RESUMEN
Managing acute myeloid leukemia (AML) is often hampered by repeated failure to achieve complete remission as well as recurrent relapse that causes an emergent need for alternative salvage therapies. The efficacy of most salvage therapies is based on anthracycline combinations. In highly pretreated patients who are not eligible for anthracycline-based protocols therapeutic alternatives are limited. For this particular group we evaluated the efficacy and safety of fludarabine, cytarabine, granulocyte colony-stimulating factor (FLAG) in combination with etoposide (FLAG-Eto) in 36 patients. The complete remission rate (CR) was 25.7% with a median overall survival of 6 months (95% CI 4.5-7.7). The median disease-free survival for CR/CRi/MLFS (CR/CR with incomplete he-matological recovery/morphologic leukemia-free state) patients was 8 months (95% CI 0.6-15.5). The mortality rate on day 30 was 8% and increased on day 60 to 17%. Our results show meaningful anti-leukemic activity of the FLAG-Eto regimen with a moderate toxicity profile in heavily pretreated relapsed/refractory AML patients enabling consolidating allogeneic stem cell transplantation.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Etopósido/administración & dosificación , Leucemia Mieloide Aguda/tratamiento farmacológico , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Citarabina/administración & dosificación , Supervivencia sin Enfermedad , Femenino , Factor Estimulante de Colonias de Granulocitos/administración & dosificación , Hemorragia/etiología , Humanos , Estimación de Kaplan-Meier , Leucemia Mieloide Aguda/mortalidad , Leucemia Mieloide Aguda/patología , Masculino , Persona de Mediana Edad , Recurrencia , Inducción de Remisión , Terapia Recuperativa , Vidarabina/administración & dosificación , Vidarabina/análogos & derivadosRESUMEN
Acute myeloid leukemia (AML) is characterized by a high failure rate to achieve complete remission as well as high relapse rates that cause an emergent need for efficient and tolerable salvage therapies. The combination of FLAG with idarubicin (FLAG-Ida) is a widely used protocol. However, its efficacy has been analyzed in only a limited number of studies with majorly small patient cohorts. Here, we analyzed 132 patients with largely primary refractory or first-time relapsed AML treated according to the FLAG-Ida protocol. The overall complete remission rate (CR + CRi) was 56% with a median overall survival of 15 months (95% CI, 5.7-25.1). The median disease-free survival for CR/CRi-patients was not reached. The mortality rate on day 30 was 9% and increased on day 60 to 16%. Our results show in relapsed/refractory AML patients a high efficacy and compatibility for the FLAG-Ida regimen.
