Activity of Exemestane in metastatic breast cancer after failure of nonsteroidal aromatase inhibitors : A Phase II Trial
Identifieur interne : 005D87 ( PascalFrancis/Checkpoint ); précédent : 005D86; suivant : 005D88Activity of Exemestane in metastatic breast cancer after failure of nonsteroidal aromatase inhibitors : A Phase II Trial
Auteurs : P. E. L Nning [Norvège, Italie, Australie, France, États-Unis, Argentine, Pays-Bas] ; E. Bajetta ; R. Murray ; M. Tubiana-Hulin ; P. D. Eisenberg ; E. Mickiewicz ; L. Celio ; P. Pitt ; M. Mita ; N. K. Aaronson ; C. Fowst ; A. Arkhipov ; E. Di Salle ; A. Polli ; G. MassiminiSource :
- Journal of clinical oncology [ 0732-183X ] ; 2000.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
Abstract
Purpose: To evaluate the antitumor activity and toxicity of a new steroidal aromatase inactivator, exemestane, in postmenopausal women with metastatic breast cancer who had progressive disease (PD) after treatment with a nonsteroidal aromatase inhibitor. Patients and Methods: In this phase II trial, eligible patients were treated with exemestane 25 mg daily (n = 241) followed, at the time PD was determined, by exemestane 100 mg daily (n = 58). Results: On the basis of the intent-to-treat analysis by independent review, exemestane 25 mg produced objective responses in 6.6% of patients (95% confidence interval [Cl], 3.8% to 10.6%) and overall success (complete response + partial response + no change for 24 weeks or longer) in 24.3% (95% Cl, 19.0% to 30.2%). The median durations of objective response and overall success were 58.4 weeks (95% Cl, 49.7 to 71.1 weeks) and 37.0 weeks (95% Cl, 35.0 to 39.4 weeks), respectively. increasing the dose of exemestane to 100 mg upon the development of PD produced one partial response (1.7%; 95% Cl, 0.0% to 9.2%). Both dosages were well tolerated and were discontinued because of adverse events in only 1.7% of patients. Conclusion: Exemestane 25 mg once daily seems to be an attractive alternative to chemotherapy for the treatment of patients with metastatic breast cancer after multiple hormonal therapies have failed.
Affiliations:
- Argentine, Australie, France, Italie, Norvège, Pays-Bas, États-Unis
- Hollande-Septentrionale, Lombardie
- Amsterdam, Milan
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Pascal:00-0297144Le document en format XML
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Androstane derivatives</term>
<term>Antineoplastic agent</term>
<term>Chemotherapy</term>
<term>Exemestane</term>
<term>Female</term>
<term>Human</term>
<term>Malignant tumor</term>
<term>Mammary gland</term>
<term>Metastasis</term>
<term>Negative therapeutic reaction</term>
<term>Phase II trial</term>
<term>Postmenopause</term>
<term>Toxicity</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Tumeur maligne</term>
<term>Glande mammaire</term>
<term>Femelle</term>
<term>Homme</term>
<term>Métastase</term>
<term>Essai clinique phase II</term>
<term>Exémestane</term>
<term>Toxicité</term>
<term>Anticancéreux</term>
<term>Postménopause</term>
<term>Chimiothérapie</term>
<term>Résistance traitement</term>
<term>Androstane dérivé</term>
<term>Hormonothérapie</term>
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<front><div type="abstract" xml:lang="en">Purpose: To evaluate the antitumor activity and toxicity of a new steroidal aromatase inactivator, exemestane, in postmenopausal women with metastatic breast cancer who had progressive disease (PD) after treatment with a nonsteroidal aromatase inhibitor. Patients and Methods: In this phase II trial, eligible patients were treated with exemestane 25 mg daily (n = 241) followed, at the time PD was determined, by exemestane 100 mg daily (n = 58). Results: On the basis of the intent-to-treat analysis by independent review, exemestane 25 mg produced objective responses in 6.6% of patients (95% confidence interval [Cl], 3.8% to 10.6%) and overall success (complete response + partial response + no change for 24 weeks or longer) in 24.3% (95% Cl, 19.0% to 30.2%). The median durations of objective response and overall success were 58.4 weeks (95% Cl, 49.7 to 71.1 weeks) and 37.0 weeks (95% Cl, 35.0 to 39.4 weeks), respectively. increasing the dose of exemestane to 100 mg upon the development of PD produced one partial response (1.7%; 95% Cl, 0.0% to 9.2%). Both dosages were well tolerated and were discontinued because of adverse events in only 1.7% of patients. Conclusion: Exemestane 25 mg once daily seems to be an attractive alternative to chemotherapy for the treatment of patients with metastatic breast cancer after multiple hormonal therapies have failed.</div>
