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Extended Benefit from Sequential Administration of Docetaxel after Standard Fluorouracil, Epirubicin, and Cyclophosphamide Regimen for Node-Positive Breast Cancer: The 8-Year Follow-Up Results of the UNICANCER-PACS01 Trial

Identifieur interne : 000193 ( Pmc/Corpus ); précédent : 000192; suivant : 000194

Extended Benefit from Sequential Administration of Docetaxel after Standard Fluorouracil, Epirubicin, and Cyclophosphamide Regimen for Node-Positive Breast Cancer: The 8-Year Follow-Up Results of the UNICANCER-PACS01 Trial

Auteurs : Bruno Coudert ; Bernard Asselain ; Mario Campone ; Marc Spielmann ; Jean-Pascal Machiels ; Frédérique Pénault-Llorca ; Daniel Serin ; Christelle Lévy ; Gilles Romieu ; Jean-Luc Canon ; Hubert Orfeuvre ; Gilles Piot ; Thierry Petit ; Guy Jerusalem ; Bruno Audhuy ; Corinne Veyret ; Marc Beauduin ; Jean-Christophe Eymard ; Anne-Laure Martin ; Henri Roché

Source :

RBID : PMC:3399644

Abstract

The initial report from the PACS01 trial demonstrated a benefit at 5 years for disease-free survival and overall survival rates with the sequential administration of docetaxel after fluorouracil, epirubicin, and cyclophosphamide for patients with node-positive, operable breast cancer. This article evaluates the impact of this regimen at 8 years.


Url:
DOI: 10.1634/theoncologist.2011-0442
PubMed: 22610153
PubMed Central: 3399644

