Activity of Exemestane in metastatic breast cancer after failure of nonsteroidal aromatase inhibitors : A Phase II Trial
Identifieur interne : 00D335 ( Main/Merge ); précédent : 00D334; suivant : 00D336Activity 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.
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L Nning</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Oncology, Haukeland University Hospital</s1><s2>Bergen</s2><s3>NOR</s3></inist:fA14><country>Norvège</country><wicri:noRegion>Bergen</wicri:noRegion></affiliation><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Istituto Nazionale Tumori and Pharmacia & Upjohn</s1><s2>Milan</s2><s3>ITA</s3></inist:fA14><country>Italie</country><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Peter MacCallum Cancer Institute</s1><s2>East Melbourne, Victoria</s2><s3>AUS</s3></inist:fA14><country>Australie</country><wicri:noRegion>Peter MacCallum Cancer Institute</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Centre Rene Huguenin</s1><s2>St Cloud</s2><s3>FRA</s3></inist:fA14><country>France</country><wicri:noRegion>St Cloud</wicri:noRegion><wicri:noRegion>Centre Rene Huguenin</wicri:noRegion><wicri:noRegion>Centre Rene Huguenin</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Marin Oncology Associates Inc</s1><s2>Greenbrae, CA</s2><s3>USA</s3></inist:fA14><country>États-Unis</country><wicri:noRegion>Marin Oncology Associates Inc</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Instituto A.H. Roffo</s1><s2>Buenos Aires</s2><s3>ARG</s3></inist:fA14><country>Argentine</country><wicri:noRegion>Instituto A.H. Roffo</wicri:noRegion></affiliation><affiliation wicri:level="3"><inist:fA14 i1="07"><s1>Netherlands Cancer Institute</s1><s2>Amsterdam</s2><s3>NLD</s3></inist:fA14><country>Pays-Bas</country><placeName><settlement type="city">Amsterdam</settlement><region nuts="2" type="province">Hollande-Septentrionale</region></placeName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Pharmacia & Upjohn</s1><s2>Kalamazoo, MI</s2><s3>USA</s3></inist:fA14><country>États-Unis</country><wicri:noRegion>Pharmacia & Upjohn</wicri:noRegion></affiliation></author><author><name sortKey="Bajetta, E" sort="Bajetta, E" uniqKey="Bajetta E" first="E." last="Bajetta">E. Bajetta</name></author><author><name sortKey="Murray, R" sort="Murray, R" uniqKey="Murray R" first="R." last="Murray">R. Murray</name></author><author><name sortKey="Tubiana Hulin, M" sort="Tubiana Hulin, M" uniqKey="Tubiana Hulin M" first="M." last="Tubiana-Hulin">M. Tubiana-Hulin</name></author><author><name sortKey="Eisenberg, P D" sort="Eisenberg, P D" uniqKey="Eisenberg P" first="P. D." last="Eisenberg">P. D. Eisenberg</name></author><author><name sortKey="Mickiewicz, E" sort="Mickiewicz, E" uniqKey="Mickiewicz E" first="E." last="Mickiewicz">E. Mickiewicz</name></author><author><name sortKey="Celio, L" sort="Celio, L" uniqKey="Celio L" first="L." last="Celio">L. Celio</name></author><author><name sortKey="Pitt, P" sort="Pitt, P" uniqKey="Pitt P" first="P." last="Pitt">P. Pitt</name></author><author><name sortKey="Mita, M" sort="Mita, M" uniqKey="Mita M" first="M." last="Mita">M. Mita</name></author><author><name sortKey="Aaronson, N K" sort="Aaronson, N K" uniqKey="Aaronson N" first="N. K." last="Aaronson">N. K. Aaronson</name></author><author><name sortKey="Fowst, C" sort="Fowst, C" uniqKey="Fowst C" first="C." last="Fowst">C. Fowst</name></author><author><name sortKey="Arkhipov, A" sort="Arkhipov, A" uniqKey="Arkhipov A" first="A." last="Arkhipov">A. Arkhipov</name></author><author><name sortKey="Di Salle, E" sort="Di Salle, E" uniqKey="Di Salle E" first="E." last="Di Salle">E. Di Salle</name></author><author><name sortKey="Polli, A" sort="Polli, A" uniqKey="Polli A" first="A." last="Polli">A. Polli</name></author><author><name sortKey="Massimini, G" sort="Massimini, G" uniqKey="Massimini G" first="G." last="Massimini">G. Massimini</name></author></analytic><series><title level="j" type="main">Journal of clinical oncology</title><title level="j" type="abbreviated">J. clin. oncol.</title><idno type="ISSN">0732-183X</idno><imprint><date when="2000">2000</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Journal of clinical oncology</title><title level="j" type="abbreviated">J. clin. oncol.</title><idno type="ISSN">0732-183X</idno></seriesStmt></fileDesc><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></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><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></front></TEI><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>Pour manipuler ce document sous Unix (Dilib)
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