Table 2. Summary of the immune-related adverse events and drug exposure in the durvalumab and atezolizumab groups.
All-cause IRAEs, treatment-related AEs and AESIs | Durvalumab group (N=100) | Atezolizumab group (N=43) | |||||
---|---|---|---|---|---|---|---|
Any grade | ≥3 grade | P | Any grade | ≥3 grade | P | ||
Any IRAE, n (%) | 23 (23.0) | 10 (10.0) | 0.37 | 7 (16.3) | 1 (2.3) | 0.22 | |
Im pneumonitis, n (%) | 6 (6.0) | 2 (2.0) | 0.61 | 1 (2.3) | 0 | 1.00 | |
Im chest distress, n (%) | 1 (1.0) | 0 | 1.00 | 0 | 0 | 1.00 | |
Im diseases of endocrine system, n (%) | 3 (3.0) | 2 (2.0) | 0.53 | 3 (7.0) | 0 | 0.16 | |
Im hepatitis, n (%) | 5 (5.0) | 4 (4.0) | 0.31 | 0 | 0 | 0.52 | |
Im rash, n (%) | 4 (4.0) | 1 (1.0) | 1.00 | 2 (4.7) | 0 | 1.00 | |
Im esophagitis, n (%) | 1 (1.0) | 0 | 1.00 | 0 | 0 | 0.22 | |
Im peritonitis, n (%) | 1 (1.0) | 0 | 1.00 | 0 | 0 | 0.22 | |
Im enteritis, n (%) | 2 (2.0) | 0 | 1.00 | 1 (2.3) | 0 | 1.00 | |
Im toxicity, n (%) | 2 (2.0) | 0 | 1.00 | 0 | 0 | 1.00 | |
Im damage, n (%) | 2 (2.0) | 0 | 1.00 | 1 (2.3) | 1 (2.3) | 0.36 | |
Im cardiotoxicity, n (%) | 4 (4.0) | 2 (2.0) | 0.36 | 0 | 0 | 1.00 | |
Im fatigue, n (%) | 2 (2.0) | 1 (1.0) | 1.00 | 0 | 0 | 1.00 | |
Number of patients with IRAEs, n (%) | 23 (23.0) | 11 (11.0) | 7 (16.3) | 1 (2.3) | 0.37 | ||
Number of doses received, median [range] | 6.0 [1–23] | 5.0 [1–31] | 0.91 | ||||
Treated with steroids therapy, n (%) | 11 (47.8) | 0 | 0.06 | ||||
Any permanent cessation due to IRAEs, n (%) | 10 (10.0) | 2 (4.7) | 0.79 | ||||
Any IRAE leading to death | 0 | 0 | 1 |
IRAE, immune-related adverse event; AE, adverse event; Im, immune-mediated; AESI, adverse event of special interest.