Clinical Validation
Confident decision-making starts with identification of the true low-risk group of patients.

Accurate assessment of risk can help patients with low-risk disease that may safely forgo chemotherapy. EndoPredict integrates gene expression with clinicopathological features to identify a large population of true low-risk patients.

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EndoPredict was independently validated to produce robust 10-year prognostic results
EndoPredict was developed using consistent criteria for patients during training and independent validation studies: ER+, HER2− patients, both node-negative (N0) and node-positive (N+). All patients received only 5 years of endocrine therapy.
Training and independent validation studies
EndoPredict identifies a consistent risk of recurrence in N0 and N+ patients
Filipits et al reported the independent validation of the EndoPredict 12-gene molecular score (EP score) and comprehensive EPclin Risk Score using data from two phase 3 studies, ABCSG-6 and ABCSG-8. Women in these studies received 5 years of endocrine therapy alone. Those in ABCSG-6 received either 5 years of tamoxifen or 2 years of tamoxifen and aminoglutethimide, followed by 3 years of tamoxifen. Those in ABCSG-8 received 5 years tamoxifen or 2 years tamoxifen followed by 3 years of anastrozole.1
Analytics of ER+
EndoPredict improves prediction of distant metastasis compared to standard assessments
EndoPredict improves prognostic accuracy in comparison to Ki-67
Kaplan-Meier analysis for distant metastasis-free survival of EPclin risk assessment on 1702 ER+, HER2− samples from ABCSG-6 and ABCSG-8 previously identified by Ki-67 molecular subtype as low-risk (luminal A molecular subtype, Ki-67 levels<14%) or high-risk (luminal B molecular subtype, Ki-67 levels ≥14%).6
Analytics of ER+
EndoPredict provides improved accuracy in comparison to tumor grade
Kaplan-Meier analysis for distant metastasis-free survival of EPclin risk assessment on 1702 ER+, HER2− samples from ABCSG-6 and ABCSG-8 previously identified by tumor grade 1, 2, or 3.6
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References: 1. Filipits M, Rudas M, Jakesz R, et al; for EP Investigators. A new molecular predictor of distant recurrence in ER-positive, HER2-negative breast cancer adds independent prognostics information to conventional clinical risk factors. Clin Cancer Res. 2011;17(18)6012-20. 2. Filipits M, Rudas M, Jakesz R, et al; for EP Investigators. A new molecular predictor of distant recurrence in ER-positive, HER2-negative breast cancer adds independent information to conventional clinical risk factors [supplementary materials]. Clin Cancer Res. 2011;17(18):6012-6020. 3. Buus R, Sestak I, Kronenwett R, et al. Comparison of EndoPredict and EPclin with Oncotype DX recurrence score for prediction of risk of distant recurrence after endocrine therapy. J Natl Cancer Inst. 2016;108(11):djw149. 4. Data on file. Myriad Genetics, Inc. 5. Buus R, Sestak I, Kronenwett R, et al. Comparison of EndoPredict and EPclin with Oncotype DX recurrence score for prediction of risk of distant recurrence after endocrine therapy [supplementary materials]. J Natl Cancer Inst. 2016;108(11):djw149. 6. Dubsky P, Filipits M, Jakesz R, et al; on behalf of Austrian Breast and Colorectal Cancer Study Group. EndoPredict improves the prognostic classification derived from common clinical guidelines in ER-positive, HER2-negative early breast cancer. Ann Oncol. 2013;24(3): 640-647. 7. Dubsky P, Filipits M, Jakesz R, et al; on behalf of Austrian Breast and Colorectal Cancer Study Group. EndoPredict improves the prognostic classification derived from common clinical guidelines in ER-positive, HER2-negative early breast cancer [supplementary materials]. Ann Oncol. 2013;24(3):640-647.

Analytics of ER+
Chemotherapy Benefit
Prediction of Distant Recurrence by EndoPredict in Patients with ER+, HER2- Breast Cancer who Received Adjuvant Endocrine Therapy plus Chemotherapy (ET+C) or Endocrine Therapy Alone (ET)
Ivana Sestak, Miguel Martin, Peter Dubsky, Federico Rojo, Jack Cuzick, Martin Filipits, Amparo Ruiz, William Gradishar, Hatem Soliman, Lee Schwartzberg, Richard Buus, Dominik Hlauschek, Alvaro Rodriguez-Lescure, Michael Gnant
Summary
  • Chemobenefit validated:
    – In over 3,700 patients with ER+, HER2- breast cancer
    – With modern (taxane-containing) treatment regimens
  • Patients with a low-risk EndoPredict result did not benefit from the addition of chemotherapy
  • Patients with a higher EndoPredict score had a greater benefit from chemotherapy
Background
EndoPredict (EPclin) is a prognostic test validated for early stage breast cancer patients with ER+, HER2- disease to help make decisions between 5 years of endocrine therapy alone or with chemotherapy.1,2,3
Objective
To investigate in a non-randomized setting whether EPclin can predict chemotherapy benefit in pre- and post-menopausal women with ER+, HER2-disease who have received five years of endocrine therapy alone (ET) or in combination with chemotherapy (ET+C).
