Bone fractures among postmenopausal patients with endocrine-responsive early breast cancer treated with 5 years of letrozole or tamoxifen in the BIG 1-98 trial
Identifieur interne : 007D27 ( Main/Exploration ); précédent : 007D26; suivant : 007D28Bone fractures among postmenopausal patients with endocrine-responsive early breast cancer treated with 5 years of letrozole or tamoxifen in the BIG 1-98 trial
Auteurs : M. Rabaglio [Suisse] ; Z. Sun [États-Unis] ; K. N. Price [États-Unis] ; M. Castiglione-Gertsch [Suisse] ; H. Hawle [Suisse] ; B. Thürlimann ; H. Mouridsen [Danemark] ; M. Campone [France] ; J. F. Forbes [Australie] ; R. J. Paridaens [Belgique] ; M. Colleoni [Italie] ; T. Pienkowski [Pologne] ; J.-M. Nogaret [Belgique] ; I. Láng [Hongrie] ; I. Smith [Royaume-Uni] ; R. D. Gelber [États-Unis] ; A. Goldhirsch [Italie, Suisse] ; A. S. Coates [Australie]Source :
- Annals of Oncology [ 0923-7534 ] ; 2009-05-27.
Abstract
Background: To compare the incidence and timing of bone fractures in postmenopausal women treated with 5 years of adjuvant tamoxifen or letrozole for endocrine-responsive early breast cancer in the Breast International Group (BIG) 1-98 trial. Methods: We evaluated 4895 patients allocated to 5 years of letrozole or tamoxifen in the BIG 1-98 trial who received at least some study medication (median follow-up 60.3 months). Bone fracture information (grade, cause, site) was collected every 6 months during trial treatment. Results: The incidence of bone fractures was higher among patients treated with letrozole [228 of 2448 women (9.3%)] versus tamoxifen [160 of 2447 women (6.5%)]. The wrist was the most common site of fracture in both treatment groups. Statistically significant risk factors for bone fractures during treatment included age, smoking history, osteoporosis at baseline, previous bone fracture, and previous hormone replacement therapy. Conclusions: Consistent with other trials comparing aromatase inhibitors to tamoxifen, letrozole was associated with an increase in bone fractures. Benefits of superior disease control associated with letrozole and lower incidence of fracture with tamoxifen should be considered with the risk profile for individual patients.
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- https://api.istex.fr/document/06D9E0FD9E0C9EAD991BC6E43B3D245723514AE4/fulltext/pdf
- http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2731016
DOI: 10.1093/annonc/mdp033
Affiliations:
- Australie, Belgique, Danemark, France, Hongrie, Italie, Pologne, Royaume-Uni, Suisse, États-Unis
- Angleterre, Canton de Berne, Grand Londres, Hongrie centrale, Hovedstaden, Lombardie, Massachusetts, Nouvelle-Galles du Sud
- Berne, Budapest, Copenhague, Londres, Milan, Sydney
- Université de Sydney
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Rabaglio</name><affiliation wicri:level="3"><country xml:lang="fr">Suisse</country><wicri:regionArea>IBCSG Coordinating Center and Inselspital, Bern</wicri:regionArea><placeName><settlement type="city">Berne</settlement><region type="région" nuts="3">Canton de Berne</region></placeName></affiliation><affiliation></affiliation></author><author><name sortKey="Sun, Z" sort="Sun, Z" uniqKey="Sun Z" first="Z." last="Sun">Z. Sun</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>IBCSG Statistical Center, Dana-Farber Cancer Institute, Boston</wicri:cityArea></affiliation></author><author><name sortKey="Price, K N" sort="Price, K N" uniqKey="Price K" first="K. N." last="Price">K. N. Price</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>IBCSG Statistical Center and Frontier Science and Technology Research Foundation, Boston, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation><affiliation></affiliation></author><author><name sortKey="Castiglione Gertsch, M" sort="Castiglione Gertsch, M" uniqKey="Castiglione Gertsch M" first="M." last="Castiglione-Gertsch">M. Castiglione-Gertsch</name><affiliation wicri:level="3"><country>Suisse</country><placeName><settlement type="city">Berne</settlement><region type="région" nuts="3">Canton de Berne</region></placeName><wicri:orgArea>IBCSG Coordinating Center</wicri:orgArea></affiliation></author><author><name sortKey="Hawle, H" sort="Hawle, H" uniqKey="Hawle H" first="H." last="Hawle">H. Hawle</name><affiliation wicri:level="3"><country>Suisse</country><placeName><settlement type="city">Berne</settlement><region type="région" nuts="3">Canton de Berne</region></placeName><wicri:orgArea>IBCSG Coordinating Center</wicri:orgArea></affiliation></author><author><name sortKey="Thurlimann, B" sort="Thurlimann, B" uniqKey="Thurlimann B" first="B." last="Thürlimann">B. Thürlimann</name><affiliation><wicri:noCountry