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Clinical Validation of EndoPredict in Pre-Menopausal Women with ER-Positive, HER2-Negative Primary Breast Cancer

PURPOSE: The EndoPredict prognostic assay is validated to predict distant recurrence and response to chemotherapy primarily in post-menopausal women with estrogen receptor–positive (ER(+)), HER2(−) breast cancer. This study evaluated the performance of EndoPredict in pre-menopausal women. EXPERIMENT...

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Autores principales: Constantinidou, Anastasia, Marcou, Yiola, Toss, Michael S., Simmons, Timothy, Bernhisel, Ryan, Hughes, Elisha, Probst, Braden, Meek, Stephanie, Kakouri, Eleni, Georgiou, Georgios, Zouvani, Ioanna, Savvidou, Gabriella, Kuhl, Vanessa, Doedt, Jennifer, Wagner, Susanne, Gutin, Alexander, Slavin, Thomas P., Lanchbury, Jerry S., Kronenwett, Ralf, Ellis, Ian O., Rakha, Emad A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Association for Cancer Research 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9561607/
https://www.ncbi.nlm.nih.gov/pubmed/36043530
http://dx.doi.org/10.1158/1078-0432.CCR-22-0619
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author Constantinidou, Anastasia
Marcou, Yiola
Toss, Michael S.
Simmons, Timothy
Bernhisel, Ryan
Hughes, Elisha
Probst, Braden
Meek, Stephanie
Kakouri, Eleni
Georgiou, Georgios
Zouvani, Ioanna
Savvidou, Gabriella
Kuhl, Vanessa
Doedt, Jennifer
Wagner, Susanne
Gutin, Alexander
Slavin, Thomas P.
Lanchbury, Jerry S.
Kronenwett, Ralf
Ellis, Ian O.
Rakha, Emad A.
author_facet Constantinidou, Anastasia
Marcou, Yiola
Toss, Michael S.
Simmons, Timothy
Bernhisel, Ryan
Hughes, Elisha
Probst, Braden
Meek, Stephanie
Kakouri, Eleni
Georgiou, Georgios
Zouvani, Ioanna
Savvidou, Gabriella
Kuhl, Vanessa
Doedt, Jennifer
Wagner, Susanne
Gutin, Alexander
Slavin, Thomas P.
Lanchbury, Jerry S.
Kronenwett, Ralf
Ellis, Ian O.
Rakha, Emad A.
author_sort Constantinidou, Anastasia
collection PubMed
description PURPOSE: The EndoPredict prognostic assay is validated to predict distant recurrence and response to chemotherapy primarily in post-menopausal women with estrogen receptor–positive (ER(+)), HER2(−) breast cancer. This study evaluated the performance of EndoPredict in pre-menopausal women. EXPERIMENTAL DESIGN: Tumor samples from 385 pre-menopausal women with ER(+), HER2(−) primary breast cancer (pT1-3, pN0-1) who did not receive chemotherapy in addition to endocrine therapy were tested with EndoPredict to produce a 12-gene EP molecular score and an integrated EPclin score that includes pathologic tumor size and nodal status. Associations of molecular and EPclin scores with 10-year distant recurrence–free survival (DRFS) were evaluated by Cox proportional hazards models and Kaplan–Meier analysis. RESULTS: After a median follow-up of 9.7 years, both the EP molecular score and the molecular-clinicopathologic EPclin score were associated with increased risk of distant recurrence [HR, 1.33; 95% confidence interval (CI), 1.18–1.50; P = 7.2 × 10(–6); HR, 3.58; 95% CI, 2.26–5.66; P = 9.8 × 10(–8), respectively]. Both scores remained significant after adjusting for clinical factors in multivariate analysis. Patients with low-risk EPclin scores (64.7%) had significantly improved DRFS compared with high-risk patients (HR, 4.61; 95% CI, 1.40–15.17; P = 4.2 × 10(–3)). At 10 years, patients with low-risk and high-risk EPclin scores had a DRFS of 97% (95% CI, 93%–99%) and 76% (95% CI, 67%–82%), respectively. CONCLUSIONS: The EPclin score is strongly associated with DRFS in pre-menopausal women who received adjuvant endocrine therapy alone. On the basis of these data, pre-menopausal women with EPclin low-risk breast cancer may be treated with endocrine therapy only and safely forgo adjuvant chemotherapy.
