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Testicular germ cell tumors (GCTs) are the most common malignancy in young men, with an increasing prevalence. Approximately 90% of all GCTs present with clinical stage (CS)-I (confined to the resected testis) or CS-II (regionally confined) disease, with only 10% presenting with dissemination above the diaphragm or involving visceral organs.

In patients with CS-I disease, active surveillance is, by far, the dominant management strategy in the United States and is strongly endorsed in North American guidelines. In CS-II disease, retroperitoneal lymph node dissection, chemotherapy, or regional radiation (in seminoma) are standard management strategies. Overall, the current treatment options for CS I-IIA/B disease are excellent with cure rates of 95%-100%.

Given the excellent oncologic outcomes in all stages of GCT presentation, there has been a growing emphasis on improving the quality of survivorship by mitigating treatment-related burden. Consequently, over recent decades, a concerted effort has mounted which emphasizes avoiding use of chemotherapy whenever possible, giving the appropriate number of chemotherapy cycles when necessary, minimizing radiation exposure associated with frequent whole-body imaging, and keeping therapeutic radiation to the absolute minimum.

Although such efforts have led to incremental progress, there remains a subset of patients with CS I-II that are inappropriately classified and subsequently submitted to overtreatment or undertreatment. This is where a novel and highly accurate GCT biomarker would exponentially improve survivorship.

MiR371 is a highly accurate, predictive liquid biomarker in detecting viable germ cell malignancy. This biomarker has the potential clinical utility in guiding decision-making for patients with both CS-I and CS-II GCTs. The high positive predictive value of miR371 alone is sufficient evidence to launch biomarker-guided trials to demonstrate clinical utility in early-stage GCTs.

Optimism surrounds the potential of a promising biomarker in accurately identifying patients that require early intervention in CS-I while limiting overtreatment in patients with CS-II disease. The overarching goal is to improve risk-stratification, limit systemic therapy, and improve cancer survivorship.

Read an interview about the study here.