Table 1. Baseline Characteristics of the Patients✫.
| Variable | Ipilimumab plus gp100 (N = 403) |
Ipilimumab Alone (N = 137) |
gp100 Alone (N = 136) |
Total (N = 676) |
|---|---|---|---|---|
| Mean age — yr | 55.6 | 56.8 | 57.4 | 56.2 |
| Sex — no. (%) | ||||
| Male | 247 (61.3) | 81 (59.1) | 73 (53.7) | 401 (59.3) |
| Female | 156 (38.7) | 56 (40.9) | 63 (46.3) | 275 (40.7) |
| ECOG performance status — no. (%)† | ||||
| 0 | 232 (57.6) | 72 (52.6) | 70 (51.5) | 374 (55.3) |
| 1 | 166 (41.2) | 64 (46.7) | 61 (44.9) | 291 (43.0) |
| 2 | 4 (1.0) | 1 (0.7) | 4 (2.9) | 9 (1.3) |
| 3 | 1 (0.2) | 0 | 0 | 1 (0.1) |
| Unknown | 0 | 0 | 1 (0.7) | 1 (0.1) |
| M stage — no. (%)‡ | ||||
| M0 | 5 (1.2) | 1 (0.7) | 4 (2.9) | 10 (1.5) |
| M1a | 37 (9.2) | 14 (10.2) | 11 (8.1) | 62 (9.2) |
| M1b | 76 (18.9) | 22 (16.1) | 23 (16.9) | 121 (17.9) |
| M1c | 285 (70.7) | 100 (73.0) | 98 (72.1) | 483 (71.4) |
| Lactate dehydrogenase level — no. (%) | ||||
| ≤Upper limit of the normal range | 252 (62.5) | 84 (61.3) | 81 (59.6) | 417 (61.7) |
| >Upper limit of the normal range | 149 (37.0) | 53 (38.7) | 52 (38.2) | 254 (37.6) |
| Unknown | 2 (0.5) | 0 | 3 (2.2) | 5 (0.7) |
| CNS metastases at baseline — no. (%) | 46 (11.4) | 15 (10.9) | 21 (15.4) | 82 (12.1) |
| Received study drug | 42 (10.4) | 15 (10.9) | 20 (14.7) | 77 (11.4) |
| Had had previous treatment for CNS metastases |
39 (9.7) | 15 (10.9) | 19 (14.0) | 73 (10.8) |
| Previous systemic therapy for metastatic disease — no. (%) |
403 (100.0) | 137 (100.0) | 136 (100.0) | 676 (100.0) |
| Previous interleukin-2 therapy — no. (%) | 89 (22.1) | 32 (23.4) | 33 (24.3) | 154 (22.8) |
✫
Percentages may not total 100 because of rounding. CNS denotes central nervous system.
†
The Eastern Cooperative Oncology Group (ECOG) status ranges from 0 to 5, with higher scores indicating greater impairment (5 indicates death).
‡
The metastasis (M) stage was classified according to the tumor–node–metastasis (TNM) categorization for melanoma of the American Joint Committee on Cancer.