A phase III randomized comparison of lapatinib plus capecitabine versus capecitabine alone in women with advanced breast cancer that has progressed on trastuzumab : updated efficacy and biomarker analyses
Identifieur interne : 003453 ( PascalFrancis/Checkpoint ); précédent : 003452; suivant : 003454A phase III randomized comparison of lapatinib plus capecitabine versus capecitabine alone in women with advanced breast cancer that has progressed on trastuzumab : updated efficacy and biomarker analyses
Auteurs : David Cameron [Royaume-Uni] ; Michelle Casey [États-Unis] ; Michael Press [États-Unis] ; Deborah Lindquist [États-Unis] ; Tadeusz Pienkowski [Pologne] ; C. Gilles Romieu [France] ; Stephen Chan [Royaume-Uni] ; Agnieszka Jagiello-Gruszfeld [Pologne] ; Bella Kaufman [Israël] ; John Crown [Irlande (pays)] ; Arlene Chan [Australie] ; Mario Campone [France] ; Patrice Viens [France] ; Neville Davidson [Royaume-Uni] ; Veira Gorbounova [Russie] ; Johannes Isaac Raats [Afrique du Sud] ; Dimosthenis Skarlos [Grèce] ; Beth Newstat [États-Unis] ; Debasish Roychowdhury [États-Unis] ; Paolo Paoletti [États-Unis] ; Cristina Oliva [États-Unis] ; Stephen Rubin [États-Unis] ; Steven Stein [États-Unis] ; Charles E. Geyer [États-Unis]Source :
- Breast cancer research and treatment [ 0167-6806 ] ; 2008.
Descripteurs français
- Pascal (Inist)
- Wicri :
English descriptors
- KwdEn :
Abstract
Purpose Lapatinib is a small molecule, dual tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor type 2 (HER2). Initial results of a phase III trial demonstrated that lapatinib plus capecitabine is superior to capecitabine alone in women with HER2-positive advanced breast cancer that progressed following prior therapy including trastuzumab. Updated efficacy and initial biomarker results from this trial are reported. Results 399 women were randomized. The addition of lapatinib prolonged TTP with a hazard ratio (HR) of 0.57 (95% CI, 0.43-0.77; P < 0.001) and provided a trend toward improved overall survival (HR: 0.78, 95% CI: 0.55-1.12, P = 0.177), and fewer cases with CNS involvement at first progression (4 vs. 13, P = 0.045). Baseline serum HER2 ECD did not predict for benefit from lapatinib. Conclusion The addition of lapatinib to capecitabine provides superior efficacy for women with HER2-positive, advanced breast cancer progressing after treatment with anthracycline-, taxane-, and trastuzumab-based therapy. Biomarker studies could not identify a subgroup of patients who failed to benefit from the addition of lapatinib to capecitabine.
Affiliations:
- Afrique du Sud, Australie, France, Grèce, Irlande (pays), Israël, Pologne, Royaume-Uni, Russie, États-Unis
- Angleterre, Attique (région), Californie, District fédéral central, Languedoc-Roussillon, Occitanie (région administrative), Provence-Alpes-Côte d'Azur, Yorkshire-et-Humber
- Athènes, Leeds, Los Angeles, Marseille, Montpellier, Moscou
- Université de Californie du Sud, Université de Leeds, Université de la Méditerranée
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Pascal:09-0067549Le document en format XML
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<author><name sortKey="Chan, Stephen" sort="Chan, Stephen" uniqKey="Chan S" first="Stephen" last="Chan">Stephen Chan</name>
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<author><name sortKey="Kaufman, Bella" sort="Kaufman, Bella" uniqKey="Kaufman B" first="Bella" last="Kaufman">Bella Kaufman</name>
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<author><name sortKey="Gorbounova, Veira" sort="Gorbounova, Veira" uniqKey="Gorbounova V" first="Veira" last="Gorbounova">Veira Gorbounova</name>
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<author><name sortKey="Raats, Johannes Isaac" sort="Raats, Johannes Isaac" uniqKey="Raats J" first="Johannes Isaac" last="Raats">Johannes Isaac Raats</name>
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<author><name sortKey="Skarlos, Dimosthenis" sort="Skarlos, Dimosthenis" uniqKey="Skarlos D" first="Dimosthenis" last="Skarlos">Dimosthenis Skarlos</name>
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<author><name sortKey="Paoletti, Paolo" sort="Paoletti, Paolo" uniqKey="Paoletti P" first="Paolo" last="Paoletti">Paolo Paoletti</name>
