Hans J Lee1, Peter Mazzone2, David Feller-Kopman3, Lonny Yarmus3, Kyle Hogarth4, Lori R Lofaro5, Bailey Griscom5, Marla Johnson5, Yoonha Choi5, Jing Huang5, Sangeeta Bhorade5, Avrum Spira6, Giulia C Kennedy5, Momen M Wahidi7. 1. Department of Medicine, Section of Interventional Pulmonology, Division of Pulmonary and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, MD. Electronic address: hlee171@jhmi.edu. 2. Division of Pulmonary and Critical Care Medicine, Cleveland Clinic Foundation, Cleveland, OH. 3. Department of Medicine, Section of Interventional Pulmonology, Division of Pulmonary and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, MD. 4. Department of Pulmonary Medicine, University of Chicago, Chicago, IL. 5. Departments of Research and Development, Clinical Operations and Medical Affairs, Veracyte, Inc., South San Francisco, CA. 6. Boston University, Boston, MA. 7. Section of Interventional Pulmonology, Division of Pulmonary and Critical Care Medicine, Duke University School of Medicine, Durham, NC.
Abstract
BACKGROUND: The Percepta genomic classifier has been clinically validated as a complement to bronchoscopy for lung nodule evaluation. RESEARCH QUESTION: The goal of this study was to examine the impact on clinical management decisions of the Percepta result in patients with low- and intermediate-risk lung nodules. STUDY DESIGN AND METHODS: A prospective "real world" registry was instituted across 35 US centers to observe physician management of pulmonary nodules following a nondiagnostic bronchoscopy. To assess the impact on management decisions of the Percepta genomic classifier, a subset of patients was analyzed who had an inconclusive bronchoscopy for a pulmonary nodule, a Percepta result, and an adjudicated lung diagnosis with at least 1 year of follow-up. In this cohort, change in the decision to pursue additional invasive procedures following Percepta results was assessed. RESULTS: A total of 283 patients met the study eligibility criteria. In patients with a low/intermediate risk of malignancy for whom the clinician had designated a plan for a subsequent invasive procedure, a negative Percepta result down-classified the risk of malignancy in 34.3% of cases. Of these down-classified patients, 73.9% had a change in their management plan from an invasive procedure to surveillance, and the majority avoided a procedure up to 12 months following the initial evaluation. In patients with confirmed lung cancers, the time to diagnosis was not significantly delayed when comparing Percepta down-classified patients vs patients who were not down-classified (P = .58). INTERPRETATION: The down-classification of nodule malignancy risk with the Percepta test decreased additional invasive procedures without a delay in time to diagnosis among those with lung cancer.
BACKGROUND: The Percepta genomic classifier has been clinically validated as a complement to bronchoscopy for lung nodule evaluation. RESEARCH QUESTION: The goal of this study was to examine the impact on clinical management decisions of the Percepta result in patients with low- and intermediate-risk lung nodules. STUDY DESIGN AND METHODS: A prospective "real world" registry was instituted across 35 US centers to observe physician management of pulmonary nodules following a nondiagnostic bronchoscopy. To assess the impact on management decisions of the Percepta genomic classifier, a subset of patients was analyzed who had an inconclusive bronchoscopy for a pulmonary nodule, a Percepta result, and an adjudicated lung diagnosis with at least 1 year of follow-up. In this cohort, change in the decision to pursue additional invasive procedures following Percepta results was assessed. RESULTS: A total of 283 patients met the study eligibility criteria. In patients with a low/intermediate risk of malignancy for whom the clinician had designated a plan for a subsequent invasive procedure, a negative Percepta result down-classified the risk of malignancy in 34.3% of cases. Of these down-classified patients, 73.9% had a change in their management plan from an invasive procedure to surveillance, and the majority avoided a procedure up to 12 months following the initial evaluation. In patients with confirmed lung cancers, the time to diagnosis was not significantly delayed when comparing Percepta down-classified patients vs patients who were not down-classified (P = .58). INTERPRETATION: The down-classification of nodule malignancy risk with the Percepta test decreased additional invasive procedures without a delay in time to diagnosis among those with lung cancer.
Authors: Marla K Johnson; Shuyang Wu; Daniel G Pankratz; Grazyna Fedorowicz; Jessica Anderson; Jie Ding; Mei Wong; Manqiu Cao; Joshua Babiarz; Lori Lofaro; P Sean Walsh; Giulia C Kennedy; Jing Huang Journal: BMC Cancer Date: 2021-04-13 Impact factor: 4.430
Authors: Sonali Sethi; Scott Oh; Alexander Chen; Christina Bellinger; Lori Lofaro; Marla Johnson; Jing Huang; Sangeeta Maruti Bhorade; William Bulman; Giulia C Kennedy Journal: BMC Pulm Med Date: 2022-01-06 Impact factor: 3.317
Authors: Peter Mazzone; Travis Dotson; Momen M Wahidi; Michael Bernstein; Hans J Lee; David Feller Kopman; Lonny Yarmus; Duncan Whitney; Christopher Stevenson; Jianghan Qu; Marla Johnson; P Sean Walsh; Jing Huang; Lori R Lofaro; Sangeeta M Bhorade; Giulia C Kennedy; Avrum Spira; M Patricia Rivera Journal: PLoS One Date: 2022-07-13 Impact factor: 3.752