Cargando…
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
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,...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9519482/ https://www.ncbi.nlm.nih.gov/pubmed/36187722 http://dx.doi.org/10.1016/j.eclinm.2022.101664 |
_version_ | 1784799409355096064 |
---|---|
author | 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 |
author_facet | 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 |
author_sort | Jones, Christopher M. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9519482 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-95194822022-09-30 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 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 eClinicalMedicine Articles 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. Elsevier 2022-09-23 /pmc/articles/PMC9519482/ /pubmed/36187722 http://dx.doi.org/10.1016/j.eclinm.2022.101664 Text en © 2022 Published by Elsevier Ltd. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Articles 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 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 |
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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9519482/ https://www.ncbi.nlm.nih.gov/pubmed/36187722 http://dx.doi.org/10.1016/j.eclinm.2022.101664 |
work_keys_str_mv | AT joneschristopherm useofanonendoscopicimmunocytologicaldevicecytospongeforpostchemoradiotherapysurveillanceinpatientswithoesophagealcancerintheukcytoflocamulticentrefeasibilitystudy AT oconnorheather useofanonendoscopicimmunocytologicaldevicecytospongeforpostchemoradiotherapysurveillanceinpatientswithoesophagealcancerintheukcytoflocamulticentrefeasibilitystudy AT odonovanmaria useofanonendoscopicimmunocytologicaldevicecytospongeforpostchemoradiotherapysurveillanceinpatientswithoesophagealcancerintheukcytoflocamulticentrefeasibilitystudy AT haywarddaniel useofanonendoscopicimmunocytologicaldevicecytospongeforpostchemoradiotherapysurveillanceinpatientswithoesophagealcancerintheukcytoflocamulticentrefeasibilitystudy AT blaskoadrienn useofanonendoscopicimmunocytologicaldevicecytospongeforpostchemoradiotherapysurveillanceinpatientswithoesophagealcancerintheukcytoflocamulticentrefeasibilitystudy AT harmanruth useofanonendoscopicimmunocytologicaldevicecytospongeforpostchemoradiotherapysurveillanceinpatientswithoesophagealcancerintheukcytoflocamulticentrefeasibilitystudy AT malhotrashalini useofanonendoscopicimmunocytologicaldevicecytospongeforpostchemoradiotherapysurveillanceinpatientswithoesophagealcancerintheukcytoflocamulticentrefeasibilitystudy AT debirambeechamirene useofanonendoscopicimmunocytologicaldevicecytospongeforpostchemoradiotherapysurveillanceinpatientswithoesophagealcancerintheukcytoflocamulticentrefeasibilitystudy AT aliasbincy useofanonendoscopicimmunocytologicaldevicecytospongeforpostchemoradiotherapysurveillanceinpatientswithoesophagealcancerintheukcytoflocamulticentrefeasibilitystudy AT baileyadam useofanonendoscopicimmunocytologicaldevicecytospongeforpostchemoradiotherapysurveillanceinpatientswithoesophagealcancerintheukcytoflocamulticentrefeasibilitystudy AT batemanandrew useofanonendoscopicimmunocytologicaldevicecytospongeforpostchemoradiotherapysurveillanceinpatientswithoesophagealcancerintheukcytoflocamulticentrefeasibilitystudy AT crosbytomdl useofanonendoscopicimmunocytologicaldevicecytospongeforpostchemoradiotherapysurveillanceinpatientswithoesophagealcancerintheukcytoflocamulticentrefeasibilitystudy AT falkstephen useofanonendoscopicimmunocytologicaldevicecytospongeforpostchemoradiotherapysurveillanceinpatientswithoesophagealcancerintheukcytoflocamulticentrefeasibilitystudy AT gollinssimon useofanonendoscopicimmunocytologicaldevicecytospongeforpostchemoradiotherapysurveillanceinpatientswithoesophagealcancerintheukcytoflocamulticentrefeasibilitystudy AT hawkinsmariaa useofanonendoscopicimmunocytologicaldevicecytospongeforpostchemoradiotherapysurveillanceinpatientswithoesophagealcancerintheukcytoflocamulticentrefeasibilitystudy AT kadrisudarshan useofanonendoscopicimmunocytologicaldevicecytospongeforpostchemoradiotherapysurveillanceinpatientswithoesophagealcancerintheukcytoflocamulticentrefeasibilitystudy AT levystephanie useofanonendoscopicimmunocytologicaldevicecytospongeforpostchemoradiotherapysurveillanceinpatientswithoesophagealcancerintheukcytoflocamulticentrefeasibilitystudy AT radhakrishnaganesh useofanonendoscopicimmunocytologicaldevicecytospongeforpostchemoradiotherapysurveillanceinpatientswithoesophagealcancerintheukcytoflocamulticentrefeasibilitystudy AT royrajarshi useofanonendoscopicimmunocytologicaldevicecytospongeforpostchemoradiotherapysurveillanceinpatientswithoesophagealcancerintheukcytoflocamulticentrefeasibilitystudy AT sripadamraj useofanonendoscopicimmunocytologicaldevicecytospongeforpostchemoradiotherapysurveillanceinpatientswithoesophagealcancerintheukcytoflocamulticentrefeasibilitystudy AT fitzgeraldrebeccac useofanonendoscopicimmunocytologicaldevicecytospongeforpostchemoradiotherapysurveillanceinpatientswithoesophagealcancerintheukcytoflocamulticentrefeasibilitystudy AT mukherjeesomnath useofanonendoscopicimmunocytologicaldevicecytospongeforpostchemoradiotherapysurveillanceinpatientswithoesophagealcancerintheukcytoflocamulticentrefeasibilitystudy |