Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.
Cytogenetic Laboratory, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Ospedale Salesi, via F. Corridoni, 11, 60100, Ancona, Italy.
Adv Ther. 2020 May;37(5):2288-2302. doi: 10.1007/s12325-020-01310-4. Epub 2020 Apr 15.
We prospectively tested in a phase II study high-dose aracytin and idarubicin plus amifostine as induction regimen in 149 patients with acute myeloid leukaemia (AML) aged ≥ 60 years, evaluated by a simplified multidimensional geriatric assessment (MGA).
Ninety-one fully or partially fit patients (61%) were allocated to intensive chemotherapy and 58 (39%) frail patients to best supportive care (BSC). Intensively treated patients, showing early death and complete response (CR) rate respectively of 5.5% and 73.6%, received 61 consolidations, followed by autologous transplant (ASCT), stem cell transplantation (SCT) or gemtuzumab ozogamicin, depending on mobilization outcome and donor availability.
The 8-year overall survival (OS) of these patients was 20.4%, with median duration of 11.4 months significantly superior to the 1.5 months of BSC arm (p < 0.001). Hyperleukocytosis and cytogenetics were predictors of survival with a relative risk of 1.8 in patients with poor karyotype without hyperleukocytosis (p = 0.02) and 3 in those with hyperleukocytosis (≥ 50,000/μl) (p = 0.002).
MGA allowed tailored post-consolidation in 53.8% of patients after high-dose aracytin induction, with long-term survival doubling that reported in the literature after standard-dose cytarabine regimens.
The study was registered with the Umin Clinical Trial Registry (www.umin.ac.jp/ctr), number R000014052.
我们前瞻性地在一项 II 期研究中检测了高剂量阿糖胞苷和伊达比星联合氨磷汀作为诱导方案，纳入了 149 名年龄≥60 岁的急性髓系白血病（AML）患者，通过简化的多维老年评估（MGA）进行评估。
91 名完全或部分适合的患者（61%）被分配到强化化疗组，58 名体弱患者（39%）接受最佳支持治疗（BSC）。接受强化治疗的患者早期死亡率和完全缓解（CR）率分别为 5.5%和 73.6%，接受了 61 次巩固治疗，然后根据动员结果和供体可用性进行自体移植（ASCT）、干细胞移植（SCT）或吉妥珠单抗奥佐米星治疗。
这些患者的 8 年总生存率（OS）为 20.4%，中位持续时间为 11.4 个月，明显优于 BSC 组的 1.5 个月（p<0.001）。高白细胞血症和细胞遗传学是生存的预测因素，在无高白细胞血症的不良核型患者中，相对风险为 1.8（p=0.02），在白细胞计数≥50,000/μl 的患者中，相对风险为 3（p=0.002）。
MGA 允许在高剂量阿糖胞苷诱导后对 53.8%的患者进行巩固治疗后的个体化治疗，长期生存时间是标准剂量阿糖胞苷方案后文献报道的两倍。
该研究在 Umin 临床试验注册中心（www.umin.ac.jp/ctr）进行注册，编号为 R000014052。
