Table 2.
ICI-Related Safety Reports of Eye Disorders |
Anti-CTLA-4 Monotherapy (N = 121) |
Anti-PD-1/PD-L1 Monotherapy (N = 411) |
Combination of Anti-PD-1 and Anti-CTLA-4 (N = 65) |
≥2 Suspected ICIs but Regimen Not Definable * (N = 37) |
---|---|---|---|---|
Median age (IQR), years | 52 (46–58) | 55 (48–60) | 54 (47–59) | 56 (52–60) |
Patient sex | ||||
Male | 65 (53.7) | 210 (51.1) | 35 (53.8) | 21 (56.8) |
Female | 55 (45.5) | 196 (47.7) | 30 (46.2) | 16 (43.2) |
Unknown | 1 (0.8) | 5 (1.2) | - | - |
Cancer type | ||||
Lung cancer | - | 127 (30.9) | 2 (3.1) | 1 (2.7) |
Malignant melanoma | 94 (77.7) | 120 (29.2) | 42 (64.6) | 27 (73.0) |
Renal cell carcinoma | - | 33 (8.0) | 7 (10.8) | 1 (2.7) |
Urothelial carcinoma | - | 9 (2.2) | - | - |
Squamous cell carcinoma of head and neck | - | 9 (2.2) | - | - |
Breast cancer | - | 9 (2.2) | - | - |
Cancer of the female reproductive system | - | 11 (2.7) | 3 (4.6) | 1 (2.7) |
Haematological malignancy | 3 (2.5) | 8 (1.9) | 1 (1.5) | - |
Gastrointestinal tract cancer | - | 6 (1.5) | 2 (3.1) | - |
Cancer of the male reproductive system | - | 2 (0.5) | - | - |
Brain cancer | 1 (0.8) | 6 (1.5) | 1 (1.5) | - |
Colon cancer | - | 4 (1.0) | - | - |
Sarcoma | - | 2 (0.5) | - | 1 (2.7) |
Thyroid cancer/parathyroid gland cancer | - | 1 (0.2) | - | - |
Mesothelioma | - | 1 (0.2) | - | - |
Neuroendocrine carcinoma | - | 2 (0.5) | - | - |
Nasopharyngeal cancer | - | 5 (1.2) | - | - |
Salivary gland cancer | - | 2 (0.5) | - | - |
Thymoma | - | 1 (0.2) | - | - |
Not reported | 23 (19.0) | 53 (13.0) | 7 (10.8) | 6 (16.2) |
Safety reports with co-reported ICI-related toxicities | 98 (81.0) | 293 (71.3) | 52 (81.3) | 28 (75.7) |
Safety reports with co-suspected drugs | 15 (12.4) | 62 (15.1) | 10 (15.4) | 1 (2.7) |
of which antineoplastic drugs (ATC L01) | 4 (3.3) | 44 (10.7) | 6 (9.2) | 1 (2.7) |
Data are n (%). * Due to ≥2 suspected ICIs with partially recorded or missing dates of administration. Abbreviations: ICI, immune checkpoint inhibitor; IQR, interquartile range; CTLA-4, cytotoxic T-lymphocyte antigen-4; PD-1, programmed cell death-1; PD-L1, programmed cell death-ligand1; ATC, anatomical, therapeutic, chemical.