Table 1.
Baseline characteristics and the efficacy outcomes of the plasma biomarker population compared to the overall study population
| Plasma biomarker population (n = 58) | Overall study population (n = 65) | |
|---|---|---|
| Age, years | ||
| Median (range) | 58 (32–75) | 57 (32–75) |
| Menopausal status, n (%) | ||
| Pre-menopausal | 9 (15.5) | 10 (15.4) |
| Post-menopausal | 49 (84.5) | 55 (84.6) |
| History of early stage disease, n (%) | 52 (89.7) | 57 (87.7) |
| Disease free interval, n (%) | ||
| ≤ 24 months | 10 (19.2) | 11 (19.3) |
| > 24 months | 42 (80.8) | 46 (80.7) |
| Hormone receptor status, n (%) | ||
| ER+ and/or PR+ | 47 (81.0) | 53 (81.5) |
| ER- and PR- | 11 (19.0) | 12 (18.5) |
| Number of metastatic lesions, n (%) | ||
| ≤ 3 | 11 (19.0) | 14 (21.5) |
| > 3 | 47 (81.0) | 51 (78.5) |
| Extent of disease | ||
| < 3 sites | 36 (62.1) | 39 (60.0) |
| ≥ 3 sites | 22 (37.9) | 26 (40.0) |
| Site of metastatic disease, n (%) | ||
| Visceral disease | 46 (79.3) | 53 (81.5) |
| Non-visceral disease | 12 (20.7) | 12 (18.5) |
| Median overall survival, months (95% CI) | 37.5 (25.4–49.6) | 35.1 (22.2–50.3) |
| Median progression-free survival, months (95% CI) | 11.3 (8.3–14.4) | 11.3 (9.7–16.0) |
| Response to treatment | ||
| Complete response/partial response | 38 (71.7) | 40 (61.5) |
| Stable disease | 13 (24.5) | 15 (23.1) |
| Progressive disease | 2 (3.8) | 3 (4.6) |