PittsburghV1, France, Analysis, bibRecord, 000550

Phase 3, Randomized, Placebo-Controlled Study of Zibotentan (ZD4054) in Patients With Castration-Resistant Prostate Cancer Metastatic to Bone

Identifieur interne : 000550 ( France/Analysis ); précédent : 000549; suivant : 000551

Phase 3, Randomized, Placebo-Controlled Study of Zibotentan (ZD4054) in Patients With Castration-Resistant Prostate Cancer Metastatic to Bone

Auteurs : Joel B. Nelson [États-Unis] ; Karim Fizazi [France] ; Kurt Miller [Allemagne] ; Celestia Higano [États-Unis] ; Judd W. Moul [États-Unis] ; Hideyuki Akaza [Japon] ; Thomas Morris [Royaume-Uni] ; Stuart Mclntosh [Royaume-Uni] ; Kristine Pemberton [Royaume-Uni] ; Martin Gleave [Canada]

Source :

Cancer [ 0008-543X ] ; 2012.

RBID : Pascal:12-0436524

Descripteurs français

Pascal (Inist)
- Essai clinique phase III, Randomisation, Placebo, Zibotentan, Homme, Castration, Cancer de la prostate, Résistance, Stade avancé, Métastase, Cancérologie, Endothéline, Cancer de l'os.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Advanced stage, Bone cancer, Cancerology, Castration, Endothelin, Human, Metastasis, Phase III trial, Placebo, Prostate cancer, Randomization, Resistance, Zibotentan.

Abstract

BACKGROUND: Endothelin-1 and the endothelin A (ET_A) receptor have been implicated in prostate cancer progression in bone. This study aimed to determine whether the specific ET_A receptor antagonist, zibotentan, prolonged overall survival (OS) in patients with castration-resistant prostate cancer and bone metastases who were pain-free or mildly symptomatic for pain. METHODS: Patients were randomized 1:1 to zibotentan 10 mg/day or placebo, plus standard prostate cancer treatment. The primary endpoint was OS. Secondary endpoints included times to pain progression, chemotherapy use, new bone metastases, and safety. Efficacy endpoints were analyzed using a log-rank test. RESULTS: A total of 594 patients were randomized (zibotentan, n = 299; placebo, n = 295). Median OS was 24.5 months in zibotentan-treated patients versus 22.5 months for placebo, but the difference did not reach statistical significance (hazard ratio, 0.87; 95.2% confidence interval, 0.69-1.10; P = .240). No statistically significant differences were observed for any secondary efficacy endpoints. Peripheral edema (44%) and headache (31%) were the most commonly reported adverse events in the zibotentan group. Cardiac failure events were higher in the zibotentan group than placebo (any grade, 5.7% and 1.7%; Common Terminology Criteria for Adverse Events grade ≥3, 3.0% and 1.0%, respectively); these were manageable and reversible. CONCLUSIONS: In this large, randomized, placebo-controlled phase 3 trial, treatment with zibotentan 10 mg/day did not lead to a statistically significant improvement in OS in this patient population. Zibotentan had an acceptable safety profile.

Affiliations:

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

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to stream Main, to step Exploration: 008993
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Pascal:12-0436524

