EndoPredict improves the prognostic classification derived from common clinical guidelines in ER-positive, HER2-negative early breast cancer

Abstract

BackgroundIn 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 methodsWe 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.ResultsAfter 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.ConclusionThe 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.

Gene Expression Analyses in Early Breast Carcinoma — Quo Vadis?

“…Among patients in Studies 6 and 8 by the Austrian Breast Cancer Study Group (ABCSG), the EP test combined with tumor size and nodal status (EPclin) in postmenopausal ER-positive/HER2-negative patients who had only received endocrine treatment made it possible to identify a low-risk group with a 10-year risk of distant metastases of 4 %. EPclin can classify 58 -61 % of the high-risk and intermediate-risk groups in the commonly used clinical and pathological risk classifications as a low-risk group with a 10-year metastasis risk of 5 % [16], and it is also valid for the development of late metastases after 5 years of endocrine therapy [17]. The GEICAM/9906 study confirmed, as expected, that the test also had independent prognostic relevance in premenopausal patients [18].…”

Clinicopathological factors predicting early and late distant recurrence in estrogen receptor-positive, HER2-negative breast cancer

“…Moreover, host factors may influence tumor biology. To date, most studies analyzing prognostic factors for early and late relapse have been performed in postmenopausal women, mainly using patients and samples in adjuvant aromatase inhibitor trials [10][11][12][13], in which patients received tamoxifen or aromatase inhibitors as adjuvant endocrine therapy. Kennecke and colleagues retrospectively analyzed risk of early [14] and late recurrence [15] among postmenopausal women with ER-positive early breast cancer treated with adjuvant tamoxifen.…”

The development of resistance to tamoxifen in patients with breast cancer: our experience

“…The literature refers to the similar conclusions by Dubsky, Ellis as well as Bartsch in their studies. [8][9][10] International Breast Cancer Study Group (IBCSG) analyzed 314 patients suffering from breast cancer of the age <35 years, and reported that relapse or death disease occurs earlier and more frequently in premenopausal group of patients.…”