Table 1.
Patient demographics and baseline disease characteristics
| Characteristics | PAL + LET | PAL + FUL | Total (N = 101) | |
|---|---|---|---|---|
| PALOMA-2 (n = 32) | Japanese phase 2 (n = 42) | PALOMA-3 (n = 27) | ||
| Age, median (range), year | 67 (44–88) | 63 (43–84) | 53 (36‒77) | 62 (36–88) |
| Weight, median (range), kg | 54 (33–88) | 50 (39–75) | 54 (41‒83) | 53 (33–88) |
| ECOG performance status, n (%) | ||||
| 0 | 27 (84) | 39 (93) | 27 (100) | 93 (92) |
| 1 | 3 (9) | 3 (7) | 0 | 6 (6) |
| 2 | 2 (6) | 0 | 0 | 2 (2) |
| Menopausal status, n (%) | ||||
| Pre-/perimenopausal | – | – | 13 (48) | 13 (13) |
| Postmenopausal | 32 (100) | 42 (100) | 14 (52) | 88 (87) |
| Visceral metastasesa, n (%) | ||||
| Yes | 20 (63) | 20 (48) | 17 (63) | 57 (56) |
| No | 12 (38) | 22 (52) | 10 (37) | 44 (44) |
| Measurable disease, n (%) | ||||
| Yes | 28 (88) | 36 (86) | 21 (78) | 85 (84) |
| No | 4 (13) | 6 (14) | 6 (22) | 16 (16) |
| Number of involved disease sites, n (%) | ||||
| 1 | 7 (22) | 12 (29) | 7 (26) | 26 (26) |
| 2 | 10 (31) | 13 (31) | 12 (44) | 35 (35) |
| 3 | 12 (38) | 12 (29) | 4 (15) | 28 (28) |
| 4 | 3 (9) | 2 (5) | 4 (15) | 9 (9) |
| > 4 | 0 | 3 (7) | 0 | 3 (3) |
| Prior systemic therapiesb | ||||
| Regimens, n (%) | ||||
| 1 | 14 (44) | 8 (19) | 7 (26) | 29 (29) |
| 2 | 4 (13) | 8 (19) | 9 (33) | 21 (21) |
| 3 | 4 (13) | 9 (21) | 5 (19) | 18 (18) |
| > 3 | 2 (6) | 3 (7) | 6 (22) | 11 (11) |
| Prior systemic therapiesb, n (%) | ||||
| Hormone therapy | 21 (66) | 27 (64) | 27 (100) | 75 (74) |
| Chemotherapy | 15 (47) | 20 (48) | 15 (56) | 50 (50) |
| Chemotherapy for advanced/metastatic | – | – | 2 (7) | 2 (2) |
| Prior lines of therapy in the context of metastatic disease | ||||
| Regimens, n (%) | ||||
| 0 | 32 (100) | 42 (100) | 7 (26)c | 81 (80) |
| 1 | – | – | 12 (44) | 12 (12) |
| 2 | – | – | 5 (19) | 5 (5) |
| ≥ 3 | – | – | 3 (11) | 3 (3) |
ECOG Eastern Cooperative Oncology Group, FUL fulvestrant, LET letrozole, PAL palbociclib
aRefers to lung (including pleura) and/or liver involvement in Japanese phase 2 study and PALOMA-2 and refers to lung, liver, brain, pleural, or peritoneal involvement in PALOMA-3
bPrior systemic therapy was defined as any systemic therapy any time before study entry, including (neo)adjuvant therapy
cPatients who progressed on or ≤ 12 months after end of adjuvant therapy