Revised Modified Response Evaluation Criteria in Solid Tumors for Assessment of Response in Malignant Pleural Mesothelioma (Version 1.1)

Our plain-English summary of Revised Modified Response Evaluation Criteria in Solid Tumors for Assessment of Response in Malignant Pleural Mesothelioma (Version 1.1), by S.G. Armato, A.K. Nowak (Journal of Thoracic Oncology, 2018).

The study

• Authors: S.G. Armato, A.K. Nowak
• Journal: Journal of Thoracic Oncology
• Published: 2018;13(7):1012-1021
• Cited by: 119 articles, as counted by NIH iCite
• Read it: PubMed · Publisher

Abstract

Introduction: Malignant pleural mesothelioma poses unique difficulties in tumor measurement and response assessment; however, robust and reproducible assessment of response is critically important in the conduct, interpretation, and reporting of clinical trials.

Methods: The current de facto standard for the assessment of mesothelioma tumor response, "modified RECIST" (Response Evaluation Criteria in Solid Tumors), was published in 2004 as a research paper. Practical application of the modified RECIST guidelines has suffered from varied interpretations, resulting in inaccuracies and inconsistencies in tumor response assessment across and within mesothelioma clinical trials. The presented "modified RECIST 1.1 for mesothelioma" response assessment guidelines provide a much-needed update that incorporates recommendations from RECIST 1.1 and approaches to other practical issues, including: (1) definition of minimally measurable disease; (2) definition of measurable lesions; (3) acceptable measurement location; (4) non-pleural disease considerations; (5) characterization of non-measurable pleural disease; (6) assessment of pathological lymph nodes; (7) establishing progressive disease; and (8) accommodations for bilateral pleural disease.

Results: These modified RECIST 1.1 guidelines for mesothelioma tumor response collate and apply research published since the development of modified RECIST, align modified RECIST with RECIST 1.1, address those aspects of tumor measurement that were neglected or not well characterized in the modified RECIST paper, and clarify ambiguous or difficult measurement issues that have been highlighted through the subsequent decade of clinical trials research.

Conclusion: Adoption of the modified RECIST 1.1 guidelines for mesothelioma is recommended to harmonize the application of tumor measurement and response assessment across the next generation of clinical trials in this disease.

Copyright © 2018 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.

In plain English

This article was a guideline, not a patient study, and did not examine asbestos. It revised "modified RECIST", 2004 rules for measuring malignant pleural mesothelioma on CT scans in clinical trials. Drawing on later research and RECIST 1.1, the authors recommended lowering minimum measurable tumor thickness from 10 mm to 7 mm. Up to six pleural sites should be measured at baseline. Later measurements should keep each site's baseline direction and observer, with stored baseline images for reference. A partial response remained a drop of at least 30% from the baseline sum, confirmed at least 4 weeks later. Progression remained a rise of at least 20% from the lowest earlier sum, now also at least 5 mm per RECIST 1.1, or an unequivocal qualifying new lesion or focus of pleural thickening. They recommended iRECIST principles for immunotherapy trials where pseudoprogression and delayed response may be a consideration. They did not recommend tumor volume in current response criteria except for research, or FDG-PET for assessing treatment response in trials. The authors concluded that adopting the guidelines is recommended to harmonize measurement across future trials.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Guideline update (recommendations revising the modified RECIST criteria for mesothelioma); not an original study of patients
• Who was studied: No patients were studied; the guidelines concern CT-based measurement and response assessment of malignant pleural mesothelioma in clinical trials
• Exposure: Not applicable: the article does not address asbestos or any other exposure; it concerns how tumors are measured on CT scans
• Main results:
  • Recommendation: the minimum measurable mesothelioma tumor thickness is lowered from 10 mm to 7 mm
  • Recommendation: up to six pleural measurement sites at baseline, no more than two per CT section, across no more than three sections at least 1 cm apart
  • Recommendation: if tumor is present at a site but too thin to measure, a default value of 2 mm is used, which differs from RECIST 1.1
  • Recommendation: later measurements at a site should be oriented in the same direction as the baseline measurement
  • Recommendation: the same observer should measure all CT scans from a given patient using the same display settings
  • Recommendation: images of the baseline measurement lines should be stored and consulted when measuring later scans
  • In bilateral disease, the pleura on both sides counts as one organ for site selection
  • Partial response is defined as a decrease of at least 30% in summed measurements from the baseline sum, confirmed on a follow-up scan at least 4 weeks later
  • Progressive disease is defined as an increase of at least 20% from the lowest prior summed measurement; following RECIST 1.1, an absolute increase of at least 5 mm is also required
  • An unequivocal new non-pleural lesion or unequivocal new focus of pleural thickening above the minimum measurable size also counts as progressive disease
  • The guidelines recommend adopting iRECIST principles for immunotherapy trials where pseudoprogression and delayed response may be a consideration
  • Tumor volume is not recommended for incorporation into current response criteria except as a research tool
  • FDG-PET is not recommended for assessing treatment response in clinical trials
• The authors' conclusion: The authors recommended adopting modified RECIST 1.1 to harmonize tumor measurement and response assessment across future mesothelioma clinical trials, stating that substantive changes were proposed only where supported by published data
• Limitations the authors state:
  • The authors note that the retained response thresholds may not suit mesothelioma's non-spherical shape, but they could not recommend different criteria without prospective validation in a clinical trial
  • The descriptive terms recommended for non-measured pleural disease are subjective

Topics

The National Library of Medicine indexes this study under subjects our site covers: Lung cancer, Mesothelioma.

Medical terms in this study, explained in our Lexicon: Modified RECIST (mRECIST), Pleural Mesothelioma, Clinical Trial, Mesothelioma, Bilateral.

Related studies

• Comparison of modified Response Evaluation Criteria in Solid Tumors, European Organization for Research and Treatment of Cancer criteria, and PET Response Criteria in Solid Tumors for evaluation of tumor response to chemotherapy and prognosis prediction in patients with unresectable malignant pleural mesothelioma — K. Kitajima, M. Maruyama, et al. (2020)
• Revised Modified RECIST Criteria in Malignant Pleural Mesothelioma (Version 1.1): A Step Forward in a Long Race — A.S. Tsao, G.W. Gladish, et al. (2018)
• Metabolic response assessment with 18F-FDG-PET/CT is superior to modified RECIST for the evaluation of response to platinum-based doublet chemotherapy in malignant pleural mesothelioma — S. Kanemura, K. Kuribayashi, et al. (2017)
• A practical guide of the Southwest Oncology Group to measure malignant pleural mesothelioma tumors by RECIST and modified RECIST criteria — A.S. Tsao, L. Garland, et al. (2011)
• A practical guide to measure "all" malignant pleural mesothelioma tumors by modified RECIST criteria? — K. Nackaerts, J. Vansteenkiste, et al. (2011)
• Phase I trial of tirapazamine in combination with cisplatin in a single dose every 3 weeks in patients with solid tumors — C.A. Johnson, D. Kilpatrick, et al. (1997)

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