Table 1.
Pre-treatment Characteristics of the Discovery and Validation Populations
| Discovery Population | Validation Population | ||||||
|---|---|---|---|---|---|---|---|
| MDACC | I-SPY | Total | MDACC | LBJ/IN/GEI | USO | Total | |
| Patients | 227 | 83 | 310 | 86 | 58 | 54 | 198 |
| Age | |||||||
| <= 50 | 112 (49%) | 30 (36%) | 142 (46%) | 48 (56%) | 30 (52%) | 31 (57%) | 109 (55%) |
| >50 | 115 (51%) | 53 (64%) | 168 (54%) | 38 (44%) | 28 (48%) | 23 (43%) | 89 (45%) |
| Mean (SD) | 51 (11) | 47 (8) | 50 (10) | 49 (11) | 51 (11) | 48 (9) | 49 (11) |
| Nodal status | |||||||
| Pos | 165 (73%) | 58 (70%) | 223 (72%) | 52 (60%) | 42 (72%) | 34 (63%) | 128 (65%) |
| Neg | 62 (27%) | 25 (30%) | 87 (28%) | 34 (40%) | 16 (28%) | 20 (37%) | 70 (35%) |
| T stage | |||||||
| 0 | 2 (1%) | – | 2 (1%) | 1 (1%) | – | – | 1 (1%) |
| 1 | 19 (8%) | 1 (1%) | 20 (6%) | 8 (9%) | 1 (1%) | 1 (2%) | 10 (5%) |
| 2 | 131 (58%) | 34 (41%) | 165 (53%) | 52 (61%) | 19 (33%) | 19 (35%) | 90 (45%) |
| 3 | 35 (15%) | 39 (47%) | 74 (24%) | 18 (21%) | 19 (33%) | 34 (63%) | 71 (36%) |
| 4 | 40 (18%) | 9 (11%) | 49 (16%) | 7 (8%) | 19 (33%) | – | 26 (13%) |
| Grade | |||||||
| 1 | 13 (6%) | 6 (7%) | 19 (6%) | 7 (8%) | 5 (8%) | 1 (2%) | 13 (7%) |
| 2 | 92 (40%) | 25 (30%) | 117 (38%) | 28 (33%) | 19 (33%) | 16 (30%) | 63 (32%) |
| 3 | 122 (54%) | 29 (35%) | 151 (49%) | 51 (59%) | 23 (40%) | 34 (63%) | 108 (54%) |
| Unknown | – | 23 (28%) | 23 (7%) | – | 11 (19%) | 3 (5%) | 14 (7%) |
| AJCC Stage | |||||||
| I | 6 (3%) | – | 6 (2%) | 2 (2%) | 0 | 0 | 2 (1%) |
| II | 126 (55%) | 39 (47%) | 165 (53%) | 57 66%) | 18 (31%) | 32 (59%) | 107 (54%) |
| III | 95 (42%) | 44 (53%) | 139 (45%) | 27 (32%) | 40 (69%) | 22 (41%) | 89 (45%) |
| ER Status | |||||||
| Pos | 131 (58%) | 43 (52%) | 174 (56%) | 60 (70%) | 37 (64%) | 27 (50%) | 124 (63%) |
| Neg | 96 (42%) | 35 (42%) | 131 (42%) | 26 (30%) | 21 (36%) | 27 (50%) | 74 (37%) |
| Indeterminate | – | 5 (6%) | 5 (2%) | – | – | – | – |
| PR Status | |||||||
| Pos | 102 (45%) | 40 (48%) | 142 (46%) | 43 (50%) | 31 (53%) | 28 (52%) | 102 (52%) |
| Neg | 125 (55%) | 37 (45%) | 162 (52%) | 43 (50%) | 27 (47%) | 26 (48%) | 96 (48%) |
| Indeterminate | – | 6 (7%) | 6 (2%) | – | – | – | – |
MDACC, M.D. Anderson Cancer Center; I-SPY, I-SPY-1 clinical trial; LBJ, Lyndon B. Johnson Hospital; IN, Instituto Nacional de Enfermedades Neoplásicas (INEN); GE, Grupo Español de Investigación en Cáncer de Mama (GEICAM); USO, US Oncology.