EsPhALL: imatinib after induction for children and adolescents with Philadelphia chromosome-positive acute lymphoblastic leukaemia
In this European trial, adding intermittent imatinib to intensive chemotherapy for childhood Philadelphia-positive leukaemia improved disease-free survival in good-risk patients and supported its use in every child with the disease.
Overview
European intergroup study of 178 children with Ph-positive ALL; 108 good-risk patients were randomised to imatinib or no imatinib in addition to BFM-type chemotherapy, and poor-risk patients all received imatinib; most underwent transplant.
Four-year disease-free survival was 72.9 percent with imatinib against 61.7 percent without in good-risk patients (not statistically significant by intention to treat but significant as treated), and toxicity was acceptable.
- Four-year disease-free survival 72.9 percent vs 61.7 percent in good-risk patients.
- Poor-risk patients on imatinib: four-year disease-free survival 53.5 percent.
Together with AALL0031, EsPhALL established kinase inhibitor plus chemotherapy as standard for paediatric Ph-positive ALL, with later trials giving imatinib continuously and reducing transplant.
- Randomisation was stopped early after AALL0031 results; intention-to-treat difference not significant.
- Intermittent imatinib schedule was later replaced by continuous dosing.
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