Closing the care gap: Development of the first U.S. consensus statements transforming exocrine pancreatic insufficiency (EPI) management in pancreatic cancer.

45 Background: EPI is a prevalent, overlooked condition in PC impacting nutritional status, treatment tolerance & QOL. Evidence on pancreatic exocrine replacement therapy (PERT) in PC shows improvements in malabsorption, weight, QOL, sarcopenia, and survival increases. In the U.S, a lack of comprehensive guidelines on EPI/PERT in PC leaves a critical gap. Canopy engaged researchers to identify U.S. priorities in clinical practice to inform guideline development through expert consensus. Methods: A national Working Group (n = 12) convened. A mixed-methods approach and modified Delphi were used: Lit review; 6x focus groups (n=28; Patients/HCPs); 6 virtual meetings to develop consensus statements (CCS); 2 Delphi survey rounds deployed. Quant. ratings were analyzed for median & IQRs). Consensus was defined as ≥ 70% in agreement/strong agreement. CCS were validated for clinical feasibility & impact. Results: The15 CCS address critical domains in care & represent the first comprehensive recommendations standardizing EPI and PERT management in PC in the US. Conclusions: These statements offer practical guidance to improve EPI diagnosis & management in PC. Standardizing practice can reduce variability and improve outcomes. Wider adoption and iterative refinement of these recommendations through implementation is needed to validate clinical outcomes and further optimize care. Highlights from the 1st U.S. clinical consensus statements on EPI in panc cancer. Domain Statement Consensus Level Standards & Ethics EPI/PERT standards should be integrated into PC guidelines & MDC planning. 88% Screening & Clinical Criteria All PC patients should be screened for EPI & re-screened at intervals after. Given prevalence in PC, EPI in PC can be diagnosed through assessing symptoms/nutritional status, without PFTs (FE-1).EPI can be suspected when a patient presents with unintentional weight loss despite adequate intake, plus min. 1 additional EPI s/s, OR presentation w/ 2-3 EPI s/s without unintentional weight loss, despite adequate intake. 94% 88% 81% Therapeutic Principles Trialing PERT is considered safe & effective in symptomatic PC patients with OR without a clinical EPI Dx. 88% Access Practical considerations for Rx should include cost; pill burden; religious beliefs. 100% Dosing & Management Sugg. starting dose: 48,000 - 72,000 units/meal; 24,000-36,000 units/snack.Routine monitoring for dose adjustments should occur within 2 weeks after initiating PERT and with onset of any new/worsening s/s. 94% 94%