J" uniqKey="Sherman E" first="Eric J." last="Sherman">Eric J. Sherman</name><affiliation wicri:level="2"><nlm:aff id="Aff4"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2171 9952</institution-id><institution-id institution-id-type="GRID">grid.51462.34</institution-id><institution>Department of Medicine,</institution><institution>Memorial Sloan Kettering Cancer Center,</institution></institution-wrap>New York, NY USA</nlm:aff><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea>New York</wicri:cityArea></affiliation></author><author><name sortKey="Shah, Manisha H" sort="Shah, Manisha H" uniqKey="Shah M" first="Manisha H." last="Shah">Manisha H. Shah</name><affiliation wicri:level="2"><nlm:aff id="Aff5"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2285 7943</institution-id><institution-id institution-id-type="GRID">grid.261331.4</institution-id><institution>Department of Internal Medicine,</institution><institution>The Ohio State University Comprehensive Cancer Center,</institution></institution-wrap>Columbus, OH USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Ohio</region></placeName><wicri:cityArea>Columbus</wicri:cityArea></affiliation></author><author><name sortKey="Robinson, Bruce" sort="Robinson, Bruce" uniqKey="Robinson B" first="Bruce" last="Robinson">Bruce Robinson</name><affiliation wicri:level="1"><nlm:aff id="Aff6"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1936 834X</institution-id><institution-id institution-id-type="GRID">grid.1013.3</institution-id><institution>Kolling Institute of Medical Research,</institution><institution>University of Sydney,</institution></institution-wrap>New South Wales, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>New South Wales</wicri:regionArea></affiliation></author><author><name sortKey="Dutcus, Corina E" sort="Dutcus, Corina E" uniqKey="Dutcus C" first="Corina E." last="Dutcus">Corina E. Dutcus</name><affiliation wicri:level="2"><nlm:aff id="Aff7"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0599 8842</institution-id><institution-id institution-id-type="GRID">grid.418767.b</institution-id><institution>Clinical Development,</institution><institution>Oncology Business Group, Eisai Inc.,</institution></institution-wrap>Woodcliff Lake, NJ USA</nlm:aff><country>États-Unis</country><placeName><region type="state">New Jersey</region></placeName><wicri:cityArea>Woodcliff Lake</wicri:cityArea></affiliation></author><author><name sortKey="Teng, Angela" sort="Teng, Angela" uniqKey="Teng A" first="Angela" last="Teng">Angela Teng</name><affiliation wicri:level="2"><nlm:aff id="Aff7"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0599 8842</institution-id><institution-id institution-id-type="GRID">grid.418767.b</institution-id><institution>Clinical Development,</institution><institution>Oncology Business Group, Eisai Inc.,</institution></institution-wrap>Woodcliff Lake, NJ USA</nlm:aff><country>États-Unis</country><placeName><region type="state">New Jersey</region></placeName><wicri:cityArea>Woodcliff Lake</wicri:cityArea></affiliation></author><author><name sortKey="Gianoukakis, Andrew G" sort="Gianoukakis, Andrew G" uniqKey="Gianoukakis A" first="Andrew G." last="Gianoukakis">Andrew G. Gianoukakis</name><affiliation wicri:level="2"><nlm:aff id="Aff8"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 0157 6501</institution-id><institution-id institution-id-type="GRID">grid.239844.0</institution-id><institution>Division of Endocrinology and Metabolism,</institution><institution>Harbor-UCLA Medical Center,</institution></institution-wrap>Torrance, CA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Torrance</wicri:cityArea></affiliation></author><author><name sortKey="Sherman, Steven I" sort="Sherman, Steven I" uniqKey="Sherman S" first="Steven I." last="Sherman">Steven I. Sherman</name><affiliation wicri:level="2"><nlm:aff id="Aff9"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2291 4776</institution-id><institution-id institution-id-type="GRID">grid.240145.6</institution-id><institution>Department of Endocrine Neoplasia and Hormonal