Criteria for tumor progression in HERBY (adapted from the RANO criteria)
| Parameter | Criterion |
|---|---|
| T1-weighted post-Gd measurable disease | ≥25% increase in the sum of the products of perpendicular diameters of the contrast-enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response with the patient on stable or increasing doses of corticosteroids |
| T1-weighted post-Gd nonmeasurable disease | Clear progression of nonmeasurable lesions |
| T2/FLAIR | Substantial increase in the T2/FLAIR nonenhancing lesion compared with the baseline scan or best response after the initiation of therapy with the patient on a stable or increasing dose of corticosteroids |
| The increase in the T2/FLAIR signal must have occurred and not be the result of comorbid events (eg, radiation therapy, demyelination, ischemic injury, seizures, postoperative changes, or other treatment effects) | |
| New lesions | Any new lesions |
| Clinical | Clear clinical deterioration due to tumor and not attributable to other causes (eg, seizures, medication adverse effects, complications of therapy, cerebrovascular events, infection, and so forth) |
| Failure to return | Failure to return for evaluation as a result of death or deteriorating condition |
Note:—Gd indicates gadolinium.