Subgroup analysis of Japanese patients in a phase 3 study of lenvatinib in radioiodine-refractory differentiated thyroid cancer.
Identifieur interne : 002B53 ( Ncbi/Checkpoint ); précédent : 002B52; suivant : 002B54Subgroup analysis of Japanese patients in a phase 3 study of lenvatinib in radioiodine-refractory differentiated thyroid cancer.
Auteurs : Naomi Kiyota [Japon] ; Martin Schlumberger [France] ; Kei Muro [Japon] ; Yuichi Ando [Japon] ; Shunji Takahashi [Japon] ; Yasukazu Kawai [Japon] ; Lori Wirth [États-Unis] ; Bruce Robinson [Australie] ; Steven Sherman [États-Unis] ; Takuya Suzuki [Japon] ; Katsuki Fujino [Japon] ; Anubha Gupta [Royaume-Uni] ; Seiichi Hayato [Japon] ; Makoto Tahara [Japon]Source :
- Cancer science [ 1349-7006 ] ; 2015.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Antinéoplasiques (pharmacocinétique), Antinéoplasiques (usage thérapeutique), Carcinomes (mortalité), Carcinomes (traitement médicamenteux), Estimation de Kaplan-Meier, Femelle, Humains, Mâle, Phénylurées (pharmacocinétique), Phénylurées (usage thérapeutique), Population d'origine asiatique, Quinoléines (pharmacocinétique), Quinoléines (usage thérapeutique), Radio-isotopes de l'iode, Résistance aux médicaments antinéoplasiques, Sujet âgé, Sujet âgé de 80 ans ou plus, Survie sans rechute, Tumeurs de la thyroïde (mortalité), Tumeurs de la thyroïde (traitement médicamenteux).
- MESH :
- mortalité : Carcinomes, Tumeurs de la thyroïde.
- pharmacocinétique : Antinéoplasiques, Phénylurées, Quinoléines.
- traitement médicamenteux : Carcinomes, Tumeurs de la thyroïde.
- usage thérapeutique : Antinéoplasiques, Phénylurées, Quinoléines.
- Adulte, Adulte d'âge moyen, Estimation de Kaplan-Meier, Femelle, Humains, Mâle, Population d'origine asiatique, Radio-isotopes de l'iode, Résistance aux médicaments antinéoplasiques, Sujet âgé, Sujet âgé de 80 ans ou plus, Survie sans rechute.
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Antineoplastic Agents (pharmacokinetics), Antineoplastic Agents (therapeutic use), Asian Continental Ancestry Group, Carcinoma (drug therapy), Carcinoma (mortality), Disease-Free Survival, Drug Resistance, Neoplasm, Female, Humans, Iodine Radioisotopes, Kaplan-Meier Estimate, Male, Middle Aged, Phenylurea Compounds (pharmacokinetics), Phenylurea Compounds (therapeutic use), Quinolines (pharmacokinetics), Quinolines (therapeutic use), Thyroid Neoplasms (drug therapy), Thyroid Neoplasms (mortality).
- MESH :
- chemical , pharmacokinetics : Antineoplastic Agents, Phenylurea Compounds, Quinolines.
- chemical , therapeutic use : Antineoplastic Agents, Phenylurea Compounds, Quinolines.
- drug therapy : Carcinoma, Thyroid Neoplasms.
- mortality : Carcinoma, Thyroid Neoplasms.
- Adult, Aged, Aged, 80 and over, Asian Continental Ancestry Group, Disease-Free Survival, Drug Resistance, Neoplasm, Female, Humans, Iodine Radioisotopes, Kaplan-Meier Estimate, Male, Middle Aged.
Abstract
Lenvatinib significantly prolonged progression-free survival (PFS) versus placebo in patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC) in the phase 3 Study of (E7080) Lenvatinib in Differentiated Cancer of the Thyroid (SELECT) trial. This subanalysis evaluated the efficacy and safety of lenvatinib in Japanese patients who participated in SELECT. Outcomes for Japanese patients (lenvatinib, n = 30; placebo, n = 10) were assessed in relationship to the SELECT population (lenvatinib, n = 261; placebo, n = 131). The primary endpoint was PFS; secondary endpoints included overall survival, overall response rate, and safety. Lenvatinib PFS benefit was shown in Japanese patients (median PFS: lenvatinib, 16.5 months; placebo, 3.7 months), although significance was not reached, presumably due to sample size (hazard ratio, 0.39; 95% confidence interval, 0.10-1.57; P = 0.067). Overall response rates were 63.3% and 0% for lenvatinib and placebo, respectively. No significant difference was found in overall survival. The lenvatinib safety profile was similar between the Japanese and overall SELECT population, except for higher incidences of hypertension (any grade: Japanese, 87%; overall, 68%; grade ≥3: Japanese, 80%; overall, 42%), palmar-plantar erythrodysesthesia syndrome (any grade: Japanese, 70%; overall, 32%; grade ≥3: Japanese, 3%; overall, 3%), and proteinuria (any grade: Japanese, 63%; overall, 31%; grade ≥3: Japanese, 20%; overall, 10%). Japanese patients had more dose reductions (Japanese, 90%; overall, 67.8%), but fewer discontinuations due to adverse events (Japanese, 3.3%; overall, 14.2%). There was no difference in lenvatinib exposure between the Japanese and overall SELECT populations after adjusting for body weight. In Japanese patients with radioiodine-refractory differentiated thyroid cancer, lenvatinib showed similar clinical outcomes to the overall SELECT population. Some differences in adverse event frequencies and dose modifications were observed. Clinical trial registration no.: NCT01321554.
