Abstract
ObjectivesTo investigate breast cancer-specific mortality by early breast cancer (EBC; Stages I-IIIC) subtype; incidence of high-risk indicators for recurrence (defined in monarchE trial); and mortality risk difference by those who did/did not meet these criteria.Materials and methodsAnalyses included patients with initial EBC diagnosis between 2010–2015 from Surveillance, Epidemiology, and End Results (SEER) data (n = 342,149). Cox proportional hazards models and Kaplan-Meier estimates examined mortality among 228,031 patients, by subtype (hormone receptor [HR]-positive [+], human epidermal growth factor receptor-2 [HER2] negative [–]; triple negative [TNBC]; HR+, HER2+; HR-, HER2+). Incidence and mortality among patients who did/did not meet monarchE clinicopathological high-risk criteria were examined.ResultsAmong patients with HR+, HER2- EBC, histologic Grade 3 (vs. Grade 1) was the most influential factor on mortality (hazard ratio, 3.61; 95%CI, 3.27, 3.98). Among patients with TNBC, ≥4 ipsilateral axillary positive nodes (vs. node negative) was the most influential factor on mortality (hazard ratio, 3.46; 95%CI, 2.87, 4.17). For patients with HR-, HER2+ or HR+, HER2+ EBC, tumor size ≥5 cm (vs. <1 cm) and ≥4 ipsilateral axillary positive nodes were the most influential factors on mortality. The 60-month mortality rate for the 12% of patients within the HR+, HER2- EBC group meeting monarchE clinicopathological high-risk criteria was 16.5%, versus 7.0% (Stage II–III and node positive) and 2.8% (Stage I or node negative) for those not meeting criteria. The 60-month mortality rate for patients with TNBC was 18.5%.ConclusionMortality risk and the relative importance of risk factors varied by subtype. monarchE clinicopathological high-risk criteria were associated with increased mortality risk among patients with HR+, HER2- EBC. Patients with HR+, HER2- EBC, and monarchE clinicopathological high-risk criteria experienced risk of mortality similar to patients with early TNBC. These data highlight a high unmet need in this select patient population who may benefit most from therapy escalation.
Highlights
Breast cancer is the most commonly diagnosed cancer and the second leading cause of cancer deaths among women in the United States (US) [1]
Consistent with expectations [2], these data confirmed that patients with hormone receptor (HR), human epidermal growth factor receptor 2 (HER2)+ or early TNBC have a disproportionately greater risk of breast cancer-specific mortality compared with HR+ Early breast cancer (EBC)
We found a distinct difference in risk of mortality between patients with Stage IIB HR +, HER2- EBC who had micrometastases with 1–3 positive ipsilateral axillary nodes and those patients who had micrometastases with 4 positive ipsilateral axillary nodes
Summary
Breast cancer is the most commonly diagnosed cancer and the second leading cause of cancer deaths among women in the United States (US) [1]. Despite the availability of EBC treatment options with curative intent, including primary surgery, radiation, chemotherapy, and adjuvant endocrine therapy (ET), nearly 30% of patients diagnosed with EBC will experience breast cancer recurrence [3], many with distant metastases [4], which is incurable. Studies have shown a subset of patients with high-risk clinical features (ie, large primary tumor size, more advanced Stage, greater extent of axillary lymph node (ALN) involvement, and high histologic Grade) are at a higher risk of recurrence [5,6,7]. In HR+, HER2- breast cancer, highly proliferative disease, as demonstrated by Ki-67 index 20% and several multi-gene assays, has been shown to be associated with higher risk of disease recurrence [5, 8,9,10,11,12]. Identifying patients with a high risk of recurrence will help optimize treatment, while potentially avoiding overtreatment in patients who are less likely to benefit [13, 14]
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