Clinical and Pathologic Factors Matter in Decision Making for Breast Cancer Care

Clinicians caring for patients with early-stage breast cancer long relied on clinical and pathologic factors to estimate an individual's risk for recurrent disease and then acted on that estimate to make adjuvant therapy recommendations. In time this “gestalt” assessment was supplanted by molecular assays that were often viewed as offering a welcome binary (yes/no) decision regarding therapy. Data from large trials such as TAILORx, RxPONDER, and MINDACT have provided confidence that a significant fraction of patients with node-negative and node-positive disease can be safely spared chemotherapy.

However, in both TAILORx and MINDACT, age was found to complicate the decision. The data suggested that patients younger than 50 could benefit from chemotherapy and that the effect was largely conferred by ovarian suppression. Complete reliance on a molecular assay result, without considering clinical-pathologic features, is not optimal.

Now, investigators report use of a tool that combines the 21-gene Recurrence Score (RS) with tumor grade, tumor size, and patient age to arrive at a more nuanced assessment of individual risk for recurrence. The tool, RSClin, was developed and validated using the National Surgical Adjuvant Breast and Bowel Project-B20 and TAILORx patient populations and the real-world Israeli Clalit patient registry.

Compared with the RS or clinicopathologic features alone, RSClin provided a better estimate of distant recurrence at 10 years in the Clalit dataset of patients with ER-positive, node-negative disease. Additionally, RSClin provided a range of absolute chemotherapy benefit, depending on variance in different clinical characteristics (e.g., grade, size).