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AIEOP-BFM ALL 2009 long-term results: Reduced dose daunorubicin for pediatric patients with B-cell ALL
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The first randomization in the multicenter AIEOP-BFM ALL 2009 trial (NCT01117441; EudraCT 2007-004270-43) assessed the safety and efficacy of two (EA; n = 1,039) vs four (CA; n = 1,040) doses of daunorubicin during induction in ND pediatric patients aged 1 to <18 years with non-high-risk B-ALL.1 Long-term results from this trial were presented at the 66th ASH Annual Meeting and Exposition by Schrappe.1 |
| Key learnings |
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EFS was similar between patients in the EA vs CA at both 5 years (92.7% vs 92.3%) and 8 years (90.6% vs 91.1%) (p = 0.83). |
| OS was also comparable between patients in the EA vs CA; the 5-year OS was 97.3% vs 97.7% and the 8-year OS was 97.2% vs 97.6% (p = 0.69). |
| The rates of systemic/invasive fungal infections (1.5% vs 0.5%) and sinus venous thrombosis (1.2% vs 0.2%) were higher in the CA vs EA. |
| These results suggest that reducing daunorubicin from two doses to four doses during induction does not comprise efficacy outcomes and may reduce toxicities in ND pediatric patients with B-ALL. |
Abbreviations: ASH, American Society of Hematology; B-ALL, B-cell acute lymphoblastic leukemia; CA, control arm; EA, experimental arm; EFS, event-free survival; ND, newly diagnosed; OS, overall survival.
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