Le document en format XML

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<author><name sortKey="Nelson, Joel B" sort="Nelson, Joel B" uniqKey="Nelson J" first="Joel B." last="Nelson">Joel B. Nelson</name>
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<author><name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name>
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<author><name sortKey="Higano, Celestia" sort="Higano, Celestia" uniqKey="Higano C" first="Celestia" last="Higano">Celestia Higano</name>
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<author><name sortKey="Moul, Judd W" sort="Moul, Judd W" uniqKey="Moul J" first="Judd W." last="Moul">Judd W. Moul</name>
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<author><name sortKey="Morris, Thomas" sort="Morris, Thomas" uniqKey="Morris T" first="Thomas" last="Morris">Thomas Morris</name>
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<author><name sortKey="Pemberton, Kristine" sort="Pemberton, Kristine" uniqKey="Pemberton K" first="Kristine" last="Pemberton">Kristine Pemberton</name>
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<wicri:noRegion>Macclesfield</wicri:noRegion>
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<author><name sortKey="Gleave, Martin" sort="Gleave, Martin" uniqKey="Gleave M" first="Martin" last="Gleave">Martin Gleave</name>
<affiliation wicri:level="1"><inist:fA14 i1="08"><s1>University of British Columbia</s1>
<s2>Vancouver</s2>
<s3>CAN</s3>
<sZ>10 aut.</sZ>
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<country>Canada</country>
<wicri:noRegion>University of British Columbia</wicri:noRegion>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Phase 3, Randomized, Placebo-Controlled Study of Zibotentan (ZD4054) in Patients With Castration-Resistant Prostate Cancer Metastatic to Bone</title>
<author><name sortKey="Nelson, Joel B" sort="Nelson, Joel B" uniqKey="Nelson J" first="Joel B." last="Nelson">Joel B. Nelson</name>
<affiliation wicri:level="4"><inist:fA14 i1="01"><s1>University of Pittsburgh</s1>
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<s3>USA</s3>
<sZ>1 aut.</sZ>
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<country>États-Unis</country>
<placeName><region type="state">Pennsylvanie</region>
<settlement type="city">Pittsburgh</settlement>
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<orgName type="university">Université de Pittsburgh</orgName>
</affiliation>
</author>
<author><name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name>
<affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Institut Gustave Roussy, University of Paris Sud</s1>
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<country>France</country>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Miller, Kurt" sort="Miller, Kurt" uniqKey="Miller K" first="Kurt" last="Miller">Kurt Miller</name>
<affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Charité Berlin</s1>
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<s3>DEU</s3>
<sZ>3 aut.</sZ>
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<country>Allemagne</country>
<placeName><region type="land" nuts="3">Berlin</region>
<settlement type="city">Berlin</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Higano, Celestia" sort="Higano, Celestia" uniqKey="Higano C" first="Celestia" last="Higano">Celestia Higano</name>
<affiliation wicri:level="4"><inist:fA14 i1="04"><s1>University of Washington</s1>
<s2>Seattle, Washington</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Washington (État)</region>
<settlement type="city">Seattle</settlement>
</placeName>
<orgName type="university">Université de Washington</orgName>
</affiliation>
</author>
<author><name sortKey="Moul, Judd W" sort="Moul, Judd W" uniqKey="Moul J" first="Judd W." last="Moul">Judd W. Moul</name>
<affiliation wicri:level="2"><inist:fA14 i1="05"><s1>Duke University Medical Center</s1>
<s2>Durham, North Carolina</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Caroline du Nord</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Akaza, Hideyuki" sort="Akaza, Hideyuki" uniqKey="Akaza H" first="Hideyuki" last="Akaza">Hideyuki Akaza</name>
<affiliation wicri:level="4"><inist:fA14 i1="06"><s1>Research Center for Advanced Science and Technology, University of Tokyo</s1>
<s2>Tokyo</s2>
<s3>JPN</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
<country>Japon</country>
<placeName><settlement type="city">Tokyo</settlement>
<region type="région">Région de Kantō</region>
<settlement type="city">Tokyo</settlement>
</placeName>
<orgName type="university">Université de Tokyo</orgName>
</affiliation>
</author>
<author><name sortKey="Morris, Thomas" sort="Morris, Thomas" uniqKey="Morris T" first="Thomas" last="Morris">Thomas Morris</name>
<affiliation wicri:level="1"><inist:fA14 i1="07"><s1>AstraZeneca, Alderley Park</s1>
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<s3>GBR</s3>
<sZ>7 aut.</sZ>
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</affiliation>
</author>
<author><name sortKey="Mclntosh, Stuart" sort="Mclntosh, Stuart" uniqKey="Mclntosh S" first="Stuart" last="Mclntosh">Stuart Mclntosh</name>
<affiliation wicri:level="1"><inist:fA14 i1="07"><s1>AstraZeneca, Alderley Park</s1>
<s2>Macclesfield</s2>
<s3>GBR</s3>
<sZ>7 aut.</sZ>
<sZ>8 aut.</sZ>
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<country>Royaume-Uni</country>
<wicri:noRegion>Macclesfield</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Pemberton, Kristine" sort="Pemberton, Kristine" uniqKey="Pemberton K" first="Kristine" last="Pemberton">Kristine Pemberton</name>
<affiliation wicri:level="1"><inist:fA14 i1="07"><s1>AstraZeneca, Alderley Park</s1>
<s2>Macclesfield</s2>
<s3>GBR</s3>
<sZ>7 aut.</sZ>
<sZ>8 aut.</sZ>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>Macclesfield</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Gleave, Martin" sort="Gleave, Martin" uniqKey="Gleave M" first="Martin" last="Gleave">Martin Gleave</name>