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<fC01 i1="01" l="ENG"><s0>Purpose: To evaluate the antitumor activity and toxicity of a new steroidal aromatase inactivator, exemestane, in postmenopausal women with metastatic breast cancer who had progressive disease (PD) after treatment with a nonsteroidal aromatase inhibitor. Patients and Methods: In this phase II trial, eligible patients were treated with exemestane 25 mg daily (n = 241) followed, at the time PD was determined, by exemestane 100 mg daily (n = 58). Results: On the basis of the intent-to-treat analysis by independent review, exemestane 25 mg produced objective responses in 6.6% of patients (95% confidence interval [Cl], 3.8% to 10.6%) and overall success (complete response + partial response + no change for 24 weeks or longer) in 24.3% (95% Cl, 19.0% to 30.2%). The median durations of objective response and overall success were 58.4 weeks (95% Cl, 49.7 to 71.1 weeks) and 37.0 weeks (95% Cl, 35.0 to 39.4 weeks), respectively. increasing the dose of exemestane to 100 mg upon the development of PD produced one partial response (1.7%; 95% Cl, 0.0% to 9.2%). Both dosages were well tolerated and were discontinued because of adverse events in only 1.7% of patients. Conclusion: Exemestane 25 mg once daily seems to be an attractive alternative to chemotherapy for the treatment of patients with metastatic breast cancer after multiple hormonal therapies have failed.</s0>
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</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Métastase</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Metastasis</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Metástasis</s0>
<s5>05</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Essai clinique phase II</s0>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Phase II trial</s0>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Ensayo clínico fase II</s0>
<s5>06</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Exémestane</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>07</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Exemestane</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>07</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Exemestano</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>07</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Toxicité</s0>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Toxicity</s0>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Toxicidad</s0>
<s5>08</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE"><s0>Anticancéreux</s0>
<s5>09</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG"><s0>Antineoplastic agent</s0>
<s5>09</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA"><s0>Anticanceroso</s0>
<s5>09</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE"><s0>Postménopause</s0>
<s5>10</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG"><s0>Postmenopause</s0>
<s5>10</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA"><s0>Postmenopausia</s0>
<s5>10</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE"><s0>Chimiothérapie</s0>
<s5>11</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG"><s0>Chemotherapy</s0>
<s5>11</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA"><s0>Quimioterapia</s0>
<s5>11</s5>
</fC03>
<fC03 i1="12" i2="X" l="FRE"><s0>Résistance traitement</s0>
<s5>12</s5>
</fC03>
<fC03 i1="12" i2="X" l="ENG"><s0>Negative therapeutic reaction</s0>
<s5>12</s5>
</fC03>
<fC03 i1="12" i2="X" l="SPA"><s0>Resistencia al tratamiento terapeútico</s0>
