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    Use of a non-endoscopic immunocytological device (Cytosponge™) for post chemoradiotherapy surveillance in patients with oesophageal cancer in the UK (CYTOFLOC): A multicentre feasibility study

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    Authors
    Jones, C. M.
    O'Connor, H.
    O'Donovan, M.
    Hayward, D.
    Blasko, A.
    Harman, R.
    Malhotra, S.
    Debiram-Beecham, I.
    Alias, B.
    Bailey, A.
    Bateman, A.
    Crosby, T. D. L.
    Falk, S.
    Gollins, S.
    Hawkins, M. A.
    Kadri, S.
    Levy, S.
    Radhakrishna, Ganesh
    Roy, R.
    Sripadam, R.
    Fitzgerald, R. C.
    Mukherjee, S.
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    Affiliation
    Department of Oncology, University of Cambridge, Cambridge, UK
    Issue Date
    2022
    
    Metadata
    Show full item record
    Abstract
    Background: Effective surveillance strategies are required for patients diagnosed with oesophageal squamous cell carcinoma (OSCC) or adenocarcinoma (OAC) for whom chemoradiotherapy (CRT) is used as a potentially-curative, organ-sparing, alternative to surgery. In this study, we evaluated the safety, acceptability and tolerability of a non-endoscopic immunocytological device (the Cytosponge™) to assess treatment response following CRT. Methods: This multicentre, single-arm feasibility trial took place in 10 tertiary cancer centres in the UK. Patients aged at least 16 years diagnosed with OSCC or OAC, and who were within 4-16 weeks of completing definitive or neo-adjuvant CRT, were included. Participants were required to have a Mellow-Pinkas dysphagia score of 0-2 and be able to swallow tablets. All patients underwent a single Cytosponge™ assessment in addition to standard of care (which included post-treatment endoscopic evaluation with biopsy for patients undergoing definitive CRT; surgery for those who received neo-adjuvant CRT). The primary outcome was the proportion of consented, evaluable patients who successfully underwent Cytosponge™ assessment. Secondary and tertiary outcomes included safety, study consent rate, acceptance rate, the suitability of obtained samples for biomarker analysis, and the comparative efficacy of Cytosponge™ to standard histology (endoscopy and biopsy or post-resection specimen) in assessing for residual disease. The trial is registered with ClinicalTrials.gov, NCT03529669. Findings: Between 18th April 2018 and 16th January 2020, 41 (42.7%; 95% confidence interval (CI) 32.7-53.2) of 96 potentially eligible patients consented to participate. Thirty-nine (95.1%, 95% CI 83.5-99.4) successfully carried out the Cytosponge™ procedure. Of these, 37 (95%) would be prepared to repeat the procedure. There were only two grade 1 adverse events attributed to use of the Cytosponge™. Thirty-five (90%) of the completed Cytosponge™ samples were suitable for biomarker analysis; 29 (83%) of these were concordant with endoscopic biopsies, three (9%) had findings suggestive of residual cancer on Cytosponge™ not found on endoscopic biopsies, and three (9%) had residual cancer on endoscopic biopsies not detected by Cytosponge™.
    Citation
    Jones CM, O'Connor H, O'Donovan M, Hayward D, Blasko A, Harman R, et al. Use of a non-endoscopic immunocytological device (Cytosponge™) for post chemoradiotherapy surveillance in patients with oesophageal cancer in the UK (CYTOFLOC): A multicentre feasibility study. EClinicalMedicine. 2022 Nov;53:101664. PubMed PMID: 36187722. Pubmed Central PMCID: PMC9519482. Epub 2022/10/04. eng.
    Journal
    EClinicalMedicine
    URI
    http://hdl.handle.net/10541/625700
    DOI
    10.1016/j.eclinm.2022.101664
    PubMed ID
    36187722
    Additional Links
    https://dx.doi.org/10.1016/j.eclinm.2022.101664
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.eclinm.2022.101664
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