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Bone mineral density and circulating biomarkers in the BIG 1-98 trial comparing adjuvant letrozole, tamoxifen and their sequences

Identifieur interne : 003C19 ( Main/Merge ); précédent : 003C18; suivant : 003C20

Bone 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 :

RBID : PMC:3982877

Abstract

Purpose

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).

Methods

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.

Results

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.

Conclusions

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.

Trial registration

clinicaltrials.gov NCT00369850


Url:
DOI: 10.1007/s10549-014-2849-2
PubMed: 24487691
PubMed Central: 3982877

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PMC:3982877

Le document en format XML

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<name sortKey="Aebi, Stefan" sort="Aebi, Stefan" uniqKey="Aebi S" first="Stefan" last="Aebi">Stefan Aebi</name>
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<name sortKey="Decensi, Andrea" sort="Decensi, Andrea" uniqKey="Decensi A" first="Andrea" last="Decensi">Andrea Decensi</name>
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<name sortKey="Tondini, Carlo" sort="Tondini, Carlo" uniqKey="Tondini C" first="Carlo" last="Tondini">Carlo Tondini</name>
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<name sortKey="Campone, Mario" sort="Campone, Mario" uniqKey="Campone M" first="Mario" last="Campone">Mario Campone</name>
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<name sortKey="Debled, Marc" sort="Debled, Marc" uniqKey="Debled M" first="Marc" last="Debled">Marc Debled</name>
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<name sortKey="Schonenberger, Astrid" sort="Schonenberger, Astrid" uniqKey="Schonenberger A" first="Astrid" last="Schönenberger">Astrid Schönenberger</name>
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<name sortKey="Zaman, Khalil" sort="Zaman, Khalil" uniqKey="Zaman K" first="Khalil" last="Zaman">Khalil Zaman</name>
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<name sortKey="Johansson, Harriet" sort="Johansson, Harriet" uniqKey="Johansson H" first="Harriet" last="Johansson">Harriet Johansson</name>
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<wicri:regionArea>Division of Cancer Prevention and Genetics, European Institute of Oncology, Milan</wicri:regionArea>
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<name sortKey="Price, Karen N" sort="Price, Karen N" uniqKey="Price K" first="Karen N." last="Price">Karen N. Price</name>
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<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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<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>
</placeName>
<wicri:cityArea>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</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Goldhirsch, Aron" sort="Goldhirsch, Aron" uniqKey="Goldhirsch A" first="Aron" last="Goldhirsch">Aron Goldhirsch</name>
<affiliation wicri:level="3">
<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>
<placeName>
<settlement type="city">Milan</settlement>
<region nuts="2">Lombardie</region>
</placeName>
</affiliation>
</author>
<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="4">
<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>
<placeName>
<settlement type="city">Sydney</settlement>
<region type="état">Nouvelle-Galles du Sud</region>
</placeName>
<orgName type="university">Université de Sydney</orgName>
</affiliation>
</author>
<author>
<name sortKey="Aebi, Stefan" sort="Aebi, Stefan" uniqKey="Aebi S" first="Stefan" last="Aebi">Stefan Aebi</name>
<affiliation wicri:level="4">
<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>
<placeName>
<settlement type="city">Berne</settlement>
<region type="région" nuts="3">Canton de Berne</region>
<settlement type="city">Berne</settlement>
</placeName>
<orgName type="university">Université de Berne</orgName>
</affiliation>
</author>
</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>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc>
<textClass></textClass>
</profileDesc>
</teiHeader>
<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>
</TEI>
</record>

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