Adjuvant Trastuzumab in HER2-Positive Breast Cancer
Identifieur interne : 006D60 ( Main/Curation ); précédent : 006D59; suivant : 006D61Adjuvant Trastuzumab in HER2-Positive Breast Cancer
Auteurs : Dennis Slamon [États-Unis] ; Wolfgang Eiermann [Allemagne] ; Nicholas Robert [États-Unis] ; Tadeusz Pienkowski [Pologne] ; Miguel Martin [Espagne] ; Michael Press [États-Unis] ; John Mackey [Canada] ; John Glaspy [États-Unis] ; Arlene Chan [Australie] ; Marek Pawlicki [États-Unis] ; Tamas Pinter [Hongrie] ; Vicente Valero [États-Unis] ; Mei-Ching Liu [Taïwan] ; Guido Sauter [Allemagne] ; Gunter Von Minckwitz [Allemagne] ; Frances Visco [États-Unis] ; Valerie Bee [France] ; Marc Buyse [Belgique] ; Belguendouz Bendahmane [France] ; Isabelle Tabah-Fisch [France] ; Mary-Ann Lindsay [France] ; Alessandro Riva [France] ; John Crown [Israël]Source :
- The New England journal of medicine [ 0028-4793 ] ; 2011.
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English descriptors
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Abstract
BACKGROUND Trastuzumab improves survival in the adjuvant treatment of HER-positive breast cancer, although combined therapy with anthracycline-based regimens has been associated with cardiac toxicity. We wanted to evaluate the efficacy and safety of a new nonanthracycline regimen with trastuzumab. METHODS We randomly assigned 3222 women with HER2-positive early-stage breast cancer to receive doxorubicin and cyclophosphamide followed by docetaxel every 3 weeks (AC-T), the same regimen plus 52 weeks of trastuzumab (AC-T plus trastuzumab), or docetaxel and carboplatin plus 52 weeks of trastuzumab (TCH). The primary study end point was disease-free survival. Secondary end points were overall survival and safety. RESULTS At a median follow-up of 65 months, 656 events triggered this protocol-specified analysis. The estimated disease-free survival rates at 5 years were 75% among patients receiving AC-T, 84% among those receiving AC-T plus trastuzumab, and 81% among those receiving TCH. Estimated rates of overall survival were 87%, 92%, and 91%, respectively. No significant differences in efficacy (disease-free or overall survival) were found between the two trastuzumab regimens, whereas both were superior to AC-T. The rates of congestive heart failure and cardiac dysfunction were significantly higher in the group receiving AC-T plus trastuzumab than in the TCH group (P<0.001). Eight cases of acute leukemia were reported: seven in the groups receiving the anthracycline-based regimens and one in the TCH group subsequent to receiving an anthracycline outside the study. CONCLUSIONS The addition of 1 year of adjuvant trastuzumab significantly improved disease-free and overall survival among women with HER2-positive breast cancer. The risk-benefit ratio favored the nonanthracycline TCH regimen over AC-T plus trastuzumab, given its similar efficacy, fewer acute toxic effects, and lower risks of cardiotoxicity and leukemia.
