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Superior efficacy of Letrozole versus tamoxifen as first-line therapy for postmenopausal women with advanced breast cancer: Results of a phase III study of the International Letrozole Breast Cancer Group

Identifieur interne : 00BB60 ( Main/Exploration ); précédent : 00BB59; suivant : 00BB61

Superior efficacy of Letrozole versus tamoxifen as first-line therapy for postmenopausal women with advanced breast cancer: Results of a phase III study of the International Letrozole Breast Cancer Group

Auteurs : Henning Mouridsen [Danemark, Russie, République populaire de Chine, Espagne, Italie, France, Afrique du Sud, États-Unis, Pays-Bas, Allemagne, Pologne, Hongrie, Belgique, Inde, Finlande, Australie, Suisse] ; Mikhail Gershanovich ; YAN SUN ; Ramon Perez-Carrion ; Corrado Boni ; Alain Monnier ; Justus Apffelstaedt ; Robert Smith ; Harm P. Sleeboom ; Fritz J Nicke ; Anna Pluzanska ; Magdolna Dank ; Dominique Becquart ; Poonamalle P. Bapsy ; Eeva Salminen ; Ray Snyder ; Mercedes Lassus ; J. Arnold Verbeek ; Beatrix Staffler ; Hilary A. Chaudri-Ross ; Margaret Dugan

Source :

RBID : Pascal:01-0292213

Descripteurs français

English descriptors

Abstract

Purpose: To compare the efficacy and tolerability of tamoxifen with that of letrozole, an oral aromatase inhibitor, with tamoxifen as first-line therapy in postmenopausal women with advanced breast cancer. Patients and Methods: Nine hundred seven patients were randomly assigned letrozole 2.5 mg once daily (453 patients) or tamoxifen 20 mg once daily (454 patients). Patients had estrogen receptor- and/or progesterone receptor-positive tumors, or both receptors were unknown. Recurrence during adjuvant antiestrogen therapy or within the following 12 months or prior endocrine therapy for advanced disease precluded enrollment. One prior chemotherapy regimen for metastatic disease was allowed. The primary end point was time to progression (TTP). Secondary end points included overall objective response rate (ORR), its duration, rate and duration of clinical benefit, time to treatment failure (TTF), overall survival, and tolerability. Results: TTP was significantly longer for letrozole than for tamoxifen (median, 41 v 26 weeks). Treatment with letrozole reduced the risk of progression by 30% (hazards ratio, 0.70; 95% confidence interval, 0.60 to 0.82, P = .0001). TTP was significantly longer for letrozole irrespective of dominant site of disease, receptor status, or prior adjuvant antiestrogen therapy. Similarly, TTF was significantly longer for letrozole (median, 40 v 25 weeks). ORR was higher for letrozole (30% v 20%; P = .0006), as was the rate of clinical benefit (49% v38%; P = .001). Survival data are currently immature and not reported here. Both treatments were well tolerated. Conclusion: Letrozole was significantly superior to tamoxifen in TTP, TTF, ORR, and clinical benefit rate. Our results support its use as first-line endocrine therapy in postmenopausal women with advanced breast cancer.


Affiliations:


