Table 1.
Baseline Characteristics
| Characteristic | Overall (N = 75) | Infliximab + CS (N = 36) | CS Alone (N = 39) | P Value |
|---|---|---|---|---|
| Median Age (Interquartile Range) | 63 years (50–71 years) | 61 years (52–72 years) | 0.633 | |
| Sex, No. (%) | ||||
| Male | 50 (66.7) | 29 (80.6) | 21 (53.8) | 0.016 |
| Female | 25 (33.3) | 7 (19.4) | 18 (46.2) | 0.016 |
| Cancer Type, No. (%) | ||||
| Melanoma | 53 (70.7) | 29 (80.6) | 24 (61.5) | 0.167 |
| Genitourinarya | 15 (20.0) | 7 (19.4) | 8 (20.5) | |
| Head and Neck Cancer | 1 (1.3) | 0 | 1 (2.6) | |
| Leukemia | 1 (1.3) | 0 | 1 (2.6) | |
| Lung Cancer | 2 (2.7) | 0 | 2 (5.1) | |
| Otherb | 3 (4.0) | 0 | 3 (7.7) | |
| Immunotherapy Type, No. (%) | ||||
| Ipilimumab | 45 (60.0) | 21 (58.3) | 24 (61.5) | 0.834 |
| Ipilimumab + Nivolumab | 12 (16.0) | 6 (16.7) | 6 (15.4) | |
| Nivolumab | 4 (5.3) | 1 (2.8) | 3 (7.7) | |
| Pembrolizumab | 13 (17.3) | 7 (19.4) | 6 (15.4) | |
| Tremelimumab | 1 (1.3) | 1 (2.8) | 0 | |
| Symptoms at Onset, No. (%) | ||||
| Diarrhea | 73 (97.3) | 36 (100) | 37 (94.9) | 0.494 |
| Nausea | 21 (28.0) | 8 (22.2) | 13 (33.3) | 0.315 |
| Vomiting | 11 (14.7) | 3 (8.3) | 8 (20.5) | 0.195 |
| Abdominal Cramps | 32 (42.7) | 13 (36.1) | 19 (48.7) | 0.351 |
| Blood in Stool | 22 (29.3) | 14 (38.9) | 8 (20.5) | 0.127 |
| Mucus in Stool | 2 (2.7) | 0 | 2 (5.1) | 0.494 |
| Elevated WBC Counts | 3 (4.0) | 1 (2.8) | 2 (5.1) | 1 |
| Pathology, No. (%) | ||||
| Positive | 37 (49.3) | 20 (55.6) | 17 (43.6) | 0.534 |
| Negative | 6 (8.0) | 2 (5.6) | 4 (10.3) | |
| Not Tested | 32 (42.7) | 14 (38.9) | 18 (46.2) | |
aIncludes renal cell carcinoma, urothelial carcinoma, and prostate cancer
bIncludes anal squamous cell cancer, pancreatic cancer, and glioblastoma
CS corticosteroids, WBC White blood cells