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<author><name sortKey="Oliva, Cristina" sort="Oliva, Cristina" uniqKey="Oliva C" first="Cristina" last="Oliva">Cristina Oliva</name>
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<author><name sortKey="Rubin, Stephen" sort="Rubin, Stephen" uniqKey="Rubin S" first="Stephen" last="Rubin">Stephen Rubin</name>
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<author><name sortKey="Stein, Steven" sort="Stein, Steven" uniqKey="Stein S" first="Steven" last="Stein">Steven Stein</name>
<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>GlaxoSmithKline</s1>
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<author><name sortKey="Geyer, Charles E" sort="Geyer, Charles E" uniqKey="Geyer C" first="Charles E." last="Geyer">Charles E. Geyer</name>
<affiliation wicri:level="1"><inist:fA14 i1="18"><s1>Department of Human Oncology, Allegheny General Hospital</s1>
<s2>Pittsburgh, PA</s2>
<s3>USA</s3>
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<wicri:noRegion>Pittsburgh, PA</wicri:noRegion>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">A phase III randomized comparison of lapatinib plus capecitabine versus capecitabine alone in women with advanced breast cancer that has progressed on trastuzumab : updated efficacy and biomarker analyses</title>
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<author><name sortKey="Casey, Michelle" sort="Casey, Michelle" uniqKey="Casey M" first="Michelle" last="Casey">Michelle Casey</name>
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<author><name sortKey="Press, Michael" sort="Press, Michael" uniqKey="Press M" first="Michael" last="Press">Michael Press</name>
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<s3>USA</s3>
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<author><name sortKey="Lindquist, Deborah" sort="Lindquist, Deborah" uniqKey="Lindquist D" first="Deborah" last="Lindquist">Deborah Lindquist</name>
<affiliation wicri:level="1"><inist:fA14 i1="04"><s1>US Oncology</s1>
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<author><name sortKey="Pienkowski, Tadeusz" sort="Pienkowski, Tadeusz" uniqKey="Pienkowski T" first="Tadeusz" last="Pienkowski">Tadeusz Pienkowski</name>
<affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Breast Cancer and Reconstruction Surgery Department, Centrum Onkologii Klinika Nowotworów Piersi i Chirurgii</s1>
<s2>Warsaw</s2>
<s3>POL</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
<country>Pologne</country>
<wicri:noRegion>Warsaw</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Gilles Romieu, C" sort="Gilles Romieu, C" uniqKey="Gilles Romieu C" first="C." last="Gilles Romieu">C. Gilles Romieu</name>
<affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Département Oncologie, CRLCC Val d'Aurelle</s1>
<s2>Montpellier</s2>
<s3>FRA</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Occitanie (région administrative)</region>
<region type="old region">Languedoc-Roussillon</region>
<settlement type="city">Montpellier</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Chan, Stephen" sort="Chan, Stephen" uniqKey="Chan S" first="Stephen" last="Chan">Stephen Chan</name>
<affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Department of Clinical Oncology, Nottingham University Hospitals</s1>
<s2>Nottingham</s2>
<s3>GBR</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>Nottingham</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Jagiello Gruszfeld, Agnieszka" sort="Jagiello Gruszfeld, Agnieszka" uniqKey="Jagiello Gruszfeld A" first="Agnieszka" last="Jagiello-Gruszfeld">Agnieszka Jagiello-Gruszfeld</name>
<affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Chemotherapy Department, ZOZ MSWiA</s1>
<s2>Olsztyn</s2>
<s3>POL</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>Pologne</country>
<wicri:noRegion>Olsztyn</wicri:noRegion>
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<sZ>10 aut.</sZ>
</inist:fA14>
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</affiliation>
