Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis
Identifieur interne : 000318 ( France/Analysis ); précédent : 000317; suivant : 000319Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis
Auteurs : Patricia Cortazar [États-Unis] ; LIJUN ZHANG [États-Unis] ; Michael Untch [Allemagne] ; Keyur Mehta [Allemagne] ; Joseph P. Costantino [États-Unis] ; Norman Wolmark [États-Unis] ; Hervé Bonnefoi [France] ; David Cameron [Royaume-Uni] ; Luca Gianni [Italie] ; Pinuccia Valagussa [Italie] ; Sandra M. Swain [États-Unis] ; Tatiana Prowell [États-Unis] ; Sibylle Loibl [Allemagne] ; D. Lawrence Wickerham [États-Unis] ; Jan Bogaerts [Belgique] ; Jose Baselga [États-Unis] ; Charles Perou [États-Unis] ; Gideon Blumenthal [États-Unis] ; Jens Blohmer [Allemagne] ; Eleftherios P. Mamounas [États-Unis] ; Jonas Bergh [Suède] ; Vladimir Semiglazov [Russie] ; Robert Justice [États-Unis] ; Holger Eidtmann [Allemagne] ; Soonmyung Paik [États-Unis] ; Martine Piccart [Belgique] ; Rajeshwari Sridhara [États-Unis] ; Peter A. Fasching [Allemagne] ; Leen Slaets [Belgique] ; SHENGHUI TANG [États-Unis] ; Bernd Gerber [Allemagne] ; Charles E. Jr Geyer [États-Unis] ; Richard Pazdur [États-Unis] ; Nina Ditsch [Allemagne] ; Priya Rastogi [États-Unis] ; Wolfgang Eiermann [Allemagne] ; Gunter Von Minckwitz [Allemagne]Source :
- Lancet : (British edition) [ 0140-6736 ] ; 2014.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Médecine.
English descriptors
- KwdEn :
Abstract
Background Pathological complete response has been proposed as a surrogate endpoint for prediction of long-term clinical benefit, such as disease-free survival, event-free survival (EFS), and overall survival (OS). We had four key objectives: to establish the association between pathological complete response and EFS and OS, to establish the definition of pathological complete response that correlates best with long-term outcome, to identify the breast cancer subtypes in which pathological complete response is best correlated with long-term outcome, and to assess whether an increase in frequency of pathological complete response between treatment groups predicts improved EFS and OS. Methods We searched PubMed, Embase, and Medline for clinical trials of neoadjuvant treatment of breast cancer. To be eligible, studies had to meet three inclusion criteria: include at least 200 patients with primary breast cancer treated with preoperative chemotherapy followed by surgery; have available data for pathological complete response, EFS, and OS; and have a median follow-up of at least 3 years. We compared the three most commonly used definitions of pathological complete response-ypT0 ypNO, ypT0/is ypNO, and ypT0/is-for their association with EFS and OS in a responder analysis. We assessed the association between pathological complete response and EFS and OS in various subgroups. Finally, we did a trial-level analysis to assess whether pathological complete response could be used as a surrogate endpoint for EFS or OS. Findings We obtained data from 12 identified international trials and 11955 patients were included in our responder analysis. Eradication of tumour from both breast and lymph nodes (ypTO ypNO or ypT0/is ypN0) was better associated with improved EFS (ypTO ypNO: hazard ratio [HR] 0?44, 95% CI 0?39-0?51; ypTO/is ypNO: 0?48, 0?43-0?54) and OS (0?36,0?30-0?44; 0?36, 0?31-0?42) than was tumour eradication from the breast alone (ypT0/is; EFS: HR 0?60, 95% CI 0?55-0?66; OS 0?51, 0?45-0?58). We used the ypTO/is ypNO definition for all subsequent analyses.
