Department of Hematology and Bone Marrow Transplantation, University of Ankara, Ankara, Turkey.
Leuk Res. 2011 Mar;35(3):340-5. doi: 10.1016/j.leukres.2010.07.005. Epub 2010 Jul 29.
This prospective multicenter phase III clinical trial was designed to assess efficacy and safety of G-CSF as an adjunct to de novo AML remission induction therapy (www.clinicaltrials.gov. NCT00820976). Patients' characteristics were similar in both arms. G-CSF improved severity and duration of leukopenia. Three-year OS were similar (25.6 ± 5.1% vs. 31.8 ± 5.6%) in both arms except for patients with myeloblastic features. Significant factors for better survival were the use of G-CSF (p=0.049), female sex (p=0.05) and single induction cycle (p<0.001) in multivariate analysis. Female patients performed better than male patients. Better survival obtained among female AML patients needs to be validated within the context of cytogenetic analysis.
这项前瞻性、多中心 III 期临床试验旨在评估 G-CSF 作为新诊断 AML 缓解诱导治疗的辅助治疗的疗效和安全性（www.clinicaltrials.gov. NCT00820976）。两组患者的特征相似。G-CSF 可改善白细胞减少症的严重程度和持续时间。除具有髓样特征的患者外，两组患者的 3 年 OS 相似（25.6±5.1% vs. 31.8±5.6%）。多因素分析显示，更好的生存的显著因素包括使用 G-CSF（p=0.049）、女性（p=0.05）和单次诱导周期（p<0.001）。女性患者的表现优于男性患者。在细胞遗传学分析的背景下，需要验证女性 AML 患者的更好生存。
