Abstract
Clinicopathological prognostic features have limited value to identify with precision newly diagnosed patients with hormone receptor (HR)-positive, HER2-negative breast cancer (BC), who would benefit from chemotherapy (CT) in addition to adjuvant hormonal therapy (HT). The 21-gene Oncotype DX Breast Recurrence Score® (RS) assay has been demonstrated to predict CT benefit, hence supporting personalized decisions on adjuvant CT. The multicenter, prospective, observational study PONDx investigated the real-life use of RS® results in Italy and its impact on treatment decisions. Physicians’ treatment recommendations (HT ± CT) were documented before and after availability of RS results, and changes in recommendations were determined. In the HR+ HER2− early BC population studied (N = 1738), physicians recommended CT + HT in 49% of patients pre-RS. RS-guided treatment decisions resulted in 36% reduction of CT recommendations. PONDx confirms that RS results provide clinically relevant information for CT recommendation in early-stage BC, resulting in a reduction of more than a third of CT use.
Highlights
Breast cancer (BC) is the most common type of malignancy in women and the second most common cancer overall
We documented the use of the Oncotype DX assay and its impact on physicians’ therapeutic recommendations in a sizeable patient population from 27 BC reference centers in 6 regions of Italy
Our data add to the growing body of evidence from Recurrence Score® (RS) result decision impact studies with N0 and N+ tumors performed in Europe[19,24,25,26], North America[27,28], or Australia[29]
Summary
Breast cancer (BC) is the most common type of malignancy in women and the second most common cancer overall. Besides the HR status, prognostic parameters include patient age, lymph node involvement, tumor size, histological type, and grade, as well as the Ki67 proliferation marker[3] These conventional clinical and histopathological markers have insufficient specificity and sensitivity to precisely predict which patients are likely to experience a significant benefit of CT on cancer recurrence that outweighs the substantial side effects. Only a minority of HR+, HER2− patients appears to benefit from CT: in a large meta-analysis performed by the Early Breast Cancer Trialists’ Collaborative Group, the reduction of the 10-year recurrence rate by adjuvant CT was
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