A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer
Identifieur interne : 00AE01 ( Main/Exploration ); précédent : 00AE00; suivant : 00AE02A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer
Auteurs : R. Charles Coombes [Royaume-Uni] ; Emma Hall [Royaume-Uni] ; Lorna J. Gibson [Royaume-Uni] ; Robert Paridaens [Belgique] ; Jacek Jassem [Pologne] ; Thierry Delozier [France] ; Stephen E. Jones [États-Unis] ; Isabel Alvarez [Espagne] ; Gianfilippo Bertelli [Royaume-Uni] ; Olaf Ortmann [Allemagne] ; Alan S. Coates [Australie] ; Emilio Bajetta [Italie] ; David Dodwell [Royaume-Uni] ; Robert E. Coleman [Royaume-Uni] ; Lesley J. Fallowfield [Royaume-Uni] ; Elizabeth Mickiewicz [Argentine] ; Jorn Andersen [Allemagne] ; Per E. Lonning [Norvège] ; Giorgio Cocconi [Italie] ; Alan Stewart [Royaume-Uni] ; Nick Stuart [Royaume-Uni] ; Claire F. Snowdon [Royaume-Uni] ; Marina Carpentieri ; Giorgio Massimini ; Judith M. Bliss [Royaume-Uni]Source :
- The New England journal of medicine [ 0028-4793 ] ; 2004.
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Abstract
BACKGROUND Tamoxifen, taken for five years, is the standard adjuvant treatment for postmenopausal women with primary, estrogen-receptor-positive breast cancer. Despite this treatment, however, some patients have a relapse. METHODS We conducted a double-blind, randomized trial to test whether, after two to three years oftamoxifen therapy, switching to exemestane was more effective than continuing tamoxifen therapy for the remainder ofthe five years of treatment. The primary end point was disease-free survival. RESULTS Of the 4742 patients enrolled, 2362 were randomly assigned to switch to exemestane, and 2380 to continue to receive tamoxifen. After a median follow-up of 30.6 months, 449 first events (local or metastatic recurrence, contralateral breast cancer, or death) were reported -183 in the exemestane group and 266 in the tamoxifen group. The unadjusted hazard ratio in the exemestane group as compared with the tamoxifen group was 0.68 (95 percent confidence interval, 0.56 to 0.82; P<0.001 by the log-rank test), representing a 32 percent reduction in risk and corresponding to an absolute benefit in terms of disease-free survival of 4.7 percent (95 percent confidence interval, 2.6 to 6.8) at three years after randomization. Overall survival was not significantly different in the two groups, with 93 deaths occurring in the exemestane group and 106 in the tamoxifen group. Severe toxic effects of exemestane were rare. Contralateral breast cancer occurred in 20 patients in the tamoxifen group and 9 in the exemestane group (P=0.04). CONCLUSIONSS Exemestane therapy after two to three years of tamoxifen therapy significantly improved disease-free survival as compared with the standard five years oftamoxifen treatment.
Affiliations:
- Allemagne, Argentine, Australie, Belgique, Espagne, France, Italie, Norvège, Pologne, Royaume-Uni, États-Unis
- Angleterre, Basse-Normandie, Grand Londres, Grand Manchester, Lombardie, Nouvelle-Galles du Sud, Région Normandie, Sussex de l'Est, Texas
- Brighton, Caen, Falmer, Houston, Londres, Manchester, Milan, Sydney
- Université de Sydney, Université du Sussex
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Charles Coombes</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Department of Cancer Medicine, Imperial College and Charing Cross Hospital</s1><s2>London</s2><s3>GBR</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>22 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Department of Cancer Medicine, Imperial College London, 6th Fl., Cyclotron Bldg., Hammersmith Hospital, Du Cane Rd.</s1><s2>London W12 ONN</s2><s3>GBR</s3><sZ>1 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>London W12 ONN</wicri:noRegion></affiliation></author><author><name sortKey="Hall, Emma" sort="Hall, Emma" uniqKey="Hall E" first="Emma" last="Hall">Emma Hall</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Institute of Cancer Research</s1><s2>Sutton</s2><s3>GBR</s3><sZ>2 aut.</sZ><sZ>25 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Institute of Cancer Research</wicri:noRegion></affiliation></author><author><name sortKey="Gibson, Lorna J" sort="Gibson, Lorna J" uniqKey="Gibson L" first="Lorna J." last="Gibson">Lorna J. 