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Prospective Evaluation of the NETest as a Liquid Biopsy for Gastroenteropancreatic and Bronchopulmonary Neuroendocrine Tumours: An ENETS Centre of Excellence Experience.
Neuroendocrinology 2020 April 25
BACKGROUND: There is a substantial unmet clinical need for an accurate and effective blood biomarker for neuroendocrine neoplasms (NEN). We therefore evaluated, under real-world conditions, the clinical utility of the NETest as a liquid biopsy in an ENETS Centre of Excellence and compared its utility with chromogranin A (CgA). Methods Cohorts: Gastroenteropancreatic (GEP)-NEN (n=253), bronchopulmonary (BP)-NEN (n=64), thymic NEN (n=1), colon cancer (n=37), NSCLC (n=63), benign lung disease (n=59) and controls (n=86).
GEPNEN: 164 (65%) had image-detectable disease (n=135) or were image-negative but resection-margin/biopsy-positive (n=29). Grading: G1 (n=106), G2 (n=49) and G3 (n=7), no data (n=2). The remainder (n=71) has no evidence of disease.
BPNEN: 43 of 64 (67%) were image-positive.
HISTOLOGY: TC (n=14), AC (n=14), SCLC (n=11), LCNEC (n=4). Disease status (stable or progressive) (RECIST 1.1). Blood sampling: NETest (n=563) and NETest/CgA matched samples (n=178). NETest (PCR) (0-100 score), positive ≥20; progressive >40. CgA (ELISA). Samples deidentified, measurement blinded.
STATISTICS: Kruskal-Wallis or Mann-Whitney, McNemar's test and AUROC. Results GEPNEN: NETest was significantly higher (34.4±1.8, p<0.0001) in disease versus disease-free (10.5±1, p<0.0001), colon cancer (18±4, p<0.0004) or controls (7±0.5, p<0.0001). Sensitivity for detecting disease compared to controls was 89%, specificity: 94%. NETest levels were increased in G2 vs. G1 (39±3 vs. 32±2, p=0.02) and correlated with stage (localized: 26±2, vs regional/distant: 40±3 p=0.0002) and progression (55±5 vs. 34±2 in stable disease, p=0.0005).
BPNEN: Diagnostic sensitivity was 100% and levels were significantly higher in image-positive bronchopulmonary carcinoids (BPC) (30±1.3) vs. controls (7±0.5, p<0.0001), no disease evident (24.1±1.3, p<0.005) or NSCLC (17±3, p=0.0001). NETest levels were higher in poorly-differentiated BPNEN (LCNEC+SCLC) (59±7) than BPC (30±1.3, p=0.0005), and progressive (57.8±7) compared to stable disease (29.4±1, p<0.0001). AUCs for differentiating disease from controls: 0.87 (GEPNEN); 0.99 (BPC) (p<0.0001). Matched CgA analyses (n=178): GEPNEN (n=135): NETest was significantly more accurate for detecting disease (99%) than CgA (53%, McNemar's test Chi2=87, p<0.0001). BPNEN (n=43): NETest was significantly more accurate for disease detection (100%) than CgA (26%, McNemar's test Chi2=30, p<0.0001). Conclusions The NETest is an accurate diagnostic for GEP- and BPNEN. It exhibits tumor biology correlation with grading, staging and progression. CgA is significantly less accurate than NETest. The NETest has substantial clinical utility that can facilitate patient management.
GEPNEN: 164 (65%) had image-detectable disease (n=135) or were image-negative but resection-margin/biopsy-positive (n=29). Grading: G1 (n=106), G2 (n=49) and G3 (n=7), no data (n=2). The remainder (n=71) has no evidence of disease.
BPNEN: 43 of 64 (67%) were image-positive.
HISTOLOGY: TC (n=14), AC (n=14), SCLC (n=11), LCNEC (n=4). Disease status (stable or progressive) (RECIST 1.1). Blood sampling: NETest (n=563) and NETest/CgA matched samples (n=178). NETest (PCR) (0-100 score), positive ≥20; progressive >40. CgA (ELISA). Samples deidentified, measurement blinded.
STATISTICS: Kruskal-Wallis or Mann-Whitney, McNemar's test and AUROC. Results GEPNEN: NETest was significantly higher (34.4±1.8, p<0.0001) in disease versus disease-free (10.5±1, p<0.0001), colon cancer (18±4, p<0.0004) or controls (7±0.5, p<0.0001). Sensitivity for detecting disease compared to controls was 89%, specificity: 94%. NETest levels were increased in G2 vs. G1 (39±3 vs. 32±2, p=0.02) and correlated with stage (localized: 26±2, vs regional/distant: 40±3 p=0.0002) and progression (55±5 vs. 34±2 in stable disease, p=0.0005).
BPNEN: Diagnostic sensitivity was 100% and levels were significantly higher in image-positive bronchopulmonary carcinoids (BPC) (30±1.3) vs. controls (7±0.5, p<0.0001), no disease evident (24.1±1.3, p<0.005) or NSCLC (17±3, p=0.0001). NETest levels were higher in poorly-differentiated BPNEN (LCNEC+SCLC) (59±7) than BPC (30±1.3, p=0.0005), and progressive (57.8±7) compared to stable disease (29.4±1, p<0.0001). AUCs for differentiating disease from controls: 0.87 (GEPNEN); 0.99 (BPC) (p<0.0001). Matched CgA analyses (n=178): GEPNEN (n=135): NETest was significantly more accurate for detecting disease (99%) than CgA (53%, McNemar's test Chi2=87, p<0.0001). BPNEN (n=43): NETest was significantly more accurate for disease detection (100%) than CgA (26%, McNemar's test Chi2=30, p<0.0001). Conclusions The NETest is an accurate diagnostic for GEP- and BPNEN. It exhibits tumor biology correlation with grading, staging and progression. CgA is significantly less accurate than NETest. The NETest has substantial clinical utility that can facilitate patient management.
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