Table 3.
Marker | All Randomly Assigned Patients (N = 1,195) |
Patients With Biomarker Data Available at Week 12 (n = 711) |
||
---|---|---|---|---|
AA Plus Prednisone (n = 797) | Prednisone Alone (n = 398) | AA Plus Prednisone (n = 484) | Prednisone Alone (n = 227) | |
CTCs, cells/7.5 mL* | n = 489 | n = 232 | n = 484 | n = 227 |
Median | 1 | 6 | 1 | 6 |
Range | 0 to 100.1 | 0 to 100.1 | 0 to 100.1 | 0 to 100.1 |
LDH, U/L | n = 656 | n = 300 | n = 476 | n = 225 |
Median | 212 | 246 | 212 | 239 |
Range | 87 to 4,895 | 133 to 3,563 | 87 to 4,895 | 133 to 2,093 |
PSA, ng/mL | n = 647 | n = 294 | n = 464 | n = 221 |
Median | 70 | 209 | 7.9 | 197.9 |
Range | 0.1 to 8,582 | 0.7 to 8,985 | 0.1 to 8,582 | 0.7 to 8,985 |
Hemoglobin, g/dL | n = 650 | n = 295 | n = 473 | n = 222 |
Median | 12.4 | 12.0 | 12.4 | 12.2 |
Range | 5.7 to 16.3 | 7.0 to 16.6 | 5.7 to 16.3 | 7.0 to 16.6 |
Phosphatase, U/L | n = 646 | n = 287 | n = 471 | n = 221 |
Median | 135 | 154 | 133 | 144 |
Range | 27 to 2,499 | 22 to 3,632 | 27 to 2,499 | 22 to 3,632 |
Albumin, g/dL | n = 664 | n = 301 | n = 486 | n = 226 |
Median | 4.1 | 4.1 | 4.1 | 4.1 |
Range | 2.6 to 5.3 | 2.8 to 5.7 | 2.6 to 5.3 | 2.8 to 5.0 |
Abbreviations: AA, abiraterone acetate; CTC, circulating tumor cell; LDH, lactate dehydrogenase; PSA, prostate-specific antigen.
CTC count > 100 cells/7.5 mL was entered as 100.1 in database. Australian patients did not contribute CTC enumeration data.