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Le document en format XML

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<title xml:lang="en" level="a">Superior efficacy of Letrozole versus tamoxifen as first-line therapy for postmenopausal women with advanced breast cancer: Results of a phase III study of the International Letrozole Breast Cancer Group</title>
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<name sortKey="Mouridsen, Henning" sort="Mouridsen, Henning" uniqKey="Mouridsen H" first="Henning" last="Mouridsen">Henning Mouridsen</name>
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<s1>Rigshospitalet</s1>
<s2>Copenhagen</s2>
<s3>DNK</s3>
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<country>Danemark</country>
<placeName>
<settlement type="city">Copenhague</settlement>
<region type="région" nuts="2">Hovedstaden</region>
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<inist:fA14 i1="02">
<s1>Petrov Research Institute of Oncology</s1>
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<s3>RUS</s3>
</inist:fA14>
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<wicri:noRegion>Petrov Research Institute of Oncology</wicri:noRegion>
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<s1>Chinese Academy of Medical Sciences</s1>
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<country>République populaire de Chine</country>
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<settlement type="city">Pékin</settlement>
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<settlement type="city">Madrid</settlement>
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<name sortKey="Gershanovich, Mikhail" sort="Gershanovich, Mikhail" uniqKey="Gershanovich M" first="Mikhail" last="Gershanovich">Mikhail Gershanovich</name>
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<author>
<name sortKey="Yan Sun" sort="Yan Sun" uniqKey="Yan Sun" last="Yan Sun">YAN SUN</name>
</author>
<author>
<name sortKey="Perez Carrion, Ramon" sort="Perez Carrion, Ramon" uniqKey="Perez Carrion R" first="Ramon" last="Perez-Carrion">Ramon Perez-Carrion</name>
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<name sortKey="Boni, Corrado" sort="Boni, Corrado" uniqKey="Boni C" first="Corrado" last="Boni">Corrado Boni</name>
</author>
<author>
<name sortKey="Monnier, Alain" sort="Monnier, Alain" uniqKey="Monnier A" first="Alain" last="Monnier">Alain Monnier</name>
</author>
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<name sortKey="Apffelstaedt, Justus" sort="Apffelstaedt, Justus" uniqKey="Apffelstaedt J" first="Justus" last="Apffelstaedt">Justus Apffelstaedt</name>
</author>
<author>
<name sortKey="Smith, Robert" sort="Smith, Robert" uniqKey="Smith R" first="Robert" last="Smith">Robert Smith</name>
</author>
<author>
<name sortKey="Sleeboom, Harm P" sort="Sleeboom, Harm P" uniqKey="Sleeboom H" first="Harm P." last="Sleeboom">Harm P. Sleeboom</name>
</author>
<author>
<name sortKey="J Nicke, Fritz" sort="J Nicke, Fritz" uniqKey="J Nicke F" first="Fritz" last="J Nicke">Fritz J Nicke</name>
</author>
<author>
<name sortKey="Pluzanska, Anna" sort="Pluzanska, Anna" uniqKey="Pluzanska A" first="Anna" last="Pluzanska">Anna Pluzanska</name>
</author>
<author>
<name sortKey="Dank, Magdolna" sort="Dank, Magdolna" uniqKey="Dank M" first="Magdolna" last="Dank">Magdolna Dank</name>
</author>
<author>
<name sortKey="Becquart, Dominique" sort="Becquart, Dominique" uniqKey="Becquart D" first="Dominique" last="Becquart">Dominique Becquart</name>
</author>
<author>
<name sortKey="Bapsy, Poonamalle P" sort="Bapsy, Poonamalle P" uniqKey="Bapsy P" first="Poonamalle P." last="Bapsy">Poonamalle P. Bapsy</name>
</author>
<author>
<name sortKey="Salminen, Eeva" sort="Salminen, Eeva" uniqKey="Salminen E" first="Eeva" last="Salminen">Eeva Salminen</name>
</author>
<author>
<name sortKey="Snyder, Ray" sort="Snyder, Ray" uniqKey="Snyder R" first="Ray" last="Snyder">Ray Snyder</name>
