Lapatinib Plus Capecitabine in Women with HER-2–Positive Advanced Breast Cancer: Final Survival Analysis of a Phase III Randomized Trial
Identifieur interne : 003D22 ( Ncbi/Merge ); précédent : 003D21; suivant : 003D23Lapatinib Plus Capecitabine in Women with HER-2–Positive Advanced Breast Cancer: Final Survival Analysis of a Phase III Randomized Trial
Auteurs : David Cameron [Royaume-Uni] ; Michelle Casey [États-Unis] ; Cristina Oliva [Royaume-Uni] ; Beth Newstat [États-Unis] ; Bradley Imwalle [États-Unis] ; Charles E. Geyer [États-Unis]Source :
- The Oncologist [ 1083-7159 ] ; 2010.
Abstract
The article presents final analyses of overall survival from a phase III trial of lapatinib and capecitabine in patients with human epidermal growth factor receptor 2–positive locally advanced or metastatic breast cancer that progressed following prior therapy including trastuzumab.
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DOI: 10.1634/theoncologist.2009-0181
PubMed: 20736298
PubMed Central: 3228041
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Geyer</name><affiliation wicri:level="2"><nlm:aff id="aff5">Department of Human Oncology, Allegheny General Hospital, Pittsburgh, Pennsylvania, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Human Oncology, Allegheny General Hospital, Pittsburgh, Pennsylvania</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author></analytic><series><title level="j">The Oncologist</title><idno type="ISSN">1083-7159</idno><idno type="eISSN">1549-490X</idno><imprint><date when="2010">2010</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>The article presents final analyses of overall survival from a phase III trial of lapatinib and capecitabine in patients with human epidermal growth factor receptor 2–positive locally advanced or metastatic breast cancer that progressed following prior therapy including trastuzumab.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Moy, B" uniqKey="Moy B">B Moy</name></author><author><name sortKey="Goss, Pe" uniqKey="Goss P">PE Goss</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Joensuu, H" uniqKey="Joensuu H">H Joensuu</name></author><author><name sortKey="Kellokumpu Lehtinen, P L" uniqKey="Kellokumpu Lehtinen P">P-L Kellokumpu-Lehtinen</name></author><author><name sortKey="Bono, P" uniqKey="Bono P">P Bono</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Piccart Gebhart, Mj" uniqKey="Piccart Gebhart M">MJ Piccart-Gebhart</name></author><author><name sortKey="Procter, M" uniqKey="Procter M">M Procter</name></author><author><name sortKey="Leyland Jones, B" uniqKey="Leyland Jones B">B Leyland-Jones</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Romond, Eh" uniqKey="Romond E">EH Romond</name></author><author><name sortKey="Perez, Ea" uniqKey="Perez E">EA Perez</name></author><author><name sortKey="Bryant, J" uniqKey="Bryant J">J Bryant</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Slamon, D" uniqKey="Slamon D">D Slamon</name></author><author><name sortKey="Eiermann, W" uniqKey="Eiermann W">W Eiermann</name></author><author><name sortKey="Robert, N" uniqKey="Robert N">N Robert</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Slamon, Dj" uniqKey="Slamon D">DJ Slamon</name></author><author><name sortKey="Leyland Jones, B" uniqKey="Leyland Jones B">B Leyland-Jones</name></author><author><name sortKey="Shak, S" uniqKey="Shak S">S Shak</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Nahta, R" uniqKey="Nahta R">R Nahta</name></author><author><name sortKey="Esteva, Fj" uniqKey="Esteva F">FJ Esteva</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Rusnak, Dw" uniqKey="Rusnak D">DW Rusnak</name></author><author><name sortKey="Lackey, K" uniqKey="Lackey K">K Lackey</name></author><author><name sortKey="Affleck, K" uniqKey="Affleck K">K Affleck</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Geyer, Ce" uniqKey="Geyer C">CE Geyer</name></author><author><name sortKey="Forster, J" uniqKey="Forster J">J Forster</name></author><author><name sortKey="Lindquist, D" uniqKey="Lindquist D">D Lindquist</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Cameron, D" uniqKey="Cameron D">D Cameron</name></author><author><name sortKey="Casey, M" uniqKey="Casey M">M Casey</name></author><author><name sortKey="Press, M" uniqKey="Press M">M Press</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Therasse, P" uniqKey="Therasse P">P Therasse</name></author><author><name sortKey="Arbuck, Sg" uniqKey="Arbuck S">SG Arbuck</name></author><author><name sortKey="Eisenhauer, Ea" uniqKey="Eisenhauer