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Immunoglobulin Gene Sequence Analysis In Chronic Lymphocytic Leukemia: From Patient Material To Sequence Interpretation
Published on: November 26, 2018
International Working Group consensus response evaluation criteria in lymphoma (RECIL 2017)
A Younes1, P Hilden2, B Coiffier3
1Lymphoma Service.
Abstract:
In recent years, the number of approved and investigational agents that can be safely administered for the treatment of lymphoma patients for a prolonged period of time has substantially increased. Many of these novel agents are evaluated in early-phase clinical trials in patients with a wide range of malignancies, including solid tumors and lymphoma. Furthermore, with the advances in genome sequencing, new "basket" clinical trial designs have emerged that select patients based on the presence of specific genetic alterations across different types of solid tumors and lymphoma. The standard response criteria currently in use for lymphoma are the Lugano Criteria which are based on [18F]2-fluoro-2-deoxy-D-glucose positron emission tomography or bidimensional tumor measurements on computerized tomography scans. These differ from the RECIST criteria used in solid tumors, which use unidimensional measurements. The RECIL group hypothesized that single-dimension measurement could be used to assess response to therapy in lymphoma patients, producing results similar to the standard criteria. We tested this hypothesis by analyzing 47 828 imaging measurements from 2983 individual adult and pediatric lymphoma patients enrolled on 10 multicenter clinical trials and developed new lymphoma response criteria (RECIL 2017). We demonstrate that assessment of tumor burden in lymphoma clinical trials can use the sum of longest diameters of a maximum of three target lesions. Furthermore, we introduced a new provisional category of a minor response. We also clarified response assessment in patients receiving novel immune therapy and targeted agents that generate unique imaging situations.
Insights
New RECIL 2017 criteria simplify lymphoma response assessment using single-dimension measurements, similar to solid tumor RECIST criteria. This aids clinical trials with novel therapies and diverse patient populations.
Area of Science:
- Oncology
- Radiology
- Clinical Trials
Background:
- Increasing novel agents for lymphoma treatment necessitate updated clinical trial evaluation methods.
- Current lymphoma response criteria (Lugano) differ from solid tumor criteria (RECIST), complicating multi-tumor trial assessments.
- Advancements in genomic sequencing enable basket trials, requiring unified response assessment across malignancies.
Framework:
- Hypothesized that single-dimension measurements, like RECIST, could effectively assess lymphoma treatment response.
- Developed the RECIL 2017 criteria based on analysis of extensive imaging data from lymphoma patients.
- Introduced a provisional 'minor response' category for nuanced treatment evaluation.
Implementation:
- Analyzed 47,828 imaging measurements from 2983 adult and pediatric lymphoma patients across 10 multicenter trials.
- Validated the use of the sum of longest diameters for up to three target lesions to assess tumor burden.
- Clarified response assessment for unique imaging findings in patients on novel immunotherapies and targeted agents.
Implications:
- RECIL 2017 offers a standardized, potentially more efficient method for lymphoma response assessment in clinical trials.
- The criteria facilitate comparison across different tumor types and treatment modalities, including novel agents.
- Improved response assessment can accelerate drug development and optimize patient care in lymphoma treatment.

