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D. Rollins
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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: 2
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.03-045 - Screening for Lung Cancer with Early CDT-Lung Blood Biomarkers and Computed Tomography (ID 6148)
14:30 - 14:30 | Author(s): D. Rollins
- Abstract
Background:
The Early Cancer Detection Test (CDT)-Lung is a serum-based biomarker consisting of a panel of tumor-associated autoantibodies that has been shown to detect lung cancer. We hypothesized that this biomarker when used in combination with a low-dose CT (LDCT) in screening of an at-risk population would increase the detection of early stage lung cancer.
Methods:
A prospective study of 1,600 subjects at high risk for lung cancer was designed. Eligibility criteria included persons 50-75 years of age, current or former smokers of ≥ 20 pack years and ˂ 10 years since quit smoking. Those with a history of lung cancer in first-degree relative(s) and any history of smoking were included. Exclusion criteria were any history of cancer within 10 years (except skin cancer), any use of oxygen, and life expectancy of < 5 years. Those fitting inclusion criteria received the Early CDT-Lung blood test and a LDCT. A nodule of ≥ 3mm was considered as a positive scan. The Early CDT-Lung test was considered positive if any one of the seven autoantibodies was positive. Telephonic follow-up was conducted over two years.
Results:
From May 2012 through June 2016, 1235 individuals were enrolled. The cohort median age was 59 years with 55% female and 45% male gender distribution. Fifty-two per cent were current smokers while 48% were former smokers. Seventy-one per cent of the LDCTs were negative for any lung nodule while 29% were positive. The Early CDT-Lung biomarker was positive in 88 (7%) of participants. In those with a positive LDCT (n=352), the biomarker was positive in 30 (8.5%). As of June 30, 2015, there have been seven confirmed lung cancers: two limited stage small cell, two Stage IB adenocarcinoma (ACA), and three Stage IA (two ACA and one squamous cell). The Early CDT-Lung blood test was positive in 2 of the 7 (29%) total cancers, both stage 1A. Early CDT-Lung was positive in 2 of 5 (40%) Stage IA/B lung cancers in total. Early CDT-Lung was negative in the two small cell cancers. There are 58 Early CDT-Lung biomarker positive individuals with a LDCT without nodules. (NCT01700257)
Conclusion:
The Early CDT-Lung biomarker was more likely to be positive in patients with nodules and lung cancer cases, particularly early stage lung cancer. Accrual to the study and follow-up of 58 biomarker positive but LDCT negative participants continues.
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P1.03-077 - Analysis of the Early CDT-Blood Biomarker for Lung Cancer in Higher vs. Lower Risk Cohorts (ID 5079)
14:30 - 14:30 | Author(s): D. Rollins
- Abstract
Background:
The Early Cancer Detection Test (CDT)-Lung Cancer Screening (LCS) Study is a prospective, lung cancer screening study testing the hypothesis that a serum biomarker consisting of a panel of seven cancer-associated autoantibodies, in combination with a low-dose CT (LDCT), would increase detection of early stage lung cancer. We analyzed nodules rates and lung cancer in “higher risk” individuals who meet the USPSTF LCS criteria (http://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/lung-cancer-screening) and “lower risk” individuals who do not meet these criteria.
Methods:
The EarlyCDT LCS study eligibility criteria included persons 50-75 years of age, current or former smokers of ≥ 20 pack years, former smokers have ˂ 10 years since quit smoking. Additionally, those with a history of lung cancer in first-degree relative(s) and any history of smoking were also included. Exclusion criteria included any history of cancer within 10 years (except skin cancer), any use of oxygen, or life expectancy < 5 years. The EarlyCDT-Lung test was considered positive if any one of the seven autoantibodies was positive.
Results:
From May 2012 through June 2016, 1235 individuals were enrolled (final target 1600). The median age was 59 years, 55% were female and 45% were male. Fifty-two per cent were current smokers while 48% were former smokers. Fifty-three percent of participants were higher risk and 47% were lower risk. The EarlyCDT-Lung was positive in 8% of higher risk individuals and 6% of lower risk individuals. Thirty-five per cent of higher risk individuals had nodules on LDCT while 27% of lower risk participants had nodules on LDCT. The EarlyCDT-Lung blood test was positive in 91 patients, 77 were higher risk and 34 were lower risk. There were 7 lung cancers, all in the higher risk group, resulting in a lung cancer rate of 1.07% in the higher risk group. The median pack years of individuals with lung cancer was 60 and the median age was 64 years. Two of the 7 lung cancer patients were positive for the EarlyCDT test. The relative risk of lung cancer in patients with a positive EarlyCDT test was 5.5 for the entire cohort and 4.5 for the higher risk group for lung cancer.
Conclusion:
There were more total nodules in the higher risk group compared to the lower risk group. There were more lung cancers in the higher risk group compared with the lower risk group. A positive EarlyCDT test is associated with an increased risk of lung cancer.