Disorders, Division of Internal Medicine,</institution><institution>The University of Texas MD Anderson Cancer Center,</institution></institution-wrap>Houston, TX USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Houston</wicri:cityArea></affiliation></author></analytic><series><title level="j">Endocrine</title><idno type="ISSN">1355-008X</idno><idno type="eISSN">1559-0100</idno><imprint><date when="2017">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Purpose</title><p>In the study of (E7080) lenvatinib in differentiated cancer of the thyroid, most patients experienced an adverse event. In this report, we examine common lenvatinib-emergent adverse events in this phase three, randomized, double-blind study.</p></sec><sec><title>Methods</title><p>Adverse events were graded per Common Terminology Criteria for Adverse Events v4.0. 392 patients were enrolled (lenvatinib: 261, placebo: 131) and received lenvatinib 24 mg/day or placebo. The main outcome measures were: associations with progression-free survival and overall survival in exploratory univariate and multivariate analyses along with additional variables.</p></sec><sec><title>Results</title><p>The most common any-grade adverse events (any grade; grade 3) in lenvatinib-treated patients included proteinuria (32%; 10%), diarrhea (67%; 9%), fatigue/asthenia/malaise (67%; 10%), rash (23%; 0.4%), and palmar-plantar erythrodysesthesia syndrome (33%; 3%). There were no grade 4 events for these adverse events. They generally occurred early (median time to first onset [weeks]: proteinuria [6.1], diarrhea [12.1], fatigue/asthenia/malaise [3.0], rash [7.3], and palmar-plantar erythrodysesthesia syndrome [5.9]), and were resolved primarily with dose modifications (median time to resolution [weeks]: proteinuria [8.8], diarrhea [18.1], fatigue/asthenia/malaise [16.3], rash [5.9], and palmar-plantar erythrodysesthesia syndrome [20.0]). Discontinuation due to these adverse events occurred in 2 (1%) patients with proteinuria and 4 (2%) with fatigue. Progression-free survival was not associated with any of the adverse events. Eastern Cooperative Oncology Group performance status (<italic>P</italic> = 0.001), follicular histology (<italic>P</italic> = 0.002), and diarrhea (<italic>P</italic> = 0.023) were associated with overall survival in multivariate analyses (median overall survival for patients with diarrhea: not reached; without: 17.1 months).</p></sec><sec><title>Conclusions</title><p>In the study of (E7080) lenvatinib in differentiated cancer of the thyroid, the most common adverse events typically occurred early and were primarily managed with dose modifications. Overall survival was significantly associated with diarrhea.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Rosen, Ls" uniqKey="Rosen L">LS Rosen</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Bose, D" uniqKey="Bose D">D Bose</name></author><author><name sortKey="Meric Bernstam, F" uniqKey="Meric Bernstam F">F Meric-Bernstam</name></author><author><name sortKey="Hofstetter, W" uniqKey="Hofstetter W">W Hofstetter</name></author><author><name sortKey="Reardon, Da" uniqKey="Reardon D">DA Reardon</name></author><author><name sortKey="Flaherty, Kt" uniqKey="Flaherty K">KT Flaherty</name></author><author><name sortKey="Ellis, Lm" uniqKey="Ellis L">LM Ellis</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Widakowich, C" uniqKey="Widakowich C">C Widakowich</name></author><author><name sortKey="De Castro, G" uniqKey="De Castro G">G de Castro</name></author><author><name sortKey="De Azambuja, E" uniqKey="De Azambuja E">E de Azambuja</name></author><author><name sortKey="Dinh, P" uniqKey="Dinh P">P Dinh</name></author><author><name sortKey="Awada, A" uniqKey="Awada A">A Awada</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Matsui, J" uniqKey="Matsui J">J Matsui</name></author><author><name sortKey="Yamamoto, Y" uniqKey="Yamamoto Y">Y Yamamoto</name></author><author><name sortKey="Funahashi, Y" uniqKey="Funahashi Y">Y Funahashi</name></author><author><name sortKey="Tsuruoka, A" uniqKey="Tsuruoka A">A Tsuruoka</name></author><author><name