Anil Vachani1, Duncan H Whitney2, Edward C Parsons3, Marc Lenburg4, J Scott Ferguson5, Gerard A Silvestri6, Avrum Spira4. 1. Pulmonary, Allergy, and Critical Care Division, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA. Electronic address: avachani@mail.med.upenn.edu. 2. Veracyte Inc, South San Francisco, CA. 3. Allegro Diagnostics, Boston, MA. 4. Division of Computational Biomedicine, Department of Medicine, Boston University School of Medicine, Boston, MA. 5. Allergy, Pulmonary, and Critical Care, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI. 6. Division of Pulmonary and Critical Care, Department of Medicine, Medical University of South Carolina, Charleston, SC.
Abstract
BACKGROUND: Bronchoscopy is often the initial diagnostic procedure performed in patients with pulmonary lesions suggestive of lung cancer. A bronchial genomic classifier was previously validated to identify patients at low risk for lung cancer after an inconclusive bronchoscopy. In this study, we evaluated the potential of the classifier to reduce invasive procedure utilization in patients with suspected lung cancer. METHODS: In two multicenter trials of patients undergoing bronchoscopy for suspected lung cancer, the classifier was measured in normal-appearing bronchial epithelial cells from a mainstem bronchus. Among patients with low and intermediate pretest probability of cancer (n = 222), subsequent invasive procedures after an inconclusive bronchoscopy were identified. Estimates of the ability of the classifier to reduce unnecessary procedures were calculated. RESULTS: Of the 222 patients, 188 (85%) had an inconclusive bronchoscopy and follow-up procedure data available for analysis. Seventy-seven (41%) patients underwent an additional 99 invasive procedures, which included surgical lung biopsy in 40 (52%) patients. Benign and malignant diseases were ultimately diagnosed in 62 (81%) and 15 (19%) patients, respectively. Among those undergoing surgical biopsy, 20 (50%) were performed in patients with benign disease. If the classifier had been used to guide decision making, procedures could have been avoided in 50% (21 of 42) of patients undergoing further invasive testing. Further, among 35 patients with an inconclusive index bronchoscopy who were diagnosed with lung cancer, the sensitivity of the classifier was 89%, with 4 (11%) patients having a false-negative classifier result. CONCLUSIONS: Invasive procedures after an inconclusive bronchoscopy occur frequently, and most are performed in patients ultimately diagnosed with benign disease. Using the genomic classifier as an adjunct to bronchoscopy may reduce the frequency and associated morbidity of these invasive procedures. TRIAL REGISTRY: ClinicalTrials.gov; Nos. NCT01309087 and NCT00746759; URL: www.clinicaltrials.gov.
BACKGROUND: Bronchoscopy is often the initial diagnostic procedure performed in patients with pulmonary lesions suggestive of lung cancer. A bronchial genomic classifier was previously validated to identify patients at low risk for lung cancer after an inconclusive bronchoscopy. In this study, we evaluated the potential of the classifier to reduce invasive procedure utilization in patients with suspected lung cancer. METHODS: In two multicenter trials of patients undergoing bronchoscopy for suspected lung cancer, the classifier was measured in normal-appearing bronchial epithelial cells from a mainstem bronchus. Among patients with low and intermediate pretest probability of cancer (n = 222), subsequent invasive procedures after an inconclusive bronchoscopy were identified. Estimates of the ability of the classifier to reduce unnecessary procedures were calculated. RESULTS: Of the 222 patients, 188 (85%) had an inconclusive bronchoscopy and follow-up procedure data available for analysis. Seventy-seven (41%) patients underwent an additional 99 invasive procedures, which included surgical lung biopsy in 40 (52%) patients. Benign and malignant diseases were ultimately diagnosed in 62 (81%) and 15 (19%) patients, respectively. Among those undergoing surgical biopsy, 20 (50%) were performed in patients with benign disease. If the classifier had been used to guide decision making, procedures could have been avoided in 50% (21 of 42) of patients undergoing further invasive testing. Further, among 35 patients with an inconclusive index bronchoscopy who were diagnosed with lung cancer, the sensitivity of the classifier was 89%, with 4 (11%) patients having a false-negative classifier result. CONCLUSIONS: Invasive procedures after an inconclusive bronchoscopy occur frequently, and most are performed in patients ultimately diagnosed with benign disease. Using the genomic classifier as an adjunct to bronchoscopy may reduce the frequency and associated morbidity of these invasive procedures. TRIAL REGISTRY: ClinicalTrials.gov; Nos. NCT01309087 and NCT00746759; URL: www.clinicaltrials.gov.
Authors: Ann Chen Wu; James P Kiley; Patricia J Noel; Shashi Amur; Esteban G Burchard; John P Clancy; Joshua Galanter; Maki Inada; Tiffanie K Jones; Jonathan A Kropski; James E Loyd; Lawrence M Nogee; Benjamin A Raby; Angela J Rogers; David A Schwartz; Don D Sin; Avrum Spira; Scott T Weiss; Lisa R Young; Blanca E Himes Journal: Am J Respir Crit Care Med Date: 2018-12-15 Impact factor: 21.405
Authors: Min-Ae Song; Jo L Freudenheim; Theodore M Brasky; Ewy A Mathe; Joseph P McElroy; Quentin A Nickerson; Sarah A Reisinger; Dominic J Smiraglia; Daniel Y Weng; Kevin L Ying; Mark D Wewers; Peter G Shields Journal: Cancer Epidemiol Biomarkers Prev Date: 2019-12-17 Impact factor: 4.254
Authors: Peter G Shields; Micah Berman; Theodore M Brasky; Jo L Freudenheim; Ewy Mathe; Joseph P McElroy; Min-Ae Song; Mark D Wewers Journal: Cancer Epidemiol Biomarkers Prev Date: 2017-06-22 Impact factor: 4.254
Authors: Kristen M Plasseraud; Jeff K Wilkinson; Kristen M Oelschlager; Trisha M Poteet; Robert W Cook; John F Stone; Federico A Monzon Journal: Diagn Pathol Date: 2017-08-04 Impact factor: 2.644
Authors: J Scott Ferguson; Ryan Van Wert; Yoonha Choi; Michael J Rosenbluth; Kate Porta Smith; Jing Huang; Avrum Spira Journal: BMC Pulm Med Date: 2016-05-17 Impact factor: 3.317