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<author><name sortKey="Campone, Mario" sort="Campone, Mario" uniqKey="Campone M" first="Mario" last="Campone">Mario Campone</name>
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<s3>FRA</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
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<wicri:noRegion>Saint Herblain</wicri:noRegion>
<wicri:noRegion>Centre René Gauducheau</wicri:noRegion>
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</affiliation>
</author>
<author><name sortKey="Viens, Patrice" sort="Viens, Patrice" uniqKey="Viens P" first="Patrice" last="Viens">Patrice Viens</name>
<affiliation wicri:level="4"><inist:fA14 i1="13"><s1>Institut Paoli Calmette, Université de la Méditerranée</s1>
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<s3>FRA</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
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<author><name sortKey="Davidson, Neville" sort="Davidson, Neville" uniqKey="Davidson N" first="Neville" last="Davidson">Neville Davidson</name>
<affiliation wicri:level="1"><inist:fA14 i1="14"><s1>Broomfield Hospital</s1>
<s2>Chelmsford</s2>
<s3>GBR</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>Broomfield Hospital</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Gorbounova, Veira" sort="Gorbounova, Veira" uniqKey="Gorbounova V" first="Veira" last="Gorbounova">Veira Gorbounova</name>
<affiliation wicri:level="3"><inist:fA14 i1="15"><s1>Russian National Cancer Research Center</s1>
<s2>Moscow</s2>
<s3>RUS</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>Russie</country>
<placeName><settlement type="city">Moscou</settlement>
<region>District fédéral central</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Raats, Johannes Isaac" sort="Raats, Johannes Isaac" uniqKey="Raats J" first="Johannes Isaac" last="Raats">Johannes Isaac Raats</name>
<affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Panorama Medical Center</s1>
<s2>Cape Town</s2>
<s3>ZAF</s3>
<sZ>16 aut.</sZ>
</inist:fA14>
<country>Afrique du Sud</country>
<wicri:noRegion>Panorama Medical Center</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Skarlos, Dimosthenis" sort="Skarlos, Dimosthenis" uniqKey="Skarlos D" first="Dimosthenis" last="Skarlos">Dimosthenis Skarlos</name>
<affiliation wicri:level="3"><inist:fA14 i1="17"><s1>2nd Medical Oncology Department of Errikos Dunan Hospital, Errikos Dynan Hospital-B</s1>
<s2>Athens</s2>
<s3>GRC</s3>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>Grèce</country>
<placeName><settlement type="city">Athènes</settlement>
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</placeName>
</affiliation>
</author>
<author><name sortKey="Newstat, Beth" sort="Newstat, Beth" uniqKey="Newstat B" first="Beth" last="Newstat">Beth Newstat</name>
<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>GlaxoSmithKline</s1>
<s2>Collegeville, PA</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>20 aut.</sZ>
<sZ>21 aut.</sZ>
<sZ>22 aut.</sZ>
<sZ>23 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>GlaxoSmithKline</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Roychowdhury, Debasish" sort="Roychowdhury, Debasish" uniqKey="Roychowdhury D" first="Debasish" last="Roychowdhury">Debasish Roychowdhury</name>
<affiliation wicri:level="4"><inist:fA14 i1="03"><s1>Norris Comprehensive Cancer Center, University of Southern California</s1>
<s2>Los Angeles, CA</s2>
<s3>USA</s3>
<sZ>3 aut.</sZ>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><settlement type="city">Los Angeles</settlement>
<region type="state">Californie</region>
</placeName>
<orgName type="university">Université de Californie du Sud</orgName>
</affiliation>
</author>
<author><name sortKey="Paoletti, Paolo" sort="Paoletti, Paolo" uniqKey="Paoletti P" first="Paolo" last="Paoletti">Paolo Paoletti</name>
<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>GlaxoSmithKline</s1>
<s2>Collegeville, PA</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>20 aut.</sZ>
<sZ>21 aut.</sZ>
<sZ>22 aut.</sZ>
<sZ>23 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>GlaxoSmithKline</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Oliva, Cristina" sort="Oliva, Cristina" uniqKey="Oliva C" first="Cristina" last="Oliva">Cristina Oliva</name>
