Bone mineral density and circulating biomarkers in the BIG 1-98 trial comparing adjuvant letrozole, tamoxifen and their sequences
Identifieur interne : 001E63 ( Pmc/Curation ); précédent : 001E62; suivant : 001E64Bone mineral density and circulating biomarkers in the BIG 1-98 trial comparing adjuvant letrozole, tamoxifen and their sequences
Auteurs : Andrea Decensi [Italie] ; Zhuoxin Sun [États-Unis] ; Aliana Guerrieri-Gonzaga [Italie] ; Beat Thürlimann [Suisse] ; Christina Mcintosh [États-Unis] ; Carlo Tondini [Italie] ; Alain Monnier [France] ; Mario Campone [France] ; Marc Debled [France] ; Astrid Schönenberger [Suisse] ; Khalil Zaman [Suisse] ; Harriet Johansson [Italie] ; Karen N. Price [États-Unis] ; Richard D. Gelber [États-Unis] ; Aron Goldhirsch [Italie] ; Alan S. Coates [Australie] ; Stefan Aebi [Suisse]Source :
- Breast cancer research and treatment [ 0167-6806 ] ; 2014.
Abstract
To determine the effects of the BIG 1-98 treatments on bone mineral density. BIG 1-98 compared 5-year adjuvant hormone therapy in postmenopausal women allocated to four groups: tamoxifen (T); letrozole (L); 2-years T, 3-years L (TL); 2-years L, 3-years T (LT).
Bone mineral density T-score was measured prospectively annually by dual energy X-ray absorption in 424 patients enrolled in a sub-study after three (n=150), four (n=200), and five years (n=74) from randomization, and one year after treatment cessation. Prevalence of osteoporosis and the association of C-telopeptide, osteocalcin and bone alkaline phosphatase with T-scores were assessed.
At 3 years, T had the highest and TL the lowest T-score. All arms except for LT showed a decline up to 5 years, with TL exhibiting the greatest. At 5 years, there were significant differences on lumbar T-score only between T and TL, whereas for femur T-score differences were significant for T vs. L or TL, and L vs. LT. The 5-year prevalence of spine and femur osteoporosis was highest on TL (14.5%, 7.1%) then L (4.3%, 5.1%), LT (4.2%, 1.4%) and T (4%, 0). C-telopeptide and osteocalcin were significantly associated with T-scores.
While adjuvant L increases bone mineral density loss compared with T, the sequence LT has an acceptable bone safety profile. C-telopeptide and osteocalcin are useful markers of bone density that may be used to monitor bone health during treatment. The sequence LT may be a valid treatment option in patients with low and intermediate risk of recurrence.
clinicaltrials.gov NCT00369850
Url:
DOI: 10.1007/s10549-014-2849-2
PubMed: 24487691
PubMed Central: 3982877
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<author><name sortKey="Tondini, Carlo" sort="Tondini, Carlo" uniqKey="Tondini C" first="Carlo" last="Tondini">Carlo Tondini</name>
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<author><name sortKey="Monnier, Alain" sort="Monnier, Alain" uniqKey="Monnier A" first="Alain" last="Monnier">Alain Monnier</name>
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<country xml:lang="fr">France</country>
<wicri:regionArea>University of Franche Comté, IRMA Team-UMR 6249 CNRS, Montbèliard</wicri:regionArea>
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<author><name sortKey="Campone, Mario" sort="Campone, Mario" uniqKey="Campone M" first="Mario" last="Campone">Mario Campone</name>
<affiliation wicri:level="1"><nlm:aff id="A8">Department of Medical Oncology, Institut de Cancerologie de l’OUEST, Saint-Herblain-Nantes, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Medical Oncology, Institut de Cancerologie de l’OUEST, Saint-Herblain-Nantes</wicri:regionArea>
</affiliation>
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<author><name sortKey="Debled, Marc" sort="Debled, Marc" uniqKey="Debled M" first="Marc" last="Debled">Marc Debled</name>
<affiliation wicri:level="1"><nlm:aff id="A9">Department of Medicine, Institut Bergonié, Bordeaux, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Medicine, Institut Bergonié, Bordeaux</wicri:regionArea>
</affiliation>
