Table 2.
Summary of efficacy (pCR) and safety (grade ≥3 AE) by body weight and exposure quartiles
| pCR | IV trastuzumab n = 263 |
SC trastuzumab n = 260 |
||
|---|---|---|---|---|
| Patients in subgroup (n) | Responders [n (%)] | Patients in subgroup (n) | Responders [n (%)] | |
| Baseline body weight quartile (kg) | ||||
| <58 | 62 | 23 (37) | 56 | 30 (54) |
| ≥58, <67 | 74 | 32 (43) | 63 | 28 (44) |
| ≥67, <79 | 68 | 28 (41) | 68 | 31 (46) |
| ≥79 | 59 | 24 (41) | 73 | 29 (40) |
| Predicted C min,ss quartile (μg/mL) | ||||
| <45.9 | 97 | 41 (42) | 33 | 12 (36) |
| ≥45.9, <61.5 | 84 | 36 (43) | 45 | 16 (36) |
| ≥61.5, <78.2 | 57 | 20 (35) | 73 | 39 (53) |
| ≥78.2 | 22 | 9 (41) | 109 | 51 (47) |
| Missing | 3 | 1 (33) | 0 | 0 |
| Grade ≥3 AEs | IV trastuzumab n = 298 |
SC trastuzumab n = 297 |
||
|---|---|---|---|---|
| Patients in subgroup (n) | Patients with AEs [n (%)] | Patients in subgroup (n) | Patients with AEs [n (%)] | |
| Baseline body weight quartile (kg) | ||||
| <59 | 77 | 50 (65) | 71 | 37 (52) |
| ≥59, <68 | 84 | 42 (50) | 70 | 37 (53) |
| ≥68, <79 | 70 | 31 (44) | 71 | 42 (59) |
| ≥79 | 67 | 33 (49) | 85 | 43 (51) |
| Predicted AUCss quartile (μg day/mL) | ||||
| <1710 | 101 | 55 (54) | 47 | 27 (57) |
| ≥1710, <2055 | 94 | 51 (54) | 52 | 25 (48) |
| ≥2055, <2479 | 69 | 31 (45) | 81 | 45 (56) |
| ≥2479 | 31 | 17 (55) | 117 | 62 (53) |
| Missing | 3 | 2 (68) | 0 | 0 |
Exposure subgroups are according to predicted values from the final population pharmacokinetic model
AUCss, steady-state area under the curve; C min,ss, steady-state trough concentration