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

Christopher M Jones; Heather O'Connor; Maria O'Donovan; Daniel Hayward; Adrienn Blasko; Ruth Harman; Shalini Malhotra; Irene Debiram-Beecham; Bincy Alias; Adam Bailey; Andrew Bateman; Tom D L Crosby; Stephen Falk; Simon Gollins; Maria A Hawkins; Sudarshan Kadri; Stephanie Levy; Ganesh Radhakrishna; Rajarshi Roy; Raj Sripadam; Rebecca C Fitzgerald; Somnath Mukherjee

doi:10.1016/j.eclinm.2022.101664

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 Sep 23:53:101664. doi: 10.1016/j.eclinm.2022.101664. eCollection 2022 Nov.

Authors

Christopher M Jones^{1

2}, Heather O'Connor³, Maria O'Donovan², Daniel Hayward⁴, Adrienn Blasko⁴, Ruth Harman⁵, Shalini Malhotra², Irene Debiram-Beecham⁴, Bincy Alias⁴, Adam Bailey⁶, Andrew Bateman⁷, Tom D L Crosby⁸, Stephen Falk⁹, Simon Gollins¹⁰, Maria A Hawkins¹¹, Sudarshan Kadri¹², Stephanie Levy^{5

13}, Ganesh Radhakrishna¹⁴, Rajarshi Roy¹⁵, Raj Sripadam¹⁶, Rebecca C Fitzgerald⁴, Somnath Mukherjee⁶

Affiliations

¹ Department of Oncology, University of Cambridge, Cambridge, UK.
² Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
³ Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.
⁴ Early Cancer Institute, University of Cambridge, Cambridge, UK.
⁵ Oncology Clinical Trials Office, University of Oxford, Oxford, UK.
⁶ Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
⁷ Southampton University Hospitals NHS Trust, Southampton, UK.
⁸ Velindre Cancer Centre, Velindre University NHS Trust, Cardiff, UK.
⁹ Bristol Haematology and Oncology Centre, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
¹⁰ North Wales Cancer Treatment Centre, Glan Clwyd Hospital, Denbighshire, UK.
¹¹ Department of Medical Physics and Biomedical Engineering, University College London, London, UK.
¹² Leicester General Hospital, University Hospitals of Leicester NHS Trust, Leicester, UK.
¹³ Department of Oncology, University of Oxford, Oxford, UK.
¹⁴ Christie Hospital, The Christie Hospitals NHS Foundation Trust, Manchester, UK.
¹⁵ Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust, Hull, UK.
¹⁶ The Clatterbridge Cancer Centre, The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, UK.

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 18^th April 2018 and 16^th 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™.

Interpretation: Use of the Cytosponge^TM 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.

Funding: Cancer Research UK, National Institute for Health Research, Medical Research Council.

Keywords: Chemoradiation; Cytosponge; Oesophageal Cancer; Radiation; Surveillance.

Associated data

ClinicalTrials.gov/NCT03529669

Abstract

Associated data

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