Table 1.
Clinical characteristics of the study population (n = 826)
| Characteristic | n (%) |
|---|---|
| Median age, years (IQR) | 62 (52–70) |
| Male sex | 524 (63.4) |
| Non-Hispanic white | 704 (85.2) |
| Comorbidities | 408 (49.4) |
| Smoking | 390 (47.2) |
| Cancer type | |
| Melanoma | 347 (42.0) |
| Solid tumor | 363 (43.9) |
| Hematologic | 116 (14.0) |
| Cancer stage (n = 709) | |
| III | 85 (12.0) |
| IV | 624 (88.0) |
| ICI type | |
| Anti-CTLA-4 | 264 (32.0) |
| Anti-PD-1/L1 | 426 (51.6) |
| Combination | 136 (16.5) |
| Median duration of ICI therapy, days (IQR) | 56 (22–116) |
| IMDC | 434 (52.5) |
| Median time to IMDC onset, weeks (IQR) | 8 (4–15) |
| Median duration of IMDC symptoms, days (IQR) | 9 (3–20) |
| Grade of colitis (n = 319) | |
| 1 | 74 (23.2) |
| 2 | 150 (47.0) |
| 3 | 84 (26.3) |
| 4 | 11 (3.4) |
| Grade of diarrhea (n = 434) | |
| 1 | 129 (29.7) |
| 2 | 120 (27.6) |
| 3 | 164 (37.8) |
| 4 | 21 (4.8) |
| Treatment of IMDC (n = 434) | |
| Immunosuppressants | 276 (63.6) |
| Symptomatic only | 158 (36.4) |
| Infliximab and/or vedolizumab add-on | 83 (10.0) |
| Antibiotic therapy | |
| No | 257 (31.1) |
| Yes | 569 (68.9) |
| Before ICI therapy only | 186 (32.7) |
| After ICI therapy and before IMDC onset | 84 (14.8) |
| Both | 299 (52.5) |
| Use of antibiotics with antianaerobic activity | 288 (50.6) |
| Recurrence of IMDC | 83 (10.0) |
| Colon perforation | 7 (1.0) |
| Nongastrointestinal irAEs | 312 (37.8) |