</author>
<author>
<name sortKey="Lassus, Mercedes" sort="Lassus, Mercedes" uniqKey="Lassus M" first="Mercedes" last="Lassus">Mercedes Lassus</name>
</author>
<author>
<name sortKey="Verbeek, J Arnold" sort="Verbeek, J Arnold" uniqKey="Verbeek J" first="J. Arnold" last="Verbeek">J. Arnold Verbeek</name>
</author>
<author>
<name sortKey="Staffler, Beatrix" sort="Staffler, Beatrix" uniqKey="Staffler B" first="Beatrix" last="Staffler">Beatrix Staffler</name>
</author>
<author>
<name sortKey="Chaudri Ross, Hilary A" sort="Chaudri Ross, Hilary A" uniqKey="Chaudri Ross H" first="Hilary A." last="Chaudri-Ross">Hilary A. Chaudri-Ross</name>
</author>
<author>
<name sortKey="Dugan, Margaret" sort="Dugan, Margaret" uniqKey="Dugan M" first="Margaret" last="Dugan">Margaret Dugan</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="2001">2001</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>Advanced stage</term>
<term>Antiestrogen</term>
<term>Antihormone</term>
<term>Antineoplastic agent</term>
<term>Chemotherapy</term>
<term>Comparative study</term>
<term>Complication</term>
<term>Enzyme inhibitor</term>
<term>Estrogen synthase</term>
<term>Human</term>
<term>Letrozole</term>
<term>Malignant tumor</term>
<term>Mammary gland</term>
<term>Non steroid compound</term>
<term>Phase III trial</term>
<term>Postmenopause</term>
<term>Tamoxifene</term>
<term>Toxicity</term>
<term>Treatment</term>
<term>Treatment efficiency</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Tumeur maligne</term>
<term>Glande mammaire</term>
<term>Stade avancé</term>
<term>Létrozole</term>
<term>Inhibiteur enzyme</term>
<term>Estrogen synthase</term>
<term>Antioestrogène</term>
<term>Antihormone</term>
<term>Anticancéreux</term>
<term>Tamoxifène</term>
<term>Postménopause</term>
<term>Essai clinique phase III</term>
<term>Efficacité traitement</term>
<term>Toxicité</term>
<term>Complication</term>
<term>Etude comparative</term>
<term>Chimiothérapie</term>
<term>Traitement</term>
<term>Homme</term>
<term>Composé non stéroïde</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 compare the efficacy and tolerability of tamoxifen with that of letrozole, an oral aromatase inhibitor, with tamoxifen as first-line therapy in postmenopausal women with advanced breast cancer. Patients and Methods: Nine hundred seven patients were randomly assigned letrozole 2.5 mg once daily (453 patients) or tamoxifen 20 mg once daily (454 patients). Patients had estrogen receptor- and/or progesterone receptor-positive tumors, or both receptors were unknown. Recurrence during adjuvant antiestrogen therapy or within the following 12 months or prior endocrine therapy for advanced disease precluded enrollment. One prior chemotherapy regimen for metastatic disease was allowed. The primary end point was time to progression (TTP). Secondary end points included overall objective response rate (ORR), its duration, rate and duration of clinical benefit, time to treatment failure (TTF), overall survival, and tolerability. Results: TTP was significantly longer for letrozole than for tamoxifen (median, 41 v 26 weeks). Treatment with letrozole reduced the risk of progression by 30% (hazards ratio, 0.70; 95% confidence interval, 0.60 to 0.82, P = .0001). TTP was significantly longer for letrozole irrespective of dominant site of disease, receptor status, or prior adjuvant antiestrogen therapy. Similarly, TTF was significantly longer for letrozole (median, 40 v 25 weeks). ORR was higher for letrozole (30% v 20%; P = .0006), as was the rate of clinical benefit (49% v38%; P = .001). Survival data are currently immature and not reported here. Both treatments were well tolerated. Conclusion: Letrozole was significantly superior to tamoxifen in TTP, TTF, ORR, and clinical benefit rate. Our results support its use as first-line endocrine therapy in postmenopausal women with advanced breast cancer.</div>