Affiliations:
- Allemagne, Belgique, France, Italie, Royaume-Uni, Russie, Suède, États-Unis
- Aquitaine, Bavière, Berlin, District de Haute-Bavière, District de Moyenne-Franconie, Lombardie, Nouvelle-Aquitaine, Région de Bruxelles-Capitale, Schleswig-Holstein, Svealand
- Berlin, Bordeaux, Bruxelles, Erlangen, Kiel, Milan, Munich, Stockholm
- Université Bordeaux II, Université Louis-et-Maximilien de Munich
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Fasching</name><affiliation wicri:level="3"><inist:fA14 i1="19"><s1>Frauenklinik des Universitätsklinikums</s1><s2>Erlangen</s2><s3>DEU</s3><sZ>28 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><settlement type="city">Erlangen</settlement><region type="land" nuts="1">Bavière</region><region type="district" nuts="2">District de Moyenne-Franconie</region></placeName></affiliation></author><author><name sortKey="Slaets, Leen" sort="Slaets, Leen" uniqKey="Slaets L" first="Leen" last="Slaets">Leen Slaets</name><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>EORTC Headquarters</s1><s2>Brussels</s2><s3>BEL</s3><sZ>15 aut.</sZ><sZ>29 aut.</sZ></inist:fA14><country>Belgique</country><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName></affiliation></author><author><name sortKey="Shenghui Tang" sort="Shenghui Tang" uniqKey="Shenghui Tang" last="Shenghui Tang">SHENGHUI TANG</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>US Food and Drug Administration</s1><s2>Silver Spring, MD</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>12 aut.</sZ><sZ>18 aut.</sZ><sZ>23 aut.</sZ><sZ>27 aut.</sZ><sZ>30 aut.</sZ><sZ>33 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>US Food and Drug Administration</wicri:noRegion></affiliation></author><author><name sortKey="Gerber, Bernd" sort="Gerber, Bernd" uniqKey="Gerber B" first="Bernd" last="Gerber">Bernd Gerber</name><affiliation wicri:level="1"><inist:fA14 i1="20"><s1>Universitäts Frauenklinik</s1><s2>Rostock</s2><s3>DEU</s3><sZ>31 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Rostock</wicri:noRegion><wicri:noRegion>Universitäts Frauenklinik</wicri:noRegion><wicri:noRegion>Universitäts Frauenklinik</wicri:noRegion></affiliation></author><author><name sortKey="Geyer, Charles E Jr" sort="Geyer, Charles E Jr" uniqKey="Geyer C" first="Charles E. Jr" last="Geyer">Charles E. Jr Geyer</name><affiliation wicri:level="1"><inist:fA14 i1="21"><s1>Virginia Commonwealth University Massey Cancer Center</s1><s2>Richmond, VA</s2><s3>USA</s3><sZ>32 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Virginia Commonwealth University Massey Cancer Center</wicri:noRegion></affiliation></author><author><name sortKey="Pazdur, Richard" sort="Pazdur, Richard" uniqKey="Pazdur R" first="Richard" last="Pazdur">Richard Pazdur</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>US Food and Drug Administration</s1><s2>Silver Spring, MD</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>12 aut.</sZ><sZ>18 aut.</sZ><sZ>23 aut.</sZ><sZ>27 aut.</sZ><sZ>30 aut.</sZ><sZ>33 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>US Food and Drug Administration</wicri:noRegion></affiliation></author><author><name sortKey="Ditsch, Nina" sort="Ditsch, Nina" uniqKey="Ditsch N" first="Nina" last="Ditsch">Nina Ditsch</name><affiliation wicri:level="4"><inist:fA14 i1="22"><s1>Hospital of the Ludwig Maximilian University of Munich</s1><s2>Munich</s2><s3>DEU</s3><sZ>34 aut.</sZ><sZ>36 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Bavière</region><region type="district" nuts="2">District de Haute-Bavière</region><settlement type="city">Munich</settlement><settlement type="city">Munich</settlement></placeName><orgName type="university">Université Louis-et-Maximilien de Munich</orgName></affiliation></author><author><name sortKey="Rastogi, Priya" sort="Rastogi, Priya" uniqKey="Rastogi P" first="Priya" last="Rastogi">Priya Rastogi</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>National Surgical Adjuvant Breast and Bowel Project</s1><s2>Pittsburgh, PA</s2><s3>USA</s3><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>14 aut.</sZ><sZ>25 aut.</sZ><sZ>35 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>National Surgical Adjuvant Breast and Bowel Project</wicri:noRegion></affiliation></author><author><name sortKey="Eiermann, Wolfgang" sort="Eiermann, Wolfgang" uniqKey="Eiermann W" first="Wolfgang" last="Eiermann">Wolfgang Eiermann</name><affiliation wicri:level="4"><inist:fA14 i1="22"><s1>Hospital of the Ludwig Maximilian University of Munich</s1><s2>Munich</s2><s3>DEU</s3><sZ>34 aut.