Pediatric blood & cancer · 2026
Variability in Calaspargase Pegol Administration and Monitoring Across U.S. Pediatric Oncology Centers.
СтатьяНазвание и аннотация: Перевод в очереди
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Morgan Lori E, Raybin Jennifer L, Chang Bill H, Miller Lane H, Maxa Kim L, Stork Linda
Аннотация
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.
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.