In a study reported in the Journal of Clinical Oncology, Dieckmann et al found that serum levels of microRNA (miR)-371a-3p (M371 test) showed very high accuracy for detecting testicular germ cell tumors.
In the prospective international study, serum samples from 616 patients with testicular germ cell tumors and 258 male controls had serum levels of miRNA-371a-3p (miR levels) measured by quantitative polymerase chain reaction. Among patients with germ cell tumors, 359 patients had seminoma and 257 had nonseminoma.
In the primary diagnosis of germ cell tumors, the M371 test exhibited sensitivity of 90.1%, specificity of 94.0%, receiver operating characteristic area under the curve of 0.966, positive predictive value of 97.2%, and negative predictive value of 82.7%. Alpha-fetoprotein, β-human chorionic gonadotropin, and lactate dehydrogenase each had sensitivities of < 50% in seminoma (approximately 50% when used in combination) and slightly higher sensitivities in nonseminomas (approximately 40%–65% each, and approximately 80% when used in combination). miR levels were significantly associated with clinical disease stage, primary tumor size, and response to treatment. Patients with relapse had higher median miR compared with controls, with elevated levels found in 38 of 46 with relapse. Among 29 relapse patients with serial measurements during treatment, 28 had significant reductions in miR when remission was achieved. Teratoma did not express miR-371a-3p.
The investigators concluded, “The M371 test outperforms the classic markers of germ cell tumors with both a sensitivity and a specificity greater than 90%. All histologic subgroups, except teratoma, express this marker. The test could be considered for clinical implementation after further validation.”
Klaus-Peter Dieckmann, MD, of Asklepios Klinik Altona, Hamburg, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by Wilhelm Sander-Stiftung, Werner Otto Stiftung, and Rotary Club Hamburg Blankenese. The study authors’ full disclosures can be found at jco.ascopubs.org.
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