Table 1.
Baseline characteristics - randomized patients.
| Characteristic | Ipilimumab 3 mg/kg (n = 40) | Ipilimumab 10 mg/kg (n = 42) | Total (N = 82) |
|---|---|---|---|
| Male gender, % | 70.0 | 57.1 | 63.4 |
| Race, n (%) | |||
| Asian | 1 (2.5) | 0 | 1 (1.2) |
| Black | 0 | 1 (2.4) | 1 (1.2) |
| White | 39 (97.5) | 41 (97.6) | 80 (97.6) |
| Age in yrs, mean (range) | 53.9 (23.0-78.0) | 56.2 (26.0-87.0) | 55.0 (23.0-87.0) |
| < 65, n (%) | 31 (77.5) | 29 (69.0) | 60 (73.2) |
| ≥ 65, n (%) | 9 (22.5) | 13 (31.0) | 22 (26.8) |
| Disease stage, n (%) | |||
| III | 1 (2.5) | 2 (4.8) | 3 (3.7) |
| IV | 39 (97.5) | 40 (95.2) | 79 (96.3) |
| M-stage, n (%) | |||
| M0 | 0 | 2 (4.8) | 2 (2.4) |
| M1A | 12 (30.0) | 9 (21.4) | 21 (25.6) |
| M1B | 6 (15.0) | 3 (7.1) | 9 (11.0) |
| M1C | 22 (55.0) | 28 (66.7) | 50 (61.0) |
| ECOG-PS, n (%) | |||
| 0 | 25 (62.5) | 27 (64.3) | 52 (63.4) |
| 1 | 15 (37.5) | 15 (35.7) | 30 (36.6) |
| Time since initial diagnosis in months, mean (range) | 69.0 (1.1-384.0) | 55.8 (3.8-237.9) | 62.2 (1.1-384.0) |
| Any prior systemic therapy received, n (%) | 29 (72.5) | 33 (78.6) | 62 (75.6) |
| Number received | |||
| 1, n (%) | 15 (37.5) | 19 (45.2) | 34 (41.5) |
| 2, n (%) | 7 (17.5) | 8 (19.0) | 15 (18.3) |
| 3, n (%) | 6 (15.0) | 5 (11.9) | 11 (13.4) |
| ≥ 5, n (%) | 1 (2.5) | 1 (2.4) | 2 (2.4) |
| Any prior immunotherapy received, n (%) | (57.5) | (61.9) | |
| interleukin-2, n (%) | (45.0) | (38.1) | |
| interferon-α, n (%) | (22.5) | (19.0) | |
| Setting of prior therapy* | |||
| Adjuvant therapy, n (%) | 10 (25.0) | 10 (23.8) | 20 (24.4) |
| Metastatic disease, n (%) | 26 (65.0) | 28 (66.7) | 54 (65.9) |
| Neoadjuvant therapy, n (%) | 0 | 1 (2.4) | 1 (1.2) |
*Systemic therapy may have been received in > 1 setting.
ECOG-PS: Eastern Cooperative Oncology Group performance status.