Denosumab and Bone Metastasis-Free Survival in Men With Nonmetastatic Castration-Resistant Prostate Cancer: Exploratory Analyses by Baseline Prostate-Specific Antigen Doubling Time
Identifieur interne : 005031 ( Main/Exploration ); précédent : 005030; suivant : 005032Denosumab and Bone Metastasis-Free Survival in Men With Nonmetastatic Castration-Resistant Prostate Cancer: Exploratory Analyses by Baseline Prostate-Specific Antigen Doubling Time
Auteurs : Matthew R. Smith [États-Unis] ; Fred Saad [Canada] ; Stephane Oudard [France] ; Neal Shore [États-Unis] ; Karim Fizazi [France] ; Paul Sieber [États-Unis] ; Bertrand Tombal [Belgique] ; Ronaldo Damiao [Brésil] ; Gavin Marx [Australie] ; Kurt Miller [Allemagne] ; Peter Van Veldhuizen [États-Unis] ; Juan Morote [Espagne] ; ZHISHEN YE [États-Unis] ; Roger Dansey [États-Unis] ; Carsten Goessl [États-Unis]Source :
- Journal of clinical oncology [ 0732-183X ] ; 2013.
Descripteurs français
- KwdFr :
- Antagonistes des androgènes (usage thérapeutique), Anticorps monoclonaux humanisés (administration et posologie), Anticorps monoclonaux humanisés (usage thérapeutique), Antigène spécifique de la prostate (sang), Antinéoplasiques (administration et posologie), Antinéoplasiques (usage thérapeutique), Calendrier d'administration des médicaments, Castration (), Dénosumab, Facteurs temps, Humains, Injections sous-cutanées, Ligand de RANK (antagonistes et inhibiteurs), Marqueurs biologiques tumoraux (sang), Mâle, Méthode en double aveugle, Odds ratio, Résultat thérapeutique, Sujet âgé, Sujet âgé de 80 ans ou plus, Survie sans rechute, Tumeurs de la prostate (anatomopathologie), Tumeurs de la prostate (métabolisme), Tumeurs de la prostate (sang), Tumeurs de la prostate (traitement médicamenteux), Tumeurs osseuses (diagnostic), Tumeurs osseuses (secondaire).
- MESH :
- administration et posologie : Anticorps monoclonaux humanisés, Antinéoplasiques.
- anatomopathologie : Tumeurs de la prostate.
- antagonistes et inhibiteurs : Ligand de RANK.
- diagnostic : Tumeurs osseuses.
- métabolisme : Tumeurs de la prostate.
- sang : Antigène spécifique de la prostate, Marqueurs biologiques tumoraux, Tumeurs de la prostate.
- secondaire : Tumeurs osseuses.
- traitement médicamenteux : Tumeurs de la prostate.
- usage thérapeutique : Antagonistes des androgènes, Anticorps monoclonaux humanisés, Antinéoplasiques.
- Pascal (Inist)
- Calendrier d'administration des médicaments, Castration, Dénosumab, Facteurs temps, Humains, Injections sous-cutanées, Mâle, Méthode en double aveugle, Odds ratio, Résultat thérapeutique, Sujet âgé, Sujet âgé de 80 ans ou plus, Survie, Homme, Métastase osseuse, Adulte, Mâle, Cancer de la prostate, Castration, Résistance, Marqueur tumoral, Antigène spécifique prostate, Survie sans rechute, Temps doublement, Cancérologie, Immunomodulateur.
