Randomized Phase 3 Trial of Abiraterone Acetate in Men with Metastatic Castration-Resistant Prostate Cancer and No Prior Chemotherapy
Identifieur interne : 005276 ( Main/Exploration ); précédent : 005275; suivant : 005277Randomized Phase 3 Trial of Abiraterone Acetate in Men with Metastatic Castration-Resistant Prostate Cancer and No Prior Chemotherapy
Auteurs : Charles J. Ryan ; Matthew R. Smith ; Johann S. De Bono ; Arturo Molina ; Christopher J. Logothetis ; Paul De Souza ; Karim Fizazi ; Paul Mainwaring ; Jm Piulats ; Siobhan Ng ; Joan Carles ; Peter F. A. Mulders ; Ethan Basch ; Eric J. Small ; Fred Saad ; Dirk Schrijvers ; Hendrik Van Poppel ; Som D. Mukherjee ; Henrik Suttmann ; Winald R. Gerritsen ; Thomas W. Flaig ; Daniel J. George ; Evan Y. Yu ; Eleni Efstathiou ; Allan Pantuck ; Eric Winquist ; Celestia S. Higano ; Youn Park ; Thian Kheoh ; Thomas Griffin ; Howard I. Scher ; Dana E. RathkopfSource :
- The New England journal of medicine [ 0028-4793 ] ; 2012.
Abstract
Abiraterone acetate, an androgen biosynthesis inhibitor, improves overall survival (OS) in metastatic castration-resistant prostate cancer (mCRPC) post-chemotherapy. Many mCRPC patients never receive chemotherapy and thus cannot benefit from abiraterone acetate; we evaluated this agent in mCRPC patients who had not received chemotherapy.
In this double-blind study, 1088 patients were randomized 1:1 to abiraterone acetate (1000 mg) plus prednisone (5 mg twice daily) or placebo plus prednisone. Co-primary end points were radiographic progression-free survival (rPFS) and OS. Secondary end points measured clinically relevant landmarks of mCRPC progression. Patient-reported outcomes included pain progression and quality of life.
The study was unblinded after a planned interim analysis (IA) at 43% of OS events. Treatment with abiraterone acetate-prednisone resulted in a 57% reduction in the risk of radiographic progression or death (hazard ratio [HR], 0.43; 95% confidence interval [CI]: 0.35 to 0.52; P<0.001; 13% OS events IA) and an estimated 25% decrease in the risk of death (HR, 0.75; 95% CI: 0.61 to 0.93; P=0.009; 43% OS events IA). Secondary end points supported superiority of abiraterone acetate-prednisone: time to cytotoxic chemotherapy initiation, opiate use for cancer-related pain, prostate-specific antigen progression (all P<0.001) and performance status deterioration (P=0.005). Self-reported time to pain progression and patient functional status degradation favored abiraterone acetate-prednisone (P=0.05 and P=0.003). Grade 3/4 mineralocorticoid-related adverse events and liver function test abnormalities were more common with abiraterone acetate-prednisone.
Abiraterone acetate produces OS and rPFS benefits, as well as significant delays in clinical deterioration and initiation of chemotherapy, in mCRPC.
Url:
DOI: 10.1056/NEJMoa1209096
PubMed: 23228172
PubMed Central: 3683570
Affiliations:
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Ryan</name></author><author><name sortKey="Smith, Matthew R" sort="Smith, Matthew R" uniqKey="Smith M" first="Matthew R." last="Smith">Matthew R. Smith</name></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></author><author><name sortKey="Molina, Arturo" sort="Molina, Arturo" uniqKey="Molina A" first="Arturo" last="Molina">Arturo Molina</name></author><author><name sortKey="Logothetis, Christopher J" sort="Logothetis, Christopher J" uniqKey="Logothetis C" first="Christopher J." last="Logothetis">Christopher J. Logothetis</name></author><author><name sortKey="De Souza, Paul" sort="De Souza, Paul" uniqKey="De Souza P" first="Paul" last="De Souza">Paul De Souza</name></author><author><name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name></author><author><name sortKey="Mainwaring, Paul" sort="Mainwaring, Paul" uniqKey="Mainwaring P" first="Paul" last="Mainwaring">Paul Mainwaring</name></author><author><name sortKey="Piulats, Jm" sort="Piulats, Jm" uniqKey="Piulats J" first="Jm" last="Piulats">Jm Piulats</name></author><author><name sortKey="Ng, Siobhan" sort="Ng, Siobhan" uniqKey="Ng S" first="Siobhan" last="Ng">Siobhan Ng</name></author><author><name sortKey="Carles, Joan" sort="Carles, Joan" uniqKey="Carles J" first="Joan" last="Carles">Joan Carles</name></author><author><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></author><author><name