UnivTrevesV1, PascalFrancis, Corpus, bibRecord, 000263

Superiority of denosumab to zoledronic acid for prevention of skeletal-related events: A combined analysis of 3 pivotal, randomised, phase 3 trials

Identifieur interne : 000263 ( PascalFrancis/Corpus ); précédent : 000262; suivant : 000264

Superiority of denosumab to zoledronic acid for prevention of skeletal-related events: A combined analysis of 3 pivotal, randomised, phase 3 trials

Auteurs : Allan Lipton ; Karim Fizazi ; Alison T. Stopeck ; David H. Henry ; Janet E. Brown ; Denise A. Yardley ; Gary E. Richardson ; Salvatore Siena ; Pablo Maroto ; Michael Clemens ; Boris Bilynskyy ; Veena Charu ; Philippe Beuzeboc ; Michael Rader ; Maria Viniegra ; Fred Saad ; Chunlei Ke ; Ada Braun ; Susie Jun

Source :

European journal of cancer : (1990) [ 0959-8049 ] ; 2012.

RBID : Pascal:12-0435730

Descripteurs français

Pascal (Inist)
- Dénosumab, Prévention, Squelette, Acide zolédronique, Essai clinique, Cancérologie, Essai clinique phase III, Métastase osseuse, Antirésorptif, Anticancéreux.

English descriptors

KwdEn :
- Antineoplastic agent, Antiresorptive agent, Bone metastasis, Cancerology, Clinical trial, Denosumab, Phase III trial, Prevention, Skeleton, Zoledronic acid.

