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

• Published in: EClinicalMedicine Vol. 53; p. 101664
• Main Authors: Jones, Christopher M, O'Connor, Heather, O'Donovan, Maria, Hayward, Daniel, Blasko, Adrienn, Harman, Ruth, Malhotra, Shalini, Debiram-Beecham, Irene, Alias, Bincy, Bailey, Adam, Bateman, Andrew, Crosby, Tom D L, Falk, Stephen, Gollins, Simon, Hawkins, Maria A, Kadri, Sudarshan, Levy, Stephanie, Radhakrishna, Ganesh, Roy, Rajarshi, Sripadam, Raj, Fitzgerald, Rebecca C, Mukherjee, Somnath
• Format: Journal Article
• Language: English
• Published: England Elsevier 01.11.2022
• Subjects: Chemoradiation; Cytosponge; Oesophageal Cancer; Radiation; Surveillance; Cytosponge; Surveillance; Chemoradiation; Oesophageal Cancer; Radiation
• ISSN: 2589-5370; 2589-5370
• DOI: 10.1016/j.eclinm.2022.101664

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. 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. Between 18 April 2018 and 16 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™. Use of the Cytosponge is safe, tolerable, and acceptable for the assessment of treatment response following CRT in OAC and OSCC. Further evaluation of Cytosponge™ in this setting is warranted. Cancer Research UK, National Institute for Health Research, Medical Research Council.