Links to Exploration step

PMC:3399644

Le document en format XML

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<name sortKey="Machiels, Jean Pascal" sort="Machiels, Jean Pascal" uniqKey="Machiels J" first="Jean-Pascal" last="Machiels">Jean-Pascal Machiels</name>
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<name sortKey="Penault Llorca, Frederique" sort="Penault Llorca, Frederique" uniqKey="Penault Llorca F" first="Frédérique" last="Pénault-Llorca">Frédérique Pénault-Llorca</name>
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<name sortKey="Serin, Daniel" sort="Serin, Daniel" uniqKey="Serin D" first="Daniel" last="Serin">Daniel Serin</name>
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<name sortKey="Canon, Jean Luc" sort="Canon, Jean Luc" uniqKey="Canon J" first="Jean-Luc" last="Canon">Jean-Luc Canon</name>
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<name sortKey="Orfeuvre, Hubert" sort="Orfeuvre, Hubert" uniqKey="Orfeuvre H" first="Hubert" last="Orfeuvre">Hubert Orfeuvre</name>
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<nlm:aff id="aff11">Medical Oncology, Centre Hospitalier Fleyriat, Bourg-en-Bresse, France;</nlm:aff>
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<name sortKey="Piot, Gilles" sort="Piot, Gilles" uniqKey="Piot G" first="Gilles" last="Piot">Gilles Piot</name>
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<name sortKey="Petit, Thierry" sort="Petit, Thierry" uniqKey="Petit T" first="Thierry" last="Petit">Thierry Petit</name>
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<name sortKey="Jerusalem, Guy" sort="Jerusalem, Guy" uniqKey="Jerusalem G" first="Guy" last="Jerusalem">Guy Jerusalem</name>
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<nlm:aff id="aff14">Medical Oncology, Centre Hospitalo-Universitaire Sart-Tilman, Liège, Belgium;</nlm:aff>
</affiliation>
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<name sortKey="Audhuy, Bruno" sort="Audhuy, Bruno" uniqKey="Audhuy B" first="Bruno" last="Audhuy">Bruno Audhuy</name>
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<nlm:aff id="aff15">Medical Oncology, Centre Hospitalier, Colmar, France;</nlm:aff>
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<name sortKey="Veyret, Corinne" sort="Veyret, Corinne" uniqKey="Veyret C" first="Corinne" last="Veyret">Corinne Veyret</name>
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<name sortKey="Beauduin, Marc" sort="Beauduin, Marc" uniqKey="Beauduin M" first="Marc" last="Beauduin">Marc Beauduin</name>
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<name sortKey="Eymard, Jean Christophe" sort="Eymard, Jean Christophe" uniqKey="Eymard J" first="Jean-Christophe" last="Eymard">Jean-Christophe Eymard</name>
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</affiliation>
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<name sortKey="Martin, Anne Laure" sort="Martin, Anne Laure" uniqKey="Martin A" first="Anne-Laure" last="Martin">Anne-Laure Martin</name>
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</affiliation>
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<name sortKey="Roche, Henri" sort="Roche, Henri" uniqKey="Roche H" first="Henri" last="Roché">Henri Roché</name>
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<nlm:aff id="aff20">Medical Oncology, Institut Claudius Regaud, Toulouse, France</nlm:aff>
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<title xml:lang="en" level="a" type="main">Extended Benefit from Sequential Administration of Docetaxel after Standard Fluorouracil, Epirubicin, and Cyclophosphamide Regimen for Node-Positive Breast Cancer: The 8-Year Follow-Up Results of the UNICANCER-PACS01 Trial</title>
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<name sortKey="Campone, Mario" sort="Campone, Mario" uniqKey="Campone M" first="Mario" last="Campone">Mario Campone</name>
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<name sortKey="Spielmann, Marc" sort="Spielmann, Marc" uniqKey="Spielmann M" first="Marc" last="Spielmann">Marc Spielmann</name>
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<nlm:aff id="aff4">Medical Oncology, Institut Gustave Roussy, Villejuif, France;</nlm:aff>
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<name sortKey="Machiels, Jean Pascal" sort="Machiels, Jean Pascal" uniqKey="Machiels J" first="Jean-Pascal" last="Machiels">Jean-Pascal Machiels</name>
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<nlm:aff id="aff5">Medical Oncology, Cliniques Universitaires Saint Luc, Bruxelles, Belgium;</nlm:aff>
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<name sortKey="Penault Llorca, Frederique" sort="Penault Llorca, Frederique" uniqKey="Penault Llorca F" first="Frédérique" last="Pénault-Llorca">Frédérique Pénault-Llorca</name>
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<nlm:aff id="aff6">Pathology Department, Centre Jean Perrin, Clermont-Ferrand, France;</nlm:aff>
