EndoPredict®

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EndoPredict® is a 2nd generation breast cancer recurrence test that combines the prognostic power of a 12-Gene Molecular Score with tumor size and lymph node status.

 

EndoPredict® provides a comprehensive assessment of the 10-year risk of distant recurrence, chemobenefit  and 5-15 years distant recurrence for women with ER+, HER2- early-stage breast cancer when treated with 5-years of endocrine therapy.

 

 

One Test – Three Clinical Answers for Breast Cancer Patients

 

EndoPredict® is the only test that answers the following three important clinical questions…

  • Can chemotherapy be avoided? (individual risk at 10 years1)
  • What is the absolute benefit from chemotherapy? (individual chemotherapy benefit2)
  • Can endocrine therapy be stopped after 5 years? (individual risk up to 15 years3)

 

…to optimize treatment for breast cancer patients. 

 

EndoPredict® in Neoadjuvant Treatment

·         Can predict response to neoadjuvant chemotherapy and neoendocrine therapy12

 

 

 

 

EndoPredict® a prognostic and predictive gene expression assay for patients with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) early-stage breast cancer (node-negative (N0) or node-positive (N+) (1-3 nodes), pre- or postmenopausal). This second generation test combines a molecular score with tumor size and nodal status to provide more prognostic and predictive power than other tests.


Superior Prognostic Performance – Results you can Trust

 

  • Identifies the largest group of women with breast cancer at true low risk (4% to 5.8% recurrence in 10 years with 5 years of endocrine therapy alone)1,3,4,5
    • More than 70% of N0 patients
    • Up to 30% of N+ patients
  • Leads to a significant reduction in chemotherapy in clinical practice6,7,8
  • Inclusion of proliferation and hormone receptor related genes for accurate early and late risk assessment9
  • Validated in four prospective retrospective studies(with consistent study cohorts and constant cutoff)1,2,3,4,10,11 providing level 1 evidence
  • Offers a clear low or high risk category and individual absolute chemotherapy benefit
  • Provides fast result within 2 days by local testing

 

 

EndoPredict® currently reimbursed in Greece, in Cyprus and other countries by Ministry of Health and by private medical insurance companies. For more information and support please contact us.

 

EndoPredict® provides a comprehensive individual result for each patient that allows for quick and confident decision-making.

 

Recommended by ALL Major international guidelines ( NCCN, ASCO, ESMO, St. Gallen, AJCC, EGMT, NICE, AGO)

 

 

 

 

SAMPLE REPORTS

 

