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

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

Place A, (2015) (Link to abstract)




The authors report the findings of the Dana-Farber Cancer Institute Acute Lymphoblastic Leukaemia Consortium Protocol 05-001 (DFCI 05-001) which compared the relative toxicity and efficacy of intravenous PEG-asparaginase and intramuscular native E coli l-asparaginase in children with newly diagnosed acute lymphoblastic leukaemia who achieved CR after 32 days of induction.  They describe that the overall frequency of asparaginase-related toxicities does not differ significantly between the 2 groups: 65 [28%] of 232 patients in the intravenous PEG-asparaginase group vs 59 [26%] of 231 patients in the intramuscular native E coli l-asparaginase group, p=0•60.  In particular they found no difference in the individual frequency of allergy (p=0•36), pancreatitis (p=0•55), or thrombotic or bleeding complications (p=0•26).


* Intravenous PEG-asparaginase is not more toxic than, and is similarly efficacious to intramuscular native E coli l-asparaginase.  This adds to previous reports showing that PEG-asparaginase is a useful alternative to other asparaginase products – now if only we could do something about the cost.