Predictive value and clinical utility of centrally-assessed ER, PgR and Ki-67 to select adjuvant endocrine therapy for premenopausal women with hormone receptor-positive, HER2-negative early breast cancer: TEXT and SOFT trials
Identifieur interne : 002979 ( Main/Exploration ); précédent : 002978; suivant : 002980Predictive value and clinical utility of centrally-assessed ER, PgR and Ki-67 to select adjuvant endocrine therapy for premenopausal women with hormone receptor-positive, HER2-negative early breast cancer: TEXT and SOFT trials
Auteurs : Meredith M. Regan ; Olivia Pagani ; Prudence A. Francis ; Gini F. Fleming ; Barbara A. Walley ; Roswitha Kammler ; Patrizia Dell'Orto ; Leila Russo ; János Sz Ke ; Franco Doimi ; Laura Villani ; Stefano Pizzolitto ; Christian Öhlschlegel ; Fausto Sessa ; Vicente Peg Cámara ; José Luis Rodríguez Peralto ; Gaëtan Macgrogan ; Marco Colleoni ; Aron Goldhirsch ; Karen N. Price ; Alan S. Coates ; Richard D. Gelber ; Giuseppe VialeSource :
- Breast cancer research and treatment [ 0167-6806 ] ; 2015.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Antigène KI-67 (métabolisme), Antinéoplasiques hormonaux (usage thérapeutique), Charge tumorale, Essais cliniques de phase III comme sujet, Essais contrôlés randomisés comme sujet, Estimation de Kaplan-Meier, Femelle, Grading des tumeurs, Humains, Jeune adulte, Marqueurs biologiques tumoraux, Modèles de hasards proportionnels, Métastase lymphatique, Pronostic, Préménopause, Récepteur ErbB-2, Récepteurs des oestrogènes (métabolisme), Récepteurs à la progestérone (métabolisme), Sujet âgé, Traitement médicamenteux adjuvant, Tumeurs du sein (diagnostic), Tumeurs du sein (mortalité), Tumeurs du sein (métabolisme), Tumeurs du sein (traitement médicamenteux).
- MESH :
- diagnostic : Tumeurs du sein.
- mortalité : Tumeurs du sein.
- métabolisme : Antigène KI-67, Récepteurs des oestrogènes, Récepteurs à la progestérone, Tumeurs du sein.
- traitement médicamenteux : Tumeurs du sein.
- usage thérapeutique : Antinéoplasiques hormonaux.
- Adulte, Adulte d'âge moyen, Charge tumorale, Essais cliniques de phase III comme sujet, Essais contrôlés randomisés comme sujet, Estimation de Kaplan-Meier, Femelle, Grading des tumeurs, Humains, Jeune adulte, Marqueurs biologiques tumoraux, Modèles de hasards proportionnels, Métastase lymphatique, Pronostic, Préménopause, Récepteur ErbB-2, Sujet âgé, Traitement médicamenteux adjuvant.
English descriptors
- KwdEn :
- Adult, Aged, Antineoplastic Agents, Hormonal (therapeutic use), Biomarkers, Tumor, Breast Neoplasms (diagnosis), Breast Neoplasms (drug therapy), Breast Neoplasms (metabolism), Breast Neoplasms (mortality), Chemotherapy, Adjuvant, Clinical Trials, Phase III as Topic, Female, Humans, Kaplan-Meier Estimate, Ki-67 Antigen (metabolism), Lymphatic Metastasis, Middle Aged, Neoplasm Grading, Premenopause, Prognosis, Proportional Hazards Models, Randomized Controlled Trials as Topic, Receptor, ErbB-2, Receptors, Estrogen (metabolism), Receptors, Progesterone (metabolism), Tumor Burden, Young Adult.
- MESH :
- chemical , metabolism : Ki-67 Antigen, Receptors, Estrogen, Receptors, Progesterone.
- chemical , therapeutic use : Antineoplastic Agents, Hormonal.
- diagnosis : Breast Neoplasms.
- drug therapy : Breast Neoplasms.
- metabolism : Breast Neoplasms.
- mortality : Breast Neoplasms.