References

  1. Filipits M. et al.: A New Molecular Predictor of Distant Recurrence in ER-Positive, HER2-Negative Breast Cancer Adds Independent Information to Conventional Clinical Risk Factors. Clin Cancer Res. 2011; 17(18):6012-6020
  2. Sestak I. et al.: Prediction of chemotherapy benefit by EndoPredict in patients with breast cancer who received adjuvant endocrine therapy plus chemotherapy or endocrine therapy alone. Breast Cancer Res Treat. 2019; 176:377-386
  3. Filipits M. et al.: Prediction of Distant Recurrence using EndoPredict among Women with ER+, HER2- Node- Positive and Node-Negative Breast Cancer Treated with Endocrine Therapy Only. Clin Cancer Res. 2019;25:3865-3872
  4. Buus et al. Comparison of EndoPredict and EPclinWithOncotype DX Recurrence Score for Prediction of Risk of Distant Recurrence After Endocrine Therapy. J Natl Cancer Inst. 2016 Jul 10; 108(11)
  5. Sestak I. 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
  6. Muller B.M. et al.: The EndoPredict Gene-Expression Assay in Clinical Practice – Performance and Impact on Clinical Decisions. 2013; 8(6): e68252
  7. Penault-Llorca et al.: A prospective multicenter non-randomized trial evaluating the effect of EndoPredict® (EPclin®) clinicogenomic test on treatment decision making among patients with intermediate clinical risk. SABCS 2016
  8. Ettl J. et al.: 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. 2017; 12(9): e0183917
  9. Dubsky P. et al.: The EndoPredict score provides prognostic information on late distant metastases in ER+/HER2- breast cancerpatients. 2013; 109, 2959–2964
  10. Dubsky P. et al.: EndoPredict improves the prognostic classification derived from common clinical guidelines in ER-positive, HER2-negative early breast cancer. Ann Oncol. 2013; 24:640-647
  11. Martin M. et al.: Clinical validation of the EndoPredict test in node-positive, chemotherapy-treated ER+/HER2− reast cancer patients: results from the GEICAM 9906 trial. 2014; 16:R38
  12. The EndoPredict Score Predicts Response to Neoadjuvant Chemotherapy and Neoendocrine Therapy in Hormone Receptor-Positive, Human Edidermal Factor Receptor 2- Negative Breast Cancer Patients from ABCSG-34 Trial. Dubsky P. et al., European Journal of Cancer, published online June 2020
  13. Filipits M. et al.: A New Molecular Predictor of Distant Recurrence in ER-Positive, HER2-Negative Breast Cancer Adds Independent Information to Conventional Clinical Risk Factors. Clin Cancer Res. 2011; 17(18):6012-6020
  14. Sestak I. et al.: Prediction of chemotherapy benefit by EndoPredict in patients with breast cancer who received adjuvant endocrine therapy plus chemotherapy or endocrine therapy alone. Breast Cancer Res Treat. 2019; 176:377-386
  15. Filipits M. et al.: Prediction of Distant Recurrence using EndoPredict among Women with ER+, HER2- Node- Positive and Node-Negative Breast Cancer Treated with Endocrine Therapy Only. Clin Cancer Res. 2019;25:3865-3872
  16. Buus et al. Comparison of EndoPredict and EPclinWithOncotype DX Recurrence Score for Prediction of Risk of Distant Recurrence After Endocrine Therapy. J Natl Cancer Inst. 2016 Jul 10; 108(11)
  17. Sestak I. 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
  18. Muller B.M. et al.: The EndoPredict Gene-Expression Assay in Clinical Practice – Performance and Impact on Clinical Decisions. 2013; 8(6): e68252
  19. Penault-Llorca et al.: A prospective multicenter non-randomized trial evaluating the effect of EndoPredict® (EPclin®) clinicogenomic test on treatment decision making among patients with intermediate clinical risk. SABCS 2016
  20. Ettl J. et al.: 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. 2017; 12(9): e0183917
  21. Dubsky P. et al.: The EndoPredict score provides prognostic information on late distant metastases in ER+/HER2- breast cancerpatients. 2013; 109, 2959–2964
  22. Dubsky P. et al.: EndoPredict improves the prognostic classification derived from common clinical guidelines in ER-positive, HER2-negative early breast cancer. Ann Oncol. 2013; 24:640-647
  23. Martin M. et al.: Clinical validation of the EndoPredict test in node-positive, chemotherapy-treated ER+/HER2− reast cancer patients: results from the GEICAM 9906 trial. 2014; 16:R38
  24. The EndoPredict Score Predicts Response to Neoadjuvant Chemotherapy and Neoendocrine Therapy in Hormone Receptor-Positive, Human Edidermal Factor Receptor 2- Negative Breast Cancer Patients from ABCSG-34 Trial. Dubsky P. et al., European Journal of Cancer, published online June 2020

 

 

Physicians additional information

 

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.

 

 

 

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.

 

 

 

EndoPredict® identifies a consistent risk of recurrence in N0 and N+ patients

 

 

 

 

 

 

EARLY / LATE RECURRENCE

 

 

 

 

EndoPredict accurately predicts early recurrence by including proliferation-related genes and late recurrence with hormone receptor–related genes.

  • 2nd generation prognostic tests include genes that predict both early and late recurrence
  • Early recurrence is defined as a recurrence that occurs within the first 5 years after initial diagnosis
  • Late recurrence is defined as a recurrence that occurs more than 5 years after initial diagnosis

 

 

 

 

CHEMOTHERAPY BENEFIT

 

Summary

 

  • Chemobenefit validated
    • In over 3700 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.
  • Patient with a higher EndoPredict score had a greater benefit from chemotherapy

 

 

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) 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 2).
  • Interaction between EPclin and treatment was significant (P=0.02).

 

 

 

 

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-positive, HER2-negative breast cancer.

 

 

References

  1. Sestak I. et al.: Breast Cancer Res Treat. 2019; 176:377-386; 2. Dubsky et al., 2012; 3. Buus et al., 2017; 4. Martin et al., 2014

 

 

 

 

 

 

 

PREDICTION OF DISTANT RECURRENCE (5-15 YEARS)

 

 

 

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.

