Table 1.
Baseline patient demographics and disease characteristics
| Characteristics | n = 398 | % |
|---|---|---|
| Median age, years | 58 (30‐86) | |
| Menopausal status | ||
| Premenopausea | 84 | 21.1 |
| Postmenopause | 314 | 78.9 |
| Disease‐free intervalb | ||
| >5 years | 181 | 43.0 |
| ≤5 years | 171 | 45.5 |
| ER status | ||
| Positive | 393 | 98.7 |
| Negative | 5 | 1.3 |
| PgR status | ||
| Positive | 285 | 71.6 |
| Negative | 95 | 23.9 |
| Unknown | 18 | 4.5 |
| Metastatic sites | ||
| Nonvisceral | 165 | 41.5 |
| Bone | 247 | 62.1 |
| Bone only | 61 | 15.3 |
| Visceral disease | 233 | 58.5 |
| Any lung | 179 | 45.0 |
| Any liver | 92 | 23.1 |
| Lungw/o liver | 138 | 34.7 |
| Liverw/o lung | 51 | 12.8 |
| Lung + liver | 41 | 10.3 |
| Pleural | 31 | 7.8 |
| Brainc | 12 | 3.0 |
| Ovary | 4 | 1.0 |
| Otherd | 9 | 2.3 |
| No. of disease sites | ||
| 1 | 122 | 30.6 |
| ≥2 | 276 | 69.4 |
| De novo metastatic disease | 46 | 11.6 |
| Adjuvant ET | ||
| Antiestrogen ± LH‐RH analog | 172 | 43.2 |
| Aromatase inhibitor ± LH‐RH analog | 102 | 25.6 |
| Antiestrogen followed by aromatase inhibitor | 13 | 3.3 |
| None | 40 | 10.0 |
| Unknown | 24 | 6.0 |
| Prior ET for metastatic disease | ||
| No | 145 | 36.4 |
| Yes | 253 | 63.6 |
| Prior ET type for metastatic disease | ||
| Antiestrogen ± LH‐RH analog | 45 | 11.3 |
| Aromatase inhibitor ± LH‐RH analog | 238 | 59.8 |
| Everolimus | 7 | 1.8 |
| Prior sensitivity to ET | ||
| Primary resistance | 71 | 17.8 |
| Secondary resistance | 295 | 74.1 |
| Prior chemotherapy for metastatic disease | ||
| No | 203 | 51.0 |
| Yes | 195 | 49.0 |
| Treatment immediately preceding fulvestrant | ||
| None | 32 | 8.0 |
| Chemotherapy | 102 | 25.6 |
| Antiestrogen ± LH‐RH analog | 45 | 11.3 |
| Aromatase inhibitor ± LH‐RH analog | 211 | 53.0 |
| Everolimus | 4 | 1 |
| Other | 4 | 1 |
Abbreviations: ER, estrogen receptor; PgR, progesterone receptor; LH‐RH, luteinizing; ET, endocrine therapy; hormone‐releasing hormone; Lungw/o liver, lung metastasis without liver involvement; Liverw/o lung, liver metastasis without lung involvement.
For premenopausal women, fulvestrant was given upon the administration of LH‐RH.
Patients with stage IV breast cancer at initial diagnosis were excluded (n = 46).
Patients with baseline brain metastases all received local brain radiotherapy, and there was no clinical evidence of disease progression at the time of fulvestrant administration.
Includes patients with baseline disease site of adrenal glands (n = 4), peritoneum (n = 3), esophagus (n = 1) and pancreas (n = 1).