AustralieFrV1, Main, Exploration, bibRecord, 005E27

Bone-Related Complications and Quality of Life in Advanced Breast Cancer: Results from a Randomized Phase III Trial of Denosumab versus Zoledronic Acid

Identifieur interne : 005E27 ( Main/Exploration ); précédent : 005E26; suivant : 005E28

Bone-Related Complications and Quality of Life in Advanced Breast Cancer: Results from a Randomized Phase III Trial of Denosumab versus Zoledronic Acid

Auteurs : Miguel Martin [Espagne] ; Richard Bell [Australie] ; Hugues Bourgeois [France] ; Adam Brufsky [États-Unis] ; Ingo Diel [Allemagne] ; Alexandru Eniu [Roumanie] ; Lesley Fallowfield [Royaume-Uni] ; Yasuhiro Fujiwara [Japon] ; Jacek Jassem [Pologne] ; Alexander H. G. Paterson [Canada] ; Diana Ritchie [Royaume-Uni] ; Gunther G. Steger [Autriche] ; Alison Stopeck [États-Unis] ; Charles Vogel [États-Unis] ; Michelle Fan [États-Unis] ; QI JIANG [Allemagne] ; Karen Chung [États-Unis] ; Roger Dansey [États-Unis] ; Ada Braun [États-Unis]

Source :

Clinical cancer research [ 1078-0432 ] ; 2012.

RBID : Pascal:12-0378243

Descripteurs français

Pascal (Inist)
- Os, Complication, Qualité de vie, Stade avancé, Cancer du sein, Essai clinique, Randomisation, Essai clinique phase III, Homme, Chimiothérapie, Dénosumab, Etude comparative, Acide zolédronique, Anticancéreux, Antirésorptif.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Advanced stage, Antineoplastic agent, Antiresorptive agent, Bone, Breast cancer, Chemotherapy, Clinical trial, Comparative study, Complication, Denosumab, Human, Phase III trial, Quality of life, Randomization, Zoledronic acid.

Abstract

Purpose: Denosumab was shown to be superior to zoledronic acid in preventing skeletal related events (SRE) in patients with breast cancer and bone metastases in a randomized, double-blind phase III study. We evaluated further results from this study related to skeletal complications and health-related quality of life (HRQoL). Experimental Design: Patients were randomized 1:1 to receive subcutaneous denosumab 120 mg (n = 1,026) and intravenous placebo, or intravenous zoledronic acid 4 mg (n = 1,020) and subcutaneous placebo every 4 weeks. Analyses reported here include the proportion of patients with one or multiple on-study SREs, time to first radiation to bone, time to first SRE or hypercalcemia of malignancy, and change in HRQoL (functional assessment of cancer therapy-general). Results: Fewer patients receiving denosumab than zoledronic acid had an on-study SRE (31% vs. 36%, P = 0.006). The incidence of first radiation to bone was 12% (n = 123) with denosumab versus 16% (n = 162) with zoledronic acid. Denosumab prolonged the time to first radiation to bone by 26% versus zoledronic acid (HR, 0.74; 95% confidence interval [CI], 0.59-0.94, P = 0.012) and prolonged the time to first SRE or hypercalcemia of malignancy by 18% (HR, 0.82; 95% CI, 0.70-0.95; P = 0.007). Ten percent more patients had a clinically meaningful improvement in HRQoL with denosumab relative to zoledronic acid, regardless of baseline pain levels. Conclusions: Denosumab was superior to zoledronic acid in reducing bone-related complications of metastatic breast cancer and maintained HRQoL, providing an efficacious, well-tolerated treatment option for patients with bone metastases from breast cancer.

Affiliations:

Allemagne, Australie, Autriche, Canada, Espagne, France, Japon, Pologne, Roumanie, Royaume-Uni, États-Unis
Angleterre, Arizona, Bade-Wurtemberg, Californie, Communauté de Madrid, District de Karlsruhe, Floride, Pennsylvanie, Région de Kantō, Sussex de l'Est, Vienne (Autriche)
Brighton, Falmer, Madrid, Mannheim, Tokyo, Vienne (Autriche)
Université du Sussex

