Tumor infiltrating lymphocytes are prognostic in triple negative breast cancer and predictive for trastuzumab benefit in early breast cancer: results from the FinHER trial
Identifieur interne : 003F09 ( Main/Exploration ); précédent : 003F08; suivant : 003F10Tumor infiltrating lymphocytes are prognostic in triple negative breast cancer and predictive for trastuzumab benefit in early breast cancer: results from the FinHER trial
Auteurs : S. Loi [Belgique, Australie] ; S. Michiels [Belgique, France] ; R. Salgado [Belgique] ; N. Sirtaine [Belgique] ; V. Jose [Belgique] ; D. Fumagalli [Belgique] ; P.-L. Kellokumpu-Lehtinen [Finlande] ; P. Bono [Finlande] ; V. Kataja [Finlande] ; C. Desmedt [Belgique] ; M. J. Piccart [Belgique] ; S. Loibl [Allemagne] ; C. Denkert [Allemagne] ; M. J. Smyth [Australie] ; H. Joensuu [Finlande] ; C. Sotiriou [Belgique]Source :
- Annals of oncology [ 0923-7534 ] ; 2014.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
Abstract
Background: We have previously shown the prognostic importance of tumor-infiltrating lymphocytes (TILs) in newly diagnosed triple-negative breast cancer (TNBC) using tumor samples from a large clinical trial cohort. In this study, we aimed to validate these findings and also investigate associations with trastuzumab benefit in HER2-overexpressing disease (HER2+). Patients and methods: A prospective-retrospective study was conducted using samples from the FinHER adjuvant, phase III trial that enrolled 1010 early-stage BC patients, 778 of whom were HER2-nonamplified. Those with HER2+ disease (n = 232) were randomized to 9 weeks of trastuzumab or no trastuzumab in addition to chemotherapy. Two pathologists independently quantified stromal TILs in 935 (92.6%) available slides. The primary end point of distant disease-free survival (DDFS) and interactions with trastuzumab were studied in Cox regression models. Results: Confirming our previous findings, in TNBC (n = 134) each 10% increase in TILs was significantly associated with decreased distant recurrence in TNBC; for DDFS the hazard ratio adjusted for clinicopathological factors: 0.77; 95% confidence interval (Cl) 0.61-0.98, P = 0.02. In HER2+ BC (n = 209), each 10% increase in lymphocytic infiltration was significantly associated with decreased distant recurrence in patients randomized to the trastuzumab arm (DDFS Pinteraction = 0.025). Conclusions: Higher levels of TILs present at diagnosis were significantly associated with decreased distant recurrence rates in primary TNBC. These results confirm our previous data and further support that TILs should be considered as a robust prognostic factor in this BC subtype. We also report for the first time an association between higher levels of TILs and increased trastuzumab benefit in HER2+ disease. Further research into why some TN and HER2+ BCs can or cannot generate a host antitumor immune response and how trastuzumab can favorably alter the immune microenvironment is warranted.
Affiliations:
- Allemagne, Australie, Belgique, Finlande, France
- Berlin, Région de Bruxelles-Capitale, Île-de-France
- Berlin, Bruxelles, Orsay
- Université Paris-Sud, Université libre de Bruxelles
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Jose</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Breast Cancer Translational Research Laboratory, Institut Jules Bordet, Université Libre de Bruxelles</s1><s2>Brussels</s2><s3>BEL</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>10 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>Belgique</country><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region><settlement type="city">Bruxelles</settlement></placeName><orgName type="university">Université libre de Bruxelles</orgName></affiliation></author><author><name sortKey="Fumagalli, D" sort="Fumagalli, D" uniqKey="Fumagalli D" first="D." last="Fumagalli">D. Fumagalli</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Breast Cancer Translational Research Laboratory, Institut Jules Bordet, Université Libre de Bruxelles</s1><s2>Brussels</s2><s3>BEL</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>10 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>Belgique</country><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region><settlement type="city">Bruxelles</settlement></placeName><orgName type="university">Université libre de Bruxelles</orgName></affiliation></author><author><name sortKey="Kellokumpu Lehtinen, P L" sort="Kellokumpu Lehtinen, P L" uniqKey="Kellokumpu Lehtinen P" first="P.-L." last="Kellokumpu-Lehtinen">P.-L. Kellokumpu-Lehtinen</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Department of Oncology, Tampere University Hospital</s1><s2>Tampere</s2><s3>FIN</s3><sZ>7 aut.