Table 1.
Baseline characteristics of cohort A.a
| Abemaciclib + NSAI (n = 207) | Placebo + NSAI (n = 99) | |
|---|---|---|
| Age, years, median (range) | 54.0 (32.0, 83.0) | 54.0 (27.0, 77.0) |
| Age category | ||
| <65 years | 157 (75.8) | 83 (83.8) |
| ⩾65 years | 50 (24.2) | 16 (16.2) |
| Country | ||
| China | 164 (79.2) | 82 (82.8) |
| Brazil | 21 (10.1) | 8 (8.1) |
| India | 18 (8.7) | 7 (7.1) |
| South Africa | 4 (1.9) | 2 (2.0) |
| Disease setting | ||
| Locoregionally recurrent | 8 (3.9) | 7 (7.1) |
| De novo metastatic | 41 (19.8) | 22 (22.2) |
| Metastatic recurrent | 157 (75.8) | 70 (70.7) |
| Measurable disease | ||
| Yes | 176 (85.0) | 83 (83.8) |
| No (evaluable bone disease only) | 31 (15.0) | 16 (16.2) |
| Nature of disease | ||
| Visceral metastases | 126 (60.9) | 59 (59.6) |
| Non-visceral metastases | 81 (39.1) | 40 (40.4) |
| Prior (neo)adjuvant ET disease-free interval | ||
| >12 months | 87 (42.0) | 41 (41.4) |
| ⩽12 months | 35 (16.9) | 20 (20.2) |
| No prior ET | 83 (40.1) | 37 (37.4) |
| Prior (neo)adjuvant ET | ||
| Aromatase inhibitor containing ET | 20 (9.7) | 13 (13.1) |
| Anti-estrogen therapy onlyb | 101 (48.8) | 48 (48.5) |
| No prior (neo)adjuvant ET | 85 (41.1) | 38 (38.4) |
| Prior (neo)adjuvant chemotherapy | ||
| Yes | 140 (67.6) | 63 (63.6) |
| No | 67 (32.4) | 36 (36.4) |
a
Data are no. (%), unless otherwise stated.
b
One patient in abemaciclib arm used ‘unknown endocrine therapy’ as the reported term and was classified into this category.
ET, endocrine therapy.