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 : 003043 ( PascalFrancis/Corpus ); précédent : 003042; suivant : 003044A 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 ; Michelle Casey ; Michael Press ; Deborah Lindquist ; Tadeusz Pienkowski ; C. Gilles Romieu ; Stephen Chan ; Agnieszka Jagiello-Gruszfeld ; Bella Kaufman ; John Crown ; Arlene Chan ; Mario Campone ; Patrice Viens ; Neville Davidson ; Veira Gorbounova ; Johannes Isaac Raats ; Dimosthenis Skarlos ; Beth Newstat ; Debasish Roychowdhury ; Paolo Paoletti ; Cristina Oliva ; Stephen Rubin ; Steven Stein ; Charles E. GeyerSource :
- Breast cancer research and treatment [ 0167-6806 ] ; 2008.
Descripteurs français
- Pascal (Inist)
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.
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NO : | PASCAL 09-0067549 INIST |
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ET : | 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 |
AU : | CAMERON (David); CASEY (Michelle); PRESS (Michael); LINDQUIST (Deborah); PIENKOWSKI (Tadeusz); GILLES ROMIEU (C.); CHAN (Stephen); JAGIELLO-GRUSZFELD (Agnieszka); KAUFMAN (Bella); CROWN (John); CHAN (Arlene); CAMPONE (Mario); VIENS (Patrice); DAVIDSON (Neville); GORBOUNOVA (Veira); RAATS (Johannes Isaac); SKARLOS (Dimosthenis); NEWSTAT (Beth); ROYCHOWDHURY (Debasish); PAOLETTI (Paolo); OLIVA (Cristina); RUBIN (Stephen); STEIN (Steven); GEYER (Charles E.) |
AF : | University of Leeds/Leeds/Royaume-Uni (1 aut.); GlaxoSmithKline/Collegeville, PA/Etats-Unis (2 aut., 18 aut., 20 aut., 21 aut., 22 aut., 23 aut.); Norris Comprehensive Cancer Center, University of Southern California/Los Angeles, CA/Etats-Unis (3 aut., 19 aut.); US Oncology/Houston, TX/Etats-Unis (4 aut.); Breast Cancer and Reconstruction Surgery Department, Centrum Onkologii Klinika Nowotworów Piersi i Chirurgii/Warsaw/Pologne (5 aut.); Département Oncologie, CRLCC Val d'Aurelle/Montpellier/France (6 aut.); Department of Clinical Oncology, Nottingham University Hospitals/Nottingham/Royaume-Uni (7 aut.); Chemotherapy Department, ZOZ MSWiA/Olsztyn/Pologne (8 aut.); Oncology Division, Chaim Sheba Medical Center/Tel-Hashomer/Israël (9 aut.); Irish Clinical Oncology Research Group/Dublin/Irlande (10 aut.); Mount Medical Centre, Mount Hospital/Perth/Australie (11 aut.); Oncology Department, Centre René Gauducheau/Gauducheau, Saint Herblain/France (12 aut.); Institut Paoli Calmette, Université de la Méditerranée/Marseille/France (13 aut.); Broomfield Hospital/Chelmsford/Royaume-Uni (14 aut.); Russian National Cancer Research Center/Moscow/Russie (15 aut.); Panorama Medical Center/Cape Town/Afrique du Sud (16 aut.); 2nd Medical Oncology Department of Errikos Dunan Hospital, Errikos Dynan Hospital-B/Athens/Grèce (17 aut.); Department of Human Oncology, Allegheny General Hospital/Pittsburgh, PA/Etats-Unis (24 aut.) |
DT : | Publication en série; Niveau analytique |
SO : | Breast cancer research and treatment; ISSN 0167-6806; Coden BCTRD6; Pays-Bas; Da. 2008; Vol. 112; No. 3; Pp. 533-543; Bibl. 19 ref. |
LA : | Anglais |
EA : | 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. |
CC : | 002B20E02; 002B02R02 |
FD : | Randomisation; Etude comparative; Lapatinib; Capécitabine; Association médicamenteuse; Adulte; Femme; Stade avancé; Cancer du sein; Trastuzumab; Efficacité traitement; Marqueur biologique; Métastase; Inhibiteur de la tyrosine kinase; Protooncogène; Gène erbB2; Anticancéreux; Promédicament |
FG : | Homme; Dérivé de la fluoropyrimidine; Pyrimidine nucléoside; Tumeur maligne; Cancer; Pathologie de la glande mammaire; Pathologie du sein; Anticorps monoclonal; Anti-HER2 |
ED : | Randomization; Comparative study; Lapatinib; Capecitabine; Drug combination; Adult; Woman; Advanced stage; Breast cancer; Trastuzumab; Treatment efficiency; Biological marker; Metastasis; Tyrosine kinase inhibitor; Protooncogene; erbB2 Gene; Antineoplastic agent; Prodrug |
EG : | Human; Fluoropyrimidine derivatives; Pyrimidine nucleoside; Malignant tumor; Cancer; Mammary gland diseases; Breast disease; Monoclonal antibody |
SD : | Aleatorización; Estudio comparativo; Lapatinib; Capecitabina; Asociación medicamentosa; Adulto; Mujer; Estadio avanzado; Cáncer del pecho; Trastuzumab; Eficacia tratamiento; Marcador biológico; Metástasis; Inhibidor tyrosine kinase; Protooncogen; Gen erbB2; Anticanceroso; Promedicamento |