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<author><name sortKey="Schonenberger, Astrid" sort="Schonenberger, Astrid" uniqKey="Schonenberger A" first="Astrid" last="Schönenberger">Astrid Schönenberger</name>
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<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Spital Langenthal SRO AG, Langenthal</wicri:regionArea>
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<author><name sortKey="Zaman, Khalil" sort="Zaman, Khalil" uniqKey="Zaman K" first="Khalil" last="Zaman">Khalil Zaman</name>
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<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Breast Center, University Hospital CHUV, Lausanne, Switzerland and Swiss Group for Clinical Cancer Research (SAKK), Bern</wicri:regionArea>
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<author><name sortKey="Johansson, Harriet" sort="Johansson, Harriet" uniqKey="Johansson H" first="Harriet" last="Johansson">Harriet Johansson</name>
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<country xml:lang="fr">Italie</country>
<wicri:regionArea>Division of Cancer Prevention and Genetics, European Institute of Oncology, Milan</wicri:regionArea>
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<author><name sortKey="Price, Karen N" sort="Price, Karen N" uniqKey="Price K" first="Karen N." last="Price">Karen N. Price</name>
<affiliation wicri:level="2"><nlm:aff id="A13">International Breast Cancer Study Group (IBCSG) Statistical Center, Frontier Science and Technology Research Foundation, Boston, MA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Massachusetts</region>
</placeName>
<wicri:cityArea>International Breast Cancer Study Group (IBCSG) Statistical Center, Frontier Science and Technology Research Foundation, Boston</wicri:cityArea>
</affiliation>
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<author><name sortKey="Gelber, Richard D" sort="Gelber, Richard D" uniqKey="Gelber R" first="Richard D." last="Gelber">Richard D. Gelber</name>
<affiliation wicri:level="2"><nlm:aff id="A14">International Breast Cancer Study Group (IBCSG) Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Harvard School of Public Health, Harvard Medical School, Boston, MA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Massachusetts</region>
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</affiliation>
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<author><name sortKey="Goldhirsch, Aron" sort="Goldhirsch, Aron" uniqKey="Goldhirsch A" first="Aron" last="Goldhirsch">Aron Goldhirsch</name>
<affiliation wicri:level="1"><nlm:aff id="A15">Division of Medical Oncology, European Institute of Oncology, Milan, Italy</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Division of Medical Oncology, European Institute of Oncology, Milan</wicri:regionArea>
</affiliation>
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<author><name sortKey="Coates, Alan S" sort="Coates, Alan S" uniqKey="Coates A" first="Alan S." last="Coates">Alan S. Coates</name>
<affiliation wicri:level="1"><nlm:aff id="A16">International Breast Cancer Study Group, Bern, Switzerland and University of Sydney, Australia</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>International Breast Cancer Study Group, Bern, Switzerland and University of Sydney</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Aebi, Stefan" sort="Aebi, Stefan" uniqKey="Aebi S" first="Stefan" last="Aebi">Stefan Aebi</name>
<affiliation wicri:level="1"><nlm:aff id="A17">Luzerner Kantonsspital, Lucerne, University of Bern, and Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland</nlm:aff>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Luzerner Kantonsspital, Lucerne, University of Bern, and Swiss Group for Clinical Cancer Research (SAKK), Bern</wicri:regionArea>
</affiliation>
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</analytic>
<series><title level="j">Breast cancer research and treatment</title>
<idno type="ISSN">0167-6806</idno>
