Qiao Shu-Kai, Guo Xiao-Nan, Ren Jin-Hai, Ren Han-Yun
Department of Hematology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei 050000, China.
Chin Med J (Engl). 2015 May 5;128(9):1215-22. doi: 10.4103/0366-6999.156134.
Lenalidomide has emerged as an important treatment for patients with multiple myeloma (MM). However, its role in the management of MM is still controversial and requires further clarification. The aim of this study was to evaluate efficacy and safety of lenalidomide for MM using a meta-analysis.
We searched the electronic databases including: PubMed, EMBASE and the Cochrane Center Register of Controlled Trials. Seven randomized clinical trials were identified, which included a total of 2357 patients with MM who received lenalidomide-containing, noncontaining lenalidomide regimens or placebo as induction therapy or maintenance therapy. The outcomes included overall response (OR) rate, complete response (CR) rate, 3-year progression-free survival (PFS) rate, 3-year overall survival (OS) rate, and different types of treatment-related adverse events. We calculated the risk ratios (RRs) as well as their 95% confidence intervals of these outcomes and pooled the results using RevMan 5.2 software.
For patients with previously untreated MM, OR rate and CR rate was significantly higher in lenalidomide-containing group than the control group. For relapsed or refractory MM patients, lenalidomide-containing regimens significantly improved the OR rate, CR rate, 3-year PFS rate and 3-year OS rate. With regard to MM patients after autologous stem cell transplantation, lenalidomide maintenance therapy significantly improved 3-year PFS rate but did not result in improved 3-year OS rate. In terms of toxicities, lenalidomide therapy has a higher rate of Grade 3-4 grade cytopenias, infection, deep-vein thrombosis, and diarrhea. Furthermore, the incidence of second primary malignancies was significantly higher in the lenalidomide group.
The lenalidomide-containing regimens as induction therapy clearly increased response rates and improved intervals of survival with acceptable toxicity rates for patients with MM. However, when physicians choose to use the lenalidomide as maintenance therapy, whether the benefits outweigh the risks should be taken into account.
来那度胺已成为多发性骨髓瘤（MM）患者的重要治疗方法。然而，其在MM治疗中的作用仍存在争议，需要进一步阐明。本研究的目的是通过荟萃分析评估来那度胺治疗MM的疗效和安全性。
我们检索了电子数据库，包括：PubMed、EMBASE和Cochrane对照试验中心注册库。共识别出7项随机临床试验，其中包括2357例MM患者，他们接受了含来那度胺、不含来那度胺的方案或安慰剂作为诱导治疗或维持治疗。结局指标包括总缓解（OR）率、完全缓解（CR）率、3年无进展生存（PFS）率、3年总生存（OS）率以及不同类型的治疗相关不良事件。我们计算了这些结局指标的风险比（RRs）及其95%置信区间，并使用RevMan 5.2软件汇总结果。
对于既往未治疗的MM患者，含来那度胺组的OR率和CR率显著高于对照组。对于复发或难治性MM患者，含来那度胺方案显著提高了OR率、CR率、3年PFS率和3年OS率。对于自体干细胞移植后的MM患者，来那度胺维持治疗显著提高了3年PFS率，但未提高3年OS率。在毒性方面，来那度胺治疗的3-4级血细胞减少、感染、深静脉血栓形成和腹泻发生率较高。此外，来那度胺组的第二原发性恶性肿瘤发生率显著更高。
含来那度胺方案作为诱导治疗明显提高了MM患者的缓解率，改善了生存时间，且毒性率可接受。然而，当医生选择将来那度胺作为维持治疗时，应考虑其利弊是否相抵。
