AustralieFrV1, Main, Exploration, bibRecord, 006D60

Adjuvant Trastuzumab in HER2-Positive Breast Cancer

Identifieur interne : 006D60 ( Main/Exploration ); précédent : 006D59; suivant : 006D61

Adjuvant 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.

RBID : Pascal:11-0457161

Descripteurs français

Pascal (Inist)
- Trastuzumab, Adjuvant, Anticorps monoclonal, Tumeur maligne, Gène onc cellulaire, Protooncogène, Cancer du sein, Gène erbB2, Glande mammaire, Médecine, Anticancéreux, Immunomodulateur, Récepteur HER2.
Wicri :
- topic : Adjuvant, Médecine.

English descriptors

KwdEn :
- Adjuvant, Antineoplastic agent, Breast cancer, C-Onc gene, Human Epidermal growth factor Receptor 2, Immunomodulator, Malignant tumor, Mammary gland, Medicine, Monoclonal antibody, Protooncogene, Trastuzumab, erbB2 Gene.

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.

Affiliations:

Links toward previous steps (curation, corpus...)

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Le 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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<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
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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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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Adjuvant Trastuzumab in HER2-Positive Breast Cancer</title>
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<author><name sortKey="Mackey, John" sort="Mackey, John" uniqKey="Mackey J" first="John" last="Mackey">John Mackey</name>
<affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Department of Oncology, University of Alberta</s1>
<s2>Edmonton</s2>
<s3>CAN</s3>
<sZ>7 aut.</sZ>
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<wicri:noRegion>Edmonton</wicri:noRegion>
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<author><name sortKey="Glaspy, John" sort="Glaspy, John" uniqKey="Glaspy J" first="John" last="Glaspy">John Glaspy</name>
<affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Jonsson Comprehensive Cancer Center, University of California-Los Angeles</s1>
<s2>Los Angeles</s2>
<s3>USA</s3>
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<placeName><settlement type="city">Los Angeles</settlement>
<region type="state">Californie</region>
</placeName>
</affiliation>
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<author><name sortKey="Chan, Arlene" sort="Chan, Arlene" uniqKey="Chan A" first="Arlene" last="Chan">Arlene Chan</name>
<affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Mount Breast Group, Mount Hospital</s1>
<s2>Perth</s2>
<s3>AUS</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
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<wicri:noRegion>Perth</wicri:noRegion>
</affiliation>
</author>
<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>
<s2>Los Angeles</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>8 aut.</sZ>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<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>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Belgique</li>
<li>Canada</li>
<li>Espagne</li>
<li>France</li>
<li>Hongrie</li>
<li>Israël</li>
<li>Pologne</li>
<li>Taïwan</li>
<li>États-Unis</li>
</country>
<region><li>Bavière</li>
<li>Californie</li>
<li>Communauté de Madrid</li>
<li>District de Darmstadt</li>
<li>District de Haute-Bavière</li>
<li>Hambourg</li>
<li>Hesse (Land)</li>
<li>Hongrie centrale</li>
<li>Texas</li>
<li>Île-de-France</li>
</region>
<settlement><li>Budapest</li>
<li>Francfort-sur-le-Main</li>
<li>Hambourg</li>
<li>Houston</li>
<li>Los Angeles</li>
<li>Madrid</li>
<li>Munich</li>
<li>Paris</li>
</settlement>
<orgName><li>Université de Californie du Sud</li>
</orgName>
</list>
