Ak Muzeyyen Aslaner, Sahip Birsen, Geduk Ayfer, Ucar Mehmer Ali, Kale Hacer, Hacibekiroglu Tugba, Polat Merve Gokcen, Kalpakci Yasin, Bolaman Ali Zahit, Guvenc Birol, Ertop Sehmus
Department of Hematology, Zonguldak Bulent Ecevit University Faculty of Medicine, Incivez, 67100 Zonguldak, Turkey.
Department of Hematology, Kocaeli University Faculty of Medicine, Kocaeli, Turkey.
Indian J Hematol Blood Transfus. 2022 Apr;38(2):299-308. doi: 10.1007/s12288-021-01458-1. Epub 2021 Jun 26.
This study aimed to evaluate the clinical efficacy of epoetin alfa and darbepoetin alfa in patients with myelodysplastic syndromes (MDS) in the real-life setting. A total of 204 patients with low-risk or intermediate-1-risk MDS who received epoetin alfa or darbepoetin alfa were included. Hemoglobin levels and transfusion need were recorded before and during 12-month treatment. Hemoglobin levels were significantly higher at each follow up visit when compared to baseline levels in both epoetin alfa (mean ± SD 8.68 ± 1.0 g/dL at baseline vs. 9.83 ± 1.45, 9.99 ± 1.55, 10.24 ± 1.77 and 10.2 ± 1.5 g/dL, respectively) and darbepoetin alfa (8.83 ± 1.09 g/dL at baseline vs. 9.62 ± 1.37, 9.78 ± 1.49, 9.9 ± 1.39 and 10.1 ± 1.5 g/dL, respectively) groups ( < 0.001 for each). Transfusion need significantly decreased from baseline at each study visit in the epoetin alfa group ( < 0.001) and only at the 12th month visit ( < 0.001) in the darbepoetin alfa group. Hemoglobin levels or transfusion need was similar between treatment groups. Overall, 12-month response rate was 58.1% for epoetin alfa and 41.9% for darbepoetin alfa, with no significant difference between treatment groups, whereas higher response rate was noted within the first three months (62.7%) compared to next 9 months (ranged 44.4-60%) of treatment in the epoetin alfa group ( ranged 0.002 to < 0.001). This real-life retrospective study revealed similar efficacy of epoetin alfa and darbepoetin alfa among low risk or intermediate-1 risk MDS patients with no difference in treatment response between treatment groups, whereas a likelihood of earlier treatment response in the epoetin alfa group.
The online version contains supplementary material available at 10.1007/s12288-021-01458-1.
本研究旨在评估在实际临床环境中,促红细胞生成素α和聚乙二醇化促红细胞生成素α对骨髓增生异常综合征(MDS)患者的临床疗效。共纳入204例接受促红细胞生成素α或聚乙二醇化促红细胞生成素α治疗的低危或中危-1 MDS患者。记录治疗前及12个月治疗期间的血红蛋白水平和输血需求。与基线水平相比,促红细胞生成素α组(基线时平均±标准差为8.68±1.0 g/dL,与之相比分别为9.83±1.45、9.99±1.55、10.24±1.77和10.2±1.5 g/dL)和聚乙二醇化促红细胞生成素α组(基线时8.83±1.09 g/dL,与之相比分别为9.62±1.37、9.78±1.49、9.9±1.39和10.1±1.5 g/dL)在每次随访时血红蛋白水平均显著升高(每组P均<0.001)。促红细胞生成素α组在每次研究访视时输血需求均较基线显著降低(P<0.001),而聚乙二醇化促红细胞生成素α组仅在第12个月访视时输血需求显著降低(P<0.001)。治疗组之间血红蛋白水平或输血需求相似。总体而言,促红细胞生成素α的12个月缓解率为58.1%,聚乙二醇化促红细胞生成素α为41.9%,治疗组之间无显著差异,而促红细胞生成素α组在前三个月的缓解率(62.7%)高于接下来9个月(缓解率范围为44.4%-60%)(P值范围为0.002至<0.001)。这项实际临床回顾性研究显示,促红细胞生成素α和聚乙二醇化促红细胞生成素α在低危或中危-1 MDS患者中的疗效相似,治疗组之间治疗反应无差异,而促红细胞生成素α组有更早出现治疗反应的可能性。
在线版本包含可在10.1007/s12288-021-01458-1获取的补充材料。