<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>GlaxoSmithKline</s1>
<s2>Collegeville, PA</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>20 aut.</sZ>
<sZ>21 aut.</sZ>
<sZ>22 aut.</sZ>
<sZ>23 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>GlaxoSmithKline</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Rubin, Stephen" sort="Rubin, Stephen" uniqKey="Rubin S" first="Stephen" last="Rubin">Stephen Rubin</name>
<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>GlaxoSmithKline</s1>
<s2>Collegeville, PA</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>20 aut.</sZ>
<sZ>21 aut.</sZ>
<sZ>22 aut.</sZ>
<sZ>23 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>GlaxoSmithKline</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Stein, Steven" sort="Stein, Steven" uniqKey="Stein S" first="Steven" last="Stein">Steven Stein</name>
<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>GlaxoSmithKline</s1>
<s2>Collegeville, PA</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>20 aut.</sZ>
<sZ>21 aut.</sZ>
<sZ>22 aut.</sZ>
<sZ>23 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>GlaxoSmithKline</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Geyer, Charles E" sort="Geyer, Charles E" uniqKey="Geyer C" first="Charles E." last="Geyer">Charles E. Geyer</name>
<affiliation wicri:level="1"><inist:fA14 i1="18"><s1>Department of Human Oncology, Allegheny General Hospital</s1>
<s2>Pittsburgh, PA</s2>
<s3>USA</s3>
<sZ>24 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Pittsburgh, PA</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">Breast cancer research and treatment</title>
<title level="j" type="abbreviated">Breast cancer res. treat.</title>
<idno type="ISSN">0167-6806</idno>
<imprint><date when="2008">2008</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">Breast cancer research and treatment</title>
<title level="j" type="abbreviated">Breast cancer res. treat.</title>
<idno type="ISSN">0167-6806</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term>
<term>Advanced stage</term>
<term>Antineoplastic agent</term>
<term>Biological marker</term>
<term>Breast cancer</term>
<term>Capecitabine</term>
<term>Comparative study</term>
<term>Drug combination</term>
<term>Lapatinib</term>
<term>Metastasis</term>
<term>Prodrug</term>
<term>Protooncogene</term>
<term>Randomization</term>
<term>Trastuzumab</term>
<term>Treatment efficiency</term>
<term>Tyrosine kinase inhibitor</term>
<term>Woman</term>
<term>erbB2 Gene</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Randomisation</term>
<term>Etude comparative</term>
<term>Lapatinib</term>
<term>Capécitabine</term>
<term>Association médicamenteuse</term>
<term>Adulte</term>
<term>Femme</term>
<term>Stade avancé</term>
<term>Cancer du sein</term>
<term>Trastuzumab</term>
<term>Efficacité traitement</term>
<term>Marqueur biologique</term>
<term>Métastase</term>
<term>Inhibiteur de la tyrosine kinase</term>
<term>Protooncogène</term>
<term>Gène erbB2</term>
<term>Anticancéreux</term>
<term>Promédicament</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Adulte</term>
<term>Femme</term>
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<front><div type="abstract" xml:lang="en">Purpose Lapatinib is a small molecule, dual tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor type 2 (HER2). Initial results of a phase III trial demonstrated that lapatinib plus capecitabine is superior to capecitabine alone in women with HER2-positive advanced breast cancer that progressed following prior therapy including trastuzumab. Updated efficacy and initial biomarker results from this trial are reported. Results 399 women were randomized. The addition of lapatinib prolonged TTP with a hazard ratio (HR) of 0.57 (95% CI, 0.43-0.77; P < 0.001) and provided a trend toward improved overall survival (HR: 0.78, 95% CI: 0.55-1.12, P = 0.177), and fewer cases with CNS involvement at first progression (4 vs. 13, P = 0.045). Baseline serum HER2 ECD did not predict for benefit from lapatinib. Conclusion The addition of lapatinib to capecitabine provides superior efficacy for women with HER2-positive, advanced breast cancer progressing after treatment with anthracycline-, taxane-, and trastuzumab-based therapy. Biomarker studies could not identify a subgroup of patients who failed to benefit from the addition of lapatinib to capecitabine.</div>