Abstract

Background: Patients with bone metastases from advanced cancer often experience skeletal-related events (SRE), which cause substantial pain and morbidity. Denosumab, a fully human monoclonal antibody that inhibits RANK Ligand (RANKL), is a novel bone-targeted agent with a distinct mechanism of action relative to the bisphosphonate zoledronic acid, for prevention of SRE. This pre-planned analysis evaluates the efficacy and safety of denosumab versus zoledronic acid across three pivotal studies. Methods: Patient-level data from three identically designed, randomised, double-blind, active-controlled, phase 3 trials of patients with breast cancer, prostate cancer, other solid tumours or multiple myeloma were combined. End-points included time to first SRE, time to first and subsequent (multiple) SRE, adverse events, time to disease progression and overall survival. Findings: Denosumab was superior to zoledronic acid in delaying time to first on-study SRE by a median 8.21 months, reducing the risk of a first SRE by 17% (hazard ratio, 0.83 [95% confidence interval (CI): 0.76-0.90]; P < 0.001). Efficacy was demonstrated for first and multiple events and across patient subgroups (prior SRE status; age). Disease progression and overall survival were similar between the treatments. In contrast to zoledronic acid, denosumab did not require monitoring or dose modification/withholding based on renal status, and was not associated with acute-phase reactions. Hypocalcaemia was more common for denosumab. Osteonecrosis of the jaw occurred at a similar rate (P = 0.13). Conclusion: Denosumab was superior to zoledronic acid in preventing SRE with favourable safety and convenience in patients with bone metastases from advanced cancer.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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A08	`01`	`1`	`ENG`	`@1 Superiority of denosumab to zoledronic acid for prevention of skeletal-related events: A combined analysis of 3 pivotal, randomised, phase 3 trials`
A11	`01`	`1`		`@1 LIPTON (Allan)`
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A11	`05`	`1`		`@1 BROWN (Janet E.)`
A11	`06`	`1`		`@1 YARDLEY (Denise A.)`
A11	`07`	`1`		`@1 RICHARDSON (Gary E.)`
A11	`08`	`1`		`@1 SIENA (Salvatore)`
A11	`09`	`1`		`@1 MAROTO (Pablo)`
A11	`10`	`1`		`@1 CLEMENS (Michael)`
A11	`11`	`1`		`@1 BILYNSKYY (Boris)`
A11	`12`	`1`		`@1 CHARU (Veena)`
A11	`13`	`1`		`@1 BEUZEBOC (Philippe)`
A11	`14`	`1`		`@1 RADER (Michael)`
A11	`15`	`1`		`@1 VINIEGRA (Maria)`
A11	`16`	`1`		`@1 SAAD (Fred)`
A11	`17`	`1`		`@1 KE (Chunlei)`
A11	`18`	`1`		`@1 BRAUN (Ada)`
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A14	`03`			`@1 University of Arizona, Arizona Cancer Center @2 Tucson, AZ @3 USA @Z 3 aut.`
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A14	`05`			`@1 Cancer Research UK Clinical Centre @2 Leeds @3 GBR @Z 5 aut.`
A14	`06`			`@1 Sarah Cannon Research Institute and Tennessee Oncology, PLLC @2 Nashville, TN @3 USA @Z 6 aut.`
A14	`07`			`@1 Cabrini Hospital @2 Malvern, Vic @3 AUS @Z 7 aut.`
A14	`08`			`@1 Ospedale Niguarda Ca' Granda @2 Milan @3 ITA @Z 8 aut.`
A14	`09`			`@1 Hospital de La Santa Creu i Sant Pau @2 Barcelona @3 ESP @Z 9 aut.`
A14	`10`			`@1 Klinikum Mutterhaus der Borromaeerinnen @2 Trier @3 DEU @Z 10 aut.`
A14	`11`			`@1 Cancer Treatment and Diagnostic Center @2 Lviv @3 UKR @Z 11 aut.`
A14	`12`			`@1 Pacific Cancer Medical Center Inc. @2 Anaheim, CA @3 USA @Z 12 aut.`
A14	`13`			`@1 Institut Curie @2 Paris @3 FRA @Z 13 aut.`
A14	`14`			`@1 Union State Bank Cancer Center, Nyack Hospital @2 Nyack, NY @3 USA @Z 14 aut.`
A14	`15`			`@1 Corporacion Medica de General San Martin @2 Buenos Aires @3 ARG @Z 15 aut.`
A14	`16`			`@1 University of Montreal Hospital Center @2 Montreal, QC @3 CAN @Z 16 aut.`
A14	`17`			`@1 Amgen Inc @2 Thousand Oaks, CA @3 USA @Z 17 aut. @Z 18 aut. @Z 19 aut.`
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A44				`@0 0000 @1 © 2012 INIST-CNRS. All rights reserved.`
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A64	`01`	`1`		`@0 European journal of cancer : (1990)`
