Incidence of Adverse Drug Reactions Due to Asparaginase Formulation Change for Treatment of Pediatric Acute Lymphoblastic Leukemia (ALL)

Document Type

Conference Proceeding - Restricted Access

Publication Date

5-8-2026

Abstract

Treatment of pediatric acute lymphoblastic leukemia (ALL) during induction therapy includes an asparaginase product in addition to corticosteroids, vincristine and consideration of an anthracycline based on risk stratification. In December 2022, the Children's Oncology Group approved of a change from pegaspargase to calaspargase due to studies demonstrating non inferiority and longer duration of action. Asparaginase products are associated with thrombosis, hypersensitivity reactions (anaphylaxis, silent inactivation), pancreatitis, transaminitis and hyperbilirubinemia. In the event of a hypersensitivity reaction, Asparaginase (Erwinia [recombinant]) is used. It is derived from a genetically engineered Pseudomonas Fluorescens as opposed to E. coli in native forms of asparaginase. There is currently limited data comparing the incidence of adverse effects of pegaspargase and calaspargase.

In 2024, Michael et al. compared 26 ALL patients receiving pegaspargase to 21 ALL and mixed phenotype acute leukemia patients receiving calaspargase from December 1, 2021, to December 1, 2023. These patients were admitted to Helen DeVos Children's Hospital. They measured the incidence of adverse drug reactions, including hypersensitivity and thrombosis. We propose expanding the research protocol to include the period from December 1, 2019, to December 1, 2025, to increase the power of the study and detect whether there are discrepancies in adverse effects between pegaspargase and calaspargase. The study will be conducted via retrospective chart review using Epic. We will compare the incidence of adverse drug reactions (thrombosis, hypersensitivity, pancreatitis, transaminitis, hyperbilirubinemia) via chi-squared analysis with a larger sample size. Other endpoints include cost of the formulations and use of asparaginase (Erwinia [recombinant]).

In the original study, findings via chi-squared analysis showed an incidence of hypersensitivity events of 33.3% for calaspargase compared to 26.9% for pegaspargase. However, the findings were not statistically significant, with a p value of 0.6329. The rate of thrombosis was 3.9% in the pegaspargase group compared to 9.5% in the calaspargase group, with a p value of 0.791. Of note, there was a statistically significant difference in cost of the medications (p = 0.0119), with a median all-admission cost of pegaspargase of $179,672 compared to $352,258 for calaspargase. There was also a statistically significant higher average number of asparaginase (Erwinia [recombinant]) doses needed in the pegaspargase group compared to the calaspargase group (p = 0.0341); however, this analysis included only nine patients and should not be generalized. It is possible that these findings reflect the low power of the study given the small sample size.

It is possible that the incidence of adverse reactions may differ between calaspargase and pegaspargase derivatives. Given the severity of adverse reactions and the high cost of asparaginase (Erwinia [recombinant]), it is crucial to identify any discrepancies in the rate of adverse reactions between the two derivatives. Increasing the sample size of the study would be helpful in identifying any possible discrepancies. This information would be valuable in guiding future treatment protocols and providing optimal care to children with ALL.

Comments

2026 Research Day Corewell Health West, Grand Rapids, MI, May 8, 2026. Abstract 2049

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