Table 1.
Demographics and baseline characteristics for patients receiving palbociclib plus endocrine therapy with/without dose reduction
| Characteristic | Palbociclib plus endocrine therapy* | ||
|---|---|---|---|
| Patients with dose reduction, 125 to 100 mg (N = 311) | Patients without dose reduction (N = 550)† | Pooled ITT population (N = 875) | |
| Age, years | |||
| Mean (range) | 59.9 (32–88) | 60.0 (30–89) | 59.9 (30–89) |
| < 65, n (%) | 192 (61.7) | 366 (66.5) | 571 (65.3) |
| ≥ 65, n (%) | 119 (38.3) | 184 (33.5) | 304 (34.7) |
| Race, n (%) | |||
| White | 211 (67.8) | 451 (82.0) | 672 (76.8) |
| Black | 7 (2.3) | 14 (2.5) | 21 (2.4) |
| Asian | 77 (24.8) | 64 (11.6) | 145 (16.6) |
| Other‡ | 16 (5.1) | 21 (3.8) | 37 (4.2) |
| Weight, mean (range), kg | 67.9 (33.0–123.0) | 72.4 (39.7–156.8) | 70.6 (33.0–156.8) |
| Height, mean (range), cm | 159.7 (134.6–182.9) | 161.3 (138.0–187.0) | 160.7 (134.6–187.0) |
| Measurable disease, n (%) | 225 (72.3) | 435 (79.1) | 671 (76.7) |
| Prior chemotherapy for advanced/metastatic disease, n (%) | 32 (10.3) | 68 (12.4) | 113 (12.9) |
| Disease site, n (%) | |||
| Visceral | 146 (46.9) | 299 (54.4) | 452 (51.7) |
| Nonvisceral | 165 (53.1) | 251 (45.6) | 423 (48.3) |
| Bone only | 84 (27.0) | 117 (21.3) | 206 (23.5) |
| Number of disease sites involved, n (%) | |||
| 1 | 103 (33.1) | 167 (30.4) | 272 (31.1) |
| 2 | 86 (27.7) | 141 (25.6) | 231 (26.4) |
| 3 | 69 (22.2) | 131 (23.8) | 203 (23.2) |
| 4 | 37 (11.9) | 68 (12.4) | 106 (12.1) |
| 5 | 16 (5.1) | 29 (5.3) | 47 (5.4) |
| Disease stage at initial diagnosis,ǁn (%) | |||
| I | 28 (9.0) | 47 (8.5) | 77 (8.8) |
| II | 99 (31.8) | 152 (27.6) | 257 (29.4) |
| III | 45 (14.5) | 95 (17.3) | 141 (16.1) |
| IV | 75 (24.1) | 148 (26.9) | 224 (25.6) |
| Other | 8 (2.6) | 13 (2.4) | 21 (2.4) |
| Unknown/missing | 23 (7.4) | 46 (8.4) | 71 (8.1) |
| Not collected | 33 (10.6) | 49 (8.9) | 84 (9.6) |
ITT intent-to-treat
*Patients in PALOMA-1 and PALOMA-2 received palbociclib plus letrozole; patients in PALOMA-3 had endocrine-resistant metastatic breast cancer and received palbociclib plus fulvestrant
†Data from patients who started on a dose < 125 mg are not included in the table
‡Not reported/missing patients
ǁStage at initial diagnosis was not collected for PALOMA-1