含不同剂量去甲氧柔红霉素的IA方案诱导治疗成人初发急性髓系白血病的疗效和安全性研究

OBJECTIVE: To investigate the efficacy and safety of IA regimen which contains idarubicin (IDA) 8 mg/m(2), 10 mg/m(2) or 12 mg/m(2) as induction chemotherapy for adult patients with de-novo acute myeloid leukemia (AML). METHODS: A total of 1 215 newly diagnosed adult AML patients, ranging from May 2011 to March 2015 in the First Affiliated Hospital of Soochow University and other 36 clinical blood centers in China were enrolled in the multicenter, single-blind, non-randomized, clinical controlled study. To compare the response rate of complete remission (CR), adverse events between different dose idarubicin combined with cytarabine (100 mg/m(2)) as induction chemotherapy in newly diagnosed patients of adult AML. RESULTS: Of 1 207 evaluable AML patients were assigned to this analysis of CR rate. The CR rates of IDA 8 mg/m(2) group, IDA 10 mg/m(2) group and IDA 12 mg/m(2) group were 73.6% (215/292), 84.1% (662/787) and 86.7% (111/128), respectively (P<0.001). After adjusted for age, blast ratio of bone marrow, FAB classification and risk stratification, the odds ratios (95% CI) of IDA 10 mg/m(2) group and IDA 12 mg/m(2) group were 0.49 (0.34–0.70) and 0.36 (0.18–0.71), as compared with the IDA 8 mg/m(2) group (P<0.001, P=0.003). In the intermediate and favorable groups, CR rates was 76.5% (163/213), 86.9% (506/582) and 86.1% (68/79) in different doses of IDA (P=0.007). Interestingly, IA regimen with IDA 10 mg/m(2) was the only beneficial factor affecting CR in this group after adjusted for age, blast ratio of bone marrow and FAB classification[OR=0.47 (95% CI 0.31–0.71), P<0.001]. CR rates in adverse group was 50.0% (18/36), 60.6% (43/71) and 81.8% (18/22) respectively (P=0.089). However, the odds ratios (95% CI) of IDA 12 mg/m(2) when compared with the IDA 8 mg/m(2) was 0.22 (0.06–0.80), after adjusted for age, blast ratio of bone marrow and FAB classification. The median time (days) of neutrophil count less than 0.5×10(9)/L in IDA 8 mg/m(2) group, IDA 10 mg/m(2) group and IDA 12 mg/m(2) group were 14 (11–18), 15 (11–20) and 18 (14–22), respectively (P=0.012) and of platelet count lower than 20×10(9)/L were 14 (7–17), 15 (11–20) and 17 (15–21), respectively (P=0.001). The incidences of lung infection in the three groups were 9.8%, 13.5% and 25.2%, respectively (P<0.001). CONCLUSION: For young adult patients (aged 18–60 years) with AML in China, intensifying induction therapy with idarubicin 10 mg/m(2) is clinically superior to IDA 8 mg/m(2) and IDA 12 mg/m(2) in favorable intermediate AML subgroup. However, idarubicin 12 mg/m(2) is more suitable to adverse AML subgroup.