Final 5-Year Results of Z-FAST Trial: Adjuvant Zoledronic Acid Maintains Bone Mass in Postmenopausal Breast Cancer Patients Receiving Letrozole
Identifieur interne : 000575 ( France/Analysis ); précédent : 000574; suivant : 000576Final 5-Year Results of Z-FAST Trial: Adjuvant Zoledronic Acid Maintains Bone Mass in Postmenopausal Breast Cancer Patients Receiving Letrozole
Auteurs : Adam M. Brufsky [États-Unis] ; W. Graydon Harker [États-Unis] ; J. Thaddeus Beck [États-Unis] ; Linda Bosserman [États-Unis] ; Charles Vogel [États-Unis] ; Christopher Seidler [États-Unis] ; LIXIAN JIN [France] ; Ghulam Warsi [France] ; Eliza Argonza-Aviles [France] ; John Hohneker [France] ; Solveig G. Ericson [France] ; Edith A. Perez [États-Unis]Source :
- Cancer [ 0008-543X ] ; 2012.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
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Abstract
BACKGROUND: Postmenopausal breast cancer (BC) patients receiving adjuvant aromatase inhibitor therapy are at risk of progressive bone loss and fractures. Zoledronic acid inhibits osteociastic bone resorption, is effective in maintaining bone health, and may therefore be beneficial in this setting. METHODS: Overall, 602 postmenopausal women with early, hormone receptor-positive BC receiving adjuvant letrozole were randomized (301 each group) to receive upfront or delayed-start zoledronic acid (4 mg intravenously every 6 months) for 5 years. The primary endpoint was the change in lumbar spine (LS) bone mineral density (BMD) at month 12. Secondary endpoints included changes in LS BMD, total hip BMD, and bone turnover markers at 2, 3, and 5 years; fracture incidence at 3 years; and time to disease recurrence. RESULTS: At month 61, the adjusted mean difference in LS and total hip BMDs between the upfront and delayed groups was 8.9% and 6.7%, respectively (P < .0001, for both). Approximately 25% of delayed patients received zoledronic acid by month 61. Only 1 patient experienced grade 4 renal dysfunction; no confirmed cases of osteonecrosis of the jaw were reported. Fracture rates (upfront, 28 [9.3%]; delayed, 33 [11%]; P = .3803) and Kaplan-Meier disease recurrence rates (upfront, 9.8 [95% confidence interval (CI), 6.0-10.3]; delayed, 10.5 [95% Cl, 6.6-14.4]; P = .6283) were similar at month 61. CONCLUSIONS: Upfront zoledronic acid seems to be the preferred treatment strategy versus delayed administration, as it significantly and progressively increases BMD in postmenopausal women with early BC receiving letrozole for 5 years, and long-term coadministration of letrozole and zoledronic acid is well tolerated.
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Brufsky</name><affiliation wicri:level="2"><inist:fA14 i1="01"><s1>Magee-Womens Hospital, University of Pittsburgh Cancer Institute</s1><s2>Pittsburgh, Pennsylvania</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Graydon Harker, W" sort="Graydon Harker, W" uniqKey="Graydon Harker W" first="W." last="Graydon Harker">W. Graydon Harker</name><affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Utah Cancer Specialists</s1><s2>Salt Lake City, Utah</s2><s3>USA</s3><sZ>2 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Utah</region></placeName></affiliation></author><author><name sortKey="Thaddeus Beck, J" sort="Thaddeus Beck, J" uniqKey="Thaddeus Beck J" first="J." last="Thaddeus Beck">J. Thaddeus Beck</name><affiliation wicri:level="2"><inist:fA14 i1="03"><s1>Highlands Oncology Group</s1><s2>Fayetteville, Arkansas</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Arkansas</region></placeName></affiliation></author><author><name sortKey="Bosserman, Linda" sort="Bosserman, Linda" uniqKey="Bosserman L" first="Linda" last="Bosserman">Linda Bosserman</name><affiliation wicri:level="2"><inist:fA14 i1="04"><s1>Wilshire Oncology Medical Group, Inc.</s1><s2>Pomona, California</s2><s3>USA</s3><sZ>4 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</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="05"><s1>Cancer Research Network, Inc.