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The treatment of younger adult patients (< 65 years) with acute myeloid leukemia (AML) with induction chemotherapy, including cytarabine (Ara-C) and an anthracycline, has high complete remission (CR) rates, however, approximately 50% of patients relapse within three years.1 The development of an effective salvage therapy for patients with relapsed or refractory (R/R) AML is therefore critical.
Dr. Nahoko Hatsumi from the Saiseikai Maebashi Hospital, Maebashi, Japan, and colleagues published a single arm, multicenter phase II study in the International Journal of Hematology evaluating the efficacy and toxicity of the FLAGM regimen in patients with R/R AML.2 Between June 2004 and February 2008, enrolled patients (n = 41; median age = 52 years; range, 18–64) received the FLAGM regimen, consisting of filgrastim (G-CSF; 300 µg/m2; subcutaneous; at start of regimen and every 24 h thereafter; total doses = 4), fludarabine (15 mg/m2; 30 min infusion; 20 h after start of regimen; every 12 h thereafter; total doses = 8), Ara-C (2 g/m2; 3 h infusion; 4 h after start of fludarabine; every 12 h, total doses = 8), and mitoxantrone (10 mg/m2; daily; 30 min infusion with Ara-C; at 72, 96, and 120 h after regimen start). The primary endpoint of this study was the CR rate following one course of therapy.
Efficacy
Safety
The study investigators concluded that this phase II study showed the FLAGM was an effective and safe salvage therapy option for patients with R/R AML. In addition to this, the authors also demonstrated that the FLAGM regimen enabled a high proportion of patients to receive SCT.
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