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C01	`01`		`ENG`	@0 Background: Patients with bone metastases from advanced cancer often experience skeletal-related events (SRE), which cause substantial pain and morbidity. Denosumab, a fully human monoclonal antibody that inhibits RANK Ligand (RANKL), is a novel bone-targeted agent with a distinct mechanism of action relative to the bisphosphonate zoledronic acid, for prevention of SRE. This pre-planned analysis evaluates the efficacy and safety of denosumab versus zoledronic acid across three pivotal studies. Methods: Patient-level data from three identically designed, randomised, double-blind, active-controlled, phase 3 trials of patients with breast cancer, prostate cancer, other solid tumours or multiple myeloma were combined. End-points included time to first SRE, time to first and subsequent (multiple) SRE, adverse events, time to disease progression and overall survival. Findings: Denosumab was superior to zoledronic acid in delaying time to first on-study SRE by a median 8.21 months, reducing the risk of a first SRE by 17% (hazard ratio, 0.83 [95% confidence interval (CI): 0.76-0.90]; P < 0.001). Efficacy was demonstrated for first and multiple events and across patient subgroups (prior SRE status; age). Disease progression and overall survival were similar between the treatments. In contrast to zoledronic acid, denosumab did not require monitoring or dose modification/withholding based on renal status, and was not associated with acute-phase reactions. Hypocalcaemia was more common for denosumab. Osteonecrosis of the jaw occurred at a similar rate (P = 0.13). Conclusion: Denosumab was superior to zoledronic acid in preventing SRE with favourable safety and convenience in patients with bone metastases from advanced cancer.
C02	`01`	`X`		`@0 002B02`
C02	`02`	`X`		`@0 002B04`
C03	`01`	`X`	`FRE`	`@0 Dénosumab @2 FR @5 01`
C03	`01`	`X`	`ENG`	`@0 Denosumab @2 FR @5 01`
C03	`01`	`X`	`SPA`	`@0 Denosumab @2 FR @5 01`
C03	`02`	`X`	`FRE`	`@0 Prévention @5 02`
C03	`02`	`X`	`ENG`	`@0 Prevention @5 02`
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C03	`03`	`X`	`SPA`	`@0 Esqueleto @5 03`
C03	`04`	`X`	`FRE`	`@0 Acide zolédronique @2 NK @2 FR @5 04`
C03	`04`	`X`	`ENG`	`@0 Zoledronic acid @2 NK @2 FR @5 04`
C03	`04`	`X`	`SPA`	`@0 Acido zoledrónico @2 NK @2 FR @5 04`
C03	`05`	`X`	`FRE`	`@0 Essai clinique @5 05`
C03	`05`	`X`	`ENG`	`@0 Clinical trial @5 05`
C03	`05`	`X`	`SPA`	`@0 Ensayo clínico @5 05`
C03	`06`	`X`	`FRE`	`@0 Cancérologie @5 06`
C03	`06`	`X`	`ENG`	`@0 Cancerology @5 06`
C03	`06`	`X`	`SPA`	`@0 Cancerología @5 06`
C03	`07`	`X`	`FRE`	`@0 Essai clinique phase III @5 07`
C03	`07`	`X`	`ENG`	`@0 Phase III trial @5 07`
C03	`07`	`X`	`SPA`	`@0 Ensayo clínico fase III @5 07`
C03	`08`	`X`	`FRE`	`@0 Métastase osseuse @2 NM @5 10`
C03	`08`	`X`	`ENG`	`@0 Bone metastasis @2 NM @5 10`
C03	`08`	`X`	`SPA`	`@0 Metástasis ósea @2 NM @5 10`
C03	`09`	`X`	`FRE`	`@0 Antirésorptif @5 25`
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C03	`09`	`X`	`SPA`	`@0 Antirresortivo @5 25`
C03	`10`	`X`	`FRE`	`@0 Anticancéreux @5 26`
C03	`10`	`X`	`ENG`	`@0 Antineoplastic agent @5 26`
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C07	`01`	`X`	`FRE`	`@0 Anticorps monoclonal @5 37`
C07	`01`	`X`	`ENG`	`@0 Monoclonal antibody @5 37`
C07	`01`	`X`	`SPA`	`@0 Anticuerpo monoclonal @5 37`
C07	`02`	`X`	`FRE`	`@0 Bisphosphonates @5 38`
C07	`02`	`X`	`ENG`	`@0 Bisphosphonates @5 38`
C07	`02`	`X`	`SPA`	`@0 Bisfosfonatos @5 38`
C07	`03`	`X`	`FRE`	`@0 Dérivé de l'acide diphosphonique @5 39`
C07	`03`	`X`	`ENG`	`@0 Diphosphonic acid derivatives @5 39`
C07	`03`	`X`	`SPA`	`@0 Difosfonico ácido derivado @5 39`
C07	`04`	`X`	`FRE`	`@0 Pathologie du système ostéoarticulaire @5 40`
C07	`04`	`X`	`ENG`	`@0 Diseases of the osteoarticular system @5 40`
C07	`04`	`X`	`SPA`	`@0 Sistema osteoarticular patología @5 40`
C07	`05`	`X`	`FRE`	`@0 Tumeur maligne @2 NM @5 41`
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C07	`05`	`X`	`SPA`	`@0 Tumor maligno @2 NM @5 41`
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C07	`06`	`X`	`ENG`	`@0 Cancer @2 NM`
C07	`06`	`X`	`SPA`	`@0 Cáncer @2 NM`
N21				`@1 338`
N44	`01`			`@1 OTO`
N82				`@1 OTO`