- Adult, Aged, Biomarkers, Tumor, Chemotherapy, Adjuvant, Clinical Trials, Phase III as Topic, Female, Humans, Kaplan-Meier Estimate, Lymphatic Metastasis, Middle Aged, Neoplasm Grading, Premenopause, Prognosis, Proportional Hazards Models, Randomized Controlled Trials as Topic, Receptor, ErbB-2, Tumor Burden, Young Adult.
Abstract
The SOFT and TEXT randomized phase III trials investigated adjuvant endocrine therapies for premenopausal women with hormone receptor-positive (HR+) early breast cancer. We investigated the prognostic and predictive value of centrally-assessed levels of estrogen receptor (ER), progesterone receptor (PgR) and Ki-67 expression in women with HER2-negative disease.
Of 5707 women enrolled, 4115 with HER2-negative (HR+/HER2-) disease had ER, PgR and Ki-67 centrally assessed by immunohistochemistry. Breast cancer-free interval (BCFI) was defined from randomization to first invasive local, regional or distant recurrence or contralateral breast cancer. The prognostic and predictive values of ER, PgR and Ki-67 expression levels were assessed using Cox modeling and STEPP methodology.
In this HR+/HER2- population, the median ER, PgR and Ki-67 expression were 95%, 90% and 18% immunostained cells. As most patients had strongly ER positive tumors, the predictive value of ER levels could not be investigated. Lower PgR and higher Ki-67 expression were associated with reduced BCFI. There was no consistent evidence of heterogeneity of the relative treatment effects according to PgR or Ki-67 expression levels though there was a greater 5-year absolute benefit of exemestane+ovarian function suppression (OFS) versus tamoxifen with or without OFS at lower levels of PgR and higher levels of Ki-67.
Women with poor prognostic features of low PgR and/or high Ki-67 have greater absolute benefit from exemestane+OFS versus tamoxifen+OFS or tamoxifen-alone, but individually PgR and Ki-67 are of limited predictive value for selecting adjuvant endocrine therapy for premenopausal women with HR+/HER2- early breast cancer.
Url:
DOI: 10.1007/s10549-015-3612-z
PubMed: 26493064
PubMed Central: 4749471
Affiliations:
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Regan</name></author><author><name sortKey="Pagani, Olivia" sort="Pagani, Olivia" uniqKey="Pagani O" first="Olivia" last="Pagani">Olivia Pagani</name></author><author><name sortKey="Francis, Prudence A" sort="Francis, Prudence A" uniqKey="Francis P" first="Prudence A." last="Francis">Prudence A. Francis</name></author><author><name sortKey="Fleming, Gini F" sort="Fleming, Gini F" uniqKey="Fleming G" first="Gini F." last="Fleming">Gini F. Fleming</name></author><author><name sortKey="Walley, Barbara A" sort="Walley, Barbara A" uniqKey="Walley B" first="Barbara A." last="Walley">Barbara A. Walley</name></author><author><name sortKey="Kammler, Roswitha" sort="Kammler, Roswitha" uniqKey="Kammler R" first="Roswitha" last="Kammler">Roswitha Kammler</name></author><author><name sortKey="Dell Orto, Patrizia" sort="Dell Orto, Patrizia" uniqKey="Dell Orto P" first="Patrizia" last="Dell'Orto">Patrizia Dell'Orto</name></author><author><name sortKey="Russo, Leila" sort="Russo, Leila" uniqKey="Russo L" first="Leila" last="Russo">Leila Russo</name></author><author><name sortKey="Sz Ke, Janos" sort="Sz Ke, Janos" uniqKey="Sz Ke J" first="János" last="Sz Ke">János Sz Ke</name></author><author><name sortKey="Doimi, Franco" sort="Doimi, Franco" uniqKey="Doimi F" first="Franco" last="Doimi">Franco Doimi</name></author><author><name sortKey="Villani, Laura" sort="Villani, Laura" uniqKey="Villani L" first="Laura" last="Villani">Laura Villani</name></author><author><name sortKey="Pizzolitto, Stefano" sort="Pizzolitto, Stefano" uniqKey="Pizzolitto