<idno type="eISSN">1573-7217</idno>
<imprint><date when="2014">2014</date>
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<front><div type="abstract" xml:lang="en"><sec id="S1"><title>Purpose</title>
<p id="P1">To determine the effects of the BIG 1-98 treatments on bone mineral density. BIG 1-98 compared 5-year adjuvant hormone therapy in postmenopausal women allocated to four groups: tamoxifen (T); letrozole (L); 2-years T, 3-years L (TL); 2-years L, 3-years T (LT).</p>
</sec>
<sec id="S2"><title>Methods</title>
<p id="P2">Bone mineral density T-score was measured prospectively annually by dual energy X-ray absorption in 424 patients enrolled in a sub-study after three (n=150), four (n=200), and five years (n=74) from randomization, and one year after treatment cessation. Prevalence of osteoporosis and the association of C-telopeptide, osteocalcin and bone alkaline phosphatase with T-scores were assessed.</p>
</sec>
<sec id="S3"><title>Results</title>
<p id="P3">At 3 years, T had the highest and TL the lowest T-score. All arms except for LT showed a decline up to 5 years, with TL exhibiting the greatest. At 5 years, there were significant differences on lumbar T-score only between T and TL, whereas for femur T-score differences were significant for T vs. L or TL, and L vs. LT. The 5-year prevalence of spine and femur osteoporosis was highest on TL (14.5%, 7.1%) then L (4.3%, 5.1%), LT (4.2%, 1.4%) and T (4%, 0). C-telopeptide and osteocalcin were significantly associated with T-scores.</p>
</sec>
<sec id="S4"><title>Conclusions</title>
<p id="P4">While adjuvant L increases bone mineral density loss compared with T, the sequence LT has an acceptable bone safety profile. C-telopeptide and osteocalcin are useful markers of bone density that may be used to monitor bone health during treatment. The sequence LT may be a valid treatment option in patients with low and intermediate risk of recurrence.</p>
</sec>
<sec id="S5"><title>Trial registration</title>
<p id="P5">clinicaltrials.gov NCT00369850</p>
</sec>
</div>
</front>
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<front><journal-meta><journal-id journal-id-type="nlm-journal-id">8111104</journal-id>
<journal-id journal-id-type="pubmed-jr-id">1254</journal-id>
<journal-id journal-id-type="nlm-ta">Breast Cancer Res Treat</journal-id>
<journal-id journal-id-type="iso-abbrev">Breast Cancer Res. Treat.</journal-id>
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<article-meta><article-id pub-id-type="pmid">24487691</article-id>
<article-id pub-id-type="pmc">3982877</article-id>
<article-id pub-id-type="doi">10.1007/s10549-014-2849-2</article-id>
<article-id pub-id-type="manuscript">NIHMS562557</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Article</subject>
</subj-group>
</article-categories>
<title-group><article-title>Bone mineral density and circulating biomarkers in the BIG 1-98 trial comparing adjuvant letrozole, tamoxifen and their sequences</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>DeCensi</surname>
<given-names>Andrea</given-names>
</name>
<xref ref-type="aff" rid="A1">1</xref>
<xref ref-type="aff" rid="A3">3</xref>
<email>andrea.decensi@galliera.it</email>
</contrib>
<contrib contrib-type="author"><name><surname>Sun</surname>
<given-names>Zhuoxin</given-names>
</name>
<xref ref-type="aff" rid="A2">2</xref>
<email>zhuxoin@jimmy.harvard.edu</email>
</contrib>
<contrib contrib-type="author"><name><surname>Guerrieri-Gonzaga</surname>
<given-names>Aliana</given-names>
</name>
<xref ref-type="aff" rid="A3">3</xref>
<email>aliana.guerrieri-gonzaga@ieo.it</email>
</contrib>
<contrib contrib-type="author"><name><surname>Thürlimann</surname>
<given-names>Beat</given-names>
</name>
<xref ref-type="aff" rid="A4">4</xref>
<email>beat.thuerlimann@kssg.ch</email>
</contrib>
<contrib contrib-type="author"><name><surname>McIntosh</surname>
<given-names>Christina</given-names>
</name>
<xref ref-type="aff" rid="A5">5</xref>
<email>cmm862@mail.harvard.edu</email>