sortKey="Basch, Ethan" sort="Basch, Ethan" uniqKey="Basch E" first="Ethan" last="Basch">Ethan Basch</name></author><author><name sortKey="Small, Eric J" sort="Small, Eric J" uniqKey="Small E" first="Eric J." last="Small">Eric J. Small</name></author><author><name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name></author><author><name sortKey="Schrijvers, Dirk" sort="Schrijvers, Dirk" uniqKey="Schrijvers D" first="Dirk" last="Schrijvers">Dirk Schrijvers</name></author><author><name sortKey="Van Poppel, Hendrik" sort="Van Poppel, Hendrik" uniqKey="Van Poppel H" first="Hendrik" last="Van Poppel">Hendrik Van Poppel</name></author><author><name sortKey="Mukherjee, Som D" sort="Mukherjee, Som D" uniqKey="Mukherjee S" first="Som D." last="Mukherjee">Som D. Mukherjee</name></author><author><name sortKey="Suttmann, Henrik" sort="Suttmann, Henrik" uniqKey="Suttmann H" first="Henrik" last="Suttmann">Henrik Suttmann</name></author><author><name sortKey="Gerritsen, Winald R" sort="Gerritsen, Winald R" uniqKey="Gerritsen W" first="Winald R." last="Gerritsen">Winald R. Gerritsen</name></author><author><name sortKey="Flaig, Thomas W" sort="Flaig, Thomas W" uniqKey="Flaig T" first="Thomas W." last="Flaig">Thomas W. Flaig</name></author><author><name sortKey="George, Daniel J" sort="George, Daniel J" uniqKey="George D" first="Daniel J." last="George">Daniel J. George</name></author><author><name sortKey="Yu, Evan Y" sort="Yu, Evan Y" uniqKey="Yu E" first="Evan Y." last="Yu">Evan Y. Yu</name></author><author><name sortKey="Efstathiou, Eleni" sort="Efstathiou, Eleni" uniqKey="Efstathiou E" first="Eleni" last="Efstathiou">Eleni Efstathiou</name></author><author><name sortKey="Pantuck, Allan" sort="Pantuck, Allan" uniqKey="Pantuck A" first="Allan" last="Pantuck">Allan Pantuck</name></author><author><name sortKey="Winquist, Eric" sort="Winquist, Eric" uniqKey="Winquist E" first="Eric" last="Winquist">Eric Winquist</name></author><author><name sortKey="Higano, Celestia S" sort="Higano, Celestia S" uniqKey="Higano C" first="Celestia S." last="Higano">Celestia S. Higano</name></author><author><name sortKey="Park, Youn" sort="Park, Youn" uniqKey="Park Y" first="Youn" last="Park">Youn Park</name></author><author><name sortKey="Kheoh, Thian" sort="Kheoh, Thian" uniqKey="Kheoh T" first="Thian" last="Kheoh">Thian Kheoh</name></author><author><name sortKey="Griffin, Thomas" sort="Griffin, Thomas" uniqKey="Griffin T" first="Thomas" last="Griffin">Thomas Griffin</name></author><author><name sortKey="Scher, Howard I" sort="Scher, Howard I" uniqKey="Scher H" first="Howard I." last="Scher">Howard I. Scher</name></author><author><name sortKey="Rathkopf, Dana E" sort="Rathkopf, Dana E" uniqKey="Rathkopf D" first="Dana E." last="Rathkopf">Dana E. Rathkopf</name></author></analytic><series><title level="j">The New England journal of medicine</title><idno type="ISSN">0028-4793</idno><idno type="eISSN">1533-4406</idno><imprint><date when="2012">2012</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="P2">Abiraterone acetate, an androgen biosynthesis inhibitor, improves overall survival (OS) in metastatic castration-resistant prostate cancer (mCRPC) post-chemotherapy. Many mCRPC patients never receive chemotherapy and thus cannot benefit from abiraterone acetate; we evaluated this agent in mCRPC patients who had not received chemotherapy.</p></sec><sec id="S2"><title>Methods</title><p id="P3">In this double-blind study, 1088 patients were randomized 1:1 to abiraterone acetate (1000 mg) plus prednisone (5 mg twice daily) or placebo plus prednisone. Co-primary end points were radiographic progression-free survival (rPFS) and OS. Secondary end points measured clinically relevant landmarks of mCRPC progression. Patient-reported outcomes included pain progression and quality of life.