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Effects of exemestane and tamoxifen on bone health within the Tamoxifen Exemestane Adjuvant Multicentre (TEAM) trial: results of a German, 12-month, prospective, randomised substudy

Identifieur interne : 000529 ( PascalFrancis/Checkpoint ); précédent : 000528; suivant : 000530

Effects of exemestane and tamoxifen on bone health within the Tamoxifen Exemestane Adjuvant Multicentre (TEAM) trial: results of a German, 12-month, prospective, randomised substudy

Auteurs : P. Hadji [Allemagne] ; M. Ziller [Allemagne] ; D. G. Kieback [Allemagne] ; W. Dornoff [Allemagne] ; H. W. Tessen [Allemagne] ; T. Menschik [France] ; J. Kuck [Allemagne] ; F. Melchert [Allemagne] ; A. Hasenburg [Allemagne]

Source :

RBID : Pascal:09-0309205

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English descriptors

Abstract

Background: Adjuvant treatment of hormone receptor-positive breast cancer in postmenopausal women with aromatase inhibitors may be associated with increased bone loss. Patients and methods: Two hundred patients were randomised to receive exemestane or tamoxifen as adjuvant treatment of hormone receptor-positive breast cancer. Bone mineral density (BMD) was assessed by dual-energy X-ray absorptiometry at baseline and after 6 and 12 months treatment. Results: One hundred and sixty-one patients were assessable. Tamoxifen treatment resulted in a 0.5% increase from baseline in BMD at the spine, which was maintained at 12 months. Exemestane-treated patients experienced a 2.6% decrease from baseline in BMD at the spine at 6 months and a further 0.2% decrease at 12 months. There were significant differences in the changes in BMD between tamoxifen and exemestane at 6 and 12 months (P = 0.0026 and P = 0.0008, respectively). The mean changes in BMD from baseline at the total hip were also significantly different between exemestane and tamoxifen at 6 and 12 months (P = 0.0009 and P = 0.04, respectively). There was no difference between tamoxifen and exemestane in mean changes in BMD from baseline at the femoral neck. Conclusions: Exemestane treatment resulted in an increase in bone loss at 6 months; bone loss stabilised after 6- to 12-month treatment.


