Saiz-Rodríguez Miriam, Labrador Jorge, Cuevas Beatriz, Martínez-Cuadrón David, Campuzano Verónica, Alcaraz Raquel, Cano Isabel, Sanz Miguel A, Montesinos Pau
Research Unit, Fundación Burgos por la Investigación de la Salud (FBIS), Hospital Universitario de Burgos, 09006 Burgos, Spain.
Department of Health Sciences, University of Burgos, 09001 Burgos, Spain.
Cancers (Basel). 2021 Nov 12;13(22):5677. doi: 10.3390/cancers13225677.
Irruption of decitabine and azacitidine has led to profound changes in the upfront management of older acute myeloid leukaemia (AML). However, they have not been directly compared in a randomised clinical trial. In addition, there are no studies comparing the optimal treatment schedule of each drug in AML. A systematic review and meta-analysis on the efficacy of decitabine and azacitidine monotherapy in newly diagnosed AML was conducted. Randomised controlled trials and retrospective studies were included. A total of 2743 patients from 23 cohorts were analysed (10 cohorts of azacitidine and 13 of decitabine). Similar response rates were observed for azacitidine (38%, 95% CI: 30-47%) compared to decitabine (40%, 95% CI: 32-48%) ( = 0.825). Overall survival (OS) between azacitidine (10.04 months, 95% CI: 8.36-11.72) and decitabine (8.79 months, 95% CI: 7.62-9.96) was also similar ( = 0.386). Patients treated with azacitidine showed a lower median OS when azacitidine was administered for 5 days (6.28 months, 95% CI: 4.23-8.32) compared to the standard 7-day schedule (10.83 months, 95% CI: 9.07-12.59, = 0.002). Among patients treated with decitabine, response rates and OS were not significantly different between 5-day and 10-day decitabine regimens. Despite heterogeneity between studies, we found no differences in response rates and OS in AML patients treated with azacitidine or decitabine.
地西他滨和阿扎胞苷的出现给老年急性髓系白血病(AML)的初始治疗带来了深刻变化。然而,它们尚未在随机临床试验中进行直接比较。此外,也没有研究比较每种药物在AML中的最佳治疗方案。我们对新诊断AML中地西他滨和阿扎胞苷单药治疗的疗效进行了系统评价和荟萃分析。纳入了随机对照试验和回顾性研究。共分析了来自23个队列的2743例患者(10个阿扎胞苷队列和13个地西他滨队列)。阿扎胞苷的缓解率为38%(95%CI:30 - 47%),地西他滨为40%(95%CI:32 - 48%),两者相似(P = 0.825)。阿扎胞苷组的总生存期(OS)为10.04个月(95%CI:8.36 - 11.72),地西他滨组为8.79个月(95%CI:7.62 - 9.96),也相似(P = 0.386)。与标准的7天给药方案(10.83个月,95%CI:9.07 - 12.59,P = 0.002)相比,阿扎胞苷给药5天时患者的中位OS较低(6.28个月,95%CI:4.23 - 8.32)。在接受地西他滨治疗的患者中,5天和10天地西他滨方案的缓解率和OS无显著差异。尽管研究之间存在异质性,但我们发现接受阿扎胞苷或地西他滨治疗的AML患者在缓解率和OS方面没有差异。