Table 1 Baseline participant characteristics for the evaluable population (n = 198)
Arm A (n = 51) | Arm B (n = 74) | Arm C (n = 73) | Arms B + C (n = 147) | |
|---|---|---|---|---|
Age, median (IQR) | 67.2 (10.3) | 67.9 (12.1) | 68.4 (11.0) | 68.1 (11.9) |
ECOG performance status | ||||
0 | 43 (84%) | 66 (89%) | 60 (82%) | 126 (86%) |
1 | 7 (14%) | 7 (9%) | 12 (16%) | 19 (13%) |
2 | 1 (2%) | 1 (1%) | 1 (1%) | 2 (1%) |
Histological grade | ||||
1 | 5 (10%) | 9 (12%) | 4 (5%) | 13 (9%) |
2 | 32 (63%) | 52 (70%) | 56 (77%) | 108 (73%) |
3 | 14 (27%) | 13 (18%) | 13 (18%) | 26 (18%) |
Histological subtype | ||||
Ductal | 38 (75%) | 60 (81%) | 51 (70%) | 111 (76%) |
Lobular | 10 (20%) | 9 (12%) | 14 (19%) | 23 (16%) |
Other | 3 (6%) | 5 (7%) | 8 (11%) | 13 (9%) |
ER Allred score | ||||
3–6 | 1 (2%) | 1 (1%) | 2 (3%) | 3 (2%) |
7–8 | 50 (98%) | 73 (99%) | 71 (97%) | 144 (98%) |
T stage | ||||
1C | 24 (47%) | 48 (65%) | 46 (63%) | 94 (64%) |
2 | 24 (47%) | 22 (30%) | 26 (36%) | 48 (33%) |
3 | 3 (6%) | 4 (5%) | 1 (1%) | 5 (3%) |
N stage | ||||
0 | 45 (88%) | 61 (82%) | 65 (89%) | 126 (86%) |
1 | 4 (8%) | 11 (15%) | 5 (7%) | 16 (11%) |
2 | 1 (2%) | 1 (1%) | 1 (1%) | 2 (1%) |
3 | - | 1 (1%) | 1 (1%) | 2 (1%) |
X | 1 (2%) | - | 1 (1%) | 1 (1%) |
PR Allred score* | ||||
0–3 | 10 (20%) | 14 (19%) | 20 (28%) | 34 (23%) |
4–6 | 11 (22%) | 12 (16%) | 12 (17%) | 24 (17%) |
7–8 | 30 (59%) | 47 (64%) | 40 (56%) | 87 (60%) |
PR status | ||||
Negative | 7 (14%) | 5 (7%) | 10 (14%) | 15 (10%) |
Positive (>1%) | 44 (86%) | 69 (93%) | 63 (86%) | 132 (90%) |
AR status† | ||||
Negative | 1 (2%) | 2 (3%) | 2 (1%) | |
Positive (>1%) | 48 (98%) | 73 (100%) | 71 (97%) | 144 (99%) |
Ki67 status | ||||
<10% | 10 (20%) | 5 (7%) | 19 (26%) | 24 (16%) |
>10% | 41 (80%) | 69 (93%) | 54 (74%) | 123 (84%) |
Mean baseline Ki67‡ | 18.9 (2.0) | 20.2 (1.6) | 18.1 (2.0) | 19.1 (1.8) |
