Share

RECIST working group issues modified guideline for immunotherapy

A recent publication in The Lancet Oncology  highlights the development, led by the RECIST Working Group, of iRECIST (immunotherapy Response Evaluation Criteria in Solid Tumours) consensus-based guideline, which addresses the novel characteristics of this new class of anticancer therapeutics, ensuring consistent trial design and data collection.

“There are a growing number of new immune modulators being introduced for cancer therapy, and current trials assessing their efficacy are using a variety of response criteria,” said Dr Lesley Seymour, Director of the Investigational New Drug Program, Canadian Cancer Trials Group and lead author on this paper. “The iRECIST guideline, developed by a multidisciplinary group including academic, commercial and regulatory experts, is based on RECIST 1.1 but incorporates additional criteria allowing for consistent interpretation of tumour progression measurements for immunotherapy treatments.”

Novel immunotherapeutics have been shown, in some patients, to trigger different responses in tumours compared to traditional chemotherapy: they may initially increase in size, followed by shrinkage (pseudoprogression). While the RECIST 1.1 guideline may not capture this unusual pattern of response, iRECIST allows for the delayed responses that occur after ‘pseudoprogression’ to be identified and better characterized. The guideline describes a standard approach to solid tumour measurement and definitions for objective change in tumour size which can be used in immunotherapy clinical trials. In addition, it defines the minimum amount of data to be collected in order to create a data warehouse that can be used to later validate iRECIST.

For more information about iRECIST, please visit the website.

Back to news list

Related News

  • EORTC: Advancing research and treatment for rare cancers

  • EORTC Fellowship Programme: celebrating more than 20 years of impactful collaboration

  • Appointment of Malte Peters as EORTC Strategic Alliance Officer

  • Unique series of workshops in partnership with the European Medicines Agency (EMA)

  • EORTC launches a prominent clinical trial in older patients with locally advanced (LA) HNSCC (Head and Neck Squamous Cell Carcinoma)

  • Seven IMMUcan abstracts selected for ESMO Immuno-Oncology Congress 2023

  • EORTC Quality of Life measures integrated in CDISC

  • EORTC and Immunocore are collaborating to launch the ATOM clinical trial of tebentafusp in Adjuvant Uveal Melanoma

  • Treatment with decitabine resulted in a similar survival and fewer adverse events compared with conventional chemotherapy in older fit patients with acute myeloid leukaemia

  • New results and forthcoming EORTC trials in rare cancers, lung, head and neck, and breast carcinomas presented at ESMO 2023