老年患者包括约75%的急性髓性白血病(AML)患者。如今,在强化化疗后设法达到完全缓解(CR)的老年患者中,预防复发的治疗选择很少。最近的随机对照试验(RCTs)旨在通过CR后维持治疗降低复发风险。
我们对RCT进行了系统评价和荟萃分析,比较了低甲基化药物(HMA)与维持药物的疗效和安全性观察,常规治疗或安慰剂治疗不适合异基因造血移植(allo-HCT)的老年AML患者.我们搜索了科克伦图书馆,截至2021年8月的PubMed和会议程序。
纳入6项试验。低甲基化药物治疗显著改善了总生存率(HR0.80,95%CI0.70~0.91,I2=30%),和疾病控制(HR0.80,95%CI0.70至0.91,I2=0)。1年死亡率(风险比[RR]0.61,95%CI0.48至0.77,I2=0)和随访结束时死亡率(RR0.77,95%CI0.67至0.88,I2=0)均显著下降。HMA组的6个月和1-2年复发率较低。控制(RR,0.59;95%CI,0.47-0.72;RR,0.74,I2=0;95%CI0.69-0.91,I2=41%,分别)。HMA与严重不良事件风险的统计学无显著增加相关(RR3.44,95%CI0.93-12.74,I2=80%)。
我们的荟萃分析显示,在不适合allo-HCT的老年患者中,HMA维持治疗可改善OS和疾病控制,且不良事件无统计学显著增加.
Older patients encompass about 75 % of patients with acute myeloid leukemia (AML). Today therapeutic options to prevent relapse in older patients who managed to achieve complete remission (CR) after intensive chemotherapy are scarce. Recent randomized controlled trials (RCTs) have aimed to reduce the risk of relapse by means of post-CR maintenance therapy.
We performed a systematic
review and meta-analysis of RCTs comparing the efficacy and safety of maintenance with hypomethylating agents (HMA) vs. observation, conventional care or placebo in older patients with AML who are not candidates for allogeneic hematopoietic transplantation (allo-HCT). We searched Cochrane Library, PubMed and conference proceedings up to August 2021.
Six trials were included. Treatment with hypomethylating agents significantly improved overall survival (HR 0.80, 95 % CI 0.70 to 0.91, I2 = 30 %), and disease control (HR 0.80, 95 % CI 0.70 to 0.91, I2 = 0). A significant decrease was seen in both one year mortality (Risk Ratio [RR] 0.61, 95 % CI 0.48 to 0.77, I2 = 0) and mortality at the end of follow-up (RR 0.77, 95 % CI 0.67 to 0.88, I2 = 0). The rate of relapse at 6 months and at one-two years was lower in the HMA arm vs. control (RR, 0.59; 95 % CI, 0.47-0.72; RR, 0.74, I2 = 0; 95 % CI 0.69 - 0.91, I2 = 41 %, respectively). HMA were associated with a statistically non-significant increase in the risk of serious adverse events (RR 3.44, 95 % CI 0.93-12.74, I2 = 80 %).
Our meta-analysis shows that in older patients who are not candidates for allo-HCT, maintenance therapy with HMA improves OS and disease control without a statistically significant increase in adverse events.