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Lonning</name><affiliation wicri:level="1"><inist:fA14 i1="18"><s1>Haukeland Hospital, University of Bergen</s1><s2>Bergen</s2><s3>NOR</s3><sZ>18 aut.</sZ></inist:fA14><country>Norvège</country><wicri:noRegion>Bergen</wicri:noRegion></affiliation></author><author><name sortKey="Cocconi, Giorgio" sort="Cocconi, Giorgio" uniqKey="Cocconi G" first="Giorgio" last="Cocconi">Giorgio Cocconi</name><affiliation wicri:level="1"><inist:fA14 i1="19"><s1>University Hospital</s1><s2>Parma</s2><s3>ITA</s3><sZ>19 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>University Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Stewart, Alan" sort="Stewart, Alan" uniqKey="Stewart A" first="Alan" last="Stewart">Alan Stewart</name><affiliation wicri:level="3"><inist:fA14 i1="20"><s1>Christie Hospital</s1><s2>Manchester</s2><s3>GBR</s3><sZ>20 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Manchester</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Manchester</region></placeName></affiliation></author><author><name sortKey="Stuart, Nick" sort="Stuart, Nick" uniqKey="Stuart N" first="Nick" last="Stuart">Nick Stuart</name><affiliation wicri:level="1"><inist:fA14 i1="21"><s1>Ysbyty Gwynedd</s1><s2>Bangor, Gwynedd</s2><s3>GBR</s3><sZ>21 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Ysbyty Gwynedd</wicri:noRegion></affiliation></author><author><name sortKey="Snowdon, Claire F" sort="Snowdon, Claire F" uniqKey="Snowdon C" first="Claire F." last="Snowdon">Claire F. Snowdon</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Department of Cancer Medicine, Imperial College and Charing Cross Hospital</s1><s2>London</s2><s3>GBR</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>22 aut.</sZ></inist:fA14><country>Royaume-Uni</country><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="Carpentieri, Marina" sort="Carpentieri, Marina" uniqKey="Carpentieri M" first="Marina" last="Carpentieri">Marina Carpentieri</name></author><author><name sortKey="Massimini, Giorgio" sort="Massimini, Giorgio" uniqKey="Massimini G" first="Giorgio" last="Massimini">Giorgio Massimini</name></author><author><name sortKey="Bliss, Judith M" sort="Bliss, Judith M" uniqKey="Bliss J" first="Judith M." last="Bliss">Judith M. Bliss</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Institute of Cancer Research</s1><s2>Sutton</s2><s3>GBR</s3><sZ>2 aut.</sZ><sZ>25 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Institute of Cancer Research</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">04-0355000</idno><date when="2004">2004</date><idno type="stanalyst">PASCAL 04-0355000 INIST</idno><idno type="RBID">Pascal:04-0355000</idno><idno type="wicri:Area/PascalFrancis/Corpus">004E32</idno><idno type="wicri:Area/PascalFrancis/Curation">001282</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">004C97</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">004C97</idno><idno type="wicri:doubleKey">0028-4793:2004:Coombes R:a:randomized:trial</idno><idno type="wicri:Area/Main/Merge">00BB24</idno><idno type="wicri:Area/Main/Curation">00AE01</idno><idno type="wicri:Area/Main/Exploration">00AE01</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer</title><author><name sortKey="Coombes, R Charles" sort="Coombes, R Charles" uniqKey="Coombes R" first="R. Charles" last="Coombes">R. Charles Coombes</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Department of Cancer Medicine, Imperial College and Charing Cross Hospital</s1><s2>London</s2><s3>GBR</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>22 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Department of Cancer Medicine, Imperial College London, 6th Fl., Cyclotron Bldg., Hammersmith Hospital, Du Cane Rd.</s1><s2>London W12 ONN</s2><s3>GBR</s3><sZ>1 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>London W12 ONN</wicri:noRegion></affiliation></author><author><name sortKey="Hall, Emma" sort="Hall, Emma" uniqKey="Hall E" first="Emma" last="Hall">Emma Hall</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Institute of Cancer Research</s1><s2>Sutton</s2><s3>GBR</s3><sZ>2 aut.