- Wicri :
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Androgen Antagonists (therapeutic use), Antibodies, Monoclonal, Humanized (administration & dosage), Antibodies, Monoclonal, Humanized (therapeutic use), Antineoplastic Agents (administration & dosage), Antineoplastic Agents (therapeutic use), Biomarkers, Tumor (blood), Bone Neoplasms (diagnosis), Bone Neoplasms (secondary), Bone metastasis, Cancerology, Castration, Castration (methods), Denosumab, Disease-Free Survival, Double-Blind Method, Doubling time, Drug Administration Schedule, Human, Humans, Immunomodulator, Injections, Subcutaneous, Male, Odds Ratio, Prostate cancer, Prostate specific antigen, Prostate-Specific Antigen (blood), Prostatic Neoplasms (blood), Prostatic Neoplasms (drug therapy), Prostatic Neoplasms (metabolism), Prostatic Neoplasms (pathology), RANK Ligand (antagonists & inhibitors), Resistance, Survival, Time Factors, Treatment Outcome, Tumoral marker.
- MESH :
- chemical , administration & dosage : Antibodies, Monoclonal, Humanized, Antineoplastic Agents.
- chemical , antagonists & inhibitors : RANK Ligand.
- chemical , blood : Biomarkers, Tumor, Prostate-Specific Antigen.
- chemical , therapeutic use : Androgen Antagonists, Antibodies, Monoclonal, Humanized, Antineoplastic Agents.
- blood : Prostatic Neoplasms.
- diagnosis : Bone Neoplasms.
- drug therapy : Prostatic Neoplasms.
- metabolism : Prostatic Neoplasms.
- methods : Castration.
- pathology : Prostatic Neoplasms.
- secondary : Bone Neoplasms.
- Aged, Aged, 80 and over, Denosumab, Disease-Free Survival, Double-Blind Method, Drug Administration Schedule, Humans, Injections, Subcutaneous, Male, Odds Ratio, Time Factors, Treatment Outcome.
Abstract
Purpose Denosumab, an anti-RANK ligand monoclonal antibody, significantly increases bone metastasis-free survival (BMFS; hazard ratio [HR], 0.85; P = .028) and delays time to first bone metastasis in men with nonmetastatic castration-resistant prostate cancer (CRPC) and baseline prostate-specific antigen (PSA) ≥ 8.0 ng/mL and/or PSA doubling time (PSADT) ≤ 10.0 months. To identify men at greatest risk for bone metastasis or death, we evaluated relationships between PSA and PSADT with BMFS in the placebo group and the efficacy and safety of denosumab in men with PSADT ≤ 10, ≤ 6, and ≤ 4 months. Patients and Methods A total of 1,432 men with nonmetastatic CRPC were randomly assigned 1:1 to monthly subcutaneous denosumab 120 mg or placebo. Enrollment began February 2006; primary analysis cutoff was July 2010, when approximately 660 men were anticipated to have developed bone metastases or died. Results In the placebo group, shorter BMFS was observed as PSADT decreased below 8 months. In analyses by shorter baseline PSADT, denosumab consistently increased BMFS by a median of 6.0, 7.2, and 7.5 months among men with PSADT ≤ 10 (HR, 0.84; P = .042), ≤ 6 (HR, 0.77; P = .006), and ≤ 4 months (HR, 0.71; P = .004), respectively. Denosumab also consistently increased time to bone metastasis by PSADT subset. No difference in survival was observed between treatment groups for the overall study population or PSADT subsets. Conclusion Patients with shorter PSADT are at greater risk for bone metastasis or death. Denosumab consistently improves BMFS in men with shorter PSADT and seems to have the greatest treatment effects in men at high risk for progression.
