[A clinical trial for homoharringtonine and low-dose cytosine arabinoside combined with G-CSF or GM-CSF to treat the relapsed or refractory acute myeloid leukemia (AML), geriatric AML and advanced myelodysplastic syndromes].

Objective: To evaluate the effectiveness and toxicity of the regimen combined homoharringtonine, low-dose cytarabine with G-CSF or GM-CSF (HAG regimen) in treating patients with relapsed or refractory AML, geriatric AML and advanced myelodysplastic syndromes (MDS).

Methods: Forty patients with AML or advanced MDS were treated with HAG regimen for remission induction and consolidation therapy. All of them were followed up till April 2006. Results 20 of them (50%) achieved complete remission (CR), including 46.2% patients with relapsed or refractory AML, 60% elderly patients with primary AML who were either untreated or treated with only one course of induction therapy previously, and 66.7% patients with MDS-RAEB. After a follow-up of 6- 47 (median 23) months from the date of remission, the median times of relapse-free survival and overall survival were (7.0 +/- 1.1) and (28 +/- 12.3) months, respectively. Myelosuppression was the most significant toxicity. The incidences of infection and hemorrhage which exceed grade II were 43.8% and 37.5%, respectively. Non-hematologic adverse effects were minimal.

Conclusion: The HAG regimen presented effective and well-tolerated. It seems promising for the treatment of relapsed or refractory AML, geriatric AML and advanced MDS.