</sZ><sZ>25 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Institute of Cancer Research</wicri:noRegion></affiliation></author><author><name sortKey="Gibson, Lorna J" sort="Gibson, Lorna J" uniqKey="Gibson L" first="Lorna J." last="Gibson">Lorna J. Gibson</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Department of Cancer Medicine, Imperial College and Charing Cross Hospital</s1><s2>London</s2><s3>GBR</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>22 aut.</sZ></inist:fA14><country>Royaume-Uni</country><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="Paridaens, Robert" sort="Paridaens, Robert" uniqKey="Paridaens R" first="Robert" last="Paridaens">Robert Paridaens</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Universitair Ziekenhuis</s1><s2>Leuven</s2><s3>BEL</s3><sZ>4 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>Universitair Ziekenhuis</wicri:noRegion></affiliation></author><author><name sortKey="Jassem, Jacek" sort="Jassem, Jacek" uniqKey="Jassem J" first="Jacek" last="Jassem">Jacek Jassem</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Medical University of Gdansk</s1><s2>Gdansk</s2><s3>POL</s3><sZ>5 aut.</sZ></inist:fA14><country>Pologne</country><wicri:noRegion>Medical University of Gdansk</wicri:noRegion></affiliation></author><author><name sortKey="Delozier, Thierry" sort="Delozier, Thierry" uniqKey="Delozier T" first="Thierry" last="Delozier">Thierry Delozier</name><affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Centre François Baclesse</s1><s2>Caen</s2><s3>FRA</s3><sZ>6 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Région Normandie</region><region type="old region">Basse-Normandie</region><settlement type="city">Caen</settlement></placeName></affiliation></author><author><name sortKey="Jones, Stephen E" sort="Jones, Stephen E" uniqKey="Jones S" first="Stephen E." last="Jones">Stephen E. Jones</name><affiliation wicri:level="3"><inist:fA14 i1="07"><s1>U.S. Oncology Research</s1><s2>Houston</s2><s3>USA</s3><sZ>7 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">Houston</settlement><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Alvarez, Isabel" sort="Alvarez, Isabel" uniqKey="Alvarez I" first="Isabel" last="Alvarez">Isabel Alvarez</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Hospital Donostia</s1><s2>San Sebastián</s2><s3>ESP</s3><sZ>8 aut.</sZ></inist:fA14><country>Espagne</country><wicri:noRegion>Hospital Donostia</wicri:noRegion></affiliation></author><author><name sortKey="Bertelli, Gianfilippo" sort="Bertelli, Gianfilippo" uniqKey="Bertelli G" first="Gianfilippo" last="Bertelli">Gianfilippo Bertelli</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>South West Wales Cancer Institute</s1><s2>Swansea</s2><s3>GBR</s3><sZ>9 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>South West Wales Cancer Institute</wicri:noRegion></affiliation></author><author><name sortKey="Ortmann, Olaf" sort="Ortmann, Olaf" uniqKey="Ortmann O" first="Olaf" last="Ortmann">Olaf Ortmann</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>University of Regensburg</s1><s2>Regensburg</s2><s3>DEU</s3><sZ>10 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Regensburg</wicri:noRegion><wicri:noRegion>University of Regensburg</wicri:noRegion><wicri:noRegion>University of Regensburg</wicri:noRegion></affiliation></author><author><name sortKey="Coates, Alan S" sort="Coates, Alan S" uniqKey="Coates A" first="Alan S." last="Coates">Alan S. Coates</name><affiliation wicri:level="4"><inist:fA14 i1="11"><s1>University of Sydney</s1><s2>Sydney</s2><s3>AUS</s3><sZ>11 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region><settlement type="city">Sydney</settlement></placeName><orgName type="university">Université de Sydney</orgName></affiliation></author><author><name sortKey="Bajetta, Emilio" sort="Bajetta, Emilio" uniqKey="Bajetta E" first="Emilio" last="Bajetta">Emilio Bajetta</name><affiliation wicri:level="3"><inist:fA14 i1="12"><s1>Istituto Nazionale per lo Studio e la Cura dei Tumori</s1><s2>Milan</s2><s3>ITA</s3><sZ>12 