TABLE 1.
Patient characteristics.
| N = 459 | |
|---|---|
| Age, years, median (range) | 58 (28–92) |
| Weight, kg, median (range) | 65 (38–127) |
| Female gender, n (%) | 455 (99.1) |
| Duration from initial diagnosis, months, median (IQR) | 79.4 (47.0–133.4) |
| Metastatic status at initial diagnosis, n (%) | |
| M0: no distant metastasis | 274 (59.8) |
| M1: metastasis to distant organs | 180 (39.3) |
| Mx: unknown | 4 (0.9) |
| Missing | 1 |
| HER2+ status, n (%) | |
| IHC 3+ | 390 (85.0) |
| IHC 2+/ISH+ | 64 (13.9) |
| IHC 2+/ISH− | 1 (0.2) |
| IHC 2+/ISH NA | 3 (0.7) |
| IHC 1+/ISH NA | 1 (0.2) |
| Expression of hormone receptors, n (%) | |
| Positive | 290 (67.0) |
| Negative | 143 (33.0) |
| Missing | 26 |
| Tumor status, a n (%) | |
| Unresectable and metastatic | 36 (18.9) |
| Metastatic only | 154 (81.1) |
| Metastatic locations, a n (%) | |
| Bone | 263 (57.3) |
| Lymph nodes | 237 (51.6) |
| Lung | 166 (36.2) |
| Liver | 152 (33.1) |
| Brain | 129 (28.1) |
| Cutaneous/subcutaneous | 64 (13.9) |
| Other | 70 (15.3) |
| ECOG performance status, a n (%) | |
| 0 | 167 (36.4) |
| 1 | 248 (54.0) |
| 2 | 42 (9.2) |
| 3 | 2 (0.4) |
Abbreviations: IHC, immunochemistry; ISH, in situ hybridization; NA, not available.
a
At the time of early access program application.