AustralieFrV1, Main, Exploration, bibRecord, 004C32

Targeted MET Inhibition in Castration-Resistant Prostate Cancer: A Randomized Phase II Study and Biomarker Analysis with Rilotumumab plus Mitoxantrone and Prednisone

Identifieur interne : 004C32 ( Main/Exploration ); précédent : 004C31; suivant : 004C33

Targeted MET Inhibition in Castration-Resistant Prostate Cancer: A Randomized Phase II Study and Biomarker Analysis with Rilotumumab plus Mitoxantrone and Prednisone

Auteurs : Charles J. Ryan [États-Unis] ; Mark Rosenthal [Australie] ; Siobhan Ng [Australie] ; Joshi Alumkal [États-Unis] ; Joel Picus [États-Unis] ; Gwenaëlle Gravis [France] ; Karim Fizazi [France] ; Frédéric Forget [Belgique] ; Jean-Pascal Machiels [Belgique] ; Sandy Srinivas [États-Unis] ; MIN ZHU [États-Unis] ; RUI TANG [États-Unis] ; Kellys. Oliner [États-Unis] ; YIZHOUJIANG [États-Unis] ; Elwyn Loh [États-Unis] ; Sarita Dubey [États-Unis] ; Winald R. Gerritsen [Pays-Bas]

Source :

Clinical cancer research [ 1078-0432 ] ; 2013.

RBID : Pascal:13-0119238

Descripteurs français

Pascal (Inist)
- Cible, Ciblage, Protooncogène, Gène onc cellulaire, Inhibiteur, Inhibition, Castration, Résistance, Cancer de la prostate, Randomisation, Homme, Essai clinique phase II, Traitement, Marqueur biologique, Analyse, Mitoxantrone, Prednisone, Anticancéreux, Rilotumumab.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Analysis, Antineoplastic agent, Biological marker, C-Onc gene, Castration, Human, Inhibition, Inhibitor, Mitoxantrone, Phase II trial, Prednisone, Prostate cancer, Protooncogene, Randomization, Resistance, Rilotumumab, Target, Targeting, Treatment.

Abstract

Purpose: To evaluate the efficacy, safety, biomarkers, and pharmacokinetics of rilotumumab, a fully human, monoclonal antibody against hepatocyte growth factor (IIGF)/scatter factor, combined with mitoxantrone and prednisone (MP) in patients with castration-resistant prostate cancer (CRPC). Experimental Design: This double-blinded phase II study randomized (1:1:1) patients with progressive, taxane-refractory CRPC to receive MP (12 mg/m² i.v. day 1, 5 mg twice a day orally days 1-21, respectively) plus 15 mg/kg rilotumumab, 7.5 mg/kg rilotumumab, or placebo (i.v. day 1) every 3 weeks. The primary endpoint was overall survival (OS). Results: One hundred and forty-four patients were randomized. Median OS was 12.2 versus 11.1 months [HR, 1.10; 80% confidence interval (CI), 0.82-1.48] in the combined rilotumumab versus control arms. Median progression-free survival was 3.0 versus 2.9 months (HR, 1.02; 80% CI, 0.79-1.31). Treatment appeared well tolerated with peripheral edema (24% vs. 8%) being more common with rilotumumab. A trend toward unfavorable OS was observed in patients with high tumor MET expression regardless of treatment. Soluble MET levels increased in all treatment arms. Total HGF levels increased in the rilotumumab arms. Rilotumumab showed linear pharmacokinetics when co-administered with MP. Conclusions: Rilotumumab plus MP had manageable toxicities and showed no efficacy improvements in this estimation study. High tumor MET expression may identify patients with CRPC with poorer prognosis.

Affiliations:

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

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Le document en format XML

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<s2>San Francisco</s2>
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<author><name sortKey="Oliner, Kellys" sort="Oliner, Kellys" uniqKey="Oliner K" first="Kellys." last="Oliner">Kellys. Oliner</name>
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<author><name sortKey="Dubey, Sarita" sort="Dubey, Sarita" uniqKey="Dubey S" first="Sarita" last="Dubey">Sarita Dubey</name>
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<author><name sortKey="Gerritsen, Winald R" sort="Gerritsen, Winald R" uniqKey="Gerritsen W" first="Winald R." last="Gerritsen">Winald R. Gerritsen</name>
<affiliation wicri:level="3"><inist:fA14 i1="13"><s1>VU Medisch Centrum, Amsterdam/Radboud University Medical Center</s1>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Targeted MET Inhibition in Castration-Resistant Prostate Cancer: A Randomized Phase II Study and Biomarker Analysis with Rilotumumab plus Mitoxantrone and Prednisone</title>
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<author><name sortKey="Alumkal, Joshi" sort="Alumkal, Joshi" uniqKey="Alumkal J" first="Joshi" last="Alumkal">Joshi Alumkal</name>
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<author><name sortKey="Gravis, Gwenaelle" sort="Gravis, Gwenaelle" uniqKey="Gravis G" first="Gwenaëlle" last="Gravis">Gwenaëlle Gravis</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="Forget, Frederic" sort="Forget, Frederic" uniqKey="Forget F" first="Frédéric" last="Forget">Frédéric Forget</name>
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<author><name sortKey="Machiels, Jean Pascal" sort="Machiels, Jean Pascal" uniqKey="Machiels J" first="Jean-Pascal" last="Machiels">Jean-Pascal Machiels</name>
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<s2>Bruxelles</s2>
<s3>BEL</s3>
<sZ>9 aut.</sZ>
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<author><name sortKey="Srinivas, Sandy" sort="Srinivas, Sandy" uniqKey="Srinivas S" first="Sandy" last="Srinivas">Sandy Srinivas</name>
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<author><name sortKey="Min Zhu" sort="Min Zhu" uniqKey="Min Zhu" last="Min Zhu">MIN ZHU</name>
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<author><name sortKey="Rui Tang" sort="Rui Tang" uniqKey="Rui Tang" last="Rui Tang">RUI TANG</name>
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<author><name sortKey="Oliner, Kellys" sort="Oliner, Kellys" uniqKey="Oliner K" first="Kellys." last="Oliner">Kellys. Oliner</name>
<affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Amgen Inc.</s1>
<s2>Thousand Oaks</s2>
<s3>USA</s3>
<sZ>12 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Amgen Inc.</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Yizhoujiang" sort="Yizhoujiang" uniqKey="Yizhoujiang" last="Yizhoujiang">YIZHOUJIANG</name>
<affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Amgen Inc.</s1>
<s2>Thousand Oaks</s2>
<s3>USA</s3>
<sZ>12 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Amgen Inc.</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Loh, Elwyn" sort="Loh, Elwyn" uniqKey="Loh E" first="Elwyn" last="Loh">Elwyn Loh</name>
<affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Amgen Inc.</s1>
<s2>South San Francisco</s2>
<s3>USA</s3>
<sZ>15 aut.</sZ>
<sZ>16 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Amgen Inc.</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Dubey, Sarita" sort="Dubey, Sarita" uniqKey="Dubey S" first="Sarita" last="Dubey">Sarita Dubey</name>
<affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Amgen Inc.</s1>
<s2>South San Francisco</s2>
<s3>USA</s3>
<sZ>15 aut.</sZ>
<sZ>16 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Amgen Inc.</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Gerritsen, Winald R" sort="Gerritsen, Winald R" uniqKey="Gerritsen W" first="Winald R." last="Gerritsen">Winald R. Gerritsen</name>
<affiliation wicri:level="3"><inist:fA14 i1="13"><s1>VU Medisch Centrum, Amsterdam/Radboud University Medical Center</s1>
<s2>Nijmegen</s2>
<s3>NLD</s3>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>Pays-Bas</country>
<placeName><settlement type="city">Nimègue</settlement>
<region type="province" nuts="2">Gueldre</region>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">Clinical cancer research</title>
<title level="j" type="abbreviated">Clin. cancer res.</title>
<idno type="ISSN">1078-0432</idno>
<imprint><date when="2013">2013</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">Clinical cancer research</title>
<title level="j" type="abbreviated">Clin. cancer res.</title>
<idno type="ISSN">1078-0432</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Analysis</term>
<term>Antineoplastic agent</term>
<term>Biological marker</term>
<term>C-Onc gene</term>
<term>Castration</term>
<term>Human</term>
<term>Inhibition</term>
<term>Inhibitor</term>
<term>Mitoxantrone</term>
<term>Phase II trial</term>
<term>Prednisone</term>
<term>Prostate cancer</term>
<term>Protooncogene</term>
<term>Randomization</term>
<term>Resistance</term>
<term>Rilotumumab</term>
<term>Target</term>
<term>Targeting</term>
<term>Treatment</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Cible</term>