</sZ><sZ>36 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Bavière</region><region type="district" nuts="2">District de Haute-Bavière</region><settlement type="city">Munich</settlement><settlement type="city">Munich</settlement></placeName><orgName type="university">Université Louis-et-Maximilien de Munich</orgName></affiliation></author><author><name sortKey="Von Minckwitz, Gunter" sort="Von Minckwitz, Gunter" uniqKey="Von Minckwitz G" first="Gunter" last="Von Minckwitz">Gunter Von Minckwitz</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>German Breast Group</s1><s2>Neu-Isenburg</s2><s3>DEU</s3><sZ>4 aut.</sZ><sZ>13 aut.</sZ><sZ>37 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Neu-Isenburg</wicri:noRegion><wicri:noRegion>German Breast Group</wicri:noRegion><wicri:noRegion>German Breast Group</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">14-0181044</idno><date when="2014">2014</date><idno type="stanalyst">PASCAL 14-0181044 INIST</idno><idno type="RBID">Pascal:14-0181044</idno><idno type="wicri:Area/PascalFrancis/Corpus">000865</idno><idno type="wicri:Area/PascalFrancis/Curation">003D66</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">000479</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">000479</idno><idno type="wicri:doubleKey">0140-6736:2014:Cortazar P:pathological:complete:response</idno><idno type="wicri:Area/Main/Merge">005402</idno><idno type="wicri:Area/Main/Curation">005130</idno><idno type="wicri:Area/Main/Exploration">005130</idno><idno type="wicri:Area/France/Extraction">000318</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis</title><author><name sortKey="Cortazar, Patricia" sort="Cortazar, Patricia" uniqKey="Cortazar P" first="Patricia" last="Cortazar">Patricia Cortazar</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>US Food and Drug Administration</s1><s2>Silver Spring, MD</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>12 aut.</sZ><sZ>18 aut.</sZ><sZ>23 aut.</sZ><sZ>27 aut.</sZ><sZ>30 aut.</sZ><sZ>33 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>US Food and Drug Administration</wicri:noRegion></affiliation></author><author><name sortKey="Lijun Zhang" sort="Lijun Zhang" uniqKey="Lijun Zhang" last="Lijun Zhang">LIJUN ZHANG</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>US Food and Drug Administration</s1><s2>Silver Spring, MD</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>12 aut.</sZ><sZ>18 aut.</sZ><sZ>23 aut.</sZ><sZ>27 aut.</sZ><sZ>30 aut.</sZ><sZ>33 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>US Food and Drug Administration</wicri:noRegion></affiliation></author><author><name sortKey="Untch, Michael" sort="Untch, Michael" uniqKey="Untch M" first="Michael" last="Untch">Michael Untch</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>HELIOS Klinikum</s1><s2>Berlin</s2><s3>DEU</s3><sZ>3 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</settlement></placeName></affiliation></author><author><name sortKey="Mehta, Keyur" sort="Mehta, Keyur" uniqKey="Mehta K" first="Keyur" last="Mehta">Keyur Mehta</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>German Breast Group</s1><s2>Neu-Isenburg</s2><s3>DEU</s3><sZ>4 aut.</sZ><sZ>13 aut.</sZ><sZ>37 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Neu-Isenburg</wicri:noRegion><wicri:noRegion>German Breast Group</wicri:noRegion><wicri:noRegion>German Breast Group</wicri:noRegion></affiliation></author><author><name sortKey="Costantino, Joseph P" sort="Costantino, Joseph P" uniqKey="Costantino J" first="Joseph P." last="Costantino">Joseph P. Costantino</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>National Surgical Adjuvant Breast and Bowel Project</s1><s2>Pittsburgh, PA</s2><s3>USA</s3><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>14 aut.</sZ><sZ>25 aut.</sZ><sZ>35 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>National Surgical Adjuvant Breast and Bowel Project</wicri:noRegion></affiliation></author><author><name sortKey="Wolmark, Norman" sort="Wolmark, Norman" uniqKey="Wolmark N" first="Norman" last="Wolmark">Norman Wolmark</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>National Surgical Adjuvant Breast and Bowel Project</s1><s2>Pittsburgh, PA</s2><s3>USA</s3><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>14 aut.</sZ><sZ>25 aut.