Management of chemotherapy-induced adverse events in patients with metastatic pancreatic ductal adenocarcinoma: A US-based modified Delphi consensus.

Abstract

e16400 Background: Metastatic pancreatic ductal adenocarcinoma (mPDAC) is an aggressive malignancy with poor prognosis. Chemotherapy (CTX) regimens, including irinotecan-based combinations, are the mainstay for patients with mPDAC; however, these are linked with adverse events (AEs) that may compromise clinical outcomes. Although management strategies for CTX-induced AEs are available, their application in US clinical practice is inconsistent. To address this gap, a modified Delphi consensus process was undertaken. Methods: A US-based modified Delphi consensus process was conducted to develop evidence-based guidance statements for managing and mitigating CTX-induced AEs in patients with mPDAC. The process included 25 experts (gastrointestinal oncologists and oncology nurses), organized into a 21-member Delphi panel and 4-member steering committee (SC). All had ≥ 3 years of experience in pancreatic cancer care; SC members also had ≥ 3 years of experience in liposomal irinotecan-based regimens. Draft statements, informed by published evidence and expert insight, were anonymously refined and approved by the SC, then voted on anonymously by the Delphi panel for up to three rounds. At each round, panellists indicated their level of agreement for each statement via a 5-point Likert scale, and could provide feedback for any they disagreed with. Consensus was defined a priori as any statement achieving ≥ 50% response and ≥ 80% agreement within a voting round. Non-consensus statements were anonymously revised by the SC based on panellist feedback and reintroduced in the next round. Results: Consensus was reached for all 25 draft statements that entered the first voting round (participation rate: 85.7%; agreement range: 82.4–100.0%), eliminating the need for further rounds. These statements, covering 7 thematic areas, include recommendations on pre-treatment assessment, patient and caregiver education, proactive management of diarrhea, nausea and vomiting, neutropenia, and neuropathy, as well as individualized approaches for higher-risk groups. For example, one diarrhea-specific statement recommends that patients with mPDAC and their caregivers receive at-home antidiarrheals with clear usage instructions, report the first loose stool, track symptoms for review, and follow reinforced dietary guidance. The statements also identify evidence gaps and priorities for future research, including the need to address disparities in AE recognition, reporting, and management. Conclusions: These statements, developed by a multidisciplinary panel of experts, provide practical guidance to optimize care for patients with mPDAC by improving consistency in managing CTX-induced AEs. Although US-based, these recommendations may be relevant to other regions.