S" first="Stefano" last="Pizzolitto">Stefano Pizzolitto</name></author><author><name sortKey="Ohlschlegel, Christian" sort="Ohlschlegel, Christian" uniqKey="Ohlschlegel C" first="Christian" last="Öhlschlegel">Christian Öhlschlegel</name></author><author><name sortKey="Sessa, Fausto" sort="Sessa, Fausto" uniqKey="Sessa F" first="Fausto" last="Sessa">Fausto Sessa</name></author><author><name sortKey="Camara, Vicente Peg" sort="Camara, Vicente Peg" uniqKey="Camara V" first="Vicente Peg" last="Cámara">Vicente Peg Cámara</name></author><author><name sortKey="Peralto, Jose Luis Rodriguez" sort="Peralto, Jose Luis Rodriguez" uniqKey="Peralto J" first="José Luis Rodríguez" last="Peralto">José Luis Rodríguez Peralto</name></author><author><name sortKey="Macgrogan, Gaetan" sort="Macgrogan, Gaetan" uniqKey="Macgrogan G" first="Gaëtan" last="Macgrogan">Gaëtan Macgrogan</name></author><author><name sortKey="Colleoni, Marco" sort="Colleoni, Marco" uniqKey="Colleoni M" first="Marco" last="Colleoni">Marco Colleoni</name></author><author><name sortKey="Goldhirsch, Aron" sort="Goldhirsch, Aron" uniqKey="Goldhirsch A" first="Aron" last="Goldhirsch">Aron Goldhirsch</name></author><author><name sortKey="Price, Karen N" sort="Price, Karen N" uniqKey="Price K" first="Karen N." last="Price">Karen N. Price</name></author><author><name sortKey="Coates, Alan S" sort="Coates, Alan S" uniqKey="Coates A" first="Alan S." last="Coates">Alan S. Coates</name></author><author><name sortKey="Gelber, Richard D" sort="Gelber, Richard D" uniqKey="Gelber R" first="Richard D." last="Gelber">Richard D. Gelber</name></author><author><name sortKey="Viale, Giuseppe" sort="Viale, Giuseppe" uniqKey="Viale G" first="Giuseppe" last="Viale">Giuseppe Viale</name></author></analytic><series><title level="j">Breast cancer research and treatment</title><idno type="ISSN">0167-6806</idno><idno type="eISSN">1573-7217</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Antineoplastic Agents, Hormonal (therapeutic use)</term><term>Biomarkers, Tumor</term><term>Breast Neoplasms (diagnosis)</term><term>Breast Neoplasms (drug therapy)</term><term>Breast Neoplasms (metabolism)</term><term>Breast Neoplasms (mortality)</term><term>Chemotherapy, Adjuvant</term><term>Clinical Trials, Phase III as Topic</term><term>Female</term><term>Humans</term><term>Kaplan-Meier Estimate</term><term>Ki-67 Antigen (metabolism)</term><term>Lymphatic Metastasis</term><term>Middle Aged</term><term>Neoplasm Grading</term><term>Premenopause</term><term>Prognosis</term><term>Proportional Hazards Models</term><term>Randomized Controlled Trials as Topic</term><term>Receptor, ErbB-2</term><term>Receptors, Estrogen (metabolism)</term><term>Receptors, Progesterone (metabolism)</term><term>Tumor Burden</term><term>Young Adult</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Antigène KI-67 (métabolisme)</term><term>Antinéoplasiques hormonaux (usage thérapeutique)</term><term>Charge tumorale</term><term>Essais cliniques de phase III comme sujet</term><term>Essais contrôlés randomisés comme sujet</term><term>Estimation de Kaplan-Meier</term><term>Femelle</term><term>Grading des tumeurs</term><term>Humains</term><term>Jeune adulte</term><term>Marqueurs biologiques tumoraux</term><term>Modèles de hasards proportionnels</term><term>Métastase lymphatique</term><term>Pronostic</term><term>Préménopause</term><term>Récepteur ErbB-2</term><term>Récepteurs des oestrogènes (métabolisme)</term><term>Récepteurs à la progestérone (métabolisme)</term><term>Sujet âgé</term><term>Traitement médicamenteux adjuvant</term><term>Tumeurs du sein (diagnostic)</term><term>Tumeurs du sein (mortalité)</term><term>Tumeurs du sein (métabolisme)</term><term>Tumeurs du sein (traitement