Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/16946
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dc.contributor.authorLlombart, Antonio-
dc.contributor.authorFrassoldati, Antonio-
dc.contributor.authorPaija, Outi-
dc.contributor.authorSleeboom, Harm Peter-
dc.contributor.authorJerusalem, Guy-
dc.contributor.authorMEBIS, Jeroen-
dc.contributor.authorDeleu, Ines-
dc.contributor.authorMiller, Joel-
dc.contributor.authorSchenk, Nora-
dc.contributor.authorNeven, Patrick-
dc.date.accessioned2014-07-13T19:32:34Z-
dc.date.available2014-07-13T19:32:34Z-
dc.date.issued2012-
dc.identifier.citationCLINICAL BREAST CANCER, 12 (1), p. 40-48-
dc.identifier.issn1526-8209-
dc.identifier.urihttp://hdl.handle.net/1942/16946-
dc.description.abstractAromatase inhibitors (AIs), an increasingly common adjuvant treatment option for postmenopausal women with hormone receptor-positive early breast cancer, are associated with bone loss that can impair patient quality of life. This study (E-ZO-FAST; Clinical Trials Identifier: NCT00171314) demonstrates that initiation of zoledronic acid therapy concurrent with adjuvant AI treatment improved skeletal health compared with zoledronic acid therapy initiated after deterioration of bone health. Background: Letrozole is a proven and effective adjuvant therapy in postmenopausal women with hormone receptor-positive (HR+) early breast cancer (EBC). As with other aromatase inhibitors (AIs), long-term letrozole administration is associated with decreased bone mineral density (BMD) and increased fracture risk. This study compared potential bone-protecting effects of immediate vs. delayed administration of zoledronic acid (ZOL) in patients with EBC receiving adjuvant letrozole. Patients and Methods: Patients with HR+ EBC in whom adjuvant letrozole treatment was initiated (2.5 mg/day for 5 years) were randomized to immediate ZOL treatment (immediate ZOL) or delayed ZOL treatment (delayed ZOL) (both at 4 mg every 6 months). Patients in the delayed ZOL group received ZOL only for a BMD T-score that decreased to < -2.0 (lumbar spine [LS] or total hip [TH]) or for fracture. The primary endpoint was percentage change in the LS BMD at month 12. Patients were stratified by established or recent postmenopausal status, baseline T-scores, and adjuvant chemotherapy history. Results: At 12 months, the LS BMD increased in the immediate ZOL group (+2.72%) but decreased in the delayed ZOL group (-2.71%); the absolute difference between groups was significant (5.43%; P < .0001). Across all subgroups, patients receiving immediate ZOL had significantly increased LS and TH BMD vs. those who received delayed ZOL (P < .0001). Differences in fracture incidence or disease recurrence could not be ascertained because of early data cutoff and low incidence of events. Adverse events were generally mild, transient, and consistent with the known safety profiles of both agents. Conclusion: Immediate ZOL administration effectively prevented BMD loss and increased BMD in postmenopausal women with HR+ EBC receiving adjuvant letrozole, regardless of BMD status at baseline. Clinical Breast Cancer, Vol. 12, No. 1, 40-8 (C) 2012 Elsevier Inc. All rights reserved.-
dc.description.sponsorshipFunding for medical editorial assistance was provided by Novartis Pharmaceuticals Corporation. We acknowledge Jerome F. Sah, PhD, ProEd Communications, Inc, for his medical editorial assistance with this manuscript. Antonio Llombart has received honoraria and research grants from Novartis, GlaxoSmithKline, Roche, Sanofi-Aventis, and Genentech, and has received other remuneration from Cephalon. Outi Paija has received lecture fees and research support from Roche, GlaxoSmithKline, Novartis, and AstraZeneca; is an advisory member for Novartis Nordic group and AstraZeneca Finland; and has given expert testimony for MSD Drugs.-
dc.language.isoen-
dc.publisherCIG MEDIA GROUP, LP-
dc.subject.otherOncology-
dc.subject.otherAromatase inhibitor; Bone mineral density; Early breast cancer; Letrozole; Postmenopausal; Zoledronic acid-
dc.titleImmediate Administration of Zoledronic Acid Reduces Aromatase Inhibitor-Associated Bone Loss in Postmenopausal Women With Early Breast Cancer: 12-Month Analysis of the E-ZO-FAST Trial-
dc.typeJournal Contribution-
dc.identifier.epage48-
dc.identifier.issue1-
dc.identifier.spage40-
dc.identifier.volume12-
local.format.pages9-
local.bibliographicCitation.jcatA1-
dc.description.notes[Llombart, Antonio] FISABIO Hosp Arnau de Vilanova, Valencia 46015, Spain. [Llombart, Antonio] Fdn Inst Valenciano Oncol, Valencia, Spain. [Frassoldati, Antonio] Univ Modena, Policlin, Sect Oncol, Dept Oncol Hematol & Lung Dis, I-41100 Modena, Italy. [Paija, Outi] Turku Univ Hosp, Dept Radiotherapy & Oncol, FIN-20520 Turku, Finland. [Sleeboom, Harm Peter] Hagaziekenhuis, The Hague, Netherlands. [Jerusalem, Guy] Domaine Univ, CHU Sart Tilman Liege, Liege, Belgium. [Miller, Joel; Schenk, Nora] Novartis Pharmaceut, E Hanover, NJ USA. [Neven, Patrick] UZ Leuven, Dept Obstet & Gynecol, Louvain, Belgium.-
local.publisher.placeDALLAS-
local.type.refereedRefereed-
local.type.specifiedArticle-
dc.identifier.doi10.1016/j.clbc.2011.08.002-
dc.identifier.isi000299862300006-
item.fulltextWith Fulltext-
item.fullcitationLlombart, Antonio; Frassoldati, Antonio; Paija, Outi; Sleeboom, Harm Peter; Jerusalem, Guy; MEBIS, Jeroen; Deleu, Ines; Miller, Joel; Schenk, Nora & Neven, Patrick (2012) Immediate Administration of Zoledronic Acid Reduces Aromatase Inhibitor-Associated Bone Loss in Postmenopausal Women With Early Breast Cancer: 12-Month Analysis of the E-ZO-FAST Trial. In: CLINICAL BREAST CANCER, 12 (1), p. 40-48.-
item.contributorLlombart, Antonio-
item.contributorFrassoldati, Antonio-
item.contributorPaija, Outi-
item.contributorSleeboom, Harm Peter-
item.contributorJerusalem, Guy-
item.contributorMEBIS, Jeroen-
item.contributorDeleu, Ines-
item.contributorMiller, Joel-
item.contributorSchenk, Nora-
item.contributorNeven, Patrick-
item.accessRightsOpen Access-
crisitem.journal.issn1526-8209-
crisitem.journal.eissn1938-0666-
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