来那度胺治疗伴或不伴5q缺失的低危/中危-1骨髓增生异常综合征的疗效和安全性：一项系统评价和Meta分析
Efficacy and Safety of Lenalidomide for Treatment of Low-/Intermediate-1-Risk Myelodysplastic Syndromes with or without 5q Deletion: A Systematic Review and Meta-Analysis.
作者信息
Lian Xin-Yue, Zhang Zhi-Hui, Deng Zhao-Qun, He Pin-Fang, Yao Dong-Ming, Xu Zi-Jun, Wen Xiang-Mei, Yang Lei, Lin Jiang, Qian Jun
机构信息
Department of Hematology, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, People's Republic of China.
Laboratory Center, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, People's Republic of China.
出版信息
PLoS One. 2016 Nov 8;11(11):e0165948. doi: 10.1371/journal.pone.0165948. eCollection 2016.
BACKGROUND
Lenalidomide could effectively induce red blood cell (RBC) transfusion independence (TI) in patients with lower-risk (Low/Intermediate-1) myelodysplastic syndrome (MDS) with or without 5q deletion. However whether lenalidomide ultimately improves the overall survival (OS) of lower-risk MDS patients and reduces the progression to AML remains controversial.
METHOD
A meta-analysis was conducted to examine the efficacy and safety of lenalidomide in the treatment of lower-risk MDS. Efficacy was assessed according to erythroid hematologic response (HI-E), cytogenetic response (CyR), OS and AML progression. Safety was evaluated based on the occurrence rates of grades 3-4 adverse events (AEs).
RESULTS
Seventeen studies were included consisting of a total of 2160 patients. The analysis indicated that the overall rate of HI-E was 58% with 95% confidence interval (CI) of 43-74%. The pooled estimates for the rates of CyR, complete CyR, and partial CyR were 44% (95% CI 19-68%), 21% (95% CI 13-30%) and 23% (95% CI 15-32%), respectively. The patients with 5q deletion had significantly higher rate of HI-E and CyR than those without 5q deletion (P = 0.002 and 0.001, respectively). The incidences of grades 3-4 neutropenia, thrombocytopenia, leukopenia, anemia, deep vein thrombosis, diarrhea, fatigue and rash were 51% (95% CI 30-73%), 31% (95% CI 20-42%), 9% (95% CI 5-13%), 7% (95% CI 2-12%), 3% (95% CI 2-5%), 3% (95% CI 1-5%), 2% (95% CI 1-4%) and 2% (95% CI 1-3%), respectively. Lenalidomide significantly improved OS (HR: 0.62, 95% CI 0.47-0.83, P = 0.001) and lowered the risk of AML progression in del(5q) patients (RR: 0.61, 95% CI 0.41-0.91, P = 0.014).
CONCLUSIONS
In spite of the AEs, lenalidomide could be effectively and safely used for the treatment of lower-risk MDS patients with or without 5q deletion.
背景
来那度胺可有效诱导低危（低危/中危1）骨髓增生异常综合征（MDS）患者（无论有无5q缺失）实现红细胞（RBC）输注独立（TI）。然而，来那度胺能否最终改善低危MDS患者的总生存期（OS）并降低进展为急性髓系白血病（AML）的风险仍存在争议。
方法
进行一项荟萃分析以检验来那度胺治疗低危MDS的疗效和安全性。根据红系血液学反应（HI-E）、细胞遗传学反应（CyR）、OS和AML进展评估疗效。基于3-4级不良事件（AE）的发生率评估安全性。
结果
纳入17项研究，共2160例患者。分析表明，HI-E的总体发生率为58%，95%置信区间（CI）为43%-74%。CyR、完全CyR和部分CyR发生率的合并估计值分别为44%（95%CI 19%-68%）、21%（95%CI 13%-30%）和23%（95%CI 15%-32%）。有5q缺失的患者HI-E和CyR发生率显著高于无5q缺失的患者（P分别为0.002和0.001）。3-4级中性粒细胞减少、血小板减少、白细胞减少、贫血、深静脉血栓形成、腹泻、疲劳和皮疹的发生率分别为51%（95%CI 30%-73%）、31%（95%CI 20%-42%）、9%（95%CI 5%-13%）、7%（95%CI 2%-12%）、3%（95%CI 2%-5%）、3%（95%CI 1%-5%）、2%（95%CI 1%-4%）和2%（95%CI 1%-3%）。来那度胺显著改善OS（风险比：0.62，95%CI 0.47-0.83，P = 0.001）并降低del(5q)患者AML进展的风险（相对危险度：0.61，95%CI 0.41-0.91，P = 0.014）。
结论
尽管存在不良事件，但来那度胺可有效且安全地用于治疗有或无5q缺失的低危MDS患者。
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