AustralieFrV1, Main, Exploration, bibRecord, 002966

Prior Endocrine Therapy Impact on Abiraterone Acetate Clinical Efficacy in Metastatic Castration-resistant Prostate Cancer: Post-hoc Analysis of Randomised Phase 3 Studies

Identifieur interne : 002966 ( Main/Exploration ); précédent : 002965; suivant : 002967

Prior Endocrine Therapy Impact on Abiraterone Acetate Clinical Efficacy in Metastatic Castration-resistant Prostate Cancer: Post-hoc Analysis of Randomised Phase 3 Studies

Auteurs : Joaquim Bellmunt [États-Unis] ; Thian Kheoh [États-Unis] ; Margaret K. Yu [États-Unis] ; Matthew R. Smith [États-Unis] ; Eric J. Small [États-Unis] ; Peter F. A. Mulders [Pays-Bas] ; Karim Fizazi [France] ; Dana E. Rathkopf [États-Unis] ; Fred Saad [Canada] ; Howard I. Scher [États-Unis] ; Mary-Ellen Taplin [États-Unis] ; Ian D. Davis [Australie] ; Dirk Schrijvers [Belgique] ; Andrew Protheroe [Royaume-Uni] ; Arturo Molina [États-Unis] ; Peter De Porre [Belgique] ; Thomas W. Griffin [États-Unis] ; Johann S. De Bono [Royaume-Uni] ; Charles J. Ryan [États-Unis] ; Stéphane Oudard [France]

Source :

European urology [ 0302-2838 ] ; 2015.

RBID : PMC:5465643

Abstract

Background

The duration of prior hormonal treatment can predict responses to subsequent therapy in patients with metastatic castration-resistant prostate cancer (mCRPC).

Objective

To determine if prior endocrine therapy duration is an indicator of abiraterone acetate (AA) sensitivity.

Design, setting, and participants

Post-hoc exploratory analysis of randomised phase 3 studies examining post-docetaxel (COU-AA-301) or chemotherapy-naïve mCRPC (COU-AA-302) patients receiving AA. The treatment effect on overall survival (OS), radiographic progression-free survival (rPFS), and prostate-specific antigen (PSA) response analysed by quartile duration of prior gonadotropin-releasing hormone agonists (GnRHa) or androgen receptor (AR) antagonist.

Intervention

Patients were randomised to AA (1000 mg, orally once daily) plus prednisone (5 mg, orally twice daily) or placebo plus prednisone. Prior endocrine therapy was GnRHa (COU-AA-301, n = 1127 [94%]; COU-AA-302, n = 1057 [97%], 45.1 mo or 36.7 mo median duration, respectively) and/or orchiectomy (COU-AA-301, n = 78 [7%] COU-AA-302, n = 44 [4%]); castrated patients received prior AR antagonists (COU-AA-301, n = 1015 [85%]; COU-AA-302, n = 1078 [99%], 15.7 mo or 16.1 mo median duration, respectively).

Outcome measurements and statistical analysis

Cox model was used to obtain hazard ratio and associated 95% confidence interval with statistical inference by log rank statistic.

Results and limitations

Clinical benefit with AA was observed for OS, rPFS, and PSA response for nearly all quartiles with GnRHa or AR antagonists in both COU-AA-301 and COU-AA-302. In COU-AA-301, patients with a longer duration of prior endocrine therapy tended to have greater AA OS, rPFS, and PSA response benefit, with lead-time chemotherapy bias potentially impacting COU-AA-301 results. Time-to-castration-resistance was not captured. This analysis is limited as a post-hoc exploratory analysis.

Conclusions

In the COU-AA-301 and COU-AA-302 studies, AA produced clinical benefits regardless of prior endocrine therapy duration in patients with mCRPC.

Patient summary

Metastatic castration-resistant prostate cancer patients derived clinical benefits with abiraterone acetate regardless of prior endocrine therapy duration.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5465643

DOI: 10.1016/j.eururo.2015.10.021
PubMed: 26508309
PubMed Central: 5465643

Affiliations:

Australie, Belgique, Canada, France, Pays-Bas, Royaume-Uni, États-Unis
Angleterre, Californie, Gueldre, Massachusetts, Oxfordshire, État de New York, Île-de-France
Nimègue, Oxford, Paris

