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PURPOSE: An effective blood-based test for pancreatic cancer (PC) screening has remained elusive. The IMMray PanCan-d is the first commercially available blood-based test specifically designed for early detection of PC; however, outcomes from its use in clinical practice have not been reported. METHODS: We performed a blinded spike-in study of 100 individuals who had an IMMray PanCan-d test, including 94 high-risk individuals (HRIs) undergoing PC surveillance and six individuals with known PC. Specimens were processed blindly following the commercial laboratory's standardized operating procedure. Positive predictive value (PPV) and negative predictive value (NPV) were calculated. RESULTS: Cohort characteristics included a median age of 63 (IQR, 55-70) years, 57% female, 96% non-Hispanic White, 57% with a pathogenic variant in a PC risk gene (BRCA2 most commonly—18%), and 83% with a family history of PC. Among IMMray PanCan-d results from 94 HRIs undergoing PC surveillance, there was one positive (1%), seven borderlines (7%), 73 negatives (78%), and 13 tests not performed because of low CA19-9 expression (14%). No PC was diagnosed among these HRIs; however, there were two sub-cm pancreatic neuroendocrine tumors, seven clinically diagnosed side branch intraductal papillary mucinous neoplasms ≥1 cm, and a sub-cm solid mass with indeterminate cytology requiring close follow-up; all these individuals had negative IMMray PanCan-d tests. Of the six spiked-in PCs, four (67%) yielded a positive and two (33%) yielded a negative. With an estimated disease prevalence of 2%, the PPV and NPV are 52% and 99%, respectively, if borderline results are considered negative and 12% and 99%, respectively, if borderline tests are considered positive. CONCLUSION: In clinical practice, IMMray PanCan-d has a robust NPV; however, PPV is dramatically influenced by whether borderline results are characterized as a positive or negative result. The IMMray PanCan-d is the first commercially available blood-based test specifically designed for early detection of pancreatic cancer, and we assessed the outcomes of this test in high-risk individuals undergoing pancreatic cancer surveillance. [ABSTRACT FROM AUTHOR]

Background and Aim: Tumor genotyping may allow for improved prognostication and targeted therapy for pancreatic ductal adenocarcinoma (PDAC). We aimed to compare endoscopic ultrasonography (EUS) with fine needle aspiration (FNA) to fine needle biopsy (FNB) for obtaining sufficient tissue for genomic analysis and theranostic potential. Methods: A retrospective cohort study of patients that underwent EUS‐FNA or EUS‐FNB with either positive or suspicious cytology for PDAC between March 2016 and December 2017. Demographic, procedural, and cytology data were recorded. Genetic alterations were recorded, and Kaplan–Meier survival curves were calculated. Results: The study included 167 patients: 145 patients had FNA and 22 patients underwent FNB. Overall, 117 samples (70.1%) were sufficient for targeted next‐generation sequencing. FNB resulted in a higher proportion of patients with sufficient samples compared with FNA (90.9% vs 66.9%; P = 0.02). In multivariable modeling, only FNB (odds ratio 4.95, 95% confidence interval 1.11–22.05, P = 0.04) was associated with sufficient sampling for genomic testing. FNB was more likely to obtain sufficient tissue from tumors ≤ 3 cm (100% vs 68.4%, P = 0.017) and tumors located in the head/neck of the pancreas (100% vs 63.1%, P = 0.03) compared with FNA. The most commonly identified alterations were in KRAS (88%), TP53 (68%), and SMAD4 (16%). Conclusions: Endoscopic ultrasonography can reliably obtain sufficient tissue from PDAC for targeted genomic sequencing for prognostication and theranostics. FNB should be considered when tumor genotyping is requested, especially for tumors ≤ 3 cm or tumors located in the head/neck of the pancreas. [ABSTRACT FROM AUTHOR]

Hematogenous dissemination is thought to be a late event in cancer progression. We recently showed in a genetic model of pancreatic ductal adenocarcinoma that pancreas cells can be detected in the bloodstream before tumor formation. To confirm these findings in humans, we used microfluidic geometrically enhanced differential immunocapture to detect circulating pancreas epithelial cells in patient blood samples. We captured more than 3 circulating pancreas epithelial cells/mL in 7 of 21 (33%) patients with cystic lesions and no clinical diagnosis of cancer (Sendai criteria negative), 8 of 11 (73%) with pancreatic ductal adenocarcinoma, and in 0 of 19 patients without cysts or cancer (controls). These findings indicate that cancer cells are present in the circulation of patients before tumors are detected, which might be used in risk assessment. [Copyright &y& Elsevier]

