AustralieFrV1, Main, Curation, bibRecord, 002239

Characterization of Tumor Size Changes Over Time From the Phase 3 Study of Lenvatinib in Thyroid Cancer

Identifieur interne : 002239 ( Main/Curation ); précédent : 002238; suivant : 002240

Characterization of Tumor Size Changes Over Time From the Phase 3 Study of Lenvatinib in Thyroid Cancer

Auteurs : Bruce Robinson ; Martin Schlumberger ; Lori J. Wirth ; Corina E. Dutcus ; James Song ; Matthew H. Taylor ; Sung-Bae Kim ; Monika K. Krzyzanowska ; Jaume Capdevila ; Steven I. Sherman ; Makoto Tahara

Source :

The Journal of Clinical Endocrinology and Metabolism [ 0021-972X ] ; 2016.

RBID : PMC:5095235

Descripteurs français

KwdFr :
- Adulte, Adulte d'âge moyen, Antinéoplasiques (administration et posologie), Antinéoplasiques (pharmacologie), Femelle, Humains, Jeune adulte, Mâle, Méthode en double aveugle, Phénylurées (administration et posologie), Phénylurées (pharmacologie), Quinoléines (administration et posologie), Quinoléines (pharmacologie), Sujet âgé, Sujet âgé de 80 ans ou plus, Survie sans rechute, Tumeurs de la thyroïde (imagerie diagnostique), Tumeurs de la thyroïde (traitement médicamenteux), Études de suivi, Évaluation de résultat (soins).
MESH :
- administration et posologie : Antinéoplasiques, Phénylurées, Quinoléines.
- imagerie diagnostique : Tumeurs de la thyroïde.
- pharmacologie : Antinéoplasiques, Phénylurées, Quinoléines.
- traitement médicamenteux : Tumeurs de la thyroïde.
- Adulte, Adulte d'âge moyen, Femelle, Humains, Jeune adulte, Mâle, Méthode en double aveugle, Sujet âgé, Sujet âgé de 80 ans ou plus, Survie sans rechute, Études de suivi, Évaluation de résultat (soins).

English descriptors

KwdEn :
- Adult, Aged, Aged, 80 and over, Antineoplastic Agents (administration & dosage), Antineoplastic Agents (pharmacology), Disease-Free Survival, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Middle Aged, Outcome Assessment (Health Care), Phenylurea Compounds (administration & dosage), Phenylurea Compounds (pharmacology), Quinolines (administration & dosage), Quinolines (pharmacology), Thyroid Neoplasms (diagnostic imaging), Thyroid Neoplasms (drug therapy), Young Adult.
MESH :
- chemical , administration & dosage : Antineoplastic Agents, Phenylurea Compounds, Quinolines.
- chemical , pharmacology : Antineoplastic Agents, Phenylurea Compounds, Quinolines.
- diagnostic imaging : Thyroid Neoplasms.
- drug therapy : Thyroid Neoplasms.
- Adult, Aged, Aged, 80 and over, Disease-Free Survival, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Middle Aged, Outcome Assessment (Health Care), Young Adult.

Abstract

Context:

Lenvatinib improved the progression-free survival (PFS) and overall response rate of patients with radioiodine-refractory differentiated thyroid cancer vs placebo in the Phase 3 Study of (E7080) Lenvatinib in Differentiated Cancer of the Thyroid (SELECT).

Objective:

The objective of the study was to characterize tumor size changes with lenvatinib treatment.

Design:

SELECT was a phase 3, randomized, double-blind, multicenter study.

Setting:

In this clinical trial, tumor assessments of lenvatinib (n = 261) and placebo-treated (n = 131) patients were performed by independent radiological review per Response Evaluation Criteria in Solid Tumors version, 1.1 at 8-week intervals.

Patients:

Patients with complete or partial response were defined as responders to lenvatinib (n = 169). Of the 92 nonresponders, 76 had at least one postbaseline tumor assessment and were included in this analysis.

Interventions:

Lenvatinib (24 mg once daily) or placebo in 28-day cycles until unacceptable toxicity, disease progression, or death.

Main Outcome Measures:

This was an exploratory analysis of key end points from SELECT, including PFS, overall response rate, and tumor reduction.

Results:

The median maximum percentage change in tumor size was −42.9% for patients receiving lenvatinib (responders, −51.9%; nonresponders, −20.2%). Tumor size reduction was most pronounced at first assessment (median, −24.7% at 8 wk after randomization); thereafter, the rate of change was slower but continuous (−1.3% per mo). In a multivariate model, percentage change in tumor size at the first assessment was a marginally significant positive predictor for PFS (P = .06).