Le document en format XML

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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Prior Endocrine Therapy Impact on Abiraterone Acetate Clinical Efficacy in Metastatic Castration-resistant Prostate Cancer: Post-hoc Analysis of Randomised Phase 3 Studies</title>
<author><name sortKey="Bellmunt, Joaquim" sort="Bellmunt, Joaquim" uniqKey="Bellmunt J" first="Joaquim" last="Bellmunt">Joaquim Bellmunt</name>
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<author><name sortKey="Rathkopf, Dana E" sort="Rathkopf, Dana E" uniqKey="Rathkopf D" first="Dana E." last="Rathkopf">Dana E. Rathkopf</name>
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<author><name sortKey="Scher, Howard I" sort="Scher, Howard I" uniqKey="Scher H" first="Howard I." last="Scher">Howard I. Scher</name>
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<author><name sortKey="Davis, Ian D" sort="Davis, Ian D" uniqKey="Davis I" first="Ian D." last="Davis">Ian D. Davis</name>
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<author><name sortKey="Protheroe, Andrew" sort="Protheroe, Andrew" uniqKey="Protheroe A" first="Andrew" last="Protheroe">Andrew Protheroe</name>
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</author>
<author><name sortKey="Molina, Arturo" sort="Molina, Arturo" uniqKey="Molina A" first="Arturo" last="Molina">Arturo Molina</name>
<affiliation wicri:level="2"><nlm:aff id="A13">Janssen Research & Development, Menlo Park, CA, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Janssen Research & Development, Menlo Park, CA</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="De Porre, Peter" sort="De Porre, Peter" uniqKey="De Porre P" first="Peter" last="De Porre">Peter De Porre</name>
<affiliation wicri:level="1"><nlm:aff id="A14">Janssen Research & Development, Beerse, Belgium</nlm:aff>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>Janssen Research & Development, Beerse</wicri:regionArea>
<wicri:noRegion>Beerse</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Griffin, Thomas W" sort="Griffin, Thomas W" uniqKey="Griffin T" first="Thomas W." last="Griffin">Thomas W. Griffin</name>
<affiliation wicri:level="2"><nlm:aff id="A3">Janssen Research and Development, Los Angeles, CA, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Janssen Research and Development, Los Angeles, CA</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="De Bono, Johann S" sort="De Bono, Johann S" uniqKey="De Bono J" first="Johann S." last="De Bono">Johann S. De Bono</name>
<affiliation wicri:level="1"><nlm:aff id="A15">The Institute of Cancer Research and The Royal Marsden Hospital, Sutton, UK</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>The Institute of Cancer Research and The Royal Marsden Hospital, Sutton</wicri:regionArea>
<wicri:noRegion>Sutton</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Ryan, Charles J" sort="Ryan, Charles J" uniqKey="Ryan C" first="Charles J." last="Ryan">Charles J. Ryan</name>
<affiliation wicri:level="2"><nlm:aff id="A5">Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Oudard, Stephane" sort="Oudard, Stephane" uniqKey="Oudard S" first="Stéphane" last="Oudard">Stéphane Oudard</name>
<affiliation wicri:level="3"><nlm:aff id="A16">Georges Pompidou Hospital, University René Descartes, Paris, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Georges Pompidou Hospital, University René Descartes, Paris</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j">European urology</title>
<idno type="ISSN">0302-2838</idno>
<idno type="eISSN">1873-7560</idno>
<imprint><date when="2015">2015</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass></textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><sec id="S1"><title>Background</title>
<p id="P1">The duration of prior hormonal treatment can predict responses to subsequent therapy in patients with metastatic castration-resistant prostate cancer (mCRPC).</p>
</sec>
<sec id="S2"><title>Objective</title>
<p id="P2">To determine if prior endocrine therapy duration is an indicator of abiraterone acetate (AA) sensitivity.</p>
</sec>
<sec id="S3"><title>Design, setting, and participants</title>
<p id="P3">Post-hoc exploratory analysis of randomised phase 3 studies examining post-docetaxel (COU-AA-301) or chemotherapy-naïve mCRPC (COU-AA-302) patients receiving AA. The treatment effect on overall survival (OS), radiographic progression-free survival (rPFS), and prostate-specific antigen (PSA) response analysed by quartile duration of prior gonadotropin-releasing hormone agonists (GnRHa) or androgen receptor (AR) antagonist.</p>
</sec>
<sec id="S4"><title>Intervention</title>
<p id="P4">Patients were randomised to AA (1000 mg, orally once daily) plus prednisone (5 mg, orally twice daily) or placebo plus prednisone. Prior endocrine therapy was GnRHa (COU-AA-301, <italic>n</italic>
 = 1127 [94%]; COU-AA-302, <italic>n</italic>
 = 1057 [97%], 45.1 mo or 36.7 mo median duration, respectively) and/or orchiectomy (COU-AA-301, <italic>n</italic>
 = 78 [7%] COU-AA-302, <italic>n</italic>
 = 44 [4%]); castrated patients received prior AR antagonists (COU-AA-301, <italic>n</italic>
