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VH Eisenberg



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    P2.11 - Screening and Early Detection (Not CME Accredited Session) (ID 960)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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      P2.11-20 - Lung EpiCheck TM - Results of the Training and Test Sets of a Methylation-Based Blood Test for Early Detection of Lung Cancer (ID 14537)

      16:45 - 18:00  |  Author(s): VH Eisenberg

      • Abstract
      • Slides

      Background

      Lung cancer is the leading cause of death from cancer worldwide. Screening with low-dose CT reduces mortality but is associated with substantial cost and harm[1].

      Dying tumor cells release cell-free DNA (cfDNA) [2], where cancer-specific methylation changes can be detected[3].

      [1] NLST. NEJM2011;365:395-409

      [2] Rauch et al. ProcNatlAcadSciUSA2008;105:252–257

      [3] Diehl et al. NatMed2008;14:985–990

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Plasma was collected from 23 centers and biobanks in Europe and Israel under IRB & informed consent.

      Inclusion criteria

      Cases

      Pathologically confirmed primary lung cancer

      Treatment naïve

      Controls

      Age 50-80 years

      Current/former smoker

      Exclusion criteria (cases only)

      Current diagnosis or history of cancer (other than lung cancer)

      Lung EpiCheck is a blood test that detects lung cancer-associated hypermethylation changes in 6 markers in cfDNA using real-time PCR. The algorithm for calculating EpiScore as well as the threshold for positivity were decided based on the training set and then tested on an independent test set.

      4c3880bb027f159e801041b1021e88e8 Result

      Table 1. Subject characteristics

      Training set

      test set

      Cases

      Controls

      Cases

      Control

      Number

      102

      265

      181

      141

      Age

      Range

      51-83

      50-82

      23-90

      51-88

      Average

      66

      63

      66

      64

      Gender # (%)

      Male

      70 (69)

      162 (61)

      133 (73)

      90 (63)

      Female

      32 (31)

      103 (39)

      48 (27)

      51 (36)

      Histology subtype # (%)

      Adenocarcinoma

      44 (43)

      77 (43)

      Squamous cell carcinoma

      37 (36)

      67 (37)

      Other NSCLC

      8 (8)

      18 (10)

      Small cell lung cancer

      10 (10)

      13 (7)

      Other

      3 (3)

      6 (3)

      Stage NSCLC # (%)

      I

      26 (28)

      39 (23)

      II

      21 (23)

      26 (15)

      III

      23 (25)

      62 (37)

      IV

      19 (21)

      36 (21)

      Unstaged

      3 (3)

      5 (3)

      Table 2. Lung EpiCheck performance

      Training set

      Test set

      AUC

      0.890

      0.887

      Specificity

      94%

      91%

      Sensitivity

      Overall

      74%

      74%

      Histological subtype*

      Adenocarcinoma

      57%

      71%

      Squamous Cell Carcinoma

      78%

      73%

      Other NSCLC

      88%

      50%

      Small cell carcinoma

      90%

      92%

      Unknown

      50%

      71%

      NSCLC

      Stage I

      50%

      59%

      Stage II

      67%

      77%

      Stage III

      82%

      76%

      Stage IV

      94%

      83%

      Unstaged

      100%

      40%

      Small cell lung cancer

      Limited

      67%

      100%

      Extensive

      100%

      86%

      8eea62084ca7e541d918e823422bd82e Conclusion

      Such promising results combined with the simplicity of the test, could offer added value in the fight against lung cancer.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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