Table 1. Baseline Characteristics of the Patients, According to Cohort.
| Characteristic | 10 mg/kg Every 2 Wk | 10 mg/kg Every 3 Wk | 2 mg/kg Every 3 Wk | Total (N = 135) | ||
|---|---|---|---|---|---|---|
| No Prior Ipilimumab (N = 41) | Prior Ipilimumab (N = 16) | No Prior Ipilimumab (N = 24) | Prior Ipilimumab (N = 32) | No Prior Ipilimumab (N = 22) | ||
| number (percent) | ||||||
| Sex | ||||||
|
| ||||||
| Male | 23 (56) | 9 (56) | 16 (67) | 17 (53) | 14 (64) | 79 (59) |
|
| ||||||
| Female | 18 (44) | 7 (44) | 8 (33) | 15 (47) | 8 (36) | 56 (41) |
|
| ||||||
| Age (yr) | ||||||
|
| ||||||
| Mean | 60.4 | 59.4 | 67 | 57.3 | 58.6 | 60.4 |
|
| ||||||
| Range | 25-94 | 29-87 | 37-87 | 32-77 | 30-79 | 25-94 |
|
| ||||||
| Race* | ||||||
|
| ||||||
| Asian | 0 | 0 | 2 (8) | 0 | 0 | 2 (1) |
|
| ||||||
| White | 41 (100) | 16 (100) | 22 (92) | 32 (100) | 22 (100) | 133 (99) |
|
| ||||||
| ECOG performance status† | ||||||
|
| ||||||
| Unknown | 1 (2) | 0 | 0 | 0 | 0 | 1 (1) |
|
| ||||||
| 0 | 32 (78) | 13 (81) | 18 (75) | 21 (66) | 13 (59) | 97 (72) |
|
| ||||||
| 1 | 8 (20) | 3 (19) | 6 (25) | 11 (34) | 9 (41) | 37 (27) |
|
| ||||||
| BRAF mutation status | ||||||
|
| ||||||
| Mutant | 13 (32) | 1 (6) | 1 (4) | 5 (16) | 6 (27) | 26 (19) |
|
| ||||||
| Nonmutant | 23 (56) | 14 (88) | 21 (88) | 21 (66) | 14 (64) | 93 (69) |
|
| ||||||
| Unknown | 5 (12) | 1 (6) | 2 (8) | 6 (19) | 2 (9) | 16 (12) |
|
| ||||||
| Brain metastasis | ||||||
|
| ||||||
| Yes | 3 (7) | 3 (19) | 0 | 4 (12) | 2 (9) | 12 (9) |
|
| ||||||
| No | 38 (93) | 13 (81) | 24 (100) | 28 (88) | 20 (91) | 123 (91) |
|
| ||||||
| Lactate dehydrogenase | ||||||
|
| ||||||
| Normal | 23 (56) | 11 (69) | 16 (67) | 17 (53) | 13 (59) | 80 (59) |
|
| ||||||
| Elevated‡ | 13 (32) | 5 (31) | 6 (25) | 7 (22) | 5 (23) | 36 (27) |
|
| ||||||
| Unknown | 5 (12) | 0 | 2 (8) | 8 (25) | 4 (18) | 19 (14) |
|
| ||||||
| M staging of extent of metastasis | ||||||
|
| ||||||
| MX | 0 | 0 | 0 | 1 (3) | 0 | 1 (1) |
|
| ||||||
| M0 | 7 (17) | 2 (12) | 2 (8) | 3 (9) | 1 (5) | 15 (11) |
|
| ||||||
| M1a | 1 (2) | 3 (19) | 6 (25) | 3 (9) | 1 (5) | 14 (10) |
|
| ||||||
| M1b | 11 (27) | 3 (19) | 7 (29) | 5 (16) | 2 (9) | 28 (21) |
|
| ||||||
| M1c | 20 (49) | 8 (50) | 9 (38) | 18 (56) | 18 (82) | 73 (54) |
|
| ||||||
| Unknown | 2 (5) | 0 | 0 | 2 (6) | 0 | 4 (3) |
|
| ||||||
| Previous treatment§ | ||||||
|
| ||||||
| No prior systemic treatment | 16 (39) | 0 | 12 (50) | 0 | 14 (64) | 42 (31) |
|
| ||||||
| Immunotherapy, excluding ipilimumab | 11 (27) | 4 (25) | 5 (21) | 10 (31) | 4 (18) | 34 (25) |
|
| ||||||
| Chemotherapy | 11 (27) | 8 (50) | 9 (38) | 14 (44) | 5 (23) | 47 (35) |
|
| ||||||
| BRAF inhibitor | 4 (10) | 0 | 1 (4) | 4 (12) | 1 (5) | 10 (7) |
*
Race was self-reported.
†
An Eastern Cooperative Oncology Group (ECOG) performance status of 0 indicates that the patient is fully active, 1 that the patient is restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, and 2 that the patient is ambulatory and capable of all self-care but unable to carry out any work activities.
‡
An elevated level was considered to be a level higher than the upper limit of the normal range.
§
This category included treatments for advanced disease. The numbers may add up to more than 100% since a patient may have received more than one type of oncologic therapy.