IDA-FLAG (idarubicin, fludarabine, cytarabine, G-CSF), an effective remission-induction therapy for poor-prognosis AML of childhood prior to allogeneic or autologous bone marrow transplantation: experiences of a phase II trial |
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Authors: | Fleischhack Hasan Graf Mann & Bode |
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Institution: | Department of Paediatric Haematology/Oncology of University Bonn, Germany,;Department of Paediatric Haematology/Oncology of University Homburg/Saar, Germany,;Department of Paediatric Haematology/Oncology of St Anna Kinderspital Wien, Austria |
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Abstract: | A phase II trial was designed to explore the potential feasibility and efficacy of a reinduction therapy consisting of fludarabine, cytarabine, idarubicin and granulocyte colony stimulating factor (G-CSF) for acute myelogenous leukaemia (AML) patients with poor prognosis. Twenty-three patients aged 1.2–17.5 years with refractory ( n = 3), relapsed ( n = 19) or secondary ( n = 1) AML were treated with the IDA-FLAG regimen, a combination therapy of idarubicin (days 2–4, 12 mg/m2/d), fludarabine (days 1–4, 30 mg/m2/d), cytarabine (days 1–4, 2000 mg/m2/d) and G-CSF (day 0 up to ANC > 1 × 109/l, 400 μg/m2/d). They received a total of 37 courses of IDA-FLAG and/or FLAG (IDA-FLAG without idarubicin). 17/23 patients achieved a complete remission (CR) with a median duration of 13.5 months (1–39 months), one patient showed a partial remission, and five were nonresponders while in CR, 11 patients underwent bone marrow or PBSC (peripheral blood stem cells) transplantation. Overall, nine patients remain in continuous complete remission with a median duration of 17.5 months (9.5–39 months). The toxicity of the IDA-FLAG courses was more severe than for the FLAG courses with marked neutropenia and thrombocytopenia (for IDA-FLAG: median 22.5 and 25 d respectively; for FLAG: median 10.5 and 14 d respectively). Pulmonary infections were the main nonhaematological toxicity. One patient died in CR from invasive aspergillosis. The IDA-FLAG regimen produced a CR of >12 months in more than half of the patients and can be recommended as a therapeutic option prior to allogeneic or autologous bone marrow transplantation. |
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Keywords: | AML resistant AML relapse AML reinduction therapy AML BMT |
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