PURPOSE: EarlyCDT-LungTM detects autoantibodies to a panel of six lung cancer-associated antigens with sensitivity of 40% and specificity of 90%. EarlyCDT-Lung has been shown to aid in detecting early-stage disease just as well as late-stage disease in high-risk individuals. The positivity rate for each antigen by stage of disease and histological subtype are presented.
METHODS: Patients with lung cancers (N=842) had EarlyCDT-Lung test measured on a serum sample taken post-diagnosis but prior to treatment. These comprised a previously-reported validation dataset and four further independent (post-validation) datasets. The previously-validated cutoff for each autoantibody assay was applied to all samples.
RESULTS: The positivity rates for the panel by stage of disease for non-small cell lung cancer (NSCLC) was 28.0% (stage 1), 35.1% (stage 2), 30.6% (stage 3) and 34.4% (stage 4) while for small cell lung cancer (SCLC) it was 49.4% and 53.1% for limited and extensive disease, respectively. There was no significant difference with increasing stage. Within stages, the positivity rate for individual autoantibody assays ranged in NSCLC from 0%-15.8% and in SCLC from 2.5%-30.9%.The positivity rates for the panel by each histological subtype of NSCLC was 25.7% (adenocarcinoma), 33.3% (large cell) and 31.1% (squamous) while for SCLC it was higher at 51.4%. Within a histological subtype, the positivity rate for individual autoantibodies ranged from 4.1%-7.8% in adenocarcinoma, 0%-13.3% in large cell, 3.0%-10.6% in squamous and 5.5%-28.6% in SCLC.
CONCLUSION: These data confirm that the panel of autoantibodies measured by EarlyCDT-Lung helps detect early-stage lung cancers with similar sensitivity to late-stage for high-risk individuals. Within this large dataset, there is a wide range of positivity for individual autoantibody assays by stage of disease and histological subtype.
CLINICAL IMPLICATIONS: The presence of autoantibodies may provide an early indication of lung cancer, even in early-stage disease and may be useful in the management of high-risk individuals. Differences in the autoantibody profiles may in the future be useful in identifying what subtype or stage of lung cancer a patient is most likely to have.
DISCLOSURE: Peter Boyle, Shareholder J. Robertson is a shareholder of Oncimmune Ltd.; Employee L. Peek is an employee of Oncimmune USA LLC; G. Healey and A. Murray are employees of Oncimmune Ltd.; Consultant fee, speaker bureau, advisory committee, etc. P. Boyle and W. Wood are members of a Scientific Advisory Board for Oncimmune Ltd. C. Chapman is a consultant to Oncimmune Ltd.; No Product/Research Disclosure Information