A new intensive induction schedule, including high-dose Idarubicin, high-dose Aracytin and Amifostine, in older AML patients: feasibility and long-term results in 42 patients.
OBJECTIVE
We evaluated the feasibility of a new regimen in elderly patients with acute myeloid leukemia (AML). The main end points were overall response rate (ORR) and toxicity; secondary end points were feasibility of peripheral blood stem cells (PBSC) collection, leukemia-free survival, and overall survival (OS).


METHODS
We treated 42 fit elderly patients with high-dose (HD) idarubicin plus HD-cytarabine (Ara-C), with amifostine.


RESULTS
We observed one treatment-related death (2%). The main extrahematological toxicity was represented by grade III to IV infections in 64% of patients. Hematological toxicity was acceptable with 15 days (range, 9-29 days) to reach >500 x 10(6)/L absolute neutrophil count and 16 days (range, 3-39 days) to achieve an unsupported platelet count >20,000 x 10(6)/L. Median duration of severe neutropenia was 12 days (range, 1-36) and median number of febrile days and intravenous antibiotics therapy was 6 (range, 0-17) and 17 days (range, 0-34), respectively, Median duration of hospitalization was 31 days (range, 20-61). ORR was 83% (34 of 41); 32 patients received intensive consolidation therapy; 15 patients were able to mobilize a sufficient number of CD34+ cells; and 14 were transplanted.


CONCLUSIONS
According to the intention to treat criteria all patients were analyzed for outcomes. Five-year OS was 19%, with median follow-up of 38 months. Patients with unfavorable cytogenetic and those with secondary AML had poorer OS; about 40% of patients could mobilize a sufficient amount of PBSC for autologous stem cell transplantation.
Olivieri
Attilio
A
Department of Hematology, Medical School, University of Ancona, Ancona, Italy. attilo.olivieri@ospedalesancarlo.it
Capelli
Debora
D
Troiani
Emanuela
E
Poloni
Antonella
A
Montanari
Mauro
M
Offidani
Massimo
M
Discepoli
Giancarlo
G
Leoni
Pietro
P
D000368:Aged; D004999:Amifostine / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003561:Cytarabine / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage / Q000009:adverse effects; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
D003561:Cytarabine; D004999:Amifostine; D015255:Idarubicin