sortKey="Watanabe, T" uniqKey="Watanabe T">T Watanabe</name></author><author><name sortKey="Wakabayashi, T" uniqKey="Wakabayashi T">T Wakabayashi</name></author><author><name sortKey="Uenaka, T" uniqKey="Uenaka T">T Uenaka</name></author><author><name sortKey="Asada, M" uniqKey="Asada M">M Asada</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Okamoto, K" uniqKey="Okamoto K">K Okamoto</name></author><author><name sortKey="Kodama, K" uniqKey="Kodama K">K Kodama</name></author><author><name sortKey="Takase, K" uniqKey="Takase K">K Takase</name></author><author><name sortKey="Sugi, Nh" uniqKey="Sugi N">NH Sugi</name></author><author><name sortKey="Yamamoto, Y" uniqKey="Yamamoto Y">Y Yamamoto</name></author><author><name sortKey="Iwata, M" uniqKey="Iwata M">M Iwata</name></author><author><name sortKey="Tsuruoka, A" uniqKey="Tsuruoka A">A Tsuruoka</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Yamamoto, Y" uniqKey="Yamamoto Y">Y Yamamoto</name></author><author><name sortKey="Matsui, J" uniqKey="Matsui J">J Matsui</name></author><author><name sortKey="Matsushima, T" uniqKey="Matsushima T">T Matsushima</name></author><author><name sortKey="Obaishi, H" uniqKey="Obaishi H">H Obaishi</name></author><author><name sortKey="Miyazaki, K" uniqKey="Miyazaki K">K Miyazaki</name></author><author><name sortKey="Nakamura, K" uniqKey="Nakamura K">K Nakamura</name></author><author><name sortKey="Tohyama, O" uniqKey="Tohyama O">O Tohyama</name></author><author><name sortKey="Semba, T" uniqKey="Semba T">T Semba</name></author><author><name sortKey="Yamaguchi, A" uniqKey="Yamaguchi A">A Yamaguchi</name></author><author><name sortKey="Hoshi, Ss" uniqKey="Hoshi S">SS Hoshi</name></author><author><name sortKey="Mimura, F" uniqKey="Mimura F">F Mimura</name></author><author><name sortKey="Haneda, T" uniqKey="Haneda T">T Haneda</name></author><author><name sortKey="Fukuda, Y" uniqKey="Fukuda Y">Y Fukuda</name></author><author><name sortKey="Kamata, J" uniqKey="Kamata J">J Kamata</name></author><author><name sortKey="Takahashi, K" uniqKey="Takahashi K">K Takahashi</name></author><author><name sortKey="Matsukura, M" uniqKey="Matsukura M">M Matsukura</name></author><author><name sortKey="Wakabayashi, T" uniqKey="Wakabayashi T">T Wakabayashi</name></author><author><name sortKey="Asada, M" uniqKey="Asada M">M Asada</name></author><author><name sortKey="Nomoto, K" uniqKey="Nomoto K">K Nomoto</name></author><author><name sortKey="Watanabe, T" uniqKey="Watanabe T">T Watanabe</name></author><author><name sortKey="Dezso, Z" uniqKey="Dezso Z">Z Dezso</name></author><author><name sortKey="Yoshimatsu, K" uniqKey="Yoshimatsu K">K Yoshimatsu</name></author><author><name sortKey="Funahashi, Y" uniqKey="Funahashi Y">Y Funahashi</name></author><author><name sortKey="Tsuruoka, A" uniqKey="Tsuruoka A">A Tsuruoka</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Schlumberger, M" uniqKey="Schlumberger M">M Schlumberger</name></author><author><name sortKey="Tahara, M" uniqKey="Tahara M">M Tahara</name></author><author><name sortKey="Wirth, Lj" uniqKey="Wirth L">LJ Wirth</name></author><author><name sortKey="Robinson, B" uniqKey="Robinson B">B Robinson</name></author><author><name sortKey="Brose, Ms" uniqKey="Brose M">MS Brose</name></author><author><name sortKey="Elisei, R" uniqKey="Elisei R">R Elisei</name></author><author><name sortKey="Habra, Ma" uniqKey="Habra M">MA Habra</name></author><author><name sortKey="Newbold, K" uniqKey="Newbold K">K Newbold</name></author><author><name sortKey="Shah, Mh" uniqKey="Shah M">MH Shah</name></author><author><name sortKey="Hoff, Ao" uniqKey="Hoff A">AO Hoff</name></author><author><name sortKey="Gianoukakis, Ag" uniqKey="Gianoukakis A">AG Gianoukakis</name></author><author><name sortKey="Kiyota, N" uniqKey="Kiyota N">N Kiyota</name></author><author><name sortKey="Taylor, Mh" uniqKey="Taylor M">MH Taylor</name></author><author><name sortKey="Kim, Sb" uniqKey="Kim S">SB Kim</name></author><author><name sortKey="Krzyzanowska, Mk" uniqKey="Krzyzanowska M">MK Krzyzanowska</name></author><author><name sortKey="Dutcus, Ce" uniqKey="Dutcus