Higher Rates of Hypersensitivity Reactions to Calaspargase Compared With Pegaspargase: A Single Center Retrospective Review

IF 2.4 3区 医学 Q2 HEMATOLOGY
Kyra McCarty, Caroline Smith, Song Zhang, Ang Gao, Bianca Patel, Jessica Cox, Naomi Winick, Tamra Slone
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引用次数: 0

Abstract

Background

Asparaginase is a critical component of curative therapy for the treatment of pediatric acute lymphoblastic leukemia (ALL) and acute lymphoblastic lymphoma (LLy). Pegaspargase (PEG) increased the duration of asparagine depletion and lowered the incidence of hypersensitivity reactions (HSRs) compared with native asparaginase. When a second pegylated product, Calasparagase pegol-mknl (Cal-PEG) replaced PEG, we observed an increased incidence of HSR, defined as anaphylaxis or silent hypersensitivity. This led to a single center, retrospective review to determine the incidence of HSR in patients with ALL or LLy who received Cal-PEG or PEG.

Procedure

Electronic medical records of all patients who received at least two doses of Cal-PEG (December 2022–December 2023) or PEG (December 2019–December 2022) were reviewed.

Result

Overall, patients who received Cal-PEG had a significantly increased rate of asparaginase-related HSR compared with patients who received PEG. Twenty-one of 44 (48%) patients receiving Cal-PEG and 35 out of 154 (23%) of patients receiving PEG experienced Grade 3 or higher anaphylaxis, or silent hypersensitivity (p = 0.001). After 2:1 matching based on propensity scoring for confounding variables, patients who received Cal-PEG continued to have a statistically significantly higher rates of HSR, with HSR occurring in 21 out of 44 (48%) and 26 out of 88 (30%) patients receiving Cal-PEG and PEG, respectively (p = 0.04).

Conclusion

The current administration of Cal-PEG in large cooperative group trials will allow for a postmarketing exploration of the true risk of HSR and associated patient-specific risk factors.

Abstract Image

与Pegaspargase相比,对Calaspargase过敏反应的发生率更高:一项单中心回顾性研究。
背景:天冬酰胺酶是儿童急性淋巴母细胞白血病(ALL)和急性淋巴母细胞淋巴瘤(LLy)治疗的关键组成部分。与天然天冬酰胺酶相比,Pegaspargase (PEG)增加了天冬酰胺耗竭的持续时间,降低了超敏反应(HSRs)的发生率。当第二种聚乙二醇化产物钙天冬酰胺酶pegolmknl (Cal-PEG)取代PEG时,我们观察到HSR的发生率增加,定义为过敏反应或无症状超敏反应。这导致了一项单中心回顾性研究,以确定接受Cal-PEG或PEG治疗的ALL或LLy患者HSR的发生率。程序:回顾所有接受过至少两剂Cal-PEG(2022年12月- 2023年12月)或PEG(2019年12月- 2022年12月)的患者的电子病历。结果:总体而言,接受Cal-PEG的患者与接受PEG的患者相比,天冬酰胺酶相关HSR的发生率显着增加。44名接受Cal-PEG治疗的患者中有21名(48%),154名接受PEG治疗的患者中有35名(23%)经历了3级或更高级别的过敏反应,或无症状超敏反应(p = 0.001)。基于混杂变量倾向评分的2:1匹配后,接受Cal-PEG的患者的HSR发生率继续具有统计学意义上的显著性升高,分别在接受Cal-PEG和PEG的44例患者中有21例(48%)和88例患者中有26例(30%)发生HSR (p = 0.04)。结论:目前在大型合作组试验中使用Cal-PEG将允许对HSR的真实风险和相关患者特异性风险因素进行上市后的探索。
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来源期刊
Pediatric Blood & Cancer
Pediatric Blood & Cancer 医学-小儿科
CiteScore
4.90
自引率
9.40%
发文量
546
审稿时长
1.5 months
期刊介绍: Pediatric Blood & Cancer publishes the highest quality manuscripts describing basic and clinical investigations of blood disorders and malignant diseases of childhood including diagnosis, treatment, epidemiology, etiology, biology, and molecular and clinical genetics of these diseases as they affect children, adolescents, and young adults. Pediatric Blood & Cancer will also include studies on such treatment options as hematopoietic stem cell transplantation, immunology, and gene therapy.
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