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Severe pegaspargase hypersensitivity reaction rates (grade ≥3) with intravenous infusion vs. intramuscular injection: analysis of 54,280 doses administered to 16,534 patients on children's oncology group (COG) clinical trials. Leuk Lymphoma 2018 07;59(7):1624-1633

Date

11/09/2017

Pubmed ID

29115886

Pubmed Central ID

PMC5940583

DOI

10.1080/10428194.2017.1397658

Abstract

PEGylated asparaginase (pegaspargase) can be administered via intramuscular (IM) injection or intravenous (IV) infusion with a hypersensitivity reaction (HSR) incidence ranging 3-41%. We evaluated grade ≥3 HSRs when given IM vs. IV on six Children's Oncology Group (COG) leukemia trials (2003-2015) to determine differences in HSR rates. 54,280 doses were administered to 16,534 patients. Considering all doses of pegaspargase during induction, consolidation, and delayed intensification, grade ≥3 HSR rate with IM injection was 5.4% (n = 482/8981) compared to 3.2% for IV (n = 245/7553) (p < .0001). If only the second and third doses of pegaspargase were analyzed, where the majority of grade ≥3 HSRs occur, the rate following IM injection was 10.1% (n = 459/4534) compared to 5.0% (n = 222/4443) for IV (p < .0001). On standardized treatment protocols conducted by the COG during 2003-2015, grade ≥3 HSR rates to pegaspargase occurred less frequently with IV infusion than IM injection.

Author List

Burke MJ, Devidas M, Maloney K, Angiolillo A, Schore R, Dunsmore K, Larsen E, Mattano LA Jr, Salzer W, Winter SS, Carroll W, Winick NJ, Loh ML, Raetz E, Hunger SP, Bleyer A

Author

Michael James Burke MD Professor in the Pediatrics department at Medical College of Wisconsin




MESH terms used to index this publication - Major topics in bold

Adolescent
Age Factors
Antineoplastic Agents
Asparaginase
Biomarkers
Child
Child, Preschool
Drug Hypersensitivity
Female
Humans
Incidence
Infusions, Intravenous
Injections, Intramuscular
Leukemia
Male
Polyethylene Glycols
Public Health Surveillance
Severity of Illness Index
jenkins-FCD Prod-482 91ad8a360b6da540234915ea01ff80e38bfdb40a