LO : | INIST-20699.354000184023480140 |
ID : | 09-0067549 |
Links to Exploration step
Pascal:09-0067549Le document en format XML
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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="Newstat, Beth" sort="Newstat, Beth" uniqKey="Newstat B" first="Beth" last="Newstat">Beth Newstat</name>
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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>
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<s3>USA</s3>
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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>
<author><name sortKey="Cameron, David" sort="Cameron, David" uniqKey="Cameron D" first="David" last="Cameron">David Cameron</name>
<affiliation><inist:fA14 i1="01"><s1>University of Leeds</s1>
<s2>Leeds</s2>
<s3>GBR</s3>
<sZ>1 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Casey, Michelle" sort="Casey, Michelle" uniqKey="Casey M" first="Michelle" last="Casey">Michelle Casey</name>
<affiliation><inist:fA14 i1="02"><s1>GlaxoSmithKline</s1>
<s2>Collegeville, PA</s2>
<s3>USA</s3>
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<sZ>18 aut.</sZ>
<sZ>20 aut.</sZ>
<sZ>21 aut.</sZ>
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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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<s2>Los Angeles, CA</s2>
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<sZ>3 aut.</sZ>
<sZ>19 aut.</sZ>
</inist:fA14>
</affiliation>
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<author><name sortKey="Lindquist, Deborah" sort="Lindquist, Deborah" uniqKey="Lindquist D" first="Deborah" last="Lindquist">Deborah Lindquist</name>
<affiliation><inist:fA14 i1="04"><s1>US Oncology</s1>
<s2>Houston, TX</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Pienkowski, Tadeusz" sort="Pienkowski, Tadeusz" uniqKey="Pienkowski T" first="Tadeusz" last="Pienkowski">Tadeusz Pienkowski</name>
<affiliation><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>
</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><inist:fA14 i1="06"><s1>Département Oncologie, CRLCC Val d'Aurelle</s1>
<s2>Montpellier</s2>
<s3>FRA</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Chan, Stephen" sort="Chan, Stephen" uniqKey="Chan S" first="Stephen" last="Chan">Stephen Chan</name>
<affiliation><inist:fA14 i1="07"><s1>Department of Clinical Oncology, Nottingham University Hospitals</s1>
<s2>Nottingham</s2>
<s3>GBR</s3>
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</inist:fA14>
</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><inist:fA14 i1="08"><s1>Chemotherapy Department, ZOZ MSWiA</s1>
<s2>Olsztyn</s2>
<s3>POL</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Kaufman, Bella" sort="Kaufman, Bella" uniqKey="Kaufman B" first="Bella" last="Kaufman">Bella Kaufman</name>
<affiliation><inist:fA14 i1="09"><s1>Oncology Division, Chaim Sheba Medical Center</s1>
<s2>Tel-Hashomer</s2>
<s3>ISR</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Crown, John" sort="Crown, John" uniqKey="Crown J" first="John" last="Crown">John Crown</name>
<affiliation><inist:fA14 i1="10"><s1>Irish Clinical Oncology Research Group</s1>
<s2>Dublin</s2>
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<sZ>10 aut.</sZ>
</inist:fA14>
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</author>
<author><name sortKey="Chan, Arlene" sort="Chan, Arlene" uniqKey="Chan A" first="Arlene" last="Chan">Arlene Chan</name>
<affiliation><inist:fA14 i1="11"><s1>Mount Medical Centre, Mount Hospital</s1>
<s2>Perth</s2>
<s3>AUS</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Campone, Mario" sort="Campone, Mario" uniqKey="Campone M" first="Mario" last="Campone">Mario Campone</name>
<affiliation><inist:fA14 i1="12"><s1>Oncology Department, Centre René Gauducheau</s1>
<s2>Gauducheau, Saint Herblain</s2>
<s3>FRA</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
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</author>
<author><name sortKey="Viens, Patrice" sort="Viens, Patrice" uniqKey="Viens P" first="Patrice" last="Viens">Patrice Viens</name>
