NCI CTCAE 5.0 | Grade | Management |
---|---|---|
Pneumonitis | II | Interrupt toripalimab until restore to grade 0–I |
III-IV or recurrent grade II | Discontinue toripalimab | |
Diarrhea and colitis | II-III | Interrupt toripalimab until restore to grade 0–I |
IV | Discontinue toripalimab | |
Hepatitis | II (3× UNL<ALT/AST<5× UNL, or 1.5 × UNL<total bilirubin<3× UNL) | Interrupt toripalimab until restore to grade 0–I |
III-IV (ALT/AST>5× UNL, or total bilirubin>3× UNL) | Discontinue toripalimab | |
Nephritis | Grade II-III elevated blood creatinine | Interrupt toripalimab until restore to grade 0–I |
Grade IV elevated blood creatinine | Discontinue toripalimab | |
Endocrine disease | Symptomatic grade II-III hypothyroidism Grade II-III hyperthyroidism Grade II-III hypophysitis Grade II adrenal insufficiency, Grade III hyperglycemia or type 1 diabetes | Interrupt toripalimab or hormone replacement therapy until restore to grade 0–I |
 | Grade IV hypothyroidism Grade IV hyperthyroidism Grade IV hypophysitis Grade III-IV adrenal insufficiency Grade IV hyperglycemia or type 1 diabetes | hormone replacement therapy |
Skin reactions | Grade III skin rash | Interrupt toripalimab until restore to grade 0–I |
Grade IV skin rash, Stevens-Johnson syndrome or toxic epidermal necrolysis | Discontinue toripalimab | |
Thrombocytopenia | III | Interrupt toripalimab until restore to grade 0–1I |
IV | Discontinue toripalimab | |
Others | Grade II-III elevated blood amylase or elevated lipase Grade II pancreatitis Grade II myocarditis Other grade II-III irAEs that occur for the first time | Interrupt toripalimab until restore to grade 0–I |
Grade IV elevated blood amylase or elevated lipase Grade III-IV pancreatitis Grade III-IV myocarditis Grade III-IV encephalitis Other grade IV irAEs that occur for the first time | Discontinue toripalimab | |
Recurrent or persistent adverse events | Recurrent grade III-IV (except for endocrine diseases) Grade II-III adverse events not recover to grade 0-I within 12 weeks after the last administration (except for endocrine diseases) Corticosteroids failed to drop to a prednisone equivalent dose of ≤10 mg/day within 12 weeks after the last dose | Discontinue toripalimab |
Infusion reaction | II | Reduce the drip rate or suspend the infusion, medication could be resumed under close observation when the symptoms are relieved |
III-IV | Discontinue toripalimab |