Table 1.
Patient characteristics
| ICI Colitis Present (n=16) n (%) | ICI Colitis Absent (n=160) n (%) | P value | |
|---|---|---|---|
| Age (year)* | 66 (52-72) | 63 (56-68) | 0.23 |
| Male | 9 (56.3) | 121 (75.6) | 0.09 |
| Race | |||
| Caucasian | 16 (100) | 106 (66.3) | 0.005 |
| Non-Caucasian | 0 (0) | 54 (33.8) | |
| Study site | |||
| PHHS | 0 (0) | 31 (19.4) | 0.052 |
| CUH | 16 (100) | 129 (80.6) | |
| Ever smoker | 9 (56.3) | 71 (44.4) | 0.36 |
| Comorbidities | |||
| Hypertension | 13 (81.3) | 117 (73.1) | 0.48 |
| Type 2 diabetes mellitus | 6 (37.5) | 47 (29.4) | 0.5 |
| Inflammatory bowel disease | 0 (0) | 2 (1.2) | 0.65 |
| Diverticulosis | 6 (37.5) | 87 (54.4) | 0.2 |
| Histological subtype | |||
| ccRCC | 15 (93.8) | 134 (83.8) | 0.29 |
| Non-ccRCC | 1 (6.3) | 26 (16.3) | |
| Nephrectomy | 13 (81.3) | 135 (84.4) | 0.75 |
| Previous radiation therapy | 11 (68.8) | 93 (58.1) | 0.41 |
| Prior Systemic Therapies | |||
| None | 5 (31.3) | 29 (18.1) | 0.45 |
| One | 6 (37.5) | 70 (43.8) | |
| Two or more | 5 (31.3) | 61 (38.1) | |
| IMDC score | |||
| Favorable | 1 (6.3) | 31 (19.4) | 0.28 |
| Intermediate | 12 (75.0) | 84 (52.5) | |
| Poor | 3 (18.8) | 34 (21.3) | |
| Missing | 0 (0) | 11 (6.9) | |
| Initial immunotherapy regimen | |||
| Nivolumab | 7 (43.8) | 126 (78.8) | 0.002 |
| Nivolumab+Ipilimumab | 9 (56.3) | 34 (21.3) | |
| Any exposure to Ipilimumab | 14 (87.5) | 70 (43.8) | 0.001 |
| Non-colitis irAEs | 10 (62.5) | 63 (39.4) | 0.07 |
| Exposure to PPIs | 14 (87.5) | 90 (56.3) | 0.015 |
Data are shown as frequencies (percentages) unless otherwise indicated.
ccRCC: clear cell renal cell carcinoma, CUH: Clements University Hospital, ICI: immune checkpoint inhibitor, IMDC: international metastatic renal cell carcinoma database consortium, irAE: immune-related adverse event, PHHS: Parkland Health & Hospital System, PPI: proton pump inhibitor.
P values were calculated by comparing patients with and without ICI colitis.
*
Data are shown as medians (interquartile ranges).