Serveur d'exploration sur les relations entre la France et l'Australie

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Effective Inhibition of Aromatase Inhibitor-associated Bone Loss by Zoledronic Acid in Postmenopausal Women With Early Breast Cancer Receiving Adjuvant Letrozole : ZO-FAST Study Results

Identifieur interne : 008D66 ( Main/Exploration ); précédent : 008D65; suivant : 008D67

Effective Inhibition of Aromatase Inhibitor-associated Bone Loss by Zoledronic Acid in Postmenopausal Women With Early Breast Cancer Receiving Adjuvant Letrozole : ZO-FAST Study Results

Auteurs : Nigel J. Bundred [Royaume-Uni] ; Ian D. Campbell [Nouvelle-Zélande] ; Neville Davidson [Royaume-Uni] ; Richard H. Deboer [Australie] ; Holger Eidtmann [Allemagne] ; Alain Monnier [France] ; Patrick Neven [Belgique] ; Gunter Von Minckwitz [Allemagne] ; Joel C. Miller [États-Unis] ; Nora L. Schenk [États-Unis] ; Robert E. Coleman [Royaume-Uni]

Source :

RBID : Pascal:08-0141620

Descripteurs français

English descriptors

Abstract

BACKGROUND. Letrozole is safe and effective in postmenopausal women with estrogen receptor-positive early breast cancer, but long-term aromatase inhibitor use may cause bone loss and increase fracture risk. This study evaluated an immediate or delayed strategy of bone protection therapy with zoledronic acid. METHODS. A total of 1065 patients who were receiving adjuvant letrozole were randomized to immediate-start or delayed-start zoledronic acid (4 mg intravenously biannually for 5 years). The delayed group received zoledronic acid if lumbar spine or total hip T-score decreased below -2.0 or when a nontraumatic fracture occurred. The primary endpoint was change in lumbar spine bone mineral density (BMD) at Month 12. Secondary endpoints included changes in total hip BMD, serum bone turnover markers, and safety at Month 12. RESULTS. Lumbar spine BMD increased from baseline in the immediate arm, while it decreased from baseline in delayed-arm patients. At Month 12, the differences between the groups in lumbar spine and total hip BMD were 5.7% (P<.0001; 95% confidence intervals [CI], 5.2% to 6.1%), and 3.6% (P<.0001; 95% CI, 3.3 to 4.0%), respectively. Both regimens were well tolerated with few serious adverse events. Bone pain was higher in the immediate group, as expected, because some patients experienced acute-phase reactions after zoledronic acid infusion. CONCLUSIONS. At 12 months, immediate zoledronic acid therapy prevented bone loss in postmenopausal women who were receiving adjuvant letrozole.


