Table 1.

Determination of intracranial responses based on CNS RECIST v1.1 protocol-specific criteria.

CriterionCRaPRaSDPD
Target lesions—up to 5 measurableb lesions in the brainNone≥30% ↓<30% ↓ but <20% ↑≥20% ↑c
Nontarget lesions in the brainNoneStable or ↓Stable or ↓c
New lesion or clinical disease progression in the brainNonenonenonePresentc
Corticosteroids for CNS diseasedPlease refer to the definitions below.
  • Abbreviations: CNS, central nervous system; CR, complete response; PR, partial response.

  • aTo confirm CR and PR, it is required that the response is sustained for at least 4 weeks.

  • bMeasurable lesions were defined as lesions ≥10 mm in the longest diameter for slice thickness between 1.5 and 3 mm; or ≥5 mm in the longest diameter for slice thickness ≤1.5 mm; nonmeasurable lesions are <5 mm in the longest diameter.

  • cProgression occurs when this criterion is present only for intracranial disease.

  • dCorticosteroids consideration for CNS response: CR, no corticosteroids above physiologic levels (ie, equivalent of 20 mg of hydrocortisone per day); PR, corticosteroid dose at the time of the MRI must be no greater than the maximum dose used in the first 6 weeks from initiation of therapy; SD and PD, corticosteroid dose does not change determination of stable disease.