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.

Artificial intelligence in cancer imaging: Clinical challenges and applications

“…Retrospective analysis of these clinical trial data sets has been invaluable in meeting the need of AI for big data to enable training and validating AI algorithms, which otherwise might have been prohibited by the expense and effort necessary to generate these data sets from scratch. In part because of the success of RECIST, quantitative CT analysis is now the workhorse of contemporary oncology, creating immediate translational potential for AI predictive models.…”

“…VOLUME 69 | NUMBER 2 | MARCH/APRIL 2019 by the expense and effort necessary to generate these data sets from scratch. In part because of the success of RECIST, quantitative CT analysis is now the workhorse of contemporary oncology, 80 creating immediate translational potential for AI predictive models.…”

A phase 1/1B trial of ADI‐PEG 20 plus nab‐paclitaxel and gemcitabine in patients with advanced pancreatic adenocarcinoma

“…Patients (age 18 years) who had an Eastern Cooperative Oncology Group performance status of 0 to 1 and had metastatic pancreatic adenocarcinoma and measurable disease according to the Response Evaluation Criteria in Solid Tumors (version 1.1) were enrolled. 21 No prior treatment for metastatic pancreatic adenocarcinoma was permitted for this cohort. Patients who received prior chemotherapy in the adjuvant setting were eligible if more than 6 months had passed since the completion of treatment.…”

Response assessment after induction chemotherapy for head and neck squamous cell carcinoma: From physical examination to modern imaging techniques and beyond

“…Because new treatment paradigms and new imaging modalities and techniques require continued reevaluation of response assessment tools, recently, the RECIST working group proposed organ‐specific modifications. However, these are not yet defined for head and neck cancer …”

“…However, these are not yet defined for head and neck cancer. 67 Although the WHO and the RECIST criteria are historically focused on a reliable assessment of any response after induction chemotherapy, new quantitative functional imaging techniques will determine a cutoff value for optimal prediction of response after subsequent chemoradiation. These cutoff values will be dependent on alternative treatment options, available treatment modifications, and the opinions of patients and their clinicians.…”