code="subField">(SAKK)</wicri:noCountry></affiliation></author><author><name sortKey="Mouridsen, H" sort="Mouridsen, H" uniqKey="Mouridsen H" first="H." last="Mouridsen">H. Mouridsen</name><affiliation wicri:level="3"><country xml:lang="fr">Danemark</country><wicri:regionArea>Danish Breast Cancer Cooperative Group, Rigshospitalet, Copenhagen</wicri:regionArea><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation></author><author><name sortKey="Campone, M" sort="Campone, M" uniqKey="Campone M" first="M." last="Campone">M. Campone</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Institut du Cancer Nantes Atlantique, CLCC René Gauducheau, Saint Herblain, Fédération Nationale des Centres de Lutte Contre le Cancer</wicri:regionArea><wicri:noRegion>Fédération Nationale des Centres de Lutte Contre le Cancer</wicri:noRegion><wicri:noRegion>Fédération Nationale des Centres de Lutte Contre le Cancer</wicri:noRegion></affiliation></author><author><name sortKey="Forbes, J F" sort="Forbes, J F" uniqKey="Forbes J" first="J. F." last="Forbes">J. F. Forbes</name><affiliation wicri:level="1"><country xml:lang="fr">Australie</country><wicri:regionArea>Australian New Zealand Breast Cancer Trials Group, University of Newcastle, Calvary Mater Newcastle, Newcastle, New South Wales</wicri:regionArea><wicri:noRegion>New South Wales</wicri:noRegion></affiliation></author><author><name sortKey="Paridaens, R J" sort="Paridaens, R J" uniqKey="Paridaens R" first="R. J." last="Paridaens">R. J. Paridaens</name><affiliation wicri:level="1"><country xml:lang="fr">Belgique</country><wicri:regionArea>Department of Medical Oncology, University Hospital Gasthuisberg, Catholic University of Leuven, Leuven</wicri:regionArea><wicri:noRegion>Leuven</wicri:noRegion></affiliation></author><author><name sortKey="Colleoni, M" sort="Colleoni, M" uniqKey="Colleoni M" first="M." last="Colleoni">M. Colleoni</name><affiliation wicri:level="3"><country xml:lang="fr">Italie</country><wicri:regionArea>Research Unit in Medical Senology, Department of Medicine, European Institute of Oncology, Milan</wicri:regionArea><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="Pienkowski, T" sort="Pienkowski, T" uniqKey="Pienkowski T" first="T." last="Pienkowski">T. Pienkowski</name><affiliation wicri:level="1"><country xml:lang="fr">Pologne</country><wicri:regionArea>Cancer Center Maria Sklodowska-Curie Memorial Institute of Oncology, Warsaw</wicri:regionArea><wicri:noRegion>Warsaw</wicri:noRegion></affiliation></author><author><name sortKey="Nogaret, J M" sort="Nogaret, J M" uniqKey="Nogaret J" first="J.-M." last="Nogaret">J.-M. Nogaret</name><affiliation wicri:level="1"><country xml:lang="fr">Belgique</country><wicri:regionArea>Department of Mammary and Pelvic Surgery, Jules Bordet Institute; Brussels</wicri:regionArea><wicri:noRegion>Jules Bordet Institute; Brussels</wicri:noRegion></affiliation></author><author><name sortKey="Lang, I" sort="Lang, I" uniqKey="Lang I" first="I." last="Láng">I. Láng</name><affiliation wicri:level="3"><country xml:lang="fr">Hongrie</country><wicri:regionArea>Department of Medical Oncology, National Institute of Oncology, Budapest</wicri:regionArea><placeName><settlement type="city">Budapest</settlement><region nuts="2">Hongrie centrale</region></placeName></affiliation></author><author><name sortKey="Smith, I" sort="Smith, I" uniqKey="Smith I" first="I." last="Smith">I. Smith</name><affiliation wicri:level="3"><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Breast Unit, The Royal Marsden Hospital, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Gelber, R D" sort="Gelber, R D" uniqKey="Gelber R" first="R. D." last="Gelber">R. D. Gelber</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>IBCSG Statistical Center, Dana-Farber Cancer Institute, Harvard School of Public Health and Harvard Medical School, Boston, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Goldhirsch, A" sort="Goldhirsch, A" uniqKey="Goldhirsch A" first="A." last="Goldhirsch">A. Goldhirsch</name><affiliation wicri:level="3"><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Medicine, European Institute of Oncology, Milan</wicri:regionArea><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation><affiliation wicri:level="1"><country xml:lang="fr">Suisse</country><wicri:regionArea>Oncology Institute of Southern Switzerland, Bellinzona</wicri:regionArea><wicri:noRegion>Bellinzona</wicri:noRegion></affiliation></author><author><name sortKey="Coates, A S" sort="Coates, A S" uniqKey="Coates A" first="A. S." last="Coates">A. S. Coates</name><affiliation wicri:level="4"><country xml:lang="fr">Australie</country><wicri:regionArea>International Breast Cancer Study Group