<tree><country name="États-Unis"><region name="Californie"><name sortKey="Slamon, Dennis" sort="Slamon, Dennis" uniqKey="Slamon D" first="Dennis" last="Slamon">Dennis Slamon</name>
</region>
<name sortKey="Glaspy, John" sort="Glaspy, John" uniqKey="Glaspy J" first="John" last="Glaspy">John Glaspy</name>
<name sortKey="Pawlicki, Marek" sort="Pawlicki, Marek" uniqKey="Pawlicki M" first="Marek" last="Pawlicki">Marek Pawlicki</name>
<name sortKey="Press, Michael" sort="Press, Michael" uniqKey="Press M" first="Michael" last="Press">Michael Press</name>
<name sortKey="Robert, Nicholas" sort="Robert, Nicholas" uniqKey="Robert N" first="Nicholas" last="Robert">Nicholas Robert</name>
<name sortKey="Valero, Vicente" sort="Valero, Vicente" uniqKey="Valero V" first="Vicente" last="Valero">Vicente Valero</name>
<name sortKey="Visco, Frances" sort="Visco, Frances" uniqKey="Visco F" first="Frances" last="Visco">Frances Visco</name>
</country>
<country name="Allemagne"><region name="Bavière"><name sortKey="Eiermann, Wolfgang" sort="Eiermann, Wolfgang" uniqKey="Eiermann W" first="Wolfgang" last="Eiermann">Wolfgang Eiermann</name>
</region>
<name sortKey="Sauter, Guido" sort="Sauter, Guido" uniqKey="Sauter G" first="Guido" last="Sauter">Guido Sauter</name>
<name sortKey="Von Minckwitz, Gunter" sort="Von Minckwitz, Gunter" uniqKey="Von Minckwitz G" first="Gunter" last="Von Minckwitz">Gunter Von Minckwitz</name>
</country>
<country name="Pologne"><noRegion><name sortKey="Pienkowski, Tadeusz" sort="Pienkowski, Tadeusz" uniqKey="Pienkowski T" first="Tadeusz" last="Pienkowski">Tadeusz Pienkowski</name>
</noRegion>
</country>
<country name="Espagne"><region name="Communauté de Madrid"><name sortKey="Martin, Miguel" sort="Martin, Miguel" uniqKey="Martin M" first="Miguel" last="Martin">Miguel Martin</name>
</region>
</country>
<country name="Canada"><noRegion><name sortKey="Mackey, John" sort="Mackey, John" uniqKey="Mackey J" first="John" last="Mackey">John Mackey</name>
</noRegion>
</country>
<country name="Australie"><noRegion><name sortKey="Chan, Arlene" sort="Chan, Arlene" uniqKey="Chan A" first="Arlene" last="Chan">Arlene Chan</name>
</noRegion>
</country>
<country name="Hongrie"><region name="Hongrie centrale"><name sortKey="Pinter, Tamas" sort="Pinter, Tamas" uniqKey="Pinter T" first="Tamas" last="Pinter">Tamas Pinter</name>
</region>
</country>
<country name="Taïwan"><noRegion><name sortKey="Liu, Mei Ching" sort="Liu, Mei Ching" uniqKey="Liu M" first="Mei-Ching" last="Liu">Mei-Ching Liu</name>
</noRegion>
</country>
<country name="France"><region name="Île-de-France"><name sortKey="Bee, Valerie" sort="Bee, Valerie" uniqKey="Bee V" first="Valerie" last="Bee">Valerie Bee</name>
</region>
<name sortKey="Bendahmane, Belguendouz" sort="Bendahmane, Belguendouz" uniqKey="Bendahmane B" first="Belguendouz" last="Bendahmane">Belguendouz Bendahmane</name>
<name sortKey="Lindsay, Mary Ann" sort="Lindsay, Mary Ann" uniqKey="Lindsay M" first="Mary-Ann" last="Lindsay">Mary-Ann Lindsay</name>
<name sortKey="Riva, Alessandro" sort="Riva, Alessandro" uniqKey="Riva A" first="Alessandro" last="Riva">Alessandro Riva</name>
<name sortKey="Tabah Fisch, Isabelle" sort="Tabah Fisch, Isabelle" uniqKey="Tabah Fisch I" first="Isabelle" last="Tabah-Fisch">Isabelle Tabah-Fisch</name>
</country>
<country name="Belgique"><noRegion><name sortKey="Buyse, Marc" sort="Buyse, Marc" uniqKey="Buyse M" first="Marc" last="Buyse">Marc Buyse</name>
</noRegion>
</country>
<country name="Israël"><noRegion><name sortKey="Crown, John" sort="Crown, John" uniqKey="Crown J" first="John" last="Crown">John Crown</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

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Adjuvant Trastuzumab in HER2-Positive Breast Cancer

Adjuvant Trastuzumab in HER2-Positive Breast Cancer

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