Final 5-Year Results of Z-FAST Trial: Adjuvant Zoledronic Acid Maintains Bone Mass in Postmenopausal Breast Cancer Patients Receiving Letrozole
Identifieur interne : 003572 ( PascalFrancis/Checkpoint ); précédent : 003571; suivant : 003573Final 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.
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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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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Final 5-Year Results of Z-FAST Trial: Adjuvant Zoledronic Acid Maintains Bone Mass in Postmenopausal Breast Cancer Patients Receiving Letrozole</title><author><name sortKey="Brufsky, Adam M" sort="Brufsky, Adam M" uniqKey="Brufsky A" first="Adam M." last="Brufsky">Adam M. 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></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">12-0116133</idno><date when="2012">2012</date><idno type="stanalyst">PASCAL 12-0116133 INIST</idno><idno type="RBID">Pascal:12-0116133</idno><idno type="wicri:Area/PascalFrancis/Corpus">004872</idno><idno type="wicri:Area/PascalFrancis/Curation">000632</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">003572</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">003572</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Final 5-Year Results of Z-FAST Trial: Adjuvant Zoledronic Acid Maintains Bone Mass in Postmenopausal Breast Cancer Patients Receiving Letrozole</title><author><name sortKey="Brufsky, Adam M" sort="Brufsky, Adam M" uniqKey="Brufsky A" first="Adam M." last="Brufsky">Adam M. 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><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0008-543X</s0></fA01><fA02 i1="01"><s0>CANCAR</s0></fA02><fA03 i2="1"><s0>Cancer</s0></fA03><fA05><s2>118</s2></fA05><fA06><s2>5</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Final 5-Year Results of Z-FAST Trial: Adjuvant Zoledronic Acid Maintains Bone Mass in Postmenopausal Breast Cancer Patients Receiving Letrozole</s1></fA08><fA11 i1="01" i2="1"><s1>BRUFSKY (Adam M.)</s1></fA11><fA11 i1="02" i2="1"><s1>GRAYDON HARKER (W.)</s1></fA11><fA11 i1="03" i2="1"><s1>THADDEUS BECK (J.)</s1></fA11><fA11 i1="04" i2="1"><s1>BOSSERMAN (Linda)</s1></fA11><fA11 i1="05" i2="1"><s1>VOGEL (Charles)</s1></fA11><fA11 i1="06" i2="1"><s1>SEIDLER (Christopher)</s1></fA11><fA11 i1="07" i2="1"><s1>LIXIAN JIN</s1></fA11><fA11 i1="08" i2="1"><s1>WARSI (Ghulam)</s1></fA11><fA11 i1="09" i2="1"><s1>ARGONZA-AVILES (Eliza)</s1></fA11><fA11 i1="10" i2="1"><s1>HOHNEKER (John)</s1></fA11><fA11 i1="11" i2="1"><s1>ERICSON (Solveig G.)</s1></fA11><fA11 i1="12" i2="1"><s1>PEREZ (Edith A.)</s1></fA11><fA14 i1="01"><s1>Magee-Womens Hospital, University of Pittsburgh Cancer Institute</s1><s2>Pittsburgh, Pennsylvania</s2><s3>USA</s3><sZ>1 aut.</sZ></fA14><fA14 i1="02"><s1>Utah Cancer Specialists</s1><s2>Salt Lake City, Utah</s2><s3>USA</s3><sZ>2 aut.