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Pascal:09-0309205

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<term>Breast cancer</term>
<term>Clinical trial</term>
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<term>Exemestane</term>
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<div type="abstract" xml:lang="en">Background: Adjuvant treatment of hormone receptor-positive breast cancer in postmenopausal women with aromatase inhibitors may be associated with increased bone loss. Patients and methods: Two hundred patients were randomised to receive exemestane or tamoxifen as adjuvant treatment of hormone receptor-positive breast cancer. Bone mineral density (BMD) was assessed by dual-energy X-ray absorptiometry at baseline and after 6 and 12 months treatment. Results: One hundred and sixty-one patients were assessable. Tamoxifen treatment resulted in a 0.5% increase from baseline in BMD at the spine, which was maintained at 12 months. Exemestane-treated patients experienced a 2.6% decrease from baseline in BMD at the spine at 6 months and a further 0.2% decrease at 12 months. There were significant differences in the changes in BMD between tamoxifen and exemestane at 6 and 12 months (P = 0.0026 and P = 0.0008, respectively). The mean changes in BMD from baseline at the total hip were also significantly different between exemestane and tamoxifen at 6 and 12 months (P = 0.0009 and P = 0.04, respectively). There was no difference between tamoxifen and exemestane in mean changes in BMD from baseline at the femoral neck. Conclusions: Exemestane treatment resulted in an increase in bone loss at 6 months; bone loss stabilised after 6- to 12-month treatment.</div>
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<fC01 i1="01" l="ENG">
<s0>Background: Adjuvant treatment of hormone receptor-positive breast cancer in postmenopausal women with aromatase inhibitors may be associated with increased bone loss. Patients and methods: Two hundred patients were randomised to receive exemestane or tamoxifen as adjuvant treatment of hormone receptor-positive breast cancer. Bone mineral density (BMD) was assessed by dual-energy X-ray absorptiometry at baseline and after 6 and 12 months treatment. Results: One hundred and sixty-one patients were assessable. Tamoxifen treatment resulted in a 0.5% increase from baseline in BMD at the spine, which was maintained at 12 months. Exemestane-treated patients experienced a 2.6% decrease from baseline in BMD at the spine at 6 months and a further 0.2% decrease at 12 months. There were significant differences in the changes in BMD between tamoxifen and exemestane at 6 and 12 months (P = 0.0026 and P = 0.0008, respectively). The mean changes in BMD from baseline at the total hip were also significantly different between exemestane and tamoxifen at 6 and 12 months (P = 0.0009 and P = 0.04, respectively). There was no difference between tamoxifen and exemestane in mean changes in BMD from baseline at the femoral neck. Conclusions: Exemestane treatment resulted in an increase in bone loss at 6 months; bone loss stabilised after 6- to 12-month treatment.</s0>
</fC01>
<fC02 i1="01" i2="X">
<s0>002B02R</s0>
</fC02>
<fC02 i1="02" i2="X">
<s0>002B20E02</s0>
</fC02>
<fC02 i1="03" i2="X">
<s0>002B15A</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE">
<s0>Exémestane</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG">
<s0>Exemestane</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA">
<s0>Exemestano</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE">
<s0>Tamoxifène</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG">
<s0>Tamoxifene</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA">
<s0>Tamoxifeno</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE">
<s0>Os</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG">
<s0>Bone</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA">
<s0>Hueso</s0>
<s5>03</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE">
<s0>Santé</s0>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG">
<s0>Health</s0>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA">
<s0>Salud</s0>
<s5>04</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE">
<s0>Essai clinique</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG">
<s0>Clinical trial</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA">
