From the Guidelines
Signatera should not be used for pancreatic cancer screening due to the lack of evidence on its clinical utility or validity outside of clinical trials. The use of circulating tumor DNA for screening, such as Signatera, is still an area of active investigation, and there is no evidence to support its use as a screening tool for pancreatic cancer 1. In fact, studies have shown that the percentage of patients with stage I cancer who have detectable circulating tumor DNA is low, and its detection is associated with a poorer outcome 1.
When considering the use of Signatera for pancreatic cancer, it's essential to understand the limitations of current biomarkers, such as CA-19-9, which may not be effective for screening due to its low sensitivity and specificity in certain populations, such as those with nonmalignant diseases or Lewis antigen a or b negativity 1.
In the context of pancreatic cancer monitoring, Signatera may have potential as a personalized, tumor-informed circulating tumor DNA test to detect minimal residual disease and monitor for recurrence in patients who have undergone surgical resection. However, this use is highly dependent on the specific clinical context and should be guided by the latest clinical evidence and recommendations from oncology experts.
Key considerations for the use of Signatera in pancreatic cancer include:
- The need for rigorous testing and validation of potential biomarkers in high-risk individuals
- The importance of combining multiple markers with high diagnostic specificity to improve diagnostic sensitivity
- The potential relationship between pancreatic cancer diagnosis and prior diagnosis of recent or new-onset diabetes in individuals older than 50 years, which may inform screening strategies 1.
From the Research
Use of Signatera for Pancreatic Cancer
- Signatera, a personalized, tumor-informed circulating tumor DNA (ctDNA) assay, has been evaluated for its feasibility in detecting recurrence prior to standard surveillance tools in patients with resectable pancreatic cancer 2.
- The study found that ctDNA-positivity at any time point was observed in 40% of patients, and during the follow-up period, 51% of patients developed radiographic evidence of recurrence after a median of 9 months of follow-up 2.
- The use of Signatera has been shown to be associated with inferior recurrence-free survival (RFS) and overall survival (OS) in patients who were ctDNA-positive versus ctDNA-negative 2, 3.
- Other studies have also demonstrated the potential of ctDNA analysis in evaluating minimal residual disease (MRD), treatment response, and posttreatment prognosis in pancreatic adenocarcinoma 4, 5.
- The current role of circulating tumor DNA in the management of pancreatic cancer is promising, but limited by its low rates of detection in some settings and lack of predictive ability in others 5.
Key Findings
- Detectable ctDNA after definitive resection correlates with shorter recurrence-free survival (RFS), overall survival (OS), and overall prognosis 4.
- ctDNA analysis, pre- and/or post-surgery, is a promising prognostic marker for pancreatic cancer 3.
- The use of Signatera and other ctDNA assays may provide a noninvasive means to assess response to chemotherapy and detect MRD in pancreatic cancer patients 2, 4.