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Original Article: Clinical

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

Michael J. BurkeMedical College of Wisconsin and Children’s Hospital of Wisconsin, Milwaukee, WI, USA; Correspondence[email protected]

Meenakshi DevidasDepartment of Biostatistics, University of Florida, Gainesville, FL, USA;

Kelly MaloneySchool of Medicine and Children’s Hospital of Colorado, University of Colorado, Aurora, CO, USA;

Anne AngiolilloChildren’s National Medical Center, Washington, DC, USA;

Reuven SchoreChildren’s National Medical Center, Washington, DC, USA;

Kimberly DunsmoreUniversity of Virginia Children’s Hospital, Charlottesville, VA, USA;

Eric LarsenMaine Children’s Cancer Program, Scarborough, ME, USA;

Len A. Mattano Jr.HARP Pharma Consulting, Mystic, CT, USA;

Wanda SalzerUS Army Medical Research and Materiel Command, Fort Detrick, MD, USA;

Stuart S. WinterHealth Sciences Center, University of New Mexico, Albuquerque, NM, USA;

William CarrollLaura and Issac Perlmutter Cancer Center at NYU, New York, NY, USA;

Naomi J. WinickSouthwestern Simmons Cancer Center, University of Texas, Dallas, TX, USA;

Mignon L. LohBenioff Children’s Hospital, University of California San Francisco, San Francisco, CA, USA;

Elizabeth RaetzDepartment of Pediatrics, University of Utah, Salt Lake City, UT, USA;

Stephen P. HungerChildren’s Hospital of Philadelphia, The Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA;

Archie BleyerDepartment of Pediatrics, Oregon Health and Science University, Portland, OR, USA

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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.

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Potential conflict of interest

Disclosure forms provided by the authors are available with the full text of this article online at https://doi.org/10.1080/10428194.2017.1397658.

Funding

This work was funded by COG Chair’s Operations grants U10 CA98543 and U10 CA180886, COG Statistics and Data Center grants U10 CA098413, and U10 CA180899.

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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

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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

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