</sZ><sZ>35 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>National Surgical Adjuvant Breast and Bowel Project</wicri:noRegion></affiliation></author><author><name sortKey="Bonnefoi, Herve" sort="Bonnefoi, Herve" uniqKey="Bonnefoi H" first="Hervé" last="Bonnefoi">Hervé Bonnefoi</name><affiliation wicri:level="4"><inist:fA14 i1="05"><s1>Institut Bergonie INSERM U916 and Université Bordeaux Segalen</s1><s2>Bordeaux</s2><s3>FRA</s3><sZ>7 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Nouvelle-Aquitaine</region><region type="old region">Aquitaine</region><settlement type="city">Bordeaux</settlement><settlement type="city">Bordeaux</settlement></placeName><orgName type="university">Université Bordeaux II</orgName></affiliation></author><author><name sortKey="Cameron, David" sort="Cameron, David" uniqKey="Cameron D" first="David" last="Cameron">David Cameron</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Edinburgh Cancer Research Centre, University of Edinburgh and NHS Lothian</s1><s3>GBR</s3><sZ>8 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Edinburgh Cancer Research Centre, University of Edinburgh and NHS Lothian</wicri:noRegion></affiliation></author><author><name sortKey="Gianni, Luca" sort="Gianni, Luca" uniqKey="Gianni L" first="Luca" last="Gianni">Luca Gianni</name><affiliation wicri:level="3"><inist:fA14 i1="07"><s1>San Raffaele Scientific Institute</s1><s2>Milan</s2><s3>ITA</s3><sZ>9 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="Valagussa, Pinuccia" sort="Valagussa, Pinuccia" uniqKey="Valagussa P" first="Pinuccia" last="Valagussa">Pinuccia Valagussa</name><affiliation wicri:level="3"><inist:fA14 i1="08"><s1>Fondazione Michelangelo</s1><s2>Milan</s2><s3>ITA</s3><sZ>10 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="Swain, Sandra M" sort="Swain, Sandra M" uniqKey="Swain S" first="Sandra M." last="Swain">Sandra M. Swain</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Medstar Washington Hospital Center</s1><s2>Washington, DC</s2><s3>USA</s3><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Medstar Washington Hospital Center</wicri:noRegion></affiliation></author><author><name sortKey="Prowell, Tatiana" sort="Prowell, Tatiana" uniqKey="Prowell T" first="Tatiana" last="Prowell">Tatiana Prowell</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>US Food and Drug Administration</s1><s2>Silver Spring, MD</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>12 aut.</sZ><sZ>18 aut.</sZ><sZ>23 aut.</sZ><sZ>27 aut.</sZ><sZ>30 aut.</sZ><sZ>33 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>US Food and Drug Administration</wicri:noRegion></affiliation></author><author><name sortKey="Loibl, Sibylle" sort="Loibl, Sibylle" uniqKey="Loibl S" first="Sibylle" last="Loibl">Sibylle Loibl</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>German Breast Group</s1><s2>Neu-Isenburg</s2><s3>DEU</s3><sZ>4 aut.</sZ><sZ>13 aut.</sZ><sZ>37 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Neu-Isenburg</wicri:noRegion><wicri:noRegion>German Breast Group</wicri:noRegion><wicri:noRegion>German Breast Group</wicri:noRegion></affiliation></author><author><name sortKey="Wickerham, D Lawrence" sort="Wickerham, D Lawrence" uniqKey="Wickerham D" first="D. Lawrence" last="Wickerham">D. Lawrence Wickerham</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>National Surgical Adjuvant Breast and Bowel Project</s1><s2>Pittsburgh, PA</s2><s3>USA</s3><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>14 aut.</sZ><sZ>25 aut.</sZ><sZ>35 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>National Surgical Adjuvant Breast and Bowel Project</wicri:noRegion></affiliation></author><author><name sortKey="Bogaerts, Jan" sort="Bogaerts, Jan" uniqKey="Bogaerts J" first="Jan" last="Bogaerts">Jan Bogaerts</name><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>EORTC Headquarters</s1><s2>Brussels</s2><s3>BEL</s3><sZ>15 aut.</sZ><sZ>29 aut.</sZ></inist:fA14><country>Belgique</country><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName></affiliation></author><author><name sortKey="Baselga, Jose" sort="Baselga, Jose" uniqKey="Baselga J" first="Jose" last="Baselga">Jose Baselga</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Memorial Sloan-Kettering Cancer Center</s1><s2>New York, NY</s2><s3>USA</s3><sZ>16 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Memorial Sloan-Kettering Cancer Center</wicri:noRegion></affiliation></author><author><name sortKey="Perou, Charles" sort="Perou, Charles" uniqKey="Perou C" first="Charles" last="Perou">Charles Perou</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Lineberger Comprehensive Cancer Center</s1><s2>Chapel Hill, NC</s2><s3>USA</s3><sZ>17 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Lineberger Comprehensive Cancer Center</wicri:noRegion></affiliation></author><author><name sortKey="Blumenthal, Gideon" sort="Blumenthal, Gideon" uniqKey="Blumenthal G" first="Gideon" last="Blumenthal">Gideon Blumenthal</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>US Food and Drug Administration</s1><s2>Silver Spring, MD</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>12 aut.