Table 1.
Baseline characteristics (intention-to-treat population)
| Palbociclib plus endocrine therapy | Palbociclib monotherapy | |
|---|---|---|
| No. of patients | 57 (100) | 58 (100) |
| Median age in years (range) | 67 (37–82) | 63 (45–81) |
| ECOG performance status | ||
| 0 | 44 (77) | 44 (76) |
| 1 | 11 (19) | 14 (24) |
| 2 | 2 (4) | 0 |
| Disease classification at initial diagnosis | ||
| De novo metastatic | 13 (23) | 13 (22) |
| Early (adjuvant) | 41 (72) | 43 (74) |
| Not classified | 3 (5) | 2 (4) |
| Sites of metastases | ||
| Visceral | 42 (74) | 45 (78) |
| Bone only | 4 (7) | 5 (8) |
| Other sites (non-visceral) | 11 (19) | 8 (14) |
| Prior lines of endocrine therapy for advanced breast cancer | ||
| 0 | 1 (2)a | 0 |
| 1 | 39 (68) | 40 (69) |
| 2 | 16 (28) | 17 (29) |
| 3 | 1 (2)a | 1 (2)a |
| Duration of most recent prior line of endocrine therapy for advanced breast cancer | ||
| No prior endocrine therapy | 1 (2) | 0 |
| ≤6 months | 10 (18) | 20 (34) |
| >6 months | 46 (80) | 38 (66) |
| Most recent endocrine therapy for advanced breast cancer | ||
| None | 1 (2) | 0 |
| Aromatase inhibitor | 34 (60) | 29 (50) |
| Fulvestrant | 22 (38) | 29 (50) |
| Receipt of prior chemotherapy for advanced breast cancer | 19 (33) | 16 (28) |
Data are represented as number (%), unless otherwise indicated.
a
Included in ITT population despite breach of eligibility criteria; one additional patient ineligible due to lack of measurable disease at baseline, is also included in ITT population.
ECOG, Eastern Cooperative Oncology Group.