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Signs and Symptoms of Chest Diseases |

Bronchial Airway Gene-Expression Testing Improves the Diagnostic Yield of Bronchoscopy for Lung Cancer: Results of the AEGIS Trial

Duncan Whitney*, PhD; Jun Luo, MS; Kate Porta, MPH; Marc Lenburg, PhD; Jerome Brody, MD; Armin Ernst, MD; Anil Vachani, MD; J. Ferguson, MD; Gerard Silvestri, MD; Avrum Spira, MD
Author and Funding Information

Allegro Diagnostics Corp, Maynard, MA


Chest. 2012;142(4_MeetingAbstracts):1025A. doi:10.1378/chest.1450411
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Abstract

SESSION TYPE: Late-Breaking Abstracts

PRESENTED ON: Tuesday, October 23, 2012 at 04:30 PM - 05:45 PM

PURPOSE: Bronchoscopy plays a central role in the diagnosis of lung cancer. Diagnostic yields vary depending on the size and location of lesion, methods to collect cells (e.g., brushing, lavage, biopsy, or needle aspirate) and adequate pathologic processing of the specimens. Previous studies have shown that gene-expression signatures from cytologically normal bronchial epithelial cells (BEC) can distinguish smokers with and without lung cancer. The objective of this study is to characterize the accuracy of the molecular test in patients undergoing bronchoscopy for suspected lung cancer.

METHODS: The AEGIS trial is a prospective, case-controlled, multi-center trial to collect bronchial epithelial cells (BEC) in patients who are current or former smokers undergoing bronchoscopy for suspicion of lung cancer. Mainstem bronchial airway brushings of 330 patients (240 confirmed cancers, 90 controls) were collected. Microarray analysis was performed and a gene-expression prediction model was optimized after splitting the sample set into independent training (N=220) and test sets (N=110). RT-PCR assays were developed for candidate biomarker genes and a multivariate test algorithm was re-optimized using RT-PCR data generated by re-analyzing 217 of the samples with sufficient RNA remaining (153 cancers, 64 controls).

RESULTS: Prediction accuracy of the PCR-based gene-expression test (30 genes) yielded a sensitivity of 77% (95% CI 71-83%). When combining results of bronchoscopy with the gene-expression test, sensitivity=94% (95% CI 91-97%) for the combined test, and specificity=73% (95% CI 67-79%), compared to a sensitivity of 74% (95% CI 68-80%) for bronchoscopy alone. The NPV=0.85 (95% CI=0.80-0.90) for the combined test, was better than the NPV=0.65 (95% CI=0.59-0.71) for bronchoscopy alone.

CONCLUSIONS: The study confirmed the ability of a gene-expression profile in cytologically normal airway epithelium to distinguish patients with and without lung cancer.

CLINICAL IMPLICATIONS: The gene test combined with bronchoscopy can be used to rule out lung cancer with improved confidence in patients with benign disease and minimize the need for additional invasive procedures in these individuals.

DISCLOSURE: Duncan Whitney: Employee: Allegro Diagnostics Corp

Jun Luo: Employee: Allegro Diagnostics Corp

Kate Porta: Employee: Allegro Diagnostics Corp

Marc Lenburg: Consultant fee, speaker bureau, advisory committee, etc.: Marc Lenburg is an advisor to Allegro Diagnostics Corp and received fees and stock options from Allegro

Jerome Brody: Shareholder: Jerome Brody received stock options from Allegro Diagnostics as a co-founder., Consultant fee, speaker bureau, advisory committee, etc.: Jerome Brody received fees as an advisor to Allegro Diagnostics Corp.

Armin Ernst: Consultant fee, speaker bureau, advisory committee, etc.: Dr. Armin Ernst received fees from Allegro Diagnostics for his role as a clinical advisor.

Anil Vachani: Consultant fee, speaker bureau, advisory committee, etc.: Dr. Anil Vachani received fees from Allegro Diagnostics for his role as a clinical advisor.

J. Ferguson: Consultant fee, speaker bureau, advisory committee, etc.: Dr. J. Scott Ferguson received fees from Allegro Diagnostics for his role as a clinical advisor.

Gerard Silvestri: Consultant fee, speaker bureau, advisory committee, etc.: Dr. Gerard Silvestri received fees from Allegro Diagnostics for his role as a clinical advisor.

Avrum Spira: Shareholder: Dr. Avrum Spira received stock options as a founder of Allegro Diagnostics, Consultant fee, speaker bureau, advisory committee, etc.: Dr. Avrum Spira received fees from Allegro Diagnostics for his role as an advisor.

A gene-expression profile to distinguish patients with and without lung cancer was developed using a large cohort of specimens collected in a prospective multi-center clinical trial. The performance of the test and description of clinical utility will be presented.

Allegro Diagnostics Corp, Maynard, MA

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