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Pascal:11-0457161Le document en format XML
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<author><name sortKey="Lindsay, Mary Ann" sort="Lindsay, Mary Ann" uniqKey="Lindsay M" first="Mary-Ann" last="Lindsay">Mary-Ann Lindsay</name>
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<author><name sortKey="Riva, Alessandro" sort="Riva, Alessandro" uniqKey="Riva A" first="Alessandro" last="Riva">Alessandro Riva</name>
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<author><name sortKey="Crown, John" sort="Crown, John" uniqKey="Crown J" first="John" last="Crown">John Crown</name>
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<country>Israël</country>
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<author><name sortKey="Glaspy, John" sort="Glaspy, John" uniqKey="Glaspy J" first="John" last="Glaspy">John Glaspy</name>
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<author><name sortKey="Chan, Arlene" sort="Chan, Arlene" uniqKey="Chan A" first="Arlene" last="Chan">Arlene Chan</name>
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<s2>Perth</s2>
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<sZ>9 aut.</sZ>
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<author><name sortKey="Pawlicki, Marek" sort="Pawlicki, Marek" uniqKey="Pawlicki M" first="Marek" last="Pawlicki">Marek Pawlicki</name>
<affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Jonsson Comprehensive Cancer Center, University of California-Los Angeles</s1>
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<placeName><settlement type="city">Los Angeles</settlement>
<region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Pinter, Tamas" sort="Pinter, Tamas" uniqKey="Pinter T" first="Tamas" last="Pinter">Tamas Pinter</name>
<affiliation wicri:level="3"><inist:fA14 i1="12"><s1>City Oncology Dispensary, St. Petersburg, Russia (M.P.); Petz Oktato Korhaz Onkoradiologia</s1>
<s2>Budapest</s2>
<s3>HUN</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>Hongrie</country>
<placeName><settlement type="city">Budapest</settlement>
<region nuts="2">Hongrie centrale</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Valero, Vicente" sort="Valero, Vicente" uniqKey="Valero V" first="Vicente" last="Valero">Vicente Valero</name>
<affiliation wicri:level="3"><inist:fA14 i1="07"><s1>University of Texas M.D. Anderson Cancer Center</s1>
<s2>Houston</s2>
<s3>USA</s3>
<sZ>12 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="Liu, Mei Ching" sort="Liu, Mei Ching" uniqKey="Liu M" first="Mei-Ching" last="Liu">Mei-Ching Liu</name>
<affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Sun Yat Sen Cancer Center</s1>
<s2>Taipei</s2>
<s3>TWN</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>Taïwan</country>
<wicri:noRegion>Sun Yat Sen Cancer Center</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Sauter, Guido" sort="Sauter, Guido" uniqKey="Sauter G" first="Guido" last="Sauter">Guido Sauter</name>
<affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Department of Pathology, University Medical Center Hamburg-Eppendorf</s1>
<s2>Hamburg</s2>
<s3>DEU</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<placeName><settlement type="city">Hambourg</settlement>
<region type="land" nuts="2">Hambourg</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Von Minckwitz, Gunter" sort="Von Minckwitz, Gunter" uniqKey="Von Minckwitz G" first="Gunter" last="Von Minckwitz">Gunter Von Minckwitz</name>
<affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Zentrum für Frauenheilkunde</s1>
<s2>Frankfurt</s2>
<s3>DEU</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<placeName><region type="land" nuts="1">Hesse (Land)</region>
<region type="district" nuts="2">District de Darmstadt</region>
<settlement type="city">Francfort-sur-le-Main</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Visco, Frances" sort="Visco, Frances" uniqKey="Visco F" first="Frances" last="Visco">Frances Visco</name>
<affiliation wicri:level="1"><inist:fA14 i1="14"><s1>National Breast Cancer Coalition</s1>
<s2>Washington, DC</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>National Breast Cancer Coalition</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Bee, Valerie" sort="Bee, Valerie" uniqKey="Bee V" first="Valerie" last="Bee">Valerie Bee</name>
<affiliation wicri:level="3"><inist:fA14 i1="15"><s1>Breast Cancer International Research Group</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>17 aut.</sZ>
<sZ>21 aut.</sZ>
<sZ>22 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Buyse, Marc" sort="Buyse, Marc" uniqKey="Buyse M" first="Marc" last="Buyse">Marc Buyse</name>
<affiliation wicri:level="1"><inist:fA14 i1="17"><s1>International Drug Development Institute</s1>
<s2>Louvain-la-Neuve</s2>
<s3>BEL</s3>
<sZ>18 aut.</sZ>
</inist:fA14>
<country>Belgique</country>
