Table 1. Clinicopathological characteristics of the RADHER trial patients.
| Characteristics | Arm T | Arm T+E | p-value a |
|---|---|---|---|
| No. of subjects | 40 (50.6%) | 39 (49.4%) | |
| Age (median/SD) | 50 (±13.3) | 51 (±12.2) | 0.48 |
| No. of serum samples | |||
| W0 | 16 | 23 | |
| W1 | 36 | 34 | |
| W4 | 36 | 31 | |
| W7 | 27 | 30 | |
| W9 | 24 | 28 | |
| W13 | 29 | 26 | |
| Menopausal status | 0.65 | ||
| Pre-Menopausal | 22 (55%) | 19 (48.7%) | |
| Post-Menopausal | 18 (45%) | 20 (51.3%) | |
| BMI (body mass index) | 1 | ||
| ≤ 25 | 24 (60%) | 23 (59%) | |
| > 25 | 15 (37.5%) | 16 (41%) | |
| Unknown | 1 (2.5%) | 0 (0%) | |
| Hormone receptors b | 0.65 | ||
| HR + | 18 (45%) | 15 (38.5%) | |
| HR - | 22 (55%) | 24 (61.5%) | |
| Size tumor residue | 0.30 | ||
| ≤ 2 cm | 18 (45%) | 24 (61.5%) | |
| > 2 cm | 13 (32.5%) | 10 (25.7%) | |
| Unknown | 9 (22.5%) | 5 (12.8%) | |
| Tumor type | 0.39 | ||
| Ductal | 33 (82.5%) | 36 (92.3%) | |
| Lobular | 1 (2.5%) | 0 (0%) | |
| Others | 6 (15%) | 3 (7.7%) | |
| SBR grade c | 0.05 | ||
| 1 | 0 (0%) | 1 (2.6%) | |
| 2 | 12 (30%) | 22 (56.4%) | |
| 3 | 20 (50%) | 11 (28.2%) | |
| Unknown | 8 (20%) | 5 (12.8%) | |
| Sataloff classification d | 0.23 | ||
| Complete Response | 6 (15%) | 3 (7.7%) | |
| Partial Response | 11 (27.5%) | 16 (41%) | |
| No Response | 21(52.5%) | 20 (51.3%) | |
| No information | 2 (5%) | 0 (0%) | |
| Toxicity e at W4 | 0.01 | ||
| Grade 1 & 2 | 35 (87.5%) | 30 (76.9%) | |
| Grade 3 & 4 | 0 (0%) | 7 (17.9%) | |
| No toxicity | 2 (5%) | 0 (0%) | |
| No information | 3 (7.5%) | 2 (5.1%) |
a p-value calculated using either the χ2 or Fisher exact tests for proportions or a Student test for median.
b Hormone receptors are receptors for estrogen and progesterone; HR-: at least one of the two receptors are negative; HR+: both receptors are positive.
c SBR (Scarff Bloom and Richardson) grade consists in three grades obtained by addition of three criteria: architecture, shape and size of the nuclei and number of dividing cells.
d Pathological response rate is centrally evaluated according to Sataloff classification (complete response: T-A; partial response: T-B; no response: T-C and T-D).
e Toxicity data was recorded after four weeks following NCI CTC criteria. The toxicity corresponds to the maximum intensity for all types of toxicities.