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L. Dodd
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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): L. Dodd
- 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.
