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). Patients and 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 × 106/L absolute neutrophil count and 16 days (range, 3–39 days) to achieve an unsupported platelet count >20,000 × 106/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. Conclusion 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.