Table 1.
Baseline demographics and characteristics of the total ITT population
| Eribulin (n = 1,062) |
Control (n = 802) |
|
|---|---|---|
| Median age, years (range) | 55.0 (24–85) | 54.0 (26–81) |
| Race, n (%) | ||
| Black | 35 (3.3) | 30 (3.7) |
| White | 966 (91.0) | 728 (90.8) |
| Asian/Pacific Islander | 21 (2.0) | 20 (2.5) |
| Other | 40 (3.8) | 24 (3.0) |
| ECOG performance status, n (%) | ||
| 0 | 467 (44.0) | 333 (41.5) |
| 1 | 537 (50.6) | 427 (53.2) |
| 2 | 50 (4.7) | 38 (4.7) |
| 3 | 0 | 1 (0.1) |
| Number of prior chemotherapy regimens | ||
| 0 | 1 (0.1) | 0 |
| 1 | 148 (13.9) | 153 (19.1) |
| 2 | 384 (36.2) | 345 (43.0) |
| 3 | 260 (24.5) | 161 (20.1) |
| ≥4 | 267 (25.1) | 142 (17.7) |
| Number of prior chemotherapy regimens for advanced disease | ||
| 0 | 117 (11.0) | 104 (13.0) |
| 1 | 288 (27.1) | 300 (37.4) |
| 2 | 373 (35.1) | 236 (29.4) |
| >2 | 284 (26.7) | 161 (20.1) |
| Number of organs involved, n (%) | ||
| 1 | 198 (18.6) | 127 (15.8) |
| 2 | 346 (32.6) | 259 (32.3) |
| 3 | 298 (28.1) | 226 (28.2) |
| ≥4 | 218 (20.5) | 189 (23.6) |
| Site of disease, n (%) | ||
| Visceral | 880 (82.9) | 694 (86.5) |
| Non-visceral only | 171 (16.1) | 101 (12.6) |
| Missing | 11 (1.0) | 7 (0.9) |
| HER2 status, n (%) | ||
| Positive | 169 (15.9) | 123 (15.3) |
| Negative | 748 (70.4) | 572 (71.3) |
| Unknown | 145 (13.7) | 107 (13.3) |
| ER status, n (%) | ||
| Positive | 595 (56.0) | 449 (56.0) |
| Negative | 376 (35.4) | 288 (35.9) |
| Unknown | 91 (8.6) | 65 (8.1) |
| Triple-negative disease, n (%) | 243 (22.9) | 185 (23.1) |
| Taxane refractory, n (%)a | ||
| Yes | 530 (49.9) | 401 (50.0) |
| No | 532 (50.1) | 401 (50.0) |
ECOG Eastern Cooperative Oncology Group, ER estrogen receptor, HER2 human epidermal growth factor receptor 2, ITT intent-to-treat, PR progesterone receptor
aRefractory defined as progressed within 60 days after taking the last dose