Randomized Phase II Trial of First-Line Trastuzumab Plus Docetaxel and Capecitabine Compared With Trastuzumab Plus Docetaxel in HER2-Positive Metastatic Breast Cancer
Identifieur interne : 007598 ( Main/Exploration ); précédent : 007597; suivant : 007599Randomized Phase II Trial of First-Line Trastuzumab Plus Docetaxel and Capecitabine Compared With Trastuzumab Plus Docetaxel in HER2-Positive Metastatic Breast Cancer
Auteurs : Andrew M. Wardley [Royaume-Uni, France, Mexique, Guatemala, Brésil, Costa Rica, Pologne, Suisse, Australie, Espagne] ; Xavier Pivot ; Flavia Morales-Vasquez ; Luis M. Zetina ; Maria De Fatima Dias Gaui ; Douglas Otero Reyes ; Jacek Jassem ; Claire Barton ; Peter Button ; Veronica Hersberger ; Antonio Anton TorresSource :
- Journal of clinical oncology [ 0732-183X ] ; 2010.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
Abstract
Purpose To evaluate trastuzumab (H) and docetaxel (T) with or without capecitabine (X) as first-line combination therapy for human epidermal growth factor receptor 2 (HER2) -positive advanced breast cancer. Patients and Methods Patients with HER2-positive locally advanced or metastatic breast cancer were randomly assigned to H (8 mg/kg loading; 6 mg/kg every 3 weeks) plus T (75 mg/m2 in HTX arm, 100 mg/m2 in HT arm, every 3 weeks) with or without X (950 mg/m2 twice per day on days 1 to 14 every 3 weeks). The primary end point was overall response rate (ORR). Results In 222 patients, median follow-up was approximately 24 months. ORR was high with both regimens (70.5% with HTX; 72.7% with HT; P = .717); complete response rate was 23.2% with HTX compared with 16.4% with HT. HTX demonstrated significantly longer progression-free survival: median 17.9 months compared with 12.8 months with HT (hazard ratio, 0.72; P = .045), which translates to a gain of around 5 months. Two-year survival probability was 75% with HTX compared with 66% with HT. Febrile neutropenia (27% v 15%) and grade 3/4 neutropenia (77% v 54%) incidences were higher with HT than HTX. Treatment-related grade 3 hand-foot syndrome (17% v < 1 %) and grade 3/4 diarrhea (11 % v 4%) occurred more commonly with HTX than HT. One case of congestive heart failure occurred in each arm. Conclusion HTX is an effective and feasible first-line therapy for HER2-positive locally advanced or metastatic breast cancer, although it should be reserved for patients with good performance status who are not receiving long-term steroids.
Affiliations:
- Australie, Brésil, Costa Rica, Espagne, France, Guatemala, Mexique, Pologne, Royaume-Uni, Suisse
- Angleterre, Bourgogne-Franche-Comté, Franche-Comté, Grand Manchester, État de Rio de Janeiro
- Besançon, Manchester, Rio de Janeiro
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Wardley</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>The Christie</s1><s2>Manchester</s2><s3>GBR</s3></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Manchester</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Manchester</region></placeName></affiliation><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>University Hospital of Besançon</s1><s2>Besançon</s2><s3>FRA</s3></inist:fA14><country>France</country><placeName><region type="region">Bourgogne-Franche-Comté</region><region type="old region">Franche-Comté</region><settlement type="city">Besançon</settlement></placeName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Instituto Nacional de Cancerología</s1><s2>Mexico City</s2><s3>MEX</s3></inist:fA14><country>Mexique</country><wicri:noRegion>Instituto Nacional de Cancerología</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Hospital Roosevelt</s1><s2>Guatemala City</s2><s3>GTM</s3></inist:fA14><country>Guatemala</country><wicri:noRegion>Hospital Roosevelt</wicri:noRegion></affiliation><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Instituto Nacional do Câncer</s1><s2>Rio de Janeiro</s2><s3>BRA</s3></inist:fA14><country>Brésil</country><placeName><settlement type="city">Rio de Janeiro</settlement><region type="state">État de Rio de Janeiro</region></placeName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Hospital Center for International Medicine Advanced</s1><s2>San José</s2><s3>CRI</s3></inist:fA14><country>Costa Rica</country><wicri:noRegion>Hospital Center for International Medicine Advanced</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Medical University of Gdansk</s1><s2>Gdansk</s2><s3>POL</s3></inist:fA14><country>Pologne</country><wicri:noRegion>Medical University of Gdansk</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>F. Hoffmann-La