Table 1 Baseline demographic and clinical characteristics of patientsa
Bireociclib plus fulvestrant (n = 204) | Placebo plus fulvestrant (n = 101) | |
---|---|---|
Median age, years (range) | 54.5 (32, 73) | 55.0 (31, 74) |
<65 years | 161 (78.9) | 85 (84.2) |
≥65 years | 43 (21.1) | 16 (15.8) |
ECOG score | ||
0 | 83 (40.7) | 45 (44.6) |
1 | 121 (59.3) | 56 (55.4) |
Menopausal status | ||
Premenopausal or perimenopausal | 75 (36.8) | 38 (37.6) |
Postmenopausal | 129 (63.2) | 63 (62.4) |
Hormone receptor status | ||
ER+PR+ | 156 (76.5) | 72 (71.3) |
ER+PR− | 48 (23.5) | 29 (28.7) |
Measurable disease | ||
Yes | 185 (90.7) | 90 (89.1) |
No | 19 (9.3) | 11 (10.9) |
Visceral metastases | ||
Yes | 140 (68.6) | 68 (67.3) |
Liver | 62 (30.4) | 37 (36.6) |
Lung | 79 (38.7) | 45 (44.6) |
No | 64 (31.4) | 33 (32.7) |
Bone-only | 26 (12.7) | 14 (13.9) |
No. of recurrent/metastatic sites | ||
1 | 62 (30.4) | 33 (32.7) |
2 | 72 (35.3) | 30 (29.7) |
≥3 | 70 (34.3) | 38 (37.6) |
Disease setting | ||
Locoregionally recurrent | 12 (5.9) | 4 (4.0) |
Metastatic | 192 (94.1) | 97 (96.0) |
Previous chemotherapy for ABC | 46 (22.5) | 27 (26.7) |
ET resistance | ||
Primary | 54 (26.5) | 24 (23.8) |
Secondary | 150 (73.5) | 77 (76.2) |
Previous endocrine therapy | ||
Letrozole/Anastrozole | 123 (60.3) | 68 (67.3) |
Exemestane | 31 (15.2) | 11 (10.9) |
Tamoxifen/Toremifene | 99 (48.5) | 45 (44.6) |