</front>
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<fA08 i1="01" i2="1" l="ENG"><s1>A phase III randomized comparison of lapatinib plus capecitabine versus capecitabine alone in women with advanced breast cancer that has progressed on trastuzumab : updated efficacy and biomarker analyses</s1>
</fA08>
<fA11 i1="01" i2="1"><s1>CAMERON (David)</s1>
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<fA11 i1="18" i2="1"><s1>NEWSTAT (Beth)</s1>
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<fA11 i1="19" i2="1"><s1>ROYCHOWDHURY (Debasish)</s1>
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<fA11 i1="20" i2="1"><s1>PAOLETTI (Paolo)</s1>
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<fA11 i1="21" i2="1"><s1>OLIVA (Cristina)</s1>
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<fA11 i1="23" i2="1"><s1>STEIN (Steven)</s1>
</fA11>
<fA11 i1="24" i2="1"><s1>GEYER (Charles E.)</s1>
</fA11>
<fA14 i1="01"><s1>University of Leeds</s1>
<s2>Leeds</s2>
<s3>GBR</s3>
<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>GlaxoSmithKline</s1>
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<sZ>2 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>20 aut.</sZ>
<sZ>21 aut.</sZ>
<sZ>22 aut.</sZ>
<sZ>23 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>Norris Comprehensive Cancer Center, University of Southern California</s1>
<s2>Los Angeles, CA</s2>
<s3>USA</s3>
<sZ>3 aut.</sZ>
<sZ>19 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>US Oncology</s1>
<s2>Houston, TX</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>Breast Cancer and Reconstruction Surgery Department, Centrum Onkologii Klinika Nowotworów Piersi i Chirurgii</s1>
<s2>Warsaw</s2>
<s3>POL</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>Département Oncologie, CRLCC Val d'Aurelle</s1>
<s2>Montpellier</s2>
<s3>FRA</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>Department of Clinical Oncology, Nottingham University Hospitals</s1>
<s2>Nottingham</s2>
<s3>GBR</s3>
<sZ>7 aut.</sZ>
</fA14>
<fA14 i1="08"><s1>Chemotherapy Department, ZOZ MSWiA</s1>
<s2>Olsztyn</s2>
<s3>POL</s3>
<sZ>8 aut.</sZ>
</fA14>
<fA14 i1="09"><s1>Oncology Division, Chaim Sheba Medical Center</s1>
<s2>Tel-Hashomer</s2>
<s3>ISR</s3>
<sZ>9 aut.</sZ>
</fA14>
<fA14 i1="10"><s1>Irish Clinical Oncology Research Group</s1>
<s2>Dublin</s2>
<s3>IRL</s3>
<sZ>10 aut.</sZ>
</fA14>
<fA14 i1="11"><s1>Mount Medical Centre, Mount Hospital</s1>
<s2>Perth</s2>
<s3>AUS</s3>
<sZ>11 aut.</sZ>
</fA14>
<fA14 i1="12"><s1>Oncology Department, Centre René Gauducheau</s1>
<s2>Gauducheau, Saint Herblain</s2>
<s3>FRA</s3>
<sZ>12 aut.</sZ>
</fA14>
<fA14 i1="13"><s1>Institut Paoli Calmette, Université de la Méditerranée</s1>
<s2>Marseille</s2>
<s3>FRA</s3>
<sZ>13 aut.</sZ>
</fA14>
<fA14 i1="14"><s1>Broomfield Hospital</s1>
<s2>Chelmsford</s2>
<s3>GBR</s3>
<sZ>14 aut.</sZ>
</fA14>
<fA14 i1="15"><s1>Russian National Cancer Research Center</s1>
<s2>Moscow</s2>
<s3>RUS</s3>
<sZ>15 aut.</sZ>
</fA14>
<fA14 i1="16"><s1>Panorama Medical Center</s1>
<s2>Cape Town</s2>
<s3>ZAF</s3>
<sZ>16 aut.</sZ>
</fA14>
<fA14 i1="17"><s1>2nd Medical Oncology Department of Errikos Dunan Hospital, Errikos Dynan Hospital-B</s1>
<s2>Athens</s2>
<s3>GRC</s3>
<sZ>17 aut.</sZ>
</fA14>
<fA14 i1="18"><s1>Department of Human Oncology, Allegheny General Hospital</s1>
<s2>Pittsburgh, PA</s2>
<s3>USA</s3>
<sZ>24 aut.</sZ>
</fA14>
<fA20><s1>533-543</s1>
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<fA23 i1="01"><s0>ENG</s0>
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<fA47 i1="01" i2="1"><s0>09-0067549</s0>
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<fA60><s1>P</s1>
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<fA64 i1="01" i2="1"><s0>Breast cancer research and treatment</s0>
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<fA66 i1="01"><s0>NLD</s0>
