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

Sullivan, Frank M. and Mair, Frances S. and Anderson, William and Armory, Pauline and Briggs, Andrew and Chew, Cindy and Dorward, Alistair and Haughney, John and Hogarth, Fiona and Kendrick, Denise and Littleford, Roberta and McConnachie, Alex and McCowan, Colin and McMeekin, Nicola and Patel, Manish and Rauchhaus, Petra and Ritchie, Lewis and Robertson, Chris and Robertson, John and Robles-Zurita, Jose and Sarvesvaran, Joseph and Sewell, Herbert and Sproule, Michael and Taylor, Thomas and Tello, Agnes and Treweek, Shaun and Vedhara, Kavita and Schembri, Stuart, Early Diagnosis of Lung Cancer Scotland (ECLS) Team (2021) Earlier diagnosis of lung cancer in a randomised trial of an autoantibody blood test followed by imaging. European Respiratory Journal, 57 (1). 00670. ISSN 0903-1936 (https://doi.org/10.1183/13993003.00670-2020)

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The EarlyCDT-Lung test is a high-specificity blood-based autoantibody biomarker that could contribute to predicting lung cancer risk. We report on the results of a phase IV biomarker evaluation of whether using the EarlyCDT-Lung test and any subsequent computed tomography (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. The Early Diagnosis of Lung Cancer Scotland (ECLS) trial was a randomised controlled trial of 12208 participants at risk of developing lung cancer in Scotland in the UK. The intervention arm received the EarlyCDT-Lung test and, if test-positive, low-dose CT scanning 6-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 out of 56 (58.9%) lung cancers were diagnosed at stage III/IV compared with 52 out of 71 (73.2%) in the control arm. The hazard ratio for stage III/IV presentation was 0.64 (95% CI 0.41-0.99). There were nonsignificant 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 low-dose CT.