Table 1.
Demographic and baseline characteristics by treatment group for patients with and without visceral metastases
| Characteristics | PALOMA-3a,b |
PALOMA-2a,b |
||||||
|---|---|---|---|---|---|---|---|---|
| PAL + FUL |
PBO + FUL |
PAL + LET |
PBO + LET |
|||||
| Visceral | Nonvisceral | Visceral | Nonvisceral | Visceral | Nonvisceral | Visceral | Nonvisceral | |
| (n = 200) | (n = 147) | (n = 104) | (n = 70) | (n = 214) | (n = 230) | (n = 110) | (n = 112) | |
| Median (range) age, years | 57.0 | 57.0 | 58.5 | 54.0 | 62.0 | 62.0 | 61.0 | 62.0 |
| (30.0–88.0) | (33.0–82.0) | (35.0–80.0) | (29.0–74.0) | (30.0–88.0) | (36.0–89.0) | (28.0–88.0) | (32.0–88.0) | |
| Involved disease sitesc | ||||||||
| Liver | 125 (62.5) | – | 80 (76.9) | – | 75 (35.0) | – | 46 (41.8) | – |
| Lymph node | 97 (48.5) | 41 (27.9) | 39 (37.5) | 24 (34.3) | 125 (58.4) | 87 (37.8) | 65 (59.1) | 45 (40.2) |
| Bone | 136 (68.0) | 128 (87.1) | 76 (73.1) | 54 (77.1) | 126 (58.9) | 199 (86.5) | 73 (66.4) | 89 (79.5) |
| Peritoneum | 1 (<1) | – | 0 | – | 4 (1.9) | – | 0 | – |
| Number of metastatic organ sitesc | ||||||||
| 1 | 17 (8.5) | 94 (63.9) | 11 (10.6) | 49 (70.0) | 17 (7.9) | 121 (52.6) | 6 (5.5) | 60 (53.6) |
| 2 | 63 (31.5) | 32 (21.8) | 37 (35.6) | 14 (20.0) | 63 (29.4) | 54 (23.5) | 26 (23.6) | 26 (23.2) |
| 3 | 58 (29.0) | 15 (10.2) | 27 (26.0) | 6 (8.6) | 66 (30.8) | 46 (20.0) | 41 (37.3) | 20 (17.9) |
| 4 | 43 (21.5) | 3 (2.0) | 20 (19.2) | 0 | 45 (21.0) | 7 (3.0) | 23 (20.9) | 6 (5.4) |
| >4 | 18 (9.0) | 2 (1.4) | 9 (8.7) | 0 | 23 (10.7) | 2 (<1.0) | 14 (12.7) | 0 |
| ECOG performance status | ||||||||
| 0 | 114 (57.0) | 92 (62.6) | 66 (63.5) | 50 (71.4) | 113 (52.8) | 144 (62.6) | 51 (46.4) | 51 (45.5) |
| 1 | 86 (43.0) | 55 (37.4) | 38 (36.5) | 20 (28.6) | 97 (45.3) | 81 (35.2) | 59 (53.6) | 58 (51.8) |
| 2 | – | – | – | – | 4 (1.9) | 5 (2.2) | 0 | 3 (2.7) |
| Prior endocrine therapyd | ||||||||
| Tamoxifen only | 4 (2.0) | 1 (<1.0) | 3 (2.9) | 1 (1.4) | 72 (33.6) | 59 (25.7) | 40 (36.4) | 33 (29.5) |
| Aromatase inhibitor | 23 (11.5) | 21 (14.3) | 9 (8.7) | 7 (10.0) | 14 (6.5) | 19 (8.3) | 8 (7.3) | 20 (17.9) |
| Both tamoxifen and aromatase inhibitor | 96 (48.0) | 63 (42.9) | 50 (48.1) | 31 (44.3) | 38 (17.8) | 40 (17.4) | 15 (13.6) | 10 (8.9) |
| Prior chemotherapye | 149 (74.5) | 103 (70.1) | 81 (77.9) | 56 (80.0) | 106 (49.5) | 107 (46.5) | 60 (54.5) | 49 (43.8) |