</sZ><sZ>18 aut.</sZ><sZ>23 aut.</sZ><sZ>27 aut.</sZ><sZ>30 aut.</sZ><sZ>33 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>US Food and Drug Administration</wicri:noRegion></affiliation></author><author><name sortKey="Blohmer, Jens" sort="Blohmer, Jens" uniqKey="Blohmer J" first="Jens" last="Blohmer">Jens Blohmer</name><affiliation wicri:level="3"><inist:fA14 i1="13"><s1>St Gertrauden Hospital</s1><s2>Berlin</s2><s3>DEU</s3><sZ>19 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</settlement></placeName></affiliation></author><author><name sortKey="Mamounas, Eleftherios P" sort="Mamounas, Eleftherios P" uniqKey="Mamounas E" first="Eleftherios P." last="Mamounas">Eleftherios P. Mamounas</name><affiliation wicri:level="1"><inist:fA14 i1="14"><s1>MD Anderson Cancer Center Orlando</s1><s2>Orlando, FL</s2><s3>USA</s3><sZ>20 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>MD Anderson Cancer Center Orlando</wicri:noRegion></affiliation></author><author><name sortKey="Bergh, Jonas" sort="Bergh, Jonas" uniqKey="Bergh J" first="Jonas" last="Bergh">Jonas Bergh</name><affiliation wicri:level="3"><inist:fA14 i1="15"><s1>Karolinskalnstitutet and University Hospital</s1><s2>Stockholm</s2><s3>SWE</s3><sZ>21 aut.</sZ></inist:fA14><country>Suède</country><placeName><settlement type="city">Stockholm</settlement><region nuts="2">Svealand</region></placeName></affiliation></author><author><name sortKey="Semiglazov, Vladimir" sort="Semiglazov, Vladimir" uniqKey="Semiglazov V" first="Vladimir" last="Semiglazov">Vladimir Semiglazov</name><affiliation wicri:level="1"><inist:fA14 i1="16"><s1>NN Petrov Research Institute of Oncology</s1><s2>St Petersburg</s2><s3>RUS</s3><sZ>22 aut.</sZ></inist:fA14><country>Russie</country><wicri:noRegion>NN Petrov Research Institute of Oncology</wicri:noRegion></affiliation></author><author><name sortKey="Justice, Robert" sort="Justice, Robert" uniqKey="Justice R" first="Robert" last="Justice">Robert Justice</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>US Food and Drug Administration</s1><s2>Silver Spring, MD</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>12 aut.</sZ><sZ>18 aut.</sZ><sZ>23 aut.</sZ><sZ>27 aut.</sZ><sZ>30 aut.</sZ><sZ>33 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>US Food and Drug Administration</wicri:noRegion></affiliation></author><author><name sortKey="Eidtmann, Holger" sort="Eidtmann, Holger" uniqKey="Eidtmann H" first="Holger" last="Eidtmann">Holger Eidtmann</name><affiliation wicri:level="3"><inist:fA14 i1="17"><s1>University Women's Hospital</s1><s2>Kiel</s2><s3>DEU</s3><sZ>24 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="2">Schleswig-Holstein</region><settlement type="city">Kiel</settlement></placeName></affiliation></author><author><name sortKey="Paik, Soonmyung" sort="Paik, Soonmyung" uniqKey="Paik S" first="Soonmyung" last="Paik">Soonmyung Paik</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>National Surgical Adjuvant Breast and Bowel Project</s1><s2>Pittsburgh, PA</s2><s3>USA</s3><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>14 aut.</sZ><sZ>25 aut.</sZ><sZ>35 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>National Surgical Adjuvant Breast and Bowel Project</wicri:noRegion></affiliation></author><author><name sortKey="Piccart, Martine" sort="Piccart, Martine" uniqKey="Piccart M" first="Martine" last="Piccart">Martine Piccart</name><affiliation wicri:level="3"><inist:fA14 i1="18"><s1>Jules Bordet Institute</s1><s2>Brussels</s2><s3>BEL</s3><sZ>26 aut.</sZ></inist:fA14><country>Belgique</country><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName></affiliation></author><author><name sortKey="Sridhara, Rajeshwari" sort="Sridhara, Rajeshwari" uniqKey="Sridhara R" first="Rajeshwari" last="Sridhara">Rajeshwari Sridhara</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>US Food and Drug Administration</s1><s2>Silver Spring, MD</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>12 aut.</sZ><sZ>18 aut.</sZ><sZ>23 aut.</sZ><sZ>27 aut.</sZ><sZ>30 aut.