Url:
Affiliations:
- Allemagne, Australie, Belgique, Brésil, Canada, Espagne, France, États-Unis
- Berlin, Catalogne, Nouvelle-Galles du Sud, Région de Bruxelles-Capitale, État de Rio de Janeiro, Île-de-France
- Barcelone, Berlin, Bruxelles, Paris, Rio de Janeiro, Sydney
- Université de Sydney
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Le document en format XML
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Smith</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Massachusetts General Hospital Cancer Center</s1><s2>Boston, MA</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Massachusetts General Hospital Cancer Center</wicri:noRegion></affiliation></author><author><name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>University of Montreal Hospital Center</s1><s2>Montreal, Quebec</s2><s3>CAN</s3><sZ>2 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>University of Montreal Hospital Center</wicri:noRegion></affiliation></author><author><name sortKey="Oudard, Stephane" sort="Oudard, Stephane" uniqKey="Oudard S" first="Stephane" last="Oudard">Stephane Oudard</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Georges Pompidou Hospital</s1><s2>Paris</s2><s3>FRA</s3><sZ>3 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Time</title><author><name sortKey="Smith, Matthew R" sort="Smith, Matthew R" uniqKey="Smith M" first="Matthew R." last="Smith">Matthew R. Smith</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Massachusetts General Hospital Cancer Center</s1><s2>Boston, MA</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Massachusetts General Hospital Cancer Center</wicri:noRegion></affiliation></author><author><name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>University of Montreal Hospital Center</s1><s2>Montreal, Quebec</s2><s3>CAN</s3><sZ>2 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>University of Montreal Hospital Center</wicri:noRegion></affiliation></author><author><name sortKey="Oudard, Stephane" sort="Oudard, Stephane" uniqKey="Oudard S" first="Stephane" last="Oudard">Stephane Oudard</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Georges Pompidou Hospital</s1><s2>Paris</s2><s3>FRA</s3><sZ>3 aut.</sZ></inist:fA14><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="Shore, Neal" sort="Shore, Neal" uniqKey="Shore N" first="Neal" last="Shore">Neal Shore</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Carolina Urological Research Center</s1><s2>Myrtle Beach, SC</s2><s3>USA</s3><sZ>4 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Carolina Urological Research Center</wicri:noRegion></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="04"><s1>Institut Gustave Roussy, University of Paris Sud</s1><s2>Villejuif</s2><s3>FRA</s3><sZ>5 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>Villejuif</wicri:noRegion><wicri:noRegion>University of Paris Sud</wicri:noRegion><wicri:noRegion>Villejuif</wicri:noRegion></affiliation></author><author><name sortKey="Sieber, Paul" sort="Sieber, Paul" uniqKey="Sieber P" first="Paul" last="Sieber">Paul Sieber</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Urological Associates of Lancaster</s1><s2>Lancaster, PA</s2><s3>USA</s3><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Urological Associates of Lancaster</wicri:noRegion></affiliation></author><author><name sortKey="Tombal, Bertrand" sort="Tombal, Bertrand" uniqKey="Tombal B" first="Bertrand" last="Tombal">Bertrand Tombal</name><affiliation wicri:level="3"><inist:fA14 i1="07"><s1>Université Catholique de Louvain Cliniques Universitaires Saint Luc</s1><s2>Bruxelles</s2><s3>BEL</s3><sZ>7 aut.</sZ></inist:fA14><country>Belgique</country><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName></affiliation></author><author><name sortKey="Damiao, Ronaldo" sort="Damiao, Ronaldo" uniqKey="Damiao R" first="Ronaldo" last="Damiao">Ronaldo Damiao</name><affiliation wicri:level="3"><inist:fA14 i1="08"><s1>Hospital Universitario Pedro Ernesto</s1><s2>Rio de Janeiro</s2><s3>BRA</s3><sZ>8 aut.