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Molecular genomic assessment using a blood-based mRNA signature (NETest) is cost effective and predicts neuroendocrine tumor recurrence with 94% accuracy.

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Title: Molecular genomic assessment using a blood-based mRNA signature (NETest) is cost effective and predicts neuroendocrine tumor recurrence with 94% accuracy.
Authors: Modlin, IM
Kidd, M
Frilling, A
Falconi, M
Filosso, PL
Malczewska, A
Kitz, A
Item 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.
Issue Date: Sep-2021
Date of Acceptance: 1-Jun-2021
URI: http://hdl.handle.net/10044/1/90439
DOI: 10.1097/SLA.0000000000005026
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/Funder: Dr. Heinz-Horst Deichmann Stiftung
Funder's Grant Number: n/a
Keywords: Surgery
11 Medical and Health Sciences
Publication Status: Published
Conference Place: United States
Online Publication Date: 2021-06-24
Appears in Collections:Department of Surgery and Cancer
Faculty of Medicine