Table 2.
Demographic and baseline disease characteristics for patients enrolled in studies TDM3569g (3.6-mg/kg cohort), TDM4258g, TDM4374g, and TDM4688g
| Baseline characteristics | Median (range) | ||||
|---|---|---|---|---|---|
| TDM3569g (n = 15) | TDM4258g (N = 112) | TDM4374g (N = 110) | TDM4688g (N = 51) | All studies (N = 288) | |
| Age (y) | 50 (35–65) | 54.5 (33–82) | 52.5 (34–77) | 52 (34–85) | 53 (33–85) |
| Weight (kg) | 65.2 (49.9–93.8) | 70.0 (37.7–137) | 69.7 (38.5–136) | 67.2 (44–105) | 69.1 (37.7–137) |
| Height (cm) | 164 (146–173) | 163 (128–178) | 163 (145–188) | 165 (145–181) | 163 (128–188)a |
| Body mass index (kg/m2) | 26.1 (16.7–32.8) | 26.4 (14.7–52.9) | 26.1 (17.1–44.1) | 26.1 (17.3–42.4) | 26.1 (14.7–52.9)a |
| Body surface area (m2) | 1.70 (1.48–2.05) | 1.76 (1.33–2.39) | 1.76 (1.29–2.40) | 1.76 (1.38–2.14) | 1.76 (1.29–2.40)a |
| Aspartate aminotransferase (IU/L) | 28 (14–100) | 32.8 (13.5–227) | 29.3 (13.5–140) | N/A | 30.8 (13.5–227)b |
| Alanine aminotransferase (IU/L) | 26.5 (9.5–173) | 29.6 (8–111) | 24 (9–170) | N/A | 26 (8–173)b |
| Platelet count (103/μL) | 243 (143–354) | 263 (127–569) | 249 (0.2–886) | N/A | 252 (112–886)b |
| Circulating HER2 ECD (ng/mL) | 24 (6.3–86.8) | 30.1 (5–560) | 30.1 (5.9–560) | N/A | 30.1 (5–560)b |
| Trastuzumab (μg/mL) | 6.2 (0.04–72.9) | 0.04 (0.04–66.9) | 0.11 (0.04–122) | 1.88 (0–148) | 0.05 (0–148) |
ECD extracellular domain; HER2 human epidermal growth factor receptor 2; N/A not available
a n = 287 patients
bFinal data for patients in study TDM4688g were not available; n = 237 patients