UnivTrevesV1, PascalFrancis, Curation, bibRecord, 000A68

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

Identifieur interne : 000A68 ( PascalFrancis/Curation ); précédent : 000A67; suivant : 000A69

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 [États-Unis] ; Karim Fizazi [France] ; Alison T. Stopeck [États-Unis] ; David H. Henry [États-Unis] ; Janet E. Brown [Royaume-Uni] ; Denise A. Yardley [États-Unis] ; Gary E. Richardson [Australie] ; Salvatore Siena [Italie] ; Pablo Maroto [Espagne] ; Michael Clemens [Allemagne] ; Boris Bilynskyy [Ukraine] ; Veena Charu [États-Unis] ; Philippe Beuzeboc [France] ; Michael Rader [États-Unis] ; Maria Viniegra [Argentine] ; Fred Saad [Canada] ; Chunlei Ke [États-Unis] ; Ada Braun [États-Unis] ; Susie Jun [États-Unis]

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.

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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`
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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.
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Le document en format XML

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<author><name sortKey="Stopeck, Alison T" sort="Stopeck, Alison T" uniqKey="Stopeck A" first="Alison T." last="Stopeck">Alison T. Stopeck</name>
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<author><name sortKey="Henry, David H" sort="Henry, David H" uniqKey="Henry D" first="David H." last="Henry">David H. Henry</name>
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<author><name sortKey="Brown, Janet E" sort="Brown, Janet E" uniqKey="Brown J" first="Janet E." last="Brown">Janet E. Brown</name>
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<author><name sortKey="Yardley, Denise A" sort="Yardley, Denise A" uniqKey="Yardley D" first="Denise A." last="Yardley">Denise A. Yardley</name>
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<author><name sortKey="Richardson, Gary E" sort="Richardson, Gary E" uniqKey="Richardson G" first="Gary E." last="Richardson">Gary E. Richardson</name>
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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="Clemens, Michael" sort="Clemens, Michael" uniqKey="Clemens M" first="Michael" last="Clemens">Michael Clemens</name>
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<country>Allemagne</country>
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<author><name sortKey="Bilynskyy, Boris" sort="Bilynskyy, Boris" uniqKey="Bilynskyy B" first="Boris" last="Bilynskyy">Boris Bilynskyy</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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<s2>Paris</s2>
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<country>France</country>
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<author><name sortKey="Rader, Michael" sort="Rader, Michael" uniqKey="Rader M" first="Michael" last="Rader">Michael Rader</name>
<affiliation wicri:level="1"><inist:fA14 i1="14"><s1>Union State Bank Cancer Center, Nyack Hospital</s1>
<s2>Nyack, NY</s2>
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<sZ>14 aut.</sZ>
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<country>États-Unis</country>
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</author>
<author><name sortKey="Viniegra, Maria" sort="Viniegra, Maria" uniqKey="Viniegra M" first="Maria" last="Viniegra">Maria Viniegra</name>
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<country>Argentine</country>
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</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="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>
<affiliation wicri:level="1"><inist:fA14 i1="17"><s1>Amgen Inc</s1>
<s2>Thousand Oaks, CA</s2>
<s3>USA</s3>
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<author><name sortKey="Braun, Ada" sort="Braun, Ada" uniqKey="Braun A" first="Ada" last="Braun">Ada Braun</name>
<affiliation wicri:level="1"><inist:fA14 i1="17"><s1>Amgen Inc</s1>
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<country>États-Unis</country>
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</author>
<author><name sortKey="Jun, Susie" sort="Jun, Susie" uniqKey="Jun S" first="Susie" last="Jun">Susie Jun</name>
<affiliation wicri:level="1"><inist:fA14 i1="17"><s1>Amgen Inc</s1>
<s2>Thousand Oaks, CA</s2>
<s3>USA</s3>
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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 wicri:level="1"><inist:fA14 i1="01"><s1>Pennsylvania State University, Milton S. Hershey Medical Center</s1>
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</inist:fA14>
<country>États-Unis</country>
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</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="02"><s1>Institut Gustave Roussy, University of Paris Sud</s1>
<s2>Villejuif</s2>
<s3>FRA</s3>
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</inist:fA14>
<country>France</country>
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</author>
<author><name sortKey="Stopeck, Alison T" sort="Stopeck, Alison T" uniqKey="Stopeck A" first="Alison T." last="Stopeck">Alison T. Stopeck</name>
<affiliation wicri:level="1"><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>
<country>États-Unis</country>
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<s3>GBR</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
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</author>
<author><name sortKey="Yardley, Denise A" sort="Yardley, Denise A" uniqKey="Yardley D" first="Denise A." last="Yardley">Denise A. Yardley</name>
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<s2>Nashville, TN</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
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<country>États-Unis</country>
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<author><name sortKey="Richardson, Gary E" sort="Richardson, Gary E" uniqKey="Richardson G" first="Gary E." last="Richardson">Gary E. Richardson</name>
<affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Cabrini Hospital</s1>
<s2>Malvern, Vic</s2>
<s3>AUS</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>Australie</country>
</affiliation>
</author>
<author><name sortKey="Siena, Salvatore" sort="Siena, Salvatore" uniqKey="Siena S" first="Salvatore" last="Siena">Salvatore Siena</name>
<affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Ospedale Niguarda Ca' Granda</s1>
<s2>Milan</s2>
<s3>ITA</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>Italie</country>
</affiliation>
</author>
<author><name sortKey="Maroto, Pablo" sort="Maroto, Pablo" uniqKey="Maroto P" first="Pablo" last="Maroto">Pablo Maroto</name>
<affiliation wicri:level="1"><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>
<country>Espagne</country>
</affiliation>
</author>
<author><name sortKey="Clemens, Michael" sort="Clemens, Michael" uniqKey="Clemens M" first="Michael" last="Clemens">Michael Clemens</name>
<affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Klinikum Mutterhaus der Borromaeerinnen</s1>
<s2>Trier</s2>
<s3>DEU</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
</affiliation>
</author>
<author><name sortKey="Bilynskyy, Boris" sort="Bilynskyy, Boris" uniqKey="Bilynskyy B" first="Boris" last="Bilynskyy">Boris Bilynskyy</name>
<affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Cancer Treatment and Diagnostic Center</s1>
<s2>Lviv</s2>
<s3>UKR</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>Ukraine</country>
</affiliation>
</author>
<author><name sortKey="Charu, Veena" sort="Charu, Veena" uniqKey="Charu V" first="Veena" last="Charu">Veena Charu</name>
<affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Pacific Cancer Medical Center Inc.</s1>
<s2>Anaheim, CA</s2>
<s3>USA</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Beuzeboc, Philippe" sort="Beuzeboc, Philippe" uniqKey="Beuzeboc P" first="Philippe" last="Beuzeboc">Philippe Beuzeboc</name>
<affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Institut Curie</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>France</country>
</affiliation>
</author>
<author><name sortKey="Rader, Michael" sort="Rader, Michael" uniqKey="Rader M" first="Michael" last="Rader">Michael Rader</name>
<affiliation wicri:level="1"><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>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Viniegra, Maria" sort="Viniegra, Maria" uniqKey="Viniegra M" first="Maria" last="Viniegra">Maria Viniegra</name>
<affiliation wicri:level="1"><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>
<country>Argentine</country>
</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="16"><s1>University of Montreal Hospital Center</s1>
<s2>Montreal, QC</s2>
<s3>CAN</s3>
<sZ>16 aut.</sZ>
</inist:fA14>
<country>Canada</country>
</affiliation>
</author>
<author><name sortKey="Ke, Chunlei" sort="Ke, Chunlei" uniqKey="Ke C" first="Chunlei" last="Ke">Chunlei Ke</name>
<affiliation wicri:level="1"><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>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Braun, Ada" sort="Braun, Ada" uniqKey="Braun A" first="Ada" last="Braun">Ada Braun</name>
<affiliation wicri:level="1"><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>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Jun, Susie" sort="Jun, Susie" uniqKey="Jun S" first="Susie" last="Jun">Susie Jun</name>
<affiliation wicri:level="1"><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>
<country>États-Unis</country>
</affiliation>
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</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>
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<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>
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<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>
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</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>
</fA08>
<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="03" i2="1"><s1>STOPECK (Alison T.)</s1>
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<fA11 i1="04" i2="1"><s1>HENRY (David H.)</s1>
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<fA11 i1="05" i2="1"><s1>BROWN (Janet E.)</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>
</fA11>
<fA11 i1="14" i2="1"><s1>RADER (Michael)</s1>
</fA11>
<fA11 i1="15" i2="1"><s1>VINIEGRA (Maria)</s1>
</fA11>
<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="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>
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<sZ>5 aut.</sZ>
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<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>Cabrini Hospital</s1>
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<s3>AUS</s3>
<sZ>7 aut.</sZ>
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<fA14 i1="08"><s1>Ospedale Niguarda Ca' Granda</s1>
<s2>Milan</s2>
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<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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<s3>DEU</s3>
<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>
<s2>Paris</s2>
<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>
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<sZ>17 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>19 aut.</sZ>
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<fA20><s1>3082-3092</s1>
</fA20>
<fA21><s1>2012</s1>
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<fA23 i1="01"><s0>ENG</s0>
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<fA43 i1="01"><s1>INIST</s1>
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<fA47 i1="01" i2="1"><s0>12-0435730</s0>
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<fA60><s1>P</s1>
</fA60>
<fA61><s0>A</s0>
</fA61>
<fA64 i1="01" i2="1"><s0>European journal of cancer : (1990)</s0>
</fA64>
<fA66 i1="01"><s0>GBR</s0>
</fA66>
<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>
</fC02>
<fC02 i1="02" i2="X"><s0>002B04</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE"><s0>Dénosumab</s0>
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<s5>01</s5>
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<fC03 i1="01" i2="X" l="ENG"><s0>Denosumab</s0>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA"><s0>Denosumab</s0>
<s2>FR</s2>
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<fC03 i1="03" i2="X" l="FRE"><s0>Squelette</s0>
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<s5>03</s5>
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<fC03 i1="03" i2="X" l="SPA"><s0>Esqueleto</s0>
<s5>03</s5>
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<fC03 i1="04" i2="X" l="FRE"><s0>Acide zolédronique</s0>
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<s5>04</s5>
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<fC03 i1="04" i2="X" l="ENG"><s0>Zoledronic acid</s0>
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<s2>FR</s2>
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<fC03 i1="04" i2="X" l="SPA"><s0>Acido zoledrónico</s0>
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<fC03 i1="05" i2="X" l="FRE"><s0>Essai clinique</s0>
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<s5>10</s5>
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<fC03 i1="08" i2="X" l="ENG"><s0>Bone metastasis</s0>
<s2>NM</s2>
<s5>10</s5>
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<s5>25</s5>
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<s5>26</s5>
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<s5>26</s5>
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<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>
</inist>
</record>

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   |texte=   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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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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