 = 1015 [85%]; COU-AA-302, <italic>n</italic>
 = 1078 [99%], 15.7 mo or 16.1 mo median duration, respectively).</p>
</sec>
<sec id="S5"><title>Outcome measurements and statistical analysis</title>
<p id="P5">Cox model was used to obtain hazard ratio and associated 95% confidence interval with statistical inference by log rank statistic.</p>
</sec>
<sec id="S6"><title>Results and limitations</title>
<p id="P6">Clinical benefit with AA was observed for OS, rPFS, and PSA response for nearly all quartiles with GnRHa or AR antagonists in both COU-AA-301 and COU-AA-302. In COU-AA-301, patients with a longer duration of prior endocrine therapy tended to have greater AA OS, rPFS, and PSA response benefit, with lead-time chemotherapy bias potentially impacting COU-AA-301 results. Time-to-castration-resistance was not captured. This analysis is limited as a post-hoc exploratory analysis.</p>
</sec>
<sec id="S7"><title>Conclusions</title>
<p id="P7">In the COU-AA-301 and COU-AA-302 studies, AA produced clinical benefits regardless of prior endocrine therapy duration in patients with mCRPC.</p>
</sec>
<sec id="S8"><title>Patient summary</title>
<p id="P8">Metastatic castration-resistant prostate cancer patients derived clinical benefits with abiraterone acetate regardless of prior endocrine therapy duration.</p>
</sec>
</div>
</front>
</TEI>
<affiliations><list><country><li>Australie</li>
<li>Belgique</li>
<li>Canada</li>
<li>France</li>
<li>Pays-Bas</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
</country>
<region><li>Angleterre</li>
<li>Californie</li>
<li>Gueldre</li>
<li>Massachusetts</li>
<li>Oxfordshire</li>
<li>État de New York</li>
<li>Île-de-France</li>
</region>
<settlement><li>Nimègue</li>
<li>Oxford</li>
<li>Paris</li>
</settlement>
</list>
<tree><country name="États-Unis"><region name="Massachusetts"><name sortKey="Bellmunt, Joaquim" sort="Bellmunt, Joaquim" uniqKey="Bellmunt J" first="Joaquim" last="Bellmunt">Joaquim Bellmunt</name>
</region>
<name sortKey="Griffin, Thomas W" sort="Griffin, Thomas W" uniqKey="Griffin T" first="Thomas W." last="Griffin">Thomas W. Griffin</name>
<name sortKey="Kheoh, Thian" sort="Kheoh, Thian" uniqKey="Kheoh T" first="Thian" last="Kheoh">Thian Kheoh</name>
<name sortKey="Molina, Arturo" sort="Molina, Arturo" uniqKey="Molina A" first="Arturo" last="Molina">Arturo Molina</name>
<name sortKey="Rathkopf, Dana E" sort="Rathkopf, Dana E" uniqKey="Rathkopf D" first="Dana E." last="Rathkopf">Dana E. Rathkopf</name>
<name sortKey="Ryan, Charles J" sort="Ryan, Charles J" uniqKey="Ryan C" first="Charles J." last="Ryan">Charles J. Ryan</name>
<name sortKey="Scher, Howard I" sort="Scher, Howard I" uniqKey="Scher H" first="Howard I." last="Scher">Howard I. Scher</name>
<name sortKey="Small, Eric J" sort="Small, Eric J" uniqKey="Small E" first="Eric J." last="Small">Eric J. Small</name>
<name sortKey="Smith, Matthew R" sort="Smith, Matthew R" uniqKey="Smith M" first="Matthew R." last="Smith">Matthew R. Smith</name>
<name sortKey="Taplin, Mary Ellen" sort="Taplin, Mary Ellen" uniqKey="Taplin M" first="Mary-Ellen" last="Taplin">Mary-Ellen Taplin</name>
<name sortKey="Yu, Margaret K" sort="Yu, Margaret K" uniqKey="Yu M" first="Margaret K." last="Yu">Margaret K. Yu</name>
</country>
<country name="Pays-Bas"><region name="Gueldre"><name sortKey="Mulders, Peter F A" sort="Mulders, Peter F A" uniqKey="Mulders P" first="Peter F. A." last="Mulders">Peter F. A. Mulders</name>
</region>
</country>
<country name="France"><noRegion><name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name>
</noRegion>
<name sortKey="Oudard, Stephane" sort="Oudard, Stephane" uniqKey="Oudard S" first="Stéphane" last="Oudard">Stéphane Oudard</name>
</country>
<country name="Canada"><noRegion><name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name>
</noRegion>
</country>
<country name="Australie"><noRegion><name sortKey="Davis, Ian D" sort="Davis, Ian D" uniqKey="Davis I" first="Ian D." last="Davis">Ian D. Davis</name>
</noRegion>
</country>
<country name="Belgique"><noRegion><name sortKey="Schrijvers, Dirk" sort="Schrijvers, Dirk" uniqKey="Schrijvers D" first="Dirk" last="Schrijvers">Dirk Schrijvers</name>
</noRegion>
<name sortKey="De Porre, Peter" sort="De Porre, Peter" uniqKey="De Porre P" first="Peter" last="De Porre">Peter De Porre</name>
</country>
<country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Protheroe, Andrew" sort="Protheroe, Andrew" uniqKey="Protheroe A" first="Andrew" last="Protheroe">Andrew Protheroe</name>
</region>
<name sortKey="De Bono, Johann S" sort="De Bono, Johann S" uniqKey="De Bono J" first="Johann S." last="De Bono">Johann S. De Bono</name>
</country>
</tree>
</affiliations>
</record>

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Prior Endocrine Therapy Impact on Abiraterone Acetate Clinical Efficacy in Metastatic Castration-resistant Prostate Cancer: Post-hoc Analysis of Randomised Phase 3 Studies

Prior Endocrine Therapy Impact on Abiraterone Acetate Clinical Efficacy in Metastatic Castration-resistant Prostate Cancer: Post-hoc Analysis of Randomised Phase 3 Studies

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