EHA 2020 – ALL: chemotherapy conditioning before stem cell transplantation falls short


  • Deepa Koli
  • Univadis
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Takeaway

  • A radiation-free chemotherapy-based conditioning before hematopoietic stem cell transplantation (HSCT) associated with poorer outcomes in young patients with acute lymphoblastic leukemia (ALL) vs total body irradiation.
  • The trial was stopped early because of futility.

Why this matters

  • Findings suggest that irradiation is necessary despite concerns of its side effects.

Study design

  • Multicenter global FORUM (For Omitting Radiation Under Majority Age) trial.
  • 413 children aged ≥4 years with a matched sibling or unrelated donor for HSCT were randomly assigned to either chemotherapy-based conditioning (fludarabine/thiotepa/busulfan or fludarabine/thiotepa/treosulfan) or total body irradiation/etoposide (radiation group).
  • Funding: None disclosed.

Key results

  • 72% of patients had B-cell precursor ALL and 23% had T-cell ALL.
  • Intent-to-treat population:
    • 2-year OS was 75% in patients assigned to the chemo-conditioning group vs 91% in the radiation group (intention to treat P<.001>
    • 2-year cumulative incidence of relapse was significantly higher in the chemo-conditioning group (33% vs 12%; P<.001>
    • 2-year event-free survival was higher in the total body irradiation group (86% vs 58%; P<.001>
    • 2-year transplant-related mortality was lower in the radiation group (2% vs 9%; P=.02).
  • In per-protocol analysis, 2-year OS was 77% in both chemotherapy groups vs 91% in the total body irradiation group (P=.003).

Limitations

  • Study stopped because of futility.