Compared with intramuscular (IM) native E coli l-asparaginase, intravenous (IV) PEG-asparaginase was not more toxic, had similar efficacy, and was associated with decreased anxiety, according to a study of 463 patients aged 1 to 18 years with newly diagnosed acute lymphoblastic leukemia (ALL). After 1:1 randomization of patients to either IM or IV therapies, researchers found:

• Treatment groups saw similar overall frequency of asparaginase-related toxicities, and similar individual frequency of allergy, pancreatitis, and thrombotic or bleeding complications.

• 5-year disease free survival was 90% in the IV group and 89% in the IM group.

• Median nadir serum asparaginase activity was significantly higher in the IV group vs the IM group.

• Patients and parent/proxies in the IM group had more anxiety vs the IV group.

• Most common grade 3 or higher adverse events were bacterial or fungal infection (20% in IV vs 22% IM) and asparaginase-related allergic reactions (6% IV vs 3% IM).

Citation: Place AE, Stevenson KE, Vrooman LM, et al. Intravenous pegylated asparaginase versus intramuscular native Escherichia coli l-asparaginase in newly diagnosed childhood acute lymphoblastic leukaemia (DFCI 05-001): a randomised, open-label phase 3 trial. [Published online ahead of print November 5, 2015]. Lancet Oncol. doi: 10.1016/S1470-2045(15)00363-0.