</sZ></fA14><fA14 i1="03"><s1>Highlands Oncology Group</s1><s2>Fayetteville, Arkansas</s2><s3>USA</s3><sZ>3 aut.</sZ></fA14><fA14 i1="04"><s1>Wilshire Oncology Medical Group, Inc.</s1><s2>Pomona, California</s2><s3>USA</s3><sZ>4 aut.</sZ></fA14><fA14 i1="05"><s1>Cancer Research Network, Inc.</s1><s2>Plantation, Florida</s2><s3>USA</s3><sZ>5 aut.</sZ></fA14><fA14 i1="06"><s1>Fallon Clinic Hematology Oncology</s1><s2>Worcester, Massachusetts</s2><s3>USA</s3><sZ>6 aut.</sZ></fA14><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></fA14><fA14 i1="08"><s1>Mayo Clinic</s1><s2>Jacksonville, Florida</s2><s3>USA</s3><sZ>12 aut.</sZ></fA14><fA20><s1>1192-1201</s1></fA20><fA21><s1>2012</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>2701</s2><s5>354000502821290030</s5></fA43><fA44><s0>0000</s0><s1>© 2012 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>35 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>12-0116133</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>Cancer</s0></fA64><fA66 i1="01"><s0>USA</s0></fA66><fC01 i1="01" l="ENG"><s0>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.</s0></fC01><fC02 i1="01" i2="X"><s0>002B04</s0></fC02><fC02 i1="02" i2="X"><s0>002B15C</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Acide zolédronique</s0><s2>NK</s2><s2>FR</s2><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Zoledronic acid</s0><s2>NK</s2><s2>FR</s2><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Acido zoledrónico</s0><s2>NK</s2><s2>FR</s2><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Essai clinique</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Clinical trial</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Ensayo clínico</s0><s5>02</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Masse osseuse</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Bone mass</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Masa oseosa</s0><s5>03</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Cancer du sein</s0><s2>NM</s2><s5>04</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Breast cancer</s0><s2>NM</s2><s5>04</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Cáncer del pecho</s0><s2>NM</s2><s5>04</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>Postménopause</s0><s5>05</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>Postmenopause</s0><s5>05</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>Postmenopausia</s0><s5>05</s5></fC03><fC03 i1="06" i2="X" l="FRE"><s0>Homme</s0><s5>06</s5></fC03><fC03 i1="06" i2="X" l="ENG"><s0>Human</s0><s5>06</s5></fC03><fC03 i1="06" i2="X" l="SPA"><s0>Hombre</s0><s5>06</s5></fC03><fC03 i1="07" i2="X" l="FRE"><s0>Létrozole</s0><s2>NK</s2><s2>FR</s2><s5>07</s5></fC03><fC03 i1="07" i2="X" l="ENG"><s0>Letrozole</s0><s2>NK</s2><s2>FR</s2><s5>07</s5></fC03><fC03 