ReviewRECIST revisited: A review of validation studies on tumour assessment
Introduction
Response evaluation criteria in solid tumours (RECIST) was introduced by a small international working group in February 2000 to facilitate, improve and standardize the evaluation and the reporting of objective tumour outcomes in early clinical trials investigating new anti-cancer agents.1 In comparison to earlier response assessment systems, the new criteria gave much more detailed recommendations on how to assess tumour lesions, how to report responses, and also took into account recent developments in medical imaging techniques. RECIST uses a unidimensional measure (the longest diameter) to quantify measurable tumour lesions as opposed to the bidimensional product (longest diameter multiplied by its perpendicular), which was commonly employed by earlier iterations of response criteria.2, 3, 4 Building on the work of others,3, 5 RECIST defines measurable lesions as those with a minimum size depending on the method of investigation. Following a principle already implemented in the SWOG response criteria,3 the threshold for defining objective progression was arbitrarily increased as compared to the WHO criteria, i.e., the increase in measurable overall tumour burden required for progression was greater in RECIST (20% in one dimension being approximately equivalent to a 44% increase in bidimensional product) than in the WHO criteria (25% increase in product).
Following the publication of RECIST, standard case report forms (CRFs) and protocol sections were created by the working group and made available on the web. A special email address was created to receive and answer questions related to the implementation of the criteria. A website was created to host the Questions and Answers to facilitate the implementation of the criteria (www.eortc.be⧹recist). Although the last comment on the website was posted in 2003, the RECIST working group continues (weekly) to answer questions and provide support for the interpretation of the criteria in specific situations.
After the publication of RECIST, some investigators raised concerns about the interest, the pertinence and the applicability of the new criteria. The main purpose of this paper is to review the work performed and published by other colleagues on the usefulness of the criteria in general and their validation in specific tumour types when available.
Section snippets
Review methodology
The search strategy was simple and made through PUBMED using the word RECIST as keyword to identify titles and abstracts published between February 2000 and November 2005. This search strategy identified 99 referenced papers. Only those manuscripts reporting on original work focused on the methodology of response evaluation and RECIST were retained for detailed review. Also excluded were editorial comments and non-English literature. Ultimately 43 papers satisfied these criteria. A second
Results
The studies included focused either on general principles relating to the implementation of RECIST (or tumour evaluation) or on a prospective or retrospective attempt to validate the utility of RECIST in certain tumour types. Accordingly, the results of this review have been divided into general and tumour specific considerations.
Discussion
RECIST has become the most frequently used response criteria for clinical trials investigating new treatments for solid tumours. The criteria are used to define response rate, progression rate and/or time to progression irrespective of the stage of development of new cancer therapeutics. Some features of the criteria have also been rapidly implemented in day to day practice of oncologists for standard patient care.
Overall, many authors agree that the development of RECIST with rigorous
Conflict of interest statement
The authors declare that they have no conflict of interest in relation to the work reported in this paper.
References (62)
- et al.
Selection of large and objectively measurable target lesions in EORTC phase II trials: impact on recruitment and response rate. EORTC soft tissue and bone sarcoma group (STBSG)
Eur J Cancer
(1993) - et al.
A statistical simulation study finds discordance between WHO criteria and RECIST guideline
J Clin Epidemiol
(2004) - et al.
A theoretical approach to choosing the minimum number of multiple tumours required for assessing treatment response
J Clin Epidemiol
(2005) - et al.
Assessment of lung cancer response after nonoperative therapy: tumour diameter, bidimensional product, and volume. A serial CT scan-based study
Int J Radiat Oncol Biol Phys
(2001) - et al.
Tumour measurements on computed tomographic images of non-small cell lung cancer were similar among cancer progressionals from different specialties
J Clin Epidemiol
(2004) - et al.
Modified RECIST criteria for assessment of response in malignant pleural mesothelioma
Ann Oncol
(2004) CT, RECIST, and malignant pleural mesothelioma
Lung Cancer
(2005)- et al.
Inadequacy of the RECIST criteria for response evaluation in patients with malignant pleural mesothelioma
Lung Cancer
(2004) - et al.
Inadequacy of the new response evaluation criteria in solid tumours (RECIST) in patients with malignant pleural mesothelioma: report of four cases
Lung Cancer
(2004) Staging and response to therapy of malignant pleural mesothelioma
Lung Cancer
(2004)
A phase II study of single-agent docetaxel in patients with metastatic esophageal cancer
Ann Oncol
Comparison of treatment response classifications between unidimensional, bidimensional, and volumetric measurements of metastatic lung lesions on chest computed tomography
Acad Radiol
18FDG-Positron emission tomography for the early prediction of response in advanced soft tissue sarcoma treated with imatinib mesylate (Glyvec)
Eur J Cancer
RECIST vs WHO: Prospective comparison of response criteria in an EORTC phase II clinical trial investigating ET-743 in advanced soft tissue sarcoma
Eur J Cancer
New guidelines to evaluate the response to treatment in solid tumours
J Natl Cancer Inst
Reporting results of cancer treatment
Cancer
Southwest oncology group standard response criteria, endpoint definitions and toxicity criteria
Invest New Drug
Are current tumour response criteria relevant for the 21st century?
Br J Radiol
The RECIST (response evaluation criteria in solid tumours) criteria: implications for diagnostic radiologists
Br J Radiol
Evaluation of the response to treatment of solid tumours – a consensus statement of the International Cancer Imaging Society
Br J Cancer
Evaluation of the response to therapy of neoplastic lesions
Radiol Med
Evaluation of RECIST criteria in determining the response to treatment in solid tumours: a north central cancer treatment group (NCCTG) investigation
Proc Am Soc Clin Oncol
Variability in response assessment in solid tumours: effect of number of lesions chosen for measurements
Clin Cancer Res
Assessment of the value of confirming responses in clinical trials in oncology
Eur J Cancer
Response evaluation criteria in solid tumours (RECIST): problems and need for modifications in paediatric oncology?
Br J Radiol
Advances in paediatric tumour imaging
Arch Dis Child
Comparison of unidimensional and bidimensional measurements in metastatic non-small cell lung cancer
Br J Cancer
Tumour response to chemotherapy: the validity and reproducibility of RECIST guidelines in NSCLC patients
Cancer Sci
The impact of an independent response evaluation committee (REC) using RECIST guidelines in a four-arm cooperative study (FACS) for advanced non-small cell lung cancer (NSCLC) in Japan
Proc Am Soc Clin Oncol
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