Clinical characteristics of gastrointestinal immune-related adverse events of immune checkpoint inhibitors and their association with survival

Table 2 Clinical characteristics of patients who developed gastrointestinal-immune-related adverse events in the programmed cell death-1/programmed death-ligand 1 and cytotoxic T-lymphocyte antigen 4 groups

Characteristic	PD-1/PD-L1, n = 34	CTLA-4, n = 9	P value
Age, yr, median (range)	69 (37-86)	56 (46-80)	0.187
Sex, n (%)			0.427
Male	29 (85.3)	7 (77.8)
Female	5 (14.7)	2 (22.2)
Drugs, n (%)
Nivolumab	12 (35.3)	0 (0.0)
Pembrolizumab	16 (47.0)	0 (0.0)
Atezolizumab	2 (5.9)	0 (0.0)
Durvalumab	4 (11.8)	0 (0.0)
Ipilimumab	0 (0.0)	6 (66.7)
Nivolumab + ipilimumab	0 (0.0)	3 (33.3)
Median ICI duration before GI-irAE onset (d), median (range)	77 (4-733)	42 (11-92)	0.127
Diarrhea frequency per day, times (range)	5.0 (0-10)	6.5 (4-15)	0.031
CTCAE Grade, n (%)			0.288
1	9 (26.5)	0 (0.0)
2-3	25 (73.5)	9 (100)
GI-irAE treatment, n (%)
Improvement without medication	13 (38.2)	1 (11.1)	0.017
Corticosteroids	11 (32.4)	8 (88.9)	0.006
Loperamide	8 (23.5)	1 (11.1)	0.657

CTCAE: Common Terminology Criteria for Adverse Events; CTLA-4: Cytotoxic T-lymphocyte antigen 4; GI-irAE: Gastrointestinal-immune-related adverse event; ICI: Immune checkpoint inhibitor; PD-1/PD-L1: Programmed cell death-1/programmed death-ligand 1.