Table 1 Demographic and baseline clinical characteristics
Characteristic | Palbociclib–Tamoxifen Group (n = 91) | Placebo–Tamoxifen Group (n = 93) |
|---|---|---|
Age, median (range), years | 60 (33–82) | 61 (35–83) |
Weight, median (range), kg | 53.9 (32.5–89.7) | 56.0 (31.7–96.0) |
BMI, median (range), kg/m2 | 21.9 (14.3–38.8) | 23.2 (13.1–35.3) |
Geographical region, n (%) | ||
 Japan | 69 (75.8) | 49 (52.7) |
 Republic of Korea | 12 (13.2) | 19 (20.4) |
 Taiwan | 6 (6.6) | 18 (19.4) |
 Singapore | 4 (4.4) | 7 (7.5) |
ECOG performance status, n (%) | ||
 0 | 72 (79.1) | 61 (65.6) |
 1 | 19 (20.9) | 32 (34.4) |
Endocrine therapya, n (%) | ||
 First-line endocrine therapy | 56 (61.5) | 56 (60.2) |
 Second-line endocrine therapy | 35 (38.5) | 37 (39.8) |
Menopausal statusa, n (%) | ||
 Pre/perimenopausal | 25 (27.5) | 27 (29.0) |
 Postmenopausal | 66 (72.5) | 66 (71.0) |
Visceral metastases, n (%) | ||
 Yes | 40 (44.0) | 50 (53.8) |
 No | 51 (56.0) | 43 (46.2) |
Bone-only metastasis, n (%) | ||
 Yes | 9 (9.9) | 7 (7.5) |
 No | 82 (90.1) | 86 (92.5) |
Prior cancer-related radiotherapy, n (%) | ||
 Yes | 34 (37.4) | 44 (47.3) |
 No | 57 (62.6) | 49 (52.7) |
Prior primary diagnosis cancer-related surgery, n (%) | ||
 Yes | 48 (52.7) | 53 (57.0) |
 No | 43 (47.3) | 40 (43.0) |
Recurrence type, n (%) | ||
 Locoregional | 4 (4.4) | 3 (3.2) |
 Local | 3 (3.3) | 3 (3.2) |
 Regional | 1 (1.1) | 5 (5.4) |
 Distant | 51 (56.0) | 55 (59.1) |
 Newly diagnosed | 32 (35.2) | 27 (29.0) |
Biomarker status, n (%)b | ||
 PIK3CA mutation | ||
  Positive | 28 (30.8) | 24 (25.8) |
  Negative | 62 (68.1) | 66 (71.0) |
 ESR1 mutation | ||
  Positive | 12 (13.2) | 9 (9.7) |
  Negative | 78 (85.7) | 81 (87.1) |
 BRCA1/2 mutation | ||
  Positive | 5 (5.5) | 3 (3.2) |
  Negative | 85 (93.4) | 87 (93.5) |
