FLAG (FLUDARABINE, CYTOSINE-ARABINOSIDE, G-CSF) FOR REFRACTORY AND RELAPSED ACUTE MYELOID-LEUKEMIA

Twenty-two patients with refractory or relapsed AML were treated with FLAG [25 mg/m(2) fludarabine daily (days 1-5), 2 g/m(2) daily Ara-C (d ays 1-5) and 400 mu g/m(2) daily G-CSF (day -1 till the absolute neutr ophil count was >500/mu l)]. Median age was 46 years (range 24-63). Ei ght patients had leukemia which was primarily refractory to convention al regimens, six were in first, seven were in second, and one was in t hird relapse. Overall, 11 of 22 (50%) patients achieved complete remis sion (CR), three had a partial response (PR), and seven did not respon d (NR). One patient died of an early cerebral hemorrhage. The median r emission duration from achievement of CR after FLAG was 9.9 months and median survival was 13.0 months. One patient is alive in CR at 31.9 m onths. Hematological toxicity of the regimen was severe. The median ti me to neutrophil recovery (ANC >500/mu l) was 21 days (range 18-33). A median of seven red cell units (range 0-22) and of six platelet conce ntrate units (range 3-28) had to be given. Median duration of febrile neutropenia was 2 days (range 0-20 days) and patients were on i.v. ant ibiotics for a median of 16 days (range 0-51). There was no death from infection. Nonhematological toxicity was remarkably low, with almost no neurotoxicity and no major hepatotoxicity. In conclusion, FLAG seem s to be an efficient and well tolerated regimen. It may be particularl y useful for patients who have a sibling or unrelated donor for subseq uent allogeneic bone marrow transplantation.