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A Goldhaber
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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): A Goldhaber
- Abstract
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%
Such promising results combined with the simplicity of the test, could offer added value in the fight against lung cancer.
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