Table 1. Baseline characteristics.
| Nivolumab followed by ipilimumab (n=68) | Ipilimumab followed by nivolumab (n=70) | |
|---|---|---|
| Age (years) | 605 (46·5-70·0) | 63·0 (52·0-73·0) |
|
| ||
| Sex | ||
| Men | 46 (68%) | 46 (66%) |
| Women | 22 (32%) | 24 (34%) |
|
| ||
| Ethnic origin | ||
| White | 65 (96%) | 66 (94%) |
| Black or African–American | 1 (1%) | 2 (3%) |
| Other | 2 (3%) | 2 (3%) |
|
| ||
| ECOG performance status | ||
| 0 | 47 (69%) | 37 (53%) |
| 1 | 21 (31%) | 33 (47%) |
|
| ||
| AJCC stage at study entry | ||
| III | 6 (9%) | 12 (17%) |
| IV | 62 (91%) | 58 (83%) |
|
| ||
| M stage | ||
| M0 | 0 | 3 (4%) |
| M1a | 3 (4%) | 7 (10%) |
| M1b | 14 (21%) | 8 (11%) |
| M1c | 45 (66%) | 43 (61%) |
| Not reported | 6 (9%) | 9 (13%) |
|
| ||
| Baseline LDH | ||
| ≤ULN | 45 (66%) | 41 (59%) |
| >ULN | 23 (34%) | 29 (41%) |
| ≤2 × ULN | 59 (87%) | 58 (83%) |
| >2 × ULN | 9 (13%) | 12 (17%) |
|
| ||
| BRAF status | ||
| BRAFV600E mutant | 19 (28%) | 20 (29%) |
| Wild type | 44 (65%) | 43 (61%) |
| Not reported | 5 (7%) | 7 (10%) |
|
| ||
| Previous systemic therapy for metastatic disease | ||
| Any previous systemic therapy | 10 (15%) | 8 (11%) |
| Previous interleukin 2 | 4 (6%) | 2 (3%) |
|
| ||
| PD-L1 expression ≥5%* | 22/53 (42%) | 10/44 (23%) |
|
| ||
| History of brain metastases | ||
| Yes | 9 (13%) | 2 (3%) |
| No | 53 (78%) | 60 (86%) |
| Not reported | 6 (9%) | 8 (11%) |
Data are median (IQR), n (%), or n/N (%). ECOG=Eastern Cooperative Oncology Group. AJCC=American Joint Committee on Cancer. LDH=lactate dehydrogenase. PD-L1=programmed death ligand 1. ULN=upper limit of normal.
*
The proportion of patients with PD-L1 expression ≥5% among those with quantifi able PD-L1 (ie, 53 patients in the nivolumab followed by ipilimumab group and 44 patients in the ipilimumab followed by nivolumab group).