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<fC01 i1="01" l="ENG"><s0>Purpose Lapatinib is a small molecule, dual tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor type 2 (HER2). Initial results of a phase III trial demonstrated that lapatinib plus capecitabine is superior to capecitabine alone in women with HER2-positive advanced breast cancer that progressed following prior therapy including trastuzumab. Updated efficacy and initial biomarker results from this trial are reported. Results 399 women were randomized. The addition of lapatinib prolonged TTP with a hazard ratio (HR) of 0.57 (95% CI, 0.43-0.77; P < 0.001) and provided a trend toward improved overall survival (HR: 0.78, 95% CI: 0.55-1.12, P = 0.177), and fewer cases with CNS involvement at first progression (4 vs. 13, P = 0.045). Baseline serum HER2 ECD did not predict for benefit from lapatinib. Conclusion The addition of lapatinib to capecitabine provides superior efficacy for women with HER2-positive, advanced breast cancer progressing after treatment with anthracycline-, taxane-, and trastuzumab-based therapy. Biomarker studies could not identify a subgroup of patients who failed to benefit from the addition of lapatinib to capecitabine.</s0>
</fC01>
<fC02 i1="01" i2="X"><s0>002B20E02</s0>
</fC02>
<fC02 i1="02" i2="X"><s0>002B02R02</s0>
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<fC03 i1="01" i2="X" l="FRE"><s0>Randomisation</s0>
<s5>01</s5>
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<fC03 i1="01" i2="X" l="ENG"><s0>Randomization</s0>
<s5>01</s5>
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<fC03 i1="01" i2="X" l="SPA"><s0>Aleatorización</s0>
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<fC03 i1="02" i2="X" l="FRE"><s0>Etude comparative</s0>
<s5>02</s5>
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<fC03 i1="02" i2="X" l="ENG"><s0>Comparative study</s0>
<s5>02</s5>
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<fC03 i1="02" i2="X" l="SPA"><s0>Estudio comparativo</s0>
<s5>02</s5>
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<fC03 i1="03" i2="X" l="FRE"><s0>Lapatinib</s0>
<s2>FR</s2>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Lapatinib</s0>
<s2>FR</s2>
<s5>03</s5>
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<s5>03</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Capécitabine</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Capecitabine</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Capecitabina</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>04</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Association médicamenteuse</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Drug combination</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Asociación medicamentosa</s0>
<s5>05</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Adulte</s0>
<s5>07</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Adult</s0>
<s5>07</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Adulto</s0>
<s5>07</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Femme</s0>
<s5>08</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Woman</s0>
<s5>08</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Mujer</s0>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Stade avancé</s0>
<s5>09</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Advanced stage</s0>
<s5>09</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Estadio avanzado</s0>
<s5>09</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE"><s0>Cancer du sein</s0>
<s2>NM</s2>
<s5>10</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG"><s0>Breast cancer</s0>
<s2>NM</s2>
<s5>10</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA"><s0>Cáncer del pecho</s0>
<s2>NM</s2>
<s5>10</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE"><s0>Trastuzumab</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>11</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG"><s0>Trastuzumab</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>11</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA"><s0>Trastuzumab</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>11</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE"><s0>Efficacité traitement</s0>
