RECIST 1.1 - Standardisation and disease-specific adaptations: Perspectives from the RECIST Working Group

Abstract

Radiologic imaging of disease sites plays a pivotal role in the management of patients with cancer. Response Evaluation Criteria in Solid Tumours (RECIST), introduced in 2000, and modified in 2009, has become the de facto standard for assessment of response in solid tumours in patients on clinical trials. The RECIST Working Group considers the ability of the global oncology community to implement and adopt updates to RECIST in a timely manner to be critical. Updates to RECIST must be tested, validated and implemented in a standardised, methodical manner in response to therapeutic and imaging technology advances as well as experience gained by users. This was the case with the development of RECIST 1.1, where an expanded data warehouse was developed to test and validate modifications. Similar initiatives are ongoing, testing RECIST in the evaluation of response to non-cytotoxic agents, immunotherapies, as well as in specific diseases. The RECIST Working Group has previously outlined the level of evidence considered necessary to formally and fully validate new imaging markers as an appropriate end-point for clinical trials. Achieving the optimal level of evidence desired is a difficult feat for phase III trials; this involves a meta-analysis of multiple prospective, randomised multicentre clinical trials. The rationale for modifications should also be considered; the modifications may be proposed to improve surrogacy, to provide a more mechanistic imaging technique, or be designed to improve reproducibility of the imaging biomarker. Here, we present the commonly described modifications of RECIST, each of which is associated with different levels of evidence and validation.

Keywords: Modifications; RECIST; Tumour response.

Conflict of interest statement

Conflict of interest statement: All authors have no conflicts relevant to the study.

Copyright © 2016. Published by Elsevier Ltd.

Figures

Fig. 1

Tc-99m MDP bone scan in a patient with metastatic prostate cancer. The patient with >20 bone lesions at baseline scan. At the week 9 visit, patient presented with two new bone lesions. At week 17 and 25, patient did not have new lesions compared to the week 9 bone scan. Image courtesy of Michael Morris, MD, Memorial Sloan Kettering Cancer Center.

Fig. 2

Computed tomography scan in a patient with malignant pleural mesothelioma in the right lung at baseline and follow-up. Note the difficulty in finding a unidimensional measurement that captures the change in tumour size from baseline to follow-up.

Fig. 3

a. Computed tomography (CT) scan in a patient with diagnosis tumour type confluent mediastinal lymph node mass measured bidimensionally at baseline and 6-week follow-up. b. CT scan in a patient with massive splenomegally and multiple pathologically enlarged retroperitoneal lymph nodes.

Fig. 4

a. Computed tomography (CT) scan of patient with non-small-cell lung cancer and evidence of pseudo-progression at the first follow-up time point with subsequent near resolution of the mass. b. CT scan with a subcutaneous metastasis in the right paraspinal region. There is transient increase in size at the second follow-up time point indicative of pseudo-progression, which subsequently resolves.

Fig. 5

Post-contrast T1-weighted MRI in a patient with a glioma – note the degree of enhancement has increased greatly over the 6-week interval between the two scans.

Fig. 6

Small foci of hepatocellular carcinoma in the right lobe of the liver on the arterial phase and delayed portal venous phase. Note the potential difference in measurement between the phases.