<affiliation wicri:level="1"><inist:fA14 i1="08"><s1>University of British Columbia</s1>
<s2>Vancouver</s2>
<s3>CAN</s3>
<sZ>10 aut.</sZ>
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<country>Canada</country>
<wicri:noRegion>University of British Columbia</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">Cancer</title>
<title level="j" type="abbreviated">Cancer</title>
<idno type="ISSN">0008-543X</idno>
<imprint><date when="2012">2012</date>
</imprint>
</series>
</biblStruct>
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<seriesStmt><title level="j" type="main">Cancer</title>
<title level="j" type="abbreviated">Cancer</title>
<idno type="ISSN">0008-543X</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Advanced stage</term>
<term>Bone cancer</term>
<term>Cancerology</term>
<term>Castration</term>
<term>Endothelin</term>
<term>Human</term>
<term>Metastasis</term>
<term>Phase III trial</term>
<term>Placebo</term>
<term>Prostate cancer</term>
<term>Randomization</term>
<term>Resistance</term>
<term>Zibotentan</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Essai clinique phase III</term>
<term>Randomisation</term>
<term>Placebo</term>
<term>Zibotentan</term>
<term>Homme</term>
<term>Castration</term>
<term>Cancer de la prostate</term>
<term>Résistance</term>
<term>Stade avancé</term>
<term>Métastase</term>
<term>Cancérologie</term>
<term>Endothéline</term>
<term>Cancer de l'os</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">BACKGROUND: Endothelin-1 and the endothelin A (ET<sub>A</sub>
) receptor have been implicated in prostate cancer progression in bone. This study aimed to determine whether the specific ET<sub>A</sub>
 receptor antagonist, zibotentan, prolonged overall survival (OS) in patients with castration-resistant prostate cancer and bone metastases who were pain-free or mildly symptomatic for pain. METHODS: Patients were randomized 1:1 to zibotentan 10 mg/day or placebo, plus standard prostate cancer treatment. The primary endpoint was OS. Secondary endpoints included times to pain progression, chemotherapy use, new bone metastases, and safety. Efficacy endpoints were analyzed using a log-rank test. RESULTS: A total of 594 patients were randomized (zibotentan, n = 299; placebo, n = 295). Median OS was 24.5 months in zibotentan-treated patients versus 22.5 months for placebo, but the difference did not reach statistical significance (hazard ratio, 0.87; 95.2% confidence interval, 0.69-1.10; P = .240). No statistically significant differences were observed for any secondary efficacy endpoints. Peripheral edema (44%) and headache (31%) were the most commonly reported adverse events in the zibotentan group. Cardiac failure events were higher in the zibotentan group than placebo (any grade, 5.7% and 1.7%; Common Terminology Criteria for Adverse Events grade ≥3, 3.0% and 1.0%, respectively); these were manageable and reversible. CONCLUSIONS: In this large, randomized, placebo-controlled phase 3 trial, treatment with zibotentan 10 mg/day did not lead to a statistically significant improvement in OS in this patient population. Zibotentan had an acceptable safety profile.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Canada</li>
<li>France</li>
<li>Japon</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
</country>
<region><li>Berlin</li>
<li>Caroline du Nord</li>
<li>Pennsylvanie</li>
<li>Région de Kantō</li>
<li>Washington (État)</li>
<li>Île-de-France</li>
</region>
<settlement><li>Berlin</li>
<li>Paris</li>
<li>Pittsburgh</li>
<li>Seattle</li>
<li>Tokyo</li>
</settlement>
<orgName><li>Université de Pittsburgh</li>
<li>Université de Tokyo</li>
<li>Université de Washington</li>
</orgName>
</list>
<tree><country name="États-Unis"><region name="Pennsylvanie"><name sortKey="Nelson, Joel B" sort="Nelson, Joel B" uniqKey="Nelson J" first="Joel B." last="Nelson">Joel B. Nelson</name>
</region>
<name sortKey="Higano, Celestia" sort="Higano, Celestia" uniqKey="Higano C" first="Celestia" last="Higano">Celestia Higano</name>
<name sortKey="Moul, Judd W" sort="Moul, Judd W" uniqKey="Moul J" first="Judd W." last="Moul">Judd W. Moul</name>
</country>
<country name="France"><region name="Île-de-France"><name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name>
</region>
</country>
<country name="Allemagne"><region name="Berlin"><name sortKey="Miller, Kurt" sort="Miller, Kurt" uniqKey="Miller K" first="Kurt" last="Miller">Kurt Miller</name>
</region>
</country>
<country name="Japon"><region name="Région de Kantō"><name sortKey="Akaza, Hideyuki" sort="Akaza, Hideyuki" uniqKey="Akaza H" first="Hideyuki" last="Akaza">Hideyuki Akaza</name>
</region>
</country>
<country name="Royaume-Uni"><noRegion><name sortKey="Morris, Thomas" sort="Morris, Thomas" uniqKey="Morris T" first="Thomas" last="Morris">Thomas Morris</name>
</noRegion>
<name sortKey="Mclntosh, Stuart" sort="Mclntosh, Stuart" uniqKey="Mclntosh S" first="Stuart" last="Mclntosh">Stuart Mclntosh</name>
<name sortKey="Pemberton, Kristine" sort="Pemberton, Kristine" uniqKey="Pemberton K" first="Kristine" last="Pemberton">Kristine Pemberton</name>
</country>
<country name="Canada"><noRegion><name sortKey="Gleave, Martin" sort="Gleave, Martin" uniqKey="Gleave M" first="Martin" last="Gleave">Martin Gleave</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

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Phase 3, Randomized, Placebo-Controlled Study of Zibotentan (ZD4054) in Patients With Castration-Resistant Prostate Cancer Metastatic to Bone

Phase 3, Randomized, Placebo-Controlled Study of Zibotentan (ZD4054) in Patients With Castration-Resistant Prostate Cancer Metastatic to Bone

Source :

Descripteurs français

English descriptors

Abstract

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Links to Exploration step

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

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