FLAGIDA-lite is an effective regimen for patients between 70 and 80 years with acute myeloid leukemia or refractory anemia with excess blasts-2 and is feasible as outpatient treatment.
We investigated a FLAGIDA-lite protocol (fludarabine 40 mg/m(2)/d orally days 1-5, cytarabine 20 mg/m(2)/d subcutaneously days 1-5, G-CSF 300 μg/d subcutaneously days 1-5, and idarrubicin 15 mg/m(2)/d orally days 1-3) in 38 consecutive patients older than 70 years of age with acute myeloid leukemia (32 patients) or refractory anemia with excess blasts-2 (six patients) and no prior therapy. Seventy-nine percent had intermediate/unfavorable karyotype and 79% had a high comorbidity. Overall response was 55% [complete response (CR) 47%] and 37% were refractory. CR rate was 52% in patients between 71 and 79 years of age and 38% in patients 80 years or older. The 4-week induction mortality was 16% (8% in patients between 70 and 79 years of age and 32% in patients 80 years or older). Overall survival (OS) at 3 years was 22% (31.3% in patients between 70 and 79 years and 15.4% in patients 80 years or older). Relapse-free survival (RFS) at 3 years was 15%. A total of 65 cycles (47 as induction and 18 as consolidation) were administered, 46 of them (70%) in an outpatient setting. In summary, this FLAGIDA-lite protocol is an effective and well-tolerated option for patients between the ages of 70 and 79 years with acute myeloid leukemia or refractory anemia with excess blasts-2 and is usually feasible as outpatient treatment, but is not beneficial for most patients 80 years or older.
Department of Hematology, Hospital Universitario Marqués de Valdecilla, Instituto de Formación e Investigación Marqués de Valdecilla, Spain. mbermudez@humv.es
Arancha
A
Bermúdez
German
G
Pérez-Vázquez
Andres
A
Insunza
Julio
J
Baro
Mercedes
M
Colorado
Eulogio
E
Conde
Zuriñe
Z
Díez-Gallarreta
Maria Luisa
ML
Gutiérrez
Monica
M
López-Duarte
Ignacio
I
Olalla
Pedro
P
Sanroma
Lucrecia
L
Yañez
Arturo
A
Iriondo
Carlos
C
Richard
D000368:Aged; D000369:Aged, 80 and over; D000553:Ambulatory Care; D000754:Anemia, Refractory, with Excess of Blasts / Q000188:drug therapy*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003561:Cytarabine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D011379:Prognosis; D016896:Treatment Outcome; D014740:Vidarabine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
D003561:Cytarabine; D016179:Granulocyte Colony-Stimulating Factor; D014740:Vidarabine; C024352:fludarabine; D015255:Idarubicin