Abstract：
:For this study, 118 children with standard-risk acute lymphoblastic leukemia (ALL) were given randomized assignments to receive native or pegylated Escherichia coli asparaginase as part of induction and 2 delayed intensification phases. Patients treated with pegaspargase had more rapid clearance of lymphoblasts from day 7 and day 14 bone marrow aspirates and more prolonged asparaginase activity than those treated with native asparaginase. In the first delayed intensification phase, 26% of native asparaginase patients had high-titer antibodies, whereas 2% of pegaspargase patients had those levels. High-titer antibodies were associated with low asparaginase activity in the native arm, but not in the pegaspargase arm. Adverse events, infections, and hospitalization were similar between arms. Event-free survival at 3 years was 82%. A population pharmacodynamic model using the nonlinear mixed effects model (NONMEM) program was developed that closely fit the measured enzyme activity and asparagine concentrations. Half-lives of asparaginase were 5.5 days and 26 hours for pegaspargase and native asparaginase, respectively. There was correlation between asparaginase enzymatic activity and depletion of asparagine or glutamine in serum. In cerebrospinal fluid asparagine, depletion was similar with both enzyme preparations. Intensive pegaspargase for newly diagnosed ALL should be tested further in a larger population.
journal_name
Bloodjournal_title
Bloodauthors
Avramis VI,Sencer S,Periclou AP,Sather H,Bostrom BC,Cohen LJ,Ettinger AG,Ettinger LJ,Franklin J,Gaynon PS,Hilden JM,Lange B,Majlessipour F,Mathew P,Needle M,Neglia J,Reaman G,Holcenberg JS,Stork Ldoi
10.1182/blood.v99.6.1986subject
Has Abstractpub_date
2002-03-15 00:00:00pages
1986-94issue
6eissn
0006-4971issn
1528-0020journal_volume
99pub_type
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