Format Inist (serveur)

NO :	PASCAL 12-0435730 INIST
ET :	Superiority of denosumab to zoledronic acid for prevention of skeletal-related events: A combined analysis of 3 pivotal, randomised, phase 3 trials
AU :	LIPTON (Allan); FIZAZI (Karim); STOPECK (Alison T.); HENRY (David H.); BROWN (Janet E.); YARDLEY (Denise A.); RICHARDSON (Gary E.); SIENA (Salvatore); MAROTO (Pablo); CLEMENS (Michael); BILYNSKYY (Boris); CHARU (Veena); BEUZEBOC (Philippe); RADER (Michael); VINIEGRA (Maria); SAAD (Fred); KE (Chunlei); BRAUN (Ada); JUN (Susie)
AF :	Pennsylvania State University, Milton S. Hershey Medical Center/Hershey, PA/Etats-Unis (1 aut.); Institut Gustave Roussy, University of Paris Sud/Villejuif/France (2 aut.); University of Arizona, Arizona Cancer Center/Tucson, AZ/Etats-Unis (3 aut.); Joan Karnell Cancer Center at Pennsylvania Hospital/Philadelphia, PA/Etats-Unis (4 aut.); Cancer Research UK Clinical Centre/Leeds/Royaume-Uni (5 aut.); Sarah Cannon Research Institute and Tennessee Oncology, PLLC/Nashville, TN/Etats-Unis (6 aut.); Cabrini Hospital/Malvern, Vic/Australie (7 aut.); Ospedale Niguarda Ca' Granda/Milan/Italie (8 aut.); Hospital de La Santa Creu i Sant Pau/Barcelona/Espagne (9 aut.); Klinikum Mutterhaus der Borromaeerinnen/Trier/Allemagne (10 aut.); Cancer Treatment and Diagnostic Center/Lviv/Ukraine (11 aut.); Pacific Cancer Medical Center Inc./Anaheim, CA/Etats-Unis (12 aut.); Institut Curie/Paris/France (13 aut.); Union State Bank Cancer Center, Nyack Hospital/Nyack, NY/Etats-Unis (14 aut.); Corporacion Medica de General San Martin/Buenos Aires/Argentine (15 aut.); University of Montreal Hospital Center/Montreal, QC/Canada (16 aut.); Amgen Inc/Thousand Oaks, CA/Etats-Unis (17 aut., 18 aut., 19 aut.)
DT :	Publication en série; Niveau analytique
SO :	European journal of cancer : (1990); ISSN 0959-8049; Royaume-Uni; Da. 2012; Vol. 48; No. 16; Pp. 3082-3092; Bibl. 36 ref.
LA :	Anglais
EA :	Background: Patients with bone metastases from advanced cancer often experience skeletal-related events (SRE), which cause substantial pain and morbidity. Denosumab, a fully human monoclonal antibody that inhibits RANK Ligand (RANKL), is a novel bone-targeted agent with a distinct mechanism of action relative to the bisphosphonate zoledronic acid, for prevention of SRE. This pre-planned analysis evaluates the efficacy and safety of denosumab versus zoledronic acid across three pivotal studies. Methods: Patient-level data from three identically designed, randomised, double-blind, active-controlled, phase 3 trials of patients with breast cancer, prostate cancer, other solid tumours or multiple myeloma were combined. End-points included time to first SRE, time to first and subsequent (multiple) SRE, adverse events, time to disease progression and overall survival. Findings: Denosumab was superior to zoledronic acid in delaying time to first on-study SRE by a median 8.21 months, reducing the risk of a first SRE by 17% (hazard ratio, 0.83 [95% confidence interval (CI): 0.76-0.90]; P < 0.001). Efficacy was demonstrated for first and multiple events and across patient subgroups (prior SRE status; age). Disease progression and overall survival were similar between the treatments. In contrast to zoledronic acid, denosumab did not require monitoring or dose modification/withholding based on renal status, and was not associated with acute-phase reactions. Hypocalcaemia was more common for denosumab. Osteonecrosis of the jaw occurred at a similar rate (P = 0.13). Conclusion: Denosumab was superior to zoledronic acid in preventing SRE with favourable safety and convenience in patients with bone metastases from advanced cancer.
CC :	002B02; 002B04
FD :	Dénosumab; Prévention; Squelette; Acide zolédronique; Essai clinique; Cancérologie; Essai clinique phase III; Métastase osseuse; Antirésorptif; Anticancéreux
FG :	Anticorps monoclonal; Bisphosphonates; Dérivé de l'acide diphosphonique; Pathologie du système ostéoarticulaire; Tumeur maligne; Cancer
ED :	Denosumab; Prevention; Skeleton; Zoledronic acid; Clinical trial; Cancerology; Phase III trial; Bone metastasis; Antiresorptive agent; Antineoplastic agent
EG :	Monoclonal antibody; Bisphosphonates; Diphosphonic acid derivatives; Diseases of the osteoarticular system; Malignant tumor; Cancer
SD :	Denosumab; Prevención; Esqueleto; Acido zoledrónico; Ensayo clínico; Cancerología; Ensayo clínico fase III; Metástasis ósea; Antirresortivo; Anticanceroso
LO :	INIST-12648.354000509589750170
ID :	12-0435730

