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

Sullivan, F. et al. (2021) Earlier diagnosis of lung cancer in a randomised trial of an autoantibody blood test followed by imaging. European Respiratory Journal, 57(1), 2000670. (doi: 10.1183/13993003.00670-2020) (PMID:32732334)

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 2 years. EarlyCDT-Lung test negative and control arm participants received standard clinical care. Outcomes were assessed at 2 years post-randomisation using validated data on cancer occurrence, cancer staging, mortality and comorbidities. At 2 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 2 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.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Patel, Professor Manish and McConnachie, Professor Alex and Chew, Cindy and Mcmeekin, Dr Nicola and Haughney, Dr John and Mair, Professor Frances and Robles-Zurita, Dr José and Mccowan, Professor Colin and Briggs, Professor Andrew
• Authors: Sullivan, F., 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., Sarvesvaran, J., Sewell, H., Sproule, M., Taylor, T., Tello, A., Treweek, S., Vedhara, K., and Schembri, S.
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > General Practice and Primary Care; College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Health Economics and Health Technology Assessment; College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre; College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
• Journal Name: European Respiratory Journal
• Publisher: European Respiratory Society
• ISSN: 0903-1936
• ISSN (Online): 1399-3003
• Published Online: 30 July 2020
• Copyright Holders: Copyright © ERS 2021
• First Published: First published in European Respiratory Journal 57(1):2000670
• Publisher Policy: Reproduced in accordance with the publisher copyright policy