Fludarabine and cytarabine as continuous sequential infusion for elderly patients with acute myeloid leukemia.
OBJECTIVE
A phase II study was conducted to investigate the effects of a therapeutic program based on the combination of fludarabine and cytarabine (ARA-C) administered as a sequential continuous infusion in untreated elderly patients with acute myeloid leukemia (AML).


METHODS
Sixty-three patients with non-M3 AML, median age 69 years (range 61-81), were accrued. Twenty-four patients (38%) had AML secondary to myelodysplastic syndrome. Fludarabine and ARA-C were administered as a continuous sequential infusion for 72 and 96 hours, respectively, after a loading dose. Patients achieving complete remission (CR) were intended to receive an additional course, followed by autologous stem cell transplantation (ASCT).


RESULTS
Overall, 42 patients (67%) achieved CR. There were 10 induction deaths (16%), while 11 patients were refractory (17%). Among those achieving a remission, 35 patients (83%) received the planned consolidation course and 29 underwent mobilization of CD34+ cells into the peripheral blood for collection, which was successful in 23 (79%). Overall, 17 patients (27% of the whole population) received ASCT. The median overall and disease-free survival were both 10 months.


CONCLUSIONS
Patients with an intermediate karyotype and those receiving ASCT had a significantly better clinical outcome. Results in terms of CR achievement, CD34+ cell collection and ASCT feasibility. A longer follow up is needed in order to evaluate the actual benefit on long-term survival.
Ferrara
Felicetto
F
Division of Hematology, Cardarelli Hospital, Naples, Italy. felicettoferrara@katamail.com
D'Arco
Alfonso M
AM
De Simone
Mariacarla
M
Mele
Giuseppina
G
Califano
Catello
C
Pocali
Barbara
B
Danise
Paolo
P
Palmieri
Salvatore
S
D000368:Aged; D000369:Aged, 80 and over; D018952:Antigens, CD34 / Q000096:biosynthesis; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003561:Cytarabine / Q000008:administration & dosage*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000150:complications; D033581:Stem Cell Transplantation; D016896:Treatment Outcome; D014740:Vidarabine / Q000008:administration & dosage / Q000031:analogs & derivatives*
D018952:Antigens, CD34; D003561:Cytarabine; D014740:Vidarabine; C024352:fludarabine