Methods
  • A total of 3,746 women with ER+, HER2- disease were included in this analysis
  • The primary objective was to evaluate the 10-year distant recurrence-free interval (DRFI) rates as a continuous function of EPclin separately for patients in ET+C and ET
Results
  • Patients with a low-risk EndoPredict result did not benefit from the addition of chemotherapy
  • Patients with higher EndoPredict scores had a greater benefit from chemotherapy
  • Baseline demographics for the two cohorts are shown in Table 1
  • Median follow-up for those on ET alone was 9.6 years (IQR 6.0-10.0) vs. 9.2 years (7.5-10.0) for ET+C
  • Clear distinction in 10-year risk between ET alone vs ET+C as the EndoPredict score increases (Figure 1)
  • Interaction between EPclin and treatment was significant (P=0.02)
Table 1Table 2
Conclusions
  • Patients with a high EPclin score on ET+C had a significantly lower 10-year distant recurrence (DR) risk than those on ET alone
  • No differences in 10-year DR risks were observed between ET alone and ET+C for low EPclin scores (<3.3 low risk cut-off)
  • Interaction between EPclin and treatment was significant (P=0.02)
    – Potential benefit of adding chemotherapy to those with high EPclin scores
  • Patients with higher EPclin scores have a disproportionate benefit from chemotherapy
  • Results give insight into the predictive value of EPclin for women with ER+, HER2- breast cancer
References: 1. Dubsky P, Filipits M, Jakesz R, et al. EndoPredict improves the prognostic classification derived from common clinical guidelines in ER+, HER2- early breast cancer. Ann Oncol . 2013;24(3):640-647. 2. Buus R, Sestak I, Kronenwett R, et al. Comparison of EndoPredict and EPclin with Oncotype DX recurrence score for prediction of risk of distant recurrence after endocrine therapy. J Natl Cancer Inst . 2016;108(11):doi: 10.1093/jnci/djw149. 3. Martin M, Brase JC, Calvo L, et al. Clinical validation of the EndoPredict test in node‑positive, chemotherapy-treated ER+/HER2- breast cancer patients: results from the GEICAM 9906 trial. Breast Cancer  Res.2014;16(2):R38. doi:10.1186/bcr3642
Prediction of Late Recurrence (5-15 Years)
Prediction of Distant Recurrence Using EndoPredict Among Women with ER+, HER2- Breast Cancer with a Maximum Follow-up of 16 Years
M. Filipits, P. Dubsky, M. Rudas, R. Greil, M. Balic, F. Fitzal, Z. Bago-Horvath, C. Singer, D. Hlauschek, R. Kronenwett, R. Bernhisel, J. Lancaster, M. Gnant
Summary
  • EndoPredict is the only prognostic test that provides recurrence risk out to 15 years to help guide extended endocrine treatment decisions
  • EndoPredict low-risk patients had a consistent 4% risk of recurrence in years 5-15
  • Patients with a lower EndoPredict risk of recurrence in years 5-15 are unlikely to benefit from extended endocrine therapy
Background
  • Treatment decisions for women with ER+, HER2- breast cancer are made at two time points: at diagnosis for adjuvant chemotherapy and at 5 years post-diagnosis for extended endocrine therapy
  • EndoPredict has been extensively validated in over 3,500 women with ER+, HER2- disease.1-6
  • Here, we further evaluate the prognostic value of EndoPredict in the combined ABCSG-6 and -8 cohort with longer-term follow-up and compare 10-year distant recurrence (DR) and 5-15 years late recurrence according to nodal status
Methods
  • Late recurrence risk validated in over 1,700 ER+, HER2- patients
    – This analysis included 1702 patients with ER+, HER2- disease who received endocrine therapy only
  • All women received 5 years of adjuvant endocrine therapy alone (no chemotherapy)
  • Analyses were performed for the overall cohort, by nodal status, and for patients who were distant recurrence free at year 5 (late recurrence)
Results
  • For patients who had not recurred by 5 years post‑diagnosis (N=1,386), EPclin was also highly prognostic 5-15 years post‑diagnosis after adjusting for clinical variables, independent from nodal status
  • Women with low EPclin had better long‑term outcomes than EPclin high‑risk patients (HR 4.52, 95% CI 2.65-7.72; p<0.0001)
