Table 2.
Detailed clinical information for patients with or without irAE and irAE events by the organ affected. n/a = not applicable. Bold/italics represent statistically significant findings (p < 0.005).
| Total | Mild irAE (Grade 1–2) |
Severe irAE (Grade 3–5) |
Time to iRAE (months) | Treated with Steroids | Pembrolizumab Discontinued Secondary to irAE | Progression-Free Survival | Overall Survival | |
|---|---|---|---|---|---|---|---|---|
| n (%) | n (%) | n (%) | Median (IQR) | n (%) | n (%) | HR (95% CI) p |
HR (95% CI) p |
|
| Patients | ||||||||
| Without irAE | 179 (68) | n/a | n/a | n/a | n/a | n/a | ref | ref |
| With irAE | 83 (32) | 52 (63) | 31 (37) | 3.4 (1.4–7.4) |
53 (65) | 42 (51) |
0.41 (0.30–0.56)
<0.001 |
0.36 (0.26–0.50)
<0.001 |
| irAE Events | ||||||||
| All | 102 | 70 (69) | 32 (31) | 3.5 (2.0–7.5) |
58 (57) | 44 (43) | n/a | n/a |
| Dermatological | 19 (19) | 13 (68) | 6 (19) | 3.0 (1.4–7.9) |
9 (47) | 7 (37) |
0.37 (0.20–0.69)
0.002 |
0.35 (0.19–0.67)
0.001 |
| Endocrine | 33 (32) | ≥28 (≥85) | ≤5 (≤15) | 3.4 (2.0–12.3) |
≤5 (≤15) | ≤5 (≤15) |
0.36 (0.23–0.57)
<0.001 |
0.30 (0.18–0.49)
<0.001 |
| Gastrointestinal | 13 (13) | ≤5 (≤38) | ≥8 (≥62) | 7.3 (5.7–12.3) |
13 (100) | 11 (85) |
0.23 (0.10–0.52)
<0.001 |
0.21 (0.09–0.52)
0.001 |
| Hepatic | 11 (11) | ≤5 (≤45) | ≥6 (≥55) | 3.4 (1.2–6.7) |
8 (73) | 8 (73) |
0.34 (0.15–0.78)
0.011 |
0.27 (0.11–0.67)
0.005 |
| Musculoskeletal | 8 (8) | 8 (100) | 0 (0) | 2.3 (1.9–5.0) |
8 (100) | ≤5 (≤63) |
0.42 (0.19–0.96)
0.039 |
0.49 (0.22–1.11)
0.088 |
| Pulmonary | 10 (10) | ≤5 (≤50 | ≥5 (≥50) | 2.3 (0.3–5.0) |
10 (100) | 9 (90) |
1.12 (0.57–2.18)
0.752 |
1.33 (0.68–2.61)
0.408 |
| Other (Cardiac, Neurological, Renal) | 8 (8) | 8 (100) | 0 (0) | 4.1 (1.7–6.6) |
6 (75) | 6 (75) | n/a | n/a |