Table 1.
Demographic and treatment characteristics
| Covariate | All patients | Patients without irAEs G ≥ 2 | Patients with irAES G ≥ 2 | Healthy Controls | p-value* |
|---|---|---|---|---|---|
| Total | 114 | 77 | 37 | 14 | |
| Median Age | 61 (21–81) | 59 (21–81) | 65 (24–81) | 31 (18–58) | 0.070 |
| Sex | |||||
| Male | 58 (51) | 34 (44) | 24 (65) | 5 (36) | 0.017 |
| Female | 56 (49) | 43 (56) | 13 (35) | 9 (64) | |
| History of prior autoimmune disease | |||||
| Yes | 8 (7) | 5 (6) | 3 (8) | NA | 0.90 |
| No | 106 (93) | 72 (94) | 34 (92) | NA | |
| Type of immunotherapy | |||||
| Anti-PD1 | 102 (89) | 74 (96) | 28 (76) | NA | |
| Anti-PD1 + Anti-CTLA4 | 12 (11) | 3 (4) | 9 (24) | NA | |
| Tumor type | 0.022 | ||||
| HNSCC | 33 (29) | 20 (26) | 13 (35) | NA | |
| Melanoma | 25 (22) | 9 (12) | 16 (43) | NA | |
| TNBC | 22 (19) | 21 (27) | 1 (3) | NA | |
| Others | 34 (30) | 27 (35) | 7 (19) | NA | |
| N of prior lines | 0.012 | ||||
| 0 | 33 (29) | 13 (17) | 19 (51) | NA | |
| 1 | 38 (33) | 26 (34) | 14 (38) | NA | |
| 2 | 25 (22) | 20 (26) | 4 (11) | NA | |
| ≥ 3 | 18 (16) | 18 (24) | 0 (0) | NA | |
| Prior Immunotherapy | 0.42 | ||||
| No | 109 (96) | 74 (96) | 34 (92) | NA | |
| Yes | 5 (4) | 3 (4) | 3 (8) | NA | |
| Study | 0.039 | ||||
| INSPIRE | 84 (74) | 65 (84) | 19 (51) | NA | |
| MET4 | 30 (26) | 12 (16) | 18 (49) | NA | |
HNSCC head and neck squamous cell cancer, irAEs immune-related adverse events, NA not applicable, TNBC triple negative breast cancer
*P-values from Cochran-Mantel–Haenszel test stratified by monotherapy (anti-PD1 alone) vs. combination therapy (anti-PD1 + anti-CTLA4) for categorical characteristics, and from logistic regression models adjusting for mono vs. combination therapy for continuous characteristics