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WCLC 2019: BioMILD Trial of Blood MicroRNA Plus Low-Dose CT to Reduce CT Repeats in Lung Cancer Screening


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Researchers from Milan reported that using a blood microRNA assay accompanied by low-dose computed tomography (CT) screening is safe and effective in screening patients for lung cancer. The results were shared at the International Association for the Study of Lung Cancer (IASLC) 2019 World Conference on Lung Cancer (WCLC) (Abstract PL02.04).

Ugo Pastorino, MD, of the Istituto Nazionale dei Tumori, reported on results from the BioMILD trial, which tested the additional value of blood microRNA assay at the time of low-dose CT on a large number of volunteers, with the aim of targeting next low-dose CT intervals on the basis of individual risk profile.

Methods

Dr. Pastorino had previously reported that that microRNA expression profiles in tumors and, for the first time, also in normal lung tissue, are indicative of aggressive lung cancer development and that specific microRNA signatures can be identified in plasma samples of patients up to 2 years before spiral CT detection of the disease.

The BioMILD trial offered a lung cancer screening program combining low-dose CT and blood microRNA assay to heavy smokers (current or former ≤ 10 years) aged 50–75 years old. At baseline, low-dose CT and microRNA were tested independently with blind evaluation. According to low-dose CT and microRNA profile, different screening intervals were chosen for the following repeats, and participants with double negative low-dose CT and microRNA were sent to a 3-year interval.

KEY POINTS

  • Preliminary analysis showed a significantly higher lung cancer incidence and overall mortality in subjects with positive low-dose CT and/or microRNA at baseline.
  • No detrimental effects on stage I lung cancer proportion, resection rates, or interval cancer incidence were observed in the group of subjects sent to 3-year low-dose CT repeat.

The BioMILD trial prospectively enrolled 4,119 volunteers at Istituto Nazionale Tumori of Milan with the median age of 60 years, a median of 42 pack-years, 79% of whom were current smokers, and 39% of whom were female. At the end of March 2019, a total of 11,012 low-dose CTs and 9,156 microRNA tests were performed, with an overall compliance at the 3-year low-dose CT interval of 93% and a median follow-up 4.2 years.

Results

Preliminary analysis showed a significantly higher lung cancer incidence and overall mortality in subjects with positive low-dose CT and/or microRNA at baseline. No detrimental effects on stage I lung cancer proportion, resection rates, or interval cancer incidence were observed in the group of subjects sent to 3-year low-dose CT repeat. Sensitivity and specificity analyses of low-dose CT and microRNA at baseline and subsequent screening rounds will be presented.

“BioMILD showed that the combination of microRNA assay and [low-dose] CT is a valuable and safe tool to assess individual risk profile and reduce unnecessary [low-dose] CT repeats in lung cancer screening,” said Dr. Pastorino in a press release.

Disclosure: For full disclosures of the study authors, visit wclc2019.iaslc.org.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
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