Table 1.
Clinical characteristics of the cohort.
| Clinical Characteristics | Monotherapy with Anti-PD-1 Antibody | Combined with Ipilimumab and Nivolumab | Total | |||
|---|---|---|---|---|---|---|
| Number of Patients | % | Number of Patients | % | Number of Patients | % | |
| Total | 36 | 100 | 59 | 100 | 95 | 100 |
| Sex | ||||||
| Male | 18 | 50 | 36 | 61 | 54 | 57 |
| Female | 18 | 50 | 23 | 39 | 41 | 43 |
| Melanoma type | ||||||
| Cutaneous | 27 | 75 | 36 | 61 | 63 | 66 |
| Acral lentiginous | 3 | 8 | 6 | 10 | 9 | 9 |
| Mucosal | 0 | 0 | 3 | 5 | 3 | 3 |
| Uveal | 2 | 6 | 4 | 7 | 6 | 6 |
| Occult | 3 | 8 | 9 | 15 | 12 | 13 |
| Other | 1 | 3 | 1 | 2 | 2 | 2 |
| AJCC cancer stage at study inclusion | ||||||
| III | 18 | 50 | 2 | 3 | 20 | 21 |
| IV | 18 | 50 | 57 | 97 | 75 | 79 |
| First line | ||||||
| Yes | 32 | 89 | 26 | 44 | 58 | 61 |
| No | 4 | 11 | 33 | 56 | 37 | 39 |
| Intention | ||||||
| Adjuvant | 20 | 56 | 0 | 0 | 20 | 21 |
| Palliative | 16 | 44 | 59 | 100 | 75 | 79 |
| Origin of tissue sequenced | ||||||
| Lymph node metastasis | 13 | 36 | 18 | 31 | 31 | 33 |
| Other metastasis | 15 | 42 | 26 | 44 | 41 | 43 |
| Primary melanoma | 6 | 17 | 9 | 15 | 15 | 16 |
| CNS metastasis | 0 | 0 | 1 | 2 | 1 | 1 |
| Local recurrence | 0 | 0 | 1 | 2 | 1 | 1 |
| Unknown | 2 | 6 | 4 | 7 | 6 | 6 |
| BRAF mutation | ||||||
| Positive | 14 | 39 | 31 | 53 | 45 | 47 |
| Negative | 22 | 61 | 28 | 47 | 50 | 53 |
| TMB values at start immunotherapy | ||||||
| Low (>3.3 Var/Mb) | 8 | 22 | 21 | 36 | 29 | 31 |
| Intermediate (3.3–23.1 Var/Mb) | 19 | 53 | 25 | 42 | 44 | 46 |
| High (>23.1 Var/Mb) | 9 | 25 | 10 | 17 | 19 | 20 |
| Not determinable | 0 | 0 | 3 | 5 | 3 | 3 |
| Pre-existing autoimmune diseases | ||||||
| Diabetes Mellitus Type 1 | 0 | 0 | 2 | 3 | 2 | 2 |
| Rheumatoid Arthritis | 1 | 3 | 1 | 2 | 2 | 2 |
| Vitiligo | 0 | 0 | 1 | 2 | 1 | 1 |
| Crohn’s Disease | 0 | 0 | 1 | 2 | 1 | 1 |
| Other | 0 | 0 | 2 | 3 | 2 | 2 |
| IRAE under immunotherapy | ||||||
| Occurrence of IRAE | 19 | 53 | 40 | 68 | 59 | 62 |
| Colitis | 2 | 6 | 18 | 31 | 20 | 21 |
| Hepatitis | 3 | 8 | 11 | 19 | 14 | 15 |
| Pancreatitis | 3 | 8 | 10 | 17 | 13 | 14 |
| Hypophysitis | 1 | 3 | 9 | 15 | 10 | 11 |
| Pneumonitis | 2 | 6 | 6 | 10 | 8 | 8 |
| Thyroiditis | 1 | 3 | 6 | 10 | 7 | 7 |
| Exanthema | 1 | 3 | 6 | 10 | 7 | 7 |
| Nephritis | 1 | 3 | 2 | 3 | 3 | 3 |
| Myositis | 0 | 0 | 3 | 5 | 3 | 3 |
| Encephalitis | 1 | 3 | 2 | 3 | 3 | 3 |
| Myocarditis | 1 | 3 | 1 | 2 | 2 | 2 |
| Protein S100 at start of immunotherapy | ||||||
| S100 elevated | 8 | 22 | 36 | 61 | 44 | 46 |
| S100 normal | 28 | 78 | 23 | 39 | 51 | 54 |
| LDH at start of immunotherapy | ||||||
| LDH elevated | 5 | 14 | 26 | 44 | 31 | 33 |
| LDH normal | 31 | 86 | 33 | 56 | 64 | 67 |
| Differential blood count at start of immunotherapy | ||||||
| Leucocytes | ||||||
| Normal | 34 | 94 | 46 | 78 | 80 | 84 |
| Increased | 2 | 6 | 8 | 14 | 10 | 11 |
| Decreased | 0 | 0 | 5 | 8 | 5 | 5 |
| Neutrophils abs. | ||||||
| Normal | 32 | 89 | 46 | 78 | 78 | 82 |
| Increased | 4 | 11 | 9 | 15 | 13 | 14 |
| Decreased | 0 | 0 | 4 | 7 | 4 | 4 |
| Neutrophils% | ||||||
| Normal | 34 | 94 | 51 | 86 | 85 | 89 |
| Increased | 1 | 3 | 6 | 10 | 7 | 7 |
| Decreased | 1 | 3 | 2 | 3 | 3 | 3 |
| Lymphocytes abs. | ||||||
| Normal | 24 | 67 | 47 | 80 | 71 | 75 |
| Increased | 1 | 3 | 1 | 2 | 2 | 2 |
| Decreased | 11 | 31 | 11 | 19 | 22 | 23 |
| Lymphocytes % | ||||||
| Normal | 17 | 47 | 36 | 61 | 53 | 56 |
| Increased | 2 | 6 | 2 | 3 | 4 | 4 |
| Decreased | 17 | 47 | 21 | 36 | 38 | 40 |
| Monocytes abs. | ||||||
| Normal | 32 | 89 | 49 | 83 | 81 | 85 |
| Increased | 3 | 8 | 9 | 15 | 12 | 13 |
| Decreased | 1 | 3 | 1 | 2 | 2 | 2 |
| Monocytes % | ||||||
| Normal | 34 | 94 | 54 | 92 | 88 | 93 |
| Increased | 2 | 6 | 5 | 8 | 7 | 7 |
| Decreased | 0 | 0 | 0 | 0 | 0 | 0 |
| Eosinophils abs. | ||||||
| Normal | 31 | 86 | 49 | 83 | 80 | 84 |
| Increased | 1 | 3 | 0 | 0 | 1 | 1 |
| Decreased | 4 | 11 | 10 | 17 | 14 | 15 |
| Eosinophils % | ||||||
| Normal | 31 | 86 | 46 | 78 | 77 | 81 |
| Increased | 1 | 3 | 0 | 0 | 1 | 1 |
| Decreased | 4 | 11 | 13 | 22 | 17 | 18 |
AJCC: American Joint Committee on Cancer; CNS: Central Nervous System; BRAF: B-Rapidly Accelerated Fibrosarcoma; TMB: Tumor Mutational Burden; IRAE: Immune-Related Adverse Event; LDH: Lactate Dehydrogenase.