Elsevier

European Journal of Cancer

Volume 62, July 2016, Pages 132-137
European Journal of Cancer

Current Perspective
RECIST 1.1—Update and clarification: From the RECIST committee

https://doi.org/10.1016/j.ejca.2016.03.081Get rights and content

Highlights

  • Clarification on how to select target lesions and what to do with measurable lesions which are not selected for target disease response assessment.

  • Clarification on the definition of stable disease.

  • Clarification on the role of Fluorodeoxy-glucose (18F) (FDG)-positron emission tomography (PET)/PET-computed tomography in the context of RECIST 1.1.

Abstract

The Response Evaluation Criteria in Solid Tumours (RECIST) were developed and published in 2000, based on the original World Health Organisation guidelines first published in 1981. In 2009, revisions were made (RECIST 1.1) incorporating major changes, including a reduction in the number of lesions to be assessed, a new measurement method to classify lymph nodes as pathologic or normal, the clarification of the requirement to confirm a complete response or partial response and new methodologies for more appropriate measurement of disease progression. The purpose of this paper was to summarise the questions posed and the clarifications provided as an update to the 2009 publication.

Introduction

World Health Organisation response guidelines were first published in 1981 [1], [2]. The Response Evaluation Criteria in Solid Tumors (RECIST) criteria were based on those criteria and were themselves updated in a 2009 in the European Journal of Cancer (RECIST 1.1) [3]. The revised guidelines incorporated major changes to the original RECIST criteria [2], including a reduction in the number of lesions to be assessed, a new measurement method to classify lymph nodes as pathologic or normal, the clarification of the requirement to confirm a complete response (CR) or partial response (PR) and new recommendations for the assessment of disease progression. Supplementary information provided included imaging guidelines, which better defined image acquisition and interpretation.

The RECIST criteria have gained widespread adoption and are widely used in oncology clinical trials. The RECIST 1.1 paper has been cited 3881 times as of December 2015 Web of Science. End-points categorised by the RECIST criteria have been used as either primary or supportive data for regulatory approval of new therapeutics by both the Food and Drug Administration and European Medicines Agency (EMA) [4]. RECIST provides a standardised set of rules for response assessment using tumour shrinkage, based upon imaging modalities that are globally available and interpretable by most clinicians. This standardisation, and the rules and criteria established, provide a framework for reproducible analysis and reporting of changes in tumour size. The reproducibility of these criteria and the correlations with historical trial results serve an important purpose in drug discovery.

Despite the widespread acceptance of RECIST, the RECIST Working Group continues its work. RECIST and RECIST 1.1 were developed and tested using data from clinical trials testing cytotoxic drugs. In the last decade, there have been substantial changes in the mechanism of action of cancer therapeutics (targeted agents, immunotherapies), as well as advances in imaging and clinical trial design and end-points. Although the majority of clinical trials continue to use RECIST as an adjunct to the gold standard end-points of survival and quality of life, the RECIST Working Group continues to build data warehouses (e.g. data from clinical trials involving targeted agents and immunotherapies, FDG-positron emission tomography [PET]/computed tomography [CT] data) to review the criteria, update them periodically as required and validate any changes in a standardised, methodical manner in response to both therapeutic and imaging technology advances. Critically, the global oncology community must be able to implement and adopt any changes proposed to RECIST in a timely and cost-effective manner.

Since the original publication, users have submitted questions on the use and interpretation of the guidelines through the RECIST website (http://www.eortc.org/recist/). These questions are reviewed by the Steering Committee and replies provided based on the 2009 publication. If not addressed in the publication, the Working Group is consulted to prepare appropriate replies. Relevant and/or frequently asked questions (FAQs) are posted on a regular basis on the RECIST website.

Here we summarise the questions and clarifications posed as an update to the 2009 publication.

Section snippets

Commonly asked questions regarding RECIST 1.1

  • 1.

    What is the frequency of tumour evaluation?

The schedule and frequency of tumour response re-evaluation is protocol specific and is based on the therapeutic, the disease, the anticipated time to response and progression, as well as practical considerations, such as cost and patient convenience.

However, in the context of phase II studies where the beneficial effect of therapy is not known, follow-up every 6–8 weeks (timed to coincide with the end of a cycle) is reasonable. Shorter or longer time

Conclusions

The RECIST Working Group is currently testing the Criteria for their applicability with modern therapeutics, imaging techniques and trial end-points. The current RECIST 1.1 criteria remain widely used. A number of users have asked questions regarding the interpretation of the 2009 Criteria and we have attempted to summarise those questions, and the answers, in this update. For further updates on the criteria, please visit the RECIST website at http://www.eortc.org/recist/

Conflict of interest statement

E. de Vries: Research grants from Roche/Genentech, Amgen, Novartis, Pieris and Servier to the institute, data monitoring committee Biomarin, advisory board Synthon. R. Ford: Dr. Ford is not a stockholder in any pharmaceutical company and holds no options, grants or patents. He is currently or was previously a consultant for the following companies (either directly through Clinical Trials Imaging Consulting, LLC., or indirectly through other pharmaceutical service companies for which he

Acknowledgements

Canadian Cancer Trials Group participation was supported by the Canadian Cancer Society Research Institute (grant #021039). This publication was supported by the EORTC Cancer Research Fund and by the National Cancer Institute (NCI) grant number 5U10-CA11488-45.

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