A PROSPECTIVE OBSERVATIONAL STUDY OF THE ADVERSE DRUG REACTIONS OF L-ASPARAGINASE IN NEWLY DIAGNOSED CHILDREN WITH ACUTE LYMPHOBLASTIC LEUKEMIA (ALL)

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Aim & Background: L-asparaginase is associated with clinically significant toxicity notwithstanding its high therapeutic efficacy. The present study aimed to evaluate the prevalence, type and severity of these adverse drug reactions amongst children aged 1 to 12 years. Materials and methods: A prospective observational study was conducted in the Pediatric Haematology-Oncology division of a tertiary care centre, after Institutional Ethics Committee clearance. 30 patients with newly diagnosed Acute Lymphoblastic Leukemia (ALL), without any coexisting comorbidities, were included, and monitored for clinical and biochemical evidence of toxicity. Baseline and weekly monitoring of liver and renal function, random blood sugar, serum triglycerides, cholesterol, and coagulation profile was performed. Data was analysed using Stata Version 23. Analysis of Variance (ANOVA) and Kruskal-Wallis equality-of-population rank test were used for parametric data and non-parametric data, respectively. Results: The mean age of the study population was 7.60 ± 3.38 years with a male preponderance. The majority of the patients (80%) were of the precursor B-cell type. While 73.34 % of patients did not show any clinical manifestations of L-asparaginase toxicity, 10% complained of pain in abdomen, and 6.67 % complained of pain at the local site. One patient each developed acute pancreatitis (requiring discontinuation of future L-asparaginase therapy), thrombosis and myalgia. Across the period of induction, serum albumin showed a statistically significant decline (p=0.01), whereas serum bilirubin trend demonstrated a statistically significant elevation (p=0.04). Serum triglyceride (p=0.048) and cholesterol (p=0.038) demonstrated a statistically significant elevation. L-asparaginase therapy did not significantly affect other biochemical parameters in this study. Conclusion: We conclude that though L-asparaginase was associated with some toxicity, it did not lead to the necessity to withhold it, except in one child. However, regular monitoring of patients on L-asparaginase for clinical and biochemical adverse effects is crucial.

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