The Oncotype DX® Breast Recurrence Score™ (RS) assay is validated to predict breast cancer (BC) recurrence and adjuvant chemotherapy benefit in select patients with lymph node-positive (LN+), hormone receptor-positive (HR+), HER2-negative BC. We assessed 5-year BC-specific survival (BCSS) in LN+ patients with RS results in SEER databases.
In this population-based study, BC cases in SEER registries (diagnosed 2004–2013) were linked to RS results from assays performed by Genomic Health (2004–2014). The primary analysis included only patients (diagnosed 2004–2012) with LN+ (including micrometastases), HR+ (per SEER), and HER2-negative (per RT-PCR) primary invasive BC (N = 6768). BCSS, assessed by RS category and number of positive lymph nodes, was calculated using the actuarial method.
The proportion of patients with RS results and LN+ disease (N = 8782) increased over time between 2004 and 2013, and decreased with increasing lymph node involvement from micrometastases to ≥4 lymph nodes. Five-year BCSS outcomes for those with RS < 18 ranged from 98.9% (95% CI 97.4–99.6) for those with micrometastases to 92.8% (95% CI 73.4–98.2) for those with ≥4 lymph nodes. Similar patterns were found for patients with RS 18–30 and RS ≥ 31. RS group was strongly predictive of BCSS among patients with micrometastases or up to three positive lymph nodes (p < 0.001).
Overall, 5-year BCSS is excellent for patients with RS < 18 and micrometastases, one or two positive lymph nodes, and worsens with additionally involved lymph nodes. Further analyses should account for treatment variables, and longitudinal updates will be important to better characterize utilization of Oncotype DX testing and long-term survival outcomes.
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One positive lymph node
One to three positive lymph nodes
Two positive lymph nodes
Two to three positive lymph nodes
Three positive lymph nodes
Four or more positive lymph nodes
Analysis of variance
Breast cancer-specific survival
Human epidermal growth factor receptor 2
Hormone receptor-positive (ER-positive, PR-positive, or both)
Reverse transcription-polymerase chain reaction
Treatment (Rx) for positive node, endocrine-responsive breast cancer
Surveillance, epidemiology, and end results
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We acknowledge Anna Lau for medical writing and editorial assistance. The ideas and opinions expressed herein are those of the author(s) and endorsement by any State, Department of Public Health, the National Cancer Institute, the Centers for Disease Control and Prevention, or their Contractors and Subcontractors is not intended nor should be inferred. The Surveillance, Epidemiology and End Results (SEER) Program is funded by the National Cancer Institute (NCI). Genomic Health performed the work to electronically submit the Recurrence Score results, but provided no funding for this study. We acknowledge the SEER registries for collecting the SEER data.
Conflict of interest
Dr. Roberts and Dr. Petkov declare no conflicts of interest. Mr. Dave Miller and Dr. Stephen Shak are employed by and have stock ownership in Genomic Health Inc.
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Roberts, M.C., Miller, D.P., Shak, S. et al. Breast cancer-specific survival in patients with lymph node-positive hormone receptor-positive invasive breast cancer and Oncotype DX Recurrence Score results in the SEER database. Breast Cancer Res Treat 163, 303–310 (2017). https://doi.org/10.1007/s10549-017-4162-3
- Breast cancer
- Disease-specific survival
- Lymph node-positive
- Oncotype DX
- Recurrence Score