EndoPredict breast cancer testing


Recurrence Risk up to 15 years

After 5 years of endocrine therapy, breast cancer recurrences in ER+ tumors continue to occur steadily, even over 20 years after diagnosis. Of those patients with ER+ breast cancer who experience recurrent disease, more than 50% occur after 5 years. Therefore assessment of risk beyond 5 years is important to identify the subgroup of patients who may benefit from extended endocrine therapy beyond 5 years.

Risk of breast cancer death after initial diagnosis

EndoPredict is the only prognostic test that successfully predicts risk of early and late recurrence for patients with node-negative and node-positive disease.

Prediction of recurrence risk (up to 15 years) was validated in 1,702 patients with ER+, HER2- disease. Analyses were performed for the overall cohort, by nodal status, and for 1,386 patients who were distant recurrence-free at year 5 (late recurrence).

The EPclin Risk Score remained prognostic for distant recurrence in the 5-15 year time period in patients that had not recurred in the first 5 years of follow-up. A patient with a high EPclin Risk Score has an approximately 4.5x higher risk of distant recurrence than a patient with a low EPclin Risk Score.

Kaplan-Meier curves of estimated Distant Recurrence Free Rate (DRFR) for patients with newly diagnosed disease in all patients
and those patients who were distant recurrence free at 5 years

This re-analysis of two clinical validation studies of EndoPredict (ABCSG6 and ABCSG8) with a longer follow-up of up to 16.6 years (median 9.6 years) confirmed that EndoPredict was highly predictive of both early and late distant recurrence (DR) in both node-negative and node-positive women.

Together with the recently published study that showed the ability of EndoPredict to predict chemotherapy benefit (Sestak et al., 2019), this study provides the basis for two critical treatment decisions at diagnosis and five years after diagnosis: 1) whether or not to give chemotherapy, and 2) whether to forgo extended endocrine therapy.

Jatoi I. et al.: Breast Cancer Adjuvant Therapy: Time to Consider Its Time-Dependent Effects. J Clin Oncol. 2011;29(17):2301-2304
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