Table 3.
Immune-related adverse events (irAEs) and surgical-related adverse events (srAEs).
| nIT and surgery group (n=29) | nIT and W&W group (n=3) | |||
|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 1 | Grade 2 | |
| irAEs during the neoadjuvant phase | ||||
| Obstruction | 1 | 1 | 0 | 0 |
| Hyperthyroidism | 1 | 0 | 0 | 0 |
| Nausea | 1 | 0 | 0 | 0 |
| Fatigue | 1 | 0 | 1 | 0 |
| Aminotransferase increased | 1 | 0 | 0 | 0 |
| Abdominal pain | 1 | 0 | 0 | 0 |
| Pruritus or rash | 0 | 1 | 0 | 0 |
| Decreased appetite | 1 | 0 | 0 | 0 |
| Arthralgia or myalgia | 1 | 0 | 0 | 0 |
| Fever | 0 | 0 | 1 | 0 |
| Total | 8/32 (25%) | 2/32 (6.25%) | 2/32(6.25%) | 0 |
| srAEs | ||||
| Incision infection | 0 | 1 | ||
| Intraoperative haemorrhage | 1 | 0 | ||
| Postoperative haemorrhage | 1 | 0 | ||
| Total | 2/29 (6.9%) | 1/29 (3.4%) | ||
| Surgery and adjuvant immunotherapy group (n=22) | ||||
| irAEs during the adjuvant phase | ||||
| Dry mouth | 1 | 0 | ||
| Dizziness | 1 | 0 | ||
| Nausea | 1 | 0 | ||
| Somnipathy | 1 | 0 | ||
| Decreased appetite | 1 | 0 | ||
| Pruritus or rash | 1 | 0 | ||
| Total | 6/22 (27.3%) | 0 | ||
nIT, Neoadjuvant immunotherapy; W&W, Watch-and-wait; irAEs, Immune-related adverse events; srAEs, Surgical-related adverse events.
one LARC patient who received nIT in this study was both dMMR and MSS, so the patient was not included in the baseline analysis. Seven patients with LACRC who achieved pCR after nIT and surgery did not receive postoperative adjuvant immunotherapy.