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Douglas Arenberg
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MA02 - Technological Advances in Diagnostics, Imaging and Therapeutics for Lung Cancer (ID 103)
- Event: WCLC 2020
- Type: Mini Oral
- Track: Diagnostics and Interventional Pulmonology
- Presentations: 1
- Moderators:
- Coordinates: 1/29/2021, 14:15 - 15:15, Scientific Program Auditorium
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MA02.05 - NAVIGATE 24-Month Results: Electromagnetic Navigation Bronchoscopy for Pulmonary Lesions at 37 Centers in Europe and the US (ID 2305)
14:15 - 15:15 | Author(s): Douglas Arenberg
- Abstract
- Presentation
Introduction
Electromagnetic navigation bronchoscopy (ENB) is a minimally invasive, image-guided approach to access lung lesions for biopsy, or fiducial placement and dye marking for stereotactic body radiation therapy or resection. To date, no studies have reported 24-month prospective follow-up from a multinational cohort.
Methods
NAVIGATE (NCT02410837) is a prospective, multicenter, observational cohort study of ENB using the superDimension™ navigation system versions 6.3 to 7.1. From April 2015 to August 2017, 1388 subjects were enrolled at 37 sites in the United States and Europe. Independent source-data verification was conducted in 33.3% of subjects. This is the first presentation of the final 24-month global data.
Results
ENB was used to aid in lung lesion biopsy in 95.7% (1329/1388), fiducial placement in 19.6% (n=14 EU, 258 US), pleural dye marking in 1.7% (23, all US), and/or lymph node biopsy in 2.6% (6 EU, 30 US). EBUS-guided staging was conducted in the same procedure in 456 subjects (9 EU, 447 US). General anesthesia and radial EBUS were used in 78.2% (56.6% EU, 81.4% US) and 50.6% (4.0% EU, 57.4% US) of procedures, respectively. Fluoroscopy and ROSE were used in 85.0% (41.7% EU, 91.0% US) and 61.7% (17.3% EU, 68.5% US), respectively. The median lesion size was 20mm (inter-quartile range 14-29mm); 49.7% were <20mm (53.5% EU, 49.1% US). The physician-estimated pretest probability of malignancy was >65% in 61.4% (74.3% EU, 59.0% US). Among the 1329 subjects undergoing ENB-guided biopsy, 94.8% (1260/1329) had navigation completed and tissue obtained. One-month, 12-month, and 24-month follow-up visits were completed in 99.0%, 80.8%, and 64.8% of subjects, respectively; follow-up on the ENB-aided diagnosis was available in 90.7% of subjects overall. The ENB-aided diagnostic yield accounting for all follow-up through 24 months was 67.8% (822/1212), excluding 117 subjects with insufficient confirmatory follow-up (range 61.9% to 70.7% assuming excluded cases were false negative and true negative for malignancy, respectively). Procedural factors possibly associated with regional differences in diagnostic yield (55.2% EU, 69.8% US) will be explored. Twelve-month and 24-month diagnoses were consistent in 91.8% of subjects (1220/1329). Sensitivity, specificity, positive predictive value, and negative predictive value for malignancy were 62.6%, 100%, 100%, and 47%, respectively. Among primary lung cancer cases, clinical stage at diagnosis was I-II in 64.7% (55.3% EU, 65.8% US). Procedure-related complications were pneumothorax in 4.7% (65/1388) (3.2% requiring intervention or hospitalization), bronchopulmonary hemorrhage in 2.7% (1.7% requiring intervention or hospitalization), and respiratory failure 0.6%, including anesthesia-related death in 1 subject.
Conclusion
NAVIGATE is the largest multicenter ENB study to date and the only multinational study to present usage patterns and ENB-aided diagnostic yield with prospective, independently verified 24-month follow-up. Despite a heterogeneous patient population and regional differences in procedural techniques, navigation bronchoscopy continues to demonstrate an excellent safety profile while allowing biopsy, staging, and fiducial and dye marking in a single anesthetic event. Most diagnoses remain consistent between 12-month and 24-month follow-up, which may impact future clinical study design. Additional multivariate analyses of the impact of regional procedural difference on diagnostic yield will be explored.
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OA10 - The Slow Pandemic – Tobacco Control in the Prevention of Lung Cancer (ID 170)
- Event: WCLC 2020
- Type: Oral
- Track: Risk Reduction and Tobacco Control
- Presentations: 1
- Moderators:
- Coordinates: 1/31/2021, 10:30 - 11:30, Scientific Program Auditorium
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OA10.07 - Discussant (ID 4153)
10:30 - 11:30 | Presenting Author(s): Douglas Arenberg
- Abstract
- Presentation
Abstract not provided
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