1. Asparaginase encapsulated in erythrocytes as second‐line treatment in hypersensitive patients with acute lymphoblastic leukaemia.
- Author
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Lynggaard, Line Stensig, Vaitkeviciene, Goda, Langenskiöld, Cecilia, Lehmann, Anne Kristine, Lähteenmäki, Päivi M., Lepik, Kristi, El Hariry, Iman, Schmiegelow, Kjeld, and Albertsen, Birgitte Klug
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LYMPHOBLASTIC leukemia ,ASPARAGINASE ,ACUTE leukemia ,ERYTHROCYTES ,TERMINATION of treatment - Abstract
Summary: Asparaginase is essential in treating acute lymphoblastic leukaemia (ALL). Asparaginase‐related hypersensitivity causes treatment discontinuation, which is associated with decreased event‐free survival. To continue asparaginase treatment after hypersensitivity, a formulation of asparaginase encapsulated in erythrocytes (eryaspase) was developed. In NOR‐GRASPALL 2016 (NCT03267030) the safety and efficacy of eryaspase was evaluated in 55 patients (aged 1–45 years; median: 6.1 years) with non‐high‐risk ALL and hypersensitivity to asparaginase conjugated with polyethylene glycol (PEG‐asparaginase). Eryaspase (150 u/kg) was scheduled to complete the intended course of asparaginase (1–7 doses) in two Nordic/Baltic treatment protocols. Forty‐nine (96.1%) patients had asparaginase enzyme activity (AEA) ≥100 iu/l 14 ± 2 days after the first eryaspase infusion [median AEA 511 iu/l; interquartile range (IQR), 291–780], whereas six of nine (66.7%) patients had AEA ≥100 iu/l 14 ± 2 days after the fourth infusion (median AEA 932 iu/l; IQR, 496–163). The mean terminal half‐life of eryaspase following the first infusion was 15.3 ± 15.5 days. Few asparaginase‐related adverse events were reported; five patients (9.1%) developed clinical allergy associated with enzyme inactivation. Replacement therapy was successfully completed in 50 patients (90.9%). Eryaspase was well tolerated, and most patients had AEA levels above the therapeutic target after the first infusion. The half‐life of eryaspase confirmed that a 2‐week schedule is appropriate. [ABSTRACT FROM AUTHOR] more...
- Published
- 2022
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