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., Dorward, A., Haughney, J., Hogarth, F., Kendrick, D., Littleford, R., McConnachie, A., McCowan, C., Mcmeekin, N., Patel, M., Rauchhaus, P., Ritchie, L., Robertson, C., Robertson, J., Robles-Zurita, J., …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