Abstract
BACKGROUND
Postremission therapy is critical in maintaining complete remission (CR) in patients with de novo acute myelogenous leukemia (AML). The aim of this trial was to compare allogeneic stem cell transplantation (SCT), high‐dose cytarabine (ara‐C; HiDAC), and autologous SCT as postremission therapy in patients with de novo AML.
METHODS
One hundred twenty patients age ≤ 60 years with previously untreated AML (non‐M3) and a performance status score of ≤ 2 received induction therapy with 3 days of idarubicin and 7 days of ara‐C (IA). Patients in CR received one course of HiDAC. Subsequently, patients age ≤ 50 years with available HLA‐compatible donors were assigned to receive allogeneic SCT; patients with “favorable” cytogenetics received a second course of HiDAC; and all others were randomized to a second course of HiDAC or autologous SCT.
RESULTS
The IA combination induced CR in 99 patients (82.5%). With a median follow‐up of 43 months (range, 18–64 years), the 3‐year survival and failure‐free survival (FFS) rates were 47% and 45%, respectively. The factors associated with longer survival were those identified for CR (i.e., age and cytogenetics). Forty‐nine patients (49%) received the assigned postremission therapy. Fifteen patients underwent allogeneic SCT. Nineteen patients underwent autologous SCT and 15 patients received a second course of HiDAC, after randomization. In the allogeneic SCT group, both the 3‐year survival and the FFS rates were 73%. In the autologous SCT and HiDAC groups, the 3‐year survival rates were 58% and 46%, respectively (P = 0.80), and the 3‐year FFS rates were 42% and 33%, respectively (P = 0.83).
CONCLUSIONS
The three postremission treatment groups had comparable survival. Allogeneic SCT is associated with a prolonged FFS. Cancer 2003;97:1721–31. © 2003 American Cancer Society.
DOI 10.1002/cncr.11240