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 : 004872 ( Main/Merge ); précédent : 004871; suivant : 004873Denosumab 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 ; Fred Saad ; Stephane Oudard ; Neal Shore ; Karim Fizazi ; Paul Sieber ; Bertrand Tombal ; Ronaldo Damiao ; Gavin Marx ; Kurt Miller ; Peter Van Veldhuizen ; Juan Morote ; Zhishen Ye ; Roger Dansey ; Carsten GoesslSource :
- 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.
- 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 sans rechute.
English descriptors
- KwdEn :
- 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), Castration (methods), Denosumab, Disease-Free Survival, Double-Blind Method, Drug Administration Schedule, Humans, Injections, Subcutaneous, Male, Odds Ratio, Prostate-Specific Antigen (blood), Prostatic Neoplasms (blood), Prostatic Neoplasms (drug therapy), Prostatic Neoplasms (metabolism), Prostatic Neoplasms (pathology), RANK Ligand (antagonists & inhibitors), Time Factors, Treatment Outcome.
- 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
Denosumab, an anti–RANK ligand monoclonal antibody, significantly increases bone metastasis–free survival (BMFS; hazard ratio [HR], 0.85;
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.
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;
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:
DOI: 10.1200/JCO.2012.44.6716
PubMed: 24043751
PubMed Central: 3795889
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PMC:3795889Le document en format XML
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Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name><affiliation><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Oudard, Stephane" sort="Oudard, Stephane" uniqKey="Oudard S" first="Stephane" last="Oudard">Stephane Oudard</name><affiliation><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Shore, Neal" sort="Shore, Neal" uniqKey="Shore N" first="Neal" last="Shore">Neal Shore</name><affiliation><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name><affiliation><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Sieber, Paul" sort="Sieber, Paul" uniqKey="Sieber P" first="Paul" last="Sieber">Paul Sieber</name><affiliation><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Tombal, Bertrand" sort="Tombal, Bertrand" uniqKey="Tombal B" first="Bertrand" last="Tombal">Bertrand Tombal</name><affiliation><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Damiao, Ronaldo" sort="Damiao, Ronaldo" uniqKey="Damiao R" first="Ronaldo" last="Damiao">Ronaldo Damiao</name><affiliation><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Marx, Gavin" sort="Marx, Gavin" uniqKey="Marx G" first="Gavin" last="Marx">Gavin Marx</name><affiliation><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Miller, Kurt" sort="Miller, Kurt" uniqKey="Miller K" first="Kurt" last="Miller">Kurt Miller</name><affiliation><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></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><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Morote, Juan" sort="Morote, Juan" uniqKey="Morote J" first="Juan" last="Morote">Juan Morote</name><affiliation><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Ye, Zhishen" sort="Ye, Zhishen" uniqKey="Ye Z" first="Zhishen" last="Ye">Zhishen Ye</name><affiliation><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Dansey, Roger" sort="Dansey, Roger" uniqKey="Dansey R" first="Roger" last="Dansey">Roger Dansey</name><affiliation><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Goessl, Carsten" sort="Goessl, Carsten" uniqKey="Goessl C" first="Carsten" last="Goessl">Carsten Goessl</name><affiliation><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">24043751</idno><idno type="pmc">3795889</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3795889</idno><idno type="RBID">PMC:3795889</idno><idno type="doi">10.1200/JCO.2012.44.6716</idno><date when="2013">2013</date><idno type="wicri:Area/Pmc/Corpus">001954</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001954</idno><idno type="wicri:Area/Pmc/Curation">001813</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">001813</idno><idno type="wicri:Area/Pmc/Checkpoint">001B79</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">001B79</idno><idno type="wicri:source">PubMed</idno><idno type="wicri:Area/PubMed/Corpus">003B13</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">003B13</idno><idno type="wicri:Area/PubMed/Curation">003983</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">003983</idno><idno type="wicri:Area/PubMed/Checkpoint">003983</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">003983</idno><idno type="wicri:Area/Ncbi/Merge">001467</idno><idno type="wicri:Area/Ncbi/Curation">001467</idno><idno type="wicri:Area/Ncbi/Checkpoint">001467</idno><idno type="wicri:doubleKey">0732-183X:2013:Smith M:denosumab:and:bone</idno><idno type="wicri:Area/Main/Merge">004872</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Denosumab and Bone Metastasis–Free Survival in Men With Nonmetastatic Castration-Resistant Prostate Cancer: Exploratory Analyses by Baseline Prostate-Specific Antigen Doubling 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><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name><affiliation><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Oudard, Stephane" sort="Oudard, Stephane" uniqKey="Oudard S" first="Stephane" last="Oudard">Stephane Oudard</name><affiliation><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Shore, Neal" sort="Shore, Neal" uniqKey="Shore N" first="Neal" last="Shore">Neal Shore</name><affiliation><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name><affiliation><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Sieber, Paul" sort="Sieber, Paul" uniqKey="Sieber P" first="Paul" last="Sieber">Paul Sieber</name><affiliation><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Tombal, Bertrand" sort="Tombal, Bertrand" uniqKey="Tombal B" first="Bertrand" last="Tombal">Bertrand Tombal</name><affiliation><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Damiao, Ronaldo" sort="Damiao, Ronaldo" uniqKey="Damiao R" first="Ronaldo" last="Damiao">Ronaldo Damiao</name><affiliation><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Marx, Gavin" sort="Marx, Gavin" uniqKey="Marx G" first="Gavin" last="Marx">Gavin Marx</name><affiliation><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Miller, Kurt" sort="Miller, Kurt" uniqKey="Miller K" first="Kurt" last="Miller">Kurt Miller</name><affiliation><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></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><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Morote, Juan" sort="Morote, Juan" uniqKey="Morote J" first="Juan" last="Morote">Juan Morote</name><affiliation><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Ye, Zhishen" sort="Ye, Zhishen" uniqKey="Ye Z" first="Zhishen" last="Ye">Zhishen Ye</name><affiliation><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Dansey, Roger" sort="Dansey, Roger" uniqKey="Dansey R" first="Roger" last="Dansey">Roger Dansey</name><affiliation><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author><author><name sortKey="Goessl, Carsten" sort="Goessl, Carsten" uniqKey="Goessl C" first="Carsten" last="Goessl">Carsten Goessl</name><affiliation><nlm:aff id="aff1">Matthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.</nlm:aff><wicri:noCountry code="subfield">CA.</wicri:noCountry></affiliation></author></analytic><series><title level="j">Journal of Clinical Oncology</title><idno type="ISSN">0732-183X</idno><idno type="eISSN">1527-7755</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><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>Castration (methods)</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>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>Time Factors</term><term>Treatment Outcome</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="MESH" 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 sans rechute</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Purpose</title><p>Denosumab, an anti–RANK ligand monoclonal antibody, significantly increases bone metastasis–free survival (BMFS; hazard ratio [HR], 0.85; <italic>P</italic> = .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.</p></sec><sec><title>Patients and Methods</title><p>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.</p></sec><sec><title>Results</title><p>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; <italic>P</italic> = .042), ≤ 6 (HR, 0.77; <italic>P</italic> = .006), and ≤ 4 months (HR, 0.71; <italic>P</italic> = .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.</p></sec><sec><title>Conclusion</title><p>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.</p></sec></div></front></TEI></record>Pour manipuler ce document sous Unix (Dilib)
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