</s1><s2>Plantation, Florida</s2><s3>USA</s3><sZ>5 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region></placeName></affiliation></author><author><name sortKey="Seidler, Christopher" sort="Seidler, Christopher" uniqKey="Seidler C" first="Christopher" last="Seidler">Christopher Seidler</name><affiliation wicri:level="2"><inist:fA14 i1="06"><s1>Fallon Clinic Hematology Oncology</s1><s2>Worcester, Massachusetts</s2><s3>USA</s3><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Lixian Jin" sort="Lixian Jin" uniqKey="Lixian Jin" last="Lixian Jin">LIXIAN JIN</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Novartis Pharmaceuticals Corporation, East Hanover</s1><s2>New Jersey</s2><s3>FRA</s3><sZ>7 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>New Jersey</wicri:noRegion><wicri:noRegion>East Hanover</wicri:noRegion><wicri:noRegion>New Jersey</wicri:noRegion></affiliation></author><author><name sortKey="Warsi, Ghulam" sort="Warsi, Ghulam" uniqKey="Warsi G" first="Ghulam" last="Warsi">Ghulam Warsi</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Novartis Pharmaceuticals Corporation, East Hanover</s1><s2>New Jersey</s2><s3>FRA</s3><sZ>7 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>New Jersey</wicri:noRegion><wicri:noRegion>East Hanover</wicri:noRegion><wicri:noRegion>New Jersey</wicri:noRegion></affiliation></author><author><name sortKey="Argonza Aviles, Eliza" sort="Argonza Aviles, Eliza" uniqKey="Argonza Aviles E" first="Eliza" last="Argonza-Aviles">Eliza Argonza-Aviles</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Novartis Pharmaceuticals Corporation, East Hanover</s1><s2>New Jersey</s2><s3>FRA</s3><sZ>7 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>New Jersey</wicri:noRegion><wicri:noRegion>East Hanover</wicri:noRegion><wicri:noRegion>New Jersey</wicri:noRegion></affiliation></author><author><name sortKey="Hohneker, John" sort="Hohneker, John" uniqKey="Hohneker J" first="John" last="Hohneker">John Hohneker</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Novartis Pharmaceuticals Corporation, East Hanover</s1><s2>New Jersey</s2><s3>FRA</s3><sZ>7 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>New Jersey</wicri:noRegion><wicri:noRegion>East Hanover</wicri:noRegion><wicri:noRegion>New Jersey</wicri:noRegion></affiliation></author><author><name sortKey="Ericson, Solveig G" sort="Ericson, Solveig G" uniqKey="Ericson S" first="Solveig G." last="Ericson">Solveig G. Ericson</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Novartis Pharmaceuticals Corporation, East Hanover</s1><s2>New Jersey</s2><s3>FRA</s3><sZ>7 aut.</sZ><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>New Jersey</wicri:noRegion><wicri:noRegion>East Hanover</wicri:noRegion><wicri:noRegion>New Jersey</wicri:noRegion></affiliation></author><author><name sortKey="Perez, Edith A" sort="Perez, Edith A" uniqKey="Perez E" first="Edith A." last="Perez">Edith A. Perez</name><affiliation wicri:level="2"><inist:fA14 i1="08"><s1>Mayo Clinic</s1><s2>Jacksonville, Florida</s2><s3>USA</s3><sZ>12 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region></placeName></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="2012">2012</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>Antineoplastic agent</term><term>Antiresorptive agent</term><term>Bone</term><term>Bone cancer</term><term>Bone mass</term><term>Breast cancer</term><term>Breast tumor</term><term>Cancerology</term><term>Clinical trial</term><term>Estrogen synthase</term><term>Human</term><term>Letrozole</term><term>Postmenopause</term><term>Resorption</term><term>Zoledronic acid</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Acide zolédronique</term><term>Essai clinique</term><term>Masse osseuse</term><term>Cancer du sein</term><term>Postménopause</term><term>Homme</term><term>Létrozole</term><term>Estrogen