From Overlooked to Essential: Transforming Pancreatic Cancer Care with EPI Management

The First U.S. Consensus Statements on Identifying and Managing Exocrine Pancreatic Insufficiency in Pancreatic Oncology Practice

About this project: a collaborative effort

This white paper was conceptualized by the Canopy Cancer Collective Learning Health Network (Canopy) and Polaris Global Health Solutions (Polaris) in alignment with Canopy’s mission to scale best practices and bold innovation that transform patient care and outcomes in pancreatic cancer.

In 2023, Canopy network members set a network-wide goal to screen every patient seen across their 14 NCI-designated cancer centers for exocrine pancreatic insufficiency (EPI). In doing so, they uncovered a critical gap: there was no standardized screening process or tool, and many centers lacked the capacity and infrastructure to screen for EPI routinely or prioritize its management. To achieve the network-wide goal—and effectively identify and treat enzyme deficiencies revealed through screening—best-practice recommendations were urgently needed. To support development of such recommendations, funding was sought, ultimately leading to the development of this paper. Polaris led the project, which included conducting qualitative research, convening the Expert Working Group on Exocrine Pancreatic Insufficiency (EPI) and Pancreatic Exocrine Replacement Treatment (PERT) in Pancreatic Oncology, and developing the framework for the white paper. Canopy provided clinical and administrative oversight and access to data, experts, historical knowledge, and resources. Members of the Expert Working Group contributed their extensive clinical expertise to the overall direction of the white paper, shaping the statements and writing specific sections.

Primary authors

• Rebekkah Schear, MIA

• Rebecca Muñoz, EdD, MPH

Supporting authors

• Dallas Lawry, DNP, FNP-C, AOCNP

• Shelby Yaceczko, DCN, RDN-AP, CNSC, CCTD

Contributing authors

The Expert Working Group on EPI/PERT in Pancreatic Cancer consists of oncology dietitians, advanced practice providers (APPs), and researchers from Canopy’s national network of cancer centers, with an average of 11 years of clinical practice (range three to 24 years). The Expert Working Group includes the following members and leaders*:

• Dallas Lawry*, DNP, FNP-C, AOCNP, Pancreatic Cancer Nurse Practitioner, UC San Diego Moores Cancer Center

• Shelby D. Yaceczko*, DCN, RDN-AP, CNSC, CCTD, Advanced Practice Dietitian, Vatche and Tamar Manoukian Division of Digestive Diseases, UCLA Health

• Mary-Eve Brown, RD, LDN, CSO, Clinical Oncology Dietitian, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

• Whitney B. Christie, MS, RD, CSO, CNSC, FAND, Outpatient Oncology Dietitian, Mary Washington Healthcare’s Regional Cancer Center

• Ashley Cox, MS, RDN, CSO, Advanced Clinical Nutrition Coordinator, Mount Sinai Hospital

• Amy Hacker-Prietz, PA-C, Physician Assistant, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

• Shelli Hardy, MCN, RD, CSO, LD, Clinical Oncology Dietitian, UT Southwestern Simmons Cancer Center

• Bailey Irvin, RD, CSO, LD, Oncology Dietitian, UT Southwestern Simmons Cancer Center

• Megan Kitagawa, MS, RD, CNSC, Clinical Dietitian, Stanford Health Care

• Kaitland R. Lauterbach, MS, RD, CSO, LD/N, Senior Oncology Clinical Dietitian, Lynn Cancer Institute, Baptist Health South Florida

• Cassadie Moravek, BS, Senior Director, Clinical Trial Portfolio and Program Management, Pancreatic Cancer Action Network (PanCAN)

• Allison Rosenzweig, PhD, Director of Scientific Research and Communications, Pancreatic Cancer Action Network

  (PanCAN)

Executive summary

Patients With Exocrine Pancreatic Insufficiency Can’t Wait: Moving Pancreatic Cancer Care Forward Now

Despite advancements in pancreatic cancer treatment, exocrine pancreatic insufficiency (EPI) remains overlooked and underdiagnosed (Landers et al., 2016), as well as undertreated (Forsmark et al., 2020). If untreated, EPI can cause distressing and undesirable symptoms that significantly interfere with daily life, such as bloating, excessive flatulence, frequent diarrhea, and abdominal pain (Barkin et al., 2024); can lead to a poorer response to treatment (Trestini et al., 2021); and poor quality of life (Barkin et al., 2024; Gooden & White, 2013). A growing body of evidence on pancreatic enzyme replacement therapy (PERT) in pancreatic cancer shows that PERT can improve malabsorption, malnutrition, and body weight (Berry & Bilbo, 2024; Dominguez‐Muñoz et al., 2024); improve symptoms and health-related quality of life (Barkin et al., 2024); prevent muscle loss during chemotherapy (Klassen et al., 2024); and is associated with an increase in survival (Dominguez-Muñoz et al., 2018; Roberts et al., 2019; Trestini et al., 2021). In the United States, the lack of widely accepted, comprehensive clinical practice guidelines or national recommendations on EPI management in pancreatic cancer leaves a critical gap in care. While parts of Europe, Asia, and Australia have recently established robust EPI/PERT management guidelines (Dominguez‐Muñoz et al., 2024), there has been no national expert consensus in the pancreatic cancer space in the U.S. introducing comprehensive recommendations on EPI/PERT management for this sub-population—until now.

