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.
Footnotes
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Conflict of interest: Prof. Sullivan reports grants from Oncimmune Ltd., grants from Scottish Government Health & Social Care Directorate of the Chief Scientist Office (CSO), during the conduct of the study.
Conflict of interest: Prof. Mair has nothing to disclose.
Conflict of interest: Dr. Anderson has nothing to disclose.
Conflict of interest: Dr. Armory reports grants from Oncimmune Ltd., grants from Scottish Government Health & Social Care Directorate of the Chief Scientist Office (CSO), during the conduct of the study.
Conflict of interest: Prof. Briggs reports grants from Scottish Government Health & Social Care Directorate of the Chief Scientist Office (CSO), grants from Oncimmune Ltd., during the conduct of the study.
Conflict of interest: Dr. Chew has nothing to disclose.
Conflict of interest: Dr. Dorward has nothing to disclose.
Conflict of interest: Dr. Haughney has nothing to disclose.
Conflict of interest: Dr. Hogarth reports grants from Scottish Government Health and Social Care Directorate of the Chief Scientist Office, grants from Oncimmune Limited, during the conduct of the study.
Conflict of interest: Prof. Kendrick has nothing to disclose.
Conflict of interest: Dr. Littleford reports grants from Scottish Government Health & Social Care Directorate of the Chief Scientist Office (CSO), grants from Oncimmune Ltd., during the conduct of the study.
Conflict of interest: Prof. McConnachie reports grants from Oncimmune Ltd., grants from Scottish Government Health & Social Care Directorate of the Chief Scientist Office (CSO), during the conduct of the study.
Conflict of interest: Prof. McCowan has nothing to disclose.
Conflict of interest: Ms. McMeekin reports grants from Oncimmune Ltd., grants from Scottish Government Health & Social Care Directorate of the Chief Scientist Office (CSO), during the conduct of the study.
Conflict of interest: Dr. Patel has nothing to disclose.
Conflict of interest: Ms. Rauchhaus reports grants from Oncimmune Ltd., grants from Scottish Government Health & Social Care Directorate of the Chief Scientist Office (CSO), during the conduct of the study.
Conflict of interest: Prof. Ritchie has nothing to disclose.
Conflict of interest: Prof. Robertson reports other from Oncimmune, during the conduct of the study; other from Oncimmune, outside the submitted work; In addition, Dr. Robertson has a patent Named inventor on 7 families of patents - some have been issued and other pending. issued and Professor Robertson was a founder of Oncimmune, a company spun out from the University of Nottingham based on his academic research. Between 2003–2013 he was Chief Scientific Officer of Oncimmune and a Director of the company. During this time he was responsible for the original drafting of the ECLS protocol. Since 2013 he have had no involvement in the science or management of the company. He has been and remain a shareholder in the company.
Conflict of interest: Professor Robertson was a founder of Oncimmune, a company spun out from the University of Nottingham based on his academic research. Between 2003-2013 he was Chief Scientific Officer of Oncimmune and a Director of the company. During this time he was responsible for the original drafting of the ECLS protocol. Since 2013 he have had no involvement in the science or management of the company. He has been and remain a shareholder in the company
Conflict of interest: Dr. Robles-Zurita reports grants from Scottish Government Health & Social Care Directorate of the Chief Scientist Office (CSO), grants from Oncimmune Ltd., during the conduct of the study.
Conflict of interest: Dr. Sarvesvaran has nothing to disclose.
Conflict of interest: Prof. Sewell reports other from Oncimmune Ltd., outside the submitted work; and Professor Herb Sewell was an external member of the Oncimmune Scientific Advisory Board from 2006 to 2013.
Conflict of interest: Dr. Sproule has nothing to disclose.
Conflict of interest: Dr. Taylor reports grants, non-financial support and other from Oncimmune Ltd, grants and personal fees from Chief Scientist Office for Scotland, grants and non-financial support from Scottish Government, outside the submitted work.
Conflict of interest: Dr. Tello reports grants from Oncimmune Ltd., during the conduct of the study.
Conflict of interest: Prof. Treweek has nothing to disclose.
Conflict of interest: Prof. vedhara has nothing to disclose.
Conflict of interest: Dr. Schembri reports grants from Oncimmune Limited, grants from Scottish Government Health & Social Care Directorate of the Chief Scientist Office, during the conduct of the study; non-financial support from Glaxosmithkline, non-financial support from Astra Zeneca, outside the submitted work.
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- Received March 12, 2020.
- Accepted July 9, 2020.
- Copyright ©ERS 2020
