All Cycles Name | NC/NA, % | Grade 1, % | Grade 2, % | Grade 3, % | Grade 4, % | Grade 5, % | All grades, % |
---|---|---|---|---|---|---|---|
Skin and subcutaneous tissue disorders | 11 | 79 | 11 | 0 | 0 | 0 | 89 |
Lung infection | 89 | 5 | 5 | 0 | 0 | 0 | 11 |
Pneumonitis | 89 | 0 | 5 | 5 | 0 | 0 | 11 |
Esophagitis | 53 | 32 | 16 | 0 | 0 | 0 | 47 |
Laryngitis | 95 | 0 | 0 | 5 | 0 | 0 | 5 |
Constipation | 74 | 16 | 11 | 0 | 0 | 0 | 26 |
Blurred vision | 89 | 11 | 0 | 0 | 0 | 0 | 11 |
Proteinuria | 63 | 37 | 0 | 0 | 0 | 0 | 37 |
Blood and lymphatic system disorders ‐ Leukopenia | 68 | 16 | 11 | 5 | 0 | 0 | 32 |
Blood and lymphatic system disorders ‐ Neutrophilic granulopenia | 68 | 0 | 32 | 0 | 0 | 0 | 32 |
Blood and lymphatic system disorders ‐ Lymphopenia | 53 | 0 | 11 | 32 | 5 | 0 | 47 |
Anemia | 95 | 5 | 0 | 0 | 0 | 0 | 5 |
Alanine aminotransferase increased | 89 | 11 | 0 | 0 | 0 | 0 | 11 |
Hyperglycemia | 74 | 26 | 0 | 0 | 0 | 0 | 26 |
Fatigue | 95 | 0 | 5 | 0 | 0 | 0 | 5 |
Cough | 95 | 0 | 0 | 5 | 0 | 0 | 5 |
Respiratory, thoracic and mediastinal disorders | 84 | 16 | 0 | 0 | 0 | 0 | 16 |
Hypothyroidism | 84 | 16 | 0 | 0 | 0 | 0 | 16 |
Treatment‐related adverse events occurring in all cycles.
All patients experienced some form of treatment‐related AEs (Table 2), but most were grade 1–2, and no grade 5 events were reported. The most common type of toxicity was cutaneous capillary hemangioma (15 [79%] with grade 1 and 2 [10%] with grade 3), which was the immune‐related AE; all cases were managed with local therapy or observation. Nine patients (47%) experienced grade 3 adverse events: six with lymphopenia (which was not treated), one with radiation pneumonitis, one with radiation laryngitis (treated with dexamethasone), and one with leukopenia (treated with granulocyte‐macrophage colony‐stimulating factor). The patient with radiation laryngitis had cervical esophageal cancer. One patient (5%) experienced grade 4 lymphopenia, which was not treated. Three patients experienced grade 1 hypothyroidism. Other organ‐specific immune‐related AEs, such as thyroiditis, stomatitis, and colitis, were not found.
Abbreviation: NC/NA, no change from baseline/no adverse event.