and University of Sydney, Sydney, New South Wales</wicri:regionArea><orgName type="university">Université de Sydney</orgName><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author></analytic><monogr></monogr><series><title level="j">Annals of Oncology</title><idno type="ISSN">0923-7534</idno><idno type="eISSN">1569-8041</idno><imprint><publisher>Oxford University Press</publisher><date type="published" when="2009-05-27">2009-05-27</date><biblScope unit="volume">20</biblScope><biblScope unit="issue">9</biblScope><biblScope unit="page" from="1489">1489</biblScope><biblScope unit="page" to="1498">1498</biblScope></imprint><idno type="ISSN">0923-7534</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0923-7534</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract">Background: To compare the incidence and timing of bone fractures in postmenopausal women treated with 5 years of adjuvant tamoxifen or letrozole for endocrine-responsive early breast cancer in the Breast International Group (BIG) 1-98 trial. Methods: We evaluated 4895 patients allocated to 5 years of letrozole or tamoxifen in the BIG 1-98 trial who received at least some study medication (median follow-up 60.3 months). Bone fracture information (grade, cause, site) was collected every 6 months during trial treatment. Results: The incidence of bone fractures was higher among patients treated with letrozole [228 of 2448 women (9.3%)] versus tamoxifen [160 of 2447 women (6.5%)]. The wrist was the most common site of fracture in both treatment groups. Statistically significant risk factors for bone fractures during treatment included age, smoking history, osteoporosis at baseline, previous bone fracture, and previous hormone replacement therapy. Conclusions: Consistent with other trials comparing aromatase inhibitors to tamoxifen, letrozole was associated with an increase in bone fractures. Benefits of superior disease control associated with letrozole and lower incidence of fracture with tamoxifen should be considered with the risk profile for individual patients.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Belgique</li><li>Danemark</li><li>France</li><li>Hongrie</li><li>Italie</li><li>Pologne</li><li>Royaume-Uni</li><li>Suisse</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Canton de Berne</li><li>Grand Londres</li><li>Hongrie centrale</li><li>Hovedstaden</li><li>Lombardie</li><li>Massachusetts</li><li>Nouvelle-Galles du Sud</li></region><settlement><li>Berne</li><li>Budapest</li><li>Copenhague</li><li>Londres</li><li>Milan</li><li>Sydney</li></settlement><orgName><li>Université de Sydney</li></orgName></list><tree><noCountry><name sortKey="Thurlimann, B" sort="Thurlimann, B" uniqKey="Thurlimann B" first="B." last="Thürlimann">B. Thürlimann</name></noCountry><country name="Suisse"><region name="Canton de Berne"><name sortKey="Rabaglio, M" sort="Rabaglio, M" uniqKey="Rabaglio M" first="M." last="Rabaglio">M. Rabaglio</name></region><name sortKey="Castiglione Gertsch, M" sort="Castiglione Gertsch, M" uniqKey="Castiglione Gertsch M" first="M." last="Castiglione-Gertsch">M. Castiglione-Gertsch</name><name sortKey="Goldhirsch, A" sort="Goldhirsch, A" uniqKey="Goldhirsch A" first="A." last="Goldhirsch">A. Goldhirsch</name><name sortKey="Hawle, H" sort="Hawle, H" uniqKey="Hawle H" first="H." last="Hawle">H. Hawle</name></country><country name="États-Unis"><region name="Massachusetts"><name sortKey="Sun, Z" sort="Sun, Z" uniqKey="Sun Z" first="Z." last="Sun">Z. Sun</name></region><name sortKey="Gelber, R D" sort="Gelber, R D" uniqKey="Gelber R" first="R. D." last="Gelber">R. D. Gelber</name><name sortKey="Price, K N" sort="Price, K N" uniqKey="Price K" first="K. N." last="Price">K. N. Price</name></country><country name="Danemark"><region name="Hovedstaden"><name sortKey="Mouridsen, H" sort="Mouridsen, H" uniqKey="Mouridsen H" first="H." last="Mouridsen">H. Mouridsen</name></region></country><country name="France"><noRegion><name sortKey="Campone, M" sort="Campone, M" uniqKey="Campone M" first="M." last="Campone">M. Campone</name></noRegion></country><country name="Australie"><noRegion><name sortKey="Forbes, J F" sort="Forbes, J F" uniqKey="Forbes J" first="J. F." last="Forbes">J. F. Forbes</name></noRegion><name sortKey="Coates, A S" sort="Coates, A S" uniqKey="Coates A" first="A. S." last="Coates">A. S. Coates</name></country><country name="Belgique"><noRegion><name sortKey="Paridaens, R J" sort="Paridaens, R J" uniqKey="Paridaens R" first="R. J." last="Paridaens">R. J. Paridaens</name></noRegion><name sortKey="Nogaret, J M" sort="Nogaret, J M" uniqKey="Nogaret J" first="J.-M." last="Nogaret">J.-M. 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