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J Clin Oncol. 2019 Dec 6:JCO1901959. doi: 10.1200/JCO.19.01959. [Epub ahead of print]

Prognostic Impact of the 21-Gene Recurrence Score Assay Among Young Women With Node-Negative and Node-Positive ER-Positive/HER2-Negative Breast Cancer.

Author information

1
Dana-Farber Cancer Institute, Boston, MA.
2
Mayo Clinic, Rochester, MN.
3
Brigham and Women's Hospital, Boston, MA.
4
Beth Israel Deaconess Medical Center, Boston, MA.
5
Massachusetts General Hospital, Boston, MA.
6
Stanford University, Palo Alto, CA.
7
University of Colorado Cancer Center, Aurora, CO.
8
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
9
Genomic Health, Redwood City, CA.

Abstract

PURPOSE:

The 21-gene recurrence score (RS) assay is prognostic among women with early-stage estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer and is used to inform recommendations for chemotherapy. Women ≤ 40 years of age represent a minority of patients studied using gene expression profiles.

METHODS:

The Young Women's Breast Cancer Study is a prospective cohort of women diagnosed with breast cancer at age ≤ 40 years and enrolled patients between 2006 and 2016 (N = 1,302). We identified patients with stage I-III ER+/HER2- breast cancer. The RS assay was performed on banked specimens for patients who had not been tested clinically. Distant recurrence-free survival (DRFS) was assessed by TAILORx and traditional RS risk groups among patients with axillary node-negative (N0) and limited node-positive (N1) breast cancer.

RESULTS:

Among eligible women (N = 577), 189 (33%) had undergone RS testing, and 320 (56%) had banked specimens sufficient for testing. Median follow-up was 6.0 years. Median age at diagnosis was 37.2 years; 300 of 509 patients (59%) had N0 breast cancer, of whom 195 (65%) had an RS of 11-25 and fewer than half (86 of 195; 44%) received chemotherapy. Six-year DRFS rates were 94.4% and 92.3% (RS < 11), 96.9% and 85.2% (RS 11-25), and 85.1% and 71.3% (RS ≥ 26) among women with N0 and N1 disease, respectively.

CONCLUSION:

The RS assay is prognostic among young women with node-negative and limited node-positive breast cancer, representing a valuable tool for risk stratification. Disease outcomes with a median follow-up of 6 years among young women with N0 disease and an RS of 0-25, a minority of whom received chemotherapy, and node-positive disease with an RS < 11 were very good, whereas those with N0 disease and an RS ≥ 26 or N1 disease with an RS ≥ 11 experienced substantial risk of early distant recurrence.

PMID:
31809240
DOI:
10.1200/JCO.19.01959

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