Earlier diagnosis of lung cancer in a randomised trial of an autoantibody blood test followed by imaging
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.
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 , Sarvesvaran , J , Sewell , H , Sproule , M , Taylor , T , Tello , A , Treweek , S , Vedhara , K & Schembri , S 2021 , ' Earlier diagnosis of lung cancer in a randomised trial of an autoantibody blood test followed by imaging ' , European Respiratory Journal , vol. 57 , no. 1 , 2000670 . https://doi.org/10.1183/13993003.00670-2020
Publication
European Respiratory Journal
Status
Peer reviewed
ISSN
0903-1936Type
Journal article
Description
Funding: Scottish Government Health and Social Care Directorate, and Oncimmune Ltd.Collections
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