<s5>12</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG"><s0>Treatment efficiency</s0>
<s5>12</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA"><s0>Eficacia tratamiento</s0>
<s5>12</s5>
</fC03>
<fC03 i1="12" i2="X" l="FRE"><s0>Marqueur biologique</s0>
<s5>13</s5>
</fC03>
<fC03 i1="12" i2="X" l="ENG"><s0>Biological marker</s0>
<s5>13</s5>
</fC03>
<fC03 i1="12" i2="X" l="SPA"><s0>Marcador biológico</s0>
<s5>13</s5>
</fC03>
<fC03 i1="13" i2="X" l="FRE"><s0>Métastase</s0>
<s5>15</s5>
</fC03>
<fC03 i1="13" i2="X" l="ENG"><s0>Metastasis</s0>
<s5>15</s5>
</fC03>
<fC03 i1="13" i2="X" l="SPA"><s0>Metástasis</s0>
<s5>15</s5>
</fC03>
<fC03 i1="14" i2="X" l="FRE"><s0>Inhibiteur de la tyrosine kinase</s0>
<s5>18</s5>
</fC03>
<fC03 i1="14" i2="X" l="ENG"><s0>Tyrosine kinase inhibitor</s0>
<s5>18</s5>
</fC03>
<fC03 i1="14" i2="X" l="SPA"><s0>Inhibidor tyrosine kinase</s0>
<s5>18</s5>
</fC03>
<fC03 i1="15" i2="X" l="FRE"><s0>Protooncogène</s0>
<s5>20</s5>
</fC03>
<fC03 i1="15" i2="X" l="ENG"><s0>Protooncogene</s0>
<s5>20</s5>
</fC03>
<fC03 i1="15" i2="X" l="SPA"><s0>Protooncogen</s0>
<s5>20</s5>
</fC03>
<fC03 i1="16" i2="X" l="FRE"><s0>Gène erbB2</s0>
<s5>21</s5>
</fC03>
<fC03 i1="16" i2="X" l="ENG"><s0>erbB2 Gene</s0>
<s5>21</s5>
</fC03>
<fC03 i1="16" i2="X" l="SPA"><s0>Gen erbB2</s0>
<s5>21</s5>
</fC03>
<fC03 i1="17" i2="X" l="FRE"><s0>Anticancéreux</s0>
<s5>23</s5>
</fC03>
<fC03 i1="17" i2="X" l="ENG"><s0>Antineoplastic agent</s0>
<s5>23</s5>
</fC03>
<fC03 i1="17" i2="X" l="SPA"><s0>Anticanceroso</s0>
<s5>23</s5>
</fC03>
<fC03 i1="18" i2="X" l="FRE"><s0>Promédicament</s0>
<s5>24</s5>
</fC03>
<fC03 i1="18" i2="X" l="ENG"><s0>Prodrug</s0>
<s5>24</s5>
</fC03>
<fC03 i1="18" i2="X" l="SPA"><s0>Promedicamento</s0>
<s5>24</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Homme</s0>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Human</s0>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Hombre</s0>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Dérivé de la fluoropyrimidine</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Fluoropyrimidine derivatives</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Fluoropirimidina derivado</s0>
<s5>37</s5>
</fC07>
<fC07 i1="03" i2="X" l="FRE"><s0>Pyrimidine nucléoside</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Pyrimidine nucleoside</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Pirimidina nucleósido</s0>
<s5>38</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Tumeur maligne</s0>
<s2>NM</s2>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>Malignant tumor</s0>
<s2>NM</s2>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Tumor maligno</s0>
<s2>NM</s2>
<s5>39</s5>
</fC07>
<fC07 i1="05" i2="X" l="FRE"><s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="05" i2="X" l="ENG"><s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="05" i2="X" l="SPA"><s0>Cáncer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="06" i2="X" l="FRE"><s0>Pathologie de la glande mammaire</s0>
<s2>NM</s2>
<s5>40</s5>
</fC07>
<fC07 i1="06" i2="X" l="ENG"><s0>Mammary gland diseases</s0>
<s2>NM</s2>
<s5>40</s5>
</fC07>
<fC07 i1="06" i2="X" l="SPA"><s0>Glándula mamaria patología</s0>
<s2>NM</s2>
<s5>40</s5>
</fC07>
<fC07 i1="07" i2="X" l="FRE"><s0>Pathologie du sein</s0>
<s2>NM</s2>
<s5>41</s5>
</fC07>
<fC07 i1="07" i2="X" l="ENG"><s0>Breast disease</s0>
<s2>NM</s2>
<s5>41</s5>
</fC07>
<fC07 i1="07" i2="X" l="SPA"><s0>Seno patología</s0>
<s2>NM</s2>
<s5>41</s5>
</fC07>
<fC07 i1="08" i2="X" l="FRE"><s0>Anticorps monoclonal</s0>
<s5>42</s5>
</fC07>
<fC07 i1="08" i2="X" l="ENG"><s0>Monoclonal antibody</s0>
<s5>42</s5>
</fC07>
<fC07 i1="08" i2="X" l="SPA"><s0>Anticuerpo monoclonal</s0>
<s5>42</s5>
</fC07>
<fC07 i1="09" i2="X" l="FRE"><s0>Anti-HER2</s0>
<s4>INC</s4>
<s5>86</s5>
</fC07>
<fN21><s1>047</s1>
</fN21>
</pA>
</standard>
</inist>
<affiliations><list><country><li>Afrique du Sud</li>
<li>Australie</li>
<li>France</li>
<li>Grèce</li>
<li>Irlande (pays)</li>
<li>Israël</li>
<li>Pologne</li>
<li>Royaume-Uni</li>
<li>Russie</li>
<li>États-Unis</li>
</country>
<region><li>Angleterre</li>
<li>Attique (région)</li>
<li>Californie</li>
<li>District fédéral central</li>
