Table 1.
Baseline Characteristics of ICI-Treated Patients Presenting With Diarrhea by CDI Status
| Characteristic | Total Patients n (%) |
CDI-Positive n (%) |
CDI-Negative n (%) |
P Value |
|---|---|---|---|---|
| Total, n | 605 | 111 | 494 | |
| Age, median (IQR), y | 65 (56–72) | 65 (58–73) | 64 (55–72) | .4 |
| Sex | .8 | |||
| Female | 289 (47.8) | 52 (46.8) | 237 (48.0) | |
| Male | 316 (52.2) | 59 (53.1) | 257 (52.0) | |
| Race | .5 | |||
| White | 490 (81.0) | 88 (79.3) | 402 (81.4) | |
| Black | 38 (6.3) | 8 (7.2) | 30 (6.1) | |
| Asian | 43 (7.1) | 6 (5.4) | 37 (7.5) | |
| Othera/Unknown | 34 (5.6) | 9 (8.1) | 25 (5.1) | |
| Ethnicity | .11 | |||
| Non-Hispanic | 552 (91.3) | 97 (87.4) | 455 (92.1) | |
| Hispanic | 37 (6.1) | 8 (7.2) | 29 (5.9) | |
| Unknown | 16 (2.6) | 6 (5.4) | 10 (2.0) | |
| Cancer type | .5 | |||
| Genitourinary | 136 (22.5) | 25 (22.5) | 111 (22.5) | |
| Lung | 64 (10.6) | 15 (13.5) | 49 (9.9) | |
| Gynecologic | 53 (8.8) | 5 (4.5) | 48 (9.7) | |
| Melanoma | 58 (9.6) | 12 (10.8) | 46 (9.3) | |
| Gastrointestinal/Hepatobiliary | 27 (4.5) | 5 (4.5) | 22 (4.5) | |
| Otherb | 267 (44.1) | 49 (44.1) | 218 (44.1) | |
| Antibiotic use <90 d before CDI test | 302 (49.9) | 71 (64.0) | 231 (46.8) | .001 |
| PPI use <90 d before CDI test | 244 (40.3) | 53 (47.8) | 191 (38.7) | .078 |
| Chemotherapy <90 d before CDI test | 318 (52.6) | 58 (52.3) | 260 (52.6) | >.9 |
| Type of ICI | .6 | |||
| PD-(L)1 | 491 (81.2) | 93 (83.8) | 398 (80.6) | |
| CTLA-4 | 14 (2.3) | 3 (2.7) | 11 (2.2) | |
| Combination | 100 (16.5) | 15 (13.5) | 85 (17.2) | |
| Duration of ICI treatment, median (IQR), d | 125 (29–374) | 130 (56–329) | 122 (27–384) | .7 |
| ICI regimen outcome | .2 | |||
| Resumed ICI | 340 (56.2) | 66 (59.5) | 274 (55.5) | |
| Stopped due to irEC | 168 (27.7) | 22 (19.8) | 146 (29.6) | |
| Stopped due to disease progression | 55 (9.1) | 12 (10.8) | 43 (8.7) | |
| Stopped due to other irAEs | 12 (2.0) | 2 (1.8) | 10 (2.0) | |
| Death | 24 (4.0) | 8 (7.2) | 16 (3.2) | |
| Completion of protocol | 6 (1.0) | 1 (0.9) | 5 (1.0) |
Bold indicates statistically significant P value.
Abbreviations: CDI, Clostridioides difficile infection; ICI, immune checkpoint inhibitor; irAE, immune-related adverse event; irEC, immune-related enterocolitis; PPI, proton pump inhibitor.
a
Includes Native American, Native Hawaiian or Pacific Islander, and multiple races.
b
Includes nonmelanoma skin cancer, head and neck/endocrine, hematologic, breast, sarcoma, neuroendocrine, brain/nervous system, and unknown primary.