“I think we need to do better from the research and understanding perspective of how to treat EPI.” – HEALTH CARE PROVIDER

This white paper introduces the first-ever national consensus statements on identifying EPI and EPI/PERT management in patients with pancreatic cancer in the U.S. These consensus statements, grounded in available evidence and real-world practice, build upon the existing limited guidance on EPI/PERT management in the National Comprehensive Cancer Network® (NCCN®) and the American Society of Clinical Oncology (ASCO) pancreatic cancer treatment guidelines,1 expanding them into a framework that includes a comprehensive set of recommendations. In the current Pancreatic Adenocarcinoma Guidelines (Version 2.2025)2 and in the ASCO Clinical Practice Guidelines for Pancreatic Adenocarcinoma (Balaban et al., 2016; Sohal et al., 2020), EPI is identified within the principles of palliative and supportive care, and the use of PERT is recommended as a supportive care measure. While these guidelines acknowledge PERT in addressing suffering and improving quality of life, they currently provide limited higher-level guidance on how to identify and manage EPI in practice, lacking detail on how to initiate and adjust treatment, and defining care team ownership of PERT decision-making and follow-through, thus limiting PERT’s usefulness in real-world care. This creates an opportunity for more comprehensive, integrated recommendations that underscore the clinical importance of EPI in improving treatment adherence and overall whole-person cancer care.

What is missing—and is crucial in order to support timely diagnosis of EPI and effective use of PERT—is a guiding framework to support clinical decision-making across the care continuum, across stages, disease progression, and treatment regimens—for patients who are at risk of EPI due to the cancer itself or its treatment.

This white paper aims to begin to fill that gap by providing practical, actionable guidance. These consensus statements aim to standardize care and reduce variability across cancer centers and oncology practices. Developing formal guidelines is a complex, resource-intensive process, but patients simply cannot afford for us to wait. The evidence and expert insights that exist now, leveraging current high-quality evidence-based guidelines on EPI in pancreatic cancer internationally and on EPI in other non-cancer conditions in the U.S., are sufficient to make practical, impactful changes until formal clinical practice guidelines are developed.

Thus, an Expert Working Group on Exocrine Pancreatic Insufficiency (EPI) and Pancreatic Enzyme Replacement Therapy (PERT) in Pancreatic Oncology (the Expert Working Group) was convened in 2024 by the Canopy Cancer Collective (Canopy), a learning health network of more than a dozen cancer centers collaborating to build, share, and scale best practices and evidence in pancreatic cancer. The methodology used to develop these consensus statements is described in detail in the Approach and Methodology section of this white paper. Briefly, however, the methods included qualitative research with healthcare providers treating EPI and pancreatic cancer and patients with lived experience with EPI, assembly of a multidisciplinary Expert Panel, and the development of key questions using the PICO framework, a structured approach for formulating clinical research questions by defining the Population, Intervention, Comparison, and Outcome (Schünemann et al., 2014), which in this study addressed specific patient populations, various PERT initiation strategies, and their impact on nutritional and symptomatic outcomes. Concurrently with qualitative data collection and throughout the consensus process, the research team conducted an iterative literature review. These data were used by the Expert Working Group to generate preliminary consensus statements, which led to a modified Delphi process. This paper features quotes which were gathered during the project’s qualitative research, to amplify critical voices, those of patients and healthcare providers, that highlight key insights and pathways to improve care.

The goal for this effort is to provide pancreatic cancer care teams, including oncologists, surgeons, registered dietitians, nurses, advanced practice providers, pharmacists, supportive care providers, and researchers, with actionable consensus statements to put into practice, test, evaluate, and refine. Additionally, by leveraging models like Canopy’s learning health network, clinical teams implementing these recommendations have the potential to generate faster learning and better sharing, enabling transformation at scale that results in more integrated, interdisciplinary care among teams and, ultimately, improved patient outcomes (Smith et al., 2013; Brown et al., 2016; Enticott et al., 2021).

Despite the widespread clinical use of PERT, there remains a notable dearth of prospective randomized controlled trials (RCTs) globally evaluating its impact on outcomes in pancreatic cancer. To date, the only prospective RCT is by Saito et al. (2018), which demonstrated nutritional benefits in patients with unresectable pancreatic cancer. Most other available evidence stems from prospective observational studies (e.g., Carnie et al., 2021) or retrospective analyses (e.g., Picozzi et al., 2025; Roberts et al., 2019; Trestini et al., 2021). These studies are valuable but often vary in design, dosing regimens, and endpoints. Several have demonstrated improvements in survival, nutritional status, and symptom relief. This evidence gap reinforces the need for rigorously designed prospective trials, especially given the urgency and high symptom burden associated with pancreatic cancer.

However, delivering high-value care means acting on the best available knowledge rather than delaying progress in the hope of perfect data. By leveraging existing evidence, though imperfect, with rigorous gathering of expert consensus among experienced clinicians, meaningful strides are possible now, potentially, improving patient outcomes and moving toward more consistent and effective care.

The Expert Working Group hopes to see robust, evidence-based clinical guidelines formally developed and integrated into existing pancreatic cancer treatment guidelines published by authoritative bodies, including professional medical societies and nonprofit consortiums. Until then, healthcare providers must rely upon what is known to work and take decisive steps forward.

The following section presents a summary of the consensus statements developed by the Expert Working Group, based on a combination of review of current literature and clinical expertise. To enhance clarity, Table 1 categorizes the classification of the extent of consensus agreement, providing a practical framework for interpreting the strength of each statement. Table 2 further details this classification by outlining the thresholds used to define different levels of consensus.