SESSION TYPE: Lung Cancer Posters I
PRESENTED ON: Wednesday, October 24, 2012 at 01:30 PM - 02:30 PM
PURPOSE: The objective of this study is to validate candidate biomarkers for the detection of lung cancer, to develop a high risk cohort and to determine whether a surveillance program will lead to early diagnosis and improved outcomes.
METHODS: We plan to enroll a cohort of 480 high-risk subjects at three sites (160 participates/site) (Vanderbilt University Medical Center, Matthew Walker Comprehensive Health Center, and the Tennessee Valley VA Healthcare System) in a five year annual screening trial for lung cancer. At each screening visit participants complete: annual blood, urine, nasal, buccal cells and sputum collection; spirometry (year 0), a low dose chest CT (year 0,1,2,5), Helical CT, slice thickness 1.25, interval 1.25 mm, 128 slice Philips scanner, autofluorescence bronchoscopy (year 0,2,5) to collect bronchial brushings and endobronchial biopsies from three pre-determined areas. Inclusion Criteria: 10 year Bach risk model >2.5%, 55 - 74 years of age, at least 25 years of smoking, at least 10 cigarettes/day, current smoker or former smoker with at least 20 PKY history of cigarette smoking total, who quit 20 years ago or less. Plus one of the following: FEV1% <70%, one or more first-degree relative with history of lung cancer, moderate or severe emphysema.
RESULTS: To date 1219 subjects have been prescreened, 762 were not eligible, we were unable to contact 62, 60 declined, 70 are on study and 131 are under review. Data has been collected for 68 subjects. Expected accrual at this point is 175. The average age is 63 (+/- 5.2), 38 (55%) are males, 63 (93%) are caucasian, 42 (39%) were ex smokers, with a 55 (+/- 21.8) pack year history of smoking and the mean FEV1 is 78% (+/- 18.6). Low dose CT has detected 156 nodules (2 per subject) and 9 subjects had no nodules. There have been no bronchoscopy detected cancers. CT found 1 T1N0MO squamous cell carcinoma that was surgically removed. Two CT detected suspicious nodules are undergoing evaluation.
CONCLUSIONS: The Nashville Lung cancer screening trial is now open at all sites. Accrual is below target. Surrogate tissues are being collected and stored in biorepository for diagnosis and risk assessment of lung cancer. CT has detected nodules in 86% of participants and found 1 nodule resected for presumed cure.
CLINICAL IMPLICATIONS: A more specific test than CT and a well defined risk model will reduce the number of false positive clinical evaluations
DISCLOSURE: The following authors have nothing to disclose: Otis Rickman, Anel Muterspaugh, Sanja Antic, Ronald Walker, Pierre Massion
Lung cancer screeningVanderbilt University Medical Center, Nashville, TN