</front>
</TEI>
<affiliations>
<list>
<country>
<li>Afrique du Sud</li>
<li>Allemagne</li>
<li>Australie</li>
<li>Belgique</li>
<li>Danemark</li>
<li>Espagne</li>
<li>Finlande</li>
<li>France</li>
<li>Hongrie</li>
<li>Inde</li>
<li>Italie</li>
<li>Pays-Bas</li>
<li>Pologne</li>
<li>Russie</li>
<li>République populaire de Chine</li>
<li>Suisse</li>
<li>États-Unis</li>
</country>
<region>
<li>Bourgogne-Franche-Comté</li>
<li>Communauté de Madrid</li>
<li>Finlande occidentale</li>
<li>Franche-Comté</li>
<li>Hambourg</li>
<li>Hollande-Méridionale</li>
<li>Hongrie centrale</li>
<li>Hovedstaden</li>
<li>Lombardie</li>
</region>
<settlement>
<li>Budapest</li>
<li>Copenhague</li>
<li>Hambourg</li>
<li>La Haye</li>
<li>Madrid</li>
<li>Milan</li>
<li>Montbéliard</li>
<li>Pékin</li>
<li>Turku</li>
</settlement>
</list>
<tree>
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<name sortKey="Apffelstaedt, Justus" sort="Apffelstaedt, Justus" uniqKey="Apffelstaedt J" first="Justus" last="Apffelstaedt">Justus Apffelstaedt</name>
<name sortKey="Bapsy, Poonamalle P" sort="Bapsy, Poonamalle P" uniqKey="Bapsy P" first="Poonamalle P." last="Bapsy">Poonamalle P. Bapsy</name>
<name sortKey="Becquart, Dominique" sort="Becquart, Dominique" uniqKey="Becquart D" first="Dominique" last="Becquart">Dominique Becquart</name>
<name sortKey="Boni, Corrado" sort="Boni, Corrado" uniqKey="Boni C" first="Corrado" last="Boni">Corrado Boni</name>
<name sortKey="Chaudri Ross, Hilary A" sort="Chaudri Ross, Hilary A" uniqKey="Chaudri Ross H" first="Hilary A." last="Chaudri-Ross">Hilary A. Chaudri-Ross</name>
<name sortKey="Dank, Magdolna" sort="Dank, Magdolna" uniqKey="Dank M" first="Magdolna" last="Dank">Magdolna Dank</name>
<name sortKey="Dugan, Margaret" sort="Dugan, Margaret" uniqKey="Dugan M" first="Margaret" last="Dugan">Margaret Dugan</name>
<name sortKey="Gershanovich, Mikhail" sort="Gershanovich, Mikhail" uniqKey="Gershanovich M" first="Mikhail" last="Gershanovich">Mikhail Gershanovich</name>
<name sortKey="J Nicke, Fritz" sort="J Nicke, Fritz" uniqKey="J Nicke F" first="Fritz" last="J Nicke">Fritz J Nicke</name>
<name sortKey="Lassus, Mercedes" sort="Lassus, Mercedes" uniqKey="Lassus M" first="Mercedes" last="Lassus">Mercedes Lassus</name>
<name sortKey="Monnier, Alain" sort="Monnier, Alain" uniqKey="Monnier A" first="Alain" last="Monnier">Alain Monnier</name>
<name sortKey="Perez Carrion, Ramon" sort="Perez Carrion, Ramon" uniqKey="Perez Carrion R" first="Ramon" last="Perez-Carrion">Ramon Perez-Carrion</name>
<name sortKey="Pluzanska, Anna" sort="Pluzanska, Anna" uniqKey="Pluzanska A" first="Anna" last="Pluzanska">Anna Pluzanska</name>
<name sortKey="Salminen, Eeva" sort="Salminen, Eeva" uniqKey="Salminen E" first="Eeva" last="Salminen">Eeva Salminen</name>
<name sortKey="Sleeboom, Harm P" sort="Sleeboom, Harm P" uniqKey="Sleeboom H" first="Harm P." last="Sleeboom">Harm P. Sleeboom</name>
<name sortKey="Smith, Robert" sort="Smith, Robert" uniqKey="Smith R" first="Robert" last="Smith">Robert Smith</name>
<name sortKey="Snyder, Ray" sort="Snyder, Ray" uniqKey="Snyder R" first="Ray" last="Snyder">Ray Snyder</name>
<name sortKey="Staffler, Beatrix" sort="Staffler, Beatrix" uniqKey="Staffler B" first="Beatrix" last="Staffler">Beatrix Staffler</name>
<name sortKey="Verbeek, J Arnold" sort="Verbeek, J Arnold" uniqKey="Verbeek J" first="J. Arnold" last="Verbeek">J. Arnold Verbeek</name>
<name sortKey="Yan Sun" sort="Yan Sun" uniqKey="Yan Sun" last="Yan Sun">YAN SUN</name>
</noCountry>
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<region name="Hovedstaden">
<name sortKey="Mouridsen, Henning" sort="Mouridsen, Henning" uniqKey="Mouridsen H" first="Henning" last="Mouridsen">Henning Mouridsen</name>
</region>
</country>
<country name="Russie">
<noRegion>
<name sortKey="Mouridsen, Henning" sort="Mouridsen, Henning" uniqKey="Mouridsen H" first="Henning" last="Mouridsen">Henning Mouridsen</name>
