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Abstract
Background. Response Evaluation Criteria In Solid Tumors (RECIST) and WHO-criteria are used to evaluate treatment effects in clinical trials. The purpose of this study was to examine interobserver and intraobserver variations in radiological response assessment using these criteria. Material and methods. Thirty-nine patients were eligible. Each patient's series of CT images were reviewed. Each patient was classified into one of four categories according RECIST and WHO-criteria. To examine interobserver variation, response classifications were independently obtained by two radiologists. One radiologist repeated the procedure on two additional different occasions to examine intraobserver variation. Kappa statistics was applied to examine agreement. Results. Interobserver variation using RECIST and WHO-criteria were 0.53 (95% CI 0.33–0.72) and 0.60 (0.39–0.80), respectively. Response rates (RR) according to RECIST obtained by reader A and reader B were 33% and 21%, respectively. RR according to WHO-criteria obtained by reader A and reader B were 33% and 23% respectively. Intraobserver variation using RECIST and WHO-criteria ranged between 0.76–0.96 and 0.86–0.91, respectively. Conclusion. Radiological tumor response evaluation according to RECIST and WHO-criteria are subject to considerable inter- and intraobserver variability. Efforts are necessary to reduce inconsistencies from current response evaluation criteria.
Acknowledgements
The authors thank Elisabeth Berg, BSc, The Medical Statistics Unit, Department of Learning, Informatics, Management and Ethics, Karolinska Institute, Stockholm, Sweden for professional statistical analysis. The authors greatly appreciate Maria Gustafsson Liljefors, MD, PhD, Katarina Bodén, MD, and Yvonne Eriksson-Alm, RT, for their advice during this study. Financial support was provided through the regional agreement on medical training and clinical research (ALF) between the Stockholm county council and the Karolinska Institute.
Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.