</contrib>
<contrib contrib-type="author"><name><surname>Tondini</surname>
<given-names>Carlo</given-names>
</name>
<xref ref-type="aff" rid="A6">6</xref>
<email>carlo.tondini@ospedaliriuniti.bergamo.it</email>
</contrib>
<contrib contrib-type="author"><name><surname>Monnier</surname>
<given-names>Alain</given-names>
</name>
<xref ref-type="aff" rid="A7">7</xref>
<email>dramonnier@orange.fr</email>
</contrib>
<contrib contrib-type="author"><name><surname>Campone</surname>
<given-names>Mario</given-names>
</name>
<xref ref-type="aff" rid="A8">8</xref>
<email>Mario.Campone@ico.unicancer.fr</email>
</contrib>
<contrib contrib-type="author"><name><surname>Debled</surname>
<given-names>Marc</given-names>
</name>
<xref ref-type="aff" rid="A9">9</xref>
<email>m.debled@bordeaux.unicancer.fr</email>
</contrib>
<contrib contrib-type="author"><name><surname>Schönenberger</surname>
<given-names>Astrid</given-names>
</name>
<xref ref-type="aff" rid="A10">10</xref>
<email>a.schoenenberger@sro.ch</email>
</contrib>
<contrib contrib-type="author"><name><surname>Zaman</surname>
<given-names>Khalil</given-names>
</name>
<xref ref-type="aff" rid="A11">11</xref>
<email>Khalil.Zaman@chuv.ch</email>
</contrib>
<contrib contrib-type="author"><name><surname>Johansson</surname>
<given-names>Harriet</given-names>
</name>
<xref ref-type="aff" rid="A12">12</xref>
<email>harriet.johansson@ieo.it</email>
</contrib>
<contrib contrib-type="author"><name><surname>Price</surname>
<given-names>Karen N.</given-names>
</name>
<xref ref-type="aff" rid="A13">13</xref>
<email>price@jimmy.harvard.edu</email>
</contrib>
<contrib contrib-type="author"><name><surname>Gelber</surname>
<given-names>Richard D.</given-names>
</name>
<xref ref-type="aff" rid="A14">14</xref>
<email>gelber@jimmy.harvard.edu</email>
</contrib>
<contrib contrib-type="author"><name><surname>Goldhirsch</surname>
<given-names>Aron</given-names>
</name>
<xref ref-type="aff" rid="A15">15</xref>
<email>aron.goldhirsch@ibcsg.org</email>
</contrib>
<contrib contrib-type="author"><name><surname>Coates</surname>
<given-names>Alan S.</given-names>
</name>
<xref ref-type="aff" rid="A16">16</xref>
<email>alan.coates@ibcsg.org</email>
</contrib>
<contrib contrib-type="author"><name><surname>Aebi</surname>
<given-names>Stefan</given-names>
</name>
<xref ref-type="aff" rid="A17">17</xref>
<email>stefan.aebi@onkologie.ch</email>
</contrib>
<on-behalf-of>for the BIG 1-98 Collaborative and International Breast Cancer Study Groups</on-behalf-of>
</contrib-group>
<aff id="A1"><label>1</label>
Division of Medical Oncology, E.O. Ospedali Galliera, Genoa, Italy</aff>
<aff id="A2"><label>2</label>
International Breast Cancer Study Group (IBCSG) Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Harvard School of Public health, Boston, MA</aff>
<aff id="A3"><label>3</label>
Division of Cancer Prevention and Genetics, European Institute of Oncology, Milan, Italy</aff>
<aff id="A4"><label>4</label>
Breast Center, Kantonsspital, St. Gallen and Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland</aff>
<aff id="A5"><label>5</label>
Department of Biostatistics, Harvard School of Public Health, Boston, MA</aff>
<aff id="A6"><label>6</label>
Oncologia Medica, Ospedale Papa Giovanni XXIII, Bergamo, Italy</aff>
<aff id="A7"><label>7</label>
University of Franche Comté, IRMA Team-UMR 6249 CNRS, Montbèliard, France</aff>
<aff id="A8"><label>8</label>
Department of Medical Oncology, Institut de Cancerologie de l’OUEST, Saint-Herblain-Nantes, France</aff>
<aff id="A9"><label>9</label>
Department of Medicine, Institut Bergonié, Bordeaux, France</aff>
<aff id="A10"><label>10</label>
Spital Langenthal SRO AG, Langenthal, Switzerland</aff>
<aff id="A11"><label>11</label>
Breast Center, University Hospital CHUV, Lausanne, Switzerland and Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland</aff>
<aff id="A12"><label>12</label>
Division of Cancer Prevention and Genetics, European Institute of Oncology, Milan, Italy</aff>
