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J. Akulian
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P2.06 - Poster Session/ Screening and Early Detection (ID 219)
- Event: WCLC 2015
- Type: Poster
- Track: Screening and Early Detection
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.06-023 - A Complete Thoracic Navigation System to Allow for Nodal and Parenchymal Molecular Assessment in NSCLC: A Prospective Human Study (ID 1174)
09:30 - 09:30 | Author(s): J. Akulian
- Abstract
Background:
Peripheral pulmonary nodules (PPN) remain a diagnostic challenge for physicians. Minimally invasive biopsy methods for molecular analysis include endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA), navigational bronchoscopy (NB) and transthoracic needle aspiration under computer tomography (CT) guidance. Recently, a combined thoracic navigation system (TNS) allowing for NB and electromagnetic navigational trans-thoracic needle aspiration (N-TTNA) has become available allowing for all necessary procedures to obtain diagnostic and molecular analysis for NSCLC to be performed during a single procedural session.
Methods:
This study was a prospective single arm study examining the success in obtaining molecular tissue in NSCLC cases from the lymph nodes and/or PPN using a novel combined diagnostic approach with TNS (EBUS, NB and N-TTNA) in a single procedural setting. Consecutive patients who consented with a PPN undergoing bronchoscopy were enrolled. All patients underwent convex EBUS for full lymph node staging followed by NB and N-TTNA. All non-diagnostic biopsies were followed with radiographic interval imaging revealing a decrease in size or resolution or a surgical biopsy was performed. The primary outcome was successful acquisition and testing of tissue for molecular analysis.
Results:
Twenty-four subjects with PPN were enrolled in this study (9 male and 15 female) with a median age of 70 years (range 52-85). An EBUS with NB and/or N-TTNA was completed in 24/24 (100%) of the patients. In this cohort, there were seven cases of Adenocarcinoma in which adequate tissue for molecular analysis was obtained in all (100%) of the cases. PPN diagnostic tissue that was adequate for molecular testing was achieved in six out of seven patients (85%). Four patients had evidence of nodal disease on EBUS and all four (100%) nodal samples were adequate for molecular analysis. When a complete TNS is performed combining convex EBUS with the combined TNS procedure for complete staging, the overall diagnostic yield was 92%. No bleeding or hemoptysis events were encountered during the study. There were two (8%) subjects required small bore pigtail catheter placement secondary to pneumothorax.
Conclusion:
This is the first human study demonstrating the sampling adequacy for both nodal and parenchymal tissue sampling for NSCLC molecular analysis in a single procedural setting. Multicentered prospective studies are needed to confirm the utility of these findings in an era of expanding need for tissue acquisition in a minimally invasive setting.
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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): J. Akulian
- 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.
