TABLE 2.
Summary of Immune‐Related Adverse Events
| Variable | Total, N = 92 | Fit Patients, n = 66 | Frail Patients, n = 26 | P |
|---|---|---|---|---|
| No. of grade ≥3 irAEs (%) | 18 (20.0) | 11 (17.0) | 7 (27.0) | .26 |
| Clinically relevant irAE, n (%) | 39 (42.0) | 24 (36.0) | 15 (58.0) | .06 |
| Requiring immunosuppressants | 8 (9.0) | 5 (8.0) | 3 (12.0) | |
| Discontinuation ICI | 8 (9.0) | 5 (8.0) | 3 (12.0) | |
| Both | 23 (25.0) | 14 (21.0) | 9 (35.0) | |
| Type of clinically relevant irAE: No. (%) | ||||
| Hepatitis | 5 (7.0) | 3 (6.0) | 2 (8.0) | |
| Nephritis | 3 (4.0) | 0 (0.0) | 3 (13.0) | |
| Colitis | 5 (7.0) | 3 (6.0) | 2 (8.0) | |
| Pneumonitis | 7 (9.0) | 4 (8.0) | 3 (13.0) | |
| Cholangitis | 2 (3.0) | 1 (2.0) | 1 (4.0) | |
| Dermatitis | 1 (1.0) | 0 (0.0) | 1 (4.0) | |
| Arthralgia/myalgia | 8 (10.0) | 7 (13.0) | 1 (4.0) | |
| Hypophysitis | 2 (3.0) | 2 (4.0) | 0 (0.0) | |
| Diabetes mellitus | 1 (1.0) | 0 (0.0) | 1 (4.0) | |
| Neurologic toxicity | 3 (4.0) | 3 (6.0) | 0 (0.0) | |
| No. of ICI discontinuations (%) | 68 (74.0) | 48 (73.0) | 20 (77.0) | .68 |
| Due to toxicity | 32 (35.0) | 21 (32.0) | 11 (42.0) | .34 |
| Due to progression | 24 (26.0) | 19 (29.0) | 5 (19.0) | .35 |
| Due to ongoing response | 36 (39.0) | 26 (39.0) | 10 (39.0) | .93 |
| Duration of steroid use: Median [95% CI], wk | 41 [33‐49] | 40 [31‐50] | 37 [29‐45] | .56 |
| No. of emergency department visits (%) | 34 (37.0) | 21 (32.0) | 13 (50.0) | .10 |
| No. of emergency department visits: Median/min‐max | 0/0‐5 | 0/0‐5 | 0.5/0‐5 | .13 |
| No. of hospital admissions (%) | 35 (36.0) | 19 (29.0) | 14 (54.0) | .02 |
| Due to toxicity | 21 (23.0) | 10 (15.0) | 11 (42.0) | <.01 |
| No. of hospitalizations: Median/min‐max | 0/0‐3 | 0/0‐3 | 1/0‐2 | .02 |
| Duration of hospitalization: Median/min‐max, d | 6/2‐38 | 5/2‐30 | 8/4‐38 | .06 |
| Time to grade ≥3 irAEs: Median [95% CI], mo | 4.0 [1.1‐6.9] | 2.0 [0.0‐5.1] | 5.0 [1.6‐8.4] | .97 |
| Time to clinically relevant irAE: Median [95% CI], mo | 4.0 [3.2‐4.8] | 4.0 [2.5‐5.5] | 4.0 [2.6‐5.4] | .73 |
Abbreviations: CI, confidence interval; G8, Geriatric 8; ICI, immune checkpoint inhibitor; irAEs, immune‐related adverse events; max, maximum; min, minimum.