The 21-gene RS assay has been shown to predict BC recurrence and adjuvant chemotherapy benefit in LN + , HR + , HER2-negative BC. We assessed 5-year BC-specific survival (BCSS) in LN+ patients with 21-gene RS results in the SEER registries, a cancer surveillance program that covers 30% of the US population.
All SEER BC cases diagnosed 2004-2012 were linked to 21-gene assays performed by the Genomic Health Clinical Laboratory. The analysis was restricted to single primary invasive BC, LN + , no distant metastases, HR+ (per SEER), HER2-negative (per RT-PCR). Using the actuarial method in SEER*Stat, BCSS was assessed for those who were diagnosed 2004-2011 with survival follow-up through 2012, by RS category and by number of positive nodes.
The proportion of women with LN + , HR+ BC who had RS results (n = 7695) increased over time between 2004 (0.3%, n = 33) and 2012 (13.8%, n = 2010), and was lower with increasing nodal involvement, from micrometastases only (36.0%, n = 792) to 4+ nodes (2.6%, n = 81) in 2012. BCSS differed significantly by both RS category (log-rank p
Overall, 5-year BCSS is excellent in patients with RS
Clinical trial identification
Legal entity responsible for the study
Dave P. Miller, Megan Roberts, Lynne Penberthy
National Cancer Institute
D.P. Miller, S. Shak: Employed by Genomic Health; stock ownership in Genomic Health
All other authors have declared no conflicts of interest.