Table 2.
Patient demographic, clinical, and treatment characteristics.
| Characteristic | Overall (n = 247) |
P+L (n = 214) |
P+F (n = 33) |
|---|---|---|---|
| Age at palbociclib initiation, years | |||
| Mean (SD) | 61.9 (10.2) | 61.9 (10.3) | 62.3 (10.1) |
| Median (range) | 62.0 (36.0–88.0) | 63.0 (36.0–88.0) | 60.0 (41.0–85.0) |
| <65, n (%) | 139 (56.3) | 117 (54.7) | 22 (66.7) |
| ≥65, n (%) | 108 (43.7) | 97 (45.3) | 11 (33.3) |
| Ethnicity, n (%) | |||
| White/Caucasian | 178 (72.1) | 153 (71.5) | 25 (75.8) |
| Asian | 34 (13.8) | 29 (13.6) | 5 (15.2) |
| Middle Eastern | 11 (4.5) | 10 (4.7) | 1 (3.0) |
| Other | 24 (9.7) | 22 (10.3) | 2 (6.1) |
| Menopause status, n (%) | |||
| Natural menopause | 224 (90.7) | 193 (90.2) | 31 (93.9) |
| Menopause induced by surgery | 6 (2.4) | 5 (2.3) | 1 (3.0) |
| Menopause induced by LHRH suppression | 17 (6.9) | 16 (7.5) | 1 (3.0) |
| ECOG PS at palbociclib initiation, n (%) | |||
| 0 | 92 (37.2) | 83 (38.8) | 9 (27.3) |
| 1 | 108 (43.7) | 92 (43.0) | 16 (48.5) |
| 2 | 42 (17.0) | 36 (16.8) | 6 (18.2) |
| 3 | 5 (2.0) | 3 (1.4) | 2 (6.1) |
| Stage at ABC/MBC diagnosis, n (%) | |||
| Locoregionally advanced (IIIb, IIIc) | 43 (17.4) | 34 (15.9) | 9 (27.3) |
| Metastatic (stage IV) | 204 (82.6) | 180 (84.1) | 24 (72.7) |
| Occurrence of breast cancer, n (%) | |||
| Recurrent | 89 (36.0) | 61 (28.5) | 28 (84.8) |
| De novo | 158 (64.0) | 153 (71.5) | 5 (15.2) |
| Metastatic sites, n (%) | |||
| No. of patients | 204 | 180 | 24 |
| Bone | 136 (66.7) | 119 (66.1) | 17 (70.8) |
| Lung | 81 (39.7) | 75 (41.7) | 6 (25.0) |
| Lymph nodes | 62 (30.4) | 55 (30.6) | 7 (29.2) |
| Liver | 43 (21.1) | 38 (21.1) | 5 (20.8) |
| Other | 31 (15.2) | 28 (15.6) | 3 (12.5) |
| Visceral disease | 119 (58.3) | 109 (60.6) | 10 (41.7) |
| Non-visceral disease | 85 (41.7) | 71 (39.4) | 14 (58.3) |
| Prior therapy for ABC/MBC, n (%) | |||
| No. of patients | 30 | 9 | 21 |
| Endocrine therapy a | 20 (66.7) | 0 (0.0) | 20 (95.2) |
| Chemotherapy | 11 (36.7) | 9 (100.0) | 2 (9.5) |
| Targeted therapy a | 2 (6.7) | 0 (0.0) | 2 (9.5) |
| Lines of treatment for ABC/MBC, n (%) | |||
| 1 | 204 (82.6) | 193 (90.2) | 11 (33.3) |
| 2 | 34 (13.8) | 15 (7.0) | 19 (57.6) |
| 3 | 8 (3.2) | 5 (2.3) | 3 (9.1) |
| 4 | 1 (0.4) | 1 (0.5) | 0 (0.0) |
ABC = advanced breast cancer; ECOG PS = Eastern Cooperative Oncology Group performance status; LHRH = luteinizing hormone-releasing hormone; MBC = metastatic breast cancer; P+F = palbociclib + fulvestrant; P+L = palbociclib + letrozole; SD = standard deviation. a Targeted and endocrine therapies were not an option before palbociclib + letrozole approval in Canada.