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Endocrine Abstracts (2020) 70 AEP567 | DOI: 10.1530/endoabs.70.AEP567

1Department of Endocrinology and Neuroendocrine Tumors, Medical University of Silesia, Katowice, Poland; 2Department of Radiology and Nuclear Medicine, Medical University of Silesia, Katowice, Poland; 3Department of Pathology in Zabrze, Medical University of Silesia, Katowice, Poland; 4Molecular Imaging and Therapy Service, Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, United States; 5Department of Endocrine Oncology, University Hospital, Uppsala, Sweden


Introduction: There is a substantial unmet clinical need for an accurate and effective blood biomarker for gastroenteropancreatic neuroendocrine tumours (GEP-NETs). Current monoanalyte biomarkers are ineffective. The NETest, a novel multianalyte signature, provides molecular information relevant to disease biology. We therefore evaluated, under real-world conditions, the clinical utility of the NETest as a liquid biopsy in GEP-NETs.

Aim(s): Independently evaluate the NETest for diagnosis of GEP-NETs and identification of disease progress in a tertiary referral centre (an ENETS Centre of Excellence).

Materials and methods: Cohorts: pancreatic NETs (PNETs, n = 67), small bowel NETs (SBNETs, n = 44) and normal controls (n = 63). Well-differentiated PNETs, n = 62, SBNETs, all (n = 44). Disease extent assessment at blood draw: morphologic imaging (n = 110)–CT (n = 106), MRI (n = 7) and/or functional 68Ga-DOTA-TATE PET/CT (n = 69) or 18F-FDG PET/CT (n = 8). Image-positive disease was defined as either CT/MRI or 68Ga-DOTA-TATE PET/CT/18F-FDG PET/CT-positive. Both CT/MRI and 68Ga-DOTA-TATE PET/CT negative diagnosis in well-differentiated NETs was considered image-negative disease. NETest (normal: 20). Assay: PCR (spotted plates). Data: mean ± s.d.

Results and diagnosis: NETest was significantly elevated in NETs (n = 111; 26 ± 21) versus controls (8 ± 4, P < 0.0001). Seventy-five GEP-NETs (42 PNET, 33 SBNET) were image-positive. Eleven (8 PNET, 3 SBNET; all well-differentiated) were image-negative. In image-positive, NETest was significantly higher (36 ± 22) vs image-negative (8 ± 7, P < 0.0001). NETest accuracy (97%), sensitivity (99%) and specificity (95%). Concordance with imaging: 1) morphologic: NETest was 92% (101/110) concordant with morphologic imaging, 2) functional: 94% (65/69) with 68Ga-DOTA-TATE PET/CT and 3) dual modality (CT/MRI and 68Ga-DOTA-TATE PET/CT): 96% (65/68). In 70 CT/MRI positive, NETest was increased in all (37 ± 22). In 40 CT/MRI negative, NETest was normal (11 ± 10) in 31. In 56 68Ga-DOTA-TATE PET/CT positive, NETest was elevated (36 ± 22) in 55. In 13 68Ga-DOTA-TATE PET/CT negative, NETest was normal (9 ± 8) in ten. Radiological disease status assessment (RECIST 1.1): NETest was significantly higher in progressive (61 ± 26; n = 11) compared to stable disease (29 ± 14; n = 64; P < 0.0001).

Conclusion: NETest is effective as a diagnostic for gastroenteropancreatic NETs. Elevated NETest accurately correlates with diagnosis and identification of disease progress in GEP-NETs.

Volume 70

22nd European Congress of Endocrinology

Online
05 Sep 2020 - 09 Sep 2020

European Society of Endocrinology 

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