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Le document en format XML

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<name sortKey="Coleman, Robert E" sort="Coleman, Robert E" uniqKey="Coleman R" first="Robert E." last="Coleman">Robert E. Coleman</name>
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<title xml:lang="en" level="a">Effective Inhibition of Aromatase Inhibitor-associated Bone Loss by Zoledronic Acid in Postmenopausal Women With Early Breast Cancer Receiving Adjuvant Letrozole : ZO-FAST Study Results</title>
<author>
<name sortKey="Bundred, Nigel J" sort="Bundred, Nigel J" uniqKey="Bundred N" first="Nigel J." last="Bundred">Nigel J. Bundred</name>
<affiliation wicri:level="3">
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<country>Royaume-Uni</country>
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<settlement type="city">Manchester</settlement>
<region type="country">Angleterre</region>
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<author>
<name sortKey="Campbell, Ian D" sort="Campbell, Ian D" uniqKey="Campbell I" first="Ian D." last="Campbell">Ian D. Campbell</name>
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<s1>Waikato Hospital, Breast Care Center</s1>
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<country>Nouvelle-Zélande</country>
<wicri:noRegion>Hamilton</wicri:noRegion>
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<author>
<name sortKey="Davidson, Neville" sort="Davidson, Neville" uniqKey="Davidson N" first="Neville" last="Davidson">Neville Davidson</name>
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<s1>Broomfield Hospital, Chelmsford Essex</s1>
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<country>Royaume-Uni</country>
<wicri:noRegion>Broomfield Hospital, Chelmsford Essex</wicri:noRegion>
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<name sortKey="Deboer, Richard H" sort="Deboer, Richard H" uniqKey="Deboer R" first="Richard H." last="Deboer">Richard H. Deboer</name>
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<inist:fA14 i1="04">
<s1>Royal Melbourne Hospital</s1>
<s2>Victoria</s2>
<s3>AUS</s3>
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<country>Australie</country>
<wicri:noRegion>Royal Melbourne Hospital</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Eidtmann, Holger" sort="Eidtmann, Holger" uniqKey="Eidtmann H" first="Holger" last="Eidtmann">Holger Eidtmann</name>
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<s1>University Frauenklinik</s1>
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<sZ>5 aut.</sZ>
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<country>Allemagne</country>
<placeName>
<region type="land" nuts="2">Schleswig-Holstein</region>
<settlement type="city">Kiel</settlement>
</placeName>
</affiliation>
</author>
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<name sortKey="Monnier, Alain" sort="Monnier, Alain" uniqKey="Monnier A" first="Alain" last="Monnier">Alain Monnier</name>
<affiliation wicri:level="3">
<inist:fA14 i1="06">
<s1>Belfort-Montbeliard Central Hospital, Medical Oncology</s1>
<s2>Montbeliard</s2>
<s3>FRA</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName>
<region type="region">Bourgogne-Franche-Comté</region>
<region type="old region">Franche-Comté</region>
<settlement type="city">Montbéliard</settlement>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Neven, Patrick" sort="Neven, Patrick" uniqKey="Neven P" first="Patrick" last="Neven">Patrick Neven</name>
<affiliation wicri:level="1">
<inist:fA14 i1="07">
<s1>Hospital Gasthuisberg</s1>
<s2>Leuven</s2>
<s3>BEL</s3>
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<country>Belgique</country>
<wicri:noRegion>Hospital Gasthuisberg</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Von Minckwitz, Gunter" sort="Von Minckwitz, Gunter" uniqKey="Von Minckwitz G" first="Gunter" last="Von Minckwitz">Gunter Von Minckwitz</name>
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<s1>German Breast Group</s1>
<s2>Frankfurt</s2>
<s3>DEU</s3>
<sZ>8 aut.</sZ>
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<country>Allemagne</country>
<placeName>
<region type="land" nuts="1">Hesse (Land)</region>
<region type="district" nuts="2">District de Darmstadt</region>
<settlement type="city">Francfort-sur-le-Main</settlement>
</placeName>
</affiliation>
</author>
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<name sortKey="Miller, Joel C" sort="Miller, Joel C" uniqKey="Miller J" first="Joel C." last="Miller">Joel C. Miller</name>
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<s1>Novartis, Florham Park</s1>
<s2>New Jersey</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName>
<region type="state">New Jersey</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Schenk, Nora L" sort="Schenk, Nora L" uniqKey="Schenk N" first="Nora L." last="Schenk">Nora L. Schenk</name>
<affiliation wicri:level="2">
<inist:fA14 i1="09">
<s1>Novartis, Florham Park</s1>
<s2>New Jersey</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName>
<region type="state">New Jersey</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Coleman, Robert E" sort="Coleman, Robert E" uniqKey="Coleman R" first="Robert E." last="Coleman">Robert E. Coleman</name>
<affiliation wicri:level="1">
<inist:fA14 i1="10">
<s1>Weston Park Hospital</s1>
<s2>Sheffield</s2>
<s3>GBR</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>Weston Park Hospital</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series>
<title level="j" type="main">Cancer</title>
<title level="j" type="abbreviated">Cancer</title>
<idno type="ISSN">0008-543X</idno>
<imprint>
