In a study reported in the Journal of Clinical Oncology, Nappi et al showed that plasma microRNA miR371 expression was associated with high specificity and positive predictive values in predicting active germ cell malignancy.
“Plasma miR371 expression predicts [active] germ cell malignancy with high specificity and positive predictive value. Although other operating characteristics of miR371 await longer follow-up for more complete definition, the findings of a highly specific liquid biopsy strongly support moving forward with large-scale, real-world clinical trials to further define full operating characteristics and to identify clinical utility and areas of patient benefit.”— Nappi et al
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Study Details
The study included 111 patients with a history of or newly diagnosed germ cell malignancy. Patients were primarily identified through the multidisciplinary testicular cancer program at BC Cancer, with later recruitment including BC Cancer satellite clinics and the Huntsman Cancer Institute at the University of Utah.
Biospecimens prospectively obtained before confirmed clinical events were analyzed for miR371 expression with blinding to analytic results and clinical status. Cases (patients with clinically confirmed active germ cell malignancy) and controls (patients with no clinically confirmed active germ cell malignancy) were assigned as such over the course of management. Risk status was based on the composite clinical picture at time points in management.
The primary objective was to determine specificity and positive predictive value of miR371 for active germ cell malignancy by mapping plasma miR371 expression to clinical events during management.
Key Findings
Overall, 132 samples from 111 male patients with a diagnosis of seminoma or nonseminoma were analyzed.
Of the 132 samples, 46 (35%) from 46 patients were associated with clinically confirmed active germ cell malignancy over the course of management. Of the 46 patients with active germ cell malignancy, 44 (96%) had plasma miR371 expression (true positives), with no false-positives identified. Two (4%) of the 46 patients had no miRNA expression despite pathologic confirmation of active germ cell malignancy (false negatives).
Overall, plasma miR371 expression in confirmed active germ cell malignancy had specificity, sensitivity, positive predictive value, and negative predictive value of 100%, 96%, 100%, and 98%, respectively. Specificity and sensitivity of plasma miR371 expression were 100% and 98%, 100% and 92%, and 100% and 97% in the low-, moderate-, and high-risk groups, with a median follow-up of 15 months.
The investigators concluded, “Plasma miR371 expression predicts [active] germ cell malignancy with high specificity and positive predictive value. Although other operating characteristics of miR371 await longer follow-up for more complete definition, the findings of a highly specific liquid biopsy strongly support moving forward with large-scale, real-world clinical trials to further define full operating characteristics and to identify clinical utility and areas of patient benefit.”
Christian Kollmannsberger, MD, of BC Cancer, Vancouver Cancer Centre, University of British Columbia, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by grants from Astellas and the National Cancer Institute. For full disclosures of the study authors, visit jco.ascopubs.org.
