TABLE 1.
Patient characteristics of the overall cohort and the subgroup with and without nAE.
| Parameters | Total cohort (n = 110) | With nAE (n = 34) | Without nAE (n = 76) | p‐value |
|---|---|---|---|---|
| Age at start of ICI | ||||
| Median (min–max), years | 63 (29–87) | 63 (29–87) | 63 (30–86) | 0.486 |
| Sex | 0.258 | |||
| Female, n (%) | 41 (37%) | 10 (29%) | 31 (41%) | |
| Male, n (%) | 69 (63%) | 24 (71%) | 45 (59%) | |
| Underlying tumor disease, n (%) | ||||
| Malignant Melanoma | 76 (69%) | 21 (61.8%) | 55 (72.37%) | 0.211 |
| NSCLC | 10 (9%) | 8 (23.5%) | 2 (2.63%) | 0.0003 |
| Renal cell carcinoma | 9 (8%) | 2 (5.88%) | 7 (9.21%) | 0.560 |
| Head and neck tumor | 5 (4.5%) | 1 (2.94%) | 4 (5.26%) | 0.593 |
| Squamous cell carcinoma | 2 (1.8%) | 0 | 2 (2.63%) | 0.344 |
| HCC | 1 (1%) | 0 | 1 (1.32%) | 0.506 |
| Endocrine carcinoma | 1 (1%) | 0 | 1 (1.32%) | 0.506 |
| Pleural mesothelioma | 1 (1%) | 0 | 1 (1.32%) | 0.506 |
| Tonsillar carcinoma | 1 (1%) | 1 (2.94%) | 0 | 0.136 |
| CUP | 1 (1%) | 1 (2.94%) | 0 | 0.136 |
| Combination | 3 (2.7%) | 0 | 3 (3.95%) | 0.244 |
| ICI used, n (%) | ||||
| Nivolumab | 61 (55.5%) | 15 (44.2%) | 46 (60.5%) | 0.144 |
| Pembrolizumab | 20 (18.2%) | 9 (26.5%) | 11 (14.5%) | 0.089 |
| Nivolumab/Ipilimumab | 19 (17.3%) | 7 (20.6%) | 12 (15.7%) | 0.543 |
| Atezolizumab | 4 (3.6%) | 1 (2.9%) | 3 (3.95%) | 0.797 |
| Cemiplimab | 2 (1.8%) | 1 (2.9%) | 1 (1.31%) | 0.559 |
| Avelumab | 1 (0.9%) | 0 | 1 (1.31%) | 0.506 |
| Ipilimumab | 1 (0.9%) | 0 | 1 (1.31%) | 0.506 |
| PD‐1‐antibody + TKI | 2 (1.8%) | 1 (2.9%) | 1 (1.31%) | 0.559 |
| Number of prior therapies, n (%) | ||||
| 0 | 73 (66.4%) | 23 (67.7%) | 50 (65.8%) | 0.851 |
| 1 | 20 (18.2%) | 6 (17.7%) | 14 (18.4%) | 0.923 |
| 2 | 7 (6.4%) | 3 (8.8%) | 4 (5.3%) | 0.484 |
| 3 | 2 (1.8%) | 1 (2.9%) | 1 (1.3%) | 0.559 |
| >3 | 5 (4.5%) | 1 (2.9%) | 4 (5.3%) | 0.593 |
| N/A | 3 (2.7%) | 0 | 3 (3.9%) | 0.244 |
| Comorbidities, n (%) | ||||
| None | 42 (38.2%) | 15 (44.1%) | 27 (35.5%) | 0.396 |
| Cardiovascular | 57 (51.8%) | 15 (44.1%) | 42 (55.3%) | 0.284 |
| Autoimmune | 1 (0.9%) | 0 | 1 (1.3%) | 0.506 |
| Combination CVSC + COPD | 4 (3.6%) | 3 (8.8%) | 1 (1.3%) | 0.152 |
| Other combinations | 3 (2.7%) | 1 (2.9%) | 2 (2.6%) | 0.927 |
| N/A | 3 (2.7%) | 0 | 3 (3.9%) | 0.244 |
| Specific irAE other than nAE total events, n (%) | 45 | 8 | 37 | |
| Thyroiditis/hyperthyroidism | 11 (24.5%) | 2 (25%) | 9 (24.3%) | 0.330 |
| Hypophysitis | 1 (2.2%) | 0 | 1 (2.7%) | 0.506 |
| Dermatitis | 3 (6.7%) | 3 (37.5%) | 0 | 0.008 |
| Mucositis | 2 (4.4%) | 1 (12.5%) | 1 (2.7%) | 0.559 |
| Hepatitis | 8 (17.8%) | 1 (12.5%) | 7 (18.9%) | 0.246 |
| Vitiligo | 2 (4.4%) | 1 (12.5%) | 1 (2.7%) | 0.559 |
| Pancreatitis | 2 (4.4%) | 0 | 2 (5.4%) | 0.344 |
| Colitis | 8 (17.8%) | 0 | 8 (21.6%) | 0.050 |
| Autoimmune thrombocytopenia | 1 (2.2%) | 0 | 1 (2.7%) | 0.506 |
| Nephritis | 3 (6.7%) | 0 | 3 (8.1%) | 0.244 |
| Arthritis | 2 (4.4%) | 0 | 2 (5.4%) | 0.344 |
| Hemophagocytic lymphohistiocytosis | 1 (2.2%) | 0 | 1 (2.7%) | 0.506 |
| Pneumonitis | 1 (2.2%) | 0 | 1 (2.7%) | 0.506 |
| Patients with >1 specific irAE including nAE, n (%) | 16 (14.5%) | 7 (20.6%) | 9 (11.8%) | 0.233 |
Abbreviations: COPD, chronic obstructive pulmonary disease; CUP, cancer of unknown primary; CVSC, cardiovascular; HCC, hepatocellular carcinoma; ICI, immune checkpoint inhibitor; irAE, immune‐related adverse events; N/A, not applicable; nAE, neurological adverse events; NSCLC, non‐small cell lung cancer; TKI, tyrosine kinase inhibitor.
Bold values indicates statistical significance.