The purpose of this study was to assess the efficacy and toxicity of HAI regimen [(
homoharringtonine 2.5 mg/(m(2)×d), days 1 - 7;
cytarabine 150 mg/(m(2)×d), days 1 - 7;
idarubicin 9 mg/(m(2)×d), days 1 - 7)] for induction treatment of newly diagnosed
acute myeloid leukemia (AML) (except
acute promyelocytic leukemia). 31 patients with newly diagnosed AML, aged 39 (14 - 58) years, were enrolled in this clinical study. The complete remission (CR) rate, especially after one course, the overall survival (OS) rate and relapse free survival (RFS) rate were estimated. The outcomes were compared between different prognostic groups according to World Health Organization (WHO) classification, genetics and initial WBC count. Safety was evaluated using standard WHO criteria. The results showed that 26 patients (84%) achieved CR after 1 course of induction. The CR rate for the patients with favorable, intermediate and unfavorable cytogenetics was 90%, 88% and 60% respectively. All 7 patients with a high initial WBC count (≥ 100×10(9)/L) obtained CR, while 19 out of 24 without a high initial WBC count obtained CR. With a median follow-up of 15(range 2-56) months, the estimated 3-year OS rate for all patients and the patients with CR was 44% and 52% respectively. The 3-year RFS rate was 51%. The patients receiving
induction chemotherapy died of the
chemotherapy. Profound myelosuppression was seen in all patients after the HAI induction with the median duration of
neutropenia (ANC < 0.2×10(9)/L) of 16 (6 - 24) days. As the most common toxicity, severe
infections (grade III-IV) involved in all the patients and the duration of febris was 6 (1 - 36) days. The incidence of septemia and invasive
fungus infection were 19.4% and 45.2% respectively. The incidence of non-
infection fever, increased
glutamic-pyruvic transaminase (GPT),
diarrhea, increased
bilirubin and oral cavity
mucositis were 6.5%, 6.5%, 3.2%, 3.2%, 3.2% respectively, as the more frequent severe non-hematological toxicities. It is concluded that HAI regimen is a high efficient induction schedule for the newly diagnosed AML, and archive the higher CR rate after one course than DNR/
Ara-C standard induction regimen. Side effects are acceptable, except severe
infection.