| Neoadjuvant | 40 (20.0) | 26 (17.7) | 20 (19.2) | 13 (18.6) | 33 (15.4) | 21 (9.1) | 15 (13.6) | 17 (15.2) |
| Adjuvant | 85 (42.5) | 66 (44.9) | 47 (45.2) | 41 (58.6) | 88 (41.1) | 92 (40.0) | 51 (46.4) | 38 (33.9) |
| Advanced/metastatic setting | 68 (34.0) | 39 (26.5) | 41 (39.4) | 21 (30.0) | – | – | – | – |
| Liver function tests | ||||||||
| AST | ||||||||
| ≤ULN | 143 (71.5) | 124 (84.4) | 69 (66.3) | 60 (85.7) | 171 (79.9) | 197 (85.7) | 92 (83.6) | 103 (92.0) |
| >1× and ≤2× ULN | 47 (23.5) | 20 (13.6) | 24 (23.1) | 4 (5.7) | 35 (16.4) | 31 (13.5) | 15 (13.6) | 9 (8.0) |
| >2× and ≤3× ULN | 6 (3.0) | 3 (2.0) | 5 (4.8) | 2 (2.9) | 6 (2.8) | 2 (0.9) | 3 (2.7) | 0 |
| >3× ULN | 4 (2.0) | 0 | 4 (3.8) | 0 | 2 (0.9) | 0 | 0 | 0 |
| ALT | ||||||||
| ≤ULN | 170 (85.0) | 131 (89.1) | 79 (76.0) | 63 (90.0) | 180 (84.1) | 202 (87.8) | 97 (88.2) | 103 (92.0) |
| >1× and ≤2× ULN | 21 (10.5) | 14 (9.5) | 20 (19.2) | 2 (2.9) | 33 (15.4) | 27 (11.7) | 12 (10.9) | 6 (5.4) |
| >2× and ≤3× ULN | 7 (3.5) | 1 (0.7) | 3 (2.9) | 3 (4.3) | 1 (0.5) | 1 (0.4) | 1 (0.9) | 2 (1.8) |
| >3× ULN | 2 (1.0) | 0 | 2 (1.9) | 0 | 0 | 0 | 0 | 1 (0.9) |
| Alkaline phosphatase | ||||||||
| ≤ULN | 152 (76.0) | 124 (84.4) | 77 (74.0) | 58 (82.9) | 165 (77.1) | 174 (75.7) | 86 (78.2) | 92 (82.1) |
| >1× and ≤2× ULN | 35 (17.5) | 19 (12.9) | 21 (20.2) | 6 (8.6) | 37 (17.3) | 47 (20.4) | 22 (20.0) | 18 (16.1) |
| >2× and ≤3× ULN | 9 (4.5) | 1 (0.7) | 4 (3.8) | 2 (2.9) | 7 (3.3) | 5 (2.2) | 2 (1.8) | 0 |
| >3× ULN | 2 (1.0) | 3 (2.0) | 2 (1.9) | 0 | 5 (2.3) | 4 (1.7) | 0 | 2 (1.8) |
Values are n (%) unless stated otherwise.
Patients with visceral metastases were defined as those reported in the case report forms by the Principle Investigators, not those reported in the IMPALA randomization system. Involved sites include both target and nontarget sites; sites with multiple lesions are counted once.
Patients in PALOMA-2 were treatment-naive for advanced breast cancer.
Data represent prior endocrine therapy for primary diagnosis.
Data represent previous chemotherapy regimen for primary diagnosis.
–, no data; ALT, alanine aminotransferase; AST, aspartate aminotransferase; ECOG, Eastern Cooperative Oncology Group; FUL, fulvestrant; LET, letrozole; PAL, palbociclib; PBO, placebo; ULN, upper limit of normal.