C">CE Dutcus</name></author><author><name sortKey="De Las Heras, B" uniqKey="De Las Heras B">B de las Heras</name></author><author><name sortKey="Zhu, J" uniqKey="Zhu J">J Zhu</name></author><author><name sortKey="Sherman, Si" uniqKey="Sherman S">SI Sherman</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Wirth, Lj" uniqKey="Wirth L">LJ Wirth</name></author><author><name sortKey="Tahara, M" uniqKey="Tahara M">M Tahara</name></author><author><name sortKey="Robinson, B" uniqKey="Robinson B">B Robinson</name></author><author><name sortKey="Francis, S" uniqKey="Francis S">S Francis</name></author><author><name sortKey="Brose, M" uniqKey="Brose M">M Brose</name></author><author><name sortKey="Habra, Ma" uniqKey="Habra M">MA Habra</name></author><author><name sortKey="Newbold, K" uniqKey="Newbold K">K Newbold</name></author><author><name sortKey="Kiyota, N" uniqKey="Kiyota N">N Kiyota</name></author><author><name sortKey="Dutcus, C" uniqKey="Dutcus C">C Dutcus</name></author><author><name sortKey="Heras, Bdl" uniqKey="Heras B">BDL Heras</name></author><author><name sortKey="Zhu, J" uniqKey="Zhu J">J Zhu</name></author><author><name sortKey="Sherman, S" uniqKey="Sherman S">S Sherman</name></author><author><name sortKey="Schlumberger, M" uniqKey="Schlumberger M">M Schlumberger</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Gianoukakis, Ag" uniqKey="Gianoukakis A">AG Gianoukakis</name></author><author><name sortKey="Mathias, E" uniqKey="Mathias E">E Mathias</name></author><author><name sortKey="Dutcus, Ce" uniqKey="Dutcus C">CE Dutcus</name></author><author><name sortKey="Kalantari, P" uniqKey="Kalantari P">P Kalantari</name></author><author><name sortKey="Yoon, S" uniqKey="Yoon S">S Yoon</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Guo, M" uniqKey="Guo M">M Guo</name></author><author><name sortKey="Sherman, M" uniqKey="Sherman M">M Sherman</name></author><author><name sortKey="Wirth, L" uniqKey="Wirth L">L Wirth</name></author><author><name sortKey="Schlumberger, M" uniqKey="Schlumberger M">M Schlumberger</name></author><author><name sortKey="Dutcus, C" uniqKey="Dutcus C">C Dutcus</name></author><author><name sortKey="Robinson, B" uniqKey="Robinson B">B Robinson</name></author><author><name sortKey="Tahara, M" uniqKey="Tahara M">M Tahara</name></author><author><name sortKey="Latimer, N" uniqKey="Latimer N">N Latimer</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Dy, Gk" uniqKey="Dy G">GK Dy</name></author><author><name sortKey="Adjei, Aa" uniqKey="Adjei A">AA Adjei</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Broekman, F" uniqKey="Broekman F">F Broekman</name></author><author><name sortKey="Giovannetti, E" uniqKey="Giovannetti E">E Giovannetti</name></author><author><name sortKey="Peters, Gj" uniqKey="Peters G">GJ Peters</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Cabanillas, Me" uniqKey="Cabanillas M">ME Cabanillas</name></author><author><name sortKey="Hu, Mi" uniqKey="Hu M">MI Hu</name></author><author><name sortKey="Durand, Jb" uniqKey="Durand J">JB Durand</name></author><author><name sortKey="Busaidy, Nl" uniqKey="Busaidy N">NL Busaidy</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Brose, Ms" uniqKey="Brose M">MS Brose</name></author><author><name sortKey="Smit, J" uniqKey="Smit J">J Smit</name></author><author><name sortKey="Capdevila, J" uniqKey="Capdevila J">J Capdevila</name></author><author><name sortKey="Elisei, R" uniqKey="Elisei R">R Elisei</name></author><author><name sortKey="Nutting, C" uniqKey="Nutting C">C Nutting</name></author><author><name sortKey="Pitoia, F" uniqKey="Pitoia F">F Pitoia</name></author><author><name sortKey="Robinson, B" uniqKey="Robinson B">B Robinson</name></author><author><name sortKey="Schlumberger, M" uniqKey="Schlumberger M">M Schlumberger</name></author><author><name sortKey="Shong, Yk" uniqKey="Shong Y">YK Shong</name></author><author><name sortKey="Takami, H" uniqKey="Takami H">H Takami</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Robinson, B" uniqKey="Robinson B">B Robinson</name></author><author><name sortKey="Schlumberger, M" uniqKey="Schlumberger