Phase 3, Randomized, Placebo-Controlled Study of Zibotentan (ZD4054) in Patients With Castration-Resistant Prostate Cancer Metastatic to Bone
Identifieur interne : 001B24 ( PascalFrancis/Curation ); précédent : 001B23; suivant : 001B25Phase 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.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
Abstract
BACKGROUND: Endothelin-1 and the endothelin A (ETA) receptor have been implicated in prostate cancer progression in bone. This study aimed to determine whether the specific ETA 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.
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Nelson</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>University of Pittsburgh</s1><s2>Pittsburgh, Pennsylvania</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country></affiliation></author><author><name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Institut Gustave Roussy, University of Paris Sud</s1><s2>Paris</s2><s3>FRA</s3><sZ>2 aut.</sZ></inist:fA14><country>France</country></affiliation></author><author><name sortKey="Miller, Kurt" sort="Miller, Kurt" uniqKey="Miller K" first="Kurt" last="Miller">Kurt Miller</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Charité Berlin</s1><s2>Berlin</s2><s3>DEU</s3><sZ>3 aut.</sZ></inist:fA14><country>Allemagne</country></affiliation></author><author><name sortKey="Higano, Celestia" sort="Higano, Celestia" uniqKey="Higano C" first="Celestia" last="Higano">Celestia Higano</name><affiliation wicri:level="1"><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></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="1"><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></affiliation></author><author><name sortKey="Akaza, Hideyuki" sort="Akaza, Hideyuki" uniqKey="Akaza H" first="Hideyuki" last="Akaza">Hideyuki Akaza</name><affiliation wicri:level="1"><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></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><s2>Macclesfield</s2><s3>GBR</s3><sZ>7 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>Royaume-Uni</country></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><sZ>9 aut.</sZ></inist:fA14><country>Royaume-Uni</country></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></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></inist:fA14><country>Canada</country></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></sourceDesc><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><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0008-543X</s0></fA01><fA02 i1="01"><s0>CANCAR</s0></fA02><fA03 i2="1"><s0>Cancer</s0></fA03><fA05><s2>118</s2></fA05><fA06><s2>22</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Phase 3, Randomized, Placebo-Controlled Study of Zibotentan (ZD4054) in Patients With Castration-Resistant Prostate Cancer Metastatic to Bone</s1></fA08><fA11 i1="01" i2="1"><s1>NELSON (Joel B.)</s1></fA11><fA11 i1="02" i2="1"><s1>FIZAZI (Karim)</s1></fA11><fA11 i1="03" i2="1"><s1>MILLER (Kurt)</s1></fA11><fA11 i1="04" i2="1"><s1>HIGANO (Celestia)</s1></fA11><fA11 i1="05" i2="1"><s1>MOUL (Judd W.)</s1></fA11><fA11 i1="06" i2="1"><s1>AKAZA (Hideyuki)</s1></fA11><fA11 i1="07" i2="1"><s1>MORRIS (Thomas)</s1></fA11><fA11 i1="08" i2="1"><s1>MCLNTOSH (Stuart)</s1></fA11><fA11 i1="09" i2="1"><s1>PEMBERTON (Kristine)</s1></fA11><fA11 i1="10" i2="1"><s1>GLEAVE (Martin)</s1></fA11><fA14 i1="01"><s1>University of Pittsburgh</s1><s2>Pittsburgh, Pennsylvania</s2><s3>USA</s3><sZ>1 aut.</sZ></fA14><fA14 i1="02"><s1>Institut Gustave Roussy, University of Paris Sud</s1><s2>Paris</s2><s3>FRA</s3><sZ>2 aut.</sZ></fA14><fA14 i1="03"><s1>Charité Berlin</s1><s2>Berlin</s2><s3>DEU</s3><sZ>3 aut.</sZ></fA14><fA14 i1="04"><s1>University of Washington</s1><s2>Seattle, Washington</s2><s3>USA</s3><sZ>4 aut.</sZ></fA14><fA14 i1="05"><s1>Duke University Medical Center</s1><s2>Durham, North Carolina</s2><s3>USA</s3><sZ>5 aut.</sZ></fA14><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></fA14><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></fA14><fA14 i1="08"><s1>University of British Columbia</s1><s2>Vancouver</s2><s3>CAN</s3><sZ>10 aut.</sZ></fA14><fA20><s1>5709-5718</s1></fA20><fA21><s1>2012</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>2701</s2><s5>354000502908330310</s5></fA43><fA44><s0>0000</s0><s1>© 2012 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>35 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>12-0436524</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>Cancer</s0></fA64><fA66 i1="01"><s0>USA</s0></fA66><fC01 i1="01" l="ENG"><s0>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.