Table 3.
Patient Characteristics, Comorbid Disease History, Pre-treatment Laboratory Values, Disease and Tumor Characteristics, and Concomitant Medications in the Discovery Cohort
| Colitis | Fisher’s exact P-value | ||
|---|---|---|---|
| No (N=176) | Yes (N=37) | ||
| N (%) | N (%) | ||
| Patient Characteristics | |||
| Male | 102 (58.0) | 22 (59.5) | 0.99 |
| Age < 70 | 117 (66.5) | 21 (56.8) | 0.26* |
| Obese (BMI ≥ 30) | 43 (24.4) | 7 (18.9) | 0.53 |
| Pre-treatment ECOG PS ≥ 1 | 34 (19.3) | 5 (13.5) | 0.49 |
| History of smoking | 80 (45.5) | 18 (48.6) | 0.72 |
| History of alcohol use | 118 (67.0) | 24 (64.9) | 0.85 |
| Influenza immunization within 3 months of treatment | 34 (19.3) | 12 (32.4) | 0.08* |
| Pneumococcal pneumonia immunization within 3 months of treatment | 35 (19.9) | 13 (35.1) | 0.05* |
| Influenza OR pneumonia immunization within 3 months of treatment | 50 (28.4) | 17 (45.9) | 0.05* |
| Comorbid Diseases | |||
| Infection in previous 6 months | 13 (7.4) | 3 (8.1) | 0.99 |
| Autoimmune disease | 12 (6.8) | 2 (5.4) | 0.99 |
| Asthma | 17 (9.7) | 2 (5.4) | 0.54 |
| Seasonal allergies | 20 (11.4) | 4 (10.8) | 0.99 |
| Asthma OR seasonal allergies | 32 (18.2) | 6 (16.2) | 0.99 |
| Pre-treatment Laboratory Values | |||
| Albumin ≤ 4.2 | 96 (54.5) | 22 (59.5) | 0.72 |
| Normal LDH (110 – 220 U/L) | 110 (62.5) | 26 (70.3) | 0.45 |
| Neutrophil-to-lymphocyte ratio (NLR) ≥ 5 | 55 (31.3)a | 6 (16.2) | 0.16* |
| NLR ≥ 3 | 107 (60.8) | 18 (48.6) | 0.34 |
| Absolute eosinophil count > 400 /uL | 29 (16.5)b | 5 (13.5) | 0.81 |
| Cancer - Disease and Treatment Characteristics | |||
| Prior chemotherapy | 34 (19.3) | 7 (18.9) | 0.99 |
| Prior targeted therapy | 37 (21.0) | 5 (13.5) | 0.37 |
| Prior chemotherapy or targeted therapy within previous 6 months | 10 (5.7) | 0 (0) | 0.22* |
| Prior radiation therapy in the previous 6 months | 44 (25.0) | 12 (32.4) | 0.41 |
| c-KIT mutation | 5 (2.8) | 1 (2.7) | 0.99 |
| BRAF mutation | 49 (27.8) | 9 (24.3) | 0.84 |
| NRAS mutation | 26 (14.8) | 4 (10.8) | 0.79 |
| c-KIT, BRAF, or NRAS mutation | 77 (43.8) | 14 (37.8) | 0.59 |
| Number of metastatic sites >1 | 174 (98.9) | 37 (100) | 0.99 |
| Number of metastatic sites >3 | 85 (48.3) | 21 (56.8) | 0.37 |
| Concomitant Medications | |||
| Angiotensin-converting enzyme inhibitor (ACEi) | 29 (16.5) | 7 (18.9) | 0.81 |
| ACEi OR Angiotensin II receptor blocker (ARB) | 41 (23.3) | 10 (27.0) | 0.67 |
| Aspirin | 29 (16.5) | 8 (21.6) | 0.48 |
| Aspirin OR nonsteroidal anti inflammatory (NSAID) | 38 (21.6) | 11 (29.7) | 0.29* |
| Proton-pump inhibitor (PPI) | 42 (23.9) | 6 (16.2) | 0.39 |
| Statin | 39 (22.2) | 10 (27.0) | 0.52 |
| Vitamin D supplementation | 60 (34.1) | 6 (16.2) | 0.03* |
This table summarizes the characteristics of 213 patients based upon those who developed ICI colitis vs. those who did not develop colitis.
*
P < 0.30, which met inclusion for consideration in the multivariable model
a
Missing NLR values from 1 colitis and 7 non-colitis patients
b
Missing eosinophil count from 1 colitis and 3 non-colitis patients