médicamenteux)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="metabolism" xml:lang="en"><term>Ki-67 Antigen</term><term>Receptors, Estrogen</term><term>Receptors, Progesterone</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Agents, Hormonal</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Breast Neoplasms</term></keywords><keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr"><term>Tumeurs du sein</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Breast Neoplasms</term></keywords><keywords scheme="MESH" qualifier="metabolism" xml:lang="en"><term>Breast Neoplasms</term></keywords><keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Breast Neoplasms</term></keywords><keywords scheme="MESH" qualifier="mortalité" xml:lang="fr"><term>Tumeurs du sein</term></keywords><keywords scheme="MESH" qualifier="métabolisme" xml:lang="fr"><term>Antigène KI-67</term><term>Récepteurs des oestrogènes</term><term>Récepteurs à la progestérone</term><term>Tumeurs du sein</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Tumeurs du sein</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Antinéoplasiques hormonaux</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Biomarkers, Tumor</term><term>Chemotherapy, Adjuvant</term><term>Clinical Trials, Phase III as Topic</term><term>Female</term><term>Humans</term><term>Kaplan-Meier Estimate</term><term>Lymphatic Metastasis</term><term>Middle Aged</term><term>Neoplasm Grading</term><term>Premenopause</term><term>Prognosis</term><term>Proportional Hazards Models</term><term>Randomized Controlled Trials as Topic</term><term>Receptor, ErbB-2</term><term>Tumor Burden</term><term>Young Adult</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Charge tumorale</term><term>Essais cliniques de phase III comme sujet</term><term>Essais contrôlés randomisés comme sujet</term><term>Estimation de Kaplan-Meier</term><term>Femelle</term><term>Grading des tumeurs</term><term>Humains</term><term>Jeune adulte</term><term>Marqueurs biologiques tumoraux</term><term>Modèles de hasards proportionnels</term><term>Métastase lymphatique</term><term>Pronostic</term><term>Préménopause</term><term>Récepteur ErbB-2</term><term>Sujet âgé</term><term>Traitement médicamenteux adjuvant</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="S1"><title>Purpose</title><p id="P1">The SOFT and TEXT randomized phase III trials investigated adjuvant endocrine therapies for premenopausal women with hormone receptor-positive (HR+) early breast cancer. We investigated the prognostic and predictive value of centrally-assessed levels of estrogen receptor (ER), progesterone receptor (PgR) and Ki-67 expression in women with HER2-negative disease.</p></sec><sec id="S2"><title>Patients and Methods</title><p id="P2">Of 5707 women enrolled, 4115 with HER2-negative (HR+/HER2-) disease had ER, PgR and Ki-67 centrally assessed by immunohistochemistry. Breast cancer-free interval (BCFI) was defined from randomization to first invasive local, regional or distant recurrence or contralateral breast cancer. The prognostic and predictive values of ER, PgR and Ki-67 expression levels were assessed using Cox modeling and STEPP methodology.</p></sec><sec id="S3"><title>Results</title><p id="P3">In this HR+/HER2- population, the median ER, PgR and Ki-67 expression were 95%, 90% and 18% immunostained cells. As most patients had strongly ER positive tumors, the predictive value of ER levels could not be investigated. Lower PgR and higher Ki-67 expression were associated with reduced BCFI. There was no consistent evidence of heterogeneity of the relative treatment effects according to PgR or Ki-67 expression levels though there was a greater 5-year absolute benefit of exemestane+ovarian function suppression (OFS) versus tamoxifen with or without OFS at lower levels of PgR and higher levels of Ki-67.