Table 1.
Patient and tumour characteristics for the whole study cohort (n = 560) by study arm and for the ER-positive/HER2-negative subgroup.
| Initial study cohort (n = 560) | ER+/HER2− cohort (n = 280) | |||
|---|---|---|---|---|
| Characteristics | Control group n (%) | TAM-treated group n (%) | Control group n (%) | TAM-treated group n (%) |
| Follow-up BCFi/OS (years)a | ||||
| Median | 28/33 | 28/33 | 28/33 | 28/33 |
| Range (10th–90th percentiles) | (25–31)/(30–35) | (25–30)/(31–35) | (26–31)/(30–35) | (25–30)/(30–35) |
| Age (years) | ||||
| Median | 45 | 45 | 46 | 46 |
| Range | 27–58 | 26–57 | 27–54 | 33–57 |
| <40 | 59 (21) | 51 (19) | 24 (16) | 17 (13) |
| ≥40 | 225 (79) | 225 (82) | 124 (84) | 115 (87) |
| Tumour size (mm) | ||||
| Median | 22 | 25 | 22 | 23 |
| Range | 2–50 | 5–75 | 2–50 | 8–50 |
| ≤20 | 121 (43) | 86 (31) | 70 (47) | 48 (37) |
| >20 | 163 (57) | 189 (69) | 78 (53) | 83 (63) |
| Missing | 0 | 1 | 0 | 1 |
| Nodal status | ||||
| Median number of positive nodes | 1 | 1 | 1.5 | 1 |
| Range | 0–22 | 0–21 | 0–15 | 0–17 |
| Node-negative | 75 (27) | 83 (30) | 35 (24) | 36 (27) |
| Node-positive | 208 (74) | 192 (70) | 113 (76) | 96 (73) |
| Missing | 1 | 1 | 0 | 0 |
| NHG | ||||
| 1 | 32 (12) | 27 (11) | 25 (17) | 22 (17) |
| 2 | 115 (44) | 105 (42) | 88 (60) | 68 (53) |
| 3 | 116 (44) | 117 (47) | 33 (23) | 39 (30) |
| Missing | 21 | 27 | 2 | 3 |
| ER | ||||
| Positive | 191 (70) | 171 (65) | 148 (100) | 132 (100) |
| Negative | 84 (31) | 91 (35) | 0 | 0 |
| Missing | 9 | 14 | 0 | 0 |
| PR | ||||
| Positive | 185 (67) | 163 (61) | 139 (94) | 118 (90) |
| Negative | 92 (33) | 103 (39) | 9 (6) | 13 (10) |
| Missing | 7 | 10 | 0 | 1 |
| HER2 | ||||
| Negative | 203 (84) | 197 (87) | 148 (100) | 132 (100) |
| Positive | 38 (16) | 30 (13) | 0 | 0 |
| Missing | 43 | 49 | 0 | 0 |
| LVI | ||||
| Absent | 138 (56) | 124 (52) | 75 (55) | 64 (53) |
| Present | 109 (44) | 113 (48) | 62 (45) | 56 (47) |
| Missing | 37 | 39 | 11 | 12 |
| Ki67 (%) | ||||
| <14 | 18 (8) | 25 (11) | 13 (10) | 18 (16) |
| 14–19 | 25 (11) | 27 (12) | 22 (18) | 15 (13) |
| ≥20 | 184 (81) | 167 (76) | 91 (72) | 82 (71) |
| Missing | 57 | 57 | 22 | 17 |
| TILs (%) | ||||
| <10 | 129 (52) | 123 (52) | 90 (66) | 86 (72) |
| 10–49 | 86 (35) | 75 (32) | 36 (26) | 29 (24) |
| 50–74 | 27 (11) | 31 (13) | 11 (8) | 5 (4) |
| ≥75 | 7 (3) | 8 (3) | 0 | 0 |
| Missing | 35 | 39 | 11 | 12 |
| Histopathological type | ||||
| Ductal/NST | 209 (84) | 200 (83) | 123 (84) | 111 (84) |
| Lobular | 22 (9) | 21 (9) | 18 (12) | 14 (11) |
| Medullary | 14 (6) | 11 (5) | 2 (1) | 1 (1) |
| Other | 5 (2) | 10 (4) | 3 (2) | 6 (5) |
| Missing | 34 | 34 | 2 | 0 |
| Subtype (IHC/ISH) | ||||
| Luminal/HER2 | 148 (64) | 132 (61) | 148 (100) | 132 (100) |
| HER2+ | 38 (16) | 30 (14) | 0 | 0 |
| TNBC | 46 (20) | 54 (25) | 0 | 0 |
| Missing | 52 | 60 | 0 | 0 |
| PAM50 intrinsic subtype | ||||
| LumA | 101 (46) | 90 (42) | 82 (66) | 66 (59) |
| LumB | 41 (19) | 42 (19) | 33 (27) | 36 (32) |
| HER2-E | 39 (18) | 35 (16) | 8 (7) | 4 (4) |
| Basal-like | 39 (18) | 50 (23) | 1 (1) | 6 (5) |
| Missing | 64 | 59 | 24 | 20 |
| ROR scoreb | ||||
| Median | 56 | 56 | 45 | 50 |
| Range | 0–94 | 1–94 | 4–94 | 12–94 |
| Low | 22 (10) | 23 (11) | 16 (13) | 15 (13) |
| Intermediate | 48 (22) | 55 (26) | 35 (28) | 29 (26) |
| High | 149 (68) | 138 (64) | 73 (59) | 68 (61) |
| Missing | 65 | 60 | 24 | 20 |
| N0 (node-negative)c | ||||
| Low (0–40) | 19 (33) | 20 (32) | 15 (52) | 14 (45) |
| Intermediate (41–60) | 11 (19) | 21 (34) | 6 (21) | 7 (23) |
| High (61–100) | 27 (47) | 21 (34) | 8 (28) | 10 (32) |
| Missing | 18 | 21 | 6 | 5 |
| N1 (1–3 positive nodes)c | ||||
| Low (0–15) | 3 (3) | 3 (3) | 1 (2) | 1 (2) |
| Intermediate (16–40) | 37 (35) | 34 (32) | 29 (45) | 22 (38) |
| High (41–100) | 65 (62) | 71 (66) | 35 (54) | 35 (60) |
| Missing | 34 | 28 | 12 | 11 |
| N2 (≥4 positive nodes)c | ||||
| High (0–100) | 57 (100) | 46 (100) | 30 (100) | 23 (100) |
| Missing | 12 | 10 | 6 | 4 |
BCFi breast cancer-free interval, ER oestrogen receptor, HER2-E human epidermal growth factor receptor 2-enriched, IHC immunohistochemistry, ISH in situ hybridisation, Lum Luminal, LVI lymphovascular invasion, NHG Nottingham histological grade, NST no special type, OS overall survival, PR progesterone receptor, ROR risk of recurrence, TAM tamoxifen, TILs tumour infiltrating lymphocytes, TNBC triple-negative breast cancer.
aPatients without events.
bThe ROR score categories were defined by the following cut-offs based on N-status; N0; low: 0–40, intermediate: 41–60, high: 61–100, N1; low: 0–15, intermediate: 15–40, high: 41–100, N2; high: 0–100.
cROR score stratified by nodal status.