Conclusions:

The change in tumor size conferred by lenvatinib was characterized by two phases: an initial, rapid decline, followed by slower, continuous shrinkage.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5095235

DOI: 10.1210/jc.2015-3989
PubMed: 27548104
PubMed Central: 5095235

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<author><name sortKey="Schlumberger, Martin" sort="Schlumberger, Martin" uniqKey="Schlumberger M" first="Martin" last="Schlumberger">Martin Schlumberger</name>
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<author><name sortKey="Wirth, Lori J" sort="Wirth, Lori J" uniqKey="Wirth L" first="Lori J." last="Wirth">Lori J. Wirth</name>
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<author><name sortKey="Dutcus, Corina E" sort="Dutcus, Corina E" uniqKey="Dutcus C" first="Corina E." last="Dutcus">Corina E. Dutcus</name>
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<author><name sortKey="Song, James" sort="Song, James" uniqKey="Song J" first="James" last="Song">James Song</name>
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<author><name sortKey="Taylor, Matthew H" sort="Taylor, Matthew H" uniqKey="Taylor M" first="Matthew H." last="Taylor">Matthew H. Taylor</name>
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<author><name sortKey="Kim, Sung Bae" sort="Kim, Sung Bae" uniqKey="Kim S" first="Sung-Bae" last="Kim">Sung-Bae Kim</name>
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<author><name sortKey="Krzyzanowska, Monika K" sort="Krzyzanowska, Monika K" uniqKey="Krzyzanowska M" first="Monika K." last="Krzyzanowska">Monika K. Krzyzanowska</name>
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<author><name sortKey="Capdevila, Jaume" sort="Capdevila, Jaume" uniqKey="Capdevila J" first="Jaume" last="Capdevila">Jaume Capdevila</name>
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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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<author><name sortKey="Tahara, Makoto" sort="Tahara, Makoto" uniqKey="Tahara M" first="Makoto" last="Tahara">Makoto Tahara</name>
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<series><title level="j">The Journal of Clinical Endocrinology and Metabolism</title>
<idno type="ISSN">0021-972X</idno>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Antineoplastic Agents (administration & dosage)</term>
<term>Antineoplastic Agents (pharmacology)</term>
<term>Disease-Free Survival</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Outcome Assessment (Health Care)</term>
<term>Phenylurea Compounds (administration & dosage)</term>
<term>Phenylurea Compounds (pharmacology)</term>
<term>Quinolines (administration & dosage)</term>
<term>Quinolines (pharmacology)</term>
<term>Thyroid Neoplasms (diagnostic imaging)</term>
<term>Thyroid Neoplasms (drug therapy)</term>
<term>Young Adult</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Antinéoplasiques (administration et posologie)</term>
<term>Antinéoplasiques (pharmacologie)</term>
<term>Femelle</term>
<term>Humains</term>
<term>Jeune adulte</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Phénylurées (administration et posologie)</term>
<term>Phénylurées (pharmacologie)</term>
<term>Quinoléines (administration et posologie)</term>
<term>Quinoléines (pharmacologie)</term>
<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
<term>Survie sans rechute</term>
<term>Tumeurs de la thyroïde (imagerie diagnostique)</term>
<term>Tumeurs de la thyroïde (traitement médicamenteux)</term>
<term>Études de suivi</term>
<term>Évaluation de résultat (soins)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antineoplastic Agents</term>
<term>Phenylurea Compounds</term>
<term>Quinolines</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="pharmacology" xml:lang="en"><term>Antineoplastic Agents</term>
<term>Phenylurea Compounds</term>
<term>Quinolines</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Antinéoplasiques</term>
<term>Phénylurées</term>
<term>Quinoléines</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnostic imaging" xml:lang="en"><term>Thyroid Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Thyroid Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="imagerie diagnostique" xml:lang="fr"><term>Tumeurs de la thyroïde</term>
</keywords>
<keywords scheme="MESH" qualifier="pharmacologie" xml:lang="fr"><term>Antinéoplasiques</term>
<term>Phénylurées</term>
<term>Quinoléines</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Tumeurs de la thyroïde</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Disease-Free Survival</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
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<term>Adulte d'âge moyen</term>
<term>Femelle</term>
<term>Humains</term>
