Oncol Res Treat. 2018;41(7-8):461-465. doi: 10.1159/000487804. Epub 2018 Jul 6.
Currently, the treatment decisions in elderly patients with acute myeloid leukemia (AML) are difficult and remain controversial. This study aims to evaluate the effect of thalidomide plus chemotherapy on elderly patients with AML.
70 elderly AML patients (median age 71 years) were enrolled into this prospective study and randomly assigned to either the control arm (PC, n = 35) or the investigational arm (TPC, n = 35). Patients in the PC arm received a non-intensive regimen composed of cytarabine, aclarubicin and G-CSF (CAG) chemotherapy for induction of remission, and patients in the TPC arm received in addition thalidomide at a maximum dose of 200 mg/day.
After 2 courses of induction therapy, complete response rate of TPC and PC arms was 54.3% and 57.1%, respectively (p = 0.810). At the last follow-up, the Kaplan-Meier estimate showed that the median overall survival (OS) and event-free survival (EFS) in patients in the PC arm was inferior to those of patients in the TPC arm. Using a stratified Cox model adjusted for randomized treatment, patients receiving thalidomide plus chemotherapy were shown to derive some survival benefit in both OS and EFS. Overall, the hematological and non-hematological toxicity were similar between the 2 treatment arms.
Thalidomide in combination with chemotherapy is an alternative treatment option for elderly patients with AML.
目前，老年急性髓系白血病（AML）患者的治疗决策困难且存在争议。本研究旨在评估沙利度胺联合化疗对老年 AML 患者的疗效。
70 例老年 AML 患者（中位年龄 71 岁）纳入本前瞻性研究，并随机分为对照组（PC 组，n=35）和研究组（TPC 组，n=35）。PC 组患者接受阿糖胞苷、阿克拉霉素和 G-CSF（CAG）非强化方案化疗诱导缓解，TPC 组患者在此基础上每天加用最大剂量 200mg 的沙利度胺。
在 2 个疗程的诱导治疗后，TPC 组和 PC 组的完全缓解率分别为 54.3%和 57.1%（p=0.810）。在最后一次随访时，Kaplan-Meier 估计显示 PC 组患者的总生存（OS）和无事件生存（EFS）中位数均低于 TPC 组患者。采用分层 Cox 模型调整随机治疗因素后，接受沙利度胺联合化疗的患者在 OS 和 EFS 方面均显示出一定的生存获益。总体而言，2 个治疗组的血液学和非血液学毒性相似。
沙利度胺联合化疗是老年 AML 患者的一种替代治疗选择。