i1="07" i2="X" l="SPA"><s0>Letrozol</s0><s2>NK</s2><s2>FR</s2><s5>07</s5></fC03><fC03 i1="08" i2="X" l="FRE"><s0>Estrogen synthase</s0><s2>FE</s2><s5>08</s5></fC03><fC03 i1="08" i2="X" l="ENG"><s0>Estrogen synthase</s0><s2>FE</s2><s5>08</s5></fC03><fC03 i1="08" i2="X" l="SPA"><s0>Estrogen synthase</s0><s2>FE</s2><s5>08</s5></fC03><fC03 i1="09" i2="X" l="FRE"><s0>Os</s0><s5>09</s5></fC03><fC03 i1="09" i2="X" l="ENG"><s0>Bone</s0><s5>09</s5></fC03><fC03 i1="09" i2="X" l="SPA"><s0>Hueso</s0><s5>09</s5></fC03><fC03 i1="10" i2="X" l="FRE"><s0>Résorption</s0><s5>11</s5></fC03><fC03 i1="10" i2="X" l="ENG"><s0>Resorption</s0><s5>11</s5></fC03><fC03 i1="10" i2="X" l="SPA"><s0>Resorción</s0><s5>11</s5></fC03><fC03 i1="11" i2="X" l="FRE"><s0>Cancérologie</s0><s5>12</s5></fC03><fC03 i1="11" i2="X" l="ENG"><s0>Cancerology</s0><s5>12</s5></fC03><fC03 i1="11" i2="X" l="SPA"><s0>Cancerología</s0><s5>12</s5></fC03><fC03 i1="12" i2="X" l="FRE"><s0>Antirésorptif</s0><s5>25</s5></fC03><fC03 i1="12" i2="X" l="ENG"><s0>Antiresorptive agent</s0><s5>25</s5></fC03><fC03 i1="12" i2="X" l="SPA"><s0>Antirresortivo</s0><s5>25</s5></fC03><fC03 i1="13" i2="X" l="FRE"><s0>Anticancéreux</s0><s5>26</s5></fC03><fC03 i1="13" i2="X" l="ENG"><s0>Antineoplastic agent</s0><s5>26</s5></fC03><fC03 i1="13" i2="X" l="SPA"><s0>Anticanceroso</s0><s5>26</s5></fC03><fC03 i1="14" i2="X" l="FRE"><s0>Cancer de l'os</s0><s4>CD</s4><s5>96</s5></fC03><fC03 i1="14" i2="X" l="ENG"><s0>Bone cancer</s0><s4>CD</s4><s5>96</s5></fC03><fC03 i1="15" i2="X" l="FRE"><s0>Tumeur sein</s0><s4>CD</s4><s5>97</s5></fC03><fC03 i1="15" i2="X" l="ENG"><s0>Breast tumor</s0><s4>CD</s4><s5>97</s5></fC03><fC03 i1="15" i2="X" l="SPA"><s0>Tumor pecho</s0><s4>CD</s4><s5>97</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Enzyme</s0><s2>FE</s2></fC07><fC07 i1="01" i2="X" l="ENG"><s0>Enzyme</s0><s2>FE</s2></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Enzima</s0><s2>FE</s2></fC07><fC07 i1="02" i2="X" l="FRE"><s0>Inhibiteur enzyme</s0><s5>37</s5></fC07><fC07 i1="02" i2="X" l="ENG"><s0>Enzyme inhibitor</s0><s5>37</s5></fC07><fC07 i1="02" i2="X" l="SPA"><s0>Inhibidor enzima</s0><s5>37</s5></fC07><fC07 i1="03" i2="X" l="FRE"><s0>Bisphosphonates</s0><s5>38</s5></fC07><fC07 i1="03" i2="X" l="ENG"><s0>Bisphosphonates</s0><s5>38</s5></fC07><fC07 i1="03" i2="X" l="SPA"><s0>Bisfosfonatos</s0><s5>38</s5></fC07><fC07 i1="04" i2="X" l="FRE"><s0>Dérivé de l'acide diphosphonique</s0><s5>39</s5></fC07><fC07 i1="04" i2="X" l="ENG"><s0>Diphosphonic acid derivatives</s0><s5>39</s5></fC07><fC07 i1="04" i2="X" l="SPA"><s0>Difosfonico ácido derivado</s0><s5>39</s5></fC07><fC07 i1="05" i2="X" l="FRE"><s0>Pathologie du système ostéoarticulaire</s0><s5>40</s5></fC07><fC07 i1="05" i2="X" l="ENG"><s0>Diseases of the osteoarticular system</s0><s5>40</s5></fC07><fC07 i1="05" i2="X" l="SPA"><s0>Sistema osteoarticular patología</s0><s5>40</s5></fC07><fC07 