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="Dodwell, David" sort="Dodwell, David" uniqKey="Dodwell D" first="David" last="Dodwell">David Dodwell</name><affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Cookridge Hospital</s1><s2>Leeds</s2><s3>GBR</s3><sZ>13 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Cookridge Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Coleman, Robert E" sort="Coleman, Robert E" uniqKey="Coleman R" first="Robert E." last="Coleman">Robert E. Coleman</name><affiliation wicri:level="1"><inist:fA14 i1="14"><s1>Cancer Research Centre, Weston Park Hospital</s1><s2>Sheffield</s2><s3>GBR</s3><sZ>14 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Sheffield</wicri:noRegion></affiliation></author><author><name sortKey="Fallowfield, Lesley J" sort="Fallowfield, Lesley J" uniqKey="Fallowfield L" first="Lesley J." last="Fallowfield">Lesley J. Fallowfield</name><affiliation wicri:level="4"><inist:fA14 i1="15"><s1>Psychosocial Oncology Group, University of Sussex</s1><s2>Brighton</s2><s3>GBR</s3><sZ>15 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Brighton</settlement><settlement type="town">Falmer</settlement><region type="nation">Angleterre</region><region nuts="2" type="region">Sussex de l'Est</region></placeName><orgName type="university">Université du Sussex</orgName></affiliation></author><author><name sortKey="Mickiewicz, Elizabeth" sort="Mickiewicz, Elizabeth" uniqKey="Mickiewicz E" first="Elizabeth" last="Mickiewicz">Elizabeth Mickiewicz</name><affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Instituto Angel Roffo</s1><s2>Buenos Aires</s2><s3>ARG</s3><sZ>16 aut.</sZ></inist:fA14><country>Argentine</country><wicri:noRegion>Instituto Angel Roffo</wicri:noRegion></affiliation></author><author><name sortKey="Andersen, Jorn" sort="Andersen, Jorn" uniqKey="Andersen J" first="Jorn" last="Andersen">Jorn Andersen</name><affiliation wicri:level="1"><inist:fA14 i1="17"><s1>Arhus University Hospital</s1><s2>Århus</s2><s3>DEU</s3><sZ>17 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Århus</wicri:noRegion><wicri:noRegion>Arhus University Hospital</wicri:noRegion><wicri:noRegion>Arhus University Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Lonning, Per E" sort="Lonning, Per E" uniqKey="Lonning P" first="Per E." last="Lonning">Per E. Lonning</name><affiliation wicri:level="1"><inist:fA14 i1="18"><s1>Haukeland Hospital, University of Bergen</s1><s2>Bergen</s2><s3>NOR</s3><sZ>18 aut.</sZ></inist:fA14><country>Norvège</country><wicri:noRegion>Bergen</wicri:noRegion></affiliation></author><author><name sortKey="Cocconi, Giorgio" sort="Cocconi, Giorgio" uniqKey="Cocconi G" first="Giorgio" last="Cocconi">Giorgio Cocconi</name><affiliation wicri:level="1"><inist:fA14 i1="19"><s1>University Hospital</s1><s2>Parma</s2><s3>ITA</s3><sZ>19 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>University Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Stewart, Alan" sort="Stewart, Alan" uniqKey="Stewart A" first="Alan" last="Stewart">Alan Stewart</name><affiliation wicri:level="3"><inist:fA14 i1="20"><s1>Christie Hospital</s1><s2>Manchester</s2><s3>GBR</s3><sZ>20 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Manchester</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Manchester</region></placeName></affiliation></author><author><name sortKey="Stuart, Nick" sort="Stuart, Nick" uniqKey="Stuart N" first="Nick" last="Stuart">Nick Stuart</name><affiliation wicri:level="1"><inist:fA14 i1="21"><s1>Ysbyty Gwynedd</s1><s2>Bangor, Gwynedd</s2><s3>GBR</s3><sZ>21 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Ysbyty Gwynedd</wicri:noRegion></affiliation></author><author><name sortKey="Snowdon, Claire F" sort="Snowdon, Claire F" uniqKey="Snowdon C" first="Claire F." last="Snowdon">Claire F. Snowdon</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Department of Cancer Medicine, Imperial College and Charing Cross Hospital</s1><s2>London</s2><s3>GBR</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>22 aut.