DOI: 10.1111/cas.12826
PubMed: 26426092
Affiliations:
- Australie, France, Japon, Royaume-Uni, États-Unis
- Massachusetts, Nouvelle-Galles du Sud, Région de Kantō, Texas
- Sydney, Tokyo
- Université de Sydney
Links toward previous steps (curation, corpus...)
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- to stream PubMed, to step Checkpoint: 002601
- to stream Ncbi, to step Merge: 002B53
- to stream Ncbi, to step Curation: 002B53
Links to Exploration step
pubmed:26426092Le document en format XML
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<author><name sortKey="Robinson, Bruce" sort="Robinson, Bruce" uniqKey="Robinson B" first="Bruce" last="Robinson">Bruce Robinson</name>
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<country xml:lang="fr">Australie</country>
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<region type="état">Nouvelle-Galles du Sud</region>
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<author><name sortKey="Sherman, Steven" sort="Sherman, Steven" uniqKey="Sherman S" first="Steven" last="Sherman">Steven Sherman</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Endocrine Neoplasia and Hormonal Disorders, Division of Internal Medicine, The University of Texas M.D. Anderson Cancer Center, Houston, Texas</wicri:regionArea>
<placeName><region type="state">Texas</region>
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<author><name sortKey="Suzuki, Takuya" sort="Suzuki, Takuya" uniqKey="Suzuki T" first="Takuya" last="Suzuki">Takuya Suzuki</name>
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<author><name sortKey="Fujino, Katsuki" sort="Fujino, Katsuki" uniqKey="Fujino K" first="Katsuki" last="Fujino">Katsuki Fujino</name>
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<author><name sortKey="Hayato, Seiichi" sort="Hayato, Seiichi" uniqKey="Hayato S" first="Seiichi" last="Hayato">Seiichi Hayato</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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<term>Aged</term>
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<term>Antineoplastic Agents (therapeutic use)</term>
<term>Asian Continental Ancestry Group</term>
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<term>Carcinomes (mortalité)</term>
<term>Carcinomes (traitement médicamenteux)</term>
<term>Estimation de Kaplan-Meier</term>
<term>Femelle</term>
<term>Humains</term>
<term>Mâle</term>
<term>Phénylurées (pharmacocinétique)</term>
<term>Phénylurées (usage thérapeutique)</term>
<term>Population d'origine asiatique</term>
<term>Quinoléines (pharmacocinétique)</term>
<term>Quinoléines (usage thérapeutique)</term>
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<term>Tumeurs de la thyroïde (mortalité)</term>
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<term>Quinolines</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Agents</term>
<term>Phenylurea Compounds</term>
<term>Quinolines</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Carcinoma</term>
<term>Thyroid Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Carcinoma</term>
<term>Thyroid Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="mortalité" xml:lang="fr"><term>Carcinomes</term>
<term>Tumeurs de la thyroïde</term>
</keywords>
<keywords scheme="MESH" qualifier="pharmacocinétique" xml:lang="fr"><term>Antinéoplasiques</term>
<term>Phénylurées</term>
<term>Quinoléines</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Carcinomes</term>
<term>Tumeurs de la thyroïde</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Antinéoplasiques</term>
<term>Phénylurées</term>
<term>Quinoléines</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Asian Continental Ancestry Group</term>
<term>Disease-Free Survival</term>
<term>Drug Resistance, Neoplasm</term>
<term>Female</term>
<term>Humans</term>
<term>Iodine Radioisotopes</term>
<term>Kaplan-Meier Estimate</term>
<term>Male</term>
<term>Middle Aged</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Estimation de Kaplan-Meier</term>
<term>Femelle</term>
<term>Humains</term>
<term>Mâle</term>
<term>Population d'origine asiatique</term>
<term>Radio-isotopes de l'iode</term>
<term>Résistance aux médicaments antinéoplasiques</term>
<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
<term>Survie sans rechute</term>
</keywords>
