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 Translational Breast Cancer Research Consortium (TBCRC) 013. Patients and Methods TBCRC 013 was a multi-center prospective registry evaluating the role of surgery of the primary tumor in patients with de novo stage IV breast cancer. From 07/2009–04/2012, 127 patients from 14 sites were enrolled; 109 patients (86%) had pre-treatment 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 21-gene RS using log-rank, Kaplan-Meier, and Cox regression. Results Median patient age was 52 years (21–79); the majority were hormone receptor positive/HER2 negative (72 [66%]) or hormone receptor positive/HER2 positive (20 [18%]). At a median follow-up of 29 months, median TTP was 20 months (95% CI 16–26) and median survival was 49 months (95% CI 40–NR). RS were generated for 101 (93%) primary tumor samples; 22 (23%) low risk (<18), 29 (28%) intermediate risk (18–30); and 50 (49%) high risk (≥31). For all patients, RS was associated with TTP (p=0.01) and 2-year OS (p=0.04). In multivariate Cox models among estrogen receptor positive/HER2 negative patients (n=69), RS was independently prognostic for TTP (hazard ratio 1.40, 95% CI 1.05–1.86, p=0.02) and 2-year OS (hazard ratio 1.83, 95% CI 1.14–2.95, p=0.013). 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 clinical management of this patient subset.

Most patients are conscious of their port scars and if offered the choice choose placement in the arm rather than the chest. Upper extremity port placement should be further explored as an alternative approach for patients with breast cancer to improve port scar consciousness.

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