Impact of the Percepta Genomic Classifier on Clinical Management Decisions in a Multicenter Prospective Study.

Journal Article (Journal Article;Multicenter Study)

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.

Full Text

Duke Authors

Cited Authors

  • Lee, HJ; Mazzone, P; Feller-Kopman, D; Yarmus, L; Hogarth, K; Lofaro, LR; Griscom, B; Johnson, M; Choi, Y; Huang, J; Bhorade, S; Spira, A; Kennedy, GC; Wahidi, MM; Percepta Registry Investigators,

Published Date

  • January 2021

Published In

Volume / Issue

  • 159 / 1

Start / End Page

  • 401 - 412

PubMed ID

  • 32758562

Electronic International Standard Serial Number (EISSN)

  • 1931-3543

Digital Object Identifier (DOI)

  • 10.1016/j.chest.2020.07.067

Language

  • eng

Conference Location

  • United States