i1="06" i2="X" l="FRE"><s0>Tumeur maligne</s0><s2>NM</s2><s5>41</s5></fC07><fC07 i1="06" i2="X" l="ENG"><s0>Malignant tumor</s0><s2>NM</s2><s5>41</s5></fC07><fC07 i1="06" i2="X" l="SPA"><s0>Tumor maligno</s0><s2>NM</s2><s5>41</s5></fC07><fC07 i1="07" i2="X" l="FRE"><s0>Cancer</s0><s2>NM</s2></fC07><fC07 i1="07" i2="X" l="ENG"><s0>Cancer</s0><s2>NM</s2></fC07><fC07 i1="07" i2="X" l="SPA"><s0>Cáncer</s0><s2>NM</s2></fC07><fC07 i1="08" i2="X" l="FRE"><s0>Pathologie de la glande mammaire</s0><s2>NM</s2><s5>42</s5></fC07><fC07 i1="08" i2="X" l="ENG"><s0>Mammary gland diseases</s0><s2>NM</s2><s5>42</s5></fC07><fC07 i1="08" i2="X" l="SPA"><s0>Glándula mamaria patología</s0><s2>NM</s2><s5>42</s5></fC07><fC07 i1="09" i2="X" l="FRE"><s0>Pathologie du sein</s0><s2>NM</s2><s5>43</s5></fC07><fC07 i1="09" i2="X" l="ENG"><s0>Breast disease</s0><s2>NM</s2><s5>43</s5></fC07><fC07 i1="09" i2="X" l="SPA"><s0>Seno patología</s0><s2>NM</s2><s5>43</s5></fC07><fC07 i1="10" i2="X" l="FRE"><s0>Antihormone</s0><s5>45</s5></fC07><fC07 i1="10" i2="X" l="ENG"><s0>Antihormone</s0><s5>45</s5></fC07><fC07 i1="10" i2="X" l="SPA"><s0>Antihormona</s0><s5>45</s5></fC07><fC07 i1="11" i2="X" l="FRE"><s0>Antioestrogène</s0><s5>46</s5></fC07><fC07 i1="11" i2="X" l="ENG"><s0>Antiestrogen</s0><s5>46</s5></fC07><fC07 i1="11" i2="X" l="SPA"><s0>Antiestrógeno</s0><s5>46</s5></fC07><fC07 i1="12" i2="X" l="FRE"><s0>Composé non stéroïde</s0><s5>47</s5></fC07><fC07 i1="12" i2="X" l="ENG"><s0>Non steroid compound</s0><s5>47</s5></fC07><fC07 i1="12" i2="X" l="SPA"><s0>Compuesto no esteroide</s0><s5>47</s5></fC07><fC07 i1="13" i2="X" l="FRE"><s0>Dérivé du triazole</s0><s5>48</s5></fC07><fC07 i1="13" i2="X" l="ENG"><s0>Triazole derivatives</s0><s5>48</s5></fC07><fC07 i1="13" i2="X" l="SPA"><s0>Triazol derivado</s0><s5>48</s5></fC07><fC07 i1="14" i2="X" l="FRE"><s0>Inhibiteur de l'aromatase</s0><s5>49</s5></fC07><fC07 i1="14" i2="X" l="ENG"><s0>Aromatase inhibitor</s0><s5>49</s5></fC07><fC07 i1="14" i2="X" l="SPA"><s0>Inhibidor aromatase</s0><s5>49</s5></fC07><fC07 i1="15" i2="X" l="FRE"><s0>Système ostéoarticulaire</s0><s5>50</s5></fC07><fC07 i1="15" i2="X" l="ENG"><s0>Osteoarticular system</s0><s5>50</s5></fC07><fC07 i1="15" i2="X" l="SPA"><s0>Sistema osteoarticular</s0><s5>50</s5></fC07><fC07 i1="16" i2="X" l="FRE"><s0>Dérivé d'azole</s0><s5>51</s5></fC07><fC07 i1="16" i2="X" l="ENG"><s0>Azole derivatives</s0><s5>51</s5></fC07><fC07 i1="16" i2="X" l="SPA"><s0>Azol derivado</s0><s5>51</s5></fC07><fN21><s1>086</s1></fN21><fN44 i1="01"><s1>OTO</s1></fN44><fN82><s1>OTO</s1></fN82></pA></standard></inist><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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|texte= Final 5-Year Results of Z-FAST Trial: Adjuvant Zoledronic Acid Maintains Bone Mass in Postmenopausal Breast Cancer Patients Receiving Letrozole
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