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.
Subject(s)
Antineoplastic Agents/therapeutic use , Lymphoma, Non-Hodgkin/diagnostic imaging , Lymphoma, Non-Hodgkin/drug therapy , Positron-Emission Tomography/standards , Response Evaluation Criteria in Solid Tumors , Tomography, X-Ray Computed/standards , Antineoplastic Agents/adverse effects , Consensus , Contrast Media/administration & dosage , Disease Progression , Disease-Free Survival , Endpoint Determination , Fluorodeoxyglucose F18/administration & dosage , Humans , Lymphoma, Non-Hodgkin/mortality , Lymphoma, Non-Hodgkin/pathology , Neoplasm Staging , Predictive Value of Tests , Time Factors , Treatment Outcome , Tumor BurdenABSTRACT
The impact of radiotherapy in aggressive NHL is not well defined. In the NHL B-94 trial of the DSHNHL, an irradiation of bulky disease areas was done after completing 6 cycles of CHOP/CHOEP chemotherapy. In the entire patient group, including those patients with extranodal disease and those who did not receive the complete chemotherapy, bulky disease was a significant independent prognostic factor concerning recurrence-free survival (66.1% (no bulk) vs. 53.3% (bulk), p=0.0001). Out of 366 patients with nodal disease only and 6 cycles of chemotherapy according to the protocol, 84 of 91 patients with bulky disease were irradiated with 36 Gy. In this group of patients the prognostic impact of bulky disease could not be shown any longer (recurrence-free survival 77.3% (no bulk) vs. 74.1% (bulk). Localized radiotherapy of bulky disease areas may therefore have contributed to an improvement in outcome in this high-risk group.
