Table 3 The safety profiles of irAEs in the combination therapy and monotherapy groups
Patients with combination therapy, No. (%) | Patients with monotherapy, No. (%) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
Total (n = 74) | Grade 1–2 | Grade 3–4 | Systemic Steroid Therapy | Discontinuation of chemotherapy due to irAE | Median onset time, median (min–max), weeks | Total (n = 74) | Grade 1–2 | Grade 3–4 | Systemic Steroid Therapy | Discontinuation of chemotherapy due to irAE | Median onset time, median (min–max), weeks | |
All irAEs | 46 (62.2) | 29 (39.2) | 17 (23.0) | 16 | 16 | 9.1 (1.0–58.3) | 41 (55.4) | 32 (43.2) | 9 (12.2) | 15 | 18 | 9.0 (0.0–79.1) |
One irAE | 32 (43.2) | 24 (32.4) | ||||||||||
Two or more | 14 (18.9) | 16 (21.6) | ||||||||||
Each irAEs | ||||||||||||
Gastrointestinal | 4 (5.4) | 2 (2.7) | 2 (2.7) | 2 | 2 | 17.4 (1.6–47.7) | 3 (4.1) | - | 3 (4.1) | 1 | 2 | 1.4 (0.7–4.9) |
Pneumonitis | 15 (20.3) | 11 (14.9) | 4 (5.4) | 7 | 6 | 18.0 (1.9–46.1) | 13 (17.6) | 10 (13.5) | 3 (4.1) | 7 | 9 | 12.1 (0.6–71.1) |
Hepatitis | 2 (2.8) | 1 (1.4) | 1 (1.4) | 1 | 1 | 3.4 (1.4–5.4) | - | - | - | - | ||
Myositis | 5 (6.8) | 3 (4.1) | 2 (2.8) | 1 | 2 | 4.0 (1.0–53.4) | 4 (5.4) | 3 (4.1) | 1 (1.4) | 2 | 3 | 7.1 (6.0–55.0) |
Nephritis | 1 (1.4) | - | 1 (1.4) | 1 | 1 | 2.0 | 1 (1.4) | 1 (1.4) | - | 1 | 1 | 15.3 |
Meningitis or Encephalitis | - | - | - | - | - | - | 2 (2.7) | - | 2 (2.7) | 2 | 2 | 2.0 (1.3–6.7) |
Skin | 21 (28.4) | 20 (27.0) | 1 (1.4) | 0 | 0 | 2.4 (1.0–58.3) | 26 (35.1) | 25 (33.8) | 1 (1.4) | 1 | 0 | 9.6 (0–77.1) |
Endocrine | ||||||||||||
Thyroid dysfunction | 9 (12.2) | 8 (10.8) | 1 (1.4) | 1 | 6.9 (3.0–26.6) | 4 (5.4) | 3 (4.1) | 1 (1.4) | 0 | 0 | 18.9 (3.4–48.1) | |
Adrenal insufficiency | 4 (5.4) | - | 4 (5.4) | 4 | 2 | 26.9 (12.4–48.0) | 1 (1.4) | 1 (1.4) | 1 (1.4) | 1 | 1 | 42.9 |
Type 1 DM | 1 (1.4) | - | 1 (1.4) | 1 | 21.9 | - | - | - | - | |||