The 2019 ASTCT consensus gave the field common definitions for cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, and those scales became the basis for trial reporting and for treatment algorithms. Since then several class effects have been described that the original criteria did not cover. ASTCT convened expert panels to do two things: revise the existing criteria for cytokine release syndrome, ICANS and immune effector cell-associated haemophagocytic lymphohistiocytosis-like syndrome, and create definitions for the toxicities that had none.
The additions are the substantive part. They cover immune effector cell-associated haematotoxicity; neurological toxicities that are not ICANS — parkinsonism, cranial nerve palsies, polyneuropathies; immune effector cell-associated enterocolitis; tumour inflammation-associated neurotoxicity; and on-target, off-tumour toxicity. Each of those has been managed ad hoc, graded inconsistently or recorded as something else, which is why late and delayed toxicities of CAR-T and T-cell engagers have been so hard to compare between products.
This lands on documentation before it lands on treatment. Any unit giving CAR-T or a bispecific T-cell engager needs its toxicity proformas, order sets and escalation triggers rewritten to the new definitions, and its staff retrained, or grades recorded from today will not be comparable with grades recorded next year. The practical test is whether a prolonged cytopenia, a movement disorder appearing weeks after infusion, or a colitis in a patient on a bispecific now has a named grade on your chart. If not, that is the gap to close.
- Update CAR-T and bispecific toxicity proformas and order sets to the revised definitions.
- Make sure prolonged cytopenia is graded as haematotoxicity rather than logged as an adverse event.
- Brief the neurology and gastroenterology teams you call on — parkinsonism and enterocolitis now have criteria.
- Re-grade prospectively rather than retrospectively; mixed criteria in one dataset are worse than either alone.
- Escalation thresholds tied to the old grades need re-checking against the new ones before they are relied on.
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