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New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1).
E A Eisenhauer1, P Therasse, J Bogaerts
1National Cancer Institute of Canada-Clinical Trials Group, 10 Stuart Street, Queen's University, Kingston, Ontario, Canada. eeisenhauer@ctg.queensu.ca
European Journal of Cancer (Oxford, England : 1990)
|December 23, 2008
Summary
Revised RECIST 1.1 criteria refine cancer tumor burden assessment by reducing the number of measurable lesions and incorporating lymph nodes. These updates improve the evaluation of treatment response and disease progression in clinical trials.
Area of Science:
- Oncology
- Radiology
- Clinical Trials
Background:
- The original RECIST (Response Evaluation Criteria in Solid Tumors) guidelines, published in 2000, became a standard for assessing tumor burden in cancer therapeutics.
- Numerous questions and issues arose from the application of RECIST, necessitating a revision to improve clarity and accuracy.
- Evidence from a large patient data warehouse, simulations, and literature reviews informed the development of the revised RECIST 1.1.
Purpose of the Study:
- To present the revised RECIST 1.1 guidelines, addressing limitations of the original version.
- To provide updated criteria for assessing tumor burden, objective response, and disease progression in cancer clinical trials.
- To incorporate new imaging modalities and refine existing assessment methods.
Main Methods:
- Reduction in the maximum number of measurable lesions from 10 to 5 total (2 per organ).
- Inclusion of pathological lymph nodes (short axis ≥ 15 mm) as measurable target lesions.
- Clarification of criteria for disease progression, including a 20% increase in the sum of diameters and a 5 mm absolute increase.
- Inclusion of guidance for 'unequivocal progression' of non-measurable disease and assessment of new lesions.
- Introduction of an imaging appendix with updated recommendations for lesion assessment.
Main Results:
- RECIST 1.1 reduces the number of lesions to assess, streamlining tumor burden evaluation.
- Pathological lymph nodes are now incorporated as target lesions, enhancing assessment accuracy.
- Disease progression criteria are clarified to prevent overcalling progression on small total tumor burdens.
- Guidance on non-measurable disease progression and new lesion detection is provided.
- Updated imaging recommendations support optimal lesion assessment.
Conclusions:
- Anatomical assessment of tumor burden remains the primary method, with no current evidence to abandon it for volumetric or functional assessments.
- FDG-PET imaging is recognized as a potential adjunct for progression determination, requiring further clinical validation.
- RECIST 1.1 provides a more refined and comprehensive framework for evaluating cancer treatment efficacy in clinical trials.