</sZ></inist:fA14><country>Brésil</country><placeName><settlement type="city">Rio de Janeiro</settlement><region type="state">État de Rio de Janeiro</region></placeName></affiliation></author><author><name sortKey="Marx, Gavin" sort="Marx, Gavin" uniqKey="Marx G" first="Gavin" last="Marx">Gavin Marx</name><affiliation wicri:level="4"><inist:fA14 i1="09"><s1>Sydney Haematology and Oncology Clinic, University of Sydney</s1><s2>Wahroonga, New South Wales</s2><s3>AUS</s3><sZ>9 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName><orgName type="university">Université de Sydney</orgName></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="10"><s1>Charité Berlin</s1><s2>Berlin</s2><s3>DEU</s3><sZ>10 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</settlement></placeName></affiliation></author><author><name sortKey="Van Veldhuizen, Peter" sort="Van Veldhuizen, Peter" uniqKey="Van Veldhuizen P" first="Peter" last="Van Veldhuizen">Peter Van Veldhuizen</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Kansas City Veterans Affairs Medical Center</s1><s2>Kansas City, MO</s2><s3>USA</s3><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Kansas City Veterans Affairs Medical Center</wicri:noRegion></affiliation></author><author><name sortKey="Morote, Juan" sort="Morote, Juan" uniqKey="Morote J" first="Juan" last="Morote">Juan Morote</name><affiliation wicri:level="3"><inist:fA14 i1="12"><s1>Hospital Vall d'Hebron</s1><s2>Barcelona</s2><s3>ESP</s3><sZ>12 aut.</sZ></inist:fA14><country>Espagne</country><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Zhishen Ye" sort="Zhishen Ye" uniqKey="Zhishen Ye" last="Zhishen Ye">ZHISHEN YE</name><affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Amgen</s1><s2>Thousand Oaks, CA</s2><s3>USA</s3><sZ>13 aut.</sZ><sZ>14 aut.</sZ><sZ>15 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Amgen</wicri:noRegion></affiliation></author><author><name sortKey="Dansey, Roger" sort="Dansey, Roger" uniqKey="Dansey R" first="Roger" last="Dansey">Roger Dansey</name><affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Amgen</s1><s2>Thousand Oaks, CA</s2><s3>USA</s3><sZ>13 aut.</sZ><sZ>14 aut.</sZ><sZ>15 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Amgen</wicri:noRegion></affiliation></author><author><name sortKey="Goessl, Carsten" sort="Goessl, Carsten" uniqKey="Goessl C" first="Carsten" last="Goessl">Carsten Goessl</name><affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Amgen</s1><s2>Thousand Oaks, CA</s2><s3>USA</s3><sZ>13 aut.</sZ><sZ>14 aut.</sZ><sZ>15 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Amgen</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">Journal of clinical oncology</title><title level="j" type="abbreviated">J. clin. oncol.</title><idno type="ISSN">0732-183X</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Journal of clinical oncology</title><title level="j" type="abbreviated">J. clin. oncol.</title><idno type="ISSN">0732-183X</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Androgen Antagonists (therapeutic use)</term><term>Antibodies, Monoclonal, Humanized (administration & dosage)</term><term>Antibodies, Monoclonal, Humanized (therapeutic use)</term><term>Antineoplastic Agents (administration & dosage)</term><term>Antineoplastic Agents (therapeutic use)</term><term>Biomarkers, Tumor (blood)</term><term>Bone Neoplasms (diagnosis)</term><term>Bone Neoplasms (secondary)</term><term>Bone metastasis</term><term>Cancerology</term><term>Castration</term><term>Castration (methods)</term><term>Denosumab</term><term>Disease-Free Survival</term><term>Double-Blind Method</term><term>Doubling time</term><term>Drug Administration Schedule</term><term>Human</term><term>Humans</term><term>Immunomodulator</term><term>Injections, Subcutaneous</term><term>Male</term><term>Odds Ratio</term><term>Prostate cancer</term><term>Prostate specific antigen</term><term>Prostate-Specific Antigen (blood)</term><term>Prostatic Neoplasms (blood)</term><term>Prostatic Neoplasms (drug therapy)</term><term>Prostatic Neoplasms (metabolism)</term><term>Prostatic Neoplasms (pathology)</term><term>RANK Ligand (antagonists & inhibitors)</term><term>Resistance</term><term>Survival</term><term>Time Factors</term><term>Treatment Outcome</term><term>Tumoral marker</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Antagonistes des androgènes (usage thérapeutique)</term><term>Anticorps monoclonaux