<date when="2008">2008</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt>
<title level="j" type="main">Cancer</title>
<title level="j" type="abbreviated">Cancer</title>
<idno type="ISSN">0008-543X</idno>
</seriesStmt>
</fileDesc>
<profileDesc>
<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Adult</term>
<term>Antineoplastic agent</term>
<term>Antiresorptive agent</term>
<term>Bone mineral density</term>
<term>Breast cancer</term>
<term>Cancerology</term>
<term>Early</term>
<term>Efficiency</term>
<term>Estrogen synthase</term>
<term>Female</term>
<term>Human</term>
<term>Letrozole</term>
<term>Osteopenia</term>
<term>Postmenopause</term>
<term>Woman</term>
<term>Zoledronic acid</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Ostéopénie</term>
<term>Efficacité</term>
<term>Estrogen synthase</term>
<term>Acide zolédronique</term>
<term>Postménopause</term>
<term>Homme</term>
<term>Cancer du sein</term>
<term>Femelle</term>
<term>Adulte</term>
<term>Létrozole</term>
<term>Femme</term>
<term>Précoce</term>
<term>Densité minérale osseuse</term>
<term>Cancérologie</term>
<term>Antirésorptif</term>
<term>Anticancéreux</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr">
<term>Homme</term>
<term>Adulte</term>
<term>Femme</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">BACKGROUND. Letrozole is safe and effective in postmenopausal women with estrogen receptor-positive early breast cancer, but long-term aromatase inhibitor use may cause bone loss and increase fracture risk. This study evaluated an immediate or delayed strategy of bone protection therapy with zoledronic acid. METHODS. A total of 1065 patients who were receiving adjuvant letrozole were randomized to immediate-start or delayed-start zoledronic acid (4 mg intravenously biannually for 5 years). The delayed group received zoledronic acid if lumbar spine or total hip T-score decreased below -2.0 or when a nontraumatic fracture occurred. The primary endpoint was change in lumbar spine bone mineral density (BMD) at Month 12. Secondary endpoints included changes in total hip BMD, serum bone turnover markers, and safety at Month 12. RESULTS. Lumbar spine BMD increased from baseline in the immediate arm, while it decreased from baseline in delayed-arm patients. At Month 12, the differences between the groups in lumbar spine and total hip BMD were 5.7% (P<.0001; 95% confidence intervals [CI], 5.2% to 6.1%), and 3.6% (P<.0001; 95% CI, 3.3 to 4.0%), respectively. Both regimens were well tolerated with few serious adverse events. Bone pain was higher in the immediate group, as expected, because some patients experienced acute-phase reactions after zoledronic acid infusion. CONCLUSIONS. At 12 months, immediate zoledronic acid therapy prevented bone loss in postmenopausal women who were receiving adjuvant letrozole.</div>
</front>
</TEI>
<affiliations>
<list>
<country>
<li>Allemagne</li>
<li>Australie</li>
<li>Belgique</li>
<li>France</li>
<li>Nouvelle-Zélande</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
</country>
<region>
<li>Angleterre</li>
<li>Bourgogne-Franche-Comté</li>
<li>District de Darmstadt</li>
<li>Franche-Comté</li>
<li>Grand Manchester</li>
<li>Hesse (Land)</li>
<li>New Jersey</li>
<li>Schleswig-Holstein</li>
</region>
<settlement>
<li>Francfort-sur-le-Main</li>
<li>Kiel</li>
<li>Manchester</li>
<li>Montbéliard</li>
</settlement>
</list>
<tree>
<country name="Royaume-Uni">
<region name="Angleterre">
<name sortKey="Bundred, Nigel J" sort="Bundred, Nigel J" uniqKey="Bundred N" first="Nigel J." last="Bundred">Nigel J. Bundred</name>
</region>
<name sortKey="Coleman, Robert E" sort="Coleman, Robert E" uniqKey="Coleman R" first="Robert E." last="Coleman">Robert E. Coleman</name>
<name sortKey="Davidson, Neville" sort="Davidson, Neville" uniqKey="Davidson N" first="Neville" last="Davidson">Neville Davidson</name>
</country>
<country name="Nouvelle-Zélande">
<noRegion>
<name sortKey="Campbell, Ian D" sort="Campbell, Ian D" uniqKey="Campbell I" first="Ian D." last="Campbell">Ian D. Campbell</name>
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<country name="Australie">
<noRegion>
<name sortKey="Deboer, Richard H" sort="Deboer, Richard H" uniqKey="Deboer R" first="Richard H." last="Deboer">Richard H. Deboer</name>
</noRegion>
</country>
<country name="Allemagne">
<region name="Schleswig-Holstein">
<name sortKey="Eidtmann, Holger" sort="Eidtmann, Holger" uniqKey="Eidtmann H" first="Holger" last="Eidtmann">Holger Eidtmann</name>
</region>
<name sortKey="Von Minckwitz, Gunter" sort="Von Minckwitz, Gunter" uniqKey="Von Minckwitz G" first="Gunter" last="Von Minckwitz">Gunter Von Minckwitz</name>
</country>
<country name="France">
<region name="Bourgogne-Franche-Comté">
<name sortKey="Monnier, Alain" sort="Monnier, Alain" uniqKey="Monnier A" first="Alain" last="Monnier">Alain Monnier</name>
</region>
</country>
<country name="Belgique">
<noRegion>
<name sortKey="Neven, Patrick" sort="Neven, Patrick" uniqKey="Neven P" first="Patrick" last="Neven">Patrick Neven</name>
</noRegion>
</country>
<country name="États-Unis">
<region name="New Jersey">
<name sortKey="Miller, Joel C" sort="Miller, Joel C" uniqKey="Miller J" first="Joel C." last="Miller">Joel C. Miller</name>
</region>
<name sortKey="Schenk, Nora L" sort="Schenk, Nora L" uniqKey="Schenk N" first="Nora L." last="Schenk">Nora L. Schenk</name>
</country>
</tree>
</affiliations>
</record>

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   |texte=   Effective Inhibition of Aromatase Inhibitor-associated Bone Loss by Zoledronic Acid in Postmenopausal Women With Early Breast Cancer Receiving Adjuvant Letrozole : ZO-FAST Study Results
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