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. 2013 Mar;24(3):640-7.
doi: 10.1093/annonc/mds334. Epub 2012 Oct 3.

EndoPredict Improves the Prognostic Classification Derived From Common Clinical Guidelines in ER-positive, HER2-negative Early Breast Cancer

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Free PMC article

EndoPredict Improves the Prognostic Classification Derived From Common Clinical Guidelines in ER-positive, HER2-negative Early Breast Cancer

P Dubsky et al. Ann Oncol. .
Free PMC article

Abstract

Background: In early estrogen receptor (ER)-positive/HER2-negative breast cancer, the decision to administer chemotherapy is largely based on prognostic criteria. The combined molecular/clinical EndoPredict test (EPclin) has been validated to accurately assess prognosis in this population. In this study, the clinical relevance of EPclin in relation to well-established clinical guidelines is assessed.

Patients and methods: We assigned risk groups to 1702 ER-positive/HER2-negative postmenopausal women from two large phase III trials treated only with endocrine therapy. Prognosis was assigned according to National Comprehensive Cancer Center Network-, German S3-, St Gallen guidelines and the EPclin. Prognostic groups were compared using the Kaplan-Meier survival analysis.

Results: After 10 years, absolute risk reductions (ARR) between the high- and low-risk groups ranged from 6.9% to 11.2% if assigned according to guidelines. It was at 18.7% for EPclin. EPclin reassigned 58%-61% of women classified as high-/intermediate-risk (according to clinical guidelines) to low risk. Women reclassified to low risk showed a 5% rate of distant metastasis at 10 years.

Conclusion: The EPclin score is able to predict favorable prognosis in a majority of patients that clinical guidelines would assign to intermediate or high risk. EPclin may reduce the indications for chemotherapy in ER-positive postmenopausal women with a limited number of clinical risk factors.

Figures

Figure 1
Figure 1
Kaplan–Meier plot of distant metastasis-free survival (MFS) by (A) German S3, (B) National Comprehensive Cancer Center Network (NCCN), (C) St Gallen guidelines and (D) EPclin risk groups. 95% confidence intervals (CI) of hazard ratios (HR) are indicated.
Figure 2
Figure 2
Kaplan–Meier plot of distant metastasis-free survival (MFS) by EPclin risk groups after considering the (A) German S3, (B) National Comprehensive Cancer Center Network (NCCN) and (C) St Gallen guidelines.
Figure 3
Figure 3
Kaplan–Meier plot of distant metastasis-free survival (MFS) by EPclin risk groups after considering the biological subtypes (A) ‘Luminal B’ and (B) ‘Luminal A’.
Figure 4
Figure 4
Kaplan–Meier plot of distant metastasis-free survival (MFS) by EPclin risk groups in (A) grade 1 tumors, (B) grade 2 tumors and (C) grade 3 tumors.
Figure 5
Figure 5
Putative risk classification scheme for estrogen receptor (ER)-positive, HER2-negative breast cancer patients by combining clinical guidelines and the EPclin test. Metastasis-free survival (MFS) rates are based on the 1702 ER-positive, HER2-negative breast cancer samples.

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