PancreaSeq Genomic Classifier (PancreaSeq GC) Improves Pancreatic Cyst Classification and Detection of Advanced Neoplasia: A Multi-institutional Validation Study.
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Singhi Aatur D, Wald Abigail I, Smith Katelyn, Wolkenstein Lynn, Bubar Robert D, Diaz-Aragon Ricardo, Grupillo Maria, Guckin Danielle, Lai Yi-Tak, Brand Randall E, McGrath Kevin, Park Walter G, Pfau Patrick R, Polanco Patricio M, Kubiliun Nisa, DeWitt John, Easler Jeffrey J, Dam Aamir, Mok Shaffer R, Wallace Michael B, Boone Brian A, Marsh Wallis, Thakkar Shyam, Fairley Kimberly J, Afghani Elham, Bhat Yasser, Ramrakhiani Sanjay, Nasr John, Thiruvengadam Nikhil R, Khalid Asif, Fasanella Kenneth, Chennat Jennifer, Das Rohit, Singh Harkirat, Slivka Adam, Gabbert Charles, Sawas Tarek, Tielleman Thomas, Vanderveldt Hendrikus Dutch, Tavakkoli Anna, Smith Lynette M, Singhi Anju H, Singhi Sara A, Romutis Stephanie, Mahmood Sultan, Hosmer Amy E, McNabb-Baltar Julia, Lennon Anne Marie, Hruban Ralph H, Shaker Nuha, Paniccia Alessandro, Zureikat Amer, Lee Kenneth K, Ongchin Melanie, Zeh Herbert, Minter Rebecca, Schmidt C Max, He Jin, Nikiforova Marina N
Аннотация
PATIENTS AND METHODS: PancreaSeq GC was blindly tested on a prospective cohort of 241 patients with diagnostic follow-up. The performance of PancreaSeq GC in this cohort, which included 186 mucinous cysts (97 with advanced neoplasia), was benchmarked against traditional diagnostics and its DNA-only predecessor, PancreaSeq.
RESULTS: PancreaSeq GC achieved 94.6% sensitivity and 96.4% specificity (area under the curve [AUC] of 0.955) for mucinous cysts. In comparison, increased fluid viscosity, elevated carcinoembryonic antigen (CEA), and PancreaSeq testing had lower sensitivities (71.4-88.2%) and lower AUC (0.824-0.941); however, PancreaSeq specificity was 100%. McNemar's test demonstrated higher sensitivity of PancreaSeq GC versus PancreaSeq for mucinous cysts (p < 0.001). For advanced neoplasia, PancreaSeq GC had 86.6% sensitivity and 97.9% specificity (AUC of 0.923), with McNemar's test confirming improved sensitivity over PancreaSeq (p = 0.031). Worrisome features, malignant cytopathology, and high-risk stigmata had lower sensitivities (44.3-84.5%) and lower AUC (0.604-0.892), while PancreaSeq had identical specificity to PancreaSeq GC. PancreaSeq GC had high accuracy in classifying intraductal oncocytic papillary neoplasms (IOPNs), intraductal tubulopapillary neoplasms (ITPNs), and cystic pancreatic neuroendocrine tumors (cPanNETs), with 97.1-100% sensitivity and 100% specificity.
CONCLUSIONS: This validation study demonstrates statistically significant improvements in PancreaSeq GC for mucinous cysts and advanced neoplasia, establishing it as a clinically valuable tool for the preoperative evaluation of pancreatic cysts.