Table 1.
Baseline characteristics of the cohort.
| All Toxicities | Skin Toxicities | ||||||
|---|---|---|---|---|---|---|---|
| Total | No toxicity | Toxicity | p Value | No Toxicity | Toxicity | p Value | |
| N = 153 | N = 37 | N = 116 | N = 77 | N = 76 | |||
| Age, Median * | 60.0 [45.0;69.0] | 60.0 [43.0;69.0] | 61.0 [46.0;68.2] | 0.309 | 62.0 [48.0;71.0] | 56.5 [44.8;66.0] | 0.171 |
| Gender | 0.348 | 0.575 | |||||
| Female | 66 (43.1%) | 13 (35.1%) | 53 (45.7%) | 31 (40.3%) | 35 (46.1%) | ||
| Male | 87 (56.9%) | 24 (64.9%) | 63 (54.3%) | 46 (59.7%) | 41 (53.9%) | ||
| AJCC stage | 0.709 | 0.014 | |||||
| Stage IIIC | 28 (18.9%) | 5 (14.3%) | 23 (20.4%) | 9 (12.0%) | 19 (26.0%) | ||
| Stage IVA | 22 (14.9%) | 7 (20.0%) | 15 (13.3%) | 9 (12.0%) | 13 (17.8%) | ||
| Stage IVB | 28 (18.9%) | 7 (20.0%) | 21 (18.6%) | 12 (16.0%) | 16 (21.9%) | ||
| Stage IVC | 70 (47.3%) | 16 (45.7%) | 54 (47.8%) | 45 (60.0%) | 25 (34.2%) | ||
| LDH | 0.427 | 0.079 | |||||
| Abnormal | 22 (14.9%) | 7 (20.6%) | 15 (13.2%) | 15 (20.8%) | 7 (9.2%) | ||
| Normal | 126 (85.1%) | 27 (79.4%) | 99 (86.8%) | 57 (79.2%) | 69 (90.8%) | ||
| Karnofsky score | 0.063 | 0.055 | |||||
| >80 | 56 (56.0%) | 9 (37.5%) | 47 (61.8%) | 25 (46.3%) | 31 (67.4%) | ||
| ≤80 | 44 (44.0%) | 15 (62.5%) | 29 (38.2%) | 29 (53.7%) | 15 (32.6%) | ||
| BRAF status: | 0.844 | 0.053 | |||||
| BRAF mutated | 37 (24.2%) | 8 (21.6%) | 29 (25.0%) | 13 (16.9%) | 24 (31.6%) | ||
| Wild type | 116 (75.8%) | 29 (78.4%) | 87 (75.0%) | 64 (83.1%) | 52 (68.4%) | ||
| Melanoma location | 0.598 | 0.277 | |||||
| Trunk | 57 (37.5%) | 13 (35.1%) | 44 (38.3%) | 23 (30.3%) | 34 (44.7%) | ||
| Lower limbs | 25 (16.4%) | 9 (24.3%) | 16 (13.9%) | 7 (9.2%) | 7 (9.2%) | ||
| Head and neck | 19 (12.5%) | 3 (8.1%) | 16 (13.9%) | 9 (11.8%) | 10 (13.2%) | ||
| Unknown | 14 (9.2%) | 3 (8.1%) | 11 (9.6%) | 17 (22.4%) | 8 (10.5%) | ||
| Acral | 13 (8.6%) | 2 (5.4%) | 11 (9.6%) | 6 (7.9%) | 7 (9.2%) | ||
| Upper limbs | 13 (8.6%) | 5 (13.5%) | 8 (7.0%) | 5 (6.6%) | 6 (7.9%) | ||
| Mucosa | 11 (7.2%) | 2 (5.4%) | 9 (7.8%) | 9 (11.8%) | 4 (5.3%) | ||
| Breslow index * | 3.5 [2.0;6.0] | 3.3 [1.9;6.0] | 3.5 [2.2;6.0] | 0.935 | 3.7 [2.0;6.6] | 3.4 [2.0;4.8] | 0.608 |
| Ulceration | 0.863 | 0.224 | |||||
| Absent | 48 (38.4%) | 11 (35.5%) | 37 (39.4%) | 20 (32.3%) | 28 (44.4%) | ||
| Present | 77 (61.6%) | 20 (64.5%) | 57 (60.6%) | 42 (67.7%) | 35 (55.6%) | ||
| Mitotic index * | 5.0 [3.0;10.0] | 6.0 [2.50;9.5] | 5.0 [3.00;9.8] | 0.974 | 5.0 [3.0;10.0] | 5.5 [4.0;9.2] | 0.726 |
| Treatment duration * | 126.0 [59;351] | 69.0 [40;233] | 164 [63;360] | 0.012 | 66.0 [42;181] | 312.0 [83;479] | <0.001 |
* Continuous variables expressed as median (IQR). Abbreviations: AJCC, American Joint Committee on Cancer; IQR, interquartile range; LDH lactate dehydrogenase.