Table 1.
Baseline patient demographics and disease characteristics
| Characteristic | Ixabepilone + bevacizumab | Paclitaxel + bevacizumab | |
|---|---|---|---|
| Arm A (n = 46) | Arm B (n = 45) | Arm C (n = 32) | |
| Age, year | |||
| Median (range) | 60 (27–80) | 59 (37–83) | 59 (37–75) |
| Karnofsky performance status, n (%) | |||
| 90–100 | 34 (73.9) | 30 (66.7) | 22 (68.8) |
| 70–80 | 10 (21.7) | 15 (33.3) | 10 (31.2) |
| <70 | 1 (2.2) | – | – |
| Not reported | 1 (2.2) | – | – |
| Hormone receptor status, n (%) | |||
| ER-positive | 37 (80.4) | 35 (77.8)a | 27 (84.4) |
| ER-negative | 8 (17.4) | 9 (20.0)a | 5 (15.6) |
| HER2-negative | 45 (97.8) | 45 (100.0) | 32 (100.0) |
| ER-negative, progesterone receptor-negative, HER2-negative | 8 (17.4) | 9 (20.0) | 5 (15.6) |
| Site of visceral disease, n (%) | |||
| Liver | 22 (47.8) | 21 (46.7) | 9 (28.1) |
| Liver and/or lung | 37 (80.4) | 28 (62.2) | 18 (56.3) |
| Median time from initial diagnosis to randomization, months | 38.5 | 37.8 | 55.2 |
| Number of disease lesions, n (%) | |||
| ≥3 | 24 (52.1) | 19 (42.2) | 14 (43.7) |
| Prior chemotherapy regimens—neoadjuvant/adjuvant setting, n (%) | |||
| 0 | 23 (50.0) | 22 (48.9) | 14 (43.8) |
| 1 | 21 (45.7) | 22 (48.9) | 13 (40.6) |
| 2 | 2 (4.3) | 1 (2.2) | 5 (15.6) |
| Prior therapy, n (%) | |||
| Any chemotherapy | 23 (50) | 23 (51) | 18 (56.3) |
| Any hormonal therapy | 25 (54.3) | 25 (55.6) | 19 (59.4) |
| Taxanes | 7 (15.2) | 6 (13.3) | 6 (18.8) |
ER estrogen-receptor, HER2 human epidermal growth factor receptor 2
aThe ER status of one patient in Arm B was unknown