Table 5.
Treatment-emergent adverse events occurred during the neoadjuvant treatment process in all patients (n=57) and surgery-related adverse events occurred within 90 days after surgery in patients who underwent surgical resection (n=48).
|
Treatment-emergent adverse events |
All n=57 (%) |
Chemotherapy n=17 (%) |
Immunotherapy n=30 (%) |
Targeted therapy n=10 (%) |
||||
|---|---|---|---|---|---|---|---|---|
| Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grade ≥3 | |
| Number of patients (%) | ||||||||
| Any event | 37 (64.9) | 11 (19.3) | 10 (58.8) | 5 (29.4) | 21 (70.0) | 5 (16.7) | 6 (60.0) | 1 (10.0) |
| Event leading to discontinuation of treatment | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| SAE | 6 (10.5) | 4 (7.0) | 2 (11.8) | 1 (5.9) | 3 (10.0) | 2 (6.7) | 1 (10.0) | 1 (10.0) |
| Any TRAE | 30 (52.6) | 11 (19.3) | 10 (58.8) | 5 (29.4) | 16 (53.3) | 5 (16.7) | 4 (40.0) | 1 (10.0) |
| Treatment-related SAE | 6 (10.5) | 4 (7.0) | 2 (11.8) | 1 (5.9) | 3 (10.0) | 2 (6.7) | 1 (10.0) | 1 (10.0) |
| Event occurring in more than 1 patient | ||||||||
| Myelosuppression | 23 (40.4) | 9 (15.8) | 7 (41.2) | 5 (29.4) | 13 (43.3) | 3 (10) | 3 (30.0) | 1 (10.0) |
| Liver dysfunction | 8 (14) | 0 (0) | 3 (17.6) | 0 (0) | 3 (10) | 0 (0) | 2 (20.0) | 0 (0) |
| Rash | 5 (8.8) | 1 (1.8) | 1 (5.9) | 1 (5.9) | 2 (6.7) | 0 (0) | 2 (20.0) | 0 (0) |
| Vomiting | 4 (7) | 2 (3.5) | 1 (5.9) | 0 (0) | 2 (6.7) | 1 (3.3) | 1 (10.0) | 1 (10.0) |
| Anemia | 4 (7) | 0 (0) | 3 (17.6) | 0 (0) | 1 (3.3) | 0 (0) | 0 (0) | 0 (0) |
| Diarrhea | 3 (5.3) | 1 (1.8) | 1 (5.9) | 1 (5.9) | 2 (6.7) | 0 (0) | (0) | (0) |
| leucopenia | 2 (3.5) | 1 (1.8) | 1 (5.9) | 0 (0) | 1 (3.3) | 1 (3.3) a | 0 (0) | 0 (0) |
| Pain | 2 (3.5) | 0 (0) | 0 (0) | 0 (0) | 2 (6.7) | 0 (0) | 0 (0) | 0 (0) |
| Nausea | 2 (3.5) | 0 (0) | 0 (0) | 0 (0) | 1 (3.3) | 0 (0) | 1 (10.0) | 0 (0) |
| Decreased appetite | 2 (3.5) | 0 (0) | 0 (0) | 0 (0) | 2 (6.7) | 0 (0) | 0 (0) | 0 (0) |
| Fatigue | 2 (3.5) | 0 (0) | 0 (0) | 0 (0) | 2 (6.7) | 0 (0) | 0 (0) | 0 (0) |
| Radiation Pneumonitis | 2 (3.5) | 0 (0) | 0 (0) | 0 (0) | 1 (3.3) | 0 (0) | 1 (10) | 0 (0) |
| Peripheral neuropathy | 2 (3.5) | 0 (0) | 1 (5.9) | 0 (0) | 1 (3.3) | 0 (0) | 0 (0) | 0 (0) |
| Oral ulceration | 2 (3.5) | 0 (0) | 0 (0) | 0 (0) | 1 (3.3) | 0 (0) | 1 (10) | 0 (0) |
| Paronychia | 2 (3.5) | 0 (0) | 0 (0) | 0 (0) | 1 (3.3) | 0 (0) | 1 (10) | 0 (0) |
| Immune-related pneumonitis | 1 (1.8) | 0 (0) | 0 (0) | 0 (0) | 1 (3.3) | 0 (0) | 0 (0) | 0 (0) |
| Surgery-related adverse events | n=48 (%) | n=13 (%) | n=26 (%) | n=9 (%) | ||||
| Surgery-related SAE | 2 (4.2) | 1 (2.1) | 1 (7.7) | 1 (7.7) | 1 (3.8) | 0 (0) | 0 (0) | 0 (0) |
| Any surgery-related adverse events | 25 (52.1) | 1 (2.1) | 8 (61.5) | 1 (7.7) | 14 (53.8) | 0 (0) | 3 (33.3) | 0 (0) |
| Hydropneumothorax | 15 (31.3) | 0 (0) | 4 (30.8) | 0 (0) | 10 (38.5) | 0 (0) | 1 (11.1) | 0 (0) |
| Subcutaneous emphysema | 14 (29.2) | 0 (0) | 4 (30.8) | 0 (0) | 8 (30.8) | 0 (0) | 2 (22.2) | 0 (0) |
| Pleural effusion | 5 (10.4) | 0 (0) | 2 (15.4) | 0 (0) | 3 (11.5) | 0 (0) | 0 (0) | 0 (0) |
| Compressive atelectasis | 2 (4.2) | 0 (0) | 1 (7.7) | 0 (0) | 1 (3.8) | 0 (0) | 0 (0) | 0 (0) |
| Pneumothorax | 1 (2.1) | 0 (0) | 0 (0) | 0 (0) | 1 (3.8) | 0 (0) | 0 (0) | 0 (0) |
| Anemia | 1 (2.1) | 0 (0) | 1 (7.7) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Pericardial effusion | 1 (2.1) | 0 (0) | 0 (0) | 0 (0) | 1 (3.8) | 0 (0) | 0 (0) | 0 (0) |
| Sinus tachycardia | 1 (2.1) | 0 (0) | 0 (0) | 0 (0) | 1 (3.8) | 0 (0) | 0 (0) | 0 (0) |
| Pain | 1 (2.1) | 0 (0) | 0 (0) | 0 (0) | 1 (3.8) | 0 (0) | 0 (0) | 0 (0) |
| Infection | 1 (2.1) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (11.1) | 0 (0) |
| Dyspnea | 0 (0) | 1 (2.1) | 0 (0) | 1 (7.7) a | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Chyle leak | 1 (2.1) | 0 (0) | 0 (0) | 0 (0) | 1 (3.8) b | 0 (0) | 0 (0) | 0 (0) |
TRAE, treatment-related adverse events; SAE, serious adverse event.
This patient experienced sudden chest tightness and dyspnea on the second day after he was out of the ICU post-surgery, prompting immediate transfer back to the ICU with suspected pulmonary embolism. After spending another three days in the ICU with intermittent non-invasive ventilation, the patient’s general condition gradually improved and he was scheduled to be discharged the following week. However, he eventually died within two weeks after surgery at home and no further information could be obtained.
This patient was diagnosed with chyle leak two days after surgery, and received appropriate treatment. As a result, his length of stay was prolonged.