International Working Group consensus response evaluation criteria in lymphoma (RECIL 2017)

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.

Keywords: FDG-PET; immunotherapy; lymphoma; response criteria; targeted therapy; waterfall plots.

Figure 1.

Treatment outcome by response category using a waterfall plot, Responses are color coded based on the cutoffs shown in Table 1. Red, progression of disease; pink, stable disease; orange, minor response; blue, partial response; dark green, complete response. Light green bars denote complete response based on integrating PET results. The horizontal dotted lines show the boundaries for partial response, minor response, stable disease, and progression of disease (Table 1).

Figure 2.

Measurement of a splitting lesion in response to therapy.

Figure 3.

Recommendation for measuring spleen long diameter. (A) Coronal view of a computerized tomography (CT) scan image, (B) maximum intensity projection image of a positron emission tomography/CT.