Asparaginase activity monitoring in pediatric acute lymphoblastic leukemia: A cross-sectional nationwide study in Spain

Abstract

Background: A cross-sectional nationwide study was designed to assess national compliance with international consensus/guidelines of monitoring asparaginase levels in children with acute lymphoblastic leukemia (ALL) treated with asparaginase in routine clinical practice. Methods: An ad hoc questionnaire was designed and completed by staff physicians from Hemato-Oncology Units throughout Spain. Results: A total of 39 physicians (64% pediatricians) with a mean (SD) age 43.5 (7.9) years and 15.3 (17.6) years of professional activity participated in the study. They accounted for 90% of hospitals in which children with ALL are treated in Spain. A total of 19 participants (48.7%) reported that asparaginase levels were routinely monitored (own center in 2 cases [10.5%], another hospital in 17 cases [89.5%]). Asparaginase was not monitored in 51.3% of the cases, mostly (80%) because unavailability of testing. When asparaginase was monitored, 68% of participants reported that this was done in all asparaginase-treated patients and 84% in all phases of the disease (induction, consolidation, re-induction, maintenance) with a time interval of 7 days for the pegylated form, 48 h for Erwinia asparaginase and 14 days for maintenance with the pegylated form. All participants reported that they modified treatment according to results of testing, with a limit of total depletion of ≥100 IU/L. Levels <100 or 20 IU/L were considered indicative of hypersensitivity by 46% of physicians. Conclusion: There is still a gap between what is recommended and what is done in clinical practice, with more than 50% of centers not monitoring the level of asparaginase activity in pediatric ALL. Protocols for asparaginase testing in daily practice should be implemented.