Abstract
Simple SummaryIt is important to address the influence of 21-gene Recurrence Score (RS) on chemotherapy decision-making stratified by clinical risk in patients with hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. Our study presented that the application of the 21-gene RS assay significantly reduced the chemotherapy rate in patients with high clinical risk. Meanwhile, there was no significant difference in the chemotherapy rate according to the implementation of the 21-gene RS assay in those with low clinical risk. Furthermore, we observed no difference in prognosis according to the application of 21-gene RS for either clinical risk. These results suggest that the 21-gene RS could be considered more positively in HR+/HER2- patients with high clinical risk to reduce chemotherapy rates without increasing the occurrence of relapse.We assessed the impact of 21-gene Recurrence Score (RS) assay on chemotherapy decision-making according to binary clinical risk stratification in patients with hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. We included patients with tumors measuring 1–5 cm, N0-1, and HR+/HER2- breast cancer who underwent surgery followed by adjuvant treatment. The clinical risk was determined by a modified version of Adjuvant! Online. We performed propensity score matching (PSM) according to the application of 21-gene RS separately in the low and high clinical risk groups. Before PSM, 342 (39.0%) of 878 patients were classified as having high clinical risk. In the high clinical risk group, 21-gene RS showed a significantly reduced chemotherapy rate of 39.3%, without increasing the recurrence. After PSM, the 21-gene RS application significantly reduced chemotherapy rate by 34.0% in 200 patients with high clinical risk (21-gene RS application, 32.0% vs. no 21-gene RS application, 66.0%, p < 0.001). There was also no significant difference in RFS according to 21-gene RS status in the high clinical risk group (log-rank test, p = 0.467). These results support the usefulness of the 21-gene RS to reduce the chemotherapy rate without adversely affecting prognosis in a high clinical risk group.
Highlights
The 21-gene recurrence score (RS) assay (Oncotype DX, Genomic Heal, Redwood City, CA, USA) is one of the most frequently used commercially available gene-expression assays in breast cancer [1,2]
In N0 patients, the clinical risk was defined as low if the tumor was ≤3 cm in diameter and had a low histologic grade (HG), ≤2 cm in diameter and had an intermediate HG, or ≤1 cm in diameter and had a high HG
Had favorable clinicopathologic factors, while the reverse trend was observed in patients with low clinical risk (Table S1)
Summary
The 21-gene recurrence score (RS) assay (Oncotype DX, Genomic Heal, Redwood City, CA, USA) is one of the most frequently used commercially available gene-expression assays in breast cancer [1,2]. The adjuvant chemotherapy reduced the risk of distant recurrence [5,6,7], there is a concern that the chemotherapy is unnecessary in the majority of patients with HR-positive, HER2-negative breast cancer. The predictive value of the 21-gene RS for chemotherapy benefit in women with ER-positive, HER2-negative breast cancer has been validated in several prospective clinical trials, including the National Surgical Adjuvant Breast and Bowel Project B-20 trial, Southwest Oncology Group (SWOG)-8814 trial, and Trial. The chemotherapy benefit was observed when the 21-gene RS was high, whether a high 21-gene RS was defined as 31 or higher, or 26 or higher. Based on these results, the National Comprehensive
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