OBJECTIVE: The aim of this study was to determine the long term survival of patients with pancreatic adenocarcinoma who underwent surgical resection and to assess the association of clinical, pathological, and treatment features with survival. METHODS: Between January, 1990, and December, 1998, 125 patients underwent a pancreaticoduodenal or partial pancreatic resection for pancreatic ductal adenocarcinoma at our institution. The records of these patients were reviewed for demographics, tumor characteristics including size, histological grade, margin status. lymph node status, surgical TNM staging, and postoperative adjuvant therapy. The primary outcome variable analyzed was survival. RESULTS: A total of 116 patients had complete follow-up and were included in the final analysis. The median survival after surgery was 16 months. The 1-, 3-, 5-, and 7-yr survival rates for all I 16 patients were 60%, 23%, 19%, and 11%. respectively. The 1-, 3-, 5-, and 7-yr survival rates for patients who received adjuvant therapy were 69%, 28%, 23%, and 18% compared with 20% and 0% in patients who did not receive adjuvant therapy (p < 0.0001). The 1-, 3-, 5-, and 7-yr survival rates for patients with negative lymph nodes were 73%, 38%, 26%. and 22%; compared with survival rates of 52%, 14%, 14%, and 9% in patients with positive lymph nodes (p = 0.01). In multivariate analyses, adjuvant therapy was the only feature found to be strongly associated with survival (hazards ratio = 0.26, 95% CI = 0.15-0.44). CONCLUSIONS: The overall 5- and 7-yr survival rates of 19% and 11% ( in our study further validate that surgical resection in patients with pancreatic adenocarcinoma can result in long term survival, particularly when performed in association with adjuvant chemoradiation. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Endoscopic ultrasound (EUS) and magnetic resonance imaging (MRI) have both been assessed individually as staging modalities for pancreatic cancer. The aim of our study was to assess whether tumor staging by both EUS and MRI in the same cohort of patients could predict resectability and unresectability in patients with pancreatic cancer. METHODS: A review of 63 patients evaluated preoperatively with both EUS and MRI for pancreatic adenocarcinoma between January 1995 and December 1998 was done. Patients were staged as resectable or unresectable by pre-defined criteria. Preoperative staging by both modalities was compared to surgical outcome and the sensitivity and predictive values of each modality for determining resectability and unresectability was determined. RESULTS: EUS did not allow for complete T- and N-staging in 10 patients; therefore, for EUS, the final analysis was done on 63 of 73 patients (86%). EUS correctly staged 22 of 36 patients with resectable tumors. The sensitivity of EUS for resectability was 61%, with a positive predictive value of 69%. All 73 patients had complete MRI examinations; therefore, the final analysis was done on all 73 patients. MRI correctly staged 30 of 41 patients with resectable tumors. The sensitivity of MRI for predicting resectability was 73% with a positive predictive value of 77%. MRI and EUS both predicted resectability in 18 patients, of whom 16 (89%) were found to be resectable on surgical exploration. MRI and EUS both predicted unresectability in 17 (27%) patients, of whom 4 (24%) were found to be resectable on surgical exploration. When both MRI and EUS agreed on resectability, the positive predictive value for resectability was 89%. When both MRI and EUS agreed on unresectability, the positive predictive value for unresectability was 76%. CONCLUSIONS: Neither MRI nor EUS alone were highly sensitive or predictive of resectability. However, when both tests agreed on resectability, nearly all patients were found to be resectable on surgical exploration. [ABSTRACT FROM AUTHOR]

Background In 2006, the Sendai Consensus Guidelines identified size >3.0 cm as the only independent predictor of malignancy in incidentally discovered pancreatic cysts. The 2012 updated guidelines increased emphasis on radiographic features over size. Earlier studies included patients with preoperatively diagnosed carcinoma or with a corresponding mass. In this report, we characterize the use of size and serum tumor markers in the initial evaluation of pancreatic cystic neoplasms without preoperatively diagnosed adenocarcinoma and correlate them with clinical and pathologic outcomes. Study Design A retrospective cohort study was undertaken of 112 patients with a resected pancreatic cystic neoplasm. Patient demographics, cyst characteristics, preoperative serum tumor markers, morbidity, and mortality were captured. Statistical analysis included nonparametric tests of comparison, multivariate logistic regression, and receiver operating characteristic curve analyses. Results One hundred and twelve pancreatic cystic neoplasms were resected; there was one perioperative death. Mucinous cysts were common (78%), followed by serous cysts (13%). In total, 17% of cysts harbored malignancy. On multivariate analysis, the risk of malignancy in cysts ≥3 cm was more than 4 times that of smaller cysts (relative risk (RR) = 4.32; 95% CI, 1.55–12.07). There was no significant difference in serum CEA, cancer antigen 19-9, or cyst-fluid CEA levels between the benign and malignant groups. At a median follow-up of 30 months, the incidence of diabetes was 15%. Conclusions Surgical resection of pancreatic cysts can be performed with low perioperative mortality and acceptable long-term morbidity. Use of cyst size as a rationale for resection of cystic lesion, as per the Sendai criteria, is justified. [ABSTRACT FROM AUTHOR]