synthase</term><term>Os</term><term>Résorption</term><term>Cancérologie</term><term>Antirésorptif</term><term>Anticancéreux</term><term>Cancer de l'os</term><term>Tumeur sein</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">BACKGROUND: Postmenopausal breast cancer (BC) patients receiving adjuvant aromatase inhibitor therapy are at risk of progressive bone loss and fractures. Zoledronic acid inhibits osteociastic bone resorption, is effective in maintaining bone health, and may therefore be beneficial in this setting. METHODS: Overall, 602 postmenopausal women with early, hormone receptor-positive BC receiving adjuvant letrozole were randomized (301 each group) to receive upfront or delayed-start zoledronic acid (4 mg intravenously every 6 months) for 5 years. The primary endpoint was the change in lumbar spine (LS) bone mineral density (BMD) at month 12. Secondary endpoints included changes in LS BMD, total hip BMD, and bone turnover markers at 2, 3, and 5 years; fracture incidence at 3 years; and time to disease recurrence. RESULTS: At month 61, the adjusted mean difference in LS and total hip BMDs between the upfront and delayed groups was 8.9% and 6.7%, respectively (P < .0001, for both). Approximately 25% of delayed patients received zoledronic acid by month 61. Only 1 patient experienced grade 4 renal dysfunction; no confirmed cases of osteonecrosis of the jaw were reported. Fracture rates (upfront, 28 [9.3%]; delayed, 33 [11%]; P = .3803) and Kaplan-Meier disease recurrence rates (upfront, 9.8 [95% confidence interval (CI), 6.0-10.3]; delayed, 10.5 [95% Cl, 6.6-14.4]; P = .6283) were similar at month 61. CONCLUSIONS: Upfront zoledronic acid seems to be the preferred treatment strategy versus delayed administration, as it significantly and progressively increases BMD in postmenopausal women with early BC receiving letrozole for 5 years, and long-term coadministration of letrozole and zoledronic acid is well tolerated.</div></front></TEI><affiliations><list><country><li>France</li><li>États-Unis</li></country><region><li>Arkansas</li><li>Californie</li><li>Floride</li><li>Massachusetts</li><li>Pennsylvanie</li><li>Utah</li></region></list><tree><country name="États-Unis"><region name="Pennsylvanie"><name sortKey="Brufsky, Adam M" sort="Brufsky, Adam M" uniqKey="Brufsky A" first="Adam M." last="Brufsky">Adam M. Brufsky</name></region><name sortKey="Bosserman, Linda" sort="Bosserman, Linda" uniqKey="Bosserman L" first="Linda" last="Bosserman">Linda Bosserman</name><name sortKey="Graydon Harker, W" sort="Graydon Harker, W" uniqKey="Graydon Harker W" first="W." last="Graydon Harker">W. Graydon Harker</name><name sortKey="Perez, Edith A" sort="Perez, Edith A" uniqKey="Perez E" first="Edith A." last="Perez">Edith A. Perez</name><name sortKey="Seidler, Christopher" sort="Seidler, Christopher" uniqKey="Seidler C" first="Christopher" last="Seidler">Christopher Seidler</name><name sortKey="Thaddeus Beck, J" sort="Thaddeus Beck, J" uniqKey="Thaddeus Beck J" first="J." last="Thaddeus Beck">J. Thaddeus Beck</name><name sortKey="Vogel, Charles" sort="Vogel, Charles" uniqKey="Vogel C" first="Charles" last="Vogel">Charles Vogel</name></country><country name="France"><noRegion><name sortKey="Lixian Jin" sort="Lixian Jin" uniqKey="Lixian Jin" last="Lixian Jin">LIXIAN JIN</name></noRegion><name sortKey="Argonza Aviles, Eliza" sort="Argonza Aviles, Eliza" uniqKey="Argonza Aviles E" first="Eliza" last="Argonza-Aviles">Eliza Argonza-Aviles</name><name sortKey="Ericson, Solveig G" sort="Ericson, Solveig G" uniqKey="Ericson S" first="Solveig G." last="Ericson">Solveig G. Ericson</name><name sortKey="Hohneker, John" sort="Hohneker, John" uniqKey="Hohneker J" first="John" last="Hohneker">John Hohneker</name><name sortKey="Warsi, Ghulam" sort="Warsi, Ghulam" uniqKey="Warsi G" first="Ghulam" last="Warsi">Ghulam Warsi</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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