Diagnostic characteristics of a serum biomarker in patients with positron emission tomography scans.

Grogan EL, Deppen S, Pecot CV, Putnam JB, Nesbitt JC, Shyr Y, Rajanbabu R, Ory B, Lambright ES, Massion PP
Ann Thorac Surg. 2010 89 (6): 1724-8; discussion 1728-9

PMID: 20494018 · PMCID: PMC3026702 · DOI:10.1016/j.athoracsur.2010.03.008

BACKGROUND - Surgery for pulmonary nodules results in a benign diagnosis in 10% to 30% of cases. Computed tomography and fluorodeoxyglucose-positron emission tomography (FDG-PET) are highly sensitive but less specific. High-risk patients (age > 55 years and smoke > 15 pack-years) for lung cancer with negative FDG-PET scans, or low-risk patients (age < 55 years or smoke < 15 pack-years) with FDG-PET-avid lesions may have higher rates of benign nodules. We hypothesized that our serum biomarker improves diagnostic accuracy by providing greater specificity.

METHODS - Fifty-eight patients with pulmonary nodules (< or = 3 cm) were prospectively enrolled. We tested the accuracy of our proteomic biomarker in the serum by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry. Malignancy rates, contingency tables, sensitivity, and specificity analyses were calculated for the entire group and in a subset of patients at high risk for benign disease.

RESULTS - We identified 46 (79%) lung cancers and 12 (21%) benign lesions. Forty-five nodules were FDG-PET-avid. In 36 high-risk patients with FDG-PET-avid lesions, 32 (89%) had cancer. Of the remaining 22 lower-risk patients, 14 (64%) had cancer (p = 0.02). The serum biomarker sensitivity was 26.1%, specificity was 91.7%, positive predictive value was 92%, negative predictive value was 24%, and overall accuracy was 40%. The serum signature accurately predicted all eight benign nodules in this 22-patient subset.

CONCLUSIONS - The serum protein biomarker has a high specificity. This biomarker has a high positive predictive value but low negative predictive value and may improve noninvasive evaluation of lung nodules. Validation in a larger population is warranted.

2010 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

MeSH Terms (13)

Aged Biomarkers Blood Proteins Diagnosis, Differential Female Humans Lung Neoplasms Male Middle Aged Multiple Pulmonary Nodules Positron-Emission Tomography Prospective Studies Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization

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