Session: 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster I
Hematology Disease Topics & Pathways:
Adverse Events
Methods: We performed a retrospective study using a de-identified database with 93 contributing health care organizations within the United States (TriNetX). We identified all patients between the ages of 1-21 years with a diagnosis of ALL (ICD-10: C91.0) from 2010-2024. Patients were then categorized into two cohorts, based on whether they received Cal-PEG or PEG. We performed 1:1 propensity score matching, based on patient demographics and baseline clinical data. Independent t-tests were performed for continuous data and chi-square tests for categorical data. We evaluated differences in outcome risk using odds ratios and 95% confidence intervals. All tests were two-tailed with an alpha level of .05.
Results: Of the 67,030 patients with a diagnosis of ALL in the database, 4139 patients met criteria to be included in the study. 3800 patients (91.8%) received PEG and 339 patients (8.2%) received Cal-PEG. Patients receiving Cal-PEG were more likely to have a diagnosis of anaphylaxis (2.9 vs 0.7%; OR 4.59, p<0.001), receive Epinephrine (35.5 vs 17.7%; OR 2.55, p <0.001) and had more admissions to the ICU (2.9 vs 1.7%; OR 1.75, p=0.101). Patients receiving Cal-PEG were also more associated with Fibrinogen repletion (2.9 vs 0.3%; OR 11.2, p<0.001) and Anti-thrombin repletion (2.9 vs 1.5%; OR 2.03, p=0.038). Among all the toxicities related to asparaginase products, venous thrombosis (7.7 vs 12.2%; OR 0.6, p=0.013) and hemorrhage (2.9 vs 11.6 %; OR 0.23, p<0.001) were less associated with Cal-PEG whereas pancreatitis, pulmonary embolism and hepatic veno-occlusive disease were not different between the two groups.
Conclusions: In our large nationwide sample, Cal-PEG was associated with increased anaphylaxis as compared to PEG in pediatric and young adult patients with ALL, and led to increased healthcare burden. Venous thrombosis and hemorrhage were less associated with Cal-PEG, even though other toxicities remained the same between the two types of asparaginase. Anaphylaxis rates need to be prospectively confirmed in Children’s Oncology Group studies, so that preventive strategy guidelines can be developed for these patients.
Disclosures: Ahuja: Genentech: Honoraria, Membership on an entity's Board of Directors or advisory committees; BioMarin: Honoraria, Membership on an entity's Board of Directors or advisory committees; CSL Behring: Honoraria, Membership on an entity's Board of Directors or advisory committees; XaTek: Membership on an entity's Board of Directors or advisory committees, Research Funding; Case Western Reserve University: Patents & Royalties: Patent for US 11,408,844 issued; US FDA: Honoraria, Other: Member of the Blood Products Advisory Committee; Governor’s Office, State of Ohio: Other: Membership on Rare Disease Advisory Council for the State of Ohio; Sanofi Genzyme: Honoraria, Membership on an entity's Board of Directors or advisory committees.