</p></sec><sec id="S3"><title>Results</title><p id="P4">The study was unblinded after a planned interim analysis (IA) at 43% of OS events. Treatment with abiraterone acetate-prednisone resulted in a 57% reduction in the risk of radiographic progression or death (hazard ratio [HR], 0.43; 95% confidence interval [CI]: 0.35 to 0.52; P<0.001; 13% OS events IA) and an estimated 25% decrease in the risk of death (HR, 0.75; 95% CI: 0.61 to 0.93; P=0.009; 43% OS events IA). Secondary end points supported superiority of abiraterone acetate-prednisone: time to cytotoxic chemotherapy initiation, opiate use for cancer-related pain, prostate-specific antigen progression (all P<0.001) and performance status deterioration (P=0.005). Self-reported time to pain progression and patient functional status degradation favored abiraterone acetate-prednisone (P=0.05 and P=0.003). Grade 3/4 mineralocorticoid-related adverse events and liver function test abnormalities were more common with abiraterone acetate-prednisone.</p></sec><sec id="S4"><title>Conclusions</title><p id="P5">Abiraterone acetate produces OS and rPFS benefits, as well as significant delays in clinical deterioration and initiation of chemotherapy, in mCRPC.</p></sec></div></front></TEI><affiliations><list></list><tree><noCountry><name sortKey="Basch, Ethan" sort="Basch, Ethan" uniqKey="Basch E" first="Ethan" last="Basch">Ethan Basch</name><name sortKey="Carles, Joan" sort="Carles, Joan" uniqKey="Carles J" first="Joan" last="Carles">Joan Carles</name><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><name sortKey="De Souza, Paul" sort="De Souza, Paul" uniqKey="De Souza P" first="Paul" last="De Souza">Paul De Souza</name><name sortKey="Efstathiou, Eleni" sort="Efstathiou, Eleni" uniqKey="Efstathiou E" first="Eleni" last="Efstathiou">Eleni Efstathiou</name><name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name><name sortKey="Flaig, Thomas W" sort="Flaig, Thomas W" uniqKey="Flaig T" first="Thomas W." last="Flaig">Thomas W. Flaig</name><name sortKey="George, Daniel J" sort="George, Daniel J" uniqKey="George D" first="Daniel J." last="George">Daniel J. George</name><name sortKey="Gerritsen, Winald R" sort="Gerritsen, Winald R" uniqKey="Gerritsen W" first="Winald R." last="Gerritsen">Winald R. Gerritsen</name><name sortKey="Griffin, Thomas" sort="Griffin, Thomas" uniqKey="Griffin T" first="Thomas" last="Griffin">Thomas Griffin</name><name sortKey="Higano, Celestia S" sort="Higano, Celestia S" uniqKey="Higano C" first="Celestia S." last="Higano">Celestia S. Higano</name><name sortKey="Kheoh, Thian" sort="Kheoh, Thian" uniqKey="Kheoh T" first="Thian" last="Kheoh">Thian Kheoh</name><name sortKey="Logothetis, Christopher J" sort="Logothetis, Christopher J" uniqKey="Logothetis C" first="Christopher J." last="Logothetis">Christopher J. Logothetis</name><name sortKey="Mainwaring, Paul" sort="Mainwaring, Paul" uniqKey="Mainwaring P" first="Paul" last="Mainwaring">Paul Mainwaring</name><name sortKey="Molina, Arturo" sort="Molina, Arturo" uniqKey="Molina A" first="Arturo" last="Molina">Arturo Molina</name><name sortKey="Mukherjee, Som D" sort="Mukherjee, Som D" uniqKey="Mukherjee S" first="Som D." last="Mukherjee">Som D. Mukherjee</name><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><name sortKey="Ng, Siobhan" sort="Ng, Siobhan" uniqKey="Ng S" first="Siobhan" last="Ng">Siobhan Ng</name><name sortKey="Pantuck, Allan" sort="Pantuck, Allan" uniqKey="Pantuck A" first="Allan" last="Pantuck">Allan Pantuck</name><name sortKey="Park, Youn" sort="Park, Youn" uniqKey="Park Y" first="Youn" last="Park">Youn Park</name><name sortKey="Piulats, Jm" sort="Piulats, Jm" uniqKey="Piulats J" first="Jm" last="Piulats">Jm Piulats</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="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name><name sortKey="Scher, Howard I" sort="Scher, Howard I" uniqKey="Scher H" first="Howard I." last="Scher">Howard I. Scher</name><name sortKey="Schrijvers, Dirk" sort="Schrijvers, Dirk" uniqKey="Schrijvers D" first="Dirk" last="Schrijvers">Dirk Schrijvers</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="Suttmann, Henrik" sort="Suttmann, Henrik" uniqKey="Suttmann H" first="Henrik" last="Suttmann">Henrik Suttmann</name><name sortKey="Van Poppel, Hendrik" sort="Van Poppel, Hendrik" uniqKey="Van Poppel H" first="Hendrik" last="Van Poppel">Hendrik Van Poppel</name><name sortKey="Winquist, Eric" sort="Winquist, Eric" uniqKey="Winquist E" first="Eric" last="Winquist">Eric Winquist</name><name sortKey="Yu, Evan Y" sort="Yu, Evan Y" uniqKey="Yu E" first="Evan Y." last="Yu">Evan Y. Yu</name></noCountry></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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