iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics

Area of Science:

• Oncology
• Clinical Trial Design
• Immunotherapy

Background:

• Cancer immunotherapies elicit distinct tumour responses compared to traditional chemotherapy.
• Accurate assessment of tumour burden is crucial for evaluating treatment efficacy and disease progression.

Purpose of the Study:

• To introduce the iRECIST (immune-Response Evaluation Criteria In Solid Tumours) guideline for cancer immunotherapy trials.
• To standardize the measurement and definition of objective changes in tumour size for immunotherapy studies.
• To define essential data points for future trials to enable iRECIST validation.

Main Methods:

• Development of a consensus guideline by the RECIST working group.
• Modification of Response Evaluation Criteria in Solid Tumours (RECIST version 1.1) for immunotherapy contexts.
• Establishment of standard approaches for solid tumour measurements and objective response definitions.

Main Results:

• The iRECIST guideline offers a standardized framework for immunotherapy trials.
• It ensures consistent trial design, data collection, and interpretation.
• Minimum data requirements are defined for future trial validation.

Conclusions:

• iRECIST facilitates consistent conduct, interpretation, and analysis of cancer immunotherapy trials.
• This guideline addresses the unique challenges of evaluating tumour response to immunotherapies.
• Standardization is key for validating novel immune modulators in oncology.