Cladribine Added to Idarubicin and Cytarabine as an Induction Regimen for Patients with De Novo Acute Myeloid Leukemia: A Multicenter, Randomized Phase III Trial.

patients_and_methods

Adult patients with newly diagnosed AML were randomized to the IAC group (cladribine 5 mg/m2/day for 5 days, idarubicin 8 mg/m2/day for 3 days, and cytarabine 100 mg/m2/day for 7 days) and the IA group (idarubicin 12 mg/m2/day for 3 days and cytarabine 100 mg/m2/day for 7 days) at a 1:2 ratio.

新诊断的成人AML患者按1:2的比例随机分配到IAC组（克拉屈滨5 mg/m2/天，连续5天；伊达比星8 mg/m2/天，连续3天；阿糖胞苷100 mg/m2/天，连续7天）和IA组（伊达比星12 mg/m2/天，连续3天；阿糖胞苷100 mg/m2/天，连续7天）。

The primary endpoint was complete remission (CR) after induction.

主要终点是诱导治疗后的完全缓解（CR）

Secondary endpoints included 2-year overall survival(OS), disease-free survival, and cumulative incidenceof relapse.

次要终点包括2年总生存（OS）、无病生存和复发累积发生率

Results

A total of 618 adult patients with newly diagnosed AML were enrolled.

共有618名新诊断的成人急性髓性白血病（AML）患者被纳入研究。

The overall CR rate was 80.5% in the IAC group compared with 72.4% in the IA group (P = 0.029).

IAC组的总体完全缓解（CR）率为80.5%，而IA组为72.4%（P = 0.029）。

The 2-year OS was 81.3% in the IAC group compared with 70.0% in the IA group (P = 0.011).

IAC组的2年总生存率为81.3%，而IA组为70.0%（P = 0.011）。

Patients on the IAC regimen achieved a higher CR rate compared to those on the IA regimen, particularly in those with adverse risk (69.8% vs. 49.1%, P = 0.008), 2-year OS (80.1% vs. IA 58.1%, P = 0.014), and disease-free survival (78.8% vs. 51.3%, P = 0.009).

接受IAC方案治疗的患者与接受IA方案治疗的患者相比，尤其是在具有不良风险特征的患者中，完全缓解（CR）率更高（69.8%对比49.1%，P = 0.008），2年总生存率（80.1%对比IA组的58.1%，P = 0.014），以及无病生存率（78.8%对比51.3%，P = 0.009）。

In the subgroup of patients older than 45 years of age, the IAC regimen exerted better CR (77.1% vs. 62.6%, P = 0.033) and 2-year OS (74.7% vs. IA 55.0%, P = 0.019).

在年龄大于45岁的患者亚组中，IAC方案的完全缓解率（CR）更高（77.1%对比62.6%，P = 0.033），并且2年总生存（OS）也更优（74.7%对比IA方案的55.0%，P = 0.019）。

There were no differences in chemotherapy-related toxicities between the groups.

两组间化疗相关的毒性反应没有差异。

Conclusions

Cladribine added to the IA regimen was safe and effective in de novo AML.

在初发急性髓细胞性白血病（AML）中，将克拉屈滨加入IA方案是安全且有效的。

Patients with adverse risk or those between 45 and 60 years of age might benefit significantly on both response and survival with the IAC regimen.

具有不良风险特征的患者或年龄在45至60岁之间的患者，使用IAC方案在反应和生存方面可能会显著受益。