Abstract
Recommendations for lung cancer screening present a tangible opportunity to integrate predictive blood-based assays with radiographic imaging. This study compares performance of autoantibody markers from prior discovery in sample cohorts from two CT screening trials. One-hundred eighty non-cancer and 6 prevalence and 44 incidence cancer cases detected in the Mayo Lung Screening Trial were tested using a panel of six autoantibody markers to define a normal range and assign cutoff values for class prediction. A cutoff for minimal specificity and best achievable sensitivity were applied to 256 samples drawn annually for three years from 95 participants in the Kentucky Lung Screening Trial. Data revealed a discrepancy in quantile distribution between the two apparently comparable sample sets, which skewed the assay’s dynamic range towards specificity. This cutoff offered 43% specificity (102/237) in the control group and accurately classified 11/19 lung cancer samples (58%), which included 4/5 cancers at time of radiographic detection (80%), and 50% of occult cancers up to five years prior to diagnosis. An apparent ceiling in assay sensitivity is likely to limit the utility of this assay in a conventional screening paradigm. Pre-analytical bias introduced by sample age, handling or storage remains a practical concern during development, validation and implementation of autoantibody assays. This report does not draw conclusions about other logical applications for autoantibody profiling in lung cancer diagnosis and management, nor its potential when combined with other biomarkers that might improve overall predictive accuracy.
Highlights
Results from the 10-year National Lung Screening Trial (NLST) show low dose CT screening confers a survival benefit in the at-risk population [1]
Our group and others have been developing autoantibody assays that could complement CT scanning in lung cancer diagnosis and management [4,5,6,7,8,9]
The primary objective of the study was to determine the ability of an autoantibody profile to detect lung cancers at the time of or before CT scan
Summary
Results from the 10-year National Lung Screening Trial (NLST) show low dose CT screening confers a survival benefit in the at-risk population [1]. Radiographic imaging is the de-facto screening modality, circulating biomarkers have potential to enhance early detection initiatives and further improve outcomes [2,3,4,5,6]. Our group and others have been developing autoantibody assays that could complement CT scanning in lung cancer diagnosis and management [4,5,6,7,8,9]. Integrity and relative comparability of two screening sample cohorts from, each with a high percentage of cancer samples drawn prior to radiographic detection, offered a unique opportunity to test principles, precepts, and dominant objectives of investigation to date [7,8,9,16,17,18]
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