</sZ></inist:fA14><country>Finlande</country><wicri:noRegion>Tampere</wicri:noRegion></affiliation></author><author><name sortKey="Bono, P" sort="Bono, P" uniqKey="Bono P" first="P." last="Bono">P. Bono</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Oncology, Helsinki University Central Hospital</s1><s2>Helsinki</s2><s3>FIN</s3><sZ>8 aut.</sZ><sZ>15 aut.</sZ></inist:fA14><country>Finlande</country><wicri:noRegion>Helsinki</wicri:noRegion></affiliation></author><author><name sortKey="Kataja, V" sort="Kataja, V" uniqKey="Kataja V" first="V." last="Kataja">V. Kataja</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Cancer Center, Kuopio University Hospital</s1><s2>Kuopio</s2><s3>FIN</s3><sZ>9 aut.</sZ></inist:fA14><country>Finlande</country><wicri:noRegion>Kuopio</wicri:noRegion></affiliation></author><author><name sortKey="Desmedt, C" sort="Desmedt, C" uniqKey="Desmedt C" first="C." last="Desmedt">C. Desmedt</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Breast Cancer Translational Research Laboratory, Institut Jules Bordet, Université Libre de Bruxelles</s1><s2>Brussels</s2><s3>BEL</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>10 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>Belgique</country><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region><settlement type="city">Bruxelles</settlement></placeName><orgName type="university">Université libre de Bruxelles</orgName></affiliation></author><author><name sortKey="Piccart, M J" sort="Piccart, M J" uniqKey="Piccart M" first="M. J." last="Piccart">M. J. Piccart</name><affiliation wicri:level="3"><inist:fA14 i1="08"><s1>Department of Medicine, Institut Jules Bordet</s1><s2>Brussels</s2><s3>BEL</s3><sZ>11 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="Loibl, S" sort="Loibl, S" uniqKey="Loibl S" first="S." last="Loibl">S. Loibl</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>German Breast Group</s1><s2>Neu-Isenburg</s2><s3>DEU</s3><sZ>12 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="Denkert, C" sort="Denkert, C" uniqKey="Denkert C" first="C." last="Denkert">C. Denkert</name><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>Charite University Hospital, Institute of Pathology</s1><s2>Berlin</s2><s3>DEU</s3><sZ>13 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="Smyth, M J" sort="Smyth, M J" uniqKey="Smyth M" first="M. J." last="Smyth">M. J. Smyth</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Immunology in Cancer and Infection Laboratory, Queensland Institute of Medical Research (QIMR) Berghofer Medical Research Institute; School of Medicine, University of Queensland</s1><s2>Herston</s2><s3>AUS</s3><sZ>14 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Herston</wicri:noRegion></affiliation></author><author><name sortKey="Joensuu, H" sort="Joensuu, H" uniqKey="Joensuu H" first="H." last="Joensuu">H. Joensuu</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Oncology, Helsinki University Central Hospital</s1><s2>Helsinki</s2><s3>FIN</s3><sZ>8 aut.</sZ><sZ>15 aut.</sZ></inist:fA14><country>Finlande</country><wicri:noRegion>Helsinki</wicri:noRegion></affiliation></author><author><name sortKey="Sotiriou, C" sort="Sotiriou, C" uniqKey="Sotiriou C" first="C." last="Sotiriou">C. Sotiriou</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Breast Cancer Translational Research Laboratory, Institut Jules Bordet, Université Libre de Bruxelles</s1><s2>Brussels</s2><s3>BEL</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>10 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>Belgique</country><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region><settlement type="city">Bruxelles</settlement></placeName><orgName type="university">Université libre de Bruxelles</orgName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">14-0214774</idno><date when="2014">2014</date><idno type="stanalyst">PASCAL 14-0214774 INIST</idno><idno type="RBID">Pascal:14-0214774</idno><idno type="wicri:Area/PascalFrancis/Corpus">000278</idno><idno type="wicri:Area/PascalFrancis/Curation">005B84</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">000037</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">000037</idno><idno type="wicri:doubleKey">0923-7534:2014:Loi S:tumor:infiltrating:lymphocytes</idno><idno type="wicri:Area/Main/Merge">003F61</idno><idno type="wicri:Area/Main/Curation">003F09</idno><idno type="wicri:Area/Main/Exploration">003F09</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Tumor infiltrating lymphocytes are prognostic in triple negative breast cancer and predictive for trastuzumab benefit