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Original Research: Lung Cancer |

Clinical Utility of a Bronchial Genomic Classifier in Patients With Suspected Lung Cancer

Anil Vachani, MD; Duncan H. Whitney, PhD; Edward C. Parsons, PhD; Marc Lenburg, PhD; J. Scott Ferguson, MD; Gerard A. Silvestri, MD; Avrum Spira, MD
Author and Funding Information

FUNDING/SUPPORT: This research was supported by Veracyte Inc.

aPulmonary, Allergy, and Critical Care Division, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA

bVeracyte Inc, South San Francisco, CA

cAllegro Diagnostics, Boston, MA

dDivision of Computational Biomedicine, Department of Medicine, Boston University School of Medicine, Boston, MA

eAllergy, Pulmonary, and Critical Care, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI

fDivision of Pulmonary and Critical Care, Department of Medicine, Medical University of South Carolina, Charleston, SC

CORRESPONDENCE TO: Anil Vachani, MD, University of Pennsylvania School of Medicine, 1016E Abramson Research Center, 3615 Civic Center Blvd, Philadelphia, PA 19104


Copyright 2016, The Authors. All Rights Reserved.


Chest. 2016;150(1):210-218. doi:10.1016/j.chest.2016.02.636
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Background  Bronchoscopy is often the initial diagnostic procedure performed in patients with pulmonary lesions suggestive of lung cancer. A bronchial genomic classifier was previously validated to identify patients at low risk for lung cancer after an inconclusive bronchoscopy. In this study, we evaluated the potential of the classifier to reduce invasive procedure utilization in patients with suspected lung cancer.

Methods  In two multicenter trials of patients undergoing bronchoscopy for suspected lung cancer, the classifier was measured in normal-appearing bronchial epithelial cells from a mainstem bronchus. Among patients with low and intermediate pretest probability of cancer (n = 222), subsequent invasive procedures after an inconclusive bronchoscopy were identified. Estimates of the ability of the classifier to reduce unnecessary procedures were calculated.

Results  Of the 222 patients, 188 (85%) had an inconclusive bronchoscopy and follow-up procedure data available for analysis. Seventy-seven (41%) patients underwent an additional 99 invasive procedures, which included surgical lung biopsy in 40 (52%) patients. Benign and malignant diseases were ultimately diagnosed in 62 (81%) and 15 (19%) patients, respectively. Among those undergoing surgical biopsy, 20 (50%) were performed in patients with benign disease. If the classifier had been used to guide decision making, procedures could have been avoided in 50% (21 of 42) of patients undergoing further invasive testing. Further, among 35 patients with an inconclusive index bronchoscopy who were diagnosed with lung cancer, the sensitivity of the classifier was 89%, with 4 (11%) patients having a false-negative classifier result.

Conclusions  Invasive procedures after an inconclusive bronchoscopy occur frequently, and most are performed in patients ultimately diagnosed with benign disease. Using the genomic classifier as an adjunct to bronchoscopy may reduce the frequency and associated morbidity of these invasive procedures.

Trial Registry  ClinicalTrials.gov; Nos. NCT01309087 and NCT00746759; URL: www.clinicaltrials.gov

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