TABLE 1.
Baseline characteristics of East Asian patients in the MONARCH 2 and 3 trials
| Characteristics | MONARCH 2 | MONARCH 3 | ||
|---|---|---|---|---|
| Abemaciclib + fulvestrant n = 147 | Placebo + fulvestrant n = 65 | Abemaciclib + NSAI n = 102 | Placebo + NSAI n = 42 | |
| Age, n (%) | ||||
| Median (range) | 55 (32‐76) | 56 (32‐81) | 60 (45‐78) | 62 (46‐85) |
| <65 y | 118 (80.3) | 48 (73.8) | 66 (64.7) | 27 (64.3) |
| ≥65 y | 29 (19.7) | 17 (26.2) | 36 (35.3) | 15 (35.7) |
| Country, n (%) | ||||
| Japan | 64 (43.5) | 31 (47.7) | 38 (37.3) | 15 (35.7) |
| Korea | 58 (39.5) | 20 (30.8) | 41 (40.2) | 18 (42.9) |
| Taiwan | 25 (17.0) | 14 (21.5) | 23 (22.5) | 9 (21.4) |
| Menopausal status | ||||
| Postmenopausal | 96 (65.3) | 41 (63.1) | NA | NA |
| Pre‐ or perimenopausal | 51 (34.7) | 24 (36.9) | ||
| Measurable disease, n (%) | ||||
| Yes | 122 (83.0) | 47 (72.3) | 86 (84.3) | 37 (88.1) |
| No | 25 (17.0) | 18 (27.7) | 16 (15.7) | 5 (11.9) |
| Metastatic site, n (%) | ||||
| Visceral | 91 (61.9) | 32 (49.2) | 50 (49.0) | 25 (59.5) |
| Bone‐only | 28 (19.0) | 20 (30.8) | 21 (20.6) | 7 (16.7) |
| other | 28 (19.0) | 13 (20.0) | 31 (30.4) | 10 (23.8) |
| Disease setting, n (%) a | ||||
| Recurrent locally advanced | 6 (4.1) | 0 | 4 (3.9) | 1 (2.4) |
| Metastatic | 141 (95.9) | 65 (100.0) | 98 (96.1) | 41 (97.6) |
| Prior neoadjuvant systemic therapy, n (%) | ||||
| Endocrine therapy | 4 (2.7) | 2 (3.1) | 0 | 1 (2.4) |
| Chemotherapy | 23 (15.6) | 13 (20.0) | 4 (3.9) | 7 (16.7) |
| Prior adjuvant systemic therapy, n (%) | ||||
| Endocrine | 116 (78.9) | 55 (84.6) | 40 (39.2) | 20 (47.6) |
| Chemotherapy | 73 (49.7) | 37 (56.9) | 36 (35.3) | 14 (33.3) |
| Most recent endocrine therapy | ||||
| Neoadjuvant/adjuvant metastatic | 82 (55.8) | 41 (63.1) | NA | NA |
| 64 (43.5) | 23 (35.4) | |||
| PgR status, n (%)b | ||||
| Positive | 110 (74.8) | 55 (84.6) | 77 (75.5) | 31 (73.8) |
| Negative | 37 (25.2) | 9 (13.8) | 25 (24.5) | 11 (26.2) |
| ECOG PS, n (%) | ||||
| 0 | 114 (77.6) | 54 (83.1) | 74 (72.5) | 33 (78.6) |
| 1 | 33 (22.4) | 11 (16.9) | 28 (27.5) | 9 (21.4) |
| Sensitivity to ET, n (%)d | ||||
| Primary resistance | 35 (23.8) | 19 (29.2) | NA | NA |
| Secondary resistance | 111 (75.5) | 45 (69.2) | ||
Abbreviations: AI, aromatase inhibitor; ET, endocrine therapy; NA, not available; NSAI, nonsteroidal aromatase inhibitor; PgR, progesterone receptor.
a
Derived based on baseline tumor lesion locations; bOne patient in MONARCH 2 placebo arm had unknown PgR status.