Table 1.
Studies included in this analysis of the Recurrence Score assay in node-positive breast cancer (N = 9055)
Studya | Years of study enrollmentb | Type of study | N | Study design | Primary endpoint(s) | Years of follow-up |
---|---|---|---|---|---|---|
SWOG S8814[18] | 1989–1995 | Prospective-retrospective; validation | 367 (62%/38% 1–3N+/≥4N+) | TAM vs. CAF→T | DFS BCSS | 10 years |
transATAC[16] | 1996–2000 | Prospective-retrospective; validation | 306 (79%/21% 1–3N+/≥4N+) | ANA vs. TAM vs. ANA + TAM | DR | 9 years |
SEER[27,28] | 2004–2013 | Prospective outcomes | 6768 (42%/54%/4% N1mi/1–3N+/≥4N+) | Population-based registry | BCSS | 5 years |
Clalit[29] | 2006–2011 | Prospective outcomes | 709 (42%/58% N1mi/1–3N+) |
Population-based registry | DR; BCSM | 5 years |
WSG PlanB[23–26] | 2009–2011 | Prospective outcomes | 905 (100% 1–3N+) | RS <12: ET RS ≥12: CT |
DFS; DDFS | 5 years |
ANA anastrozole, BCSM breast cancer-specific mortality, BCSS breast cancer-specific survival, CAF cyclophosphamide, doxorubicin, 5-fluorouracil, CT chemotherapy, DDFS distant disease-free survival, DFS disease-free survival, DR distant recurrence, ET endocrine therapy, T or TAM tamoxifen
aNumbers in brackets denote reference citations
bFor prospective-retrospective studies, this refers to the time period when the parent study enrolled patients