Review
RECIST revisited: A review of validation studies on tumour assessment

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Abstract

The response evaluation criteria in solid tumours (RECIST) was developed in the late 1990s to replace the WHO criteria for response evaluation. The new criteria included important changes such as unidimensional tumour measurement, selection of target lesions with a minimum size, details concerning imaging modalities and a new threshold for assignment of objective progression.

RECIST was published in February 2000 and very quickly came into operation first in clinical trials performed under the auspices of EORTC, US NCI or NCI Canada Clinical Trials Group but was adopted quickly thereafter by the entire cancer clinical research community. As several key features of RECIST were based on analysis of retrospective clinical data, it was felt important to carefully monitor the implementation of the guidelines and stimulate prospective validation studies. This paper reviews the literature that has been published on RECIST from 2000 up to November 2005. In total 60 papers and ASCO, abstracts directly refer to research studies or reviews related to RECIST and its implementation. Amongst the 60 references identified for this review, 11 papers refer to validation studies (seven prospective and four retrospective), six papers refer to the comparison of unidimensional measurements versus bi or tri-dimensional measurements, 12 papers address issues raised with the implementation of RECIST in Mesothelioma and Gastro-Intestinal Stromal Tumours and four papers report on an adaptation of RECIST for specific tumour types.

In general, RECIST has been well received by the scientific community and most validation studies fully support the implementation of the new criteria. As expected, however, some issues have been identified. In keeping with the mathematical differences in definition of progression, RECIST delays the identification of progression as compared to WHO criteria in some instances. RECIST criteria are not easily applicable in some types of trials such as those in paediatric tumours and in mesothelioma. Furthermore, anatomical changes in the tumour as described by RECIST may be detected later than functional changes in some circumstances, as for example in Gastro-Intestinal Stromal Tumours treated with Imatinib. However, there is no other universal method of tumour assessment as yet and functional imaging methods have not been validated and will not be widely available for some time. The findings of this review, together with experience acquired thus far and the results of some ongoing research projects, have paved the way for RECIST 2.0 to be hopefully announced later this year.

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.

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