</s0></fC01><fC02 i1="01" i2="X"><s0>002B04</s0></fC02><fC02 i1="02" i2="X"><s0>002B14D02</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Essai clinique phase III</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Phase III trial</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Ensayo clínico fase III</s0><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Randomisation</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Randomization</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Aleatorización</s0><s5>02</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Placebo</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Placebo</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Placebo</s0><s5>03</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Zibotentan</s0><s2>FR</s2><s5>04</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Zibotentan</s0><s2>FR</s2><s5>04</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Zibotentán</s0><s2>FR</s2><s5>04</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>Homme</s0><s5>05</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>Human</s0><s5>05</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>Hombre</s0><s5>05</s5></fC03><fC03 i1="06" i2="X" l="FRE"><s0>Castration</s0><s5>06</s5></fC03><fC03 i1="06" i2="X" l="ENG"><s0>Castration</s0><s5>06</s5></fC03><fC03 i1="06" i2="X" l="SPA"><s0>Castración</s0><s5>06</s5></fC03><fC03 i1="07" i2="X" l="FRE"><s0>Cancer de la prostate</s0><s2>NM</s2><s5>07</s5></fC03><fC03 i1="07" i2="X" l="ENG"><s0>Prostate cancer</s0><s2>NM</s2><s5>07</s5></fC03><fC03 i1="07" i2="X" l="SPA"><s0>Cáncer de la próstata</s0><s2>NM</s2><s5>07</s5></fC03><fC03 i1="08" i2="X" l="FRE"><s0>Résistance</s0><s5>08</s5></fC03><fC03 i1="08" i2="X" l="ENG"><s0>Resistance</s0><s5>08</s5></fC03><fC03 i1="08" i2="X" l="SPA"><s0>Resistencia</s0><s5>08</s5></fC03><fC03 i1="09" i2="X" l="FRE"><s0>Stade avancé</s0><s5>09</s5></fC03><fC03 i1="09" i2="X" l="ENG"><s0>Advanced stage</s0><s5>09</s5></fC03><fC03 i1="09" i2="X" l="SPA"><s0>Estadio avanzado</s0><s5>09</s5></fC03><fC03 i1="10" i2="X" l="FRE"><s0>Métastase</s0><s5>10</s5></fC03><fC03 i1="10" i2="X" l="ENG"><s0>Metastasis</s0><s5>10</s5></fC03><fC03 i1="10" i2="X" l="SPA"><s0>Metástasis</s0><s5>10</s5></fC03><fC03 i1="11" i2="X" l="FRE"><s0>Cancérologie</s0><s5>11</s5></fC03><fC03 i1="11" i2="X" l="ENG"><s0>Cancerology</s0><s5>11</s5></fC03><fC03 i1="11" i2="X" l="SPA"><s0>Cancerología</s0><s5>11</s5></fC03><fC03 i1="12" i2="X" l="FRE"><s0>Endothéline</s0><s5>13</s5></fC03><fC03 i1="12" i2="X" l="ENG"><s0>Endothelin</s0><s5>13</s5></fC03><fC03 i1="12" i2="X" l="SPA"><s0>Endothelina</s0><s5>13</s5></fC03><fC03 i1="13" i2="X" l="FRE"><s0>Cancer de l'os</s0><s4>CD</s4><s5>96</s5></fC03><fC03 i1="13" i2="X" l="ENG"><s0>Bone cancer</s0><s4>CD</s4><s5>96</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Antagoniste</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="ENG"><s0>Antagonist</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Antagonista</s0><s5>37</s5></fC07><fC07 i1="02" i2="X" l="FRE"><s0>Récepteur endothéline</s0><s5>38</s5></fC07><fC07 i1="02" i2="X" l="ENG"><s0>Endothelin receptor</s0><s5>38</s5></fC07><fC07 i1="02" i2="X" l="SPA"><s0>Receptor endotelina</s0><s5>38</s5></fC07><fC07 i1="03" i2="X" l="FRE"><s0>Pathologie de l'appareil génital mâle</s0><s5>39</s5></fC07><fC07 i1="03" i2="X" l="ENG"><s0>Male genital diseases</s0><s5>39</s5></fC07><fC07 i1="03" i2="X" l="SPA"><s0>Aparato genital macho patología</s0><s5>39</s5></fC07><fC07 i1="04" i2="X" l="FRE"><s0>Pathologie de l'appareil urinaire</s0><s5>40</s5></fC07><fC07 i1="04" i2="X" l="ENG"><s0>Urinary system disease</s0><s5>40</s5></fC07><fC07 i1="04" i2="X" l="SPA"><s0>Aparato urinario patología</s0><s5>40</s5></fC07><fC07 i1="05" i2="X" l="FRE"><s0>Tumeur maligne</s0><s2>NM</s2><s5>41</s5></fC07><fC07 i1="05" i2="X" l="ENG"><s0>Malignant tumor</s0><s2>NM</s2><s5>41</s5></fC07><fC07 i1="05" i2="X" l="SPA"><s0>Tumor maligno</s0><s2>NM</s2><s5>41</s5></fC07><fC07 i1="06" i2="X" l="FRE"><s0>Cancer</s0><s2>NM</s2></fC07><fC07 i1="06" i2="X" l="ENG"><s0>Cancer</s0><s2>NM</s2></fC07><fC07 i1="06" i2="X" l="SPA"><s0>Cáncer</s0><s2>NM</s2></fC07><fC07 i1="07" i2="X" l="FRE"><s0>Pathologie de la prostate</s0><s5>42</s5></fC07><fC07 i1="07" i2="X" l="ENG"><s0>Prostate disease</s0><s5>42</s5></fC07><fC07 i1="07" i2="X" l="SPA"><s0>Prostata patología</s0><s5>42</s5></fC07><fC07 i1="08" i2="X" l="FRE"><s0>Pathologie du système ostéoarticulaire</s0><s5>43</s5></fC07><fC07 i1="08" i2="X" l="ENG"><s0>Diseases of the osteoarticular system</s0><s5>43</s5></fC07><fC07 i1="08" i2="X" l="SPA"><s0>Sistema osteoarticular patología</s0><s5>43</s5></fC07><fN21><s1>338</s1></fN21><fN44 i1="01"><s1>OTO</s1></fN44><fN82><s1>OTO</s1></fN82></pA></standard></inist></record>Pour manipuler ce document sous Unix (Dilib)
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|wiki= Wicri/Amérique
|area= PittsburghV1
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|clé= Pascal:12-0436524
|texte= Phase 3, Randomized, Placebo-Controlled Study of Zibotentan (ZD4054) in Patients With Castration-Resistant Prostate Cancer Metastatic to Bone
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