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. Burke; Meenakshi Devidas; Kelly Maloney; Anne Angiolillo; Reuven Schore; Kimberly Dunsmore; Eric Larsen; Len A. Mattano; Wanda Salzer; Stuart S. Winter; William Carroll; Naomi J. Winick; Mignon L. Loh; Elizabeth Raetz; Stephen P. Hunger; Archie Bleyer

doi:10.1080/10428194.2017.1397658

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. Burke, Meenakshi Devidas, Kelly Maloney, Anne Angiolillo, Reuven Schore, Kimberly Dunsmore, Eric Larsen, Len A. Mattano, Wanda Salzer, Stuart S. Winter, William Carroll, Naomi J. Winick, Mignon L. Loh, Elizabeth Raetz, Stephen P. Hunger, Archie Bleyer

Research output: Contribution to journal › Article › peer-review

33 Scopus citations

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.

Original language	English (US)
Pages (from-to)	1624-1633
Number of pages	10
Journal	Leukemia and Lymphoma
Volume	59
Issue number	7
DOIs	https://doi.org/10.1080/10428194.2017.1397658
State	Published - Jul 3 2018

Keywords

ALL
Pegaspargase
asparaginase
hypersensitivity
intramuscular
intravenous

ASJC Scopus subject areas

Hematology
Oncology
Cancer Research

Access to Document

10.1080/10428194.2017.1397658

Fingerprint

Dive into the research topics of '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'. Together they form a unique fingerprint.

Cite this

Burke, M. J., Devidas, M., Maloney, K., Angiolillo, A., Schore, R., Dunsmore, K., Larsen, E., Mattano, L. A., Salzer, W., Winter, S. S., Carroll, W., Winick, N. J., Loh, M. L., Raetz, E., Hunger, S. P., & Bleyer, A. (2018). 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. Leukemia and Lymphoma, 59(7), 1624-1633. https://doi.org/10.1080/10428194.2017.1397658

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. / Burke, Michael J.; Devidas, Meenakshi; Maloney, Kelly et al.
In: Leukemia and Lymphoma, Vol. 59, No. 7, 03.07.2018, p. 1624-1633.

Research output: Contribution to journal › Article › peer-review

Burke, MJ, Devidas, M, Maloney, K, Angiolillo, A, Schore, R, Dunsmore, K, Larsen, E, Mattano, LA, Salzer, W, Winter, SS, Carroll, W, Winick, NJ, Loh, ML, Raetz, E, Hunger, SP & Bleyer, A 2018, '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', Leukemia and Lymphoma, vol. 59, no. 7, pp. 1624-1633. https://doi.org/10.1080/10428194.2017.1397658

Burke MJ, Devidas M, Maloney K, Angiolillo A, Schore R, Dunsmore K et al. 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. Leukemia and Lymphoma. 2018 Jul 3;59(7):1624-1633. doi: 10.1080/10428194.2017.1397658

@article{2f3a93161ab146b18abd9bfcff7edda4,

title = "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{\textquoteright}s oncology group (COG) clinical trials",

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{\textquoteright}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.",

keywords = "ALL, Pegaspargase, asparaginase, hypersensitivity, intramuscular, intravenous",

author = "Burke, {Michael J.} and Meenakshi Devidas and Kelly Maloney and Anne Angiolillo and Reuven Schore and Kimberly Dunsmore and Eric Larsen and Mattano, {Len A.} and Wanda Salzer and Winter, {Stuart S.} and William Carroll and Winick, {Naomi J.} and Loh, {Mignon L.} and Elizabeth Raetz and Hunger, {Stephen P.} and Archie Bleyer",

note = "Publisher Copyright: {\textcopyright} 2017, {\textcopyright} 2017 Informa UK Limited, trading as Taylor & Francis Group.",

year = "2018",

month = jul,

day = "3",

doi = "10.1080/10428194.2017.1397658",

language = "English (US)",

volume = "59",

pages = "1624--1633",

journal = "Leukemia and Lymphoma",

issn = "1042-8194",

publisher = "Informa Healthcare",

number = "7",

}

TY - JOUR

T1 - Severe pegaspargase hypersensitivity reaction rates (grade ≥3) with intravenous infusion vs. intramuscular injection

T2 - analysis of 54,280 doses administered to 16,534 patients on children’s oncology group (COG) clinical trials

AU - Burke, Michael J.

AU - Devidas, Meenakshi

AU - Maloney, Kelly

AU - Angiolillo, Anne

AU - Schore, Reuven

AU - Dunsmore, Kimberly

AU - Larsen, Eric

AU - Mattano, Len A.

AU - Salzer, Wanda

AU - Winter, Stuart S.

AU - Carroll, William

AU - Winick, Naomi J.

AU - Loh, Mignon L.

AU - Raetz, Elizabeth

AU - Hunger, Stephen P.

AU - Bleyer, Archie

PY - 2018/7/3

Y1 - 2018/7/3

N2 - 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.

AB - 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.

KW - ALL

KW - Pegaspargase

KW - asparaginase

KW - hypersensitivity

KW - intramuscular

KW - intravenous

UR - http://www.scopus.com/inward/record.url?scp=85033406042&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85033406042&partnerID=8YFLogxK

U2 - 10.1080/10428194.2017.1397658

DO - 10.1080/10428194.2017.1397658

M3 - Article

C2 - 29115886

AN - SCOPUS:85033406042

SN - 1042-8194

VL - 59

SP - 1624

EP - 1633

JO - Leukemia and Lymphoma

JF - Leukemia and Lymphoma

IS - 7

ER -

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

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this