A noninvasive plasma microRNA signature classifier combined with low-dose CT was associated with a fivefold reduction in the false-positive rate for lung cancer detection compared with CT alone, according to results of a retrospective study.
The analysis included 939 smokers enrolled in the Multicenter Italian Lung Detection trial who had been assigned low-dose CT (n=652) or observation (n=287).
Overall, 69 participants had lung cancer.
Researchers then retrospectively analyzed plasma samples from the participants with the microRNA signature classifier (MSC).
Among patients in both arms, MSC was associated with 87% sensitivity and 81% specificity for lung cancer detection. The negative predictive value for detection was 99% and the negative predictive value for lung cancer death was 99.86%.
Researchers then evaluated data from patients in the low-dose CT arm. Among these patients, MSC was associated with 88% sensitivity and 80% specificity, whereas low-dose CT was associated with a 79% sensitivity and 81% specificity.
The false-positive rate with low-dose CT was 19.4%; however, when combined with MSC, this rate decreased by more than fivefold (3.7%).
“This large validation study indicates that MSC has predictive, diagnostic and prognostic value and could reduce the false-positive rate of low-dose CT, thus improving the efficacy of lung cancer screening,” the researchers wrote.
Pierre P. Massion
In an accompanying editorial, Pierre P. Massion, MD, of the division of pulmonary and critical care medicine at Vanderbilt University, wrote that biomarker analyses such as the microRNA diagnostic may assist in interpreting the increasing number of low-dose CT scans likely to be performed as part of lung cancer screening programs.
“Biomarkers will hopefully come to the rescue of the imprecision regarding probabilities of disease in the management of pulmonary nodules and, in particular, indeterminate pulmonary nodules in patients at high risk for lung cancer,” Massion wrote. “Although biomarkers may rule cancer in or out among lung nodules, ultimately such biomarkers should prompt a change of practice of appropriate referral for both noninvasive follow-up and definitive diagnosis and treatment.”
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Disclosure: Massion reports no relevant financial disclosures. See the study for a full list of the researchers’ relevant financial disclosures.