O7.01RESPONSE ASSESSMENT IN NEURO-ONCOLOGY (RANO) CRITERIA FOR BRAIN METASTASES

• Published in: Neuro-oncology (Charlottesville, Va.) Vol. 16; no. Suppl 2; p. ii15
• Main Authors: Wen, P.Y., Lee, E.Q., Van Den Bent, M., Soffieti, R., Bendszus, M., Mehta, M., Baumert, B., Vogelbaum, M., Chang, S.M., Lin, N.U.
• Format: Journal Article
• Language: English
• Published: Oxford University Press 01-09-2014
• Subjects: Oral Presentations
• ISSN: 1522-8517; 1523-5866
• DOI: 10.1093/neuonc/nou174.52

Currently, there are no standard criteria for evaluating response to therapy in patients with brain metastases. An international multidisciplinary group, The Response Assessment in Neuro-Oncology (RANO) Metastatic Working Group has proposed a RANO-Brain Metastases (RANO-BM) Criteria is based on a modification of RECIST 1.1 criteria and uses unidimensional measurements. Since the CNS is considered as a separate compartment. CNS response will be scored independent of extracranial response. Measurable disease is defined as a contrast enhancing lesion that can be accurately measured in at least one dimension with a minimum size of 10 mm, visible on two or more axial slices that are preferably at most 5 mm apart with no gap. In addition, although the longest diameter in the plane of measurement is to be recorded, the diameter perpendicular to the longest diameter in the plane of measurement should be at least 5 mm for the lesion to be considered measurable. Best overall CNS response represents a composite of radiographic CNS target and non-target response, corticosteroid use, and clinical status. In non-randomized trials where CNS response is the primary endpoint, confirmation of PR or CR at least 4 weeks later is required. The proposed criteria are: Complete response (CR): Disappearance of all CNS target lesions sustained for at least 4 weeks; no new lesions; no corticosteroids; stable or improved clinically. Partial response (PR): At least a 30% decrease in the sum longest diameter (LD) of CNS target lesions, taking as reference the baseline sum LD, sustained for at least 4 weeks; no new lesions; no corticosteroids; stable or improved clinically. Progressive disease (PD): At least a 20% increase in the sum LD of CNS target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. The group is further refining the proposed criteria to address a number of situations specific to brain metastases. These criteria will hopefully help standardize assessment of response in brain metastases trials and improve the ability to conduct these studies in a more uniform manner.