Table 1.
Patient demographics and baseline disease characteristics of the overall and Japanese population (ITT population)
| Characteristic | Overall population | Japanese patients | ||
|---|---|---|---|---|
| PAL + FUL (n = 347) | PBO + FUL (n = 174) | PAL + FUL (n = 27) | PBO + FUL (n = 8) | |
| Age, years | ||||
| Median (range) | 57 (30‒88) | 56 (29‒80) | 53 (36‒77) | 57 (39‒79) |
| < 65, n (%) | 261 (75.2) | 131 (75.3) | 22 (81.5) | 6 (75.0) |
| ≥ 65, n (%) | 86 (24.8) | 43 (24.7) | 5 (18.5) | 2 (25.0) |
| Weight, median (range), kg | 67.2 (35.6‒142.0) | 69.8 (35.1‒126.8) | 54.4 (41.0‒82.7) | 52.4 (44.0‒59.0) |
| ECOG performance status, n (%) | ||||
| 0 | 207 (59.7) | 115 (66.1) | 27 (100.0) | 7 (87.5) |
| 1 | 140 (40.3) | 59 (33.9) | 0 | 1 (12.5) |
| Menopausal status,an (%) | ||||
| Pre-/peri- | 72 (20.7) | 36 (20.7) | 13 (48.1) | 4 (50.0) |
| Post- | 275 (79.3) | 138 (79.3) | 14 (51.9) | 4 (50.0) |
| Visceral metastases,an (%) | ||||
| Yes | 206 (59.4) | 105 (60.3) | 17 (63.0) | 7 (87.5) |
| No | 141 (40.6) | 69 (39.7) | 10 (37.0) | 1 (12.5) |
| Sensitivity to prior hormonal therapy,a,bn (%) | 274 (79.0) | 136 (78.2) | 22 (81.5) | 5 (62.5) |
| Measurable disease, n (%) | 268 (77.2) | 138 (79.3) | 21 (77.8) | 8 (100.0) |
| Number of disease sites, n (%) | ||||
| 1 | 111 (32.0) | 60 (34.5) | 7 (25.9) | 3 (37.5) |
| 2 | 99 (28.5) | 50 (28.7) | 12 (44.4) | 1 (12.5) |
| 3 | 73 (21.0) | 36 (20.7) | 4 (14.8) | 1 (12.5) |
| ≥ 4 | 62 (17.9) | 26 (14.9) | 4 (14.8) | 3 (37.5) |
| Not reported | 2 (0.6) | 2 (1.1) | – | – |
| Prior chemotherapy as metastatic treatment, n (%) | 107 (30.8) | 63 (36.2) | 2 (7.4) | 1 (12.5) |
| Prior lines of therapy in the context of metastatic disease, n (%) | ||||
| 0 | 84 (24.2) | 45 (25.9) | 7 (25.9) | 3 (37.5) |
| 1 | 132 (38.0) | 70 (40.2) | 12 (44.4) | 3 (37.5) |
| 2 | 90 (25.9) | 43 (24.7) | 5 (18.5) | 2 (25.0) |
| ≥ 3 | 41 (11.8) | 16 (9.2) | 3 (11.1) | 0 |
ECOG Eastern Cooperative Oncology Group, FUL fulvestrant, ITT intent-to-treat, PAL palbociclib, PBO placebo
aBased on case report form data
bDefined as either (1) documented clinical benefit (complete response, partial response, stable disease ≥ 24 weeks) to ≥ 1 prior hormonal therapy in the metastatic setting or (2) ≥ 24 months of adjuvant hormonal therapy before recurrence