<wicri:noRegion>International Drug Development Institute</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Bendahmane, Belguendouz" sort="Bendahmane, Belguendouz" uniqKey="Bendahmane B" first="Belguendouz" last="Bendahmane">Belguendouz Bendahmane</name>
<affiliation wicri:level="3"><inist:fA14 i1="16"><s1>Sanofi-Aventis</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>19 aut.</sZ>
<sZ>20 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Tabah Fisch, Isabelle" sort="Tabah Fisch, Isabelle" uniqKey="Tabah Fisch I" first="Isabelle" last="Tabah-Fisch">Isabelle Tabah-Fisch</name>
<affiliation wicri:level="3"><inist:fA14 i1="16"><s1>Sanofi-Aventis</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>19 aut.</sZ>
<sZ>20 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Lindsay, Mary Ann" sort="Lindsay, Mary Ann" uniqKey="Lindsay M" first="Mary-Ann" last="Lindsay">Mary-Ann Lindsay</name>
<affiliation wicri:level="3"><inist:fA14 i1="15"><s1>Breast Cancer International Research Group</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>17 aut.</sZ>
<sZ>21 aut.</sZ>
<sZ>22 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Riva, Alessandro" sort="Riva, Alessandro" uniqKey="Riva A" first="Alessandro" last="Riva">Alessandro Riva</name>
<affiliation wicri:level="3"><inist:fA14 i1="15"><s1>Breast Cancer International Research Group</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>17 aut.</sZ>
<sZ>21 aut.</sZ>
<sZ>22 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Crown, John" sort="Crown, John" uniqKey="Crown J" first="John" last="Crown">John Crown</name>
<affiliation wicri:level="1"><inist:fA14 i1="18"><s1>All Ireland Cooperative Oncology Research Group, St. Vincent's University Hospital</s1>
<s2>Dublin</s2>
<s3>ISR</s3>
<sZ>23 aut.</sZ>
</inist:fA14>
<country>Israël</country>
<wicri:noRegion>Dublin</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="2011">2011</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>Adjuvant</term>
<term>Antineoplastic agent</term>
<term>Breast cancer</term>
<term>C-Onc gene</term>
<term>Human Epidermal growth factor Receptor 2</term>
<term>Immunomodulator</term>
<term>Malignant tumor</term>
<term>Mammary gland</term>
<term>Medicine</term>
<term>Monoclonal antibody</term>
<term>Protooncogene</term>
<term>Trastuzumab</term>
<term>erbB2 Gene</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Trastuzumab</term>
<term>Adjuvant</term>
<term>Anticorps monoclonal</term>
<term>Tumeur maligne</term>
<term>Gène onc cellulaire</term>
<term>Protooncogène</term>
<term>Cancer du sein</term>
<term>Gène erbB2</term>
<term>Glande mammaire</term>
<term>Médecine</term>
<term>Anticancéreux</term>
<term>Immunomodulateur</term>
<term>Récepteur HER2</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Adjuvant</term>
<term>Médecine</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">BACKGROUND Trastuzumab improves survival in the adjuvant treatment of HER-positive breast cancer, although combined therapy with anthracycline-based regimens has been associated with cardiac toxicity. We wanted to evaluate the efficacy and safety of a new nonanthracycline regimen with trastuzumab. METHODS We randomly assigned 3222 women with HER2-positive early-stage breast cancer to receive doxorubicin and cyclophosphamide followed by docetaxel every 3 weeks (AC-T), the same regimen plus 52 weeks of trastuzumab (AC-T plus trastuzumab), or docetaxel and carboplatin plus 52 weeks of trastuzumab (TCH). The primary study end point was disease-free survival. Secondary end points were overall survival and safety. RESULTS At a median follow-up of 65 months, 656 events triggered this protocol-specified analysis. The estimated disease-free survival rates at 5 years were 75% among patients receiving AC-T, 84% among those receiving AC-T plus trastuzumab, and 81% among those receiving TCH. Estimated rates of overall survival were 87%, 92%, and 91%, respectively. No significant differences in efficacy (disease-free or overall survival) were found between the two trastuzumab regimens, whereas both were superior to AC-T. The rates of congestive heart failure and cardiac dysfunction were significantly higher in the group receiving AC-T plus trastuzumab than in the TCH group (P<0.001). Eight cases of acute leukemia were reported: seven in the groups receiving the anthracycline-based regimens and one in the TCH group subsequent to receiving an anthracycline outside the study. CONCLUSIONS The addition of 1 year of adjuvant trastuzumab significantly improved disease-free and overall survival among women with HER2-positive breast cancer. The risk-benefit ratio favored the nonanthracycline TCH regimen over AC-T plus trastuzumab, given its similar efficacy, fewer acute toxic effects, and lower risks of cardiotoxicity and leukemia.</div>
</front>
</TEI>
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