</p></sec><sec id="S4"><title>Conclusions</title><p id="P4">Women with poor prognostic features of low PgR and/or high Ki-67 have greater absolute benefit from exemestane+OFS versus tamoxifen+OFS or tamoxifen-alone, but individually PgR and Ki-67 are of limited predictive value for selecting adjuvant endocrine therapy for premenopausal women with HR+/HER2- early breast cancer.</p></sec></div></front></TEI><affiliations><list></list><tree><noCountry><name sortKey="Camara, Vicente Peg" sort="Camara, Vicente Peg" uniqKey="Camara V" first="Vicente Peg" last="Cámara">Vicente Peg Cámara</name><name sortKey="Coates, Alan S" sort="Coates, Alan S" uniqKey="Coates A" first="Alan S." last="Coates">Alan S. Coates</name><name sortKey="Colleoni, Marco" sort="Colleoni, Marco" uniqKey="Colleoni M" first="Marco" last="Colleoni">Marco Colleoni</name><name sortKey="Dell Orto, Patrizia" sort="Dell Orto, Patrizia" uniqKey="Dell Orto P" first="Patrizia" last="Dell'Orto">Patrizia Dell'Orto</name><name sortKey="Doimi, Franco" sort="Doimi, Franco" uniqKey="Doimi F" first="Franco" last="Doimi">Franco Doimi</name><name sortKey="Fleming, Gini F" sort="Fleming, Gini F" uniqKey="Fleming G" first="Gini F." last="Fleming">Gini F. Fleming</name><name sortKey="Francis, Prudence A" sort="Francis, Prudence A" uniqKey="Francis P" first="Prudence A." last="Francis">Prudence A. Francis</name><name sortKey="Gelber, Richard D" sort="Gelber, Richard D" uniqKey="Gelber R" first="Richard D." last="Gelber">Richard D. Gelber</name><name sortKey="Goldhirsch, Aron" sort="Goldhirsch, Aron" uniqKey="Goldhirsch A" first="Aron" last="Goldhirsch">Aron Goldhirsch</name><name sortKey="Kammler, Roswitha" sort="Kammler, Roswitha" uniqKey="Kammler R" first="Roswitha" last="Kammler">Roswitha Kammler</name><name sortKey="Macgrogan, Gaetan" sort="Macgrogan, Gaetan" uniqKey="Macgrogan G" first="Gaëtan" last="Macgrogan">Gaëtan Macgrogan</name><name sortKey="Ohlschlegel, Christian" sort="Ohlschlegel, Christian" uniqKey="Ohlschlegel C" first="Christian" last="Öhlschlegel">Christian Öhlschlegel</name><name sortKey="Pagani, Olivia" sort="Pagani, Olivia" uniqKey="Pagani O" first="Olivia" last="Pagani">Olivia Pagani</name><name sortKey="Peralto, Jose Luis Rodriguez" sort="Peralto, Jose Luis Rodriguez" uniqKey="Peralto J" first="José Luis Rodríguez" last="Peralto">José Luis Rodríguez Peralto</name><name sortKey="Pizzolitto, Stefano" sort="Pizzolitto, Stefano" uniqKey="Pizzolitto S" first="Stefano" last="Pizzolitto">Stefano Pizzolitto</name><name sortKey="Price, Karen N" sort="Price, Karen N" uniqKey="Price K" first="Karen N." last="Price">Karen N. Price</name><name sortKey="Regan, Meredith M" sort="Regan, Meredith M" uniqKey="Regan M" first="Meredith M." last="Regan">Meredith M. Regan</name><name sortKey="Russo, Leila" sort="Russo, Leila" uniqKey="Russo L" first="Leila" last="Russo">Leila Russo</name><name sortKey="Sessa, Fausto" sort="Sessa, Fausto" uniqKey="Sessa F" first="Fausto" last="Sessa">Fausto Sessa</name><name sortKey="Sz Ke, Janos" sort="Sz Ke, Janos" uniqKey="Sz Ke J" first="János" last="Sz Ke">János Sz Ke</name><name sortKey="Viale, Giuseppe" sort="Viale, Giuseppe" uniqKey="Viale G" first="Giuseppe" last="Viale">Giuseppe Viale</name><name sortKey="Villani, Laura" sort="Villani, Laura" uniqKey="Villani L" first="Laura" last="Villani">Laura Villani</name><name sortKey="Walley, Barbara A" sort="Walley, Barbara A" uniqKey="Walley B" first="Barbara A." last="Walley">Barbara A. Walley</name></noCountry></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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