Baseline computed tomography screening and blood microRNA predict lung cancer risk and define adequate intervals in the BioMILD trial

Baseline computed tomography screening and blood microRNA predict lung cancer risk and define adequate intervals in the BioMILD trial

Large randomized trials have demonstrated that lung cancer (LC) screening with low-dose computed tomography (LDCT) reduces LC mortality in heavy smokers. We previously showed in the MILD screening trial that the combination of a prespecified circulating microRNA (miRNA) signature classifier (MSC) an...

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Bibliographic Details
Published in:Annals of oncology Vol. 33; no. 4; pp. 395 - 405
Main Authors: Pastorino, U., Boeri, M., Sestini, S., Sabia, F., Milanese, G., Silva, M., Suatoni, P., Verri, C., Cantarutti, A., Sverzellati, N., Corrao, G., Marchianò, A., Sozzi, G.
Format: Journal Article
Language:English
Published: England Elsevier Ltd 01-04-2022
Subjects:
Early Detection of Cancer - methods
Humans
low-dose computed tomography
lung cancer screening
Lung Neoplasms - diagnostic imaging
Lung Neoplasms - genetics
Mass Screening - methods
microRNA
MicroRNAs - genetics
Prospective Studies
Risk Factors
risk profile
Tomography, X-Ray Computed
microRNA
lung cancer screening
risk profile
low-dose computed tomography
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Summary:Large randomized trials have demonstrated that lung cancer (LC) screening with low-dose computed tomography (LDCT) reduces LC mortality in heavy smokers. We previously showed in the MILD screening trial that the combination of a prespecified circulating microRNA (miRNA) signature classifier (MSC) and LDCT improves the accuracy of LDCT alone. The primary aim of the prospective BioMILD study was to assess the additional value of the blood MSC assay at the time of baseline LDCT with the goal of personalizing LC screening intervals. The study enrolled 4119 volunteers from January 2013 to March 2016, with a median follow-up of 5.3 years. Baseline LDCT and miRNAs stratified participants into four groups: CT−/MSC− (n = 2664; 64.7%); CT−/MSC+ (n = 800; 19.4%); CT+/MSC− (n = 446; 10.8%); and CT+/MSC+ (n = 209; 5.1%). As per the protocol, those in the CT−/MSC− and CT−/MSC+ groups were allocated to LDCT repeat at 3-year and 1-year intervals; CT+ participants were allocated for 1-year or earlier intervals on the basis of LDCT features independent of MSC results. CT+ participants had a 15.8-fold higher 4-year LC incidence than CT− participants (95% confidence interval 10.34-24.05), and MSC+ participants had a 2.0-fold higher 4-year LC incidence than MSC− participants (95% confidence interval 1.40-2.90); there was no evidence that the MSC effect differed between CT+ and CT− participants. LC incidence at 4 years was 0.8% in CT−/MSC−, 1.1% in CT−/MSC+, 10.8% in CT+/MSC−, and 20.1% in CT+/MSC+ participants. LC mortality rates at 5 years in the four risk groups were 0.5 in CT−/MSC−, 1.5 in CT−/MSC+, 4.2 in CT+/MSC−, and 10.1 in CT+/MSC+. The combined use of LDCT and blood miRNAs at baseline predicts individual LC incidence and mortality, with a major effect of MSC for LDCT-positive individuals. These findings may have important implications in personalizing screening intervals. •Baseline LDCT and blood microRNAs define individual lung cancer risk profiles.•Targeted LDCT intervals reduce unnecessary repeat LDCT.•A biomarker-based risk test showed a major added value for CT+ participants.
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ISSN:0923-7534
1569-8041
DOI:10.1016/j.annonc.2022.01.008