Table 1.
Patient characteristics by the development of any irAE
| Characteristic | All patients (n = 186), n (%) | No irAE, (n = 98), n (%) | Any irAE, (n = 88), n (%) | p value |
|---|---|---|---|---|
| Age, median (range) | 63.5 (55–74) | 62 (54–74) | 67 (57–75) | .078 |
| Sex, male, n (%) | 109 (58.6) | 62 (63.3) | 47 (53.4) | .173 |
| BRAFa mutation positive, n (%) | 51 (27.4) | 31 (31.6) | 20 (22.7) | .174 |
| ECOG, n (%) | .254 | |||
| 0 | 46 (24.7) | 19 (19.4) | 27 (30.7) | |
| 1 | 109 (58.6) | 61 (62.2) | 48 (54.5) | |
| 2+ | 26 (14) | 16 (16.3) | 10 (11.4) | |
| Unknown | 5 (2.7) | 2 (2) | 3 (3.4) | |
| M stage,b n (%) | .098 | |||
| 0/1a | 44 (23.7) | 22 (22.4) | 22 (25) | |
| 1b | 39 (21) | 15 (15.3) | 24 (27.3) | |
| 1c | 67 (36) | 37 (37.8) | 30 (34.1) | |
| 1d | 36 (19.4) | 24 (24.5) | 12 (13.6) | |
| LDH, n (%) | .251 | |||
| ≤ULN | 110 (59.1) | 53 (54.1) | 57 (64.8) | |
| >ULN | 74 (39.8) | 44 (44.9) | 30 (34.1) | |
| Unknown | 2 (1.1) | 1 (1) | 1 (1.1) | |
| Line of anti‐PD‐1, n (%) | .019 | |||
| 1 | 79 (42.5) | 33 (33.7) | 46 (52.3) | |
| 2 | 40 (21.5) | 26 (26.5) | 14 (15.9) | |
| 3 | 56 (30.1) | 30 (30.6) | 26 (29.5) | |
| ≥4 | 11 (5.9) | 9 (9.2) | 2 (2.3) | |
| Median no. of cycles (IQR) | 11 (5–20) | 8 (4–14) | 13 (8–25) | <.001 |
a
BRAF mutations include V600E/Ec/D/K/R.
b
American Joint Committee on Cancer 2017 melanoma staging classification. Patients treated for unresectable stage III (M0) were included with M1a for statistical analysis.
Abbreviations: ECOG, Eastern Cooperative Group; IQR, interquartile range; irAE, immune‐related adverse event; LDH, lactate dehydrogenase; PD‐1, programmed cell death protein 1; ULN, upper limit of normal.