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spelling pubmed-95616072023-01-05 Clinical Validation of EndoPredict in Pre-Menopausal Women with ER-Positive, HER2-Negative Primary Breast Cancer Constantinidou, Anastasia Marcou, Yiola Toss, Michael S. Simmons, Timothy Bernhisel, Ryan Hughes, Elisha Probst, Braden Meek, Stephanie Kakouri, Eleni Georgiou, Georgios Zouvani, Ioanna Savvidou, Gabriella Kuhl, Vanessa Doedt, Jennifer Wagner, Susanne Gutin, Alexander Slavin, Thomas P. Lanchbury, Jerry S. Kronenwett, Ralf Ellis, Ian O. Rakha, Emad A. Clin Cancer Res Precision Medicine and Imaging PURPOSE: The EndoPredict prognostic assay is validated to predict distant recurrence and response to chemotherapy primarily in post-menopausal women with estrogen receptor–positive (ER(+)), HER2(−) breast cancer. This study evaluated the performance of EndoPredict in pre-menopausal women. EXPERIMENTAL DESIGN: Tumor samples from 385 pre-menopausal women with ER(+), HER2(−) primary breast cancer (pT1-3, pN0-1) who did not receive chemotherapy in addition to endocrine therapy were tested with EndoPredict to produce a 12-gene EP molecular score and an integrated EPclin score that includes pathologic tumor size and nodal status. Associations of molecular and EPclin scores with 10-year distant recurrence–free survival (DRFS) were evaluated by Cox proportional hazards models and Kaplan–Meier analysis. RESULTS: After a median follow-up of 9.7 years, both the EP molecular score and the molecular-clinicopathologic EPclin score were associated with increased risk of distant recurrence [HR, 1.33; 95% confidence interval (CI), 1.18–1.50; P = 7.2 × 10(–6); HR, 3.58; 95% CI, 2.26–5.66; P = 9.8 × 10(–8), respectively]. Both scores remained significant after adjusting for clinical factors in multivariate analysis. Patients with low-risk EPclin scores (64.7%) had significantly improved DRFS compared with high-risk patients (HR, 4.61; 95% CI, 1.40–15.17; P = 4.2 × 10(–3)). At 10 years, patients with low-risk and high-risk EPclin scores had a DRFS of 97% (95% CI, 93%–99%) and 76% (95% CI, 67%–82%), respectively. CONCLUSIONS: The EPclin score is strongly associated with DRFS in pre-menopausal women who received adjuvant endocrine therapy alone. On the basis of these data, pre-menopausal women with EPclin low-risk breast cancer may be treated with endocrine therapy only and safely forgo adjuvant chemotherapy. American Association for Cancer Research 2022-10-14 2022-08-31 /pmc/articles/PMC9561607/ /pubmed/36043530 http://dx.doi.org/10.1158/1078-0432.CCR-22-0619 Text en ©2022 The Authors; Published by the American Association for Cancer Research https://creativecommons.org/licenses/by-nc-nd/4.0/This open access article is distributed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) license.
spellingShingle Precision Medicine and Imaging
Constantinidou, Anastasia
Marcou, Yiola
Toss, Michael S.
Simmons, Timothy
Bernhisel, Ryan
Hughes, Elisha
Probst, Braden
Meek, Stephanie
Kakouri, Eleni
Georgiou, Georgios
Zouvani, Ioanna
Savvidou, Gabriella
Kuhl, Vanessa
Doedt, Jennifer
Wagner, Susanne
Gutin, Alexander
Slavin, Thomas P.
Lanchbury, Jerry S.
Kronenwett, Ralf
Ellis, Ian O.
Rakha, Emad A.
Clinical Validation of EndoPredict in Pre-Menopausal Women with ER-Positive, HER2-Negative Primary Breast Cancer
title Clinical Validation of EndoPredict in Pre-Menopausal Women with ER-Positive, HER2-Negative Primary Breast Cancer
title_full Clinical Validation of EndoPredict in Pre-Menopausal Women with ER-Positive, HER2-Negative Primary Breast Cancer
title_fullStr Clinical Validation of EndoPredict in Pre-Menopausal Women with ER-Positive, HER2-Negative Primary Breast Cancer
title_full_unstemmed Clinical Validation of EndoPredict in Pre-Menopausal Women with ER-Positive, HER2-Negative Primary Breast Cancer
title_short Clinical Validation of EndoPredict in Pre-Menopausal Women with ER-Positive, HER2-Negative Primary Breast Cancer
title_sort clinical validation of endopredict in pre-menopausal women with er-positive, her2-negative primary breast cancer
topic Precision Medicine and Imaging
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9561607/
https://www.ncbi.nlm.nih.gov/pubmed/36043530
http://dx.doi.org/10.1158/1078-0432.CCR-22-0619
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