M">M Schlumberger</name></author><author><name sortKey="Wirth, Lj" uniqKey="Wirth L">LJ Wirth</name></author><author><name sortKey="Dutcus, C" uniqKey="Dutcus C">C Dutcus</name></author><author><name sortKey="Heras, Bdl" uniqKey="Heras B">BDL Heras</name></author><author><name sortKey="Zhu, J" uniqKey="Zhu J">J Zhu</name></author><author><name sortKey="Taylor, Mh" uniqKey="Taylor M">MH Taylor</name></author><author><name sortKey="Kim, S" uniqKey="Kim S">S Kim</name></author><author><name sortKey="Krzyzanowska, Mk" uniqKey="Krzyzanowska M">MK Krzyzanowska</name></author><author><name sortKey="Capdevila, J" uniqKey="Capdevila J">J Capdevila</name></author><author><name sortKey="Sherman, S" uniqKey="Sherman S">S Sherman</name></author><author><name sortKey="Tahara, M" uniqKey="Tahara M">M Tahara</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Zhang, Hl" uniqKey="Zhang H">HL Zhang</name></author><author><name sortKey="Qin, Xj" uniqKey="Qin X">XJ Qin</name></author><author><name sortKey="Wang, Hk" uniqKey="Wang H">HK Wang</name></author><author><name sortKey="Gu, Wj" uniqKey="Gu W">WJ Gu</name></author><author><name sortKey="Ma, Cg" uniqKey="Ma C">CG Ma</name></author><author><name sortKey="Shi, Gh" uniqKey="Shi G">GH Shi</name></author><author><name sortKey="Zhou, Lp" uniqKey="Zhou L">LP Zhou</name></author><author><name sortKey="Ye, Dw" uniqKey="Ye D">DW Ye</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Donskov, F" uniqKey="Donskov F">F Donskov</name></author><author><name sortKey="Michaelson, Md" uniqKey="Michaelson M">MD Michaelson</name></author><author><name sortKey="Puzanov, I" uniqKey="Puzanov I">I Puzanov</name></author><author><name sortKey="Davis, Mp" uniqKey="Davis M">MP Davis</name></author><author><name sortKey="Bjarnason, Ga" uniqKey="Bjarnason G">GA Bjarnason</name></author><author><name sortKey="Motzer, Rj" uniqKey="Motzer R">RJ Motzer</name></author><author><name sortKey="Goldstein, D" uniqKey="Goldstein D">D Goldstein</name></author><author><name sortKey="Lin, X" uniqKey="Lin X">X Lin</name></author><author><name sortKey="Cohen, Dp" uniqKey="Cohen D">DP Cohen</name></author><author><name sortKey="Wiltshire, R" uniqKey="Wiltshire R">R Wiltshire</name></author><author><name sortKey="Rini, Bi" uniqKey="Rini B">BI Rini</name></author></analytic></biblStruct></listBibl></div1></back></TEI><pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Endocrine</journal-id><journal-id journal-id-type="iso-abbrev">Endocrine</journal-id><journal-title-group><journal-title>Endocrine</journal-title></journal-title-group><issn pub-type="ppub">1355-008X</issn><issn pub-type="epub">1559-0100</issn><publisher><publisher-name>Springer US</publisher-name><publisher-loc>New York</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">28155175</article-id><article-id pub-id-type="pmc">5368192</article-id><article-id pub-id-type="publisher-id">1233</article-id><article-id pub-id-type="doi">10.1007/s12020-017-1233-5</article-id><article-categories><subj-group subj-group-type="heading"><subject>Original Article</subject></subj-group></article-categories><title-group><article-title>Incidence and timing of common adverse events in
Lenvatinib-treated patients from the SELECT trial and
their association with survival outcomes</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Haddad</surname><given-names>Robert I.</given-names></name><address><phone>+617-632-5910</phone><email>Robert_Haddad@dfci.harvard.edu</email></address><xref ref-type="aff" rid="Aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Schlumberger</surname><given-names>Martin</given-names></name><xref ref-type="aff" rid="Aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Wirth</surname><given-names>Lori J.</given-names></name><xref ref-type="aff" rid="Aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Sherman</surname><given-names>Eric J.</given-names></name><xref ref-type="aff" rid="Aff4">4</xref></contrib><contrib contrib-type="author"><name><surname>Shah</surname><given-names>Manisha H.