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<name sortKey="Serin, Daniel" sort="Serin, Daniel" uniqKey="Serin D" first="Daniel" last="Serin">Daniel Serin</name>
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<nlm:aff id="aff7">Medical Oncology, Institut Sainte-Catherine, Avignon, France;</nlm:aff>
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<name sortKey="Levy, Christelle" sort="Levy, Christelle" uniqKey="Levy C" first="Christelle" last="Lévy">Christelle Lévy</name>
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<nlm:aff id="aff8">Medical Oncology, Centre François Baclesse, Caen, France;</nlm:aff>
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<name sortKey="Romieu, Gilles" sort="Romieu, Gilles" uniqKey="Romieu G" first="Gilles" last="Romieu">Gilles Romieu</name>
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<nlm:aff id="aff9">Medical Oncology, Centre Val d'Aurelle, Montpellier, France;</nlm:aff>
</affiliation>
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<name sortKey="Canon, Jean Luc" sort="Canon, Jean Luc" uniqKey="Canon J" first="Jean-Luc" last="Canon">Jean-Luc Canon</name>
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<nlm:aff id="aff10">Medical Oncology, Grand Hôpital Charleroi, Charleroi, Belgium;</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Orfeuvre, Hubert" sort="Orfeuvre, Hubert" uniqKey="Orfeuvre H" first="Hubert" last="Orfeuvre">Hubert Orfeuvre</name>
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<nlm:aff id="aff11">Medical Oncology, Centre Hospitalier Fleyriat, Bourg-en-Bresse, France;</nlm:aff>
</affiliation>
</author>
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<name sortKey="Piot, Gilles" sort="Piot, Gilles" uniqKey="Piot G" first="Gilles" last="Piot">Gilles Piot</name>
<affiliation>
<nlm:aff id="aff12">Medical Oncology, Centre Medico-Chirurgical les Ormeaux, Le Havre, France;</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Petit, Thierry" sort="Petit, Thierry" uniqKey="Petit T" first="Thierry" last="Petit">Thierry Petit</name>
<affiliation>
<nlm:aff id="aff13">Medical Oncology, Centre Paul Strauss, Strasbourg, France;</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Jerusalem, Guy" sort="Jerusalem, Guy" uniqKey="Jerusalem G" first="Guy" last="Jerusalem">Guy Jerusalem</name>
<affiliation>
<nlm:aff id="aff14">Medical Oncology, Centre Hospitalo-Universitaire Sart-Tilman, Liège, Belgium;</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Audhuy, Bruno" sort="Audhuy, Bruno" uniqKey="Audhuy B" first="Bruno" last="Audhuy">Bruno Audhuy</name>
<affiliation>
<nlm:aff id="aff15">Medical Oncology, Centre Hospitalier, Colmar, France;</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Veyret, Corinne" sort="Veyret, Corinne" uniqKey="Veyret C" first="Corinne" last="Veyret">Corinne Veyret</name>
<affiliation>
<nlm:aff id="aff16">Medical Oncology, Centre Henri Becquerel, Rouen, France;</nlm:aff>
</affiliation>
</author>
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<name sortKey="Beauduin, Marc" sort="Beauduin, Marc" uniqKey="Beauduin M" first="Marc" last="Beauduin">Marc Beauduin</name>
<affiliation>
<nlm:aff id="aff17">Medical Oncology, Hôpital Jolimont, Haine-Saint-Paul, Belgium;</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Eymard, Jean Christophe" sort="Eymard, Jean Christophe" uniqKey="Eymard J" first="Jean-Christophe" last="Eymard">Jean-Christophe Eymard</name>
<affiliation>
<nlm:aff id="aff18">Medical Oncology, Institut Jean Godinot, Reims, France;</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Martin, Anne Laure" sort="Martin, Anne Laure" uniqKey="Martin A" first="Anne-Laure" last="Martin">Anne-Laure Martin</name>
<affiliation>
<nlm:aff id="aff19">Unicancer, Fédération Nationale des Centres de Lutte Contre le Cancer, Paris, France;</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Roche, Henri" sort="Roche, Henri" uniqKey="Roche H" first="Henri" last="Roché">Henri Roché</name>
<affiliation>
<nlm:aff id="aff20">Medical Oncology, Institut Claudius Regaud, Toulouse, France</nlm:aff>
</affiliation>
</author>
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<series>
<title level="j">The Oncologist</title>
<idno type="ISSN">1083-7159</idno>
<idno type="eISSN">1549-490X</idno>
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<date when="2012">2012</date>
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<div type="abstract" xml:lang="en">
<p>The initial report from the PACS01 trial demonstrated a benefit at 5 years for disease-free survival and overall survival rates with the sequential administration of docetaxel after fluorouracil, epirubicin, and cyclophosphamide for patients with node-positive, operable breast cancer. This article evaluates the impact of this regimen at 8 years.</p>
</div>
</front>
