A Pilot Study of Intensified PEG-Asparaginase in High-risk Acute Lymphoblastic Leukemia: Children's Oncology Group Study AALL08P1. Issue 6 (August 2016)

• Record Type: Journal Article
• Authors: Rodriguez, Vilmarie; Kairalla, John; Salzer, Wanda L.; Raetz, Elizabeth A.; Loh, Mignon LC; Carroll, Andrew J.; Heerema, Nyla A.; Wood, Brent L.; Borowitz, Michael J.; Burke, Michael J.; Asselin, Barbara L.; Devidas, Meenakshi; Winick, Naomi J.; Carroll, William L.; Hunger, Stephen P.; Dreyer, ZoAnn E.
• Is Part Of: Journal of pediatric hematology/oncology. Volume 38:Issue 6(2016)
• Publication Date: 2016-08
• Subjects: intensified asparaginase -- acute lymphoblastic leukemia -- high risk -- toxicities; Pediatric hematology -- Periodicals; Tumors in children -- Periodicals; 618.9215
• DOI: 10.1097/MPH.0000000000000589
• Languages: English
• ISSNs: 1077-4114

Abstract

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. Abstract : Supplemental Digital Content is available in the text.