Links to Exploration step

Pascal:12-0435730

Le document en format XML

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<author><name sortKey="Siena, Salvatore" sort="Siena, Salvatore" uniqKey="Siena S" first="Salvatore" last="Siena">Salvatore Siena</name>
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<author><name sortKey="Maroto, Pablo" sort="Maroto, Pablo" uniqKey="Maroto P" first="Pablo" last="Maroto">Pablo Maroto</name>
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<author><name sortKey="Charu, Veena" sort="Charu, Veena" uniqKey="Charu V" first="Veena" last="Charu">Veena Charu</name>
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<author><name sortKey="Beuzeboc, Philippe" sort="Beuzeboc, Philippe" uniqKey="Beuzeboc P" first="Philippe" last="Beuzeboc">Philippe Beuzeboc</name>
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<author><name sortKey="Rader, Michael" sort="Rader, Michael" uniqKey="Rader M" first="Michael" last="Rader">Michael Rader</name>
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<author><name sortKey="Viniegra, Maria" sort="Viniegra, Maria" uniqKey="Viniegra M" first="Maria" last="Viniegra">Maria Viniegra</name>
<affiliation><inist:fA14 i1="15"><s1>Corporacion Medica de General San Martin</s1>
<s2>Buenos Aires</s2>
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<author><name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name>
<affiliation><inist:fA14 i1="16"><s1>University of Montreal Hospital Center</s1>
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<author><name sortKey="Ke, Chunlei" sort="Ke, Chunlei" uniqKey="Ke C" first="Chunlei" last="Ke">Chunlei Ke</name>
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<author><name sortKey="Braun, Ada" sort="Braun, Ada" uniqKey="Braun A" first="Ada" last="Braun">Ada Braun</name>
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</author>
<author><name sortKey="Jun, Susie" sort="Jun, Susie" uniqKey="Jun S" first="Susie" last="Jun">Susie Jun</name>
<affiliation><inist:fA14 i1="17"><s1>Amgen Inc</s1>
<s2>Thousand Oaks, CA</s2>
<s3>USA</s3>
<sZ>17 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>19 aut.</sZ>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Superiority of denosumab to zoledronic acid for prevention of skeletal-related events: A combined analysis of 3 pivotal, randomised, phase 3 trials</title>
<author><name sortKey="Lipton, Allan" sort="Lipton, Allan" uniqKey="Lipton A" first="Allan" last="Lipton">Allan Lipton</name>
<affiliation><inist:fA14 i1="01"><s1>Pennsylvania State University, Milton S. Hershey Medical Center</s1>
<s2>Hershey, PA</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name>
<affiliation><inist:fA14 i1="02"><s1>Institut Gustave Roussy, University of Paris Sud</s1>
<s2>Villejuif</s2>
<s3>FRA</s3>
<sZ>2 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Stopeck, Alison T" sort="Stopeck, Alison T" uniqKey="Stopeck A" first="Alison T." last="Stopeck">Alison T. Stopeck</name>
<affiliation><inist:fA14 i1="03"><s1>University of Arizona, Arizona Cancer Center</s1>
<s2>Tucson, AZ</s2>
<s3>USA</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Henry, David H" sort="Henry, David H" uniqKey="Henry D" first="David H." last="Henry">David H. Henry</name>
<affiliation><inist:fA14 i1="04"><s1>Joan Karnell Cancer Center at Pennsylvania Hospital</s1>
<s2>Philadelphia, PA</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Brown, Janet E" sort="Brown, Janet E" uniqKey="Brown J" first="Janet E." last="Brown">Janet E. Brown</name>
<affiliation><inist:fA14 i1="05"><s1>Cancer Research UK Clinical Centre</s1>
<s2>Leeds</s2>
<s3>GBR</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Yardley, Denise A" sort="Yardley, Denise A" uniqKey="Yardley D" first="Denise A." last="Yardley">Denise A. Yardley</name>
<affiliation><inist:fA14 i1="06"><s1>Sarah Cannon Research Institute and Tennessee Oncology, PLLC</s1>
<s2>Nashville, TN</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Richardson, Gary E" sort="Richardson, Gary E" uniqKey="Richardson G" first="Gary E." last="Richardson">Gary E. Richardson</name>
<affiliation><inist:fA14 i1="07"><s1>Cabrini Hospital</s1>
<s2>Malvern, Vic</s2>
<s3>AUS</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Siena, Salvatore" sort="Siena, Salvatore" uniqKey="Siena S" first="Salvatore" last="Siena">Salvatore Siena</name>
<affiliation><inist:fA14 i1="08"><s1>Ospedale Niguarda Ca' Granda</s1>
<s2>Milan</s2>
<s3>ITA</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Maroto, Pablo" sort="Maroto, Pablo" uniqKey="Maroto P" first="Pablo" last="Maroto">Pablo Maroto</name>
<affiliation><inist:fA14 i1="09"><s1>Hospital de La Santa Creu i Sant Pau</s1>
<s2>Barcelona</s2>
<s3>ESP</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Clemens, Michael" sort="Clemens, Michael" uniqKey="Clemens M" first="Michael" last="Clemens">Michael Clemens</name>
<affiliation><inist:fA14 i1="10"><s1>Klinikum Mutterhaus der Borromaeerinnen</s1>
<s2>Trier</s2>
<s3>DEU</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Bilynskyy, Boris" sort="Bilynskyy, Boris" uniqKey="Bilynskyy B" first="Boris" last="Bilynskyy">Boris Bilynskyy</name>
<affiliation><inist:fA14 i1="11"><s1>Cancer Treatment and Diagnostic Center</s1>
<s2>Lviv</s2>
<s3>UKR</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Charu, Veena" sort="Charu, Veena" uniqKey="Charu V" first="Veena" last="Charu">Veena Charu</name>
<affiliation><inist:fA14 i1="12"><s1>Pacific Cancer Medical Center Inc.</s1>
<s2>Anaheim, CA</s2>
<s3>USA</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Beuzeboc, Philippe" sort="Beuzeboc, Philippe" uniqKey="Beuzeboc P" first="Philippe" last="Beuzeboc">Philippe Beuzeboc</name>
<affiliation><inist:fA14 i1="13"><s1>Institut Curie</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Rader, Michael" sort="Rader, Michael" uniqKey="Rader M" first="Michael" last="Rader">Michael Rader</name>