<s0>Ensayo clínico</s0>
<s5>05</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE">
<s0>Allemagne</s0>
<s2>NG</s2>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG">
<s0>Germany</s0>
<s2>NG</s2>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA">
<s0>Alemania</s0>
<s2>NG</s2>
<s5>06</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE">
<s0>Prospective</s0>
<s5>07</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG">
<s0>Prospective</s0>
<s5>07</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA">
<s0>Prospectiva</s0>
<s5>07</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE">
<s0>Randomisation</s0>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG">
<s0>Randomization</s0>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA">
<s0>Aleatorización</s0>
<s5>08</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE">
<s0>Inhibiteur de l'aromatase</s0>
<s5>09</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG">
<s0>Aromatase inhibitor</s0>
<s5>09</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA">
<s0>Inhibidor aromatase</s0>
<s5>09</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE">
<s0>Densité minérale osseuse</s0>
<s5>10</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG">
<s0>Bone mineral density</s0>
<s5>10</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA">
<s0>Masa mineral ósea</s0>
<s5>10</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE">
<s0>Précoce</s0>
<s5>11</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG">
<s0>Early</s0>
<s5>11</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA">
<s0>Precoz</s0>
<s5>11</s5>
</fC03>
<fC03 i1="12" i2="X" l="FRE">
<s0>Cancer du sein</s0>
<s2>NM</s2>
<s5>12</s5>
</fC03>
<fC03 i1="12" i2="X" l="ENG">
<s0>Breast cancer</s0>
<s2>NM</s2>
<s5>12</s5>
</fC03>
<fC03 i1="12" i2="X" l="SPA">
<s0>Cáncer del pecho</s0>
<s2>NM</s2>
<s5>12</s5>
</fC03>
<fC03 i1="13" i2="X" l="FRE">
<s0>Fracture</s0>
<s5>13</s5>
</fC03>
<fC03 i1="13" i2="X" l="ENG">
<s0>Fracture</s0>
<s5>13</s5>
</fC03>
<fC03 i1="13" i2="X" l="SPA">
<s0>Fractura</s0>
<s5>13</s5>
</fC03>
<fC03 i1="14" i2="X" l="FRE">
<s0>Ostéoporose</s0>
<s5>14</s5>
</fC03>
<fC03 i1="14" i2="X" l="ENG">
<s0>Osteoporosis</s0>
<s5>14</s5>
</fC03>
<fC03 i1="14" i2="X" l="SPA">
<s0>Osteoporosis</s0>
<s5>14</s5>
</fC03>
<fC03 i1="15" i2="X" l="FRE">
<s0>Anticancéreux</s0>
<s5>23</s5>
</fC03>
<fC03 i1="15" i2="X" l="ENG">
<s0>Antineoplastic agent</s0>
<s5>23</s5>
</fC03>
<fC03 i1="15" i2="X" l="SPA">
<s0>Anticanceroso</s0>
<s5>23</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE">
<s0>Europe</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="01" i2="X" l="ENG">
<s0>Europe</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="01" i2="X" l="SPA">
<s0>Europa</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="02" i2="X" l="FRE">
<s0>Dérivé de l'androstane</s0>
<s2>FR</s2>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG">
<s0>Androstane derivatives</s0>
<s2>FR</s2>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA">
<s0>Androstano derivado</s0>
<s2>FR</s2>
<s5>37</s5>
</fC07>
<fC07 i1="03" i2="X" l="FRE">
<s0>Estrogen synthase</s0>
<s2>FE</s2>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG">
<s0>Estrogen synthase</s0>
<s2>FE</s2>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA">
<s0>Estrogen synthase</s0>
<s2>FE</s2>
<s5>38</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE">
<s0>Enzyme</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="04" i2="X" l="ENG">
<s0>Enzyme</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="04" i2="X" l="SPA">
<s0>Enzima</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="05" i2="X" l="FRE">
<s0>Inhibiteur enzyme</s0>
<s5>39</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG">
<s0>Enzyme inhibitor</s0>
<s5>39</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA">
<s0>Inhibidor enzima</s0>
<s5>39</s5>
</fC07>
<fC07 i1="06" i2="X" l="FRE">
<s0>Stéroïde</s0>
<s5>40</s5>
</fC07>
<fC07 i1="06" i2="X" l="ENG">
<s0>Steroid</s0>
<s5>40</s5>
</fC07>
<fC07 i1="06" i2="X" l="SPA">
<s0>Esteroide</s0>
<s5>40</s5>
</fC07>
<fC07 i1="07" i2="X" l="FRE">
<s0>Antihormone</s0>
<s5>41</s5>
</fC07>
<fC07 i1="07" i2="X" l="ENG">
<s0>Antihormone</s0>
<s5>41</s5>
</fC07>
<fC07 i1="07" i2="X" l="SPA">
<s0>Antihormona</s0>
<s5>41</s5>
