Abstract
Background/purpose
The 21-gene recurrence score (RS) assay evaluates the likelihood of distant recurrence and benefit of chemotherapy in lymph node-negative, estrogen receptor (ER)-positive, HER2-negative breast cancer patients. The RS categories are associated with the risk of locoregional recurrence (LRR) in some, but not all studies.
Methods
We reviewed the institutional database to identify consecutive female patients with node-negative, ER+/HER2− breast carcinoma tested for the 21-gene RS assay and treated at our center from 2008 to 2013. We collected data on clinicopathologic features, treatment, and outcome. Statistical analysis was performed using SAS version 9.4 or R version 3.3.2.
Results
Of 2326 patients, 60% (1394) were in the low RS group, 33.4% (777) in the intermediate RS group, and 6.6% (155) in the high RS group. Median follow-up was 53 months. A total of 44 LRRs were observed, with a cumulative incidence of 0.17% at 12 months and 1.6% at 48 months. The cumulative incidence of LRR at 48 months was 0.84%, 2.72% and 2.80% for low, intermediate, and high RS groups, respectively (p < 0.01). Univariate analysis showed that the risk of LRR was associated with the RS categories (p < 0.01), T stage (p < 0.01) and lymphovascular invasion (LVI) (p = 0.009). There was no difference in LRR rates by initial local treatment (total mastectomy vs. breast-conserving surgery plus radiation therapy). The RS remained significantly associated with LRR after adjusting for LVI and T stage. Compared to patients with low RS, the risk of LRR was increased more than 4-fold (hazard ratio: 4.61, 95% CI 1.90–11.19, p < 0.01), and 3-fold (hazard ratio: 2.81, 95% CI 1.41–5.56, p < 0.01) for high and intermediate risk categories, respectively.
Conclusions
Our study confirms that RS is significantly associated with the risk of LRR in node-negative, ER+/HER2− breast cancer patients. Our findings suggest that in addition to its value for prognostic stage grouping and decision-making regarding adjuvant systemic therapy, the role of the RS in identifying patients not requiring radiotherapy should be studied.
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Acknowledgements
This work was supported in part by a National Institutes of Health/National Cancer Institute Cancer Center Support Grant (P30CA008748). We thank Ms. Alicja Wiszowaty for her invaluable assistance with data collection.
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The study was approved by the Institutional Review Board. For this type (retrospective) of study formal consent is not required.
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The experiments (data analyses) comply with the current laws of the country in which they were performed (United States of America).
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Turashvili, G., Chou, J.F., Brogi, E. et al. 21-Gene recurrence score and locoregional recurrence in lymph node-negative, estrogen receptor-positive breast cancer. Breast Cancer Res Treat 166, 69–76 (2017). https://doi.org/10.1007/s10549-017-4381-7
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DOI: https://doi.org/10.1007/s10549-017-4381-7