Earlier diagnosis of lung cancer in a randomised trial of an autoantibody blood test followed by imaging

Sullivan, Frank M.; Mair, Frances S.; Anderson, William; Armory, Pauline; Briggs, Andrew; Chew, Cindy; Dorward, Alistair; Haughney, John; Hogarth, Fiona; Kendrick, Denise; Littleford, Roberta; McConnachie, Alex; McCowan, Colin; Mcmeekin, Nicola; Patel, Manish; Rauchhaus, Petra; Ritchie, Lewis; Robertson, Chris; Robertson, John; Robles-Zurita, Jose; Sarvesvaran, Joseph; Sewell, Herbert; Sproule, Michael; Taylor, Thomas; Tello, Agnes; Treweek, Shaun; Vedhara, Kavita; Schembri, Stuart

Abstract

The EarlyCDT-Lung test is a high specificity blood-based autoantibody biomarker that could contribute to predicting lung cancer risk. Here we report on the results of a phase IV biomarker evaluation of whether using the EarlyCDT-Lung test and any subsequent CT scanning to identify those at high risk of lung cancer reduces the incidence of patients with stage III/IV/Unspecified lung cancer at diagnosis, compared with the standard clinical practice at the time the study began.

ECLS was a randomised controlled trial of 12,208 participants at risk of developing lung cancer in Scotland. The intervention arm received the EarlyCDT-Lung test and, if test positive, low-dose CT scanning six-monthly for up to two years. EarlyCDT-Lung test negative and control arm participants received standard clinical care. Outcomes were
assessed at two years post-randomisation using validated data on cancer occurrence, cancer staging, mortality and comorbidities.
At two years, 127 lung cancers were detected in the study population (1.0%). In the intervention arm, 33/56 (58.9%) lung cancers were diagnosed at stage III/IV compared to 52/71 (73.2%) in the control arm. The hazard ratio for stage III/IV presentation was 0.64 (95% confidence interval 0.41, 0.99). There were non-significant differences in lung cancer and all-cause mortality after two years.

ECLS compared EarlyCDT-Lung plus CT screening to standard clinical care (symptomatic presentation), and was not designed to assess the incremental contribution of the EarlyCDT-Lung test. The observation of a stage-shift towards earlier-stage lung cancer diagnosis merits further investigations to evaluate whether the EarlyCDT-Lung test adds anything to the emerging standard of LDCT.

Registration: ClinicalTrials.Gov registration number NCT01925625.

Citation

Sullivan, F. M., Mair, F. S., Anderson, W., Armory, P., Briggs, A., Chew, C., …Schembri, S. (2021). Earlier diagnosis of lung cancer in a randomised trial of an autoantibody blood test followed by imaging. European Respiratory Journal, 57(1), Article 2000670. https://doi.org/10.1183/13993003.00670-2020

• Journal Article Type: Article
• Acceptance Date: Jul 10, 2020
• Online Publication Date: Jul 30, 2020
• Publication Date: Jan 14, 2021
• Deposit Date: Jul 21, 2020
• Publicly Available Date: Jul 31, 2021
• Journal: European Respiratory Journal
• Print ISSN: 0903-1936
• Electronic ISSN: 1399-3003
• Publisher: European Respiratory Society
• Peer Reviewed: Peer Reviewed
• Volume: 57
• Issue: 1
• Article Number: 2000670
• DOI: https://doi.org/10.1183/13993003.00670-2020
• Keywords: Early CDT-Lung, blood-based biomarker, phase IV biomarker evaluation, lung cancer, lung cancer screening, primary care
• Public URL: https://nottingham-repository.worktribe.com/output/4765238
• Publisher URL: https://erj.ersjournals.com/content/57/1/2000670