humanisés (administration et posologie)</term><term>Anticorps monoclonaux humanisés (usage thérapeutique)</term><term>Antigène spécifique de la prostate (sang)</term><term>Antinéoplasiques (administration et posologie)</term><term>Antinéoplasiques (usage thérapeutique)</term><term>Calendrier d'administration des médicaments</term><term>Castration ()</term><term>Dénosumab</term><term>Facteurs temps</term><term>Humains</term><term>Injections sous-cutanées</term><term>Ligand de RANK (antagonistes et inhibiteurs)</term><term>Marqueurs biologiques tumoraux (sang)</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Odds ratio</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Survie sans rechute</term><term>Tumeurs de la prostate (anatomopathologie)</term><term>Tumeurs de la prostate (métabolisme)</term><term>Tumeurs de la prostate (sang)</term><term>Tumeurs de la prostate (traitement médicamenteux)</term><term>Tumeurs osseuses (diagnostic)</term><term>Tumeurs osseuses (secondaire)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antibodies, Monoclonal, Humanized</term><term>Antineoplastic Agents</term></keywords><keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en"><term>RANK Ligand</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Biomarkers, Tumor</term><term>Prostate-Specific Antigen</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Androgen Antagonists</term><term>Antibodies, Monoclonal, Humanized</term><term>Antineoplastic Agents</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Anticorps monoclonaux humanisés</term><term>Antinéoplasiques</term></keywords><keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr"><term>Tumeurs de la prostate</term></keywords><keywords scheme="MESH" qualifier="antagonistes et inhibiteurs" xml:lang="fr"><term>Ligand de RANK</term></keywords><keywords scheme="MESH" qualifier="blood" xml:lang="en"><term>Prostatic Neoplasms</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Bone Neoplasms</term></keywords><keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr"><term>Tumeurs osseuses</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Prostatic Neoplasms</term></keywords><keywords scheme="MESH" qualifier="metabolism" xml:lang="en"><term>Prostatic Neoplasms</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Castration</term></keywords><keywords scheme="MESH" qualifier="métabolisme" xml:lang="fr"><term>Tumeurs de la prostate</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Prostatic Neoplasms</term></keywords><keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>Antigène spécifique de la prostate</term><term>Marqueurs biologiques tumoraux</term><term>Tumeurs de la prostate</term></keywords><keywords scheme="MESH" qualifier="secondaire" xml:lang="fr"><term>Tumeurs osseuses</term></keywords><keywords scheme="MESH" qualifier="secondary" xml:lang="en"><term>Bone Neoplasms</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Tumeurs de la prostate</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Antagonistes des androgènes</term><term>Anticorps monoclonaux humanisés</term><term>Antinéoplasiques</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Aged, 80 and over</term><term>Denosumab</term><term>Disease-Free Survival</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Humans</term><term>Injections, Subcutaneous</term><term>Male</term><term>Odds Ratio</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Calendrier d'administration des médicaments</term><term>Castration</term><term>Dénosumab</term><term>Facteurs temps</term><term>Humains</term><term>Injections sous-cutanées</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Odds ratio</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Survie</term><term>Homme</term><term>Métastase osseuse</term><term>Adulte</term><term>Mâle</term><term>Cancer de la prostate</term><term>Castration</term><term>Résistance</term><term>Marqueur tumoral</term><term>Antigène spécifique prostate</term><term>Survie sans rechute</term><term>Temps doublement</term><term>Cancérologie</term><term>Immunomodulateur</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term><term>Adulte</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Purpose Denosumab, an