Molecular genomic assessment using a blood-based mRNA signature (NETest) is cost effective and predicts neuroendocrine tumor recurrence with 94% accuracy.
File(s)FINAL_ASA Manuscript_4.20.2021 (Frilling Andrea).docx (1.41 MB)
Accepted version
Author(s)
Type
Journal Article
Abstract
INTRODUCTION: Identification of residual disease after neuroendocrine tumor (NET) resection is critical for management. Post-surgery imaging is insensitive, expensive and current biomarkers ineffective. We evaluated whether the NETest, a multigene liquid biopsy blood biomarker, correlated with surgical resection and could predict recurrence. METHODS: Multicenter evaluation of NET resections over 24 months (n=103): 47 pancreas, 26 small bowel, 26 lung, 2 appendix, 1 duodenum, 1 stomach. Surgery: R0 (83), R1/R2 (20). 1 ml blood collected at D0 and POD30. Transcript quantification by PCR (normal: ≤20), CgA by NeoLISA (normal≤108ng/mL). Standard-of-care (SoC) follow-up costs were calculated and compared to POD30 NETest-stratification approach. Analyses: Wilcoxon-paired test, Chi2-test. RESULTS: D0 biomarkers: NETest: 103/103 (100%)-positive while 23/103 (22%) were CgA-positive (Chi2=78, p<0.0001).In the R0 group, the NETest decreased 59±28 to 26±23 (p<0.0001); 36% (30/83) remained elevated. No significant decrease was evident for CgA. In the R1/R2 group the NETest decreased but 100% remained elevated. CgA levels did not decrease.An elevated POD30 NETest were present in R0 and 25 (83%) developed radiological recurrences. Normal score R0 s (n=53) did not develop recurrence (Chi2=56, p<0.0001). Recurrence prediction was 94% accurate with the NETest.Cost evaluation: Using the NETest to stratify postoperative imaging resulted in a cost-savings of 42%. CONCLUSION: NETest diagnosis is more accurate than CgA (100% vs. 22%). Surgery significantly decreased NETest. An elevated POD30 NETest predicted recurrence with 94% accuracy and post-surgical POD30 NETest follow-up stratification decreased costs by 42%. CgA had no surgical utility. Further studies would define the accuracy and cost-effectiveness of the NETest in the detection of post-operative recurrent disease.
Date Issued
2021-09
Date Acceptance
2021-06-01
Citation
Annals of Surgery, 2021, 274 (3), pp.481-490
ISSN
0003-4932
Publisher
Lippincott, Williams & Wilkins
Start Page
481
End Page
490
Journal / Book Title
Annals of Surgery
Volume
274
Issue
3
Copyright Statement
© 2021 Wolters Kluwer Health, Inc. All rights reserved.
Sponsor
Dr. Heinz-Horst Deichmann Stiftung
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/34183517
PII: 00000658-900000000-93465
Grant Number
n/a
Subjects
Surgery
11 Medical and Health Sciences
Publication Status
Published
Coverage Spatial
United States
Date Publish Online
2021-06-24