Study validates endometrial cancer recurrence blood test

A test, which uses circulating tumour DNA to detect and quantify cancer left in the body, has been validated in endometrial cancer.

The US clinical genetic testing company Natera has announced that a new study validated its Signatera “personalised” blood test in endometrial cancer.

Endometrial cancer, also known as uterine cancer, is the most commonly diagnosed gynaecologic cancer in the US. About 50,000 American women are diagnosed with the disease every year.

Disease incidence has been rising, but mortality has been rising even faster, potentially due to a higher frequency of aggressive high-risk subtypes of the disease.

More accurate risk stratification is needed to identify those patients who will benefit from therapeutic interventions with curative intent. Current guidelines rely on clinicopathological risk factors to define risk groups and aid in adjuvant treatment decision-making.

However, the decision to administer adjuvant therapy for patients with high-risk and high-intermediate-risk endometrial cancer remains unclear.

The study, published in Gynecologic Oncology, analysed 267 plasma samples drawn after surgery from 101 patients with endometrial cancer.

The patient cohort was composed of multiple histological subtypes, with patients stratified based on clinicopathological risk factors into high-risk (52 per cent), high-intermediate (22 per cent), low-risk (15 per cent) and other (12 per cent).

The research found that patients who tested Signatera-positive at either a single time point or longitudinally experienced significantly higher rates of recurrence than those who tested Signatera-negative.

Signatera MRD status was the only significant risk factor for recurrence when adjusted for clinicopathological risk groups and molecular subgroups, the researchers showed.

Minetta Liu, chief medical officer of oncology at Natera, said: “This study provides clinical validation of Signatera as a powerful post-surgical biomarker of recurrence risk for patients with endometrial cancer.

“Use of Signatera in clinical workflows may help physicians and patients tailor their adjuvant treatment decisions based on direct evidence of molecular residual disease.”