Revisiting the definition of estrogen receptor positivity in HER2-negative primary breast cancer

Abstract

Background: Although 1% has been used as cut-off for estrogen receptor (ER) positivity, several studies have reported that tumors with ER < 1% have characteristics similar to those with 1%≤ER<10%. We hypothesized that in patients with HER2-negative breast cancer, a cut-off of 10% is more useful than one of 1% in discriminating for both a better pCR rate to neoadjuvant chemotherapy and a better long-term outcome with adjuvant hormonal therapy. Our objectives were to identify a percentage of ER expression below which pCR was likely and to determine whether this cut-off value can identify patients who would benefit from adjuvant hormonal therapy.Patients and methods: Patients with stage II or III HER2-negative primary breast cancer who received neoadjuvant chemotherapy followed by definitive surgery between June 1982 and June 2013 were included. Logistic regression models were used to assess the association between each variable and pCR. Cox models were used to analyze time to recurrence (TTR) and overall survival (OS). The recursive partitioning and regression trees method was used to calculate the cut-off value of ER expression.Results: A total of 3055 patients were analyzed. Low percentage of ER was significantly associated with high pCR rate (OR = 0.99, 95% CI = 0.986-0.994, P<0.001). The recommended cut-off of ER expression below which pCR was likely was 9.5%. Among patients with ER ≥ 10% tumors, but not those with 1%≤ER<10% tumors, adjuvant hormonal therapy was significantly associated with long TTR (HR = 0.24, 95% CI = 0.16-0.36, P<0.001) and OS (HR = 0.32, 95% CI = 0.2-0.5, P<0.001).Conclusion: Stage II or III HER2-negative primary breast cancer with ER < 10% behaves clinically like TNBC in terms of pCR and survival outcomes and patients with such tumors may have a limited benefit from adjuvant hormonal therapy. It may be more clinically relevant to define TNBC as HER2-negative breast cancer with <10%, rather than <1%, of ER and/or PR expression.

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