</sZ><sZ>33 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>US Food and Drug Administration</wicri:noRegion></affiliation></author><author><name sortKey="Fasching, Peter A" sort="Fasching, Peter A" uniqKey="Fasching P" first="Peter A." last="Fasching">Peter A. Fasching</name><affiliation wicri:level="3"><inist:fA14 i1="19"><s1>Frauenklinik des Universitätsklinikums</s1><s2>Erlangen</s2><s3>DEU</s3><sZ>28 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><settlement type="city">Erlangen</settlement><region type="land" nuts="1">Bavière</region><region type="district" nuts="2">District de Moyenne-Franconie</region></placeName></affiliation></author><author><name sortKey="Slaets, Leen" sort="Slaets, Leen" uniqKey="Slaets L" first="Leen" last="Slaets">Leen Slaets</name><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>EORTC Headquarters</s1><s2>Brussels</s2><s3>BEL</s3><sZ>15 aut.</sZ><sZ>29 aut.</sZ></inist:fA14><country>Belgique</country><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName></affiliation></author><author><name sortKey="Shenghui Tang" sort="Shenghui Tang" uniqKey="Shenghui Tang" last="Shenghui Tang">SHENGHUI TANG</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>US Food and Drug Administration</s1><s2>Silver Spring, MD</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>12 aut.</sZ><sZ>18 aut.</sZ><sZ>23 aut.</sZ><sZ>27 aut.</sZ><sZ>30 aut.</sZ><sZ>33 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>US Food and Drug Administration</wicri:noRegion></affiliation></author><author><name sortKey="Gerber, Bernd" sort="Gerber, Bernd" uniqKey="Gerber B" first="Bernd" last="Gerber">Bernd Gerber</name><affiliation wicri:level="1"><inist:fA14 i1="20"><s1>Universitäts Frauenklinik</s1><s2>Rostock</s2><s3>DEU</s3><sZ>31 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Rostock</wicri:noRegion><wicri:noRegion>Universitäts Frauenklinik</wicri:noRegion><wicri:noRegion>Universitäts Frauenklinik</wicri:noRegion></affiliation></author><author><name sortKey="Geyer, Charles E Jr" sort="Geyer, Charles E Jr" uniqKey="Geyer C" first="Charles E. Jr" last="Geyer">Charles E. Jr Geyer</name><affiliation wicri:level="1"><inist:fA14 i1="21"><s1>Virginia Commonwealth University Massey Cancer Center</s1><s2>Richmond, VA</s2><s3>USA</s3><sZ>32 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Virginia Commonwealth University Massey Cancer Center</wicri:noRegion></affiliation></author><author><name sortKey="Pazdur, Richard" sort="Pazdur, Richard" uniqKey="Pazdur R" first="Richard" last="Pazdur">Richard Pazdur</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>US Food and Drug Administration</s1><s2>Silver Spring, MD</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>12 aut.</sZ><sZ>18 aut.</sZ><sZ>23 aut.</sZ><sZ>27 aut.</sZ><sZ>30 aut.</sZ><sZ>33 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>US Food and Drug Administration</wicri:noRegion></affiliation></author><author><name sortKey="Ditsch, Nina" sort="Ditsch, Nina" uniqKey="Ditsch N" first="Nina" last="Ditsch">Nina Ditsch</name><affiliation wicri:level="4"><inist:fA14 i1="22"><s1>Hospital of the Ludwig Maximilian University of Munich</s1><s2>Munich</s2><s3>DEU</s3><sZ>34 aut.</sZ><sZ>36 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Bavière</region><region type="district" nuts="2">District de Haute-Bavière</region><settlement type="city">Munich</settlement><settlement type="city">Munich</settlement></placeName><orgName type="university">Université Louis-et-Maximilien de Munich</orgName></affiliation></author><author><name sortKey="Rastogi, Priya" sort="Rastogi, Priya" uniqKey="Rastogi P" first="Priya" last="Rastogi">Priya Rastogi</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>National Surgical Adjuvant Breast and Bowel Project</s1><s2>Pittsburgh, PA</s2><s3>USA</s3><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>14 aut.</sZ><sZ>25 aut.</sZ><sZ>35 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>National Surgical Adjuvant Breast and Bowel Project</wicri:noRegion></affiliation></author><author><name sortKey="Eiermann, Wolfgang" sort="Eiermann, Wolfgang" uniqKey="Eiermann W" first="Wolfgang" last="Eiermann">Wolfgang Eiermann</name><affiliation wicri:level="4"><inist:fA14 i1="22"><s1>Hospital of the Ludwig Maximilian University of Munich</s1><s2>Munich</s2><s3>DEU</s3><sZ>34 aut.</sZ><sZ>36 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Bavière</region><region type="district" nuts="2">District de Haute-Bavière</region><settlement type="city">Munich</settlement><settlement type="city">Munich</settlement></placeName><orgName type="university">Université Louis-et-Maximilien de Munich</orgName></affiliation></author><author><name sortKey="Von Minckwitz, Gunter" sort="Von Minckwitz, Gunter" uniqKey="Von Minckwitz G" first="Gunter" last="Von Minckwitz">Gunter Von Minckwitz</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>German Breast Group</s1><s2>Neu-Isenburg</s2><s3>DEU</s3><sZ>4 aut.</sZ><sZ>13 aut.