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<front><div type="abstract" xml:lang="en">Lenvatinib significantly prolonged progression-free survival (PFS) versus placebo in patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC) in the phase 3 Study of (E7080) Lenvatinib in Differentiated Cancer of the Thyroid (SELECT) trial. This subanalysis evaluated the efficacy and safety of lenvatinib in Japanese patients who participated in SELECT. Outcomes for Japanese patients (lenvatinib, n = 30; placebo, n = 10) were assessed in relationship to the SELECT population (lenvatinib, n = 261; placebo, n = 131). The primary endpoint was PFS; secondary endpoints included overall survival, overall response rate, and safety. Lenvatinib PFS benefit was shown in Japanese patients (median PFS: lenvatinib, 16.5 months; placebo, 3.7 months), although significance was not reached, presumably due to sample size (hazard ratio, 0.39; 95% confidence interval, 0.10-1.57; P = 0.067). Overall response rates were 63.3% and 0% for lenvatinib and placebo, respectively. No significant difference was found in overall survival. The lenvatinib safety profile was similar between the Japanese and overall SELECT population, except for higher incidences of hypertension (any grade: Japanese, 87%; overall, 68%; grade ≥3: Japanese, 80%; overall, 42%), palmar-plantar erythrodysesthesia syndrome (any grade: Japanese, 70%; overall, 32%; grade ≥3: Japanese, 3%; overall, 3%), and proteinuria (any grade: Japanese, 63%; overall, 31%; grade ≥3: Japanese, 20%; overall, 10%). Japanese patients had more dose reductions (Japanese, 90%; overall, 67.8%), but fewer discontinuations due to adverse events (Japanese, 3.3%; overall, 14.2%). There was no difference in lenvatinib exposure between the Japanese and overall SELECT populations after adjusting for body weight. In Japanese patients with radioiodine-refractory differentiated thyroid cancer, lenvatinib showed similar clinical outcomes to the overall SELECT population. Some differences in adverse event frequencies and dose modifications were observed. Clinical trial registration no.: NCT01321554.</div>
</front>
</TEI>
<affiliations><list><country><li>Australie</li>
<li>France</li>
<li>Japon</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
</country>
<region><li>Massachusetts</li>
<li>Nouvelle-Galles du Sud</li>
<li>Région de Kantō</li>
<li>Texas</li>
</region>
<settlement><li>Sydney</li>
<li>Tokyo</li>
</settlement>
<orgName><li>Université de Sydney</li>
</orgName>
</list>
<tree><country name="Japon"><noRegion><name sortKey="Kiyota, Naomi" sort="Kiyota, Naomi" uniqKey="Kiyota N" first="Naomi" last="Kiyota">Naomi Kiyota</name>
</noRegion>
<name sortKey="Ando, Yuichi" sort="Ando, Yuichi" uniqKey="Ando Y" first="Yuichi" last="Ando">Yuichi Ando</name>
<name sortKey="Fujino, Katsuki" sort="Fujino, Katsuki" uniqKey="Fujino K" first="Katsuki" last="Fujino">Katsuki Fujino</name>
<name sortKey="Hayato, Seiichi" sort="Hayato, Seiichi" uniqKey="Hayato S" first="Seiichi" last="Hayato">Seiichi Hayato</name>
<name sortKey="Kawai, Yasukazu" sort="Kawai, Yasukazu" uniqKey="Kawai Y" first="Yasukazu" last="Kawai">Yasukazu Kawai</name>
<name sortKey="Muro, Kei" sort="Muro, Kei" uniqKey="Muro K" first="Kei" last="Muro">Kei Muro</name>
<name sortKey="Suzuki, Takuya" sort="Suzuki, Takuya" uniqKey="Suzuki T" first="Takuya" last="Suzuki">Takuya Suzuki</name>
<name sortKey="Tahara, Makoto" sort="Tahara, Makoto" uniqKey="Tahara M" first="Makoto" last="Tahara">Makoto Tahara</name>
<name sortKey="Takahashi, Shunji" sort="Takahashi, Shunji" uniqKey="Takahashi S" first="Shunji" last="Takahashi">Shunji Takahashi</name>
</country>
<country name="France"><noRegion><name sortKey="Schlumberger, Martin" sort="Schlumberger, Martin" uniqKey="Schlumberger M" first="Martin" last="Schlumberger">Martin Schlumberger</name>
</noRegion>
</country>
<country name="États-Unis"><region name="Massachusetts"><name sortKey="Wirth, Lori" sort="Wirth, Lori" uniqKey="Wirth L" first="Lori" last="Wirth">Lori Wirth</name>
</region>
<name sortKey="Sherman, Steven" sort="Sherman, Steven" uniqKey="Sherman S" first="Steven" last="Sherman">Steven Sherman</name>
</country>
<country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Robinson, Bruce" sort="Robinson, Bruce" uniqKey="Robinson B" first="Bruce" last="Robinson">Bruce Robinson</name>
</region>
</country>
<country name="Royaume-Uni"><noRegion><name sortKey="Gupta, Anubha" sort="Gupta, Anubha" uniqKey="Gupta A" first="Anubha" last="Gupta">Anubha Gupta</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>
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