Impact of circulating microRNA test (miRNA‐371a‐3p) on appropriateness of treatment and cost outcomes in patients with Stage I non‐seminomatous germ cell tumours

Abstract

Objectives To determine whether utilisation of a serum microRNA (miRNA) test could improve treatment appropriateness and cost‐effectiveness for patients with Stage I non‐seminomatous germ cell tumours (NSGCTs). Patients and Methods A decision tree model was built to investigate treatment course, clinical and cost outcomes for patients with Stage IA (T1N0M0S0) and IB (T2–4N0M0S0) NSGCT. The model compared outcomes and cost of standard approach using histopathology, conventional serum tumour markers and radiographic staging (standard model) to a miRNA‐based approach using the standard model + post‐orchidectomy serum miR‐371a‐3p (marker model). Probabilities of expected treatment and outcomes were based on presence/absence of cancer upon entering into the model. Overtreatment was defined as adjuvant chemotherapy or primary retroperitoneal lymph node dissection in a patient without cancer. Undertreatment was defined as initial surveillance for a patient with cancer. Results Utilising the miRNA marker‐based approach, 26% of patients avoid overtreatment and 8% avoid undertreatment in Stage IA NSGCT; 27% avoid overtreatment and 23% avoid undertreatment in Stage IB disease. Appropriate treatment decision‐making increased from 65% to 94% and 50% to 92% for Stage IA and IB, respectively. The miRNA‐based approach remained cost‐effective over a wide range of performance characteristics with savings of ~$1400 (American dollars)/patient for both Stage IA and IB disease. Conclusion A miRNA‐based approach may potentially select patients with Stage I NSGCT for correct treatment in a cost‐effective manner. Identification of residual teratoma‐only remains an issue. Prospective studies are necessary to validate these findings.

DigiMir Test: Establishing a Novel Pipeline for MiR-371a Quantification Using Droplet Digital PCR in Liquid Biopsies From Testicular Germ Cell Tumor Patients

“…Finally, we also tested an additional setting of relevance, which is the follow-up of these patients (57). Follow-up routinely involves repeat measurements of classical serum tumor markers (which show important limitations in detecting relapses) and continuing imaging [both costly, with limited sensitivity for very small metastatic deposits and exposing young patients to radiation if computed tomography is performed (30,58,59)]. In this sense, hsa-miR-371a-3p measurements are attractive for adequate monitoring and for guiding treatment decisions (34).…”

Combining Hypermethylated RASSF1A Detection Using ddPCR with miR-371a-3p Testing: An Improved Panel of Liquid Biopsy Biomarkers for Testicular Germ Cell Tumor Patients

“…miR-371a-3p has emerged as the most remarkable non-invasive biomarker for diagnosis and follow-up of TGCT patients, as demonstrated by several retrospective and also prospective works by various groups [13][14][15][16][17] (for a recent review see [18]). Its introduction in the clinic is to occur soon and may reduce costs in patient follow-up [19]. However, its major limitation is the inability to detect a subset of NS, which is teratoma (TE) [17,[20][21][22].…”

miRNAs for testicular germ cell tumours: Contemporary indications for diagnosis, surveillance and follow‐up

“…38 Finally, Bagrodia et al, built a decision tree model for CS IA and IB NSGCTs comparing histopathology, conventional STMs and imaging (Standard model) versus the standard model + miR371a-3p. 39 They reported that by using the miRNA marker-based approach, 26% of patients avoid overtreatment and 8% avoid undertreatment in CS IA, and 27% avoid overtreatment and 23%undertreatment in Clinical…”

“…They reported that by using the miRNA marker‐based approach, 26% of patients avoid overtreatment and 8% avoid undertreatment in CS IA, and 27% avoid overtreatment and 23%undertreatment in Clinical Stage IB (CS IB). Also, the accuracy of traditional TGCTs staging might increase from 65% to 94% for CS IA and from 50% to 92% for CS IB 39 . However, it should be noted this model was created before we published our data that more accurately depicts the performance characteristics of post‐orchiectomy miR‐371a‐3p in CS I disease 15 .…”