Table 1 Baseline patient demographics and characteristics
Chemotherapy-naive | Chemotherapy-treated | |
|---|---|---|
JPN-201 (n = 48) | JPN-202 (n = 46) | |
Median age (range), years | 70 (46–89) | 71 (51–83) |
Gleason score | ||
< 7 | 0 % | 0 % |
7 | 8.3 % | 17.4 % |
≥ 8 | 89.6 % | 78.3 % |
Unknown | 2.1 % | 4.3 % |
ECOG-PS score | ||
0 | 83.3 % | 52.2 % |
1 | 16.7 % | 34.8 % |
2 | – | 13.0 % |
Extent of disease | ||
Bone | 91.7 % | 95.7 % |
Hepatic | 2.1 % | 4.3 % |
Lymphatic | 39.6 % | 37.0 % |
Pulmonary | 0 % | 10.9 % |
Other | 0 % | 6.5 % |
Median months from initiating LHRH agonist to first dose (range) | 21.91 (6.2–191.6) | 41.23 (4.4–182.8) |
Median baseline PSA (range), ng/mL | 31.40 (6.0–469.0) | 147.00 (7.2–1450.0) |
Median baseline hemoglobin (range), g/dL | 12.85 (10.2–15.2) | 11.80 (9.0–14.9) |
Median LDH (range), IU/L | 212.0 (164–1045) | 211.0 (122–723) |
Median alkaline phosphatase (range), IU/L | 292.0 (139–2643) | 327.0 (69–2991) |
No. of previous chemotherapy regimens | ||
1 | – | 39.1 % |
2 | – | 60.9 % |