</sZ><sZ>37 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Neu-Isenburg</wicri:noRegion><wicri:noRegion>German Breast Group</wicri:noRegion><wicri:noRegion>German Breast Group</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">Lancet : (British edition)</title><title level="j" type="abbreviated">Lancet : (Br. ed.)</title><idno type="ISSN">0140-6736</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Lancet : (British edition)</title><title level="j" type="abbreviated">Lancet : (Br. ed.)</title><idno type="ISSN">0140-6736</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Breast cancer</term><term>Clinical benefit</term><term>Complete</term><term>Long term</term><term>Mammary gland</term><term>Medicine</term><term>Pool</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Cancer du sein</term><term>Complet</term><term>Long terme</term><term>Glande mammaire</term><term>Pool</term><term>Médecine</term><term>Bénéfice clinique</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Médecine</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background Pathological complete response has been proposed as a surrogate endpoint for prediction of long-term clinical benefit, such as disease-free survival, event-free survival (EFS), and overall survival (OS). We had four key objectives: to establish the association between pathological complete response and EFS and OS, to establish the definition of pathological complete response that correlates best with long-term outcome, to identify the breast cancer subtypes in which pathological complete response is best correlated with long-term outcome, and to assess whether an increase in frequency of pathological complete response between treatment groups predicts improved EFS and OS. Methods We searched PubMed, Embase, and Medline for clinical trials of neoadjuvant treatment of breast cancer. To be eligible, studies had to meet three inclusion criteria: include at least 200 patients with primary breast cancer treated with preoperative chemotherapy followed by surgery; have available data for pathological complete response, EFS, and OS; and have a median follow-up of at least 3 years. We compared the three most commonly used definitions of pathological complete response-ypT0 ypNO, ypT0/is ypNO, and ypT0/is-for their association with EFS and OS in a responder analysis. We assessed the association between pathological complete response and EFS and OS in various subgroups. Finally, we did a trial-level analysis to assess whether pathological complete response could be used as a surrogate endpoint for EFS or OS. Findings We obtained data from 12 identified international trials and 11955 patients were included in our responder analysis. Eradication of tumour from both breast and lymph nodes (ypTO ypNO or ypT0/is ypN0) was better associated with improved EFS (ypTO ypNO: hazard ratio [HR] 0?44, 95% CI 0?39-0?51; ypTO/is ypNO: 0?48, 0?43-0?54) and OS (0?36,0?30-0?44; 0?36, 0?31-0?42) than was tumour eradication from the breast alone (ypT0/is; EFS: HR 0?60, 95% CI 0?55-0?66; OS 0?51, 0?45-0?58). We used the ypTO/is ypNO definition for all subsequent analyses.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Belgique</li><li>France</li><li>Italie</li><li>Royaume-Uni</li><li>Russie</li><li>Suède</li><li>États-Unis</li></country><region><li>Aquitaine</li><li>Bavière</li><li>Berlin</li><li>District de Haute-Bavière</li><li>District de Moyenne-Franconie</li><li>Lombardie</li><li>Nouvelle-Aquitaine</li><li>Région de Bruxelles-Capitale</li><li>Schleswig-Holstein</li><li>Svealand</li></region><settlement><li>Berlin</li><li>Bordeaux</li><li>Bruxelles</li><li>Erlangen</li><li>Kiel</li><li>Milan</li><li>Munich</li><li>Stockholm</li></settlement><orgName><li>Université Bordeaux II</li><li>Université Louis-et-Maximilien de Munich</li></orgName></list><tree><country name="États-Unis"><noRegion><name sortKey="Cortazar, Patricia" sort="Cortazar, Patricia" uniqKey="Cortazar P" first="Patricia" last="Cortazar">Patricia Cortazar</name></noRegion><name sortKey="Baselga, Jose" sort="Baselga, Jose" uniqKey="Baselga J" first="Jose" last="Baselga">Jose Baselga</name><name sortKey="Blumenthal, Gideon" sort="Blumenthal, Gideon" uniqKey="Blumenthal G" first="Gideon" last="Blumenthal">Gideon Blumenthal</name><name sortKey="Costantino, Joseph P" sort="Costantino, Joseph P" uniqKey="Costantino J" first="Joseph P." last="Costantino">Joseph P. Costantino</name><name sortKey="Geyer, Charles E Jr" sort="Geyer, Charles E Jr" uniqKey="Geyer C" first="Charles E. Jr" last="Geyer">Charles E. Jr Geyer</name><name