ESMO recommendations on the use of circulating tumour DNA assays for patients with cancer: a report from the ESMO Precision Medicine Working Group

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Institut Català de la Salut

[Pascual J] Medical Oncology Intercenter Unit, Regional and Virgen de la Victoria University Hospitals, IBIMA, Malaga, Spain. [Attard G] Urological Cancer Research, University College London, London, UK. [Bidard FC] Department of Medical Oncology, Institut Curie, Paris, France. University of Versailles Saint-Quentin-en-Yvelines (UVSQ)/Paris-Saclay University, Saint Cloud, France. [Curigliano G] Department of Oncology and Hemato-Oncology, University of Milano, Milan, Italy. Division of Early Drug Development, European Institute of Oncology, IRCCS, Milan, Italy. [De Mattos-Arruda L] IrsiCaixa, Hospital Universitari Trias i Pujol, Badalona, Spain. Germans Trias i Pujol Research Institute (IGTP), Badalona, Spain. [Diehn M] Department of Radiation Oncology, Stanford University School of Medicine, Stanford, USA. [Seoane J] Preclinical and Translational Research Programme, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. ICREA, CIBERONC, Barcelona, Spain. Medical School, Universitat Autònoma de Barcelona, Bellaterra, Spain

Vall d'Hebron Barcelona Hospital Campus

Publication date

2023-04-17T12:55:42Z

2023-04-17T12:55:42Z

2022-08



Abstract

Circulating tumour DNA (ctDNA); Liquid biopsy; Precision medicine


DNA tumoral circulant (ctDNA); Biòpsia líquida; Medicina de precisió


ADN tumoral circulante (ctDNA); Biopsia líquida; Medicina de precisión


Circulating tumour DNA (ctDNA) assays conducted on plasma are rapidly developing a strong evidence base for use in patients with cancer. The European Society for Medical Oncology convened an expert working group to review the analytical and clinical validity and utility of ctDNA assays. For patients with advanced cancer, validated and adequately sensitive ctDNA assays have utility in identifying actionable mutations to direct targeted therapy, and may be used in routine clinical practice, provided the limitations of the assays are taken into account. Tissue-based testing remains the preferred test for many cancer patients, due to limitations of ctDNA assays detecting fusion events and copy number changes, although ctDNA assays may be routinely used when faster results will be clinically important, or when tissue biopsies are not possible or inappropriate. Reflex tumour testing should be considered following a non-informative ctDNA result, due to false-negative results with ctDNA testing. In patients treated for early-stage cancers, detection of molecular residual disease or molecular relapse, has high evidence of clinical validity in anticipating future relapse in many cancers. Molecular residual disease/molecular relapse detection cannot be recommended in routine clinical practice, as currently there is no evidence for clinical utility in directing treatment. Additional potential applications of ctDNA assays, under research development and not recommended for routine practice, include identifying patients not responding to therapy with early dynamic changes in ctDNA levels, monitoring therapy for the development of resistance mutations before clinical progression, and in screening asymptomatic people for cancer. Recommendations for reporting of results, future development of ctDNA assays and future clinical research are made.


This project was funded by the European Society for Medical Oncology (no grant number).

Document Type

Article


Published version

Language

English

Publisher

Elsevier

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Annals of Oncology;33(8)

https://doi.org/10.1016/j.annonc.2022.05.520

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Attribution-NonCommercial-NoDerivatives 4.0 International

http://creativecommons.org/licenses/by-nc-nd/4.0/

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