Lucia Nappi, MD, highlights data on miR371 in early-stage testicular cancer

In the following interview, conducted at the 2026 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois, Lucia Nappi, MD, PhD, FRCPC, discusses interim findings from the prospective S1823/GCC.1 study (NCT04435756) evaluating circulating microRNA-371 (miR371) as a biomarker for relapse detection in patients with early-stage germ cell tumors managed with active surveillance.¹ Nappi is a medical oncologist at BC Cancer in Vancouver and an assistant professor in the Department of Urologic Sciences at the University of British Columbia.

Nappi explained that the study was developed to address limitations of current surveillance strategies for germ cell tumors, which rely heavily on serial CT imaging and conventional serum tumor markers such as α-fetoprotein, β-human chorionic gonadotropin, and lactate dehydrogenase. Although active surveillance is the standard approach for many patients with clinical stage I disease and selected patients with stage II disease, existing methods can fail to identify relapse early and expose predominantly young patients to cumulative radiation from repeated imaging. According to Nappi, miR371, a circulating microRNA highly expressed in seminomatous and nonseminomatous germ cell tumors, has demonstrated promising accuracy in retrospective studies, prompting investigators to evaluate its performance in a large surveillance cohort prospectively.

S1823 is an investigator-initiated, international prospective cohort study. The trial enrolled 948 eligible patients between 2020 and 2024, including 630 patients with clinical stage I or stage IIA disease managed with active surveillance. The study's primary objective was to define the operating characteristics of plasma miR371 for detecting relapse and determine whether biomarker positivity could precede clinically apparent recurrence.

In the prespecified interim analysis, investigators evaluated a total study population of 224 patients. Among this cohort, miR371 demonstrated a specificity of 94% and a negative predictive value of 90%. Sensitivity and positive predictive value were lower and varied according to relapse stage, with sensitivity increasing as disease burden increased (P = .07).

According to Nappi, one of the most clinically relevant findings was the strong prognostic value of a negative miR371 result following orchiectomy. She noted that patients who tested negative for miR371 within approximately 3 months after surgery had a substantially lower likelihood of relapse, whereas most patients with positive postorchiectomy miR371 results ultimately experienced recurrence.

Nappi said these early results highlight the potential of miR371 to improve surveillance strategies and reduce reliance on imaging. However, she cautioned that further research is still needed before this tool can be implemented into routine clinical practice.

REFERENCE

1. Nappi L, Colby S, Hamilton RW, et al; SWOG S1823 / CCTG GCC.1 Investigators. First interim analysis of SWOG S1823: operating characteristics of circulating microRNA 371a-3p (miR371) in predicting active germ cell malignancy (aGCM) in patients (pts) with early-stage testicular cancer. J Clin Oncol. 2026 (suppl 17; abstr LBA5003). doi:10.1200/JCO.2026.44.17_suppl.LBA5003