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.

Department of Paediatric Haematology/Oncology of University Bonn, Germany.
British Journal of Haematology (Impact Factor: 4.94). 09/1998; 102(3):647-55. DOI: 10.1046/j.1365-2141.1998.00836.x
Source: PubMed

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=11) 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, 2000mg/ m2/d) and G-CSF (day 0 up to ANC > 1 x 10(9)/l, 400 microg/m2/ d). They received a total of 3 7 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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    ABSTRACT: Background: Patients with Refractory/Relapsed (R/R) acute leukemia (AL) have a poor prognosis. Objective: We aimed to evaluate the chemotherapy regimen fludara-bine, cytarabine, granulocyte colony-stimulating factor, and idarubicin (FLAG-IDA) in patients with R/R AL. Patients: We studied 33 patients with R/R AL. Distribu-tion of the AL subtype was: myeloblastic n=17 (52%), lymphoblastic n=14 (42%),) and biphenotypic n=2 (6%). Results: Complete remission (CR) was achieved in 15 cases (45.5%) and seven patients dead resulting in a mortality of 21.1%. In patients with hematological recov-ery the median time to neutrophils recovery (> 0.5 x 10 9 / l) was 24 days (range 10-38); platelet levels of more than 20 x 10 9 /l and 50 x 10 9 /l were reached in a median time of 24 (range 17-44) and 27 days (range 18-51), respectively. After CR, five patients underwent allogeneic transplan-tation and 10 patients received a second course of FLAG-IDA. Ten out of 15 patients who achieved CR with FLAG-IDA relapsed at a median of 7.7 months (95% CI 1.8 to 13.6 months). Overall survival (OS) after FLAG-IDA in the surviving cohort had a median of 4 months. We found a significantly better OS in patients who received allo-geneic transplantation post-FLAG-IDA than those who did not (median 11.4 months vs. 2.7 months; HR 0.29; 95% CI 0.1 to 0.6; p=0.017). Conclusions: In our series, FLAG-IDA demonstrated to be an effective salvage chemo-therapy regimen, however, the benefit in survival of this rescue treatment was restrained to patients who under-went allogeneic transplantation.

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