Journal
JOURNAL OF CLINICAL ONCOLOGY
Volume 34, Issue 20, Pages 2359-U95Publisher
AMER SOC CLINICAL ONCOLOGY
DOI: 10.1200/JCO.2015.63.1960
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Funding
- Translational Breast Cancer Research Consortium
- Avon Foundation
- Breast Cancer Research Foundation
- Susan G. Komen
- Genomic Health
- National Institutes of Health/National Cancer Institute, Cancer Center Support Grant [P30 CA008748]
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Purpose The objective of this study was to determine whether the 21-gene Recurrence Score (RS) provides clinically meaningful information in patients with de novo stage IV breast cancer enrolled in the Translational Breast Cancer Research Consortium (TBCRC) 013. Patients and Methods TBCRC 013 was a multicenter prospective registry that evaluated the role of surgery of the primary tumor in patients with de novo stage IV breast cancer. From July 2009 to April 2012, 127 patients from 14 sites were enrolled; 109 (86%) patients had pretreatment primary tumor samples suitable for 21-gene RS analysis. Clinical variables, time to first progression (TTP), and 2-year overall survival (OS) were correlated with the 21-gene RS by using log-rank, Kaplan-Meier, and Cox regression. Results Median patient age was 52 years (21 to 79 years); the majority had hormone receptor-positive/human epidermal growth factor receptor 2 (HER2)-negative (72 [66%]) or hormone receptorpositive/HER2-positive (20 [18%]) breast cancer. At a median follow-up of 29 months, median TTP was 20 months (95% CI, 16 to 26 months), and median survival was 49 months (95% CI, 40 months to not reached). An RS was generated for 101 (93%) primary tumor samples: 22 (23%) low risk (< 18), 29 (28%) intermediate risk (18 to 30); and 50 (49%) high risk (>= 31). For all patients, RSwas associated with TTP (P=.01) and 2-year OS (P=.04). In multivariable Cox regression models among 69 patients with estrogen receptor (ER)-positive/HER2-negative cancer, RS was independently prognostic for TTP (hazard ratio, 1.40; 95% CI, 1.05 to 1.86; P=.02) and 2-year OS (hazard ratio, 1.83; 95% CI, 1.14 to 2.95; P=.013). Conclusion The 21-gene RS is independently prognostic for both TTP and 2-year OS in ER-positive/HER2-negative de novo stage IV breast cancer. Prospective validation is needed to determine the potential role for this assay in the clinical management of this patient subset. (C) 2016 by American Society of Clinical Oncology
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