Objectives: We aimed to analyze the association between the onsets of PE and of progressive disease (PD) in CT scans of oncological patients undergoing clinical trials. Methods: We retrospectively searched our oncological clinical trials database (1/2012 - 6/2017). We retrieved patients who underwent protocol baseline and follow-up CT scans. RECIST 1.1 categories of response were calculated for each scan at interpretation. The entire dataset was searched for reports with incidental PE. For patients with incidental PE, we collected all the scans conducted up to and including the scan with PE. For each scan, we retrieved the recorded RECIST 1.1 category. We excluded patients with PE at baseline. The frequency of incidental PE in oncological clinical trial patients was calculated. For patients with incidental PE, we evaluated the association between PE and PD. Results: During the study period, 1,070 patients underwent 3,818 CTs. The total number of follow-up months was 7,292 months. 18 patients developed incidental PE during follow-up. Thus, the frequency of incidental PE in oncological clinical trial patients was 3% per year of follow-up. Patients with incidental PE underwent 60 scans up to development of PE. Of 42 non-baseline scans, 6/6 (100%) PD showed PE, and 5/36 (13.9%) non-PD showed PE, making PE onset associated with PD onset (p < 0.001). Conclusion: In oncological clinical trials, the frequency of incidental PE is 3% per year of follow-up. The onset of incidental PE is linked to the onset of PD. Advances in knowledge: Incidental PE is associated with the onset of disease progression. Radiologists interpret oncological scans should be aware of the association between PE and PD.
e14149 Background: Oncologists often need an objective, quantitative assessment of a patient's response to therapy. Lacking a standardized format, the oncologist may request a RECIST (Response Evaluation Criteria in Solid Tumors) analysis. RECIST, however, was developed to provide standardized assessment in the context of randomized clinical trials. RECIST is based on the prospective analysis of a limited sample of tumor lesions or lymph nodes, whereas the clinician naturally makes clinical decisions retrospectively. Furthermore, RECIST has definitions, rules, and criteria for classifying responses that may not apply in the clinical setting, and it does not include consistent rules for merging or splitting lymph nodes, mixed tumor responses, lesions that may cavitate, and a wide range of individualistic responses encountered in clinical practice. Methods: To address these issues, we have modified our working Excel-based template for RECIST 1.1 assessment to include a "myRECIST" feature, so that the radiologist can enter data and examine a range of pre-defined or customizable scenarios, including RECIST1.1, iRECIST, Lugano, volumetric and other parametric protocols. With a few interactions, this template can produce exportable tables and graphs of tumor responses that can guide therapy, as shown in the attached image. Definitions are standardized and linked to RADLEX ontology for specificity and subsequent analysis. Results: This template has been developed for clinical use and is available for downloading from our institutional web-site. Conclusions: We have developed, for public use, a free, easy-to-use, down-loadable Excel template for evaluating prospective or retrospective scenarios of tumor response to therapy that avoids the restrictions of the RECIST methodology. This template may prove useful to oncologists both in and out of the context of randomized clinical trials. We call this "myRECIST."
e18053 Background: RECIST, among methodologies designed to provide an objective assessment of tumor response to therapy, is based on the measurement of Target Lesions (TLs) and classification of response according to an objective scale of beneficial response or progressive disease (PD). The “PD point” (the time-point at which RECIST 1.1 first classifies the trial as PD) is a common end-point in clinical trials and is defined as that point when the objective response rate is > 20%. However, RECIST also allows for the subjective assessment of non-TL lesions (NTLs) and new lesions (NLs) to determine the PD point. We sought to determine which of these parameters was most influential in determining PD. Methods: We evaluated the formal RECIST 1.1 assessments for consecutive patient enrollments in randomized clinical trials prepared by two senior radiologists at our institution from 2013 through 2018. Data was evaluated at the “PD point.” Results: There were 1260 patients, with 4499 CT or MRI scans. Of these, 581 trials concluded with PD. There were seven groups (+/-/-, -/+/-, -/-/+ . . . +/+/+) according to the status of TLs, NTLs, and NLs at the PD point. In 538 patients (92.6%), TLs were unnecessary in determining the PD point. Two-thirds of these had objective response rates of < 40%. Measurable and non-measurable NTLs were equally responsible for PD, and the strongest determinant of PD was the unequivocal appearance of new lesions. Conclusions: In this study, subjective parameters, as defined by RECIST 1.1, were far more likely to result in a determination of PD than objective ones. These findings may have relevance for considering the value of RECIST 1.1 as a scientific standard for therapeutic efficacy as well as in the design of new methodologies for the assessment of tumor response.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.