Table 1.
Patient characteristics and prior therapies
| T-DXd (n = 261) |
T-DM1 (n = 263) |
|||
|---|---|---|---|---|
| Patients with BMs (n = 43) | Patients without BMs (n = 218) | Patients with BMs (n = 39) | Patients without BMs (n = 224) | |
| Age, median (range), years | 52.8 (29.2-76.2) | 54.4 (27.9-83.1) | 51.8 (26.0-78.2) | 54.8 (20.2-83.0) |
| Female, n (%) | 43 (100) | 217 (99.5) | 38 (97.4) | 224 (100) |
| Region, n (%) | ||||
| Europe | 10 (23.3) | 44 (20.2) | 4 (10.3) | 46 (20.5) |
| Asia | 24 (55.8) | 125 (57.3) | 30 (76.9) | 130 (58.0) |
| North America | 1 (2.3) | 16 (7.3) | 1 (2.6) | 16 (7.1) |
| Rest of the worlda | 8 (18.6) | 33 (15.1) | 4 (10.3) | 32 (14.3) |
| HER2 status (IHC), n (%) | ||||
| 3+ | 39 (90.7) | 195 (89.4) | 38 (97.4) | 194 (86.6) |
| 2+ | 4 (9.3) | 21 (9.6) | 1 (2.6) | 29 (12.9) |
| 1+/not evaluable | 0/0 | 1 (0.5)/1 (0.5) | 0/0 | 0/1 (0.4) |
| ECOG PS, n (%) | ||||
| 0/1 | 20 (46.5)/23 (53.5) | 134 (61.5)/83 (38.1) | 21 (53.8)/18 (46.2) | 154 (68.8)/69 (30.8) |
| Hormone receptor, n (%) | ||||
| Positive/negative | 23 (53.5)/20 (46.5) | 108 (49.5)/110 (50.5) | 19 (48.7)/20 (51.3) | 115 (51.3)/109 (48.7) |
| Visceral disease, n (%) | ||||
| Yes/no | 34 (79.1)/9 (20.9) | 150 (68.8)/68 (31.2) | 33 (84.6)/6 (15.4) | 152 (67.9)/72 (32.1) |
| Prior treatment for mBC, n (%) | 43 (100) | 217 (99.5) | 39 (100) | 223 (99.6) |
| Prior lines of therapy in the metastatic setting, n (%) | ||||
| 0-1 | 15 (34.9) | 94 (43.1) | 12 (30.8) | 91 (40.6) |
| ≥2 | 28 (65.1) | 124 (56.9) | 27 (69.2) | 133 (59.4) |
| Prior anti-HER2 therapy, n (%) | ||||
| Trastuzumab | 43 (100) | 217 (99.5) | 39 (100) | 223 (99.6) |
| Pertuzumab | 26 (60.5) | 136 (62.4) | 21 (53.8) | 137 (61.2) |
| Prior HER2 TKI therapy, n (%) | 10 (23.3) | 32 (14.7) | 12 (30.8) | 24 (10.7) |
| Prior treatment for BMs, n (%) | ||||
| None | 20 (46.5) | — | 19 (48.7) | — |
| RT alone | 16 (37.2) | 15 (38.5) | ||
| Surgery alone | 1 (2.3) | 2 (5.1) | ||
| RT and surgery | 6 (14.0) | 3 (7.7) | ||
| Time since prior RT to the brain, median (range), months | 1.6 (0.5-45.2) | — | 3.4 (0.5-80.1) | — |
BMs, brain metastases; ECOG PS, Eastern Cooperative Oncology Group performance status; HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry; ISH, in situ hybridization; mBC, metastatic breast cancer; RT, radiotherapy; T-DM1, trastuzumab emtansine; T-DXd, trastuzumab deruxtecan, TKI, tyrosine kinase inhibitor.
a
Includes South America and Australia.