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Data from: Assessment of plasma proteomics biomarker’s ability to distinguish benign from malignant lung nodules Silvestri, Gerard A.; Tanner, Nichole T.; Kearney, Paul; Vachani, Anil; Massion, Pierre P.; Porter, Alexander; Springmeyer, Steven C.; Fang, Kenneth C.; Midthun, David; Mazzone, Peter J.; Madtes, D.; Landis, J.; Levesque, A.; Rothe, K.; Balaan, M.; Dimitt, B.; Fortin, B.; Ettinger, N.; Pierre, A.; Yarmus, L.; Oakjones-Burgess, K.; Desai, N.; Hammoud, Z.; Sorenson, A.; Murali, R.; Pass, H.; Lackey, A.; Carter, L.; King, S.; Kuo, E.; Jacques, L.; Hong, G.; Henderson, M.; Lamberti, J.; Balekian, A.; Allison, F.
Description
Abstract
Background: Lung nodules are a diagnostic challenge, with an estimated yearly incidence of 1.6 million in the United States. This study evaluated the accuracy of an integrated proteomic classifier in identifying benign nodules in patients with a pretest probability of cancer (pCA) ≤ 50%. Methods: A prospective, multicenter observational trial of 685 patients with 8- to 30-mm lung nodules was conducted. Multiple reaction monitoring mass spectrometry was used to measure the relative abundance of two plasma proteins, LG3BP and C163A. Results were integrated with a clinical risk prediction model to identify likely benign nodules. Sensitivity, specificity, and negative predictive value were calculated. Estimates of potential changes in invasive testing had the integrated classifier results been available and acted on were made. Results: A subgroup of 178 patients with a clinician-assessed pCA ≤ 50% had a 16% prevalence of lung cancer. The integrated classifier demonstrated a sensitivity of 97% (CI, 82-100), a specificity of 44% (CI, 36-52), and a negative predictive value of 98% (CI, 92-100) in distinguishing benign from malignant nodules. The classifier performed better than PET, validated lung nodule risk models, and physician cancer probability estimates (P < .001). If the integrated classifier results were used to direct care, 40% fewer procedures would be performed on benign nodules, and 3% of malignant nodules would be misclassified. Conclusions: When used in patients with lung nodules with a pCA ≤ 50%, the integrated classifier accurately identifies benign lung nodules with good performance characteristics. If used in clinical practice, invasive procedures could be reduced by diverting benign nodules to surveillance. Trial Registry: ClinicalTrials.gov; No.: NCT01752114; URL: www.clinicaltrials.gov).
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Data File Supporting Publication
Item Metadata
| Title |
Data from: Assessment of plasma proteomics biomarker’s ability to distinguish benign from malignant lung nodules
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| Creator |
Silvestri, Gerard A.; Tanner, Nichole T.; Kearney, Paul; Vachani, Anil; Massion, Pierre P.; Porter, Alexander; Springmeyer, Steven C.; Fang, Kenneth C.; Midthun, David; Mazzone, Peter J.; Madtes, D.; Landis, J.; Levesque, A.; Rothe, K.; Balaan, M.; Dimitt, B.; Fortin, B.; Ettinger, N.; Pierre, A.; Yarmus, L.; Oakjones-Burgess, K.; Desai, N.; Hammoud, Z.; Sorenson, A.; Murali, R.; Pass, H.; Lackey, A.; Carter, L.; King, S.; Kuo, E.; Jacques, L.; Hong, G.; Henderson, M.; Lamberti, J.; Balekian, A.; Allison, F.
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| Date Issued |
2021-05-19
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| Description |
Abstract
Background: Lung nodules are a diagnostic challenge, with an estimated yearly incidence of 1.6 million in the United States. This study evaluated the accuracy of an integrated proteomic classifier in identifying benign nodules in patients with a pretest probability of cancer (pCA) ≤ 50%. Methods: A prospective, multicenter observational trial of 685 patients with 8- to 30-mm lung nodules was conducted. Multiple reaction monitoring mass spectrometry was used to measure the relative abundance of two plasma proteins, LG3BP and C163A. Results were integrated with a clinical risk prediction model to identify likely benign nodules. Sensitivity, specificity, and negative predictive value were calculated. Estimates of potential changes in invasive testing had the integrated classifier results been available and acted on were made. Results: A subgroup of 178 patients with a clinician-assessed pCA ≤ 50% had a 16% prevalence of lung cancer. The integrated classifier demonstrated a sensitivity of 97% (CI, 82-100), a specificity of 44% (CI, 36-52), and a negative predictive value of 98% (CI, 92-100) in distinguishing benign from malignant nodules. The classifier performed better than PET, validated lung nodule risk models, and physician cancer probability estimates (P < .001). If the integrated classifier results were used to direct care, 40% fewer procedures would be performed on benign nodules, and 3% of malignant nodules would be misclassified. Conclusions: When used in patients with lung nodules with a pCA ≤ 50%, the integrated classifier accurately identifies benign lung nodules with good performance characteristics. If used in clinical practice, invasive procedures could be reduced by diverting benign nodules to surveillance. Trial Registry: ClinicalTrials.gov; No.: NCT01752114; URL: www.clinicaltrials.gov).; Usage notes Data File Supporting Publication |
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| Type | |
| Notes |
Dryad version number: 1 Version status: submitted Dryad curation status: Published Sharing link: https://datadryad.org/stash/share/UIljfvFP1w7rWs76G8sc8VKIqzeN19Ci74DrQ4F0CwY</p> Storage size: 106162 Visibility: public |
| Date Available |
2020-06-30
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| Provider |
University of British Columbia Library
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| License |
CC0 1.0
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| DOI |
10.14288/1.0397623
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| URI | |
| Publisher DOI | |
| Rights URI | |
| Aggregated Source Repository |
Dataverse
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CC0 1.0