Roche Ltd</s1><s2>Basel</s2><s3>CHE</s3></inist:fA14><country>Suisse</country><wicri:noRegion>F. Hoffmann-La Roche Ltd</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Roche Products Pty Ltd</s1><s2>Dee Why, New South Wales</s2><s3>AUS</s3></inist:fA14><country>Australie</country><wicri:noRegion>Roche Products Pty Ltd</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Hospital Universitario Miguel Servet</s1><s2>Zaragoza</s2><s3>ESP</s3></inist:fA14><country>Espagne</country><wicri:noRegion>Hospital Universitario Miguel Servet</wicri:noRegion></affiliation></author><author><name sortKey="Pivot, Xavier" sort="Pivot, Xavier" uniqKey="Pivot X" first="Xavier" last="Pivot">Xavier Pivot</name></author><author><name sortKey="Morales Vasquez, Flavia" sort="Morales Vasquez, Flavia" uniqKey="Morales Vasquez F" first="Flavia" last="Morales-Vasquez">Flavia Morales-Vasquez</name></author><author><name sortKey="Zetina, Luis M" sort="Zetina, Luis M" uniqKey="Zetina L" first="Luis M." last="Zetina">Luis M. Zetina</name></author><author><name sortKey="Dias Gaui, Maria De Fatima" sort="Dias Gaui, Maria De Fatima" uniqKey="Dias Gaui M" first="Maria De Fatima" last="Dias Gaui">Maria De Fatima Dias Gaui</name></author><author><name sortKey="Otero Reyes, Douglas" sort="Otero Reyes, Douglas" uniqKey="Otero Reyes D" first="Douglas" last="Otero Reyes">Douglas Otero Reyes</name></author><author><name sortKey="Jassem, Jacek" sort="Jassem, Jacek" uniqKey="Jassem J" first="Jacek" last="Jassem">Jacek Jassem</name></author><author><name sortKey="Barton, Claire" sort="Barton, Claire" uniqKey="Barton C" first="Claire" last="Barton">Claire Barton</name></author><author><name sortKey="Button, Peter" sort="Button, Peter" uniqKey="Button P" first="Peter" last="Button">Peter Button</name></author><author><name sortKey="Hersberger, Veronica" sort="Hersberger, Veronica" uniqKey="Hersberger V" first="Veronica" last="Hersberger">Veronica Hersberger</name></author><author><name sortKey="Anton Torres, Antonio" sort="Anton Torres, Antonio" uniqKey="Anton Torres A" first="Antonio" last="Anton Torres">Antonio Anton Torres</name></author></analytic><series><title level="j" type="main">Journal of clinical oncology</title><title level="j" type="abbreviated">J. clin. oncol.</title><idno type="ISSN">0732-183X</idno><imprint><date when="2010">2010</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Journal of clinical oncology</title><title level="j" type="abbreviated">J. clin. oncol.</title><idno type="ISSN">0732-183X</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Advanced stage</term><term>Antineoplastic agent</term><term>Breast cancer</term><term>C-Onc gene</term><term>Cancerology</term><term>Capecitabine</term><term>Clinical trial</term><term>Comparative study</term><term>Docetaxel</term><term>First line treatment</term><term>Human Epidermal growth factor Receptor 2</term><term>Metastasis</term><term>Phase II trial</term><term>Prodrug</term><term>Protooncogene</term><term>Randomization</term><term>Trastuzumab</term><term>erbB2 Gene</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Essai clinique phase II</term><term>Essai clinique</term><term>Randomisation</term><term>Docétaxel</term><term>Trastuzumab</term><term>Etude comparative</term><term>Traitement de première intention</term><term>Gène onc cellulaire</term><term>Protooncogène</term><term>Capécitabine</term><term>Gène erbB2</term><term>Stade avancé</term><term>Métastase</term><term>Cancer du sein</term><term>Cancérologie</term><term>Anticancéreux</term><term>Promédicament</term><term>Récepteur HER2</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Purpose To evaluate trastuzumab (H) and docetaxel (T) with or without capecitabine (X) as first-line combination therapy for human epidermal growth factor receptor 2 (HER2) -positive advanced breast cancer. Patients and Methods Patients with HER2-positive locally advanced or metastatic breast cancer were randomly assigned to H (8 mg/kg loading; 6 mg/kg every 3 weeks) plus T (75 mg/m<sup>2</sup> in HTX arm, 100 mg/m<sup>2</sup> in HT arm, every 3 weeks) with or without X (950 mg/m<sup>2</sup> twice per day on days 1 to 14 every 3 weeks). The primary end point was overall response rate (ORR). Results In 222 patients, median follow-up was approximately 24 months. ORR was high with both regimens (70.5% with HTX; 72.7% with HT; P = .717); complete response rate was 23.2% with HTX compared with 16.4% with HT. HTX demonstrated significantly longer progression-free survival: median 17.9 months compared with 12.8 months with HT (hazard ratio, 0.72; P = .045), which translates to a gain of around 5 months. Two-year survival probability was 75% with HTX compared with 66% with HT. Febrile neutropenia (27% v 15%) and grade 3/4 neutropenia (77% v 54%) incidences were higher with HT than HTX. Treatment-related grade 3 hand-foot syndrome (17% v < 1 %) and grade 3/4 diarrhea (11 % v 4%) occurred more commonly with HTX than HT. One case of congestive heart failure occurred in each arm. Conclusion HTX is an effective and feasible first-line therapy for HER2-positive locally advanced or metastatic breast cancer, although it should be reserved for patients with good performance status who are not receiving long-term steroids.