Table 1.
Patient characteristics according to cirAE-related ICI therapy status.
| Characteristic | Overall (n=112) | With cirAE (n=36) | Without cirAE (n=76) | P value |
|---|---|---|---|---|
| Age, mean (SD), year | 65.0 (10.3) | 66.8 (10.3) | 64.2 (10.2) | 0.202 |
| <65 | 57 (50.9) | 14 (38.9) | 43 (56.6) | 0.120 |
| 65-75 | 39 (34.8) | 14 (38.9) | 25 (32.9) | |
| >75 | 16 (14.3) | 8 (22.2) | 8 (10.5) | |
| Sex | ||||
| Male | 67 (59.8) | 22 (61.1) | 45 (59.2) | 1.000 |
| Female | 45 (40.2) | 14 (38.9) | 31 (40.8) | |
| Cancer type | ||||
| Lung | 63 (56.3) | 17 (47.2) | 46 (60.5) | 0.564 |
| Liver | 22 (19.6) | 9 (25.0) | 13 (17.1) | |
| Melanoma | 11 (9.8) | 4 (11.1) | 7 (9.2) | |
| Other† | 16 (14.3) | 6 (16.7) | 10 (13.2) | |
| Cancer stage‡ | ||||
| II/III | 31 (27.9) | 11 (30.6) | 20 (26.7) | 0.659 |
| IV | 80 (72.1) | 25 (69.4) | 55 (73.3) | |
| ECOG performance scale‡ | ||||
| 0 | 17 (15.2) | 4 (11.1) | 13 (17.1) | 0.069 |
| 1 | 82 (73.2) | 31 (86.1) | 51 (67.1) | |
| 2 | 13 (11.6) | 1 (2.8) | 12 (15.8) | |
| Pre-ICI therapy‡ | ||||
| Traditional chemotherapy | 56 (50.5) | 15 (41.7) | 41 (54.7) | 0.465 |
| Radiotherapy | 5 (4.5) | 1 (2.8) | 4 (5.3) | |
| Targeted agent | 23 (20.7) | 9 (25.0) | 14 (18.7) | |
| Concurrent chemoradiation therapy | 5 (4.5) | 2 (5.6) | 3 (4.0) | |
| Traditional chemotherapy plus radiotherapy | 6 (5.4) | 1 (2.8) | 5 (6.7) | |
| None | 16 (14.4) | 8 (22.2) | 8 (10.7) | |
| ICI precipitating first cirAE | ||||
| Anti-PD-1 | 63 (56.2) | 21 (58.3) | 42 (55.2) | 0.833 |
| Anti-PD-L1 | 44 (39.3) | 13 (36.1) | 31 (40.8) | |
| Anti-CTLA-4 or anti-CTLA-4 plus anti-PD-1/PD-L1 | 5 (4.5) | 2 (5.6) | 3 (4.0) | |
| Comorbid conditions | ||||
| Hypertension | 39 (34.8) | 16 (44.4) | 23 (30.3) | 0.202 |
| Diabetes mellitus | 18 (16.1) | 9 (25.0) | 9 (11.8) | 0.099 |
| Coronary artery disease | 3 (2.7) | 2 (5.6) | 1 (1.3) | 0.241 |
| Chronic kidney disease | 4 (3.6) | 4 (11.1) | 0 (0.0) | 0.009 |
| Chronic pulmonary disease | 7 (6.2) | 1 (2.8) | 6 (7.9) | 0.426 |
| Cirrhosis | 13 (11.6) | 4 (11.1) | 9 (11.8) | 1.000 |
| Charlson comorbidity index, median (IQR) | 8 (7-9) | 8 (8-9.5) | 8 (7-9) | 0.260 |
| Multimorbidity (excluded cancer) | 23 (20.5) | 10 (27.8) | 13 (17.1) | 0.216 |
| History of drug allergy | 21 (18.8) | 6 (16.7) | 15 (19.7) | 0.799 |
| Laboratory variables | ||||
| Hemoglobin, g/dL | 11.5 (1.9) | 11.6 (2.0) | 11.5 (1.9) | 0.842 |
| White blood cells count x 103, µ/L, median (IQR) | 6.8 (5.4-8.8) | 7.0 (5.3-8.8) | 6.7 (5.4-8.8) | 0.728 |
| Platelet count x 103, µ/L, median (IQR) | 255 (195-344) | 235 (190-351) | 264 (200-338) | 0.691 |
| Neutrophil-to-lymphocyte ratio, median (IQR) | 2.7 (1.9-5.1) | 2.2 (1.7-3.5) | 3.0 (2.0-5.3) | 0.069 |
| Platelet-to-lymphocyte ratio, median (IQR) | 162.8 (118.4-231.7) |
154.8 (95.8-231.8) |
169.9 (122.9-231.7) |
0.320 |
| Serum albumin, g/dL | 3.8 (0.6) | 3.8 (0.6) | 3.8 (0.6) | 0.799 |
| Total protein, g/dL | 7.6 (1.0) | 7.7 (1.0) | 7.5 (0.7) | 0.158 |
| Globulin, g/dL | 3.7 (0.8) | 3.8 (0.9) | 3.6 (0.7) | 0.191 |
| Albumin-to-globulin ratio | 1.1 (0.3) | 1.1 (0.3) | 1.1 (0.3) | 0.546 |
| Aspartate aminotransferase, U/L, median (IQR) | 19 (14-32) | 19 (13-51.5) | 19 (14-27) | 0.344 |
| Alanine transaminase, U/L, median (IQR) | 23 (19-36) | 26 (18.5-46) | 23 (19-31) | 0.728 |
| Alkaline phosphatase, U/L, median (IQR) | 91 (71-122) | 101.5 (71-120) | 86 (70-130) | 0.794 |
| Data collection | ||||
| Prospective cohort | 48 (42.9) | 21 (58.3) | 27 (35.5) | 0.026 |
| Retrospective cohort | 64 (57.1) | 15 (41.7) | 49 (64.5) | |
Values are numbers with percentages in parentheses or expressed as mean (SD), unless otherwise indicated.
†Other cancer types included head and neck, genitourinary (renal, urothelial), bladder cancer, colorectal carcinoma, cervical cancer, and gastric cancer.
‡Missing data for one patient.
cirAEs, cutaneous immune-related adverse events; CTLA-4, cytotoxic T-lymphocyte antigen-4; ECOG, Eastern Cooperative Oncology Group; ICI, immune checkpoint inhibitor; IQR, interquartile range; PD-1, programmed cell death-1; PD-L1, programmed cell death-1-ligand 1.