</sZ></inist:fA14><country>Royaume-Uni</country><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="Carpentieri, Marina" sort="Carpentieri, Marina" uniqKey="Carpentieri M" first="Marina" last="Carpentieri">Marina Carpentieri</name></author><author><name sortKey="Massimini, Giorgio" sort="Massimini, Giorgio" uniqKey="Massimini G" first="Giorgio" last="Massimini">Giorgio Massimini</name></author><author><name sortKey="Bliss, Judith M" sort="Bliss, Judith M" uniqKey="Bliss J" first="Judith M." last="Bliss">Judith M. Bliss</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Institute of Cancer Research</s1><s2>Sutton</s2><s3>GBR</s3><sZ>2 aut.</sZ><sZ>25 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Institute of Cancer Research</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">The New England journal of medicine</title><title level="j" type="abbreviated">N. Engl. j. med.</title><idno type="ISSN">0028-4793</idno><imprint><date when="2004">2004</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">The New England journal of medicine</title><title level="j" type="abbreviated">N. Engl. j. med.</title><idno type="ISSN">0028-4793</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Breast cancer</term><term>Clinical trial</term><term>Exemestane</term><term>Female</term><term>Malignant tumor</term><term>Mammary gland</term><term>Medicine</term><term>Postmenopause</term><term>Primary</term><term>Primitive</term><term>Tamoxifene</term><term>Treatment</term><term>Woman</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Tumeur maligne</term><term>Essai clinique</term><term>Exémestane</term><term>Tamoxifène</term><term>Traitement</term><term>Postménopause</term><term>Femme</term><term>Femelle</term><term>Primaire</term><term>Primitif</term><term>Glande mammaire</term><term>Médecine</term><term>Cancer du sein</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Femme</term><term>Médecine</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">BACKGROUND Tamoxifen, taken for five years, is the standard adjuvant treatment for postmenopausal women with primary, estrogen-receptor-positive breast cancer. Despite this treatment, however, some patients have a relapse. METHODS We conducted a double-blind, randomized trial to test whether, after two to three years oftamoxifen therapy, switching to exemestane was more effective than continuing tamoxifen therapy for the remainder ofthe five years of treatment. The primary end point was disease-free survival. RESULTS Of the 4742 patients enrolled, 2362 were randomly assigned to switch to exemestane, and 2380 to continue to receive tamoxifen. After a median follow-up of 30.6 months, 449 first events (local or metastatic recurrence, contralateral breast cancer, or death) were reported -183 in the exemestane group and 266 in the tamoxifen group. The unadjusted hazard ratio in the exemestane group as compared with the tamoxifen group was 0.68 (95 percent confidence interval, 0.56 to 0.82; P<0.001 by the log-rank test), representing a 32 percent reduction in risk and corresponding to an absolute benefit in terms of disease-free survival of 4.7 percent (95 percent confidence interval, 2.6 to 6.8) at three years after randomization. Overall survival was not significantly different in the two groups, with 93 deaths occurring in the exemestane group and 106 in the tamoxifen group. Severe toxic effects of exemestane were rare. Contralateral breast cancer occurred in 20 patients in the tamoxifen group and 9 in the exemestane group (P=0.04). CONCLUSIONSS Exemestane therapy after two to three years of tamoxifen therapy significantly improved disease-free survival as compared with the standard five years oftamoxifen treatment.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Argentine</li><li>Australie</li><li>Belgique</li><li>Espagne</li><li>France</li><li>Italie</li><li>Norvège</li><li>Pologne</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Basse-Normandie</li><li>Grand Londres</li><li>Grand Manchester</li><li>Lombardie</li><li>Nouvelle-Galles du Sud</li><li>Région Normandie</li><li>Sussex de l'Est</li><li>Texas</li></region><settlement><li>Brighton</li><li>Caen</li><li>Falmer</li><li>Houston</li><li>Londres</li><li>Manchester</li><li>Milan</li><li>Sydney</li></settlement><orgName><li>Université de Sydney</li><li>Université du