Table 1. Patient Demographic Details at Baseline.
| Variable | No. (%) | ||
|---|---|---|---|
| All patients (n = 486) | Fulvestrant-palbociclib (n = 243) | Letrozole-palbociclib (n = 243) | |
| Age, median (range), y | 63 (25-90) | 64 (25-88) | 62 (35-90) |
| Race | |||
| Asian | 3 (0.6) | 2 (0.8) | 1 (0.4) |
| Black | 4 (0.8) | 3 (1.2) | 1 (0.4) |
| White | 461 (94.9) | 231 (95.1) | 230 (94.7) |
| Unknown | 18 (3.7) | 7 (2.9) | 11 (4.5) |
| ECOG performance statusa | |||
| 0 | 275 (56.6) | 151 (62.1) | 124 (51.0) |
| 1 | 187 (38.5) | 80 (32.9) | 107 (44.0) |
| 2 | 24 (4.9) | 12 (4.9) | 12 (4.9) |
| Menopausal status | |||
| Premenopausal | 37 (7.6) | 17 (7.0) | 20 (8.2) |
| Postmenopausal | 449 (92.4) | 226 (93.0) | 223 (91.8) |
| Type of disease | |||
| De novo | 198 (40.7) | 102 (42.0) | 96 (39.5) |
| Recurrent | 288 (59.3) | 141 (58.0) | 147 (60.5) |
| Disease site | |||
| Visceral | 233 (47.9) | 115 (47.3) | 118 (48.6) |
| Nonvisceral | 253 (52.1) | 128 (52.7) | 125 (51.4) |
| No. of disease sites | |||
| <3 | 274 (52.1) | 141 (58.0) | 133 (51.4) |
| ≥3 | 212 (47.9) | 102 (42.0) | 110 (48.6) |
| Measurable disease | |||
| Yes | 376 (77.4) | 195 (80.2) | 181 (74.5) |
| No | 110 (22.6) | 48 (19.8) | 62 (25.5) |
| Previous treatment in early setting | |||
| Neoadjuvant chemotherapy | 46 (9.5) | 25 (10.3) | 21 (8.6) |
| Adjuvant chemotherapy | 144 (29.6) | 73 (30.0) | 71 (29.2) |
| Tamoxifen only | 107 (22.0) | 48 (19.8) | 59 (24.3) |
| Aromatase inhibitors only | 47 (9.7) | 26 (10.7) | 21 (8.6) |
| Tamoxifen and aromatase inhibitors | 70 (14.4) | 39 (16.0) | 31 (12.8) |
a
Eastern Cooperative Oncology Group (ECOG) performance status is graded as follows: 0, fully active; 1, restricted in strenuous activity but capable of light house and office work; 2, ambulatory and capable of self-care but unable to carry out work activities; 3, capable of only limited self-care; 4, cannot perform self-care; 5, dead.