Table 1.
Patient characteristics, overall (N = 335) and stratified by irAE occurrence during follow-up
| Characteristics | Total (N = 335) | irAEs during study follow-up | p-value1 | ||
|---|---|---|---|---|---|
| No (N = 213) | Yes (N = 122) | ||||
| Age [years], Median (IQR) | 69.0 (59.0–76.0) | 68.0 (59.0–75.0) | 70.0 (60.0–77.0) | 0.387 | |
| Sex, male | 250 (74.6%) | 168 (78.9%) | 82 (67.2%) | 0.026 | |
| ECOG | 0.026 | ||||
| 0 | 171 (51.0%) | 98 (46.0%) | 73 (59.8%) | ||
| 1 | 124 (37.0%) | 90 (42.3%) | 34 (27.9%) | ||
| > 1 | 40 (11.9%) | 25 (11.7%) | 15 (12.3%) | ||
| Localization of metastases1 | 0.067 | ||||
| Lymph node only disease | 111 (34.6%) | 63 (30.7%) | 48 (41.4%) | ||
| Visceral metastases | 210 (65.4%) | 142 (69.3%) | 68 (58.6%) | ||
| Liver metastases | 71 (22.1%) | 52 (25.4%) | 19 (16.4%) | ||
| IO-Agent | 0.594 | ||||
| Nivolumab | 41 (12.2%) | 29 (13.6%) | 12 (9.8%) | ||
| Pembrolizumab | 199 (59.4%) | 126 (59.2%) | 73 (59.8%)) | ||
| Atezolizumab | 52 (15.5%) | 34 (16.0%) | 18 (14.8%) | ||
| Avelumab | 43 (12.8%) | 24 (11.3%) | 19 (15.6%) | ||
| Therapy line | 0.533 | ||||
| First-line | 68 (20.3%) | 42 (19.7%) | 26 (21.3%) | ||
| Second-line or further lines | 233 (69.6%) | 152 (71.4%) | 81 (66.4%) | ||
| Switch Maintenance | 34 (10.1%) | 19 (8.9%) | 15 (12.3%) | ||
| Therapy duration [months], Median (IQR) | 5.0 (2.0–12.0) | 4.0 (2.0–8.5) | 10.0 (4.0–26.0) | < 0.001 | |
| irAE grade, n (%) | – | ||||
| 1–2 | – | – | 72 (59.0%) | ||
| 3–4 | – | – | 45 (36.9%) | ||
| 5 | – | – | 5 (4.1%) | ||
| Systemic corticosteroid administration | – | – | 62 (50.8%) | – | |
| Deaths during FU | 193 (57.6%) | 137 (64.3%) | 56 (45.9%) | 0.001 | |
| Time until death [months], Median (IQR)3 | 6.0 (2.0–14.5) | 5.2 (1.7–11.2) | 12.9 (4.8–23.0) | < 0.001 | |
| Follow-up time [months], Median (IQR)4 | 21.1 (10.7–34.4) | 16.8 (9.7–27.3) | 27.9 (13.0–38.6) | 0.014 | |
1p-values from Wilcoxon test for quantitative data, and Fisher’s exact test for qualitative data
2Information missing for 14 patients
3Calculated based on the 193 patients who died during follow-up
4Calculated based on the 142 patients who did not die during follow-up