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

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.