<s5>12</s5>
</fC03>
<fC03 i1="13" i2="X" l="FRE"><s0>Androstane dérivé</s0>
<s2>FR</s2>
<s5>29</s5>
</fC03>
<fC03 i1="13" i2="X" l="ENG"><s0>Androstane derivatives</s0>
<s2>FR</s2>
<s5>29</s5>
</fC03>
<fC03 i1="13" i2="X" l="SPA"><s0>Androstano derivado</s0>
<s2>FR</s2>
<s5>29</s5>
</fC03>
<fC03 i1="14" i2="X" l="FRE"><s0>Hormonothérapie</s0>
<s4>INC</s4>
<s5>86</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Glande mammaire pathologie</s0>
<s2>NM</s2>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Mammary gland diseases</s0>
<s2>NM</s2>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Glándula mamaria patología</s0>
<s2>NM</s2>
<s5>37</s5>
</fC07>
<fN21><s1>199</s1>
</fN21>
</pA>
</standard>
</inist>
<affiliations><list><country><li>Argentine</li>
<li>Australie</li>
<li>France</li>
<li>Italie</li>
<li>Norvège</li>
<li>Pays-Bas</li>
<li>États-Unis</li>
</country>
<region><li>Hollande-Septentrionale</li>
<li>Lombardie</li>
</region>
<settlement><li>Amsterdam</li>
<li>Milan</li>
</settlement>
</list>
<tree><noCountry><name sortKey="Aaronson, N K" sort="Aaronson, N K" uniqKey="Aaronson N" first="N. K." last="Aaronson">N. K. Aaronson</name>
<name sortKey="Arkhipov, A" sort="Arkhipov, A" uniqKey="Arkhipov A" first="A." last="Arkhipov">A. Arkhipov</name>
<name sortKey="Bajetta, E" sort="Bajetta, E" uniqKey="Bajetta E" first="E." last="Bajetta">E. Bajetta</name>
<name sortKey="Celio, L" sort="Celio, L" uniqKey="Celio L" first="L." last="Celio">L. Celio</name>
<name sortKey="Di Salle, E" sort="Di Salle, E" uniqKey="Di Salle E" first="E." last="Di Salle">E. Di Salle</name>
<name sortKey="Eisenberg, P D" sort="Eisenberg, P D" uniqKey="Eisenberg P" first="P. D." last="Eisenberg">P. D. Eisenberg</name>
<name sortKey="Fowst, C" sort="Fowst, C" uniqKey="Fowst C" first="C." last="Fowst">C. Fowst</name>
<name sortKey="Massimini, G" sort="Massimini, G" uniqKey="Massimini G" first="G." last="Massimini">G. Massimini</name>
<name sortKey="Mickiewicz, E" sort="Mickiewicz, E" uniqKey="Mickiewicz E" first="E." last="Mickiewicz">E. Mickiewicz</name>
<name sortKey="Mita, M" sort="Mita, M" uniqKey="Mita M" first="M." last="Mita">M. Mita</name>
<name sortKey="Murray, R" sort="Murray, R" uniqKey="Murray R" first="R." last="Murray">R. Murray</name>
<name sortKey="Pitt, P" sort="Pitt, P" uniqKey="Pitt P" first="P." last="Pitt">P. Pitt</name>
<name sortKey="Polli, A" sort="Polli, A" uniqKey="Polli A" first="A." last="Polli">A. Polli</name>
<name sortKey="Tubiana Hulin, M" sort="Tubiana Hulin, M" uniqKey="Tubiana Hulin M" first="M." last="Tubiana-Hulin">M. Tubiana-Hulin</name>
</noCountry>
<country name="Norvège"><noRegion><name sortKey="L Nning, P E" sort="L Nning, P E" uniqKey="L Nning P" first="P. E." last="L Nning">P. E. L Nning</name>
</noRegion>
</country>
<country name="Italie"><region name="Lombardie"><name sortKey="L Nning, P E" sort="L Nning, P E" uniqKey="L Nning P" first="P. E." last="L Nning">P. E. L Nning</name>
</region>
</country>
<country name="Australie"><noRegion><name sortKey="L Nning, P E" sort="L Nning, P E" uniqKey="L Nning P" first="P. E." last="L Nning">P. E. L Nning</name>
</noRegion>
</country>
<country name="France"><noRegion><name sortKey="L Nning, P E" sort="L Nning, P E" uniqKey="L Nning P" first="P. E." last="L Nning">P. E. L Nning</name>
</noRegion>
</country>
<country name="États-Unis"><noRegion><name sortKey="L Nning, P E" sort="L Nning, P E" uniqKey="L Nning P" first="P. E." last="L Nning">P. E. L Nning</name>
</noRegion>
<name sortKey="L Nning, P E" sort="L Nning, P E" uniqKey="L Nning P" first="P. E." last="L Nning">P. E. L Nning</name>
</country>
<country name="Argentine"><noRegion><name sortKey="L Nning, P E" sort="L Nning, P E" uniqKey="L Nning P" first="P. E." last="L Nning">P. E. L Nning</name>
</noRegion>
</country>
<country name="Pays-Bas"><region name="Hollande-Septentrionale"><name sortKey="L Nning, P E" sort="L Nning, P E" uniqKey="L Nning P" first="P. E." last="L Nning">P. E. L Nning</name>
</region>
</country>
</tree>
</affiliations>
</record>
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