Response Evaluation Criteria in Solid Tumors （在实体肿瘤反应评估标准）.pdf

Appendix N Response Evaluation Criteria in Solid Tumors (RECIST) The Response Evaluation Criteria in Solid Tumors (RECIST) were published in February 2000 by the European Organization for Research and Treatment of Cancer (EORTC), the National Cancer Institute of the United States, and the National Cancer Institute of Canada Clinical Trials Group. RECIST criteria are used to evaluate a patient’s response to the therapy used to treat their disease. The content of this appendix has been modified to fit the needs of the CIBMTR data collection forms. For the complete text and more detailed information regarding confirmation of response, methods of measurement, and use of RECIST in clinical trials, see /protocolDevelopment/docs/quickrcst.doc and /protocolDevelopment/docs/therasserecistjnci.pdf. Baseline documentation of Target and Non-Target lesions: • All measurable lesions up to a maximum of five lesions per organ and 10 lesions in total that are representative of all involved organs should be identified as target lesions recorded, and measured at baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter (LD) for all target lesions will be calculated and reported as the baseline sum LD. The baseline sum LD will be used as the reference by which to characterize the objective tumor. • All other lesions (or sites of disease) should be identified as non-target lesions and should also be recorded at baseline. Measurements of these lesions are not required, but the presence or absence of each should be noted throughout follow-up. ® Copyright ©