<affiliation><inist:fA14 i1="13"><s1>Institut Paoli Calmette, Université de la Méditerranée</s1>
<s2>Marseille</s2>
<s3>FRA</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
</affiliation>
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<author><name sortKey="Davidson, Neville" sort="Davidson, Neville" uniqKey="Davidson N" first="Neville" last="Davidson">Neville Davidson</name>
<affiliation><inist:fA14 i1="14"><s1>Broomfield Hospital</s1>
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<s3>GBR</s3>
<sZ>14 aut.</sZ>
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</affiliation>
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<author><name sortKey="Gorbounova, Veira" sort="Gorbounova, Veira" uniqKey="Gorbounova V" first="Veira" last="Gorbounova">Veira Gorbounova</name>
<affiliation><inist:fA14 i1="15"><s1>Russian National Cancer Research Center</s1>
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<s3>RUS</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
</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><inist:fA14 i1="16"><s1>Panorama Medical Center</s1>
<s2>Cape Town</s2>
<s3>ZAF</s3>
<sZ>16 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Skarlos, Dimosthenis" sort="Skarlos, Dimosthenis" uniqKey="Skarlos D" first="Dimosthenis" last="Skarlos">Dimosthenis Skarlos</name>
<affiliation><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>
</affiliation>
</author>
<author><name sortKey="Newstat, Beth" sort="Newstat, Beth" uniqKey="Newstat B" first="Beth" last="Newstat">Beth Newstat</name>
<affiliation><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>
</affiliation>
</author>
<author><name sortKey="Roychowdhury, Debasish" sort="Roychowdhury, Debasish" uniqKey="Roychowdhury D" first="Debasish" last="Roychowdhury">Debasish Roychowdhury</name>
<affiliation><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>
</affiliation>
</author>
<author><name sortKey="Paoletti, Paolo" sort="Paoletti, Paolo" uniqKey="Paoletti P" first="Paolo" last="Paoletti">Paolo Paoletti</name>
<affiliation><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>
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</affiliation>
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<author><name sortKey="Oliva, Cristina" sort="Oliva, Cristina" uniqKey="Oliva C" first="Cristina" last="Oliva">Cristina Oliva</name>
<affiliation><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>
</affiliation>
</author>
<author><name sortKey="Rubin, Stephen" sort="Rubin, Stephen" uniqKey="Rubin S" first="Stephen" last="Rubin">Stephen Rubin</name>
<affiliation><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>
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</affiliation>
</author>
<author><name sortKey="Stein, Steven" sort="Stein, Steven" uniqKey="Stein S" first="Steven" last="Stein">Steven Stein</name>
<affiliation><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>
</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><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>
</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>
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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>
</TEI>
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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>
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<fA11 i1="01" i2="1"><s1>CAMERON (David)</s1>
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<fA11 i1="16" i2="1"><s1>RAATS (Johannes Isaac)</s1>
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<fA11 i1="17" i2="1"><s1>SKARLOS (Dimosthenis)</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="23" i2="1"><s1>STEIN (Steven)</s1>
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<fA11 i1="24" i2="1"><s1>GEYER (Charles E.)</s1>
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<sZ>20 aut.</sZ>
<sZ>21 aut.</sZ>
<sZ>22 aut.</sZ>
<sZ>23 aut.</sZ>
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<fA14 i1="03"><s1>Norris Comprehensive Cancer Center, University of Southern California</s1>
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<sZ>19 aut.</sZ>
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<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>
