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G. Silvestri
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ED 06 - Treatment of Elderly and High Risk Patients with Localized NSCLC (ID 6)
- Event: WCLC 2015
- Type: Education Session
- Track: Treatment of Localized Disease - NSCLC
- Presentations: 1
- Moderators:A. Ardizzoni
- Coordinates: 9/08/2015, 14:15 - 15:45, 702+704+706
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ED06.04 - Pulmonary (ID 1797)
15:20 - 15:40 | Author(s): G. Silvestri
- Abstract
- Presentation
Abstract not provided
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ORAL 39 - Potential Biomarkers for CT Screening (ID 149)
- Event: WCLC 2015
- Type: Oral Session
- Track: Screening and Early Detection
- Presentations: 1
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ORAL39.07 - A Bronchial Genomic Classifier Measured in Airway Epithelial Cells Improves Diagnostic Sensitivity of Bronchoscopy for Lung Cancer (ID 2215)
17:50 - 18:01 | Author(s): G. Silvestri
- Abstract
- Presentation
Background:
Bronchoscopy is often used for the diagnosis of lung cancer however its sensitivity is imperfect, especially for small and peripheral lesions. Adjunctive methods to improve the sensitivity of cancer detection would reduce the need for more invasive follow-up procedures when bronchoscopy is non-diagnostic. It has previously been shown that gene expression of cytologically-normal bronchial airway epithelial cells is altered in smokers with lung cancer. In this study we evaluated the performance of a bronchial genomic classifier to predict malignancy in an independent cohort of suspect lung cancer patients.
Methods:
A bronchial genomic classifier consisting of the expression of 23 genes measured in the airway epithelium was evaluated in a previously published, independent cohort (n=163) of current and former undergoing bronchoscopy for suspect lung cancer. In cases where bronchoscopy was non-diagnostic for malignancy, the performance of the classifier was evaluated using ROC-AUC, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
Results:
In the test set, bronchoscopy led to a diagnosis in 40 of 78 patients with cancer (sensitivity=51%, 95% CI 40-63%). The combination of the classifier with bronchoscopy improved the sensitivity to 96% (95% CI 89-99%; p <0.001); see Table. The prediction accuracy of the classifier was similar in lesions <3cm, as well as across cancer stage and histology. Among the 123 patients with a non-diagnostic bronchoscopy, 38 were ultimately diagnosed with lung cancer (prevalence of 31%). In this group of patients, the classifier had an AUC of 0.81 (95% CI, 0.73-0.88), accurately identifying 35 of the 38 lung cancer patients (sensitivity=92%; 95% CI, 78-98%), and 45 of 85 patients with benign lesions (specificity=53%; 95% CI, 42-63%). Of the 48 patients with a negative classifier result, 45 were diagnosed with benign lesions (NPV=94%, 95% CI 83-99%).Table. Performance of bronchoscopy, classifier, and the combined procedures in the test set
a) The performance of the classifier was evaluated for patients in whom bronchoscopy did not result in a finding of lung cancer (n=123).Category Bronchoscopy Classifier[a] Combined Total, N 163 123 163 Lung Cancer, N 78 38 78 Benign Lesion, N 85 85 85 Sens. (95% CI) 51% (40-62%) 92% (78-98%) 96% (89-99%) Spec. (95% CI) 100% (95-100%) 53% (42-63%) 53% (42-63%) NPV (95% CI) 69% (60-77%) 94% (83-99%) 94% (83-98%) PPV (95% CI) 100% (90-100%) 47% (36-58%) 65% (56-73%)
Conclusion:
A gene expression classifier measured in bronchial epithelial cells is able to accurately identify those at low risk for lung cancer in patients who have undergone bronchoscopy with non-diagnostic results. Due to the high sensitivity and NPV of the classifier, it could potentially inform clinical decisions regarding the need for further invasive testing for lung cancer in patients whose bronchoscopy is non diagnostic.
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P3.03 - Poster Session/ Treatment of Locoregional Disease – NSCLC (ID 214)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Locoregional Disease – NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.03-038 - A Multi-Center Trial Comparing Standard 22-Gauge and 22-Gauge Bibevel (ProCore) Needles for Endobronchial Ultrasound (ID 3036)
09:30 - 09:30 | Author(s): G. Silvestri
- Abstract
Background:
Endobronchial ultrasound fine needle aspiration (EBUS-FNA) is recommended as the first tissue sampling procedure for the staging and diagnosis of known or suspected lung cancer. With the advent of targeted agents for lung cancer therapy, there is an increasing demand to extend EBUS-FNA samples for molecular testing. While it has been shown to be adequate for EGFR mutational analysis in 77-96% of samples, as new discoveries are made the challenge is to obtain enough quality tissue via EBUS-FNA. Bibevel (ProCore) needle technology used during endoscopic ultrasound (EUS) procedures has been shown to provide larger samples of tissue for histologic diagnosis of gastrointestinal malignancies. This same needle technology may also provide more tissue during EBUS to allow for better histologic and molecular analysis than standard EBUS-FNA. The goal of this study is to determine the utility of the 22-gauge (G) ProCore EBUS needle by comparing it to standard single bevel 22G EBUS needles.
Methods:
This multicenter randomized trial will enroll 200 patients with known or suspected lung cancer during standard of care diagnostic/staging EBUS. A maximum of two lymph nodes (pathologic in size (>1cm) and/or hypermetabolic on PET/CT) will be included in the comparison. A total of 8 passes will be taken from each node (4 from the bibevel needle, 4 from standard) and cell blocks compared by a blinded pathologist . The primary outcome is tumor cells per mm[2]. Descriptive statistics will be used to characterize the study subjects and their outcomes with the 2 different needles. For the within-subject (i.e. between needle) comparisons of tumor quantity and ability to perform commercially available immunohistochemical stains and mutational analysis, non-parametric Wilcoxon signed rank tests will be used. Since cell block quality will be quantified as simply which needle’s sample provided the better sample, the non-parametric sign test will be used. All hypothesis testing will be 2-sided, using an alpha level of 0.05
Results:
Forty-one patients from three centers have been enrolled, with 48 lymph nodes sampled. There is an even gender distribution (22 (54%) male, 19 (46%) female). The majority are non-Hispanic white (n=30, 73%). 22 patients have (54%) have a malignant diagnosis, 12 (30%) a benign diagnosis, and 2 (5%) have been non-diagnostic. Minor complications include bleeding at the site in 7 (17%). There have been no major complications.
Conclusion:
Data for the primary outcomes have yet to be analyzed, however the trial design is feasible and thus far the use of two separate needles during EBUS has shown to be safe.