sortKey="Justice, Robert" sort="Justice, Robert" uniqKey="Justice R" first="Robert" last="Justice">Robert Justice</name><name sortKey="Lijun Zhang" sort="Lijun Zhang" uniqKey="Lijun Zhang" last="Lijun Zhang">LIJUN ZHANG</name><name sortKey="Mamounas, Eleftherios P" sort="Mamounas, Eleftherios P" uniqKey="Mamounas E" first="Eleftherios P." last="Mamounas">Eleftherios P. Mamounas</name><name sortKey="Paik, Soonmyung" sort="Paik, Soonmyung" uniqKey="Paik S" first="Soonmyung" last="Paik">Soonmyung Paik</name><name sortKey="Pazdur, Richard" sort="Pazdur, Richard" uniqKey="Pazdur R" first="Richard" last="Pazdur">Richard Pazdur</name><name sortKey="Perou, Charles" sort="Perou, Charles" uniqKey="Perou C" first="Charles" last="Perou">Charles Perou</name><name sortKey="Prowell, Tatiana" sort="Prowell, Tatiana" uniqKey="Prowell T" first="Tatiana" last="Prowell">Tatiana Prowell</name><name sortKey="Rastogi, Priya" sort="Rastogi, Priya" uniqKey="Rastogi P" first="Priya" last="Rastogi">Priya Rastogi</name><name sortKey="Shenghui Tang" sort="Shenghui Tang" uniqKey="Shenghui Tang" last="Shenghui Tang">SHENGHUI TANG</name><name sortKey="Sridhara, Rajeshwari" sort="Sridhara, Rajeshwari" uniqKey="Sridhara R" first="Rajeshwari" last="Sridhara">Rajeshwari Sridhara</name><name sortKey="Swain, Sandra M" sort="Swain, Sandra M" uniqKey="Swain S" first="Sandra M." last="Swain">Sandra M. Swain</name><name sortKey="Wickerham, D Lawrence" sort="Wickerham, D Lawrence" uniqKey="Wickerham D" first="D. Lawrence" last="Wickerham">D. Lawrence Wickerham</name><name sortKey="Wolmark, Norman" sort="Wolmark, Norman" uniqKey="Wolmark N" first="Norman" last="Wolmark">Norman Wolmark</name></country><country name="Allemagne"><region name="Berlin"><name sortKey="Untch, Michael" sort="Untch, Michael" uniqKey="Untch M" first="Michael" last="Untch">Michael Untch</name></region><name sortKey="Blohmer, Jens" sort="Blohmer, Jens" uniqKey="Blohmer J" first="Jens" last="Blohmer">Jens Blohmer</name><name sortKey="Ditsch, Nina" sort="Ditsch, Nina" uniqKey="Ditsch N" first="Nina" last="Ditsch">Nina Ditsch</name><name sortKey="Eidtmann, Holger" sort="Eidtmann, Holger" uniqKey="Eidtmann H" first="Holger" last="Eidtmann">Holger Eidtmann</name><name sortKey="Eiermann, Wolfgang" sort="Eiermann, Wolfgang" uniqKey="Eiermann W" first="Wolfgang" last="Eiermann">Wolfgang Eiermann</name><name sortKey="Fasching, Peter A" sort="Fasching, Peter A" uniqKey="Fasching P" first="Peter A." last="Fasching">Peter A. Fasching</name><name sortKey="Gerber, Bernd" sort="Gerber, Bernd" uniqKey="Gerber B" first="Bernd" last="Gerber">Bernd Gerber</name><name sortKey="Loibl, Sibylle" sort="Loibl, Sibylle" uniqKey="Loibl S" first="Sibylle" last="Loibl">Sibylle Loibl</name><name sortKey="Mehta, Keyur" sort="Mehta, Keyur" uniqKey="Mehta K" first="Keyur" last="Mehta">Keyur Mehta</name><name sortKey="Von Minckwitz, Gunter" sort="Von Minckwitz, Gunter" uniqKey="Von Minckwitz G" first="Gunter" last="Von Minckwitz">Gunter Von Minckwitz</name></country><country name="France"><region name="Nouvelle-Aquitaine"><name sortKey="Bonnefoi, Herve" sort="Bonnefoi, Herve" uniqKey="Bonnefoi H" first="Hervé" last="Bonnefoi">Hervé Bonnefoi</name></region></country><country name="Royaume-Uni"><noRegion><name sortKey="Cameron, David" sort="Cameron, David" uniqKey="Cameron D" first="David" last="Cameron">David Cameron</name></noRegion></country><country name="Italie"><region name="Lombardie"><name sortKey="Gianni, Luca" sort="Gianni, Luca" uniqKey="Gianni L" first="Luca" last="Gianni">Luca Gianni</name></region><name sortKey="Valagussa, Pinuccia" sort="Valagussa, Pinuccia" uniqKey="Valagussa P" first="Pinuccia" last="Valagussa">Pinuccia Valagussa</name></country><country name="Belgique"><region name="Région de Bruxelles-Capitale"><name sortKey="Bogaerts, Jan" sort="Bogaerts, Jan" uniqKey="Bogaerts J" first="Jan" last="Bogaerts">Jan Bogaerts</name></region><name sortKey="Piccart, Martine" sort="Piccart, Martine" uniqKey="Piccart M" first="Martine" last="Piccart">Martine Piccart</name><name sortKey="Slaets, Leen" sort="Slaets, Leen" uniqKey="Slaets L" first="Leen" last="Slaets">Leen Slaets</name></country><country name="Suède"><region name="Svealand"><name sortKey="Bergh, Jonas" sort="Bergh, Jonas" uniqKey="Bergh J" first="Jonas" last="Bergh">Jonas Bergh</name></region></country><country name="Russie"><noRegion><name sortKey="Semiglazov, Vladimir" sort="Semiglazov, Vladimir" uniqKey="Semiglazov V" first="Vladimir" last="Semiglazov">Vladimir Semiglazov</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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