Combined low-dose cytarabine, melphalan and mitoxantone for older patients with acute myeloid leukemia or high-risk myelodysplastic syndrome

Background: Low-dose cytarabine (ara-C) has been used to treat older patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS), but has resulted in complete remission for < 20% of cases. A pilot study of the efficacy of a combination chemotherapy using low-dose ara-C, melphalan (Mel), and mitoxantrone (Mit) was conducted. Patients and Methods: The treatment comprised ara-C (10 mg/m(2)) twice daily, melphalan (2 mg/body) every other day, and mitoxantrone (3 mg/m(2)) every 3 days. The treatment was discontinued if the nuclear cell count was < 15,000 mu l with < 20% blast count in the bone marrow. The primary end-points were initial response and tolerability. Results: The study comprised 9 patients with AML or high-risk MDS (median age, 75 years). Complete remission was achieved in 3 patients. All the patients displayed grade 4 neutropenia and thrombocytopenia. One patient died from sepsis. Conclusion: The present regimen was more effective and displayed similar safety, compared with low-dose ara-C alone.