</noRegion>
</country>
<country name="République populaire de Chine">
<noRegion>
<name sortKey="Mouridsen, Henning" sort="Mouridsen, Henning" uniqKey="Mouridsen H" first="Henning" last="Mouridsen">Henning Mouridsen</name>
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</country>
<country name="Espagne">
<region name="Communauté de Madrid">
<name sortKey="Mouridsen, Henning" sort="Mouridsen, Henning" uniqKey="Mouridsen H" first="Henning" last="Mouridsen">Henning Mouridsen</name>
</region>
</country>
<country name="Italie">
<noRegion>
<name sortKey="Mouridsen, Henning" sort="Mouridsen, Henning" uniqKey="Mouridsen H" first="Henning" last="Mouridsen">Henning Mouridsen</name>
</noRegion>
<name sortKey="Mouridsen, Henning" sort="Mouridsen, Henning" uniqKey="Mouridsen H" first="Henning" last="Mouridsen">Henning Mouridsen</name>
</country>
<country name="France">
<region name="Bourgogne-Franche-Comté">
<name sortKey="Mouridsen, Henning" sort="Mouridsen, Henning" uniqKey="Mouridsen H" first="Henning" last="Mouridsen">Henning Mouridsen</name>
</region>
</country>
<country name="Afrique du Sud">
<noRegion>
<name sortKey="Mouridsen, Henning" sort="Mouridsen, Henning" uniqKey="Mouridsen H" first="Henning" last="Mouridsen">Henning Mouridsen</name>
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<country name="États-Unis">
<noRegion>
<name sortKey="Mouridsen, Henning" sort="Mouridsen, Henning" uniqKey="Mouridsen H" first="Henning" last="Mouridsen">Henning Mouridsen</name>
</noRegion>
<name sortKey="Mouridsen, Henning" sort="Mouridsen, Henning" uniqKey="Mouridsen H" first="Henning" last="Mouridsen">Henning Mouridsen</name>
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<country name="Pays-Bas">
<region name="Hollande-Méridionale">
<name sortKey="Mouridsen, Henning" sort="Mouridsen, Henning" uniqKey="Mouridsen H" first="Henning" last="Mouridsen">Henning Mouridsen</name>
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</country>
<country name="Allemagne">
<region name="Hambourg">
<name sortKey="Mouridsen, Henning" sort="Mouridsen, Henning" uniqKey="Mouridsen H" first="Henning" last="Mouridsen">Henning Mouridsen</name>
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</country>
<country name="Pologne">
<noRegion>
<name sortKey="Mouridsen, Henning" sort="Mouridsen, Henning" uniqKey="Mouridsen H" first="Henning" last="Mouridsen">Henning Mouridsen</name>
</noRegion>
</country>
<country name="Hongrie">
<region name="Hongrie centrale">
<name sortKey="Mouridsen, Henning" sort="Mouridsen, Henning" uniqKey="Mouridsen H" first="Henning" last="Mouridsen">Henning Mouridsen</name>
</region>
</country>
<country name="Belgique">
<noRegion>
<name sortKey="Mouridsen, Henning" sort="Mouridsen, Henning" uniqKey="Mouridsen H" first="Henning" last="Mouridsen">Henning Mouridsen</name>
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</country>
<country name="Inde">
<noRegion>
<name sortKey="Mouridsen, Henning" sort="Mouridsen, Henning" uniqKey="Mouridsen H" first="Henning" last="Mouridsen">Henning Mouridsen</name>
</noRegion>
</country>
<country name="Finlande">
<region name="Finlande occidentale">
<name sortKey="Mouridsen, Henning" sort="Mouridsen, Henning" uniqKey="Mouridsen H" first="Henning" last="Mouridsen">Henning Mouridsen</name>
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</country>
<country name="Australie">
<noRegion>
<name sortKey="Mouridsen, Henning" sort="Mouridsen, Henning" uniqKey="Mouridsen H" first="Henning" last="Mouridsen">Henning Mouridsen</name>
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</country>
<country name="Suisse">
<noRegion>
<name sortKey="Mouridsen, Henning" sort="Mouridsen, Henning" uniqKey="Mouridsen H" first="Henning" last="Mouridsen">Henning Mouridsen</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

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