E">EA Eisenhauer</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Henderson, Ic" uniqKey="Henderson I">IC Henderson</name></author><author><name sortKey="Patek, Aj" uniqKey="Patek A">AJ Patek</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Di Leo, A" uniqKey="Di Leo A">A Di Leo</name></author><author><name sortKey="Gomez, Hl" uniqKey="Gomez H">HL Gomez</name></author><author><name sortKey="Aziz, Z" uniqKey="Aziz Z">Z Aziz</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Johnston, S" uniqKey="Johnston S">S Johnston</name></author><author><name sortKey="Pippen, J" uniqKey="Pippen J">J Pippen</name></author><author><name sortKey="Pivot, X" uniqKey="Pivot X">X Pivot</name></author></analytic></biblStruct></listBibl></div1></back></TEI><pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Oncologist</journal-id><journal-id journal-id-type="iso-abbrev">Oncologist</journal-id><journal-id journal-id-type="pmc">oncologist</journal-id><journal-id journal-id-type="hwp">theoncologist</journal-id><journal-id journal-id-type="publisher-id">The Oncologist</journal-id><journal-title-group><journal-title>The Oncologist</journal-title></journal-title-group><issn pub-type="ppub">1083-7159</issn><issn pub-type="epub">1549-490X</issn><publisher><publisher-name>AlphaMed Press</publisher-name><publisher-loc>Durham, NC, USA</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">20736298</article-id><article-id pub-id-type="pmc">3228041</article-id><article-id pub-id-type="publisher-id">3630615</article-id><article-id pub-id-type="doi">10.1634/theoncologist.2009-0181</article-id><article-categories><subj-group subj-group-type="heading"><subject>Academia–Pharma Intersect</subject><subj-group><subject>Breast Cancer</subject></subj-group></subj-group></article-categories><title-group><article-title>Lapatinib Plus Capecitabine in Women with HER-2–Positive Advanced Breast Cancer: Final Survival Analysis of a Phase III Randomized Trial</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Cameron</surname><given-names>David</given-names></name><xref ref-type="aff" rid="aff1"><sup>a</sup></xref></contrib><contrib contrib-type="author"><name><surname>Casey</surname><given-names>Michelle</given-names></name><xref ref-type="aff" rid="aff2"><sup>b</sup></xref></contrib><contrib contrib-type="author"><name><surname>Oliva</surname><given-names>Cristina</given-names></name><xref ref-type="aff" rid="aff3"><sup>c</sup></xref></contrib><contrib contrib-type="author"><name><surname>Newstat</surname><given-names>Beth</given-names></name><xref ref-type="aff" rid="aff2"><sup>b</sup></xref></contrib><contrib contrib-type="author"><name><surname>Imwalle</surname><given-names>Bradley</given-names></name><xref ref-type="aff" rid="aff4"><sup>d</sup></xref></contrib><contrib contrib-type="author"><name><surname>Geyer</surname><given-names>Charles E.</given-names></name><xref ref-type="aff" rid="aff5"><sup>e</sup></xref></contrib><aff id="aff1"><sup>a</sup>University of Leeds, Leeds, United Kingdom;</aff><aff id="aff2"><sup>b</sup>GlaxoSmithKline, Collegeville, Pennsylvania, USA;</aff><aff id="aff3"><sup>c</sup>Takeda Pharmaceutical Company, Limited, London, United Kingdom;</aff><aff id="aff4"><sup>d</sup>Health Learning Systems, Parsippany, New Jersey, USA;</aff><aff id="aff5"><sup>e</sup>Department of Human Oncology, Allegheny General Hospital, Pittsburgh, Pennsylvania, USA</aff></contrib-group><author-notes><corresp>Correspondence: David Cameron, M.D., University of Edinburgh, Edinburgh Cancer Research Centre, Edinburgh, Scotland EH4 1XU, UK. Telephone:
<phone>44-0-131-777-3538</phone>; Fax:
<fax>44-0-131-777-3520</fax>; e-mail: <email>d.cameron@ed.ac.uk</email></corresp><fn fn-type="conflict"><p><bold>Disclosures: David Cameron:</bold><italic>Consultant/advisory role:</italic> GlaxoSmithKline, Roche; <bold>Michelle Casey:</bold><italic>Employment/leadership position:</italic> GlaxoSmithKline; <italic>Ownership interest:</italic> GlaxoSmithKline; <bold>Cristina Oliva:</bold><italic>Employment/leadership position:</italic> Takeda, GlaxoSmithKline; <italic>Ownership interest:</italic> GlaxoSmithKline; <bold>Beth Newstat:</bold><italic>Employment/leadership position:</italic> GlaxoSmithKline; <italic>Ownership interest:</italic> GlaxoSmithKline; <bold>Bradley Imwalle:</bold> None; <bold>Charles E. Geyer:</bold> None.</p><p>The content of this article has been reviewed by independent peer reviewers to ensure that it is balanced, objective, and free from commercial bias. No financial relationships relevant to the content of this article have been disclosed by the independent peer reviewers.