PancraGen, an integrated molecular pathology test that combines molecular analysis with clinical test results to assess the malignant potential of pancreatic cysts, provided more accurate results compared with management recommended by current guidelines in a recent trial.
“The results from this study indicate that PancraGen (integrated molecular pathology; formerly PathFinderTG-Pancreas, PDI) testing can help health care providers make the most appropriate management recommendations for their patients,” Mohammad Al-Haddad, MD, MSc, FASGE, FACG, director of endoscopy at Cleveland Clinic Abu Dhabi, said in a press release.
Aiming to evaluate the clinical performance of integrated molecular pathology (IMP) in diagnosing pancreatic adenocarcinoma in patients with pancreatic cysts that lack definitive malignant cytology results, and also its utility in stratifying these patients based on risk for malignancy, Al-Haddad and colleagues retrospectively reviewed medical records obtained from a U.S. National Pancreatic Cyst Registry from April 2011 to August 2013. They evaluated performance based on the correlation between the actual clinical outcomes of 492 patients (mean age, 64.9 years) and their previous IMP diagnosis (benign, statistically indolent, statistically higher risk or aggressive) compared with an International Consensus Guideline (Sendai 2012) criteria model for surveillance vs. surgery.
Compared with the Sendai model, IMP demonstrated superior specificity (90.6; 95% CI, 87.4-93.2 vs. 46.2; 95% CI, 41.4-51.1), positive predictive value (57.9; 95% CI, 47.3-68 vs. 20.8; 95% CI, 16.2-25.9) and positive likelihood ratio (8.9; 95% CI, 6.5-12.2 vs. 1.7; 95% CI, 1.5-1.9; all P < .0001).
Patients with benign and statistically indolent IMP diagnoses had a 97% probability of a benign outcome for up to 7 years and 8 months after initial IMP testing. HRs for malignancy relative to benign and statistically indolent diagnoses were 30.8 for statistically higher risk diagnoses and 76.3 for aggressive diagnoses (both P < .0001).
Patients who met Sendai criteria for surveillance had a 97% probability of a benign outcome for up to 7 years and 8 months after initial IMP testing, but for those who met Sendai criteria for surgery the HR for malignancy was only 9 (P < .0001). In patients who met Sendai criteria for surgery, benign and statistically indolent IMP diagnoses had a 93% and 97% probability of benign outcome, respectively, whereas HRs relative to benign and statistically indolent diagnoses for statistically higher risk and aggressive IMP diagnoses were 16.1 (95% CI, 7.6-34.3) and 50.2 (95% CI, 22.6-111.5), respectively (both P < .0001).
“IMP is more accurate than Sendai 2012 criteria in risk stratifying patients according to their potential for pancreatic adenocarcinoma,” the researchers concluded. “IMP may therefore improve guideline-recommended patient management strategies by increasing confidence that observation is more appropriate in the majority of patients, who are likely to have a benign disease course.” – by Adam Leitenberger
Disclosure: Al-Haddad reports he received a grant for this research from RedPath to his institution during the conduct of the study, and received personal fees from AbbVie, Boston Scientific and Forest outside of the submitted work. Please see the full study for a list of all other authors’ relevant financial disclosures.