Table 1.
Association between patient characteristics and treatment group
| Characteristic | Immunosuppressant N = 141 |
No immunosuppressant N = 41 |
P value |
|---|---|---|---|
| Age in years, mean (SD) | 60 (15) | 58 (19) | 0.371 |
| Male sex, n (%) | 94 (66.7) | 25 (61.0) | 0.576 |
| White race, n (%) | 135 (95.7) | 32 (78.0) | 0.001 |
| Comorbidities present, n (%) | 79 (56.0) | 28 (68.3) | 0.207 |
| Smoking, n (%) | 74 (52.5) | 22 (53.7) | 1.000 |
| NSAID, n (%) | 76 (53.9) | 20 (48.8) | 0.597 |
| Malignancy type, n (%) | 0.016 | ||
| Melanoma | 62 (44.0) | 15 (36.6) | |
| Solid | 74 (52.5) | 19 (46.3) | |
| Hematological | 5 (3.5) | 7 (17.1) | |
| Cancer stagea, n (%) | 1.000 | ||
| III | 13 (9.6) | 3 (8.8) | |
| IV | 122 (90.4) | 31 (91.2) | |
| Checkpoint inhibitor type, n (%) | 0.051 | ||
| CTLA-4 | 59 (41.8) | 12 (29.3) | |
| PD-1/L-1 | 45 (31.9) | 22 (53.7) | |
| Combinationb | 37 (26.2) | 7 (17.1) | |
| Diarrhea grade | < 0.001 | ||
| 1 | 4 (2.8) | 20 (48.8) | |
| 2 | 43 (30.5) | 17 (41.5) | |
| 3–4 | 94 (66.7) | 4 (9.8) | |
| Colitis grade | < 0.001 | ||
| 1 | 23 (16.3) | 14 (34.1) | |
| 2 | 59 (41.8) | 27 (65.9) | |
| 3–4 | 59 (41.8) | 0 (0.0) | |
| Endoscopic evaluation | 0.223 | ||
| Flexible sigmoidoscopy | 33 (23.4) | 14 (34.1) | |
| Colonoscopy | 108 (76.6) | 27 (65.9) | |
| Distribution of colitis | < 0.001 | ||
| Terminal ileum involved | 10 (7.1) | 1 (2.4) | |
| Right colon only | 4 (2.8) | 1 (2.4) | |
| Left colon only | 48 (34.0) | 9 (22.0) | |
| Entire colon | 39 (27.7) | 3 (7.3) | |
| Normal | 40 (28.4) | 27 (65.9) | |
| IBD like endoscopic patternc | 0.229 | ||
| Crohn’s colitis | 32 (31.7) | 7 (50.0) | |
| Ulcerative colitis | 69 (68.3) | 7 (50.0) |
Abbreviation: NSAID, non-steroidal antiinflammatory drugs, CTLA-4 cytotoxic T-lymphocyte antigen-4, PD-1/L-1 programmed cell death receptor-1 and ligand 1, SD standard deviation
a American Joint Committee on Cancer (AJCC) Cancer Staging System, 13 patients are missing
b Combination: ipilimumab + nivolumab
c Only 115 patients were included for the IBD like endoscopic pattern evaluation