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Le document en format XML

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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Bone-Related Complications and Quality of Life in Advanced Breast Cancer: Results from a Randomized Phase III Trial of Denosumab versus Zoledronic Acid</title>
<author><name sortKey="Martin, Miguel" sort="Martin, Miguel" uniqKey="Martin M" first="Miguel" last="Martin">Miguel Martin</name>
<affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Complutense University and Hospital General Universitario Gregorio Maranon, Servicio De Oncologia Medica</s1>
<s2>Madrid</s2>
<s3>ESP</s3>
<sZ>1 aut.</sZ>
</inist:fA14>
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<author><name sortKey="Bell, Richard" sort="Bell, Richard" uniqKey="Bell R" first="Richard" last="Bell">Richard Bell</name>
<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Andrew Love Cancer Centre, Barwon Health, Geelong</s1>
<s2>Victoria</s2>
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</inist:fA14>
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<author><name sortKey="Bourgeois, Hugues" sort="Bourgeois, Hugues" uniqKey="Bourgeois H" first="Hugues" last="Bourgeois">Hugues Bourgeois</name>
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<author><name sortKey="Brufsky, Adam" sort="Brufsky, Adam" uniqKey="Brufsky A" first="Adam" last="Brufsky">Adam Brufsky</name>
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<author><name sortKey="Fujiwara, Yasuhiro" sort="Fujiwara, Yasuhiro" uniqKey="Fujiwara Y" first="Yasuhiro" last="Fujiwara">Yasuhiro Fujiwara</name>
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<author><name sortKey="Jassem, Jacek" sort="Jassem, Jacek" uniqKey="Jassem J" first="Jacek" last="Jassem">Jacek Jassem</name>
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<author><name sortKey="Paterson, Alexander H G" sort="Paterson, Alexander H G" uniqKey="Paterson A" first="Alexander H. G." last="Paterson">Alexander H. G. Paterson</name>
<affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Tom Baker Cancer Centre</s1>
<s2>Calgary, Alberta</s2>
<s3>CAN</s3>
<sZ>10 aut.</sZ>
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<country>Canada</country>
<wicri:noRegion>Tom Baker Cancer Centre</wicri:noRegion>
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<author><name sortKey="Ritchie, Diana" sort="Ritchie, Diana" uniqKey="Ritchie D" first="Diana" last="Ritchie">Diana Ritchie</name>
<affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Beatson Oncology Centre, Glasgow</s1>
<s2>Scotland</s2>
<s3>GBR</s3>
<sZ>11 aut.</sZ>
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<country>Royaume-Uni</country>
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<author><name sortKey="Steger, Gunther G" sort="Steger, Gunther G" uniqKey="Steger G" first="Gunther G." last="Steger">Gunther G. Steger</name>
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<region nuts="2" type="province">Vienne (Autriche)</region>
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<author><name sortKey="Stopeck, Alison" sort="Stopeck, Alison" uniqKey="Stopeck A" first="Alison" last="Stopeck">Alison Stopeck</name>
<affiliation wicri:level="2"><inist:fA14 i1="13"><s1>Arizona Cancer Center, University of Arizona</s1>
<s2>Tucson, Arizona</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Arizona</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Vogel, Charles" sort="Vogel, Charles" uniqKey="Vogel C" first="Charles" last="Vogel">Charles Vogel</name>
<affiliation wicri:level="2"><inist:fA14 i1="14"><s1>Sylvester Comprehensive Cancer Center at Deerfield, Deerfield Beach</s1>
<s2>Florida</s2>
<s3>USA</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Floride</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Fan, Michelle" sort="Fan, Michelle" uniqKey="Fan M" first="Michelle" last="Fan">Michelle Fan</name>
<affiliation wicri:level="2"><inist:fA14 i1="15"><s1>Department of Biostatistics, Amgen Inc.</s1>
<s2>Thousand Oaks, California</s2>
<s3>USA</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Qi Jiang" sort="Qi Jiang" uniqKey="Qi Jiang" last="Qi Jiang">QI JIANG</name>
<affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Onkologische Schwerpunktpraxis</s1>
<s2>Mannheim</s2>
<s3>DEU</s3>
<sZ>5 aut.</sZ>
<sZ>16 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<placeName><region type="land" nuts="1">Bade-Wurtemberg</region>
<region type="district" nuts="2">District de Karlsruhe</region>
<settlement type="city">Mannheim</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Chung, Karen" sort="Chung, Karen" uniqKey="Chung K" first="Karen" last="Chung">Karen Chung</name>
<affiliation wicri:level="2"><inist:fA14 i1="16"><s1>Global Health Economics, Amgen Inc.</s1>
<s2>Thousand Oaks, California</s2>
<s3>USA</s3>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Dansey, Roger" sort="Dansey, Roger" uniqKey="Dansey R" first="Roger" last="Dansey">Roger Dansey</name>
<affiliation wicri:level="2"><inist:fA14 i1="17"><s1>Department of Global Development, Amgen Inc.</s1>
<s2>Thousand Oaks, California</s2>
<s3>USA</s3>
<sZ>18 aut.</sZ>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Braun, Ada" sort="Braun, Ada" uniqKey="Braun A" first="Ada" last="Braun">Ada Braun</name>
<affiliation wicri:level="2"><inist:fA14 i1="17"><s1>Department of Global Development, Amgen Inc.</s1>
<s2>Thousand Oaks, California</s2>
<s3>USA</s3>
<sZ>18 aut.</sZ>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">Clinical cancer research</title>
<title level="j" type="abbreviated">Clin. cancer res.</title>
<idno type="ISSN">1078-0432</idno>
<imprint><date when="2012">2012</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">Clinical cancer research</title>
<title level="j" type="abbreviated">Clin. cancer res.</title>
<idno type="ISSN">1078-0432</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Advanced stage</term>
<term>Antineoplastic agent</term>
<term>Antiresorptive agent</term>
<term>Bone</term>
<term>Breast cancer</term>
<term>Chemotherapy</term>
<term>Clinical trial</term>
<term>Comparative study</term>
<term>Complication</term>
<term>Denosumab</term>
<term>Human</term>
<term>Phase III trial</term>
<term>Quality of life</term>
<term>Randomization</term>
<term>Zoledronic acid</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Os</term>
<term>Complication</term>
<term>Qualité de vie</term>
<term>Stade avancé</term>
<term>Cancer du sein</term>
<term>Essai clinique</term>
<term>Randomisation</term>
<term>Essai clinique phase III</term>
<term>Homme</term>
<term>Chimiothérapie</term>
<term>Dénosumab</term>
<term>Etude comparative</term>
<term>Acide zolédronique</term>
<term>Anticancéreux</term>
<term>Antirésorptif</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Purpose: Denosumab was shown to be superior to zoledronic acid in preventing skeletal related events (SRE) in patients with breast cancer and bone metastases in a randomized, double-blind phase III study. We evaluated further results from this study related to skeletal complications and health-related quality of life (HRQoL). Experimental Design: Patients were randomized 1:1 to receive subcutaneous denosumab 120 mg (n = 1,026) and intravenous placebo, or intravenous zoledronic acid 4 mg (n = 1,020) and subcutaneous placebo every 4 weeks. Analyses reported here include the proportion of patients with one or multiple on-study SREs, time to first radiation to bone, time to first SRE or hypercalcemia of malignancy, and change in HRQoL (functional assessment of cancer therapy-general). Results: Fewer patients receiving denosumab than zoledronic acid had an on-study SRE (31% vs. 36%, P = 0.006). The incidence of first radiation to bone was 12% (n = 123) with denosumab versus 16% (n = 162) with zoledronic acid. Denosumab prolonged the time to first radiation to bone by 26% versus zoledronic acid (HR, 0.74; 95% confidence interval [CI], 0.59-0.94, P = 0.012) and prolonged the time to first SRE or hypercalcemia of malignancy by 18% (HR, 0.82; 95% CI, 0.70-0.95; P = 0.007). Ten percent more patients had a clinically meaningful improvement in HRQoL with denosumab relative to zoledronic acid, regardless of baseline pain levels. Conclusions: Denosumab was superior to zoledronic acid in reducing bone-related complications of metastatic breast cancer and maintained HRQoL, providing an efficacious, well-tolerated treatment option for patients with bone metastases from breast cancer.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Autriche</li>
