Recurrence Risk at 10 years
Independently Validated For Robust Prognostic Results
EndoPredict was developed using consistent criteria for patients during training and independent validation studies: pre- and postmenopausal patients with ER+, HER2- breast cancer, both node negative (N0) or node positive (N+). These “clean” (solely ER+, HER2-) cohorts are one reason for the test’s stronger performance compared to tests that included HER2+ patients in their training cohorts. The score and the cutoff value are consistent in all studies and have never changed.
The patients in the ABCSG6, ABCSG8 and TransATAC studies as well as the Premenopausal study were treated with endocrine therapy alone. The prognostic value of EndoPredict under chemotherapy was demonstrated by the GEICAM/9906 study. All patients received only 5 years of endocrine therapy.
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
Buus 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 Jul 10;108(11)
Martin M. et al.: Clinical Validation of the EndoPredict Test in Node-Positive, Chemotherapy-Treated ER+/HER2- Breast Cancer Patients: Results from the GEICAM 9906 Trial. BCR. 2014;16:R38
Large Low Risk Group
In all validation studies, EndoPredict identified a large true low risk group in all patients including N+ of up to 65% with a risk of recurrence within 10 years of less than 6%.
EndoPredict consistently identifies a high percentage of patients with a low risk of recurrence
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
Buus 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 Jul 10;108(11)
Prognostic in Premenopausal Patients
EndoPredict is validated for both post- and premenopausal patients. Recent data from ASCO 2021 reconfirm the reliable long-term prognosis by EndoPredict and the use of EndoPredict in young patients.
In a study of 385 premenopausal patients with up to three affected lymph nodes, treated with adjuvant endocrine therapy alone and a median follow-up time of 9.7 years, EndoPredict successfully identified two-thirds of patients with low risk of distant recurrence that could safely forego chemotherapy. EPclin Risk Score was strongly associated with 10-year DRFS regardless of nodal status.
EndoPredict identifies premenopausal patients who do not need chemotherapy
ASCO 2021 (Constantinidou A. et al., J Clin Oncol 39, 2021 (suppl 15; abstr 537))
Clear Risk Groups In Different Subgroups
EndoPredict provides additional prognostic information to supplement common prognostic factors such as nodal status, tumor grade or Ki67. This has been demonstrated in four validation studies.
Risk Assessment Independent From Nodal Status
In validation studies, 78% of node negative patients were identified as low risk, but 22% were classified as high risk with a need for more aggressive therapy. In node positive patients, EndoPredict identified up to 30% low risk patients who could forego chemotherapy.
Filipits 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
Risk Assessment Independent From Grading
EndoPredict identifies high and low risk patients independent from tumor grade. In validation studies, 22% of patients with grade 1 tumors were identified as high risk and 19% of patients with grade 3 tumors as low risk. In the grade 2 group, EndoPredict classified 60% of patients as low risk with a recurrence risk of less than 10%.
Dubsky 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
Risk Assessment Independent From Ki67-Based Luminal A And B Classification
EndoPredict identifies high and low risk patients independent from Ki67-based luminal A and B classification. In validation studies, EndoPredict classified 29% of luminal A patients as high risk and 34% of luminal B patients as low risk.
Dubsky 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
