Table 1.
Baseline characteristics
| Pembrolizumab n=487 |
Placebo n=489 |
|
| Age, median (IQR), years | 60 (51–68)* | 61 (53–69)† |
| Sex | ||
| Male | 300 (61.6) | 289 (59.1) |
| Female | 187 (38.4) | 200 (40.9) |
| Cancer stage‡ | ||
| IIA | 1 (0.2) | 0 |
| IIB | 309 (63.4) | 316 (64.6) |
| IIC | 171 (35.1) | 169 (34.6) |
| IIIC | 4 (0.8) | 1 (0.2) |
| IV | 0 | 2 (0.4) |
| Missing | 2 (0.4) | 1 (0.2) |
| Melanoma subtype | ||
| Nodular | 232 (47.6) | 241 (49.3) |
| Superficial spreading | 103 (21.1) | 94 (19.2) |
| Acral | 23 (4.7) | 28 (5.7) |
| Lentiginous | 25 (5.1) | 18 (3.7) |
| Desmoplastic | 20 (4.1) | 21 (4.3) |
| Unknown | 21 (4.3) | 21 (4.3) |
| Other | 63 (12.9) | 66 (11.2) |
| Tumor thickness | ||
| ≤4 mm | 202 (41.5) | 201 (41.1) |
| >4 mm | 285 (58.5) | 288 (58.9) |
| Ulceration | ||
| Yes | 373 (76.6) | 373 (76.3) |
| No | 114 (23.4) | 116 (23.7) |
| Mitotic rate, median (range), per mm2 | 5.0 (0–67)§ | 5.0 (0–38)§ |
| <5 per mm2 | 186 (38.2) | 198 (40.5) |
| ≥5 per mm2 | 245 (50.3) | 223 (45.6) |
| Missing/unknown | 56 (11.5) | 68 (13.9) |
| Tumor-infiltrating lymphocytes | ||
| Absent | 97 (19.9) | 118 (24.1) |
| Present | 220 (45.2) | 203 (41.5) |
| Brisk | 58 (11.9) | 53 (10.8) |
| Non-brisk | 162 (33.3) | 150 (30.7) |
| Unknown | 170 (34.9) | 168 (34.4) |
Data are n (%) unless otherwise specified.
*Age ranged from 16 to 84 years. One (0.2%) patient was aged <18 years.
†Age ranged from 17 to 87 years. One (0.2%) patient was aged <18 years.
‡Enrollment of patients with IIA, IIIC, and IV disease was recorded as a protocol deviation.
§Mitotic rate of “0/mm2” indicates that mitosis was not detected.