Table 1.
Baseline characteristics for the whole trial population
| All patients | COU-AA-301 | IMMC-38 | |
|---|---|---|---|
| Patients (n) | 486 | 364 | 122 |
| CTC count (cells/7.5 ml) | 19.5 (9–43.8) | 18 (9–38.5) | 24 (10–97) |
| PSA (ng/ml) | 214.4 (69–579) | 197.3 (64.8–570) | 244 (90–604) |
| ALP (U/l) | 216 (121–385.5) | 205.5 (116–401.5) | 231 (129.8–363.8) |
| LDH (U/l) | 263 (199.3–389.5) | 267 (199.5–384.8) | 250 (199.3–404.8) |
| Hemoglobin (g/dl) | 11.4 (10.3–12.5) | 11.2 (10.2–12.4) | 11.8 (10.8–12.9) |
| Albumin (g/dl) | 3.9 (3.6–4.2) | 4 (3.7–4.2) | 3.7 (3.4–4) |
| ECOG PS, n (%)a | |||
| 0–1 | 419 (87.3) | 315 (86.5) | 104 (89.7) |
| 2 | 61 (12.7) | 49 (13.5) | 12 (10.3) |
CTC = circulating tumor cell; PSA = prostate-specific antigen; ALP = alkaline phosphatase; LDH = lactate dehydrogenase; ECOG PS = Eastern Cooperative Oncology Group performance status.
a
Six missing baseline ECOG PS values in the IMMC-38 data set.