Pathologic Considerations and Standardization in Mesothelioma Clinical Trials

Our plain-English summary of Pathologic Considerations and Standardization in Mesothelioma Clinical Trials, by M.S. Tsao, M. Carbone, F. Galateau-Salle, et al (Journal of Thoracic Oncology, 2019).

The study

• Authors: M.S. Tsao, M. Carbone, F. Galateau-Salle, A.L. Moreira, A.G. Nicholson, A.C. Roden, A.A. Adjei, M.C. Aubry, D.A. Fennell, D. Gomez, D. Harpole, M. Hesdorffer, F.R. Hirsch, G. Liu, S. Malik, A. Nowak, T. Peikert, R. Salgia, P. Szlosarek, E. Taioli, H. Yang, A. Tsao, A.S. Mansfield
• Journal: Journal of Thoracic Oncology
• Published: 2019;14(10):1704-1717
• Cited by: 10 articles, as counted by NIH iCite
• Read it: PubMed · Publisher

Abstract

The accurate diagnosis of mesothelioma is critical for the appropriate clinical management of this cancer. Many issues complicate making the diagnosis of mesothelioma including the presence of reactive mesothelial cells in benign pleural effusions, the heterogeneity of mesothelioma histopathology, the relatively high incidence of other epithelial malignancies that metastasize to the pleura, and primary sarcomas that arise within the pleura. Given the rapidly evolving field of molecular profiling and the need for translational correlates in mesothelioma clinical trials, the National Cancer Institute (NCI)-International Association for the Study of Lung Cancer-Mesothelioma Applied Research Foundation Clinical Trials Planning Meeting was convened in March 2017 to develop a consensus on standard pathology guidelines for future NCI-sponsored clinical trials in mesothelioma. This consensus statement covers recommendations for specimen handling, pathologic classification and diagnosis, biobanking, and tissue correlative studies.

Copyright © 2019 International Association for the Study of Lung Cancer. All rights reserved.

In plain English

This article was a consensus statement, not a new study. It came from a planning meeting held in March 2017 by the U.S. National Cancer Institute (NCI), the International Association for the Study of Lung Cancer and the Mesothelioma Applied Research Foundation. It set out pathology guidelines for future NCI-sponsored clinical trials in mesothelioma. Drawing on published work, the authors made recommendations on taking and handling tissue and fluid samples, classifying and diagnosing mesothelioma, storing samples in biobanks with patients' informed consent, and running laboratory marker studies. They recommended:

• sampling multiple areas;
• fixing specimens that are not frozen in formalin for 6 to 72 hours;
• distinguishing malignant pleural mesothelioma from reactive cell growth and from cancers that spread to the pleura;
• reporting the tissue subtype;
• assessing BAP1.

They noted there was no consensus on the best number and size of samples. The article also discussed mesothelioma of the peritoneum, pericardium and tunica vaginalis. It did not study asbestos exposure. The authors concluded that trials need standardized tissue sampling, pathologic assessment and diagnosis.

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: consensus statement (special article) giving pathology guidelines for clinical trials; not an original study
• Who was studied: No patients were studied. The statement came from an NCI, International Association for the Study of Lung Cancer and Mesothelioma Applied Research Foundation Clinical Trials Planning Meeting held in March 2017. It addressed future NCI-sponsored mesothelioma clinical trials.
• Main results:
  • Recommendation for diagnostic biopsies: sampling multiple areas is preferable to help diagnosis.
  • Recommendation: specimens that are not frozen should be fixed in formalin for 6 to 72 hours.
  • The authors stated that there is currently no consensus on the best number and size of biopsy samples.
  • Recommendation for pleurectomy specimens: checking surgical margins is not necessary, because complete removal of the tumor is not possible except in localized subtypes.
  • Recommendation for biobanking: informed consent following the International Conference on Harmonisation Guideline for Good Clinical Practice should be obtained, and standardized datasets should be used for clinical and pathologic annotations.
  • Recommendation: malignant pleural mesothelioma must be distinguished from reactive proliferations and metastases, and histologic subtypes must be determined. Staining (IHC) and p16 FISH testing may help.
  • Recommendation: BAP1 should be assessed with IHC or with a sequencing technique sensitive enough to detect its mutations.
  • Recommendation: the REMARK reporting recommendations for tumor marker prognostic studies should be followed.
• The authors' conclusion: The authors concluded that, with biomarker work expected to be a critical part of future trials, standardization is needed in patient tissue sampling, pathologic assessment and diagnosis. They added that these issues are often overlooked in clinical trial design.

Topics

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

Medical terms in this study, explained in our Lexicon: Mesothelioma, Clinical Trial, Reactive Mesothelial Cells, Pleural Effusion, Histopathology, Metastasis, Pleura, Sarcoma.

Related studies

• Radiologic Considerations and Standardization of Malignant Pleural Mesothelioma Imaging Within Clinical Trials: Consensus Statement from the NCI Thoracic Malignancy Steering Committee - International Association for the Study of Lung Cancer - Mesothelioma Applied Research Foundation Clinical Trials Planning Meeting — R.R. Gill, A.S. Tsao, et al. (2019)
• Current and Future Management of Malignant Mesothelioma: A Consensus Report from the National Cancer Institute Thoracic Malignancy Steering Committee, International Association for the Study of Lung Cancer, and Mesothelioma Applied Research Foundation — A.S. Tsao, O.W. Lindwasser, et al. (2018)
• Clinical Trials with Oncolytic Measles Virus: Current Status and Future Prospects — P. Msaouel, M. Opyrchal, et al. (2018)
• The concept of mesothelioma in situ, with consideration of its potential impact on cytology diagnosis — S. Klebe, Y. Nakatani, et al. (2021)
• Systematic review of response rates of sarcomatoid malignant pleural mesotheliomas in clinical trials — A.S. Mansfield, J.T. Symanowski, et al. (2014)
• Current readings: Window-of-opportunity trials for thoracic malignancies — A.S. Tsao (2014)

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