</given-names></name><xref ref-type="aff" rid="Aff5">5</xref></contrib><contrib contrib-type="author"><name><surname>Robinson</surname><given-names>Bruce</given-names></name><xref ref-type="aff" rid="Aff6">6</xref></contrib><contrib contrib-type="author"><name><surname>Dutcus</surname><given-names>Corina E.</given-names></name><xref ref-type="aff" rid="Aff7">7</xref></contrib><contrib contrib-type="author"><name><surname>Teng</surname><given-names>Angela</given-names></name><xref ref-type="aff" rid="Aff7">7</xref></contrib><contrib contrib-type="author"><name><surname>Gianoukakis</surname><given-names>Andrew G.</given-names></name><xref ref-type="aff" rid="Aff8">8</xref></contrib><contrib contrib-type="author"><name><surname>Sherman</surname><given-names>Steven I.</given-names></name><xref ref-type="aff" rid="Aff9">9</xref></contrib><aff id="Aff1"><label>1</label><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0378 8294</institution-id><institution-id institution-id-type="GRID">grid.62560.37</institution-id><institution>Head and Neck Oncology Program, Dana Farber Cancer Institute,</institution><institution>Brigham and Women’s Hospital,</institution></institution-wrap>Boston, MA USA</aff><aff id="Aff2"><label>2</label><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2284 9388</institution-id><institution-id institution-id-type="GRID">grid.14925.3b</institution-id><institution>Department of Nuclear Medicine and Endocrine Oncology,</institution><institution>Gustave Roussy and University Paris-Sud,</institution></institution-wrap>Villejuif, France</aff><aff id="Aff3"><label>3</label><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0386 9924</institution-id><institution-id institution-id-type="GRID">grid.32224.35</institution-id><institution>Department of Medicine,</institution><institution>Massachusetts General Hospital,</institution></institution-wrap>Boston, MA USA</aff><aff id="Aff4"><label>4</label><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2171 9952</institution-id><institution-id institution-id-type="GRID">grid.51462.34</institution-id><institution>Department of Medicine,</institution><institution>Memorial Sloan Kettering Cancer Center,</institution></institution-wrap>New York, NY USA</aff><aff id="Aff5"><label>5</label><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2285 7943</institution-id><institution-id institution-id-type="GRID">grid.261331.4</institution-id><institution>Department of Internal Medicine,</institution><institution>The Ohio State University Comprehensive Cancer Center,</institution></institution-wrap>Columbus, OH USA</aff><aff id="Aff6"><label>6</label><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1936 834X</institution-id><institution-id institution-id-type="GRID">grid.1013.3</institution-id><institution>Kolling Institute of Medical Research,</institution><institution>University of Sydney,</institution></institution-wrap>New South Wales, Australia</aff><aff id="Aff7"><label>7</label><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0599 8842</institution-id><institution-id institution-id-type="GRID">grid.418767.b</institution-id><institution>Clinical Development,</institution><institution>Oncology Business Group, Eisai Inc.,</institution></institution-wrap>Woodcliff Lake, NJ USA</aff><aff id="Aff8"><label>8</label><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 0157 6501</institution-id><institution-id institution-id-type="GRID">grid.239844.0</institution-id><institution>Division of Endocrinology and Metabolism,</institution><institution>Harbor-UCLA Medical Center,</institution></institution-wrap>Torrance, CA USA</aff><aff id="Aff9"><label>9</label><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2291 4776</institution-id><institution-id institution-id-type="GRID">grid.240145.6</institution-id><institution>Department of Endocrine Neoplasia and Hormonal Disorders, Division of Internal Medicine,</institution><institution>The University of Texas MD Anderson Cancer Center,</institution></institution-wrap>Houston, TX USA</aff></contrib-group><pub-date pub-type="epub"><day>3</day><month>2</month><year>2017</year></pub-date><pub-date