<term>Ciblage</term>
<term>Protooncogène</term>
<term>Gène onc cellulaire</term>
<term>Inhibiteur</term>
<term>Inhibition</term>
<term>Castration</term>
<term>Résistance</term>
<term>Cancer de la prostate</term>
<term>Randomisation</term>
<term>Homme</term>
<term>Essai clinique phase II</term>
<term>Traitement</term>
<term>Marqueur biologique</term>
<term>Analyse</term>
<term>Mitoxantrone</term>
<term>Prednisone</term>
<term>Anticancéreux</term>
<term>Rilotumumab</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Purpose: To evaluate the efficacy, safety, biomarkers, and pharmacokinetics of rilotumumab, a fully human, monoclonal antibody against hepatocyte growth factor (IIGF)/scatter factor, combined with mitoxantrone and prednisone (MP) in patients with castration-resistant prostate cancer (CRPC). Experimental Design: This double-blinded phase II study randomized (1:1:1) patients with progressive, taxane-refractory CRPC to receive MP (12 mg/m<sup>2</sup>
 i.v. day 1, 5 mg twice a day orally days 1-21, respectively) plus 15 mg/kg rilotumumab, 7.5 mg/kg rilotumumab, or placebo (i.v. day 1) every 3 weeks. The primary endpoint was overall survival (OS). Results: One hundred and forty-four patients were randomized. Median OS was 12.2 versus 11.1 months [HR, 1.10; 80% confidence interval (CI), 0.82-1.48] in the combined rilotumumab versus control arms. Median progression-free survival was 3.0 versus 2.9 months (HR, 1.02; 80% CI, 0.79-1.31). Treatment appeared well tolerated with peripheral edema (24% vs. 8%) being more common with rilotumumab. A trend toward unfavorable OS was observed in patients with high tumor MET expression regardless of treatment. Soluble MET levels increased in all treatment arms. Total HGF levels increased in the rilotumumab arms. Rilotumumab showed linear pharmacokinetics when co-administered with MP. Conclusions: Rilotumumab plus MP had manageable toxicities and showed no efficacy improvements in this estimation study. High tumor MET expression may identify patients with CRPC with poorer prognosis.</div>
</front>
</TEI>
<affiliations><list><country><li>Australie</li>
<li>Belgique</li>
<li>France</li>
<li>Pays-Bas</li>
<li>États-Unis</li>
</country>
<region><li>Californie</li>
<li>Gueldre</li>
<li>Oregon</li>
<li>Provence-Alpes-Côte d'Azur</li>
<li>Région de Bruxelles-Capitale</li>
</region>
<settlement><li>Bruxelles</li>
<li>Louvain-la-Neuve</li>
<li>Marseille</li>
<li>Nimègue</li>
<li>Portland</li>
<li>San Francisco</li>
</settlement>
<orgName><li>Université catholique de Louvain</li>
</orgName>
</list>
<tree><country name="États-Unis"><region name="Californie"><name sortKey="Ryan, Charles J" sort="Ryan, Charles J" uniqKey="Ryan C" first="Charles J." last="Ryan">Charles J. Ryan</name>
</region>
<name sortKey="Alumkal, Joshi" sort="Alumkal, Joshi" uniqKey="Alumkal J" first="Joshi" last="Alumkal">Joshi Alumkal</name>
<name sortKey="Dubey, Sarita" sort="Dubey, Sarita" uniqKey="Dubey S" first="Sarita" last="Dubey">Sarita Dubey</name>
<name sortKey="Loh, Elwyn" sort="Loh, Elwyn" uniqKey="Loh E" first="Elwyn" last="Loh">Elwyn Loh</name>
<name sortKey="Min Zhu" sort="Min Zhu" uniqKey="Min Zhu" last="Min Zhu">MIN ZHU</name>
<name sortKey="Oliner, Kellys" sort="Oliner, Kellys" uniqKey="Oliner K" first="Kellys." last="Oliner">Kellys. Oliner</name>
<name sortKey="Picus, Joel" sort="Picus, Joel" uniqKey="Picus J" first="Joel" last="Picus">Joel Picus</name>
<name sortKey="Rui Tang" sort="Rui Tang" uniqKey="Rui Tang" last="Rui Tang">RUI TANG</name>
<name sortKey="Srinivas, Sandy" sort="Srinivas, Sandy" uniqKey="Srinivas S" first="Sandy" last="Srinivas">Sandy Srinivas</name>
<name sortKey="Yizhoujiang" sort="Yizhoujiang" uniqKey="Yizhoujiang" last="Yizhoujiang">YIZHOUJIANG</name>
</country>
<country name="Australie"><noRegion><name sortKey="Rosenthal, Mark" sort="Rosenthal, Mark" uniqKey="Rosenthal M" first="Mark" last="Rosenthal">Mark Rosenthal</name>
</noRegion>
<name sortKey="Ng, Siobhan" sort="Ng, Siobhan" uniqKey="Ng S" first="Siobhan" last="Ng">Siobhan Ng</name>
</country>
<country name="France"><region name="Provence-Alpes-Côte d'Azur"><name sortKey="Gravis, Gwenaelle" sort="Gravis, Gwenaelle" uniqKey="Gravis G" first="Gwenaëlle" last="Gravis">Gwenaëlle Gravis</name>
</region>
<name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name>
</country>
<country name="Belgique"><noRegion><name sortKey="Forget, Frederic" sort="Forget, Frederic" uniqKey="Forget F" first="Frédéric" last="Forget">Frédéric Forget</name>
</noRegion>
<name sortKey="Machiels, Jean Pascal" sort="Machiels, Jean Pascal" uniqKey="Machiels J" first="Jean-Pascal" last="Machiels">Jean-Pascal Machiels</name>
</country>
<country name="Pays-Bas"><region name="Gueldre"><name sortKey="Gerritsen, Winald R" sort="Gerritsen, Winald R" uniqKey="Gerritsen W" first="Winald R." last="Gerritsen">Winald R. Gerritsen</name>
</region>
</country>
</tree>
</affiliations>
</record>

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Targeted MET Inhibition in Castration-Resistant Prostate Cancer: A Randomized Phase II Study and Biomarker Analysis with Rilotumumab plus Mitoxantrone and Prednisone

Targeted MET Inhibition in Castration-Resistant Prostate Cancer: A Randomized Phase II Study and Biomarker Analysis with Rilotumumab plus Mitoxantrone and Prednisone

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