 

 

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 cohorts2-5confirms 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. et al.: Clin Cancer Res. 2019;25:3865-3872; 2. Filipits et. al. Clin Cancer Res 2011;17(18): 6012-20; 3. Dubsky et. al. Br J Cancer 2013;109(12): 2959-64; 4. Dubsky et. al. Ann Oncol 2013;24(3): 640-7; 5. Fitzal et.al. Br J Cancer 2015;112(8): 1405-10; 6. Buus et.al. J Natl Cancer Inst. 2016;108(11); 7. Sestak et.al. JAMA Oncol. 2018;4(4):545-553

 

 

 

 

The EndoPredict Score Predicts Response to
Neoadjuvant Chemotherapy and Neoendocrine Therapy

 

 

EndoPredict® is the only predictive and prognostic gene expression test that answers three important clinical questions in N0/N+ breast  cancer: What is the recurrence risk at 10 years? What is the chemotherapy benefit? What is the late recurrence risk at 5-15 years?

In a recently published prospective translational study, the EndoPredict® (EP) 12-Gene Molecular Score (MS) is shown to be a significant predictor of response to neoadjuvant chemotherapy (NaCT) and neoadjuvant endocrine therapy (NET) for patients with hormone receptor-positive, HER2-negative early-stage breast cancer.


The analysis included 217 patients with HR+, HER2- tumors participating in ABCSG-34. Patients received either NaCT (8 cycles of anthracycline/taxane-based chemotherapy) or NET (6 months of letrozole) based on menopausal status, HR expression, grade, and Ki67. Diagnostic cores were tested using EndoPredict to produce the EP 12-Gene MS. Primary endpoint was residual cancer burden score at surgery.

 

·         Patients with a low-risk EP 12-Gene MS rarely responded with substantial tumor shrinkage after NaCT but had a higher probability to respond to NET.

·         Patients with a high-risk EP 12-Gene MS rarely responded to NET and had a higher probability to respond to NaCT.

 

 

The key clinical value of this study is the high negative predictive value of the EP 12-Gene MS, indicating that patients with a low EP 12-Gene MS have a very low probability to achieve a good tumor response after NaCT but a higher probability to respond to NET. This is clinically relevant to surgical planning. Although clearly dependent on multiple factors, breast conservation is unlikely to be driven by NaCT in the low-risk EP 12-Gene MS group.
 
In addition, the study shows that a high EP 12-Gene MS was strongly associated with a poor tumor response to NET. Adjuvant endocrine therapy remains an important therapy in these patients, but neoendocrine treatment is very unlikely to be beneficial in terms of tumor shrinkage.

The EP 12-Gene MS can add valuable information to aid personalized treatment selection in neoadjuvant therapy. Another advantage of EndoPredict® when the indication for neoadjuvant therapy is even more critical.

Reference:The EndoPredict Score Predicts Response to Neoadjuvant Chemotherapy and Neoendocrine Therapy in Hormone Receptor-Positive, Human Edidermal Factor Receptor 2- Negative Breast Cancer Patients from ABCSG-34 Trial. Dubsky P. et al., European Journal of Cancer, published online June 2020

 

 

 

 

EndoPredict® Prospective Data

 

 

First prospective outcome data for the second-generation multigene

test EndoPredict® in ER-positive/HER2-negative breast cancer

Introduction

Ettl J. et al. Archives of Gynecology and Obstetrics 2020

 

The study, from the Technical University Munich (LMU), is a prospective analysis of 373 patients tested with EP in the clinic setting with 41.6 (1.6 – 65.9) months of median follow-up to date.  

 

 

 

This independent study confirms what we already know of EndoPredict from our validation prospective-retrospective studies:

 

  • Large proportion of true low-risk patients: all: 64%; pN0: 76%; pN1: 24%
  • Good outcome of EPclin low-risk patients: 3year DMFS 99.6%
  • 5-fold increase in the risk of distant recurrence for EPclin high-risk patients compared to EPclin low-risk
  • Chemotherapy benefit of EPclin high-risk patients

 

 

 

 

EndoPredict® Vs Other Molecular Tests

 

 

 

 

 

 

 

 

 

 

 

PRINCIPLE OF THE ENDOPREDICT TEST / APP

 

 

FROM TUMOR BIOLOGY TO THERAPY DECISION IN THREE STEPS

The EndoPredict computer animation illustrates the functional principle of the EndoPredict test, which is used for determining the prognosis of breast cancer patients. The test consists of the molecular finger print determined by the gene expression within the tumor tissue and is combined with the clinical status of the tumor. In context with other patients’ data, the test result assists the treating physicians and the tumor board in their decision as to whether chemotherapy is necessary or not.

 

https://app.endopredict.com/index.html

 

The computer animation answers the following questions:

  1. How do the various genes in the tumor influence the prognosis?
  2. How do the molecular fingerprint and the clinical data of tumor size and nodal status contribute to the EPclin score?
  3. What is the benefit a patient can expect from the chemotherapy?

 

 

 

 

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