Characteristics | I-SPY 1 TRIAL evaluable patients (n = 221) | Matched T1-T2 pairs (n = 36) | P-value | Matched T1-TS pairs (n = 39) | P-value |
---|---|---|---|---|---|
Age, yr | 0.77a | 0.86a | |||
Median (range) | 49 (26–28) | 47 (31–68) | 48 (34–65) | ||
Clinical tumor size, cm | |||||
Median (range) | 6 (0–25)c | 6 (3–17) | 0.55a | 6 (0–25)c | 0.88a |
Clinically node-positive at diagnosis | 143 (65 %) | 25 (69 %) | 26 (67 %) | ||
Histological grade (baseline) | |||||
Low | 18 (8 %) | 1 (3 %) | 0.39b | 4 (10 %) | 0.83b |
Intermediate | 96 (43 %) | 20 (56 %) | 17 (44 %) | ||
High | 103 (47 %) | 15 (42 %) | 18 (46 %) | ||
Indeterminate | 4 (2 %) | 0 | 0 | ||
Clinical stage (baseline) | |||||
I | 3 (1 %) | 0 | 0.80b | 0 | 0.66b |
II | 104 (47 %) | 15 (42 %) | |||
III | 96 (43 %) | 18 (50 %) | 16 (41 %) | ||
Inflammatory | 17 (8 %) | 3 (8 %) | 5 (13 %) | ||
Indeterminate | 1 (<1 %) | 0 | 0 | ||
Hormone receptor-positive (ER or PR) at baseline | 131 (59 %) | 24 (67 %) | 0.55b | 26 (68 %) | 0.41b |
HER2-positive at baseline | 67 (31 %) | 6 (17 %) | 0.12b | 3 (8 %) | 0.006b |
Neoadjuvant treatment | |||||
AC only | 11 (5 %) | 3 8 %) | 0.21b | 2 (5 %) | 0.38b |
AC + taxane | 187 (85 %) | 33 (92 %) | 33 (85 %) | ||
AC + T + Trastuzumab | 20 (9 %) | 0 | 2 (5 %) | ||
AC + T + Other | 3 (1 %) | 0 | 2 (5 %) | ||
Surgery type | |||||
Mastectomy | 123 (56 %) | 19 (53 %) | 0.95b | 22 (56 %) | 0.58b |
Lumpectomy | 92 (41 %) | 16 (44 %) | 17 (44 %) | ||
No surgery | 6 (3 %) | 1 (3 %) | |||
RCB | |||||
0 | 56 (25 %) | 6 (17 %) | 0.29b | 0 | 0.0002b |
I | 18 (8 %) | 1 (3 %) | 1 (3 %) | ||
II | 86 (39 %) | 16 (44 %) | 18 (46 %) | ||
III | 41 (19 %) | 10 (28 %) | 16 (41 %) | ||
Undetermined | 20 (9 %) | 3 (8 %) | 4 (10 %) |