<li>Languedoc-Roussillon</li>
<li>Occitanie (région administrative)</li>
<li>Provence-Alpes-Côte d'Azur</li>
<li>Yorkshire-et-Humber</li>
</region>
<settlement><li>Athènes</li>
<li>Leeds</li>
<li>Los Angeles</li>
<li>Marseille</li>
<li>Montpellier</li>
<li>Moscou</li>
</settlement>
<orgName><li>Université de Californie du Sud</li>
<li>Université de Leeds</li>
<li>Université de la Méditerranée</li>
</orgName>
</list>
<tree><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Cameron, David" sort="Cameron, David" uniqKey="Cameron D" first="David" last="Cameron">David Cameron</name>
</region>
<name sortKey="Chan, Stephen" sort="Chan, Stephen" uniqKey="Chan S" first="Stephen" last="Chan">Stephen Chan</name>
<name sortKey="Davidson, Neville" sort="Davidson, Neville" uniqKey="Davidson N" first="Neville" last="Davidson">Neville Davidson</name>
</country>
<country name="États-Unis"><noRegion><name sortKey="Casey, Michelle" sort="Casey, Michelle" uniqKey="Casey M" first="Michelle" last="Casey">Michelle Casey</name>
</noRegion>
<name sortKey="Geyer, Charles E" sort="Geyer, Charles E" uniqKey="Geyer C" first="Charles E." last="Geyer">Charles E. Geyer</name>
<name sortKey="Lindquist, Deborah" sort="Lindquist, Deborah" uniqKey="Lindquist D" first="Deborah" last="Lindquist">Deborah Lindquist</name>
<name sortKey="Newstat, Beth" sort="Newstat, Beth" uniqKey="Newstat B" first="Beth" last="Newstat">Beth Newstat</name>
<name sortKey="Oliva, Cristina" sort="Oliva, Cristina" uniqKey="Oliva C" first="Cristina" last="Oliva">Cristina Oliva</name>
<name sortKey="Paoletti, Paolo" sort="Paoletti, Paolo" uniqKey="Paoletti P" first="Paolo" last="Paoletti">Paolo Paoletti</name>
<name sortKey="Press, Michael" sort="Press, Michael" uniqKey="Press M" first="Michael" last="Press">Michael Press</name>
<name sortKey="Roychowdhury, Debasish" sort="Roychowdhury, Debasish" uniqKey="Roychowdhury D" first="Debasish" last="Roychowdhury">Debasish Roychowdhury</name>
<name sortKey="Rubin, Stephen" sort="Rubin, Stephen" uniqKey="Rubin S" first="Stephen" last="Rubin">Stephen Rubin</name>
<name sortKey="Stein, Steven" sort="Stein, Steven" uniqKey="Stein S" first="Steven" last="Stein">Steven Stein</name>
</country>
<country name="Pologne"><noRegion><name sortKey="Pienkowski, Tadeusz" sort="Pienkowski, Tadeusz" uniqKey="Pienkowski T" first="Tadeusz" last="Pienkowski">Tadeusz Pienkowski</name>
</noRegion>
<name sortKey="Jagiello Gruszfeld, Agnieszka" sort="Jagiello Gruszfeld, Agnieszka" uniqKey="Jagiello Gruszfeld A" first="Agnieszka" last="Jagiello-Gruszfeld">Agnieszka Jagiello-Gruszfeld</name>
</country>
<country name="France"><region name="Occitanie (région administrative)"><name sortKey="Gilles Romieu, C" sort="Gilles Romieu, C" uniqKey="Gilles Romieu C" first="C." last="Gilles Romieu">C. Gilles Romieu</name>
</region>
<name sortKey="Campone, Mario" sort="Campone, Mario" uniqKey="Campone M" first="Mario" last="Campone">Mario Campone</name>
<name sortKey="Viens, Patrice" sort="Viens, Patrice" uniqKey="Viens P" first="Patrice" last="Viens">Patrice Viens</name>
</country>
<country name="Israël"><noRegion><name sortKey="Kaufman, Bella" sort="Kaufman, Bella" uniqKey="Kaufman B" first="Bella" last="Kaufman">Bella Kaufman</name>
</noRegion>
</country>
<country name="Irlande (pays)"><noRegion><name sortKey="Crown, John" sort="Crown, John" uniqKey="Crown J" first="John" last="Crown">John Crown</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="Russie"><region name="District fédéral central"><name sortKey="Gorbounova, Veira" sort="Gorbounova, Veira" uniqKey="Gorbounova V" first="Veira" last="Gorbounova">Veira Gorbounova</name>
</region>
</country>
<country name="Afrique du Sud"><noRegion><name sortKey="Raats, Johannes Isaac" sort="Raats, Johannes Isaac" uniqKey="Raats J" first="Johannes Isaac" last="Raats">Johannes Isaac Raats</name>
</noRegion>
</country>
<country name="Grèce"><region name="Attique (région)"><name sortKey="Skarlos, Dimosthenis" sort="Skarlos, Dimosthenis" uniqKey="Skarlos D" first="Dimosthenis" last="Skarlos">Dimosthenis Skarlos</name>
</region>
</country>
</tree>
</affiliations>
</record>
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