<aff id="A13"><label>13</label>
International Breast Cancer Study Group (IBCSG) Statistical Center, Frontier Science and Technology Research Foundation, Boston, MA</aff>
<aff id="A14"><label>14</label>
International Breast Cancer Study Group (IBCSG) Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Harvard School of Public Health, Harvard Medical School, Boston, MA</aff>
<aff id="A15"><label>15</label>
Division of Medical Oncology, European Institute of Oncology, Milan, Italy</aff>
<aff id="A16"><label>16</label>
International Breast Cancer Study Group, Bern, Switzerland and University of Sydney, Australia</aff>
<aff id="A17"><label>17</label>
Luzerner Kantonsspital, Lucerne, University of Bern, and Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland</aff>
<author-notes><corresp id="FN1">Corresponding author prior to publication: Karen N Price, IBCSG Statistical Center, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA 02215, Mailstop CLS-11007, tel: +1 617-632-2459; fax: +1 617-632-2444; <email>price@jimmy.harvard.edu</email>
</corresp>
<corresp id="FN2">Corresponding author after publication: Andrea DeCensi, MD, Division of Medical Oncology, E.O. Ospedali Galliera, Mura delle Cappuccine 14, 16128 Genoa, Italy, tel.: +39-0105634501; fax: +39-01057481090; <email>andrea.decensi@galliera.it</email>
</corresp>
</author-notes>
<pub-date pub-type="nihms-submitted"><day>31</day>
<month>3</month>
<year>2014</year>
</pub-date>
<pub-date pub-type="epub"><day>01</day>
<month>2</month>
<year>2014</year>
</pub-date>
<pub-date pub-type="ppub"><month>4</month>
<year>2014</year>
</pub-date>
<pub-date pub-type="pmc-release"><day>01</day>
<month>4</month>
<year>2015</year>
</pub-date>
<volume>144</volume>
<issue>2</issue>
<fpage>321</fpage>
<lpage>329</lpage>
<pmc-comment>elocation-id from pubmed: 10.1007/s10549-014-2849-2</pmc-comment>
<abstract><sec id="S1"><title>Purpose</title>
<p id="P1">To determine the effects of the BIG 1-98 treatments on bone mineral density. BIG 1-98 compared 5-year adjuvant hormone therapy in postmenopausal women allocated to four groups: tamoxifen (T); letrozole (L); 2-years T, 3-years L (TL); 2-years L, 3-years T (LT).</p>
</sec>
<sec id="S2"><title>Methods</title>
<p id="P2">Bone mineral density T-score was measured prospectively annually by dual energy X-ray absorption in 424 patients enrolled in a sub-study after three (n=150), four (n=200), and five years (n=74) from randomization, and one year after treatment cessation. Prevalence of osteoporosis and the association of C-telopeptide, osteocalcin and bone alkaline phosphatase with T-scores were assessed.</p>
</sec>
<sec id="S3"><title>Results</title>
<p id="P3">At 3 years, T had the highest and TL the lowest T-score. All arms except for LT showed a decline up to 5 years, with TL exhibiting the greatest. At 5 years, there were significant differences on lumbar T-score only between T and TL, whereas for femur T-score differences were significant for T vs. L or TL, and L vs. LT. The 5-year prevalence of spine and femur osteoporosis was highest on TL (14.5%, 7.1%) then L (4.3%, 5.1%), LT (4.2%, 1.4%) and T (4%, 0). C-telopeptide and osteocalcin were significantly associated with T-scores.</p>
</sec>
<sec id="S4"><title>Conclusions</title>
<p id="P4">While adjuvant L increases bone mineral density loss compared with T, the sequence LT has an acceptable bone safety profile. C-telopeptide and osteocalcin are useful markers of bone density that may be used to monitor bone health during treatment. The sequence LT may be a valid treatment option in patients with low and intermediate risk of recurrence.</p>
</sec>
<sec id="S5"><title>Trial registration</title>
<p id="P5">clinicaltrials.gov NCT00369850</p>
</sec>
</abstract>
<kwd-group><kwd>breast cancer</kwd>
<kwd>adjuvant drug therapy</kwd>
<kwd>aromatase inhibitor</kwd>
<kwd>bone density</kwd>
<kwd>bone turnover</kwd>
</kwd-group>
</article-meta>
</front>
</pmc>
</record>
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