Low-dose cytarabine plus aclarubicin for patients with previously untreated acute myeloid leukemia or high-risk myelodysplastic syndrome ineligible for standard-dose cytarabine plus anthracycline.

Background: In order to assess the role of the combination of low-dose cytarabine (Ara-C) plus aclarubicin (CA) in remission induction for patients with untreated acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS), we retrospectively analyzed the efficacy and safety of CA. Patients and Methods: Data of twenty patients with untreated AML or high-risk MDS who were ineligible for standard-dose Ara-C plus anthracycline and received CA as remission- induction therapy were analyzed. CA consisted of low-dose Ara- C (10 mg/m 2 , subcutaneous injection every 12 hours, for 14 days) and aclarubicin (14 mg/m 2 for patients <70 years old and 10 mg/m 2 for patients ≥70 years old in a one-hour infusion for 4 days). Granulocyte colony-stimulating factor (G-CSF) was used from day 1 of CA to white blood cell count (WBC) recovery, except for patients with initial WBC of more than 20.0×10 3 /mm 3 . Results: Eleven patients (55%) achieved complete remission. All four patients whose WBC were ≥20.0×10 3 /mm 3 and did not receive G-CSF were refractory to CA. The predicted 2-year overall survival rate and median survival duration of all 20 patients were 37.9% and 363 days, respectively. The predicted 1-year relapse-free survival (RFS) rate and median duration of RFS of 11 patients who achieved complete remission were 30.3% and 332 days, respectively. Only one patient died due to transfusion-related acute lung injury. No patients died due to severe infections. Conclusion: CA combination with G-CSF as remission-induction therapy is promising and well-tolerated in patients with previously untreated AML or high-risk MDS who are ineligible for standard-dose Ara-C plus anthracycline without leukocytosis. In order to improve RFS, intensive postremission chemotherapy or allogeneic hematopoietic stem cell transplantation should be introduced. Combination of standard-dose cytarabine (Ara-C) plus daunorubicin or idarubicin, named 3+7, is the standard remission-induction therapy for untreated acute myeloid leukemia (AML). The complete remission (CR) rate is