<affiliation><inist:fA14 i1="14"><s1>Union State Bank Cancer Center, Nyack Hospital</s1>
<s2>Nyack, NY</s2>
<s3>USA</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Viniegra, Maria" sort="Viniegra, Maria" uniqKey="Viniegra M" first="Maria" last="Viniegra">Maria Viniegra</name>
<affiliation><inist:fA14 i1="15"><s1>Corporacion Medica de General San Martin</s1>
<s2>Buenos Aires</s2>
<s3>ARG</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name>
<affiliation><inist:fA14 i1="16"><s1>University of Montreal Hospital Center</s1>
<s2>Montreal, QC</s2>
<s3>CAN</s3>
<sZ>16 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Ke, Chunlei" sort="Ke, Chunlei" uniqKey="Ke C" first="Chunlei" last="Ke">Chunlei Ke</name>
<affiliation><inist:fA14 i1="17"><s1>Amgen Inc</s1>
<s2>Thousand Oaks, CA</s2>
<s3>USA</s3>
<sZ>17 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>19 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Braun, Ada" sort="Braun, Ada" uniqKey="Braun A" first="Ada" last="Braun">Ada Braun</name>
<affiliation><inist:fA14 i1="17"><s1>Amgen Inc</s1>
<s2>Thousand Oaks, CA</s2>
<s3>USA</s3>
<sZ>17 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>19 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Jun, Susie" sort="Jun, Susie" uniqKey="Jun S" first="Susie" last="Jun">Susie Jun</name>
<affiliation><inist:fA14 i1="17"><s1>Amgen Inc</s1>
<s2>Thousand Oaks, CA</s2>
<s3>USA</s3>
<sZ>17 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>19 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">European journal of cancer : (1990)</title>
<title level="j" type="abbreviated">Eur. j. cancer : (1990)</title>
<idno type="ISSN">0959-8049</idno>
<imprint><date when="2012">2012</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">European journal of cancer : (1990)</title>
<title level="j" type="abbreviated">Eur. j. cancer : (1990)</title>
<idno type="ISSN">0959-8049</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antineoplastic agent</term>
<term>Antiresorptive agent</term>
<term>Bone metastasis</term>
<term>Cancerology</term>
<term>Clinical trial</term>
<term>Denosumab</term>
<term>Phase III trial</term>
<term>Prevention</term>
<term>Skeleton</term>
<term>Zoledronic acid</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Dénosumab</term>
<term>Prévention</term>
<term>Squelette</term>
<term>Acide zolédronique</term>
<term>Essai clinique</term>
<term>Cancérologie</term>
<term>Essai clinique phase III</term>
<term>Métastase osseuse</term>
<term>Antirésorptif</term>
<term>Anticancéreux</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Background: Patients with bone metastases from advanced cancer often experience skeletal-related events (SRE), which cause substantial pain and morbidity. Denosumab, a fully human monoclonal antibody that inhibits RANK Ligand (RANKL), is a novel bone-targeted agent with a distinct mechanism of action relative to the bisphosphonate zoledronic acid, for prevention of SRE. This pre-planned analysis evaluates the efficacy and safety of denosumab versus zoledronic acid across three pivotal studies. Methods: Patient-level data from three identically designed, randomised, double-blind, active-controlled, phase 3 trials of patients with breast cancer, prostate cancer, other solid tumours or multiple myeloma were combined. End-points included time to first SRE, time to first and subsequent (multiple) SRE, adverse events, time to disease progression and overall survival. Findings: Denosumab was superior to zoledronic acid in delaying time to first on-study SRE by a median 8.21 months, reducing the risk of a first SRE by 17% (hazard ratio, 0.83 [95% confidence interval (CI): 0.76-0.90]; P < 0.001). Efficacy was demonstrated for first and multiple events and across patient subgroups (prior SRE status; age). Disease progression and overall survival were similar between the treatments. In contrast to zoledronic acid, denosumab did not require monitoring or dose modification/withholding based on renal status, and was not associated with acute-phase reactions. Hypocalcaemia was more common for denosumab. Osteonecrosis of the jaw occurred at a similar rate (P = 0.13). Conclusion: Denosumab was superior to zoledronic acid in preventing SRE with favourable safety and convenience in patients with bone metastases from advanced cancer.</div>
</front>
</TEI>
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<fA08 i1="01" i2="1" l="ENG"><s1>Superiority of denosumab to zoledronic acid for prevention of skeletal-related events: A combined analysis of 3 pivotal, randomised, phase 3 trials</s1>
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<fA11 i1="01" i2="1"><s1>LIPTON (Allan)</s1>
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<fA11 i1="02" i2="1"><s1>FIZAZI (Karim)</s1>
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<fA11 i1="08" i2="1"><s1>SIENA (Salvatore)</s1>
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<fA11 i1="09" i2="1"><s1>MAROTO (Pablo)</s1>
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<fA11 i1="10" i2="1"><s1>CLEMENS (Michael)</s1>
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<fA11 i1="11" i2="1"><s1>BILYNSKYY (Boris)</s1>
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<fA11 i1="12" i2="1"><s1>CHARU (Veena)</s1>
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<fA11 i1="13" i2="1"><s1>BEUZEBOC (Philippe)</s1>
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<fA11 i1="14" i2="1"><s1>RADER (Michael)</s1>
</fA11>
<fA11 i1="15" i2="1"><s1>VINIEGRA (Maria)</s1>
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<fA11 i1="16" i2="1"><s1>SAAD (Fred)</s1>
</fA11>
<fA11 i1="17" i2="1"><s1>KE (Chunlei)</s1>
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<fA11 i1="18" i2="1"><s1>BRAUN (Ada)</s1>
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<fA11 i1="19" i2="1"><s1>JUN (Susie)</s1>
</fA11>