</fC07>
<fC07 i1="08" i2="X" l="FRE">
<s0>Antioestrogène</s0>
<s5>42</s5>
</fC07>
<fC07 i1="08" i2="X" l="ENG">
<s0>Antiestrogen</s0>
<s5>42</s5>
</fC07>
<fC07 i1="08" i2="X" l="SPA">
<s0>Antiestrógeno</s0>
<s5>42</s5>
</fC07>
<fC07 i1="09" i2="X" l="FRE">
<s0>Composé non stéroïde</s0>
<s5>43</s5>
</fC07>
<fC07 i1="09" i2="X" l="ENG">
<s0>Non steroid compound</s0>
<s5>43</s5>
</fC07>
<fC07 i1="09" i2="X" l="SPA">
<s0>Compuesto no esteroide</s0>
<s5>43</s5>
</fC07>
<fC07 i1="10" i2="X" l="FRE">
<s0>Modulateur sélectif des récepteurs aux oestrogènes</s0>
<s5>44</s5>
</fC07>
<fC07 i1="10" i2="X" l="ENG">
<s0>Selective estrogen receptor modulator</s0>
<s5>44</s5>
</fC07>
<fC07 i1="10" i2="X" l="SPA">
<s0>Modulador selectivo del receptor de estrógeno</s0>
<s5>44</s5>
</fC07>
<fC07 i1="11" i2="X" l="FRE">
<s0>Système ostéoarticulaire</s0>
<s5>45</s5>
</fC07>
<fC07 i1="11" i2="X" l="ENG">
<s0>Osteoarticular system</s0>
<s5>45</s5>
</fC07>
<fC07 i1="11" i2="X" l="SPA">
<s0>Sistema osteoarticular</s0>
<s5>45</s5>
</fC07>
<fC07 i1="12" i2="X" l="FRE">
<s0>Tumeur maligne</s0>
<s2>NM</s2>
<s5>46</s5>
</fC07>
<fC07 i1="12" i2="X" l="ENG">
<s0>Malignant tumor</s0>
<s2>NM</s2>
<s5>46</s5>
</fC07>
<fC07 i1="12" i2="X" l="SPA">
<s0>Tumor maligno</s0>
<s2>NM</s2>
<s5>46</s5>
</fC07>
<fC07 i1="13" i2="X" l="FRE">
<s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="13" i2="X" l="ENG">
<s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="13" i2="X" l="SPA">
<s0>Cáncer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="14" i2="X" l="FRE">
<s0>Pathologie de la glande mammaire</s0>
<s2>NM</s2>
<s5>47</s5>
</fC07>
<fC07 i1="14" i2="X" l="ENG">
<s0>Mammary gland diseases</s0>
<s2>NM</s2>
<s5>47</s5>
</fC07>
<fC07 i1="14" i2="X" l="SPA">
<s0>Glándula mamaria patología</s0>
<s2>NM</s2>
<s5>47</s5>
</fC07>
<fC07 i1="15" i2="X" l="FRE">
<s0>Pathologie du sein</s0>
<s2>NM</s2>
<s5>48</s5>
</fC07>
<fC07 i1="15" i2="X" l="ENG">
<s0>Breast disease</s0>
<s2>NM</s2>
<s5>48</s5>
</fC07>
<fC07 i1="15" i2="X" l="SPA">
<s0>Seno patología</s0>
<s2>NM</s2>
<s5>48</s5>
</fC07>
<fC07 i1="16" i2="X" l="FRE">
<s0>Pathologie du système ostéoarticulaire</s0>
<s5>49</s5>
</fC07>
<fC07 i1="16" i2="X" l="ENG">
<s0>Diseases of the osteoarticular system</s0>
<s5>49</s5>
</fC07>
<fC07 i1="16" i2="X" l="SPA">
<s0>Sistema osteoarticular patología</s0>
<s5>49</s5>
</fC07>
<fC07 i1="17" i2="X" l="FRE">
<s0>Traumatisme</s0>
<s5>50</s5>
</fC07>
<fC07 i1="17" i2="X" l="ENG">
<s0>Trauma</s0>
<s5>50</s5>
</fC07>
<fC07 i1="17" i2="X" l="SPA">
<s0>Traumatismo</s0>
<s5>50</s5>
</fC07>
<fN21>
<s1>222</s1>
</fN21>
<fN44 i1="01">
<s1>OTO</s1>
</fN44>
<fN82>
<s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
<affiliations>
<list>
<country>
<li>Allemagne</li>
<li>France</li>
</country>
<region>
<li>Bade-Wurtemberg</li>
<li>Berlin</li>
<li>District de Fribourg-en-Brisgau</li>
<li>District de Giessen</li>
<li>District de Karlsruhe</li>
<li>Hesse (Land)</li>
<li>Île-de-France</li>
</region>
<settlement>
<li>Berlin</li>
<li>Fribourg-en-Brisgau</li>
<li>Mannheim</li>
<li>Marbourg</li>
<li>Paris</li>
</settlement>
</list>
<tree>
<country name="Allemagne">
<region name="Hesse (Land)">
<name sortKey="Hadji, P" sort="Hadji, P" uniqKey="Hadji P" first="P." last="Hadji">P. Hadji</name>
</region>
<name sortKey="Dornoff, W" sort="Dornoff, W" uniqKey="Dornoff W" first="W." last="Dornoff">W. Dornoff</name>
<name sortKey="Hasenburg, A" sort="Hasenburg, A" uniqKey="Hasenburg A" first="A." last="Hasenburg">A. Hasenburg</name>
<name sortKey="Kieback, D G" sort="Kieback, D G" uniqKey="Kieback D" first="D. G." last="Kieback">D. G. Kieback</name>
<name sortKey="Kuck, J" sort="Kuck, J" uniqKey="Kuck J" first="J." last="Kuck">J. Kuck</name>
<name sortKey="Melchert, F" sort="Melchert, F" uniqKey="Melchert F" first="F." last="Melchert">F. Melchert</name>
<name sortKey="Tessen, H W" sort="Tessen, H W" uniqKey="Tessen H" first="H. W." last="Tessen">H. W. Tessen</name>
<name sortKey="Ziller, M" sort="Ziller, M" uniqKey="Ziller M" first="M." last="Ziller">M. Ziller</name>
</country>
<country name="France">
<region name="Île-de-France">
<name sortKey="Menschik, T" sort="Menschik, T" uniqKey="Menschik T" first="T." last="Menschik">T. Menschik</name>
</region>
</country>
</tree>
</affiliations>
</record>

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