Table 1.
Baseline characteristics.
| Parameter | Category | Thigh N = 110; N (%) |
Abdominal wall N = 109; N (%) | Overall N = 219; N (%) |
|---|---|---|---|---|
| Age, years | Median | 50.0 | 50.0 | 50.0 |
| Min, Max | 25.0, 69.0 | 30.0, 67.0 | 25.0, 69.0 | |
| BMI (kg/m2) | Median | 24.0 | 24.6 | 24.2 |
| Min, Max | 17.4, 50.7 | 18.4, 43.2 | 17.4, 50.7 | |
| Pre-study trastuzumab treatment (i.v.), weeks | Median Min, Max |
12.4 7.0, 26.9 |
12.2 6.0, 23.9 |
12.3 6.0, 26.9 |
| missing | 0 | 1 | 1 | |
| Tumour stage (all) | c/pT1 | 53 (48.2) | 42 (38.5) | 95 (43.4) |
| c/pT2 | 43 (39.1) | 57 (52.3) | 100 (45.7) | |
| c/pT3 | 11 (10.0) | 7 (6.4) | 18 (8.2) | |
| c/pT4 | 3 (2.7) | 3 (2.8) | 6 (2.7) | |
| Nodal status (all) | c/pN0 | 14 (12.7) | 11 (10.1) | 25 (11.4) |
| c/pN1 | 59 (53.6) | 64 (58.7) | 123 (56.2) | |
| c/pN2 | 26 (23.6) | 14 (12.8) | 40 (18.3) | |
| c/pN3 | 11 (10.0) | 20 (18.3) | 31 (14.2) | |
| ER/PR central testing | both ER and PR negative ER and/or PR positive |
35 (79.5) 9 (20.5) |
30 (81.1) 7 (18.9) |
65 (80.2) 16 (19.8) |
| missing | 66 | 72 | 138 | |
| Ki67, central testing | ≤20% | 17 (15.5) | 18 (16.5) | 35 (16.0) |
| >20% | 93 (84.5) | 91 (83.5) | 184 (84.0) | |
| Setting of chemotherapy | neoadjuvant | 30 (27.3) | 27 (24.8) | 57 (26.0) |
| adjuvant | 80 (72.7) | 82 (75.2) | 162 (74.0) | |
| Treatment arm | EnPC dtEC-dtD | 57 (51.8) 53 (48.2) |
54 (49.5) 55 (50.5) |
111 (50.7) 108 (49.3) |
| Histological tumour type | Ductal/ductal-lobular Lobular missing |
84 (76.4) 3 (2.7) |
84 (77.1) 2 (1.8) |
168 (76.7) 5 (2.3) |
| Within the PK cohort | N = 17 | N = 13 | N = 30 | |
| Treatment arma | EnPC | 9 (52.9) | 7 (53.8) | 16 (53.3) |
| dtEC-dtD | 8 (47.1) | 6 (46.2) | 14 (46.7) | |
| Age groupa | ≤50 years | 11 (64.7) | 8 (61.5) | 19 (63.3) |
| >50 years | 6 (35.3) | 5 (38.5) | 11 (36.7) | |
| BMI | Median | 25.4 | 26.2 | 25.9 |
| Min, Max | 18.8, 32.0 | 20.7, 42.0 | 18.8, 42.0 |
BMI, body mass index; dt EC-dtD, 4 cycles of dose dense dose tailored epirubicin and cyclophosphamide followed by 4 cycles of docetaxel q2w; EnPC, epirubicin (150 mg/m2), followed by 3 cycles of nab-paclitaxel (330 mg/m2) followed by 3 cycles of cyclophosphamide (2000 mg/m2) q2w; ER, estrogen receptor; PK, pharmacokinetics; PR, progesterone receptor.
a
Stratification factors for randomization in the pharmacokinetic part of the substudy.