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Abstract
Background: To evaluate the performance of the 21-gene recurrence score (RS) assay in predicting chemotherapy benefit in the Surveillance, Epidemiology, and End Results population, we aimed to assess breast cancer-specific mortality (BCSM) by chemotherapy use within each of the RS categories. Methods: Data on breast cancer (BC) cases diagnosed between 2004 and 2015 with available RS results were released. Our analysis included patients with hormone receptor-positive, node-negative early-stage BC (n = 89,402), and three RS groups were defined; RS < 11, low; RS 11–25, intermediate; RS > 25, high. A propensity score matched-analysis was performed to assess and compare BCSM. Results: Chemotherapy was significantly associated with a reduced risk of BC death among patients in the high RS group (hazard ratio = 0.782; 95% CI, 0.618–0.990; p = 0.041). However, in the low and intermediate RS groups, there were no significant differences in BCSM between patients who received chemotherapy and those who did not. Among those with RS 11–25, chemotherapy benefit varied with tumor size (p = 0.001). Conclusions: Our findings provide real-world evidence that the 21-gene RS assay is predictive of chemotherapy benefit among patients in clinical practice. More refined risk estimates would be needed for patients with an intermediate RS.
Highlights
The 21-gene recurrence score (RS) assay (Oncotype DX, Genomic Health, Redwood City, CA, USA) is one of several commercially-available gene expression assays used to guide treatment decisions in patients with hormone receptor-positive early-stage breast cancer (BC) [1]
The original primary cohort included a total of 89,402 patients with hormone receptor-positive, node-negative with T1 or T2 BC that had results from the 21-gene RS assay (Figure S1)
We noted an overall increase in the use of this assay over time (2004 through 2015; Table S1)
Summary
The 21-gene recurrence score (RS) assay (Oncotype DX, Genomic Health, Redwood City, CA, USA) is one of several commercially-available gene expression assays used to guide treatment decisions in patients with hormone receptor-positive early-stage breast cancer (BC) [1]. RS was predictive of distant recurrence and breast cancer-specific mortality (BCSM) [8,9,10,11]. The RS based on the 21-gene assay predicted benefit from adjuvant chemotherapy; patients with a high. To evaluate the performance of the 21-gene recurrence score (RS) assay in predicting chemotherapy benefit in the Surveillance, Epidemiology, and End Results population, we aimed to assess breast cancer-specific mortality (BCSM) by chemotherapy use within each of the RS categories. Our analysis included patients with hormone receptor-positive, node-negative early-stage BC (n = 89,402), and three RS groups were defined; RS < 11, low; RS 11–25, intermediate; RS > 25, high. Conclusions: Our findings provide real-world evidence that the 21-gene RS assay is predictive of chemotherapy benefit among patients in clinical practice
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