Introduction: L-asparaginase (L-ASP) is one of the most effective medications for the treatment of acute lymphoblastic leukaemia (ALL) in children, and allergic reactions to the therapy are considered the most significant side effects.
Objective: The aim of this study was to determine the prevalence and type of allergic reactions, as well as to identify potential risk factors for the development of allergic reactions during L-ASP therapy in children with ALL.
Methods: The study encompassed 70 patients under 18 years of age, who were treated at the Institute for Child and Youth Healthcare of Vojvodina, Novi Sad in the period January 2000 - June 2009. We analyzed the frequency and type of allergic reactions during the administration of L-ASP, the onset of allergic reaction in relation to the phase of therapy of underlying disease, as well as the prevalence of allergic reactions in relation to drug administration method.
Results: Allergic reaction manifested in 17 patients (24%). In 14 patients (82%) allergic reaction to L-ASP manifested as urticaria, bronchospasm or anaphylaxis, whereas a mild local reaction was observed in only three patients (18%). In a group treated, according to the high-risk protocol, the prevalence of allergic reactions was statistically significantly higher in the intermediate-risk group of patients (p < 0.01), i.e. statistically significantly more frequent, as compared to the standard-risk group of patients (p < 0.05). The majority of patients (11; 65%) developed allergic reactions to the 9th dose of L-ASP, i.e. the first dose during the reinduction phase. The time interval between the last L-ASP dose in the induction phase and the 1st dose in the reinduction phase was at least four weeks. With respect to administration method, the majority of patients (16; 94%) developed allergic reaction after intravenous application of L-ASP.
Conclusion: Potential risk factors for the development of allergic reaction to L-ASP are a high-risk therapy group, intravenous administration route and repeated application of the drug after at least four-week cessation period.