<fA14 i1="01"><s1>Pennsylvania State University, Milton S. Hershey Medical Center</s1>
<s2>Hershey, PA</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>Institut Gustave Roussy, University of Paris Sud</s1>
<s2>Villejuif</s2>
<s3>FRA</s3>
<sZ>2 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>University of Arizona, Arizona Cancer Center</s1>
<s2>Tucson, AZ</s2>
<s3>USA</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>Joan Karnell Cancer Center at Pennsylvania Hospital</s1>
<s2>Philadelphia, PA</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>Cancer Research UK Clinical Centre</s1>
<s2>Leeds</s2>
<s3>GBR</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>Sarah Cannon Research Institute and Tennessee Oncology, PLLC</s1>
<s2>Nashville, TN</s2>
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<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>Cabrini Hospital</s1>
<s2>Malvern, Vic</s2>
<s3>AUS</s3>
<sZ>7 aut.</sZ>
</fA14>
<fA14 i1="08"><s1>Ospedale Niguarda Ca' Granda</s1>
<s2>Milan</s2>
<s3>ITA</s3>
<sZ>8 aut.</sZ>
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<fA14 i1="09"><s1>Hospital de La Santa Creu i Sant Pau</s1>
<s2>Barcelona</s2>
<s3>ESP</s3>
<sZ>9 aut.</sZ>
</fA14>
<fA14 i1="10"><s1>Klinikum Mutterhaus der Borromaeerinnen</s1>
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<sZ>10 aut.</sZ>
</fA14>
<fA14 i1="11"><s1>Cancer Treatment and Diagnostic Center</s1>
<s2>Lviv</s2>
<s3>UKR</s3>
<sZ>11 aut.</sZ>
</fA14>
<fA14 i1="12"><s1>Pacific Cancer Medical Center Inc.</s1>
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<sZ>12 aut.</sZ>
</fA14>
<fA14 i1="13"><s1>Institut Curie</s1>
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<s3>FRA</s3>
<sZ>13 aut.</sZ>
</fA14>
<fA14 i1="14"><s1>Union State Bank Cancer Center, Nyack Hospital</s1>
<s2>Nyack, NY</s2>
<s3>USA</s3>
<sZ>14 aut.</sZ>
</fA14>
<fA14 i1="15"><s1>Corporacion Medica de General San Martin</s1>
<s2>Buenos Aires</s2>
<s3>ARG</s3>
<sZ>15 aut.</sZ>
</fA14>
<fA14 i1="16"><s1>University of Montreal Hospital Center</s1>
<s2>Montreal, QC</s2>
<s3>CAN</s3>
<sZ>16 aut.</sZ>
</fA14>
<fA14 i1="17"><s1>Amgen Inc</s1>
<s2>Thousand Oaks, CA</s2>
<s3>USA</s3>
<sZ>17 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>19 aut.</sZ>
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<fA20><s1>3082-3092</s1>
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<fA60><s1>P</s1>
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<fA64 i1="01" i2="1"><s0>European journal of cancer : (1990)</s0>
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<fC01 i1="01" l="ENG"><s0>Background: Patients with bone metastases from advanced cancer often experience skeletal-related events (SRE), which cause substantial pain and morbidity. Denosumab, a fully human monoclonal antibody that inhibits RANK Ligand (RANKL), is a novel bone-targeted agent with a distinct mechanism of action relative to the bisphosphonate zoledronic acid, for prevention of SRE. This pre-planned analysis evaluates the efficacy and safety of denosumab versus zoledronic acid across three pivotal studies. Methods: Patient-level data from three identically designed, randomised, double-blind, active-controlled, phase 3 trials of patients with breast cancer, prostate cancer, other solid tumours or multiple myeloma were combined. End-points included time to first SRE, time to first and subsequent (multiple) SRE, adverse events, time to disease progression and overall survival. Findings: Denosumab was superior to zoledronic acid in delaying time to first on-study SRE by a median 8.21 months, reducing the risk of a first SRE by 17% (hazard ratio, 0.83 [95% confidence interval (CI): 0.76-0.90]; P < 0.001). Efficacy was demonstrated for first and multiple events and across patient subgroups (prior SRE status; age). Disease progression and overall survival were similar between the treatments. In contrast to zoledronic acid, denosumab did not require monitoring or dose modification/withholding based on renal status, and was not associated with acute-phase reactions. Hypocalcaemia was more common for denosumab. Osteonecrosis of the jaw occurred at a similar rate (P = 0.13). Conclusion: Denosumab was superior to zoledronic acid in preventing SRE with favourable safety and convenience in patients with bone metastases from advanced cancer.</s0>
</fC01>
<fC02 i1="01" i2="X"><s0>002B02</s0>
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<fC03 i1="04" i2="X" l="FRE"><s0>Acide zolédronique</s0>
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<fC03 i1="04" i2="X" l="ENG"><s0>Zoledronic acid</s0>
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<s5>10</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Metástasis ósea</s0>
<s2>NM</s2>
<s5>10</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE"><s0>Antirésorptif</s0>
<s5>25</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG"><s0>Antiresorptive agent</s0>
<s5>25</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA"><s0>Antirresortivo</s0>
<s5>25</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE"><s0>Anticancéreux</s0>
<s5>26</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG"><s0>Antineoplastic agent</s0>
<s5>26</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA"><s0>Anticanceroso</s0>
<s5>26</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Anticorps monoclonal</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Monoclonal antibody</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Anticuerpo monoclonal</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Bisphosphonates</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Bisphosphonates</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Bisfosfonatos</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="FRE"><s0>Dérivé de l'acide diphosphonique</s0>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Diphosphonic acid derivatives</s0>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Difosfonico ácido derivado</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Pathologie du système ostéoarticulaire</s0>
