Table 2.
Severity, onset, and management of immune-related adverse events in stage IV non-small-cell lung cancer patients.
IrAE grade and impact on ICI administration | Steroid treatment | ||||||||
---|---|---|---|---|---|---|---|---|---|
Any grade, % (n) of all patients | Time to onset(days) | G≥3, % (n) of each organ | ICI suspension, % (n) of each organ | ICI termination, % (n) of each organ | Steroids,% (n) of each organ | Initial daily dose, 1 mean (SD) | Average daily dose, 1 mean (SD) | Duration, days (SD) | |
Affected organ | |||||||||
Endocrine | 4.9 (44***) | 132 | 27 (12) | 43 (19) | 16 (7) | 27 (12) | 18 (33) | 12 (26) | 31 (107) |
Lungs | 4.4 (40***) | 105 | 73 (29***) | 95 (38***) | 80 (32***) | 93 (37***) | 75 (41)*** | 53 (60)*** | 41 (36) |
Musculoskeletal | 4.3 (38***) | 246* | 21 (8) | 58 (22) | 47 (18) | 74 (28***) | 33 (52) | 20 (36) | 128 (202)*** |
Colon | 4.1 (37***) | 168 | 62 (23*) | 84 (31***) | 65 (24***) | 81 (30***) | 62 (44)* | 40 (34)* | 44 (42) |
Liver | 3.7 (33**) | 67 | 73 (24**) | 94 (31***) | 82 (27***) | 82 (27***) | 87 (92)*** | 47 (37)*** | 33 (27) |
Skin | 2.6 (23) | 182 | 17 (5) | 52(12) | 35 (8) | 35 (8) | 21 (36) | 9 (15) | 23 (55) |
Nervous system | 0.7 (6) | 52 | 67 (4) | 100 (6) | 67(4) | 67 (4) | 111 (196)* | 35 (39) | 21 (23) |
Heart | 0.4 (4) | 75 | 100 (4) | 100(4) | 75 (3) | 50 (2) | 135 (244)** | 36 (45) | 39 (61) |
Kidney | 0.3 (3) | 669*** | 67 (2) | 100 (3) | 100 (3) | 100 (3) | 67 (29) | 42 (12) | 86 (97) |
Pancreas | 0.3 (3) | 311 | 67 (2) | 67 (2) | 67 (2) | 67 (2) | 52 (50) | 23 (21) | 53 (65) |
Blood | 0.1 (1) | 838 | 100 (1) | 100 (1) | 100 (1) | 100 (1) | 100 (n/a) | 57 (na) | 20 (na) |
p-value | <0.001 | <0.001 | <0.001 | 0.003 | <0.001 | <0.001 | <0.001 | <0.001 | 0.002 |
IrAEs of various organs are listed in order of decreasing frequency according to Figure 2C (n = 894 stage IV patients). Statistical comparisons to detect increased values across organs were performed using either a chi-square test against the even distribution (frequency of irAEs with any grade or grade ≥3, rates of ICI suspension (that is interruption or termination), or termination, rate of steroid treatment, or one-way ANOVA (time to onset, dose and duration of steroids), followed by the Dunnett’s post-hoc test with endocrine irAE as reference. Statistically significant results are highlighted in bold.
G, grade 3; irAE, immune related adverse events; ICI, immunotherapy; SD, standard deviation; n/a, not applicable; ***p < 0.001; **p < 0.01; *p < 0.05.
1in mg prednisone.