Table 3.
Treatment-related adverse events
Treatment-related1 | Grade 1-2 | Grade 3 | Grade 4 |
---|---|---|---|
Any | 22 (100) | 15 (68.2) | 1 (4.5) |
Led to dose reduction2 | 1 (4.5) | 12 (54.5) | 1 (4.5) |
Led to discontinuation3 | 1 (4.5) | 1 (4.5) | 0 |
Adverse events | |||
Anemia | 19 (86.4) | 3 (13.6) | 0 |
Thrombocytopenia | 4 (18.2) | 3 (13.6) | 0 |
Neutropenia | 2 (9.1) | 2 (9.1) | 1 (4.5) |
Leukopenia | 9 (40.9) | 1 (4.5) | 0 |
AST elevation | 1 (4.5) | 1 (4.5) | 0 |
ALT elevation | 1 (4.5) | 1 (4.5) | 0 |
Total bilirubin elevation | 1 (4.5) | 0 | 0 |
Blood cholesterol elevation | 14 (63.6) | 0 | 0 |
Blood triglyceride elevation | 17 (77.3) | 0 | 0 |
Serum creatinine elevation | 1 (4.5) | 0 | 0 |
Creatine phosphokinase elevation | 1 (4.5) | 0 | 0 |
Hyperglycemia | 9 (40.9) | 0 | 0 |
Hair loss | 8 (36.4) | 0 | 0 |
Weight loss | 2 (9.1) | 0 | 0 |
Mucositis | 9 (40.9) | 7 (31.8) | 0 |
Nausea | 19 (86.4) | 1 (4.5) | 0 |
Vomit | 14 (63.6) | 1 (4.5) | 0 |
Diarrhea | 5 (22.7) | 2 (9.1) | 0 |
Fatigue | 20 (90.9) | 0 | 0 |
Dizziness | 3 (13.6) | 0 | 0 |
Peripheral neuropathy | 2 (9.1) | 0 | 0 |
Toxic effects specific to radiotherapy | |||
Neck skin reaction | 16 (72.7) | 0 | 0 |
Pharyngitis | 10 (45.5) | 0 | 0 |
Dry mouth | 16 (72.7) | 0 | 0 |
Deafness | 10 (45.5) | 1 (4.5) | 0 |
Nasopharyngeal necrosis | 1 (4.5) | 0 | 0 |
Trismus | 9 (40.9) | 0 | 0 |
Immune-related adverse events | |||
Pneumonia | 1 (4.5) | 0 | 0 |
Hypothyroidism | 0 | 0 | 0 |
Pruritus | 7 (31.8) | 1 (4.5) | 0 |
Rash | 1 (4.5) | 1 (4.5) | 0 |
Capillary hyperplasia | 2 (9.1) | 0 | 0 |
Note: data are n (%), unless otherwise noted.
Abbreviations are as follows: AST, aspartate transaminase; ALT, alanine transaminase.
Treatment-related adverse events occurred in at least one patient. No patients had serious treatment-related adverse events.
Dose reduction of cisplatin and 5-fluorouracil.
Discontinuation of toripalimab.