Ct evaluation of lymph nodes that merge or split during the course of a clinical trial: Limitations of recist 1.1

Abstract

Purpose: To compare Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 with volumetric measurement in the setting of target lymph nodes that split into two or more nodes or merge into one conglomerate node. Materials and Methods: In this retrospective study, target lymph nodes were evaluated on CT scans from 166 patients with different types of cancer; 158 of the scans came from The Cancer Imaging Archive. Each target node was measured using RECIST 1.1 criteria before and after merging or splitting, followed by volumetric segmentation. To compare RECIST 1.1 with volume, a single-dimension hypo-thetical diameter (HD) was determined from the nodal volume. The nodes were divided into three groups: (a) one-target merged (one target node merged with other nodes); (b) two-target merged (two neighboring target nodes merged); and (c) split node (a conglomerate node cleaved into smaller fragments). Bland-Altman analysis and t test were applied to compare RECIST 1.1 with HD. On the basis of the RECIST 1.1 concept, we compared response category changes between RECIST 1.1 and HD. Results: The data set consisted of 30 merged nodes (19 one-target merged and 11 two-target merged) and 20 split nodes (mean age for all 50 included patients, 50 years ± 7 [standard deviation]; 38 men). RECIST 1.1, volumetric, and HD measurements indicated an increase in size in all one-target merged nodes. While volume and HD indicated an increase in size for nodes in the two-target merged group, RECIST 1.1 showed a decrease in size in all two-target merged nodes. Although volume and HD demonstrated a decrease in size of all split nodes, RECIST 1.1 indicated an increase in size in 60% (12 of 20) of the nodes. Discrepancy of the response categories between RECIST 1.1 and HD was observed in 5% (one of 19) in one-target merged, 82% (nine of 11) in two-target merged, and 55% (11 of 20) in split nodes. Conclusion: RECIST 1.1 does not optimally reflect size changes when lymph nodes merge or split.