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A Pilot Study of Intensified PEG-Asparaginase in High-risk Acute Lymphoblastic Leukemia: Children's Oncology Group Study AALL08P1. J Pediatr Hematol Oncol 2016 08;38(6):409-17

Date

06/15/2016

Pubmed ID

27299599

Pubmed Central ID

PMC4955695

DOI

10.1097/MPH.0000000000000589

Abstract

AALL08P1 was designed to determine whether biweekly intensified pegaspargase (I-PEG) was feasible and safe in pediatric patients with newly diagnosed high-risk B-precursor lymphoblastic leukemia when given with Children's Oncology Group hemiaugmented BFM therapy. High-risk average (HR-Avg) patients received standard pegaspargase dosing (6 doses), whereas high-risk high (HR-High) patients received I-PEG biweekly from the start of Consolidation until day 1 of Maintenance. Feasibility and safety were defined in advance as ≥65% of patients tolerating at least 8 doses of I-PEG and 90% requiring ≤49 weeks from day 1 of Consolidation to the initiation of Maintenance. Targeted toxicities included allergic reactions, anaphylaxis, pancreatitis, thrombosis, bleeding, central nervous system events, and sepsis. AALL08P1 enrolled 104 patients; 54 were classified as HR-Avg and 30 as HR-High after completion of induction therapy. Only 53% (16/30) of the HR-High patients received ≥8 total doses of I-PEG and 50% (15/30) took ≤49 weeks from start of Consolidation to the initiation of Maintenance. I-PEG did not significantly increase grade 2 to 5 targeted toxicities. I-PEG was not feasible or safe as defined in AALL08P1. Complete assessment of this regimen was limited due to removal of patients from I-PEG regimen and early closure of the study.

Author List

Rodriguez V, Kairalla J, Salzer WL, Raetz EA, Loh ML, Carroll AJ, Heerema NA, Wood BL, Borowitz MJ, Burke MJ, Asselin BL, Devidas M, Winick NJ, Carroll WL, Hunger SP, Dreyer ZE

Author

Michael James Burke MD Professor in the Pediatrics department at Medical College of Wisconsin




MESH terms used to index this publication - Major topics in bold

Adolescent
Adult
Antineoplastic Agents
Asparaginase
Child
Child, Preschool
Female
Humans
Induction Chemotherapy
Infant
Male
Pilot Projects
Polyethylene Glycols
Precursor Cell Lymphoblastic Leukemia-Lymphoma
jenkins-FCD Prod-482 91ad8a360b6da540234915ea01ff80e38bfdb40a