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Lung Cancer |

Prospective Validation of a Bronchial Genomic Classifier for Lung Cancer in Patients Undergoing Diagnostic Bronchoscopy: The AEGIS Trials FREE TO VIEW

Anil Vachani, MD; Gerard Silvestri, MD; Duncan Whitney, PhD; J Ferguson, MD; Kate Porta, MPH; Edward Parsons, PhD; Jerome Brody, MD; Marc Lenburg, PhD; Avrum Spira, MD
Author and Funding Information

Veracyte Inc, South San Francisco, CA


Chest. 2015;148(4_MeetingAbstracts):544A. doi:10.1378/chest.2280365
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Abstract

SESSION TITLE: Lung Cancer Diagnosis

SESSION TYPE: Original Investigation Slide

PRESENTED ON: Wednesday, October 28, 2015 at 02:45 PM - 04:15 PM

PURPOSE: Bronchoscopy is commonly deployed in patients with pulmonary lesions suspicious for lung cancer, though is limited in its sensitivity depending on the size and location of the lesion. When malignancy is not found from bronchoscopy, there is a clinical dilemma as to next tests to pursue. This can often result in additional invasive biopsies, although many lesions are found to be benign. Our goal was to validate a previously derived bronchial genomic classifier measured in bronchial epithelial cells that could improve the diagnostic performance of bronchoscopy and identify those at low probability of lung cancer if bronchoscopy was non-diagnostic.

METHODS: Current or former smokers undergoing bronchoscopy for suspected lung cancer were enrolled at 28 centers in two multicenter prospective studies (AEGIS-1 and -2). Bronchial brushings were collected from the normal appearing mainstem bronchus for gene-expression profiling. A gene-expression classifier was used to assess the probability of lung cancer. Patients were followed for up to 12 months post-bronchoscopy until a final diagnosis of lung cancer or benign disease was established. The performance of the classifier was assessed overall, as well as according to the pre-bronchoscopy probability of malignancy (POM), as assessed by physicians.

RESULTS: There were 298 patients in AEGIS-1 and 341 in AEGIS-2 that met all criteria for analysis and were evaluated using the gene expression classifier. Bronchoscopy alone was non-diagnostic for lung cancer in 43% of patients in the combined studies. The bronchial genomic classifier correctly identified 431 of 487 cancers (sensitivity=89%; 95%CI, 85-91) and 72 of 152 benign lesions (specificity=47%; 95%CI, 39-56) in the combined studies. In 101 patients with an intermediate POM (10-60%) of cancer, bronchoscopy was non-diagnostic in 83% of patients and the classifier had a negative predictive value (NPV) of 91% (95% CI, 75-98). The classifier and bronchoscopy combined had a sensitivity of 97% (95% CI, 75-98) which was independent of lesion size and location within the lung.

CONCLUSIONS: The bronchial genomic classifier improves the sensitivity of bronchoscopy for detecting lung cancer and identifies those patients at low probability of malignancy.

CLINICAL IMPLICATIONS: .In intermediate probability patients with a non-diagnostic bronchoscopy, a negative classifier score warrants consideration of a more conservative diagnostic approach that could reduce unnecessary invasive testing in patients without lung cancer.

DISCLOSURE: Anil Vachani: Consultant fee, speaker bureau, advisory committee, etc.: Allegro Diagnostics Corp Gerard Silvestri: Consultant fee, speaker bureau, advisory committee, etc.: Allegro Diagnostics Corp Duncan Whitney: Employee: Veracyte Inc J Ferguson: Consultant fee, speaker bureau, advisory committee, etc.: Allegro Diagnostics Corp Kate Porta: Employee: Veracyte Inc. Edward Parsons: Consultant fee, speaker bureau, advisory committee, etc.: Veracyte Inc. Jerome Brody: Consultant fee, speaker bureau, advisory committee, etc.: Allegro Diagnostics Corp Marc Lenburg: Consultant fee, speaker bureau, advisory committee, etc.: Allegro Diagnostics Corp, Grant monies (from sources other than industry): Boston University grant Avrum Spira: Consultant fee, speaker bureau, advisory committee, etc.: Allegro Diagnostics Corp, Consultant fee, speaker bureau, advisory committee, etc.: Veracyte Inc, Grant monies (from sources other than industry): Boston University grant

A gene expression classifier has been used to evaluate patients at risk of lung cancer during bronchoscopy.


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