Table 1.
Baseline demographics and disease characteristics of enrolled Japanese postmenopausal patients with ER+/HER2− ABC
| Characteristic | Palbociclib + Letrozole N = 42 |
|---|---|
| Median age (range), y | 62.5 (43‐84) |
| Median weight (range), kg | 50.4 (38.6‐74.5) |
| ECOG performance status, n (%) | |
| 0 | 39 (92.9) |
| 1 | 3 (7.1) |
| Disease site (visceral involvement), n (%)a | |
| Visceral | 20 (47.6) |
| Non‐visceral | 22 (52.4) |
| Disease site (bone involvement), n (%) | |
| Bone only | 6 (14.3) |
| Other with measurable disease | 36 (85.7) |
| Disease site, n (%)b | |
| Bone | 24 (57.1) |
| Breast | 17 (40.5) |
| Pleural effusion | 4 (9.5) |
| Lung | 14 (33.3) |
| Pleura | 4 (9.5) |
| Lymph node | 23 (54.8) |
| Liver | 5 (11.9) |
| Other | 7 (16.7) |
| No. involved disease site(s), n (%) | |
| 1 | 12 (28.6) |
| 2 | 13 (31.0) |
| 3 | 12 (28.6) |
| 4 | 2 (4.8) |
| 5 | 2 (4.8) |
| 6 | 1 (2.4) |
| Disease‐free interval, n (%)c | |
| ≤12 mo | 8 (19.0) |
| >12 mo | 20 (47.6) |
| De novo metastatic disease | 14 (33.3) |
| Stage at initial diagnosis, n (%) | |
| I/IA | 6 (14.3) |
| IIA | 8 (19.0) |
| IIB | 9 (21.4) |
| IIIA | 2 (4.8) |
| IIIB | 1 (2.4) |
| IIIC | 1 (2.4) |
| IV | 12 (28.6) |
| Unknown | 3 (7.1) |
| Biomarkers | |
| Ki‐67‐positive cells, n (%)d | 42 (100) |
| ≤20% | 19 (45.2) |
| >20% | 23 (54.8) |
| Prior therapies for primary diagnosis, yes, n (%) | |
| Prior surgery | 30 (71.4) |
| Prior radiation therapy | 19 (45.2) |
| Prior systemic therapye | 28 (66.7) |
| Chemotherapy | 20 (47.6) |
| Endocrine | 27 (64.3) |
ABC, advanced breast cancer; ECOG, Eastern Cooperative Oncology Group; ER+, estrogen receptor‐positive; HER2−, human epidermal growth factor receptor 2‐negative.
Visceral refers to lung (including pleura) and/or liver involvement.
Involved sites include both target and non‐target sites. Sites with multiple lesions were counted once. Patients may have contributed to >1 category.
Disease‐free interval was calculated as the time between end of neoadjuvant or adjuvant treatment and onset of metastatic disease or disease recurrence.
Tumor tissue samples were from metastatic/recurrent tumor lesions whenever possible; when unavailable, a de novo fresh biopsy was recommended if judged by the investigator to be feasible and safe. Original diagnostic tissue was also collected when available.
Neoadjuvant or adjuvant therapy.