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F. Aquilini



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    MA01 - Improvement and Implementation of Lung Cancer Screening (ID 368)

    • Event: WCLC 2016
    • Type: Mini Oral Session
    • Track: Radiology/Staging/Screening
    • Presentations: 1
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      MA01.09 - Mortality, Survival and Incidence Rates in the ITALUNG Randomised Lung Cancer Screening Trial (ITALY) (ID 4249)

      11:54 - 12:00  |  Author(s): F. Aquilini

      • Abstract
      • Slides

      Background:
      Low Dose Computed Tomography (LDCT) screening for lung cancer (LC) is still not recommended in Europe.

      Methods:
      71.232 invitation letters were sent to subjects registered with local General Practitioners, aged 55­69 years. (Fig.1) From eligible respondents, we randomised 3206 eligible subjects, smokers and ex- smokers (< 10 years), to the active arm receiving 4 annual LDCT (n=1613) and to control arm receiving usual care (n=1593). Each LDCT was read by 2 radiologists and size of Non Calcific Nodules measured manually. Study design and performance data were already published. All subjects, enrolled from 2004-2009,were followed up for lung cancer incidence and mortality (average: 8.3 and 9.3 years, respectively); characteristics of enrolled subjects are presented in Table1. Figure 1Figure 2





      Results:
      Reductions of 17% (RR=0.83; 95%: 0.67-1.03) for overall and 30% (RR=0.70; 95%CI: 0.47-1.03) for LC-specific mortality were estimated. 67 lung cancers were diagnosed in the active, compared with 72 in the control group (RR=0.92; 95%CI: 0.66–1.28). A greater proportion of Stage I (36% vs 6%, (p<0.0001) was observed in the active group.

      Conclusion:
      LDCT screening could reduce LC-specific and overall mortality. The number of Lung cancer diagnosed in the two groups did not suggest over-diagnosis, after 8.5 years of follow-up time.

      Information from this presentation has been removed upon request of the author.

      Information from this presentation has been removed upon request of the author.

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    P1.03 - Poster Session with Presenters Present (ID 455)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Radiology/Staging/Screening
    • Presentations: 1
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      P1.03-046 - Selection of Subjects at High-Risk for LDCT Lung Cancer Screening Using a Molecular Panel: Results by the ITALUNG Biomarker Study (ID 4279)

      14:30 - 14:30  |  Author(s): F. Aquilini

      • Abstract

      Background:
      Low Dose Computer Tomography (LDCT) screening has been shown effective in reducing overall and lung cancer mortality, but there are still concerns for efficiency and the cost/harm benefit ratio.reduce costs. Subjects enrolled in trials evaluating LCDT as a test for the early detection of lung cancer represent the ideal population in which to study the possible use of molecular markers in a combined approach of screening.

      Methods:
      Out of 1406 subjects randomised in the intervention arm of the ITALUNG study and attending at baseline test, 1356 were enrolled, after specific consent, in the ITALUNG biomarker study. Screen detected lung cancers detected over the 4-years of screening (N=36 out of 38 in ITALUNG active arm) and 481 randomly selected subjects without lung cancer at end of the study follow up, were included in this analysis . DNA in plasma was quantified at baseline by Real Time PCR; microsatellite instability (MSI) and loss of heterozygosity (LOH) was assessed in blood and sputum. ITALUNG Biomarker Panel (IBP) was considered as positive if MSI /LOH and/or DNA Plasma values (cutoff 5 ng / ml) were positive.

      Results:
      The IBP results are shown in Table 1. Accuracy measure were estimated and showed high sensitivity for baseline screen-detected cases (94.4%) with a specificity of 60.0% (ROC Area:77%). Sensitivity and specificity were 66.7% and 60.1% for lung cancers screen detected at repeated LDCT (ROC Area: 63.4%). Figure 1



      Conclusion:
      The IBP showed good accuracy for the identification of screen detected baseline lung cancers, with a very high sensitivity and a specificity of about 60%. The analysis of IBP of the baseline sample showed low prediction at repeated test. IBP was confirmed as a potentially valid tool for baseline selection of high-risk subjects, saving about the 60% of the tests. Low predictive capacity of screen detected cases at repeated tests needs further investigation.