in early breast cancer: results from the FinHER trial</title><author><name sortKey="Loi, S" sort="Loi, S" uniqKey="Loi S" first="S." last="Loi">S. Loi</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Breast Cancer Translational Research Laboratory, Institut Jules Bordet, Université Libre de Bruxelles</s1><s2>Brussels</s2><s3>BEL</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>10 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>Belgique</country><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region><settlement type="city">Bruxelles</settlement></placeName><orgName type="university">Université libre de Bruxelles</orgName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Division of Research and Cancer Medicine, Peter MacCallum Cancer Centre</s1><s2>East Melbourne</s2><s3>AUS</s3><sZ>1 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>East Melbourne</wicri:noRegion></affiliation></author><author><name sortKey="Michiels, S" sort="Michiels, S" uniqKey="Michiels S" first="S." last="Michiels">S. Michiels</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Breast Cancer Translational Research Laboratory, Institut Jules Bordet, Université Libre de Bruxelles</s1><s2>Brussels</s2><s3>BEL</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>10 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>Belgique</country><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region><settlement type="city">Bruxelles</settlement></placeName><orgName type="university">Université libre de Bruxelles</orgName></affiliation><affiliation wicri:level="4"><inist:fA14 i1="03"><s1>Service de Biostatistique et D'Epidemiology, Gustave Roussy, Universite Paris-Sud</s1><s2>Villejuif</s2><s3>FRA</s3><sZ>2 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>Villejuif</wicri:noRegion><wicri:noRegion>Universite Paris-Sud</wicri:noRegion><placeName><settlement type="city">Orsay</settlement><region type="region" nuts="2">Île-de-France</region></placeName><orgName type="university">Université Paris-Sud</orgName></affiliation></author><author><name sortKey="Salgado, R" sort="Salgado, R" uniqKey="Salgado R" first="R." last="Salgado">R. Salgado</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Department of Anatomical Pathology, Institut Jules Bordet</s1><s2>Brussels</s2><s3>BEL</s3><sZ>3 aut.</sZ><sZ>4 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="Sirtaine, N" sort="Sirtaine, N" uniqKey="Sirtaine N" first="N." last="Sirtaine">N. Sirtaine</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Department of Anatomical Pathology, Institut Jules Bordet</s1><s2>Brussels</s2><s3>BEL</s3><sZ>3 aut.</sZ><sZ>4 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="Jose, V" sort="Jose, V" uniqKey="Jose V" first="V." last="Jose">V. Jose</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Breast Cancer Translational Research Laboratory, Institut Jules Bordet, Université Libre de Bruxelles</s1><s2>Brussels</s2><s3>BEL</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>10 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>Belgique</country><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region><settlement type="city">Bruxelles</settlement></placeName><orgName type="university">Université libre de Bruxelles</orgName></affiliation></author><author><name sortKey="Fumagalli, D" sort="Fumagalli, D" uniqKey="Fumagalli D" first="D." last="Fumagalli">D. Fumagalli</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Breast Cancer Translational Research Laboratory, Institut Jules Bordet, Université Libre de Bruxelles</s1><s2>Brussels</s2><s3>BEL</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>10 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>Belgique</country><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region><settlement type="city">Bruxelles</settlement></placeName><orgName type="university">Université libre de Bruxelles</orgName></affiliation></author><author><name sortKey="Kellokumpu Lehtinen, P L" sort="Kellokumpu Lehtinen, P L" uniqKey="Kellokumpu Lehtinen P" first="P.-L." last="Kellokumpu-Lehtinen">P.-L. Kellokumpu-Lehtinen</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Department of Oncology, Tampere University Hospital</s1><s2>Tampere</s2><s3>FIN</s3><sZ>7 aut.</sZ></inist:fA14><country>Finlande</country><wicri:noRegion>Tampere</wicri:noRegion></affiliation></author><author><name sortKey="Bono, P" sort="Bono, P" uniqKey="Bono P" first="P." last="Bono">P. Bono</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Oncology, Helsinki University Central Hospital</s1><s2>Helsinki</s2><s3>FIN</s3><sZ>8 aut.</sZ><sZ>15 aut.