Autologous stem cell transplantation for acute myeloid leukemia in first remission

We studied the feasibility, toxicity, and efficacy of a 2-step approach to autologous stem cell transplantation for patients with acute myeloid leukem ia in first remission. Step 1 consisted of consolidation chemotherapy inclu ding cytarabine 2000 mg/m(2) twice daily for 4 days concurrent with etoposi de 40 mg/kg by continuous infusion over 4 days. During the recovery from th is chemotherapy, peripheral blood stem cells were collected under granulocy te colony-stimulating factor stimulation. Step 2, autologous stem cell tran splantation, involved the preparative regimen of busulfan 16 mg/kg followed by etoposide 60 mg/kg and reinfusion of unpurged peripheral blood stem cel ls. A total of 128 patients were treated. During step 1, there was 1 treatm ent-related death. A median CD34(+) cell dose of 14 (x10(6)/kg) was collect ed in 3 aphereses. Ten patients suffered relapse before transplantation, an d 117 patients (91%) proceeded to transplantation. During step 2, there wer e 2 treatment-related deaths, and 35 patients subsequently suffered relapse . With median follow-up of 30 months, 5-year disease-free survival for all patients entered in the study is projected to be 55%. By cytogenetic risk g roup, 5-year disease-free survival is 73% for favorable-risk patients, 51% for intermediate-risk patients, and 0% for poor-risk patients. We conclude that this 2-step approach to autologous transplantation produces excellent stem cell yields and allows a high percentage of patients to receive the in tended therapy. Preliminary efficacy analysis is very encouraging, with out comes that appear superior to those of conventional chemotherapy.