Table 3.
Adverse events.
| Any grade | Grade ≥3 | |||||
|---|---|---|---|---|---|---|
| CCRT alone (n=58) | CCRT+ICI (n=43) | P | CCRT alone (n=58) | CCRT+ICI (n=43) | P | |
| Hematological events | ||||||
| Leukopenia | 0.039 | 0.990 | ||||
| no | 4 (6.9%) | 10 (23.3%) | 35 (60.3%) | 26 (60.5%) | ||
| yes | 54 (93.1%) | 33 (76.7%) | 23 (39.7%) | 17 (39.5%) | ||
| Neutropenia | 0.213 | 0.843 | ||||
| no | 15 (25.9%) | 17 (39.5%) | 44 (75.9%) | 31 (72.1%) | ||
| yes | 43 (74.1%) | 26 (60.5%) | 14 (24.1%) | 12 (27.9%) | ||
| Anemia | 0.983 | 0.870 | ||||
| no | 8 (13.8%) | 5 (11.6%) | 53 (91.4%) | 38 (88.4%) | ||
| yes | 50 (86.2%) | 38 (88.4%) | 5 (8.6%) | 5 (11.6%) | ||
| Thrombocytopenia | 0.150 | 0.999 | ||||
| no | 34 (58.6%) | 32 (74.4%) | 53 (91.4%) | 40 (93.0%) | ||
| yes | 24 (41.4%) | 11 (25.6%) | 5 (8.6%) | 3 (7.0%) | ||
| Non-hematological events | ||||||
| Liver dysfunction | 0.999 | 0.999 | ||||
| no | 53 (91.4%) | 39 (90.7%) | 57 (98.3%) | 43 (100.0%) | ||
| yes | 5 (8.6%) | 4 (9.3%) | 1 (1.7%) | 0 (0.0%) | ||
| Creatine kinase increased | 0.243 | 0.243 | ||||
| no | 58 (100.0%) | 42 (97.7%) | 58 (100.0%) | 42 (97.7%) | ||
| yes | 0 (0.0%) | 1 (2.3%) | 0 (0.0%) | 1 (2.3%) | ||
| Hypothyroidism | 0.349 | 0.880 | ||||
| no | 58 (100.0%) | 41 (95.3%) | 58 (100.0%) | 42 (97.7%) | ||
| yes | 0 (0.0%) | 2 (4.7%) | 0 (0.0%) | 1 (2.3%) | ||
| Nausea | 0.182 | 0.998 | ||||
| no | 41 (70.7%) | 24 (55.8%) | 57 (98.3%) | 43 (100.0%) | ||
| yes | 17 (29.3%) | 19 (44.2%) | 1 (1.7%) | 0 (0.0%) | ||
| Vomiting | 0.470 | 0.612 | ||||
| no | 47 (81.0%) | 38 (88.4%) | 56 (96.6%) | 43 (100.0%) | ||
| yes | 11 (19.0%) | 5 (11.6%) | 2 (3.4%) | 0 (0.0%) | ||
| Diarrhea | 0.998 | 0.998 | ||||
| no | 57 (98.3%) | 42 (97.7%) | 57 (98.3%) | 43 (100.0%) | ||
| yes | 1 (1.7%) | 1 (2.3%) | 1 (1.7%) | 0 (0.0%) | ||
| Dermatitis | 0.349 | 0.999 | ||||
| no | 58 (100.0%) | 41 (95.3%) | 58 (100.0%) | 43 (100.0%) | ||
| yes | 0 (0.0%) | 2 (4.7%) | 0 (0.0%) | 0 (0.0%) | ||
| Fistula | 0.999 | 0.999 | ||||
| no | 56 (96.6%) | 41 (95.3%) | 56 (96.6%) | 41 (95.3%) | ||
| yes | 2 (3.4%) | 2 (4.7%) | 2 (3.4%) | 2 (4.7%) | ||
| Pneumonitis | 0.008 | 0.421 | ||||
| no | 37 (63.8%) | 15 (34.9%) | 56 (96.6%) | 39 (90.7%) | ||
| yes | 21 (36.2%) | 28 (65.1%) | 2 (3.4%) | 4 (9.3%) | ||
CCRT, concurrent chemoradiotherapy; ICI, immune checkpoint inhibitors.