Objective: To explore outcomes in adult with de novo acute myeloid leukemia (AML) received IA10 (10 mg/m(2) d1-3 idarubicin plus cytarabine 100 mg/m(2) d1-7) regimen as induction chemotherapy. Methods: From January 2008 to February 2016, data of consecutive newly-diagnosed AML (non-M(3)) adults treated with IA10 who achieved morphologic leukemia-free state (MLFS) but not accepted allogeneic hematopoietic stem cell transplantation (allo-HSCT) were assessed retrospectively. Results: A total of 198 patients were included in this study with 96 (48.5%) male and a median age of 42 years old (range, 18-62 years old). Using the SWOG cytogenetic classification, 45 (22.7%), 104 (52.5%), 24 (12.1%) and 25 (12.6%) patients belonged to favorable, intermediate, unfavorable and unknown categories, respectively. 6 (3.0%) patients had monosomal karyotype, and 28 (14.1%) positive FLT3-ITD mutation. A complete remission (CR, defined as MLFS with ANC ≥ 1×10(9)/L and PLT ≥ 100×10(9)/L) achieved in 168 (84.8%) patients, a CRp (defined as MLFS with incomplete PLT recovery) in 16 (8.1%) and a CRi (defined as MLFS with incomplete ANC and PLT recovery) in 14 (7.1%). With a median follow-up period of 15 months (range, 1 to 70 months) in survivors, the probabilities of cumulative incident of relapse (CIR), disease free survival (DFS) and overall survival (OS) rates at 2-year were 45.2%, 46.9% and 62.9%, respectively; the median durations of relapse, DFS and OS were 34, 20 and 37 months respectively. At the time of achieving first MLFS, multivariate analyses showed that positive FLT3-ITD mutation and CRi were common adverse factors affecting CIR, DFS and OS; unfavorable-risk of SWOG criteria was an adverse factor affecting CIR and DFS; monosomal karyotype was associated with shorter OS. After first consolidation therapy, FLT3-ITD mutation positive and unfavorable-risk of SWOG criteria had negatively impact on CIR, DFS and OS; peripheral blasts ≥ 0.50 and positive MRD (defined as RQ-PCR WT1 mRNA ≥ 0.6% or any level of abnormal blast population detected by flow cytometry) after first consolidation therapy were common adverse factors affecting CIR and DFS; CRi was an adverse factor affecting DFS and OS. Conclusions: In adult with de novo AML received IA10 regimen as induction regimen, unfavorable molecular markers or cytogenetics at diagnosis and CRi independently predicted poor outcome. In addition, a higher percentage of peripheral blasts, monosomal karyotype and positive MRD after first consolidation therapy had negatively impact on outcomes.
目的： 探讨接受IA10[去甲氧柔红霉素（IDA）10 mg·m(-2)·d(-1)×3 d联合阿糖胞苷（Ara-C）100 mg·m(-2)·d(-1)×7 d]作为诱导方案且未接受异基因造血干细胞移植（allo-HSCT）的成人急性髓系白血病（AML）患者的预后影响因素。 方法： 回顾2008年1月至2016年2月收治的接受IA10作为诱导化疗方案、获得形态学无白血病状态（MLFS）后未接受allo-HSCT的198例AML（不包括急性早幼粒细胞白血病）连续病例，分析诊断时特征、首次获得MLFS时血细胞恢复程度、首次获得MLFS时和巩固1个疗程后微小残留病（MRD）水平对预后的影响。 结果： 198例患者中，男96例（48.5%），中位年龄42（18~62）岁。SWOG分组：低危45例（22.7%），中危104例（52.5%），高危24例（12.1%），危险度未知25例（12.6%）。FLT3-ITD突变阳性28例（14.1%）。完全缓解（CR，MLFS伴ANC≥1×10(9)/L和PLT≥100×10(9)/L）168例（84.8%），CRp（MLFS伴PLT未恢复）16例（8.1%），CRi（MLFS伴ANC和PLT均未恢复）14例（7.1%）。131例（66.2%）存活患者中位随访时间15（1~70）个月，2年累积复发率（CIR）、无病生存（DFS）、总生存（OS）率分别为45.2%、46.9%、62.9%,中位复发、DFS、OS时间分别为34、20、37个月。在所有获得MLFS的患者中进行多因素分析，FLT3-ITD突变阳性和CRi是影响患者CIR、DFS、OS的共同不利因素；SWOG危险度为高危是影响患者CIR和DFS的共同不利因素；单体核型是影响患者OS的独立危险因素。分析接受巩固治疗≥1个疗程的患者，FLT3-ITD突变阳性和SWOG危险度为高危是影响患者CIR、DFS、OS的共同不利因素；外周血原始细胞≥0.50和巩固治疗1个疗程后MRD阳性[FCM和（或）WT1 mRNA阳性]是影响患者CIR和DFS的共同不利因素；CRi是影响患者DFS和OS的共同不利因素。 结论： 对于接受IA10作为诱导方案且获得MLFS后未接受allo-HSCT的初治成人AML患者，初诊时不良的遗传学特征和CRi是影响患者总体预后的不利因素。此外，外周血原始细胞比例高、单体核型和巩固治疗1个疗程后MRD阳性也与预后不良相关。.
Keywords: Idarubicin; Leukemia, myeloid, acute; Prognosis.