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Original Research |

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

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

Research support: This research was supported by Veracyte Inc.

Conflicts of Interest: Drs. Vachani, Silvestri, and Ferguson served on a scientific advisory board for Allegro Diagnostics from April, 2012 to Sept, 2014. EC Parsons was formerly an employee of Allegro Diagnostics. DH Whitney is an employee of Veracyte. Dr. Spira is a consultant to Veracyte and a founder of Allegro Diagnostics. Dr. Lenburg is a consultant to Veracyte and former consultant to Allegro Diagnostics.

Clinical Trial Registration: NCT01309087 and NCT00746759

AUTHOR CONTRIBUTIONS

Dr. Vachani has access to all study data and takes responsibility for the integrity of the data and the accuracy of the analysis.

Dr. Vachani also contributed to the study design, data analysis and manuscript writing.

Dr. Parsons contributed to the study design, data analysis and manuscript writing.

Dr. Whitney contributed to the study design, data analysis and manuscript writing.

Dr. Lenburg contributed to the study design, data analysis and manuscript writing.

Dr. Silvestri contributed to the study design, data analysis and manuscript writing.

Dr. Ferguson contributed to the study design, data analysis and manuscript writing.

Dr. Spira contributed to the study design, data analysis and manuscript writing.

Address for Correspondence / Reprints: Anil Vachani, MD, MS University of Pennsylvania School of Medicine 1016E Abramson Research Center 3615 Civic Center Blvd Philadelphia, PA 19104 .


Copyright 2016, American College of Chest Physicians. All Rights Reserved.


Chest. 2016. doi:10.1016/j.chest.2016.02.636
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Abstract

Background  Bronchoscopy is often the initial diagnostic procedure performed in patients with pulmonary lesions suspicious for 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 evaluate 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 following an inconclusive bronchoscopy were identified. Estimates of the classifier’s ability 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 additional invasive procedures, which included surgical lung biopsy in 40 (52%) patients. Benign and malignant disease 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. Were the classifier 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 that were diagnosed with lung cancer, the sensitivity of the classifier was 89%, with 4 (11%) patients having a falsely negative classifier result.

Conclusions  Invasive procedures following an inconclusive bronchoscopy occur frequently and the majority 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.



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