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<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>
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<article-id pub-id-type="pmc">3399644</article-id>
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<subj-group subj-group-type="heading">
<subject>Breast Cancer</subject>
</subj-group>
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<title-group>
<article-title>Extended Benefit from Sequential Administration of Docetaxel after Standard Fluorouracil, Epirubicin, and Cyclophosphamide Regimen for Node-Positive Breast Cancer: The 8-Year Follow-Up Results of the UNICANCER-PACS01 Trial</article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author" corresp="yes">
<name>
<surname>Coudert</surname>
<given-names>Bruno</given-names>
</name>
<xref ref-type="aff" rid="aff1">
<sup>a</sup>
</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Asselain</surname>
<given-names>Bernard</given-names>
</name>
<xref ref-type="aff" rid="aff2">
<sup>b</sup>
</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Campone</surname>
<given-names>Mario</given-names>
</name>
<xref ref-type="aff" rid="aff3">
<sup>c</sup>
</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Spielmann</surname>
<given-names>Marc</given-names>
</name>
<xref ref-type="aff" rid="aff4">
<sup>d</sup>
</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Machiels</surname>
<given-names>Jean-Pascal</given-names>
</name>
<xref ref-type="aff" rid="aff5">
<sup>e</sup>
</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Pénault-Llorca</surname>
<given-names>Frédérique</given-names>
</name>
<xref ref-type="aff" rid="aff6">
<sup>f</sup>
</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Serin</surname>
<given-names>Daniel</given-names>
</name>
<xref ref-type="aff" rid="aff7">
<sup>g</sup>
</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Lévy</surname>
<given-names>Christelle</given-names>
</name>
<xref ref-type="aff" rid="aff8">
<sup>h</sup>
</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Romieu</surname>
<given-names>Gilles</given-names>
</name>
<xref ref-type="aff" rid="aff9">
<sup>i</sup>
</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Canon</surname>
<given-names>Jean-Luc</given-names>
</name>
<xref ref-type="aff" rid="aff10">
<sup>j</sup>
</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Orfeuvre</surname>
<given-names>Hubert</given-names>
</name>
<xref ref-type="aff" rid="aff11">
<sup>k</sup>
</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Piot</surname>
<given-names>Gilles</given-names>
</name>
<xref ref-type="aff" rid="aff12">
<sup>l</sup>
</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Petit</surname>
<given-names>Thierry</given-names>
</name>
<xref ref-type="aff" rid="aff13">
<sup>m</sup>
</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Jerusalem</surname>
<given-names>Guy</given-names>
</name>
<xref ref-type="aff" rid="aff14">
<sup>n</sup>
</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Audhuy</surname>
<given-names>Bruno</given-names>
</name>
<xref ref-type="aff" rid="aff15">
<sup>o</sup>
</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Veyret</surname>
<given-names>Corinne</given-names>
</name>
<xref ref-type="aff" rid="aff16">
<sup>p</sup>
</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Beauduin</surname>
<given-names>Marc</given-names>
</name>
<xref ref-type="aff" rid="aff17">
<sup>q</sup>
</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Eymard</surname>
<given-names>Jean-Christophe</given-names>
</name>
<xref ref-type="aff" rid="aff18">
<sup>r</sup>
</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Martin</surname>
<given-names>Anne-Laure</given-names>
</name>
<xref ref-type="aff" rid="aff19">
<sup>s</sup>
</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Roché</surname>
<given-names>Henri</given-names>
</name>
<xref ref-type="aff" rid="aff20">
<sup>t</sup>
</xref>
</contrib>
<on-behalf-of>on behalf of the UNICANCER Breast Group</on-behalf-of>
<aff id="aff1">
<sup>a</sup>
Medical Oncology, Centre Georges-François Leclerc, Dijon, France;</aff>
<aff id="aff2">
<sup>b</sup>
Statistical Department, Institut Curie, Paris, France;</aff>
<aff id="aff3">
<sup>c</sup>
Medical Oncology, Institut de Cancérologie de l'Ouest, Centre René Gauducheau, Nantes, France;</aff>
<aff id="aff4">
<sup>d</sup>
Medical Oncology, Institut Gustave Roussy, Villejuif, France;</aff>
<aff id="aff5">
<sup>e</sup>
Medical Oncology, Cliniques Universitaires Saint Luc, Bruxelles, Belgium;</aff>
<aff id="aff6">
<sup>f</sup>
Pathology Department, Centre Jean Perrin, Clermont-Ferrand, France;</aff>
<aff id="aff7">
<sup>g</sup>
Medical Oncology, Institut Sainte-Catherine, Avignon, France;</aff>
<aff id="aff8">
<sup>h</sup>
Medical Oncology, Centre François Baclesse, Caen, France;</aff>
<aff id="aff9">
<sup>i</sup>
Medical Oncology, Centre Val d'Aurelle, Montpellier, France;</aff>