pub-type="pmc-release"><day>3</day><month>2</month><year>2017</year></pub-date><pub-date pub-type="ppub"><year>2017</year></pub-date><volume>56</volume><issue>1</issue><fpage>121</fpage><lpage>128</lpage><history><date date-type="received"><day>6</day><month>9</month><year>2016</year></date><date date-type="accepted"><day>10</day><month>1</month><year>2017</year></date></history><permissions><copyright-statement>© The Author(s) 2017</copyright-statement><license license-type="OpenAccess"><license-p>This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0/">http://creativecommons.org/licenses/by/4.0/</ext-link>), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.</license-p></license></permissions><abstract id="Abs1"><sec><title>Purpose</title><p>In the study of (E7080) lenvatinib in differentiated cancer of the thyroid, most patients experienced an adverse event. In this report, we examine common lenvatinib-emergent adverse events in this phase three, randomized, double-blind study.</p></sec><sec><title>Methods</title><p>Adverse events were graded per Common Terminology Criteria for Adverse Events v4.0. 392 patients were enrolled (lenvatinib: 261, placebo: 131) and received lenvatinib 24 mg/day or placebo. The main outcome measures were: associations with progression-free survival and overall survival in exploratory univariate and multivariate analyses along with additional variables.</p></sec><sec><title>Results</title><p>The most common any-grade adverse events (any grade; grade 3) in lenvatinib-treated patients included proteinuria (32%; 10%), diarrhea (67%; 9%), fatigue/asthenia/malaise (67%; 10%), rash (23%; 0.4%), and palmar-plantar erythrodysesthesia syndrome (33%; 3%). There were no grade 4 events for these adverse events. They generally occurred early (median time to first onset [weeks]: proteinuria [6.1], diarrhea [12.1], fatigue/asthenia/malaise [3.0], rash [7.3], and palmar-plantar erythrodysesthesia syndrome [5.9]), and were resolved primarily with dose modifications (median time to resolution [weeks]: proteinuria [8.8], diarrhea [18.1], fatigue/asthenia/malaise [16.3], rash [5.9], and palmar-plantar erythrodysesthesia syndrome [20.0]). Discontinuation due to these adverse events occurred in 2 (1%) patients with proteinuria and 4 (2%) with fatigue. Progression-free survival was not associated with any of the adverse events. Eastern Cooperative Oncology Group performance status (<italic>P</italic> = 0.001), follicular histology (<italic>P</italic> = 0.002), and diarrhea (<italic>P</italic> = 0.023) were associated with overall survival in multivariate analyses (median overall survival for patients with diarrhea: not reached; without: 17.1 months).</p></sec><sec><title>Conclusions</title><p>In the study of (E7080) lenvatinib in differentiated cancer of the thyroid, the most common adverse events typically occurred early and were primarily managed with dose modifications. Overall survival was significantly associated with diarrhea.</p></sec></abstract><kwd-group xml:lang="en"><title>Keywords</title><kwd>Lenvatinib</kwd><kwd>Adverse event</kwd><kwd>Dose reduction</kwd><kwd>Dose interruption</kwd></kwd-group><custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name><meta-value>© Springer Science+Business Media New York 2017</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Asie/explor/AustralieFrV1/Data/Pmc/Curation
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000B57 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Pmc/Curation/biblio.hfd -nk 000B57 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Asie
|area= AustralieFrV1
|flux= Pmc
|étape= Curation
|type= RBID
|clé= PMC:5368192
|texte= Incidence and timing of common adverse events in
Lenvatinib-treated patients from the SELECT trial and
their association with survival outcomes
}}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/Pmc/Curation/RBID.i -Sk "pubmed:28155175" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Pmc/Curation/biblio.hfd \
| NlmPubMed2Wicri -a AustralieFrV1
| This area was generated with Dilib version V0.6.33. |  |