</sZ></inist:fA14><country>Finlande</country><wicri:noRegion>Helsinki</wicri:noRegion></affiliation></author><author><name sortKey="Kataja, V" sort="Kataja, V" uniqKey="Kataja V" first="V." last="Kataja">V. Kataja</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Cancer Center, Kuopio University Hospital</s1><s2>Kuopio</s2><s3>FIN</s3><sZ>9 aut.</sZ></inist:fA14><country>Finlande</country><wicri:noRegion>Kuopio</wicri:noRegion></affiliation></author><author><name sortKey="Desmedt, C" sort="Desmedt, C" uniqKey="Desmedt C" first="C." last="Desmedt">C. Desmedt</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Breast Cancer Translational Research Laboratory, Institut Jules Bordet, Université Libre de Bruxelles</s1><s2>Brussels</s2><s3>BEL</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>10 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>Belgique</country><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region><settlement type="city">Bruxelles</settlement></placeName><orgName type="university">Université libre de Bruxelles</orgName></affiliation></author><author><name sortKey="Piccart, M J" sort="Piccart, M J" uniqKey="Piccart M" first="M. J." last="Piccart">M. J. Piccart</name><affiliation wicri:level="3"><inist:fA14 i1="08"><s1>Department of Medicine, Institut Jules Bordet</s1><s2>Brussels</s2><s3>BEL</s3><sZ>11 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="Loibl, S" sort="Loibl, S" uniqKey="Loibl S" first="S." last="Loibl">S. Loibl</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>German Breast Group</s1><s2>Neu-Isenburg</s2><s3>DEU</s3><sZ>12 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="Denkert, C" sort="Denkert, C" uniqKey="Denkert C" first="C." last="Denkert">C. Denkert</name><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>Charite University Hospital, Institute of Pathology</s1><s2>Berlin</s2><s3>DEU</s3><sZ>13 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="Smyth, M J" sort="Smyth, M J" uniqKey="Smyth M" first="M. J." last="Smyth">M. J. Smyth</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Immunology in Cancer and Infection Laboratory, Queensland Institute of Medical Research (QIMR) Berghofer Medical Research Institute; School of Medicine, University of Queensland</s1><s2>Herston</s2><s3>AUS</s3><sZ>14 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Herston</wicri:noRegion></affiliation></author><author><name sortKey="Joensuu, H" sort="Joensuu, H" uniqKey="Joensuu H" first="H." last="Joensuu">H. Joensuu</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Oncology, Helsinki University Central Hospital</s1><s2>Helsinki</s2><s3>FIN</s3><sZ>8 aut.</sZ><sZ>15 aut.</sZ></inist:fA14><country>Finlande</country><wicri:noRegion>Helsinki</wicri:noRegion></affiliation></author><author><name sortKey="Sotiriou, C" sort="Sotiriou, C" uniqKey="Sotiriou C" first="C." last="Sotiriou">C. Sotiriou</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Breast Cancer Translational Research Laboratory, Institut Jules Bordet, Université Libre de Bruxelles</s1><s2>Brussels</s2><s3>BEL</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>10 aut.</sZ><sZ>16 aut.</sZ></inist:fA14><country>Belgique</country><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region><settlement type="city">Bruxelles</settlement></placeName><orgName type="university">Université libre de Bruxelles</orgName></affiliation></author></analytic><series><title level="j" type="main">Annals of oncology</title><title level="j" type="abbreviated">Ann. oncol.</title><idno type="ISSN">0923-7534</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Annals of oncology</title><title level="j" type="abbreviated">Ann. oncol.</title><idno type="ISSN">0923-7534</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antineoplastic agent</term><term>Biological marker</term><term>Breast cancer</term><term>Clinical trial</term><term>Early</term><term>Infiltration</term><term>Prediction</term><term>Predictive factor</term><term>Prognosis</term><term>Result</term><term>Trastuzumab</term><term>Treatment efficiency</term><term>Triple negative breast cancer</term><term>Tumor infiltrating lymphocyte</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Lymphocyte infiltrant tumeur</term><term>Pronostic</term><term>Trastuzumab</term><term>Précoce</term><term>Cancer du sein</term><term>Résultat</term><term>Essai clinique</term><term>Infiltration</term><term>Prédiction</term><term>Facteur prédictif</term><term>Marqueur biologique</term><term>Efficacité traitement</term><term>Anticancéreux</term><term>Cancer du sein triple négatif</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background: We have previously shown the