Table 2.
Patients’ characteristics according to ICI regimen.
| Characteristics | Population (35) |
Anti-PD-1 Monotherapy (26) |
Anti-PD-1 + Anti-CTLA-4 Combination Therapy (9) |
p-Value | |
|---|---|---|---|---|---|
| Median age at ICI-DILI, years (IQR) | 62 (48–73) | 65 (55–73) | 48 (45–62) | 0.043 | |
| Sex, male, n (%) | 14 (40) | 10 (38) | 4 (44) | 0.756 | |
| Underlying cancer | Melanoma, n (%) | 19 (54) | 10 (38.5) | 9 (100) | 0.003 |
| Lymphoma, n (%) | 1 (3) | 1 (4) | 0 (0) | ||
| Non-small-cell lung cancer, n (%) | 10 (28) | 10 (38.5) | 0 (0) | ||
| Other, n (%) | 5 (14) | 5 (19) | 0 (0) | ||
| Previous chemotherapy, n (%) | 15 (43) | 13 (50) | 2 (22) | 0.153 | |
| Treatment line, n (IQR) | 1 (1–2) | 1 (1–2) | 1 (1–2) | 0.555 | |
| Number of ICI cycles, n (IQR) | 3 (1–4) | 2.5 (1–4.25) | 3 (2.5–4) | 0.476 | |
| Other IRAES, n (%) | 12 (34) | 8 (31) | 4 (44) | 0.463 | |
| AST, U/L (IQR) | 163 (75–483) | 156 (64–490) | 194 (96–428) | 0.942 | |
| ALT, U/L (IQR) | 300 (115–665) | 344 (115–665) | 285 (114–891) | 0.961 | |
| ALP, U/L (IQR) | 152 (108–223) | 172 (112–250) | 126 (71–166) | 0.104 | |
| Gamma-GT, U/L (IQR) | 147 (76–488) | 196 (94–526) | 115 (32–154) | 0.104 | |
| Total bilirubin, (umol/L) (IQR) | 8.2 (5.2–15.2) | 7.6 (5–19.2) | 9.8 (6.4–10.6) | 0.438 | |
| Prothrombin time, (PT) (%) | 100 (78–100) | 98 (72–100) | 100 (81–101) | 0.524 | |
| Platelets × 103/μL, (IQR) | 231 (199–255) | 231 (193–251) | 226 (193–281) | 0.925 | |
| R-factor (IQR) | 4.8 (2.4–9.1) | 4.35 (2.28–6.68) | 5.9 (2.5–21.5) | 0.184 | |
| RUCAM score (IQR) | 7 (6–9) | 8 (6.7–9) | 6 (6–8) | 0.130 | |
| Auto antibodies, n (%) | FAN > 1/80 ASMA > 1/80 |
19 (54) 2 (6) |
14 (54) 2 (8) |
5 (57) 0 (0) |
0.956 0.398 |
| Corticosteroid therapy, n(%) | 20 (57) | 13 (50) | 7 (78) | 0.153 | |
| Time until liver function tests normalization, days (IQR) | 60 (40–120) | 49 (37–67) | 120 (75–150) | 0.007 | |
| Histological pattern, n (%), available for 20 patients |
Toxic | 6 (30) | 5 (36) | 1 (17) | 0.406 |
| Autoimmune | 1 (5) | 0 (0) | 1 (17) | 0.141 | |
| Granulomatous | 6 (30) | 3 (21) | 3 (50) | 0.253 | |
| Mixed (toxic + autoimmune) | 1 (5) | 1 (7) | 0 (0) | 0.497 | |
| None | 6 (30) | 5 (36) | 1 (17) | 0.355 | |
| Histological pattern, n (%) | Minimal necrosis | 10 (50) | 9 (45) | 1 (5) | 0.057 |
| Mild necrosis | 2 (10) | 0 (0) | 2 (10) | 0.026 | |
| Severe necrosis | 7 (35) | 3 (15) | 4 (20) | 0.058 | |
| ICI discontinuation, n (%) | 32 (91) | 23 (88) | 9 (100) | 0.294 | |
| ICI dose reduction, n (%) | 4 (11) | 1 (4) | 3 (33) | 0.021 | |
| ICI rechallenge, n (%) | Yes Same ICI Other ICI No |
4 (11) 4 (11) 27 (77) |
2 (8) 3 (11) 21 (80) |
2 (22) 1 (11) 6 (77) |
0.244 0.073 |