Interpace Biosciences Inc. (IDXG)

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Abstract on oral presentation being given Oct 19th...

https://www.eventscribe.com/2016/ACG/

Simultaneous Plenary Session 1: Pancreatico-Biliary / Endoscopy
56 - DNA Analysis of Pancreatic Cystic Lesions Has Value in Assessing Risk of Future Malignancy

Wednesday, October 19

8:40 AM - 8:50 AM

Room: Venetian Ballroom F

Presenting Author(s):

James J. Farrell, MD

Yale University School of Medicine, New Haven, CT
Tamas Gonda, MD – Boston Scientific: Speaker's Bureau; Cook Endoscopy: Consultant
Sara Jackson, PhD – Interpace Diagnostics: Employee
Nicole Toney, MPH – Interpace Diagnostics: Employee

Introduction: We aimed to determine the incremental value of DNA analysis of pancreatic cyst fluid in assessing risk of malignancy over long term follow-up, given the predictive value of clinical features used to routinely evaluate such lesions. Patient outcomes (benign or malignant)1 were used to assess the predictive value of individual and cumulative DNA abnormalities in various clinical scenarios.

Methods: DNA analysis included tumor suppressor gene (TSG) loss of heterozygosity mutations, KRAS, and/or elevated DNA quantity. The ability of 0-3 DNA abnormalities (KRAS, TSG, and/or elevated DNA) to predict malignancy after surgery or at long-term follow-up in cysts lacking or having concomitant high-risk stigmata (HRS) or clinical/imaging worrisome features (WF) was determined. HRS features included jaundice or MPD dilation ≥10 mm. Cases of frankly malignant cytology were not available for analysis. WF included size (>3 cm), pancreatitis history, MPD dilation 5-9 mm, abrupt change in duct caliber, and/or non-definitive solid component or mural nodule.

Results: Four hundred ninety-two cases (66 malignant) with surgical pathology (n=209) or long-term follow-up of 2.0-7.7 yrs (n=283) were analyzed (Table 1). 31/492 initially had HRS; 461/492 initially lacked HRS. Malignancy was found in 58% initially having HRS. Malignancy was found in only 10% initially lacking HRS, but in 30% when 2-3 DNA abnormalities were also initially present, and only 3% when all DNA abnormalities were initially absent. Malignancy was found in 4% initially lacking HRS and all WF, but in 9% when 2-3 DNA abnormalities were also initially present. Malignancy was found in 17% initially lacking HRS and having 1 WF, but in 50% when 2-3 DNA abnormalities were also initially present, and in only 2% when all DNA abnormalities were initially absent. Malignancy was found in 30% initially lacking HRS and having 2 or more WF, but in 80% when 2-3 DNA abnormalities were also initially present, and in only 8% when all DNA abnormalities were initially absent.

Discussion: In the absence of HRS, analysis of pancreatic cysts for TSG mutations, KRAS, and DNA quantity provides value to assessing risk of future malignancy. The presence of 2 or more DNA abnormalities can help identify patients in need of more aggressive management. The absence of all DNA abnormalities can help identify patients in need of less aggressive management.

References: 1. Al-Haddad MA, et al. Endoscopy 2015; 47:1-11.