Table 2.
Baseline Characteristics
| Characteristic | Ipilimumab dose |
|||||
|---|---|---|---|---|---|---|
| 3 mg/kg |
5 mg/kg | 10 mg/kg |
||||
| −XRT (n = 8) | +XRT (n = 7) | −XRT (n = 6) | −XRT (n = 16; %) | +XRT (n = 34; %) | ±XRT (n = 50; %) | |
| Age (years) | ||||||
| Median | 69 | 68 | 57 | 65 | 66 | 65 |
| Range | 55–78 | 54–81 | 51–68 | 53–76 | 50–83 | 50–83 |
| Race | ||||||
| Asian | 0 | 0 | 0 | 0 | 1 (3) | 1 (2) |
| Black | 0 | 1 | 0 | 0 | 3 (9) | 3 (6) |
| White | 8 | 6 | 6 | 16 (100) | 30 (88) | 46 (92) |
| ECOG performance status | ||||||
| 0 | 5 | 4 | 5 | 10 (63) | 9 (27) | 19 (38) |
| 1 | 3 | 2 | 1 | 6 (37) | 22 (65) | 28 (56) |
| 2 | 0 | 1 | 0 | 0 | 0 | 0 |
| Not reported | 0 | 0 | 0 | 0 | 3 (9) | 3 (6) |
| Time from diagnosis (months) | ||||||
| Median | 79 | 61 | 34 | 60 | 67 | 65 |
| Range | 41–135 | 20–198 | 10–98 | 22–204 | 10–239 | 10–239 |
| Selected tumor lesionsa | ||||||
| Lymph node | 3 | 2 | 2 | 7 (44) | 20 (59) | 27 (54) |
| Liver | 0 | 1 | 0 | 2 (13) | 5 (15) | 7 (14) |
| Lung | 0 | 0 | 2 | 0 | 6 (18) | 6 (12) |
| Bone lesions (no.) | ||||||
| Median | 4 | 6 | 5 | 2.5 | 8 | 6 |
| Range | 1–11 | 2–11 | 2–10 | 1–12 | 1–15 | 1–15 |
| Hemoglobin decreased | ||||||
| Grade 0–1 | 7 | 4 | 6 | 15 (94) | 25 (74) | 40 (80) |
| Grade 2–3 | 0 | 2 | 0 | 1 (6) | 5 (15) | 6 (12) |
| Not reported | 1 | 1 | 0 | 0 | 4 (12) | 4 (8) |
| Alkaline phosphatase increased | ||||||
| Grade 0–1 | 8 | 5 | 6 | 13 (81) | 25 (74) | 38 (76) |
| Grade 2–3 | 0 | 1 | 0 | 3 (19) | 5 (15) | 8 (16) |
| Grade 4 | 0 | 0 | 0 | 0 | 1 (3) | 1 (2) |
| Not reported | 0 | 1 | 0 | 0 | 3 (9) | 3 (6) |
| Serum PSA (ng/ml) | ||||||
| Median | 91 | 47 | 38 | 132 | 120 | 133 |
| Range | 7–449 | 14–197 | 3–111 | 13–2581 | 8–1314 | 8–2581 |
| Selected prior therapyb | ||||||
| Surgery | 7 | 5 | 6 | 16 (100) | 28 (82) | 44 (88) |
| Radiotherapy | 8 | 4 | 5 | 9 (56) | 20 (59) | 29 (58) |
| Goserelin | 1 | 2 | 0 | 3 (19) | 13 (38) | 16 (32) |
| Leuprolide | 7 | 7 | 6 | 14 (88) | 28 (82) | 42 (84) |
| Bicalutamide | 6 | 5 | 6 | 15 (94) | 29 (85) | 45 (90) |
| Flutamide | 0 | 1 | 0 | 3 (19) | 3 (9) | 6 (12) |
| Nilutamide | 4 | 1 | 0 | 3 (19) | 9 (27) | 12 (24) |
| Chemotherapyc | 0 | 4 | 2 | 6 (38) | 21 (62) | 27 (54) |
aReported in ≥10% of patients. Patients may have had lesions at more than one site.
bReported in ≥ 10% of patients. Patients may have received more than one therapy.
cDocetaxel.
XRT, external-beam radiotherapy; ECOG, Eastern Cooperative Oncology Group; PSA, prostate-specific antigen.