<aff id="aff10">
<sup>j</sup>
Medical Oncology, Grand Hôpital Charleroi, Charleroi, Belgium;</aff>
<aff id="aff11">
<sup>k</sup>
Medical Oncology, Centre Hospitalier Fleyriat, Bourg-en-Bresse, France;</aff>
<aff id="aff12">
<sup>l</sup>
Medical Oncology, Centre Medico-Chirurgical les Ormeaux, Le Havre, France;</aff>
<aff id="aff13">
<sup>m</sup>
Medical Oncology, Centre Paul Strauss, Strasbourg, France;</aff>
<aff id="aff14">
<sup>n</sup>
Medical Oncology, Centre Hospitalo-Universitaire Sart-Tilman, Liège, Belgium;</aff>
<aff id="aff15">
<sup>o</sup>
Medical Oncology, Centre Hospitalier, Colmar, France;</aff>
<aff id="aff16">
<sup>p</sup>
Medical Oncology, Centre Henri Becquerel, Rouen, France;</aff>
<aff id="aff17">
<sup>q</sup>
Medical Oncology, Hôpital Jolimont, Haine-Saint-Paul, Belgium;</aff>
<aff id="aff18">
<sup>r</sup>
Medical Oncology, Institut Jean Godinot, Reims, France;</aff>
<aff id="aff19">
<sup>s</sup>
Unicancer, Fédération Nationale des Centres de Lutte Contre le Cancer, Paris, France;</aff>
<aff id="aff20">
<sup>t</sup>
Medical Oncology, Institut Claudius Regaud, Toulouse, France</aff>
</contrib-group>
<author-notes>
<corresp>Correspondence: Bruno Coudert, M.D., Centre Georges-François Leclerc, 1 Rue du Professeur Marion, 21000 Dijon, France. Telephone:
<phone>+33 (0)3 80 73 77 20</phone>
; Fax:
<fax>+33 (0)3 80 73 77 12</fax>
; e-mail:
<email>bcoudert@cgfl.fr</email>
</corresp>
<fn fn-type="conflict">
<p>
<bold>Disclosures: Bruno Coudert:</bold>
Sanofi-Aventis, Roche (C/A); Lilly, AstraZeneca, Amgen (H);
<bold>Mario Campone:</bold>
Novartis (C/A). The other authors indicated no financial relationships.</p>
</fn>
</author-notes>
<pub-date pub-type="ppub">
<month>7</month>
<year>2012</year>
</pub-date>
<pub-date pub-type="epub">
<day>18</day>
<month>5</month>
<year>2012</year>
</pub-date>
<volume>17</volume>
<issue>7</issue>
<fpage>900</fpage>
<lpage>909</lpage>
<history>
<date date-type="received">
<day>15</day>
<month>12</month>
<year>2011</year>
</date>
<date date-type="accepted">
<day>26</day>
<month>4</month>
<year>2012</year>
</date>
</history>
<permissions>
<copyright-statement>©AlphaMed Press</copyright-statement>
<copyright-year>2012</copyright-year>
</permissions>
<self-uri xlink:title="pdf" xlink:type="simple" xlink:href="onc00712000900.pdf"></self-uri>
<abstract abstract-type="precis">
<p>The initial report from the PACS01 trial demonstrated a benefit at 5 years for disease-free survival and overall survival rates with the sequential administration of docetaxel after fluorouracil, epirubicin, and cyclophosphamide for patients with node-positive, operable breast cancer. This article evaluates the impact of this regimen at 8 years.</p>
</abstract>
<abstract>
<sec>
<title>Purpose.</title>
<p>The initial report from the Programme Action Concertée Sein (PACS) PACS01 trial demonstrated a benefit at 5 years for disease-free survival (DFS) and overall survival (OS) rates with the sequential administration of docetaxel after FEC100 (fluorouracil 500 mg/m
<sup>2</sup>
, epirubicin 100 mg/m
<sup>2</sup>
, and cyclophosphamide 500 mg/m
<sup>2</sup>
) for patients with node-positive, operable breast cancer. We evaluate here the impact of this regimen at 8 years.</p>
</sec>
<sec>
<title>Patients and Methods.</title>
<p>Between June 1997 and March 2000, a total of 1,999 patients (age <65) with localized, resectable, non-pretreated, unilateral breast cancer were randomly assigned to receive either standard FEC100 for 6 cycles or 3 cycles of FEC100 followed by 3 cycles of 100 mg/m
<sup>2</sup>
docetaxel (FEC-D), both given every 21 days. Radiotherapy was mandatory after conservative surgery and tamoxifen was given for 5 years to hormone receptor (HR)-positive patients. Five-year DFS was the trial's main endpoint. Updated 8-year survival data are presented.</p>
</sec>
<sec>
<title>Results.</title>
<p>With a median follow-up of 92.8 months, 639 patients experienced at least one event. A total number of 383 deaths were registered. Eight-year DFS rates were 65.8% with FEC alone and 70.2% with FEC-D. OS rates at 8 years were 78% with FEC alone and 83.2% with FEC-D. Cox regression analysis adjusted for age and number of positive nodes showed a 15% reduction in the relative risk of relapse and a 25% reduction in the relative risk of death in favor of FEC-D. Significant relative risk reductions were observed in the HR-positive, HER2-positive, and Ki67 ≥20% subpopulations.</p>
</sec>
<sec>
<title>Conclusion.</title>
<p>Benefits for DFS and OS rates with the sequential FEC-D regimen are fully confirmed at 8 years.</p>
</sec>
</abstract>
<kwd-group>
<kwd>Breast cancer</kwd>
<kwd>Adjuvant treatment</kwd>
<kwd>Epirubicin</kwd>
<kwd>Docetaxel</kwd>
<kwd>Sequential treatment</kwd>
<kwd>Randomized trial</kwd>
</kwd-group>
</article-meta>
</front>
</pmc>
</record>

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