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Stuart Schembri

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    PL02 - Presidential Symposium including Top 7 Rated Abstracts (ID 89)

    • Event: WCLC 2019
    • Type: Plenary Session
    • Track:
    • Presentations: 1
    • Now Available
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      PL02.03 - Early Detection of Cancer of the Lung Scotland (ECLS): Trial Results (Now Available) (ID 557)

      08:00 - 10:15  |  Author(s): Stuart Schembri

      • Abstract
      • Presentation
      • Slides


      Scotland has one of the highest rates of lung cancer in the world -- 460 men and 340 women in 100 000 are diagnosed with lung cancer every year. In the UK, survival from lung cancer is poor with less than 9% of patients still alive at five years after diagnosis, due primarily to the late stage of presentation. The EarlyCDT®-Lung Test is a novel Autoantibody(AAB) diagnostic test for the early detection of lung cancer allowing stratification of individuals according to their risk of developing lung cancer. The Test measures seven AABs; p53, NYESO-1, CAGE, GBU4-5, HuD, MAGE A4 & SOX2. It identifies 41% of lung cancers with a high specificity of 90%. This compares to CT scanning, which when used
      alone as a prevalence screening test, identifies 67% of lung cancers developing over the following 12 months, but has a low specificity of around 49%. The autoantibodies detected in the test have not been shown to vary with age, gender and ethnicity. The primary research question is: ‘Does using the EarlyCDT®-Lung Test, followed by X-ray and CT scanning, to identify those at high risk of lung cancer reduce the incidence of patients with late-stage lung cancer (III & IV) or unclassified presentation (U) at diagnosis, compared to standard clinical practice?’


      An RCT in 12,208 participants

      Asymptomatic adults aged 50 to 75 who had a high risk of developing lung cancer over the next 24 months were eligible to participate. 5 290/12 209 (43.3%) of the subjects lived in the most deprived quintile with the mean age at recruitment 60.5 years and the mean pack years smoked 38.2 . Participants were allocated to intervention or comparison group during the recruitment visit using a web-based randomization system. Test positive patients were offered a chest X-ray followed by a non-contrast thoracic CT scan. If the initial CT scan revealed no evidence of lung cancer then subsequent CT scans were offered 6 monthly for 24 months. Individuals with abnormalities were followed up over the study period or referred for clinical care as appropriate. All individuals entering the study were followed up via record linkage including the Scottish Cancer Registry.


      UK standard clinical practice



      The difference, at 24 months after randomisation, between the rates of patients with stage III, IV or unclassified lung cancer at diagnosis in the intervention arm & control arm;


      Eight further measures including mortality, economic and psychological.

      Using an assumption of 600/100,000 for late stage lung cancer in the population studied and acknowledging that recruitment is over a 2 year period the study has a power of 80% to detect a 35% reduction associated with the use of the EarlyCDT-Lung test to identify cases.

      Cox proportional hazards models were used to estimate the hazard ratio of the rate of late stage lung cancer in the intervention arm compared to the control arm. Participants who were lost to follow up were censored. The models adjust for age, gender, smoking history, and practice. Random cluster effects were included rather than fixed effects for practices. Comparisons of proportions were carried out using chi square tests. Fisher’s Exact test was used if the numbers of events are small.


      127 lung cancers were diagnosed in the study period (56 in the intervention group and 71 in the control arm). 9.8% of the intervention group had a positive EarlyCDT-Lung test and 3.4% (n=18) of these were diagnosed with lung cancer in the study period.

      Fewer participants in the intervention group were diagnosed at a late-stage (III & IV) compared with the control group (33 vs 52). The rate of late-stage (III & IV) lung cancer diagnosis in the intervention group was 58.9% and in the control group was 73.2%. The number of early-stage (I & II) lung cancers diagnosed in the intervention group was higher than in the control group (23 vs 19). The EarlyCDT-Lung test was positive for 12 of
      the 23 early cancers (sensitivity 52.2%, 95% CI 30.6% to 73.2%) and for 6 of the 33 late-stage cancers (sensitivity 18.2%, 95% CI 7.2% to 35.5%).

      The study was not powered to detect a difference in mortality, however there was a non significant trend suggesting fewer deaths in the intervention arm compared to the control (87 vs 108 respectively). Similar results were noted relating to lung cancer-specific mortality (17 vs 24).


      Our results show that the combination of the EarlyCDT-Lung followed by CT imaging in those with a positive blood test, results in a significant decrease in late stage diagnosis of lung cancer and may decrease all cause and lung cancer specific mortality. We shall continue follow up of all participants’ lung cancer and mortality outcomes at 5 years using Scottish ISD (Information Services Division) data to study these effects further.

      Blood-based biomarker panels, such as the EarlyCDT-Lung test, may have an important role in future lung cancer screening programmes. Further studies including ones to establish the ideal testing frequency are required.

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