anti-RANK ligand monoclonal antibody, significantly increases bone metastasis-free survival (BMFS; hazard ratio [HR], 0.85; P = .028) and delays time to first bone metastasis in men with nonmetastatic castration-resistant prostate cancer (CRPC) and baseline prostate-specific antigen (PSA) ≥ 8.0 ng/mL and/or PSA doubling time (PSADT) ≤ 10.0 months. To identify men at greatest risk for bone metastasis or death, we evaluated relationships between PSA and PSADT with BMFS in the placebo group and the efficacy and safety of denosumab in men with PSADT ≤ 10, ≤ 6, and ≤ 4 months. Patients and Methods A total of 1,432 men with nonmetastatic CRPC were randomly assigned 1:1 to monthly subcutaneous denosumab 120 mg or placebo. Enrollment began February 2006; primary analysis cutoff was July 2010, when approximately 660 men were anticipated to have developed bone metastases or died. Results In the placebo group, shorter BMFS was observed as PSADT decreased below 8 months. In analyses by shorter baseline PSADT, denosumab consistently increased BMFS by a median of 6.0, 7.2, and 7.5 months among men with PSADT ≤ 10 (HR, 0.84; P = .042), ≤ 6 (HR, 0.77; P = .006), and ≤ 4 months (HR, 0.71; P = .004), respectively. Denosumab also consistently increased time to bone metastasis by PSADT subset. No difference in survival was observed between treatment groups for the overall study population or PSADT subsets. Conclusion Patients with shorter PSADT are at greater risk for bone metastasis or death. Denosumab consistently improves BMFS in men with shorter PSADT and seems to have the greatest treatment effects in men at high risk for progression.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Belgique</li><li>Brésil</li><li>Canada</li><li>Espagne</li><li>France</li><li>États-Unis</li></country><region><li>Berlin</li><li>Catalogne</li><li>Nouvelle-Galles du Sud</li><li>Région de Bruxelles-Capitale</li><li>État de Rio de Janeiro</li><li>Île-de-France</li></region><settlement><li>Barcelone</li><li>Berlin</li><li>Bruxelles</li><li>Paris</li><li>Rio de Janeiro</li><li>Sydney</li></settlement><orgName><li>Université de Sydney</li></orgName></list><tree><country name="États-Unis"><noRegion><name sortKey="Smith, Matthew R" sort="Smith, Matthew R" uniqKey="Smith M" first="Matthew R." last="Smith">Matthew R. Smith</name></noRegion><name sortKey="Dansey, Roger" sort="Dansey, Roger" uniqKey="Dansey R" first="Roger" last="Dansey">Roger Dansey</name><name sortKey="Goessl, Carsten" sort="Goessl, Carsten" uniqKey="Goessl C" first="Carsten" last="Goessl">Carsten Goessl</name><name sortKey="Shore, Neal" sort="Shore, Neal" uniqKey="Shore N" first="Neal" last="Shore">Neal Shore</name><name sortKey="Sieber, Paul" sort="Sieber, Paul" uniqKey="Sieber P" first="Paul" last="Sieber">Paul Sieber</name><name sortKey="Van Veldhuizen, Peter" sort="Van Veldhuizen, Peter" uniqKey="Van Veldhuizen P" first="Peter" last="Van Veldhuizen">Peter Van Veldhuizen</name><name sortKey="Zhishen Ye" sort="Zhishen Ye" uniqKey="Zhishen Ye" last="Zhishen Ye">ZHISHEN YE</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="France"><region name="Île-de-France"><name sortKey="Oudard, Stephane" sort="Oudard, Stephane" uniqKey="Oudard S" first="Stephane" last="Oudard">Stephane Oudard</name></region><name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name></country><country name="Belgique"><region name="Région de Bruxelles-Capitale"><name sortKey="Tombal, Bertrand" sort="Tombal, Bertrand" uniqKey="Tombal B" first="Bertrand" last="Tombal">Bertrand Tombal</name></region></country><country name="Brésil"><region name="État de Rio de Janeiro"><name sortKey="Damiao, Ronaldo" sort="Damiao, Ronaldo" uniqKey="Damiao R" first="Ronaldo" last="Damiao">Ronaldo Damiao</name></region></country><country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Marx, Gavin" sort="Marx, Gavin" uniqKey="Marx G" first="Gavin" last="Marx">Gavin Marx</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="Espagne"><region name="Catalogne"><name sortKey="Morote, Juan" sort="Morote, Juan" uniqKey="Morote J" first="Juan" last="Morote">Juan Morote</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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