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Brésil</li><li>Costa Rica</li><li>Espagne</li><li>France</li><li>Guatemala</li><li>Mexique</li><li>Pologne</li><li>Royaume-Uni</li><li>Suisse</li></country><region><li>Angleterre</li><li>Bourgogne-Franche-Comté</li><li>Franche-Comté</li><li>Grand Manchester</li><li>État de Rio de Janeiro</li></region><settlement><li>Besançon</li><li>Manchester</li><li>Rio de Janeiro</li></settlement></list><tree><noCountry><name sortKey="Anton Torres, Antonio" sort="Anton Torres, Antonio" uniqKey="Anton Torres A" first="Antonio" last="Anton Torres">Antonio Anton Torres</name><name sortKey="Barton, Claire" sort="Barton, Claire" uniqKey="Barton C" first="Claire" last="Barton">Claire Barton</name><name sortKey="Button, Peter" sort="Button, Peter" uniqKey="Button P" first="Peter" last="Button">Peter Button</name><name sortKey="Dias Gaui, Maria De Fatima" sort="Dias Gaui, Maria De Fatima" uniqKey="Dias Gaui M" first="Maria De Fatima" last="Dias Gaui">Maria De Fatima Dias Gaui</name><name sortKey="Hersberger, Veronica" sort="Hersberger, Veronica" uniqKey="Hersberger V" first="Veronica" last="Hersberger">Veronica Hersberger</name><name sortKey="Jassem, Jacek" sort="Jassem, Jacek" uniqKey="Jassem J" first="Jacek" last="Jassem">Jacek Jassem</name><name sortKey="Morales Vasquez, Flavia" sort="Morales Vasquez, Flavia" uniqKey="Morales Vasquez F" first="Flavia" last="Morales-Vasquez">Flavia Morales-Vasquez</name><name sortKey="Otero Reyes, Douglas" sort="Otero Reyes, Douglas" uniqKey="Otero Reyes D" first="Douglas" last="Otero Reyes">Douglas Otero Reyes</name><name sortKey="Pivot, Xavier" sort="Pivot, Xavier" uniqKey="Pivot X" first="Xavier" last="Pivot">Xavier Pivot</name><name sortKey="Zetina, Luis M" sort="Zetina, Luis M" uniqKey="Zetina L" first="Luis M." last="Zetina">Luis M. Zetina</name></noCountry><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Wardley, Andrew M" sort="Wardley, Andrew M" uniqKey="Wardley A" first="Andrew M." last="Wardley">Andrew M. Wardley</name></region></country><country name="France"><region name="Bourgogne-Franche-Comté"><name sortKey="Wardley, Andrew M" sort="Wardley, Andrew M" uniqKey="Wardley A" first="Andrew M." last="Wardley">Andrew M. Wardley</name></region></country><country name="Mexique"><noRegion><name sortKey="Wardley, Andrew M" sort="Wardley, Andrew M" uniqKey="Wardley A" first="Andrew M." last="Wardley">Andrew M. Wardley</name></noRegion></country><country name="Guatemala"><noRegion><name sortKey="Wardley, Andrew M" sort="Wardley, Andrew M" uniqKey="Wardley A" first="Andrew M." last="Wardley">Andrew M. Wardley</name></noRegion></country><country name="Brésil"><region name="État de Rio de Janeiro"><name sortKey="Wardley, Andrew M" sort="Wardley, Andrew M" uniqKey="Wardley A" first="Andrew M." last="Wardley">Andrew M. Wardley</name></region></country><country name="Costa Rica"><noRegion><name sortKey="Wardley, Andrew M" sort="Wardley, Andrew M" uniqKey="Wardley A" first="Andrew M." last="Wardley">Andrew M. Wardley</name></noRegion></country><country name="Pologne"><noRegion><name sortKey="Wardley, Andrew M" sort="Wardley, Andrew M" uniqKey="Wardley A" first="Andrew M." last="Wardley">Andrew M. Wardley</name></noRegion></country><country name="Suisse"><noRegion><name sortKey="Wardley, Andrew M" sort="Wardley, Andrew M" uniqKey="Wardley A" first="Andrew M." last="Wardley">Andrew M. Wardley</name></noRegion></country><country name="Australie"><noRegion><name sortKey="Wardley, Andrew M" sort="Wardley, Andrew M" uniqKey="Wardley A" first="Andrew M." last="Wardley">Andrew M. Wardley</name></noRegion></country><country name="Espagne"><noRegion><name sortKey="Wardley, Andrew M" sort="Wardley, Andrew M" uniqKey="Wardley A" first="Andrew M." last="Wardley">Andrew M. Wardley</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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