Table 1.
Patient Demographic and Baseline Clinical Characteristics (intent-to-treat population)
| Characteristic | Eribulin (n = 554) |
Capecitabine (n = 548) |
||
|---|---|---|---|---|
| No. of Patients | % | No. of Patients | % | |
| Age, years | ||||
| Median | 54.0 | 53.0 | ||
| Range | 24-80 | 26-80 | ||
| Race | ||||
| White | 496 | 89.5 | 495 | 90.3 |
| Asian/Pacific Islander | 18 | 3.2 | 18 | 3.3 |
| Black or African American | 15 | 2.7 | 16 | 2.9 |
| Other | 25 | 4.5 | 19 | 3.5 |
| Geographic region | ||||
| Eastern Europe | 307 | 55.4 | 305 | 55.7 |
| Latin America | 105 | 19.0 | 104 | 19.0 |
| Western Europe | 80 | 14.4 | 77 | 14.1 |
| North America | 44 | 7.9 | 43 | 7.8 |
| Asia | 13 | 2.3 | 12 | 2.2 |
| South Africa | 5 | 0.9 | 7 | 1.3 |
| ECOG performance status | ||||
| 0 | 250 | 45.1 | 230 | 42.0 |
| 1 | 293 | 52.9 | 301 | 54.9 |
| 2 | 11 | 2.0 | 16 | 2.9 |
| 3 | 0 | 0 | 1 | 0.2 |
| No. of prior chemotherapy regimens | ||||
| 0 | 1 | 0.2 | 0 | 0 |
| 1 | 147 | 26.5 | 153 | 27.9 |
| 2 | 319 | 57.6 | 314 | 57.3 |
| 3 | 84 | 15.2 | 78 | 14.2 |
| 4 | 3 | 0.5 | 2 | 0.4 |
| 5 | 0 | 0 | 1 | 0.2 |
| No. of prior chemotherapy regimens for advanced disease | ||||
| 0 | 116 | 20.9 | 104 | 19.0 |
| 1 | 280 | 50.5 | 293 | 53.5 |
| 2 | 154 | 27.8 | 146 | 26.6 |
| > 2 | 4 | 0.7 | 5 | 0.9 |
| Refractory to treatment with:* | ||||
| Taxane | 250 | 45.1 | 260 | 47.4 |
| Anthracycline | 134 | 24.2 | 139 | 25.4 |
| Taxane and anthracycline | 91 | 16.4 | 103 | 18.8 |
| HER2 status | ||||
| Positive | 86 | 15.5 | 83 | 15.1 |
| Negative | 375 | 67.7 | 380 | 69.3 |
| Not done | 93 | 16.8 | 85 | 15.5 |
| ER status | ||||
| Positive | 259 | 46.8 | 278 | 50.7 |
| Negative | 233 | 42.1 | 216 | 39.4 |
| Not done | 62 | 11.2 | 54 | 9.9 |
| PgR status | ||||
| Positive | 227 | 41.0 | 234 | 42.7 |
| Negative | 262 | 47.3 | 248 | 45.3 |
| Not done | 65 | 11.7 | 66 | 12.0 |
| Triple (HER2/ER/PgR) negative | 150 | 27.1 | 134 | 24.5 |
| Most common metastatic sites† | ||||
| Bone | 299 | 54.0 | 308 | 56.2 |
| Lung | 279 | 50.4 | 280 | 51.1 |
| Lymph nodes | 268 | 48.4 | 274 | 50.0 |
| Liver | 247 | 44.6 | 271 | 49.5 |
| No. of organs involved | ||||
| 1 | 113 | 20.4 | 92 | 16.8 |
| 2 | 174 | 31.4 | 177 | 32.3 |
| 3 | 153 | 27.6 | 149 | 27.2 |
| ≥ 4 | 114 | 20.6 | 129 | 23.5 |
| Missing | 0 | 0 | 1 | 0.2 |
| Site of disease‡ | ||||
| Visceral | 467 | 84.3 | 483 | 88.1 |
| Nonvisceral only | 81 | 14.6 | 61 | 11.1 |
| Missing | 6 | 1.1 | 4 | 0.7 |
Abbreviations: ECOG, Eastern Cooperative Oncology Group; ER, estrogen receptor; HER2, human epidermal growth factor receptor 2; PgR, progesterone receptor.
*
Refractory was defined as progression within 60 days after taking the last dose.
†
Reported by at least 20% of the total population.
‡
Visceral/nonvisceral was determined by independent assessment.