Table 1.
Summary of patient characteristics
| Efficacy analysis sets | De novo metastatic or locally advanced | Recurrent metastatic | |
|---|---|---|---|
| Characteristic | n = 1031 | n = 207 | n = 824 |
| Age (ABC diagnosis), years | |||
| Median | 60.0 | 60.0 | 60.0 |
| Range | 29–91 | 35–90 | 29–91 |
| Age group (ABC diagnosis), (n [%]) | |||
| < 60 | 486 (47.1) | 97 (46.9) | 389 (47.2) |
| ≥ 60 | 545 (52.9) | 110 (53.1) | 435 (52.8) |
| Fulvestrant treatment lines | |||
| 1st | 21 (2.0) | 3 (1.4) | 18 (2.2) |
| 2nd | 232 (22.5) | 50 (24.2) | 182 (22.1) |
| 3rd | 276 (26.8) | 59 (28.5) | 217 (26.3) |
| 4th or more | 502 (48.7) | 95 (45.9) | 407 (49.4) |
| ABC diagnosis to fulvestrant use, years | |||
| Median | 3.4 | 3.2 | 3.4 |
| Range | 0–26.9a | 0–18.2 | 0–26.9b |
| ABC diagnosis to fulvestrant use, group, years | |||
| < 3 | 473 (45.9) | 96 (46.4) | 377 (45.8) |
| ≥ 3 | 557 (54.0) | 111 (53.6) | 446 (54.1) |
| Missing | 1 (0.1) | 0 | 1 (0.1) |
| DFI, years | |||
| Median | NA | NA | 5.5 |
| Range | NA | NA | 0–31.8b |
| DFI, group, years | |||
| < 5 | NA | NA | 380 (46.1) |
| ≥ 5 | NA | NA | 443 (53.8) |
| Missing | NA | NA | 1 (0.1) |
| Visceral metastasis | |||
| No | 588 (57.0) | 106 (51.2) | 482 (58.5) |
| Yes | 443 (43.0) | 101 (48.8) | 342 (41.5) |
| Central nerve metastasis | |||
| No | 1017 (98.6) | 203 (98.1) | 814 (98.8) |
| Yes | 14 (1.4) | 4 (1.9) | 10 (1.2) |
| Histological type | |||
| IDC | 863 (83.7) | 173 (83.6) | 690 (83.7) |
| ILC | 48 (4.7) | 7 (3.4) | 41 (5.0) |
| Other | 120 (11.6) | 27 (13.0) | 93 (11.3) |
| Histological or nuclear grade | |||
| 1 | 314 (30.5) | 48 (23.2) | 266 (32.3) |
| 2 | 240 (23.3) | 54 (26.1) | 186 (22.6) |
| 3 | 125 (12.1) | 28 (13.5) | 97 (11.8) |
| NA | 352 (34.1) | 77 (37.2) | 275 (33.4) |
| Hormonal receptor | |||
| ER(+) PgR(−) | 198 (19.2) | 36 (17.4) | 162 (19.7) |
| ER(+) PgR(+) | 765 (74.2) | 159 (76.8) | 606 (73.5) |
| ER( +) PgR(NA) | 68 (6.6) | 12 (5.8) | 56 (6.8) |
| HER2 | |||
| Negative | 884 (85.7) | 174 (84.1) | 710 (86.2) |
| Positive | 94 (9.1) | 21 (10.1) | 73 (8.9) |
| Missing | 53 (5.1) | 12 (5.8) | 41 (5.0) |
| Prior palliative chemotherapy use | |||
| No | 548 (53.2) | 95 (45.9) | 453 (55.0) |
| Yes | 483 (46.8) | 112 (54.1) | 371 (45.0) |
Results are n (%) unless otherwise noted
ABC advanced breast cancer, DFI disease-free interval, ER estrogen receptor, HER2 human epidermal growth factor receptor 2, IDC invasive ductal carcinoma, ILC invasive lobular carcinoma, PgR progesterone receptor
an = 1030
bn = 823