Dexamethasone (DEX) versus prednisone (PRED) during induction for children with high-risk acute lymphoblastic leukemia (HR-ALL): A report from the Children’s Oncology Group Study AALL0232.

9504 Background: When compared to PRED, the administration of DEX during Induction has been associated with improved outcomes in patients with ALL. However, DEX has also been associated with an increased risk of osteonecrosis (ON) and when given in combination with an anthracycline has an increased risk of induction mortality. Methods: AALL0232 was a Phase 3, randomized trial for patients 1-30 years of age with NCI high risk B-precursor ALL that utilized a 2 x 2 factorial design with an augmented intensity BFM backbone. Patients were randomized to receive DEX 10 mg/m2/day for 14 days versus PRED 60 mg/m2/day for 28 days during Induction and high dose methotrexate (HD MTX) versus Capizzi escalating methotrexate plus PEG asparaginase (C-MTX-ASNase) during Interim Maintenance 1, forming four arms: DH, DC, PH, and PC. In June 2008, the study was amended to exclude patients > 10 years of age from the Induction steroid randomization due to an excessive incidence of ON. Results: Between January 2004 and Septembe...