- 2025-02-26
- Clinical cancer research : an official journal of the American Association for Cancer Research 31(8)
- Xiang Zhang
- Yue Han
- Huiying Qiu
- Miaoxinqi Han
- Aining Sun
- Shengli Xue
- Zhengming Jin
- Miao Miao
- Ying Wang
- Chengcheng Fu
- Xiaowen Tang
- Suning Chen
- Caixia Li
- Lian Bai
- Zhihong Lin
- Jun Chen
- Haohao Han
- Jia Chen
- Depei Wu
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 618
- Population
- 618 adult patients with de novo acute myeloid leukemia (AML)
- Methods
- Randomized at a 1:2 ratio to IAC (cladribine 5 mg/m2/day for 5 days, idarubicin 8 mg/m2/day for 3 days, cytarabine 100 mg/m2/day for 7 days) versus IA (idarubicin 12 mg/m2/day for 3 days and cytarabine 100 mg/m2/day for 7 days)
- Blinding
- Open-label
- Duration
- not explicitly stated in terms of follow-up duration; treatment duration described but not total study duration
- Funding
- Unclear
Purpose
To assess the efficacy and safety of an induction regimen composed of idarubicin, cytarabine, and cladribine (IAC) in patients with de novo acute myeloid leukemia (AML).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. The primary endpoint was complete remission (CR) after induction. Secondary endpoints included 2-year overall survival (OS), disease-free survival, and cumulative incidence of relapse.Results
A total of 618 adult patients with newly diagnosed AML were enrolled. The overall CR rate was 80.5% in the IAC group compared with 72.4% in the IA group (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). 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). 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). There were no differences in chemotherapy-related toxicities between the groups.Conclusions
Cladribine added to the IA regimen was safe and effective in de novo AML. 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.