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
dc.contributor.author | Jones, C. M. | |
dc.contributor.author | O'Connor, H. | |
dc.contributor.author | O'Donovan, M. | |
dc.contributor.author | Hayward, D. | |
dc.contributor.author | Blasko, A. | |
dc.contributor.author | Harman, R. | |
dc.contributor.author | Malhotra, S. | |
dc.contributor.author | Debiram-Beecham, I. | |
dc.contributor.author | Alias, B. | |
dc.contributor.author | Bailey, A. | |
dc.contributor.author | Bateman, A. | |
dc.contributor.author | Crosby, T. D. L. | |
dc.contributor.author | Falk, S. | |
dc.contributor.author | Gollins, S. | |
dc.contributor.author | Hawkins, M. A. | |
dc.contributor.author | Kadri, S. | |
dc.contributor.author | Levy, S. | |
dc.contributor.author | Radhakrishna, Ganesh | |
dc.contributor.author | Roy, R. | |
dc.contributor.author | Sripadam, R. | |
dc.contributor.author | Fitzgerald, R. C. | |
dc.contributor.author | Mukherjee, S. | |
dc.date.accessioned | 2022-10-26T12:58:53Z | |
dc.date.available | 2022-10-26T12:58:53Z | |
dc.date.issued | 2022 | en |
dc.identifier.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. | en |
dc.identifier.pmid | 36187722 | en |
dc.identifier.doi | 10.1016/j.eclinm.2022.101664 | en |
dc.identifier.uri | http://hdl.handle.net/10541/625700 | |
dc.description.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™. | en |
dc.language.iso | en | en |
dc.relation.url | https://dx.doi.org/10.1016/j.eclinm.2022.101664 | en |
dc.title | 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 | en |
dc.type | Article | en |
dc.contributor.department | Department of Oncology, University of Cambridge, Cambridge, UK | en |
dc.identifier.journal | EClinicalMedicine | en |
dc.description.note | en] | |
refterms.dateFOA | 2022-11-01T13:21:39Z |