miR-371a-3p Predicts Recurrence in Stage I Testicular Cancer

Interim results from the CLIMATE study indicate that plasma miR-371a-3p is a superior marker for predicting recurrence in stage I testicular cancer when compared to existing biomarkers. The findings suggest that this marker of measurable residual disease could significantly refine the selection process for patients who require adjuvant chemotherapy following an orchiectomy.

The results of the prospective cohort trial, which enrolled 200 patients across Australia and New Zealand, were presented at the 2026 ASCO Genitourinary Cancers Symposium.

In the current management of stage I testicular cancer, clinicians face a persistent dilemma in identifying which patients truly require adjuvant treatment and which can be safely managed through active surveillance alone. While the disease is highly curable and orchiectomy is sufficient for many, a subset of patients will experience a relapse.

To reduce the risk of recurrence in high-risk patients, adjuvant chemotherapy is typically administered in one or two cycles of bleomycin, etoposide and cisplatin, a combination known as BEP.

However, the tools currently available to define which patients are high-risk are imprecise. This imprecision can lead to the administration of unnecessary treatment and associated toxicity for patients who could have been cured by orchiectomy alone.

The CLIMATE study focused on miR-371a-3p, a small non-coding RNA that is highly expressed in germ cell tumors and can be detected in circulating blood. By utilizing this marker, researchers aimed to optimize the use of adjuvant chemotherapy to maximize patient outcomes while minimizing unnecessary medical intervention.

The interim data revealed a stark difference in relapse-free survival rates based on the presence of the marker. For patients who tested negative for miR-371a-3p, the relapse-free survival rate at two years was 88.9%.

Conversely, the relapse-free survival rate at two years was only 31.4% for patients who were miR-371-positive.

Ben Tran, MD, MBBS, FRACP, a medical oncologist at the Peter MacCallum Cancer Centre in Melbourne, Australia, noted that the marker has the potential to optimize the selection of patients for adjuvant chemotherapy.

Adjuvant chemotherapy is considered for those at high risk of recurrence. However, its use can lead to unnecessary treatment and toxicity for the majority of patients who may be cured by orchiectomy alone,

Ben Tran, MD, MBBS, FRACP

Dr. Tran further emphasized the necessity of more precise diagnostic tools to improve the efficiency of cancer treatment pathways.

Improved biomarkers that identify patients at very high risk of recurrence are needed so that we can optimize the use of adjuvant chemotherapy and minimize treatment while maximizing outcomes.

Ben Tran, MD, MBBS, FRACP

The ability to accurately identify patients with measurable residual disease through a blood test could reduce the clinical burden of over-treatment and ensure that intensive chemotherapy is reserved for those with the highest risk of relapse.