  • The low-risk group had a distant recurrence‑free survival (DRFS) of 95.7% (95% CI, 93.4%, 98.1%) during years 5-15 post‑diagnosis, while the high‑risk group had a DRFS of 84.1% (95% CI, 78.9%, 89.6%) over this period (Figure 1)
Figure 1
Conclusions
  • Here we show that EPclin successfully predicts risk of early (0-10 years) and late (5-15 years) recurrence for patients with both node-negative and node-positive disease
  • This analysis of longer follow-up on previously published cohorts1-4 confirms that EPclin can identify a large group of patients at low risk of distant recurrence after 10 years who may be adequately treated with only 5 years of adjuvant endocrine therapy
  • Replication of these results for the distant recurrence period (5-15 years) indicates that EPclin scores are also informative for selecting patients who may safely forgo extended endocrine therapy
References: 1. Filipits M, Rudas M, Jakesz R, et al. A new molecular predictor of distant recurrence in ER+, HER2- breast cancer adds independent information to conventional clinical risk factors. Clin Cancer Res. 2011;17(18)6012-6020. 2. Dubsky P, Brase JC, Jakesz R, et al. The EndoPredict score provides prognostic information on late distant metastasis in ER+/HER2- breast cancer patients. Br J Cancer. 2013;109(12):2959-2964. 3. Dubsky P, Filipits M, Jakesz R. EndoPredict improves the prognostic classification derived from common clinical guidelines in ER+, HER2- early breast cancer. Ann Oncol. 2013;24(3):640-647. doi: 10.1093/annonc/mds334. 4. Fitzal F, Filipits M, Rudas M, et al. The genomic expression test EndoPredict is a prognostic tool for identifying risk of local recurrence in postmenopausal endocrine receptor-positive, her2neu-negative breast cancer patients randomised within the prospective ABCSG 8 trial. Br J Cancer.
2015;112(8):1405-1410. 5. Buus R, Sestak I, Kronenwett R, et al. Comparison of EndoPredict and EPclin With Oncotype DX Recurrence Score for Prediction of Risk of Distant Recurrence After Endocrine Therapy. J Natl Cancer Inst. 2016;108(11). doi: 10.1093/jnci/djw149. 6. Sestak I, Buus R, Cuzick J, et al. Comparison of the Performance of 6 Prognostic Signatures for Estrogen Receptor-Positive Breast Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2018;4(4):545-553.
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Publications
2019
2018
Dec 07, 2018
Prediction of Distant Recurrence Using EndoPredict Among Women with ER+, HER2- Breast Cancer with a Maximum Follow-up of 16 Years
Author: Martin Filipits
Publication: SABCS 2018
Dec 06, 2018
Prediction of Distant Recurrence by EndoPredict in Patients with Estrogen Receptor-Positive, HER2- Breast Cancer who Received Adjuvant Endocrine Therapy plus Chemotherapy (ET+C) or Endocrine Therapy Alone (ET)
Author: Ivana Sestak
Publication: SABCS 2018
Dec 05, 2018
RESCUE: REACHING FOR EVIDENCE-BASED CHEMOTHERAPY USE IN ENDOCRINE SENSITIVE BREAST CANCER, A prospective health care study on risk assessment by the clinicomolecular test EndoPredict® and long-term patient outcome in early luminal breast cancer
Author: Johannes Ettl
Publication: SABCS 2018
Jun 02, 2018
In Silico Evaluation of the 12-Gene Molecular Score (EndoPredict) and the Recurrence Score (Oncotype DX) as Predictors of Response to Neo-adjuvant Chemotherapy in Estrogen Receptor Positive, HER2 Negative Breast Cancer
Author: Hatem Soliman, MD
Publication: ASCO 2018
Jun 02, 2018
Predicting Expected Absolute Chemotherapy Treatment Benefit in Women with Early-Stage Breast Cancer using a 12-Gene Expression Assay
Author: William Gradishar, MD
Publication: ASCO 2018
Feb 15, 2018
Comparison of the Performance of 6 Prognostic Signatures for Estrogen Receptor – Positive Breast Cancer: A Secondary Analysis of a Randomized Clinical Trial
Author: Ivana Sestak, Richard Buus, Jack Cuzick, Peter Dubsky, Ralf Kronenwett, Carsten Denkert, Sean Ferree, Dennis Sgroi, Catherine Schnabel, Frederick L. Baehner, Elizabeth Mallon, Mitch Dowsett
Publication:
2017
Sep 06, 2017
Decision impact and feasibility of different ASCO-recommended biomarkers in early breast cancer: Prospective comparison of molecular marker EndoPredict and protein marker uPA/PAI-1
