Abstract
BACKGROUND: Acute lymphoblastic leukemia (ALL) is the most common pediatric cancer globally. PEG-asparaginase (PEG-ASPA), a cornerstone of ALL treatment, significantly improves outcomes but is associated with serious toxicities, including acute pancreatitis (AP). This study evaluates the incidence and associated risk factors of PEG-ASPA-induced AP among pediatric ALL patients in Saudi Arabia. METHODS: This multicenter retrospective cohort study included pediatric ALL patients treated with PEG-ASPA between January 2019 and October 2023 at three tertiary Saudi centers. Data included demographics, risk stratification, PEG-ASPA doses, and toxicity. AP was defined per CTCAE v5.0 criteria. A multivariate logistic regression model was used to evaluate risk factors. RESULTS: Of 322 pediatric patients, 5% (n=16) developed AP. Events were more frequent in children >10 years old (44%) and during consolidation (38%) and interim maintenance 2 (38%) phases. Multivariate analysis showed that age >10 years (OR=3.65), high-risk protocols (OR=2.07), and >5 PEG-ASPA doses (OR=1.58) were associated with increased AP risk. Most cases were grade 2 or 3 and resolved with supportive care. CONCLUSION: The incidence of PEG-ASPA-induced AP among pediatric ALL patients in Saudi Arabia is consistent with international data. Higher age, intensive protocols, and cumulative dosing may increase risk. Routine monitoring of pancreatic enzymes and triglycerides prior to PEG-ASPA administration is recommended to enhance early detection and reduce the risk of severe toxicity.