From the Children’s Oncology Group: Evidence-Based Recommendations for PEG-Asparaginase Nurse Monitoring, Hypersensitivity Reaction Management, and Patient/Family Education

Abstract

PEG-aspariginase is a backbone chemotherapy agent in pediatric acute lymphoblastic leukemia and in some non-Hodgkin lymphoma therapies. Nurses lack standardized guidelines for monitoring patients receiving PEG-asparaginase and for educating patients/families about hypersensitivity reaction risks. An electronic search of six databases using publication years 2000–2015 and multiple professional organizations and clinical resources was conducted. Evidence sources were reviewed for topic applicability. Each of the final 23 sources was appraised by two team members. The GRADE system was used to assign a quality and strength rating for each recommendation. Multiple recommendations were developed: four relating to nurse monitoring of patients during and after drug administration, eight guiding hypersensitivity reaction management, and four concerning patient/family educational content. These strong recommendations were based on moderate, low, or very-low quality evidence. Several recommendations relied upon generalized drug hypersensitivity guidelines. Additional research is needed to safely guide PEG-asparaginase monitoring, hypersensitivity reaction management and patient/family education. Nurses administering PEG-asparaginase play a critical role in the early identification and management of hypersensitivity reactions.

Universal premedication and therapeutic drug monitoring for asparaginase‐based therapy prevents infusion‐associated acute adverse events and drug substitutions

“…As foreign proteins, all asparaginase products are associated with systemic clinical hypersensitivity reactions, manifested on the spectrum of urticaria, bronchospasm, angioedema, or anaphylaxis . The incidence of hypersensitivity varies widely based on form, routes, frequency, etc., but is usually estimated at 10% to 30% .…”

“…As foreign proteins, all asparaginase products are associated with systemic clinical hypersensitivity reactions, manifested on the spectrum of urticaria, bronchospasm, angioedema, or anaphylaxis. 12,13 The incidence of hypersensitivity varies widely based on form, routes, frequency, etc., but is usually estimated at 10% to 30%. [13][14][15][16][17][18] These clinical reactions have been shown to be strongly associated with the production of neutralizing antibodies and lack of asparaginase activity, although the severity of the reaction does not correlate with the risk of neutralization.…”

Epidemiologic patterns of in-hospital anaphylaxis in pediatric surgical patients

“…While it is not possible to determine the triggering agent for anaphylaxis using this dataset, chemotherapeutic agents and more recent monoclonal antibody treatments have been recognized causes of immediate hypersensitivity and anaphylaxis in bone marrow transplant patients, but these events have typically only been documented in case reports or as adverse events in clinical trials. 6–8 The exact mechanism for hypersensitivity to these agents is unclear, and while mild to moderate reactions are relatively common, severe hypersensitivity reactions are thought to be rare. 9 Since severe hypersensitivity after treatment with chemotherapy has not been well described in a population-based study, its incidence may be underestimated, resulting in inadequate preparation for responding to these events.…”

Development of Processes for Recombinant L-Asparaginase II Production by Escherichia coli Bl21 (De3): From Shaker to Bioreactors

“…In clinical practice, L-ASNase from two prokaryotic microorganisms are used, Escherichia coli and Dickeya dadantii (previously named as Erwinia chrysanthemi). E. coli L-ASNase formulations are used as line first treatment and E. chrysanthemi L-ASNase is used as second line treatment [8,10,11].…”