<li>Canada</li>
<li>Espagne</li>
<li>France</li>
<li>Japon</li>
<li>Pologne</li>
<li>Roumanie</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
</country>
<region><li>Angleterre</li>
<li>Arizona</li>
<li>Bade-Wurtemberg</li>
<li>Californie</li>
<li>Communauté de Madrid</li>
<li>District de Karlsruhe</li>
<li>Floride</li>
<li>Pennsylvanie</li>
<li>Région de Kantō</li>
<li>Sussex de l'Est</li>
<li>Vienne (Autriche)</li>
</region>
<settlement><li>Brighton</li>
<li>Falmer</li>
<li>Madrid</li>
<li>Mannheim</li>
<li>Tokyo</li>
<li>Vienne (Autriche)</li>
</settlement>
<orgName><li>Université du Sussex</li>
</orgName>
</list>
<tree><country name="Espagne"><region name="Communauté de Madrid"><name sortKey="Martin, Miguel" sort="Martin, Miguel" uniqKey="Martin M" first="Miguel" last="Martin">Miguel Martin</name>
</region>
</country>
<country name="Australie"><noRegion><name sortKey="Bell, Richard" sort="Bell, Richard" uniqKey="Bell R" first="Richard" last="Bell">Richard Bell</name>
</noRegion>
</country>
<country name="France"><noRegion><name sortKey="Bourgeois, Hugues" sort="Bourgeois, Hugues" uniqKey="Bourgeois H" first="Hugues" last="Bourgeois">Hugues Bourgeois</name>
</noRegion>
</country>
<country name="États-Unis"><region name="Pennsylvanie"><name sortKey="Brufsky, Adam" sort="Brufsky, Adam" uniqKey="Brufsky A" first="Adam" last="Brufsky">Adam Brufsky</name>
</region>
<name sortKey="Braun, Ada" sort="Braun, Ada" uniqKey="Braun A" first="Ada" last="Braun">Ada Braun</name>
<name sortKey="Chung, Karen" sort="Chung, Karen" uniqKey="Chung K" first="Karen" last="Chung">Karen Chung</name>
<name sortKey="Dansey, Roger" sort="Dansey, Roger" uniqKey="Dansey R" first="Roger" last="Dansey">Roger Dansey</name>
<name sortKey="Fan, Michelle" sort="Fan, Michelle" uniqKey="Fan M" first="Michelle" last="Fan">Michelle Fan</name>
<name sortKey="Stopeck, Alison" sort="Stopeck, Alison" uniqKey="Stopeck A" first="Alison" last="Stopeck">Alison Stopeck</name>
<name sortKey="Vogel, Charles" sort="Vogel, Charles" uniqKey="Vogel C" first="Charles" last="Vogel">Charles Vogel</name>
</country>
<country name="Allemagne"><region name="Bade-Wurtemberg"><name sortKey="Diel, Ingo" sort="Diel, Ingo" uniqKey="Diel I" first="Ingo" last="Diel">Ingo Diel</name>
</region>
<name sortKey="Qi Jiang" sort="Qi Jiang" uniqKey="Qi Jiang" last="Qi Jiang">QI JIANG</name>
</country>
<country name="Roumanie"><noRegion><name sortKey="Eniu, Alexandru" sort="Eniu, Alexandru" uniqKey="Eniu A" first="Alexandru" last="Eniu">Alexandru Eniu</name>
</noRegion>
</country>
<country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Fallowfield, Lesley" sort="Fallowfield, Lesley" uniqKey="Fallowfield L" first="Lesley" last="Fallowfield">Lesley Fallowfield</name>
</region>
<name sortKey="Ritchie, Diana" sort="Ritchie, Diana" uniqKey="Ritchie D" first="Diana" last="Ritchie">Diana Ritchie</name>
</country>
<country name="Japon"><region name="Région de Kantō"><name sortKey="Fujiwara, Yasuhiro" sort="Fujiwara, Yasuhiro" uniqKey="Fujiwara Y" first="Yasuhiro" last="Fujiwara">Yasuhiro Fujiwara</name>
</region>
</country>
<country name="Pologne"><noRegion><name sortKey="Jassem, Jacek" sort="Jassem, Jacek" uniqKey="Jassem J" first="Jacek" last="Jassem">Jacek Jassem</name>
</noRegion>
</country>
<country name="Canada"><noRegion><name sortKey="Paterson, Alexander H G" sort="Paterson, Alexander H G" uniqKey="Paterson A" first="Alexander H. G." last="Paterson">Alexander H. G. Paterson</name>
</noRegion>
</country>
<country name="Autriche"><region name="Vienne (Autriche)"><name sortKey="Steger, Gunther G" sort="Steger, Gunther G" uniqKey="Steger G" first="Gunther G." last="Steger">Gunther G. Steger</name>
</region>
</country>
</tree>
</affiliations>
</record>

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Bone-Related Complications and Quality of Life in Advanced Breast Cancer: Results from a Randomized Phase III Trial of Denosumab versus Zoledronic Acid

Bone-Related Complications and Quality of Life in Advanced Breast Cancer: Results from a Randomized Phase III Trial of Denosumab versus Zoledronic Acid

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