# AALL0232: dexamethasone and high-dose methotrexate improve outcome in high-risk B-cell acute lymphoblastic leukaemia in children and young adults

Source: https://onco.cc/key-papers/paper-aall0232-larsen-jco-2016/  
OnCo record `paper-aall0232-larsen-jco-2016` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: Journal of Clinical Oncology
- Year: 2016
- DOI: 10.1200/JCO.2015.62.4544
- Authors: Larsen EC, Devidas M, Chen S, et al.
- Findings: 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.
- What it means: High-dose methotrexate interim maintenance and age-adapted steroid choice are standard in high-risk paediatric B-ALL protocols.
- Caveats: Large factorial design with interactions between the two randomisations.

## Sources

- J Clin Oncol 2016: https://doi.org/10.1200/JCO.2015.62.4544
- PubMed: https://pubmed.ncbi.nlm.nih.gov/27114587/

## Connected records

- cancers: [High-risk acute lymphoblastic leukaemia in children (high-risk B-ALL and T-ALL)](https://onco.cc/cancers/all-paediatric-high-risk/)
- drugs: [Dexamethasone](https://onco.cc/drugs/dexamethasone/), [Methotrexate](https://onco.cc/drugs/methotrexate/)
- journals: [Journal of Clinical Oncology](https://onco.cc/journals/jco/)

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