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<s3>POL</s3>
<sZ>5 aut.</sZ>
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<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>
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<sZ>24 aut.</sZ>
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<fA47 i1="01" i2="1"><s0>09-0067549</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>
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<fC02 i1="01" i2="X"><s0>002B20E02</s0>
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<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>
<server><NO>PASCAL 09-0067549 INIST</NO>
<ET>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</ET>
<AU>CAMERON (David); CASEY (Michelle); PRESS (Michael); LINDQUIST (Deborah); PIENKOWSKI (Tadeusz); GILLES ROMIEU (C.); CHAN (Stephen); JAGIELLO-GRUSZFELD (Agnieszka); KAUFMAN (Bella); CROWN (John); CHAN (Arlene); CAMPONE (Mario); VIENS (Patrice); DAVIDSON (Neville); GORBOUNOVA (Veira); RAATS (Johannes Isaac); SKARLOS (Dimosthenis); NEWSTAT (Beth); ROYCHOWDHURY (Debasish); PAOLETTI (Paolo); OLIVA (Cristina); RUBIN (Stephen); STEIN (Steven); GEYER (Charles E.)</AU>
<AF>University of Leeds/Leeds/Royaume-Uni (1 aut.); GlaxoSmithKline/Collegeville, PA/Etats-Unis (2 aut., 18 aut., 20 aut., 21 aut., 22 aut., 23 aut.); Norris Comprehensive Cancer Center, University of Southern California/Los Angeles, CA/Etats-Unis (3 aut., 19 aut.); US Oncology/Houston, TX/Etats-Unis (4 aut.); Breast Cancer and Reconstruction Surgery Department, Centrum Onkologii Klinika Nowotworów Piersi i Chirurgii/Warsaw/Pologne (5 aut.); Département Oncologie, CRLCC Val d'Aurelle/Montpellier/France (6 aut.); Department of Clinical Oncology, Nottingham University Hospitals/Nottingham/Royaume-Uni (7 aut.); Chemotherapy Department, ZOZ MSWiA/Olsztyn/Pologne (8 aut.); Oncology Division, Chaim Sheba Medical Center/Tel-Hashomer/Israël (9 aut.); Irish Clinical Oncology Research Group/Dublin/Irlande (10 aut.); Mount Medical Centre, Mount Hospital/Perth/Australie (11 aut.); Oncology Department, Centre René Gauducheau/Gauducheau, Saint Herblain/France (12 aut.); Institut Paoli Calmette, Université de la Méditerranée/Marseille/France (13 aut.); Broomfield Hospital/Chelmsford/Royaume-Uni (14 aut.); Russian National Cancer Research Center/Moscow/Russie (15 aut.); Panorama Medical Center/Cape Town/Afrique du Sud (16 aut.); 2nd Medical Oncology Department of Errikos Dunan Hospital, Errikos Dynan Hospital-B/Athens/Grèce (17 aut.); Department of Human Oncology, Allegheny General Hospital/Pittsburgh, PA/Etats-Unis (24 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Breast cancer research and treatment; ISSN 0167-6806; Coden BCTRD6; Pays-Bas; Da. 2008; Vol. 112; No. 3; Pp. 533-543; Bibl. 19 ref.</SO>
<LA>Anglais</LA>
<EA>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.</EA>
<CC>002B20E02; 002B02R02</CC>
<FD>Randomisation; Etude comparative; Lapatinib; Capécitabine; Association médicamenteuse; Adulte; Femme; Stade avancé; Cancer du sein; Trastuzumab; Efficacité traitement; Marqueur biologique; Métastase; Inhibiteur de la tyrosine kinase; Protooncogène; Gène erbB2; Anticancéreux; Promédicament</FD>
<FG>Homme; Dérivé de la fluoropyrimidine; Pyrimidine nucléoside; Tumeur maligne; Cancer; Pathologie de la glande mammaire; Pathologie du sein; Anticorps monoclonal; Anti-HER2</FG>
<ED>Randomization; Comparative study; Lapatinib; Capecitabine; Drug combination; Adult; Woman; Advanced stage; Breast cancer; Trastuzumab; Treatment efficiency; Biological marker; Metastasis; Tyrosine kinase inhibitor; Protooncogene; erbB2 Gene; Antineoplastic agent; Prodrug</ED>
<EG>Human; Fluoropyrimidine derivatives; Pyrimidine nucleoside; Malignant tumor; Cancer; Mammary gland diseases; Breast disease; Monoclonal antibody</EG>
<SD>Aleatorización; Estudio comparativo; Lapatinib; Capecitabina; Asociación medicamentosa; Adulto; Mujer; Estadio avanzado; Cáncer del pecho; Trastuzumab; Eficacia tratamiento; Marcador biológico; Metástasis; Inhibidor tyrosine kinase; Protooncogen; Gen erbB2; Anticanceroso; Promedicamento</SD>
<LO>INIST-20699.354000184023480140</LO>
<ID>09-0067549</ID>
</server>
</inist>
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