Table 2 Summary of results from validation studies (level 1B) and the WSG PlanB study (level 1A)

From: Clinical relevance of the 21-gene Recurrence Score® assay in treatment decisions for patients with node-positive breast cancer in the genomic era

 

Standard RS cut-offs

RS <18

RS 18–30

RS ≥31

SWOG S8814 (N+; N = 367)

N (%)

146 (40%)

103 (28%)

118 (32%)

% CT/% no CT

62%/38%

55%/45%

60%/40%

10-y DFS; HR (95% CI) for CT + HT vs. HT

1.02 (0.54, 1.93)

0.72 (0.39, 1.31)

0.59 (0.35, 1.01)

p-value

0.97

0.48

0.03

transATAC (N+; N = 306)

N (%)

160 (52%)

94 (31%)

52 (17%)

% CT/% no CT

0%/100%

0%/100%

0%/100%

9-y DR (95% CI)

17% (12%, 24%)

28% (20%, 39%)

49% (35%, 64%)

p-value

<0.001 (RS results associated with risk of DR)

 

Non-standard RS cut-offs

 

RS <12

RS 12–25

RS >25

PlanB (1–3N+; N = 905)

N (%)

170 (19%)a

567 (63%)

168 (19%)

% CT/% no CT

0%/100%a

100%/0%

100%/0%

5-y DFS (95% CI)

94.4%a (89.5%, 99.3%)

94.3% (91.9%, 96.7%)

83.6% (77.1%, 90.1%)

p-value

<0.001

 5-y DDFS

97.9%

96.0%

86.0%

p-value

<0.001 for RS >25 vs. RS <12 or RS 12–25

  1. CI confidence interval, CT chemotherapy, DFS disease-free survival, DR distant recurrence, HR hazard ratio, HT hormonal therapy, RS Recurrence Score result
  2. aOf 170 patients with 1–3N+ breast cancer and RS <12, 110 patients received hormonal therapy alone; the remaining 60 patients received chemotherapy. Data shown here are for the 110 patients with 1–3N+ breast cancer and RS <12 who received hormonal therapy alone