Table 1.
Demographics and baseline disease characteristics for patients who did and did not receive first subsequent CT in PALOMA-2 by treatment arm.
| Without First Subsequent CT |
With First Subsequent CT |
|||
|---|---|---|---|---|
| PAL + LET |
PBO + LET |
PAL + LET |
PBO + LET |
|
| (n = 361) | (n = 171) | (n = 83) | (n = 51) | |
| Age, median, y | 63.0 | 61.0 | 59.0 | 61.0 |
| < 65, n (%) | 206 (57.1) | 108 (63.2) | 57 (68.7) | 33 (64.7) |
| ≥ 65, n (%) | 155 (42.9) | 63 (36.8) | 26 (31.3) | 18 (35.3) |
| Race,*n (%) | ||||
| White | 275 (76.2) | 130 (76.0) | 69 (83.1) | 42 (82.4) |
| Black | 6 (1.7) | 3 (1.8) | 2 (2.4) | 0 |
| Asian | 55 (15.2) | 25 (14.6) | 10 (12.0) | 5 (9.8) |
| Other | 25 (6.9) | 13 (7.6) | 2 (2.4) | 4 (7.8) |
| Weight, median, kg | 67.3 | 66.7 | 71.2 | 67.0 |
| Disease site, n (%) | ||||
| Visceral | 167 (46.3) | 76 (44.4) | 47 (56.6) | 34 (66.7) |
| Nonvisceral | 194 (53.7) | 95 (55.6) | 36 (43.4) | 17 (33.3) |
| Disease-free completion of prior (neo)adjuvant therapy, n (%) | ||||
| De novo metastatic | 141 (39.1) | 65 (38.0) | 26 (31.3) | 16 (31.4) |
| DFI ≤ 12 mo | 69 (19.1) | 33 (19.3) | 29 (34.9) | 15 (29.4) |
| DFI > 12 mo | 151 (41.8) | 73 (42.7) | 28 (33.7) | 20 (39.2) |
| Nature of prior (neo)adjuvant anticancer therapy, n (%) | ||||
| Prior systemic therapy | ||||
| No | 141 (39.1) | 65 (38.0) | 26 (31.3) | 16 (31.4) |
| Yes | 220 (60.9) | 106 (62.0) | 57 (68.7) | 35 (68.6) |
| Prior CT for primary diagnosis, n (%) | ||||
| No | 194 (53.7) | 92 (53.8) | 37 (44.6) | 21 (41.2) |
| Yes | 167 (46.3) | 79 (46.2) | 46 (55.4) | 30 (58.8) |
| Neoadjuvant | 39 (10.8) | 23 (13.5) | 15 (18.1) | 9 (17.6) |
| Adjuvant | 143 (39.6) | 64 (37.4) | 37 (44.6) | 25 (49.0) |
| Prior hormonal therapy for primary diagnosis, n (%) | ||||
| No | 163 (45.2) | 77 (45.0) | 31 (37.3) | 19 (37.3) |
| Yes | 198 (54.8) | 94 (55.0) | 52 (62.7) | 32 (62.7) |
| Prior hormonal therapies, n (%) | ||||
| 1 | 128 (35.5) | 62 (36.3) | 30 (36.1) | 25 (49.0) |
| > 1 | 70 (19.4) | 32 (18.7) | 22 (26.5) | 7 (13.7) |
CT = chemotherapy; DFI = disease-free interval; LET = letrozole; PAL = palbociclib; PBO = placebo.
*Other includes not reported/missing patients.