Variability in Calaspargase Pegol Administration and Monitoring Across U.S. Pediatric Oncology Centers.

Document Type

Article

Publication Date

7-2026

Identifier

DOI: 10.1002/1545-5017.70274

Abstract

INTRODUCTION: Asparaginase is a foundational medication in the treatment of pediatric acute lymphoblastic leukemia and lymphoma (ALL/LLy), but its safety and efficacy are complicated by antibody-mediated toxicities. The recent transition to calaspargase pegol (sc-PEG) in the United States introduces questions regarding optimal administration, reaction classification, and therapeutic drug monitoring (TDM). Existing studies offer conflicting results with limited generalizability, and standardized evidence-based guidelines remain lacking.

METHODS: We developed a brief electronic survey to assess practices related to sc-PEG administration, TDM, and reaction classification at U.S. pediatric cancer centers. The survey was distributed in two phases, and responses were reconciled to ensure one representative submission per institution.

RESULTS: We received completed responses from 46 unique institutions. Most (93.3%) reported routine premedication prior to sc-PEG infusion; however, eight different premedication regimens were used. Infusion strategies also varied: 47.4% of centers used a flat two-hour rate, 33.3% an escalating rate, and 11.9% a one-hour flat rate. Forty-two centers (91.3%) had a standard TDM approach, but timing and criteria for serum asparaginase activity (SAA) monitoring differed. While 91.3% used both clinical signs and SAA levels to identify hypersensitivity, only 67.4% adhered to COG guidelines outlining SAA adequacy thresholds. Fewer than half (41.3%) systematically tracked hypersensitivity or silent inactivation.

CONCLUSION: This survey reveals substantial variability in sc-PEG administration and monitoring practices across U.S. pediatric cancer centers, underscoring the lack of standardized, evidence-based guidelines. These findings highlight the need for prospective research to define optimal strategies and improve the accuracy of hypersensitivity recognition with sc-PEG.

Journal Title

Pediatric blood & cancer

Volume

73

Issue

7

First Page

70274

Last Page

70274

MeSH Keywords

Humans; Asparaginase; Polyethylene Glycols; Child; United States; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Drug Monitoring; Antineoplastic Agents; Surveys and Questionnaires; Female; Child, Preschool; Cancer Care Facilities; Male

PubMed ID

41964526

Keywords

asparaginase; hypersensitivity; leukemia

Comments

Grants and funding

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