Sussex</li></orgName></list><tree><noCountry><name sortKey="Carpentieri, Marina" sort="Carpentieri, Marina" uniqKey="Carpentieri M" first="Marina" last="Carpentieri">Marina Carpentieri</name><name sortKey="Massimini, Giorgio" sort="Massimini, Giorgio" uniqKey="Massimini G" first="Giorgio" last="Massimini">Giorgio Massimini</name></noCountry><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Coombes, R Charles" sort="Coombes, R Charles" uniqKey="Coombes R" first="R. Charles" last="Coombes">R. Charles Coombes</name></region><name sortKey="Bertelli, Gianfilippo" sort="Bertelli, Gianfilippo" uniqKey="Bertelli G" first="Gianfilippo" last="Bertelli">Gianfilippo Bertelli</name><name sortKey="Bliss, Judith M" sort="Bliss, Judith M" uniqKey="Bliss J" first="Judith M." last="Bliss">Judith M. Bliss</name><name sortKey="Coleman, Robert E" sort="Coleman, Robert E" uniqKey="Coleman R" first="Robert E." last="Coleman">Robert E. Coleman</name><name sortKey="Coombes, R Charles" sort="Coombes, R Charles" uniqKey="Coombes R" first="R. Charles" last="Coombes">R. Charles Coombes</name><name sortKey="Dodwell, David" sort="Dodwell, David" uniqKey="Dodwell D" first="David" last="Dodwell">David Dodwell</name><name sortKey="Fallowfield, Lesley J" sort="Fallowfield, Lesley J" uniqKey="Fallowfield L" first="Lesley J." last="Fallowfield">Lesley J. Fallowfield</name><name sortKey="Gibson, Lorna J" sort="Gibson, Lorna J" uniqKey="Gibson L" first="Lorna J." last="Gibson">Lorna J. Gibson</name><name sortKey="Hall, Emma" sort="Hall, Emma" uniqKey="Hall E" first="Emma" last="Hall">Emma Hall</name><name sortKey="Snowdon, Claire F" sort="Snowdon, Claire F" uniqKey="Snowdon C" first="Claire F." last="Snowdon">Claire F. Snowdon</name><name sortKey="Stewart, Alan" sort="Stewart, Alan" uniqKey="Stewart A" first="Alan" last="Stewart">Alan Stewart</name><name sortKey="Stuart, Nick" sort="Stuart, Nick" uniqKey="Stuart N" first="Nick" last="Stuart">Nick Stuart</name></country><country name="Belgique"><noRegion><name sortKey="Paridaens, Robert" sort="Paridaens, Robert" uniqKey="Paridaens R" first="Robert" last="Paridaens">Robert Paridaens</name></noRegion></country><country name="Pologne"><noRegion><name sortKey="Jassem, Jacek" sort="Jassem, Jacek" uniqKey="Jassem J" first="Jacek" last="Jassem">Jacek Jassem</name></noRegion></country><country name="France"><region name="Région Normandie"><name sortKey="Delozier, Thierry" sort="Delozier, Thierry" uniqKey="Delozier T" first="Thierry" last="Delozier">Thierry Delozier</name></region></country><country name="États-Unis"><region name="Texas"><name sortKey="Jones, Stephen E" sort="Jones, Stephen E" uniqKey="Jones S" first="Stephen E." last="Jones">Stephen E. Jones</name></region></country><country name="Espagne"><noRegion><name sortKey="Alvarez, Isabel" sort="Alvarez, Isabel" uniqKey="Alvarez I" first="Isabel" last="Alvarez">Isabel Alvarez</name></noRegion></country><country name="Allemagne"><noRegion><name sortKey="Ortmann, Olaf" sort="Ortmann, Olaf" uniqKey="Ortmann O" first="Olaf" last="Ortmann">Olaf Ortmann</name></noRegion><name sortKey="Andersen, Jorn" sort="Andersen, Jorn" uniqKey="Andersen J" first="Jorn" last="Andersen">Jorn Andersen</name></country><country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Coates, Alan S" sort="Coates, Alan S" uniqKey="Coates A" first="Alan S." last="Coates">Alan S. Coates</name></region></country><country name="Italie"><region name="Lombardie"><name sortKey="Bajetta, Emilio" sort="Bajetta, Emilio" uniqKey="Bajetta E" first="Emilio" last="Bajetta">Emilio Bajetta</name></region><name sortKey="Cocconi, Giorgio" sort="Cocconi, Giorgio" uniqKey="Cocconi G" first="Giorgio" last="Cocconi">Giorgio Cocconi</name></country><country name="Argentine"><noRegion><name sortKey="Mickiewicz, Elizabeth" sort="Mickiewicz, Elizabeth" uniqKey="Mickiewicz E" first="Elizabeth" last="Mickiewicz">Elizabeth Mickiewicz</name></noRegion></country><country name="Norvège"><noRegion><name sortKey="Lonning, Per E" sort="Lonning, Per E" uniqKey="Lonning P" first="Per E." last="Lonning">Per E. Lonning</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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