On December 9, 2022 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported that the publication of a new study in JCO Precision Oncology highlighting the clinical utility of its personalized and tumor-informed molecular residual disease test, Signatera, for postoperative risk stratification and prediction of recurrence in patients with stage I-III esophageal and gastric cancers (EGCs) (Press release, Natera, DEC 9, 2022, View Source [SID1234624997]). The full study can be found here.
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EGCs are the sixth most common cancers worldwide,1 affecting approximately 47,000 new patients per year in the U.S.2 In patients with localized disease, despite treatment with curative-intent therapy, over 50% recur within three years.3-5 Today, clinical practice guidelines support either adjuvant therapy or observation post surgery, so there is a strong unmet need for better risk stratification tools to help inform these risk-based management decisions. In addition, due to the high rate of recurrence, guidelines recommend frequent monitoring for recurrence with imaging, endoscopic evaluation or tumor markers.6
This real-world study, one of the largest reported EGC studies to date, included 943 plasma samples collected from 295 patients across more than 70 institutions. The primary analysis focused on the 212 patients with stage I-III disease. Signatera ctDNA status was evaluated at diagnosis (prior to neoadjuvant treatment), post surgery and then serially during routine surveillance, with median clinical followup of 417 days.
Key takeaways from the study include:
Pre-treatment: ctDNA was detectable in 96% (23/24) of patients with preoperative samples.
Post surgery (within 16 weeks): ctDNA was detected post-surgically in 23.5% (16/68) of patients. ctDNA-positive patients experienced a higher rate of recurrence (81.2%) in comparison to ctDNA-negative patients (13.5%). ctDNA-positive patients experienced inferior RFS (HR: 10.7, 95% CI: 4.3-29.3, p<0.0001).
Surveillance setting (at least 2 weeks after completion of adjuvant treatment): the recurrence rate in patients with a ctDNA-positive result was 95.2% (20/21) compared to 7.9% (5/63) in patients who remained ctDNA-negative. ctDNA-positive patients experienced inferior RFS (HR: 17.7, 95% CI: 7.3-50.7, p<0.0001).
Multivariate analysis: ctDNA was the strongest prognostic factor compared to all other clinicopathological risk factors including disease stage, location, and MSI status (HR: 11.82, 95% CI: 6.18-22.6, p<0.001).
"This study shows how longitudinal assessment using Signatera allows for accurate post operative risk stratification and adjuvant therapy or surveillance monitoring in patients with esophagogastric cancers in a real-world setting," said Samuel Klempner, M.D., associate professor at Massachusetts General Hospital and corresponding author of the study. "Unfortunately, many gastroesophageal cancers recur after definitive treatment, and patients with advanced disease have a poor prognosis. This study highlights the potential for Signatera to better identify patients at highest risk of recurrence and help develop novel treatment approaches."
About Signatera
Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. Signatera is intended to detect and quantify cancer left in the body, at levels down to a single tumor molecule in a tube of blood, to identify recurrence earlier and to help optimize treatment decisions.