Author: Johannes Ettl, Evelyn Klein, Alexander Hapfelmeier, Kirsten Grosse Lackmann, Stefan Paepke, Christoph Petry, Katja Specht, Laura Wolff, Heinz Höfler, Marion Kiechle
Publication:
2016
Dec 08, 2016
UCBG 2-14: A prospective multicenter non-randomized trial evaluating the effect of EndoPredict® (EPclin®) clinicogenomic test on treatment decision making among patients with intermediate clinical risk
Author: F Penault-Llorca, F Kwiatkovski, J Grenier, C Levy, M Leheurteur, L Uwer, O Derbel, A Le Rol, JP Jacquin, C Jouannaud, N Quenel-Tueux, V Girre, C Foa, E Guardiola, A Lortholary, S Catala, J Lemonnier, S Delaloge
Publication: SABCS16
Jul 10, 2016
Comparison of EndoPredict and EPclin With Oncotype DX Recurrence Score for Prediction of Risk of Distant Recurrence After Endocrine Therapy
Author: Buus et al
Publication:
Feb 16, 2016
Prognostic ability of EndoPredict compared to research-based versions of the PAM50 risk of recurrence (ROR) scores in nodepositive, estrogen receptor-positive, and HER2- breast cancer. A GEICAM/9906 sub-study
Author: Martin et al.
Publication:
2015
2014
Nov 18, 2014
Cost-Effectiveness Analysis of Prognostic Gene Expression Signature-Based Stratification of Early Breast Cancer Patients. PharmacoEconomics
Author: Blank et al
Publication: PharmacoEconomics
Sep 14, 2014
Preanalytical variables and performance of diagnostic RNA-based gene expression analysis in breast cancer
Author: Poremba et al
Publication: Virchows Arch
2013
Oct 24, 2013
The EndoPredict score provides prognostic information on late distant metastasis in ER+/HER2− breast cancer patients.
Author: Dubsky et al.
Publication: British Journal of Cancer. 109: 2959-2964
Aug 29, 2013
From High-Throuput Microarray-Based Screening to Clinical Application: The Development of a Second Generation Multigen Test for Breast Cancer Prognosis
Author: Brase et al
Publication: MDPI
Jul 31, 2013
Clinical validation of the EndoPredict test in node-positive chemotherapy-treated ER+/HER2- breast cancer patients: results from the GEICAM/9906 trial
Author: Martin et al
Publication: Breast Cancer Res. 2014 Apr 12;16(2):R38
Jun 27, 2013
The EndoPredict Gene-Expression Assay in Clinical Practice – Performance and Impact on Clinical Decisions
Author: Müller et al
Publication: PLOS ONE
2012
Oct 05, 2012
Decentral gene expression analysis: analytical validation of the Endopredict genomic multianalyte breast cancer prognosis test
Author: Kronenwett et al
Publication: BMC Cancer
Oct 03, 2012
EndoPredict improves the prognostic classification derived from common clinical guidelines in ER+, HER2- early breast cancer
Author: Dubsky et al
Publication: Ann Oncol
Jul 01, 2012
Comparison of the RNA-based EndoPredict multigene test between core biopsies and corresponding surgical breast cancer sections
Author: Müller et al
Publication: J Clin Pathol
Feb 28, 2012
Decentral gene expression analysis for ER+/Her2- breast cancer – results of a proficiency testing program for the EndoPredict assay.
Author: Denkert et al
Publication: Virchows Arch. 460: 251-259
2011
Sep 15, 2011
A new molecular predictor of distant recurrence in ER+, HER2- breast cancer adds independent information to conventional clinical risk factors
Author: Filipits et al
Publication: Clinical Cancer Research 17: 6012-6020
Mar 01, 2011
Quantitative determination of estrogen receptor, progesterone receptor, and HER2 mRNA in formalin-fixed paraffin-embedded tissue–a new option for predictive biomarker assessment in breast cancer
Author: Muller et al
Publication: Diagnostic Molecular Pathology. 20: 1-10
2010
Apr 15, 2010
ERBB2 and TOP2A in breast cancer: a comprehensive analysis of gene amplification, RNA levels, and protein expression and their influence on prognosis and prediction
Author: Brase et al
Publication: Clinical Cancer Research 16: 2391-2401
Jan 01, 2010
Tumor-associated lymphocytes as an independent predictor of response to neoadjuvant chemotherapy in breast cancer
Author: Denkert et al
Publication: Journal of Clinical Oncology 28: 105-113
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