Nicholas Hornstein, Gastrointestinal Medical Oncologist at Northwell Health, shared a post on X:
“Same labs. Different toxicity.
CTCAE v6.0 changes how we grade cytopenias. This matters if you run clinical trials. CTCAE drives DLTs, dose holds, and how safety signals are interpreted. Small threshold changes can meaningfully alter trial results.
What changed in v6.0 vs v5.0
Big picture
Overall downgrading. Many lab values that used to be called Grade 3 or 4 are now lower grade, and this better reflects clinical practice.
Neutropenia
ANC 1000 to 1500 is now Grade 1 (was Grade 2). The old Grade 1 gone (poof). Grade 4 is stricter with a cutoff of less than 100 (previously less than 500).
Thrombocytopenia
Grade 3 is wider at 10k to 50k (previously 25k to 50k). Grade 4 is stricter at less than 10k (previously less than 25k).
Bottom line
Expect fewer high grade cytopenias on paper even if the drug is the same.
Be careful comparing new trials to older data. This is closer to how we actually take care of patients. Either way, as an investigator, this is a fantastic change.”
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