</p></fn></author-notes><pub-date pub-type="ppub"><month>9</month><year>2010</year></pub-date><pub-date pub-type="epub"><day>24</day><month>8</month><year>2010</year></pub-date><volume>15</volume><issue>9</issue><fpage>924</fpage><lpage>934</lpage><history><date date-type="received"><day>10</day><month>8</month><year>2009</year></date><date date-type="accepted"><day>13</day><month>7</month><year>2010</year></date></history><permissions><copyright-statement>©AlphaMed Press</copyright-statement><copyright-year>2010</copyright-year><license license-type="open-access"><license-p>available online without subscription through the open access option.</license-p></license></permissions><self-uri xlink:title="pdf" xlink:type="simple" xlink:href="onc00910000924.pdf"></self-uri><abstract abstract-type="precis"><p>The article presents final analyses of overall survival from a phase III trial of lapatinib and capecitabine in patients with human epidermal growth factor receptor 2–positive locally advanced or metastatic breast cancer that progressed following prior therapy including trastuzumab.</p></abstract><abstract><sec><title>Objectives.</title><p>A planned interim analysis of study EGF100151 prompted early termination of enrollment based on a longer time to progression with lapatinib and capecitabine than with capecitabine alone in patients with human epidermal growth factor receptor (HER)-2<sup>+</sup> previously treated advanced breast cancer or metastatic breast cancer (MBC). Here, we report final analyses of overall survival.</p></sec><sec><title>Patients and Methods.</title><p>Women with HER-2<sup>+</sup> MBC who progressed after regimens that included, but were not limited to, anthracyclines, taxanes, and trastuzumab, were randomized to lapatinib (1,250 mg/day) plus capecitabine (2,000 mg/m<sup>2</sup>) or capecitabine monotherapy (2,500 mg/m<sup>2</sup>) on days 1–14 of a 21-day cycle.</p></sec><sec><title>Results.</title><p>At enrollment termination, 399 patients were randomized, and nine were being screened and were offered combination treatment. In total, 207 and 201 patients were enrolled to combination therapy and monotherapy, respectively. Thirty-six patients receiving monotherapy crossed over to combination therapy following enrollment termination. The median overall survival times were 75.0 weeks for the combination arm and 64.7 weeks for the monotherapy arm (hazard ratio [HR], 0.87; 95% confidence interval [CI], 0.71–1.08; <italic>p</italic> = .210). A Cox regression analysis considering crossover as a time-dependent covariate suggested a 20% lower risk for death for patients treated with combination therapy (HR, 0.80; 95% CI, 0.64–0.99; <italic>p</italic> = .043). The low incidence of serious adverse events was consistent with previously reported rates.</p></sec><sec><title>Conclusions.</title><p>Although premature enrollment termination and subsequent crossover resulted in insufficient power to detect differences in overall survival, exploratory analyses demonstrate a trend toward a survival advantage with lapatinib plus capecitabine. These data continue to support the efficacy of lapatinib in patients with HER-2<sup>+</sup> MBC.</p></sec></abstract><kwd-group><kwd>Breast cancer</kwd><kwd>Lapatinib</kwd><kwd>Metastatic</kwd><kwd>Capecitabine</kwd><kwd>Survival</kwd><kwd>HER-2</kwd></kwd-group></article-meta></front></pmc><affiliations><list><country><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Grand Londres</li><li>New Jersey</li><li>Pennsylvanie</li><li>Yorkshire-et-Humber</li></region><settlement><li>Leeds</li><li>Londres</li></settlement><orgName><li>Université de Leeds</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="Oliva, Cristina" sort="Oliva, Cristina" uniqKey="Oliva C" first="Cristina" last="Oliva">Cristina Oliva</name></country><country name="États-Unis"><region name="Pennsylvanie"><name sortKey="Casey, Michelle" sort="Casey, Michelle" uniqKey="Casey M" first="Michelle" last="Casey">Michelle Casey</name></region><name sortKey="Geyer, Charles E" sort="Geyer, Charles E" uniqKey="Geyer C" first="Charles E." last="Geyer">Charles E. Geyer</name><name sortKey="Imwalle, Bradley" sort="Imwalle, Bradley" uniqKey="Imwalle B" first="Bradley" last="Imwalle">Bradley Imwalle</name><name sortKey="Newstat, Beth" sort="Newstat, Beth" uniqKey="Newstat B" first="Beth" last="Newstat">Beth Newstat</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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