AALL0232: dexamethasone and high-dose methotrexate improve outcome in high-risk B-cell acute lymphoblastic leukaemia in children and young adults
In high-risk childhood B-cell acute lymphoblastic leukaemia, high-dose methotrexate beat escalating-dose methotrexate, and dexamethasone beat prednisone in children under 10, defining the backbone still used in Children's Oncology Group trials.
Overview
Phase 3 factorial trial of 3,154 patients aged 1 to 30 with high-risk B-ALL randomised to dexamethasone or prednisone during induction and to high-dose methotrexate or Capizzi escalating methotrexate with asparaginase during interim maintenance.
Five-year event-free survival was 79.6 percent with high-dose methotrexate against 75.2 percent with Capizzi methotrexate; dexamethasone improved event-free survival in patients under 10 (91.2 versus 83.2 percent) but increased osteonecrosis in older patients.
- Five-year event-free survival 79.6 percent (high-dose methotrexate) vs 75.2 percent (Capizzi).
- Dexamethasone benefit in patients under 10; more osteonecrosis in those 10 and over.
High-dose methotrexate interim maintenance and age-adapted steroid choice are standard in high-risk paediatric B-ALL protocols.
- Large factorial design with interactions between the two randomisations.
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