prognostic importance of tumor-infiltrating lymphocytes (TILs) in newly diagnosed triple-negative breast cancer (TNBC) using tumor samples from a large clinical trial cohort. In this study, we aimed to validate these findings and also investigate associations with trastuzumab benefit in HER2-overexpressing disease (HER2+). Patients and methods: A prospective-retrospective study was conducted using samples from the FinHER adjuvant, phase III trial that enrolled 1010 early-stage BC patients, 778 of whom were HER2-nonamplified. Those with HER2+ disease (n = 232) were randomized to 9 weeks of trastuzumab or no trastuzumab in addition to chemotherapy. Two pathologists independently quantified stromal TILs in 935 (92.6%) available slides. The primary end point of distant disease-free survival (DDFS) and interactions with trastuzumab were studied in Cox regression models. Results: Confirming our previous findings, in TNBC (n = 134) each 10% increase in TILs was significantly associated with decreased distant recurrence in TNBC; for DDFS the hazard ratio adjusted for clinicopathological factors: 0.77; 95% confidence interval (Cl) 0.61-0.98, P = 0.02. In HER2+ BC (n = 209), each 10% increase in lymphocytic infiltration was significantly associated with decreased distant recurrence in patients randomized to the trastuzumab arm (DDFS P<sub>interaction</sub> = 0.025). Conclusions: Higher levels of TILs present at diagnosis were significantly associated with decreased distant recurrence rates in primary TNBC. These results confirm our previous data and further support that TILs should be considered as a robust prognostic factor in this BC subtype. We also report for the first time an association between higher levels of TILs and increased trastuzumab benefit in HER2+ disease. Further research into why some TN and HER2+ BCs can or cannot generate a host antitumor immune response and how trastuzumab can favorably alter the immune microenvironment is warranted.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Belgique</li><li>Finlande</li><li>France</li></country><region><li>Berlin</li><li>Région de Bruxelles-Capitale</li><li>Île-de-France</li></region><settlement><li>Berlin</li><li>Bruxelles</li><li>Orsay</li></settlement><orgName><li>Université Paris-Sud</li><li>Université libre de Bruxelles</li></orgName></list><tree><country name="Belgique"><region name="Région de Bruxelles-Capitale"><name sortKey="Loi, S" sort="Loi, S" uniqKey="Loi S" first="S." last="Loi">S. Loi</name></region><name sortKey="Desmedt, C" sort="Desmedt, C" uniqKey="Desmedt C" first="C." last="Desmedt">C. Desmedt</name><name sortKey="Fumagalli, D" sort="Fumagalli, D" uniqKey="Fumagalli D" first="D." last="Fumagalli">D. Fumagalli</name><name sortKey="Jose, V" sort="Jose, V" uniqKey="Jose V" first="V." last="Jose">V. Jose</name><name sortKey="Michiels, S" sort="Michiels, S" uniqKey="Michiels S" first="S." last="Michiels">S. Michiels</name><name sortKey="Piccart, M J" sort="Piccart, M J" uniqKey="Piccart M" first="M. J." last="Piccart">M. J. Piccart</name><name sortKey="Salgado, R" sort="Salgado, R" uniqKey="Salgado R" first="R." last="Salgado">R. Salgado</name><name sortKey="Sirtaine, N" sort="Sirtaine, N" uniqKey="Sirtaine N" first="N." last="Sirtaine">N. Sirtaine</name><name sortKey="Sotiriou, C" sort="Sotiriou, C" uniqKey="Sotiriou C" first="C." last="Sotiriou">C. Sotiriou</name></country><country name="Australie"><noRegion><name sortKey="Loi, S" sort="Loi, S" uniqKey="Loi S" first="S." last="Loi">S. Loi</name></noRegion><name sortKey="Smyth, M J" sort="Smyth, M J" uniqKey="Smyth M" first="M. J." last="Smyth">M. J. Smyth</name></country><country name="France"><region name="Île-de-France"><name sortKey="Michiels, S" sort="Michiels, S" uniqKey="Michiels S" first="S." last="Michiels">S. Michiels</name></region></country><country name="Finlande"><noRegion><name sortKey="Kellokumpu Lehtinen, P L" sort="Kellokumpu Lehtinen, P L" uniqKey="Kellokumpu Lehtinen P" first="P.-L." last="Kellokumpu-Lehtinen">P.-L. Kellokumpu-Lehtinen</name></noRegion><name sortKey="Bono, P" sort="Bono, P" uniqKey="Bono P" first="P." last="Bono">P. Bono</name><name sortKey="Joensuu, H" sort="Joensuu, H" uniqKey="Joensuu H" first="H." last="Joensuu">H. Joensuu</name><name sortKey="Kataja, V" sort="Kataja, V" uniqKey="Kataja V" first="V." last="Kataja">V. Kataja</name></country><country name="Allemagne"><noRegion><name sortKey="Loibl, S" sort="Loibl, S" uniqKey="Loibl S" first="S." last="Loibl">S. Loibl</name></noRegion><name sortKey="Denkert, C" sort="Denkert, C" uniqKey="Denkert C" first="C." last="Denkert">C. 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