Zonguldak Bülent Ecevit University Faculty of Medicine, Department of Hematology, Zonguldak, Türkiye
Kocaeli University Faculty of Medicine, Department of Hematology, Kocaeli, Türkiye
Turk J Haematol. 2023 May 29;40(2):92-100. doi: 10.4274/tjh.galenos.2023.2022.0437. Epub 2023 Feb 17.
This study was undertaken to evaluate the long-term clinical efficacy of epoetin alfa and darbepoetin alfa in patients with myelodysplastic syndrome (MDS) in a 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 needs were recorded before treatment and at 12 months, 24 months, 36 months, and 48 months of treatment.
At the 36-month (p=0.025) and 48-month (p=0.022) visits, epoetin alfa yielded significantly higher hemoglobin levels compared to darbepoetin alfa. Transfusion needs were also significantly lower with epoetin alfa compared to darbepoetin alfa at 24 months (p=0.012) and in the low-risk group compared to the intermediate-risk group at 24 months (p=0.018), 36 months (p=0.025), and 48 months (p<0.001). Treatment response rates at the 24-month, 36-month, and 48-month visits in the epoetin alfa (43.0%, 33.6%, and 27.1%), darbepoetin alfa (29.9%, 22.7%, and 16.5%), low-risk (39.3%, 30.0%, and 26.0%), and intermediate-risk (29.6%, 24.1%, and 11.1%) groups were lower than those obtained at 12 months, and the values differed significantly for the 36-month and 48-month visits with values ranging from p<0.05 to p<0.001.
This real-life long-term ESA extension study investigated the clinical efficacy of epoetin alfa and darbepoetin alfa for up to 48 months, revealing that treatment efficacy reached a plateau starting from the 24 month of therapy with a continuing decrease in treatment response rates regardless of treatment type, risk status, or gender. Nonetheless, significantly higher hemoglobin levels and marked improvement in transfusion needs were evident in epoetin-treated patients compared to darbepoetin-treated patients and in the low-risk group compared to the intermediate-risk group.
本研究旨在评估促红细胞生成素阿尔法和达贝泊汀阿尔法在骨髓增生异常综合征（MDS）患者真实环境中的长期临床疗效。
共纳入 204 例低危或中危-1 级 MDS 患者，接受促红细胞生成素阿尔法或达贝泊汀阿尔法治疗。记录治疗前及治疗 12、24、36、48 个月时的血红蛋白水平和输血需求。
36 个月时（p=0.025）和 48 个月时（p=0.022），促红细胞生成素阿尔法治疗组的血红蛋白水平明显高于达贝泊汀阿尔法治疗组。与达贝泊汀阿尔法治疗组相比，促红细胞生成素阿尔法治疗组在 24 个月时（p=0.012）和低危组在 24、36 和 48 个月时（p=0.018、p=0.025 和 p<0.001）的输血需求也明显降低。24、36 和 48 个月时的治疗反应率在促红细胞生成素阿尔法（43.0%、33.6%和 27.1%）、达贝泊汀阿尔法（29.9%、22.7%和 16.5%）、低危（39.3%、30.0%和 26.0%）和中危（29.6%、24.1%和 11.1%）组均低于 12 个月时，且在 36 和 48 个月时的差异具有统计学意义（p<0.05 至 p<0.001）。
本真实世界长期 ESA 扩展研究调查了促红细胞生成素阿尔法和达贝泊汀阿尔法长达 48 个月的临床疗效，结果表明，治疗疗效从治疗 24 个月开始达到平台期，治疗反应率持续下降，无论治疗类型、风险状况或性别如何。然而，与达贝泊汀阿尔法治疗组和中危组相比，促红细胞生成素阿尔法治疗组的血红蛋白水平显著升高，输血需求明显改善。