<term>Jeune adulte</term>
<term>Mâle</term>
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<front><div type="abstract" xml:lang="en"><sec><title>Context:</title>
<p>Lenvatinib improved the progression-free survival (PFS) and overall response rate of patients with radioiodine-refractory differentiated thyroid cancer vs placebo in the Phase 3 <italic>S</italic>
tudy of (E7080) Lenvatinib in Differentiated Cancer of the Thyroid (SELECT).</p>
</sec>
<sec><title>Objective:</title>
<p>The objective of the study was to characterize tumor size changes with lenvatinib treatment.</p>
</sec>
<sec><title>Design:</title>
<p>SELECT was a phase 3, randomized, double-blind, multicenter study.</p>
</sec>
<sec><title>Setting:</title>
<p>In this clinical trial, tumor assessments of lenvatinib (n = 261) and placebo-treated (n = 131) patients were performed by independent radiological review per Response Evaluation Criteria in Solid Tumors version, 1.1 at 8-week intervals.</p>
</sec>
<sec><title>Patients:</title>
<p>Patients with complete or partial response were defined as responders to lenvatinib (n = 169). Of the 92 nonresponders, 76 had at least one postbaseline tumor assessment and were included in this analysis.</p>
</sec>
<sec><title>Interventions:</title>
<p>Lenvatinib (24 mg once daily) or placebo in 28-day cycles until unacceptable toxicity, disease progression, or death.</p>
</sec>
<sec><title>Main Outcome Measures:</title>
<p>This was an exploratory analysis of key end points from SELECT, including PFS, overall response rate, and tumor reduction.</p>
</sec>
<sec><title>Results:</title>
<p>The median maximum percentage change in tumor size was −42.9% for patients receiving lenvatinib (responders, −51.9%; nonresponders, −20.2%). Tumor size reduction was most pronounced at first assessment (median, −24.7% at 8 wk after randomization); thereafter, the rate of change was slower but continuous (−1.3% per mo). In a multivariate model, percentage change in tumor size at the first assessment was a marginally significant positive predictor for PFS (<italic>P</italic>
 = .06).</p>
</sec>
<sec><title>Conclusions:</title>
<p>The change in tumor size conferred by lenvatinib was characterized by two phases: an initial, rapid decline, followed by slower, continuous shrinkage.</p>
</sec>
</div>
</front>
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<author><name sortKey="Yamamoto, Y" uniqKey="Yamamoto Y">Y Yamamoto</name>
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<author><name sortKey="Funahashi, Y" uniqKey="Funahashi Y">Y Funahashi</name>
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</author>
<author><name sortKey="Uenaka, T" uniqKey="Uenaka T">T Uenaka</name>
</author>
<author><name sortKey="Watanabe, T" uniqKey="Watanabe T">T Watanabe</name>
</author>
<author><name sortKey="Tsuruoka, A" uniqKey="Tsuruoka A">A Tsuruoka</name>
</author>
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</author>
<author><name sortKey="Takase, K" uniqKey="Takase K">K Takase</name>
</author>
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</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>
</analytic>
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</author>
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</author>
<author><name sortKey="Ng, C" uniqKey="Ng C">C Ng</name>
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</author>
<author><name sortKey="Zhang, H" uniqKey="Zhang H">H Zhang</name>
</author>
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</author>
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<author><name sortKey="Zheng, L" uniqKey="Zheng L">L Zheng</name>
</author>
<author><name sortKey="Liu, W" uniqKey="Liu W">W Liu</name>
</author>
<author><name sortKey="Winer, D" uniqKey="Winer D">D Winer</name>
</author>
<author><name sortKey="Asa, Sl" uniqKey="Asa S">SL Asa</name>
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<author><name sortKey="Ezzat, S" uniqKey="Ezzat S">S Ezzat</name>
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</author>
<author><name sortKey="Ikemori Kawada, M" uniqKey="Ikemori Kawada M">M Ikemori-Kawada</name>
</author>
<author><name sortKey="Jestel, A" uniqKey="Jestel A">A Jestel</name>
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	Serveur d'exploration sur les relations entre la France et l'Australie
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Characterization of Tumor Size Changes Over Time From the Phase 3 Study of Lenvatinib in Thyroid Cancer

Characterization of Tumor Size Changes Over Time From the Phase 3 Study of Lenvatinib in Thyroid Cancer

Source :

Descripteurs français

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

Links to Exploration step

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri

Pour générer des pages wiki