Abstract
PurposeProspectively collected outcome data of patients (pts) whose adjuvant systemic therapy recommendation was based on the clinico-molecular test EndoPredict® (EP) are presented.MethodsPts with ER-positive, HER2-negative early breast cancer with 0–3 positive lymph nodes were enrolled. The EP was carried out on all tumor samples. Pts were evaluated for treatment compliance, local recurrence, distant metastases and overall survival. Censored time-to-event outcomes were analysed by Cox proportional hazards models. Additional estimates of the event-free-survival were calculated by the Kaplan–Meier method. Hypothesis testing was conducted on two-sided exploratory 5% significance levels.Results373 consecutive pts were enrolled. EP classified 238 pts (63.8%) as low risk and 135 pts (36.2%) as high risk. Median follow-up was 41.6 months. Risk for disease recurrence or death in EPclin high-risk patients was twofold higher in comparison with EPclin low-risk patients (hazard ratio (HR) 2.05 (95% CI 0.85–4.96; p = 0.110). Patients with EPclin high risk were at significant higher risk of distant metastases than patients with EPclin low risk (HR 5.18; 95% CI 1.04–25.74; p = 0.0443). EPclin high-risk patients who actually underwent adjuvant CTX had a 3-year-DFS of 96.3% (95% CI 92.2–100) in contrast to EPclin high-risk patients without CTX (3-year-DFS: 91.5% (95% CI 82.7–100%); HR 0.32; 95% CI 0.10–1.05; p = 0.061).ConclusionThese first prospective outcome results show that EP, in clinical routine, is a valid clinico-molecular test, to predict DFS and to guide decision of adjuvant CTX use in ER-positive, HER2-negative early breast cancer pts with 0–3 positive lymph nodes. Adjuvant CTX seems to be beneficial for EPclin high-risk patients.
Highlights
In patients diagnosed with early breast cancer, the lifetime risk for relapse and development of metastases is still high
Three-year disease-free survival (DFS) and distant metastasis-free survival (DMFS) in the EPclin low-risk group was 96.6% and 99.6% versus 94.9% and 97.6% in the EPclin high-risk group
The most important finding is the fivefold increased risk for distant metastases in EPclin high-risk patients versus EPclin low-risk patients (HR 5.18, p = 0,04). This is in line with formerly published data from retrospective analyses using EP as a prognostic biomarker in estrogen receptor (ER)-positive, HER2negative patient cohorts; EP could be shown to be an independent predictor of distant recurrence based on retrospective analyses of prospectively collected clinical data from the ABCSG6&8 and TransATAC [10, 15]
Summary
In patients diagnosed with early breast cancer, the lifetime risk for relapse and development of metastases is still high. National and international guidelines recommend adjuvant CTX for patients at high risk for recurrence, while low-risk tumors are to be treated without the use of adjuvant chemotherapy [1, 2]. This implies that accurate risk stratification plays a key role in chemotherapy decision making when treating patients with ER-positive, HER2-negative early. The current proliferation marker Ki-67 and grading have been shown to be inconsistent within different pathologists [3] This is one of the reasons why these markers are viewed insufficient to obtain adequate risk stratification in a ER-positive, HER2-negative population [4]. Gallen Consensus Conference stated that genomic assays are valuable tools for determining whether adjuvant CTX should be recommended or not [5]
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