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

被引：36

作者：

Burke, Michael J. ^{[1
,2
]}

Devidas, Meenakshi ^{[3
]}

Maloney, Kelly ^{[4
,5
]}

Angiolillo, Anne ^{[6
]}

Schore, Reuven ^{[6
]}

Dunsmore, Kimberly ^{[7
]}

Larsen, Eric ^{[8
]}

Mattano, Len A., Jr. ^{[9
]}

Salzer, Wanda ^{[10
]}

Winter, Stuart S. ^{[11
]}

Carroll, William ^{[12
]}

Winick, Naomi J. ^{[13
]}

Loh, Mignon L. ^{[14
]}

Raetz, Elizabeth ^{[15
]}

Hunger, Stephen P. ^{[16
]}

Bleyer, Archie ^{[17
]}

机构：

[1] Med Coll Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI 53226 USA

[2] Childrens Hosp Wisconsin, Milwaukee, WI 53201 USA

[3] Univ Florida, Dept Biostat, Gainesville, FL USA

[4] Univ Colorado, Sch Med, Aurora, CO USA

[5] Childrens Hosp Colorado, Aurora, CO USA

[6] Childrens Natl Med Ctr, Washington, DC 20010 USA

[7] Univ Virginia, Childrens Hosp, Charlottesville, VA USA

[8] Maine Childrens Canc Program, Scarborough, ME USA

[9] HARP Pharma Consulting, Mystic, CT USA

[10] US Army Med Res & Mat Command, Ft Detrick, MD USA

[11] Univ New Mexico, Hlth Sci Ctr, Albuquerque, NM 87131 USA

[12] NYU, Laura & Issac Perlmutter Canc Ctr, New York, NY USA

[13] Univ Texas Dallas, Southwestern Simmons Canc Ctr, Dallas, TX USA

[14] Univ Calif San Francisco, Benioff Childrens Hosp, San Francisco, CA 94143 USA

[15] Univ Utah, Dept Pediat, Salt Lake City, UT USA

[16] Univ Penn, Childrens Hosp Philadelphia, Perelman Sch Med, Philadelphia, PA 19104 USA

[17] Oregon Hlth & Sci Univ, Dept Pediat, 3181 Sw Sam Jackson Pk Rd, Portland, OR 97201 USA

来源：

LEUKEMIA & LYMPHOMA | 2018年 / 59卷 / 07期

关键词：

Pegaspargase; asparaginase; hypersensitivity; intravenous; intramuscular; ALL; ACUTE LYMPHOBLASTIC-LEUKEMIA; L-ASPARAGINASE THERAPY; ANTIBODIES; HYPERAMMONEMIA; CHEMOTHERAPY;

D O I：

10.1080/10428194.2017.1397658

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：1624 / 1633

页数：10

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