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Table 3 Recommended dose adjustments for toripalimab

From: Toripalimab combined with concurrent platinum-based Chemoradiotherapy in patients with locally advanced cervical Cancer: an open-label, single-arm, phase II trial

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

  1. Abbreviations: ALT Alanine aminotransferase, AST Aspartate aminotransferase, UNL Upper normal limit, irAE Immunotherapy-related adverse event