Earlier diagnosis of lung cancer in a randomised trial of an autoantibody blood test followed by imaging
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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.
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
European Respiratory Journal
Copyright © 2020 ERS. This work has been made available online in accordance with publisher policies or with permission. Permission for further reuse of this content should be sought from the publisher or the rights holder. This is the author created accepted manuscript following peer review and may differ slightly from the final published version. The final published version of this work is available at https://doi.org/10.1183/13993003.00670-2020
DescriptionFunding: Scottish Government Health and Social Care Directorate, and Oncimmune Ltd.
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