<s5>40</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>Diseases of the osteoarticular system</s0>
<s5>40</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Sistema osteoarticular patología</s0>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="FRE"><s0>Tumeur maligne</s0>
<s2>NM</s2>
<s5>41</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG"><s0>Malignant tumor</s0>
<s2>NM</s2>
<s5>41</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA"><s0>Tumor maligno</s0>
<s2>NM</s2>
<s5>41</s5>
</fC07>
<fC07 i1="06" i2="X" l="FRE"><s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="06" i2="X" l="ENG"><s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="06" i2="X" l="SPA"><s0>Cáncer</s0>
<s2>NM</s2>
</fC07>
<fN21><s1>338</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
<server><NO>PASCAL 12-0435730 INIST</NO>
<ET>Superiority of denosumab to zoledronic acid for prevention of skeletal-related events: A combined analysis of 3 pivotal, randomised, phase 3 trials</ET>
<AU>LIPTON (Allan); FIZAZI (Karim); STOPECK (Alison T.); HENRY (David H.); BROWN (Janet E.); YARDLEY (Denise A.); RICHARDSON (Gary E.); SIENA (Salvatore); MAROTO (Pablo); CLEMENS (Michael); BILYNSKYY (Boris); CHARU (Veena); BEUZEBOC (Philippe); RADER (Michael); VINIEGRA (Maria); SAAD (Fred); KE (Chunlei); BRAUN (Ada); JUN (Susie)</AU>
<AF>Pennsylvania State University, Milton S. Hershey Medical Center/Hershey, PA/Etats-Unis (1 aut.); Institut Gustave Roussy, University of Paris Sud/Villejuif/France (2 aut.); University of Arizona, Arizona Cancer Center/Tucson, AZ/Etats-Unis (3 aut.); Joan Karnell Cancer Center at Pennsylvania Hospital/Philadelphia, PA/Etats-Unis (4 aut.); Cancer Research UK Clinical Centre/Leeds/Royaume-Uni (5 aut.); Sarah Cannon Research Institute and Tennessee Oncology, PLLC/Nashville, TN/Etats-Unis (6 aut.); Cabrini Hospital/Malvern, Vic/Australie (7 aut.); Ospedale Niguarda Ca' Granda/Milan/Italie (8 aut.); Hospital de La Santa Creu i Sant Pau/Barcelona/Espagne (9 aut.); Klinikum Mutterhaus der Borromaeerinnen/Trier/Allemagne (10 aut.); Cancer Treatment and Diagnostic Center/Lviv/Ukraine (11 aut.); Pacific Cancer Medical Center Inc./Anaheim, CA/Etats-Unis (12 aut.); Institut Curie/Paris/France (13 aut.); Union State Bank Cancer Center, Nyack Hospital/Nyack, NY/Etats-Unis (14 aut.); Corporacion Medica de General San Martin/Buenos Aires/Argentine (15 aut.); University of Montreal Hospital Center/Montreal, QC/Canada (16 aut.); Amgen Inc/Thousand Oaks, CA/Etats-Unis (17 aut., 18 aut., 19 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>European journal of cancer : (1990); ISSN 0959-8049; Royaume-Uni; Da. 2012; Vol. 48; No. 16; Pp. 3082-3092; Bibl. 36 ref.</SO>
<LA>Anglais</LA>
<EA>Background: Patients with bone metastases from advanced cancer often experience skeletal-related events (SRE), which cause substantial pain and morbidity. Denosumab, a fully human monoclonal antibody that inhibits RANK Ligand (RANKL), is a novel bone-targeted agent with a distinct mechanism of action relative to the bisphosphonate zoledronic acid, for prevention of SRE. This pre-planned analysis evaluates the efficacy and safety of denosumab versus zoledronic acid across three pivotal studies. Methods: Patient-level data from three identically designed, randomised, double-blind, active-controlled, phase 3 trials of patients with breast cancer, prostate cancer, other solid tumours or multiple myeloma were combined. End-points included time to first SRE, time to first and subsequent (multiple) SRE, adverse events, time to disease progression and overall survival. Findings: Denosumab was superior to zoledronic acid in delaying time to first on-study SRE by a median 8.21 months, reducing the risk of a first SRE by 17% (hazard ratio, 0.83 [95% confidence interval (CI): 0.76-0.90]; P < 0.001). Efficacy was demonstrated for first and multiple events and across patient subgroups (prior SRE status; age). Disease progression and overall survival were similar between the treatments. In contrast to zoledronic acid, denosumab did not require monitoring or dose modification/withholding based on renal status, and was not associated with acute-phase reactions. Hypocalcaemia was more common for denosumab. Osteonecrosis of the jaw occurred at a similar rate (P = 0.13). Conclusion: Denosumab was superior to zoledronic acid in preventing SRE with favourable safety and convenience in patients with bone metastases from advanced cancer.</EA>
<CC>002B02; 002B04</CC>
<FD>Dénosumab; Prévention; Squelette; Acide zolédronique; Essai clinique; Cancérologie; Essai clinique phase III; Métastase osseuse; Antirésorptif; Anticancéreux</FD>
<FG>Anticorps monoclonal; Bisphosphonates; Dérivé de l'acide diphosphonique; Pathologie du système ostéoarticulaire; Tumeur maligne; Cancer</FG>
<ED>Denosumab; Prevention; Skeleton; Zoledronic acid; Clinical trial; Cancerology; Phase III trial; Bone metastasis; Antiresorptive agent; Antineoplastic agent</ED>
<EG>Monoclonal antibody; Bisphosphonates; Diphosphonic acid derivatives; Diseases of the osteoarticular system; Malignant tumor; Cancer</EG>
<SD>Denosumab; Prevención; Esqueleto; Acido zoledrónico; Ensayo clínico; Cancerología; Ensayo clínico fase III; Metástasis ósea; Antirresortivo; Anticanceroso</SD>
<LO>INIST-12648.354000509589750170</LO>
<ID>12-0435730</ID>
</server>
</inist>
</record>

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Superiority of denosumab to zoledronic acid for prevention of skeletal-related events: A combined analysis of 3 pivotal, randomised, phase 3 trials

Superiority of denosumab to zoledronic acid for prevention of skeletal-related events: A combined analysis of 3 pivotal, randomised, phase 3 trials

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