Department of Hematology, Anhui Medical University Affiliated Anhui Provincial Hospital, Hefei, Anhui 230001, China.
Ann Hematol. 2012 Nov;91(11):1779-84. doi: 10.1007/s00277-012-1520-4. Epub 2012 Jul 7.
The aim of the study was to perform a meta-analysis of the efficacy and safety of (bortezomib plus lenalidomide/thalidomide)- vs. (bortezomib or lenalidomide/thalidomide)-containing regimens as induction therapy in newly diagnosed multiple myeloma. We searched electronic and printed sources for relevant articles published. Inclusion criteria was as follows: randomized controlled trials (RCT) of (bortezomib plus lenalidomide/thalidomide) vs. (bortezomib or lenalidomide/thalidomide)-containing regimens as induction therapy in newly diagnosed multiple myeloma. Two reviewers independently assessed potentially eligible studies and extracted relevant data. We retrieved five RCT studies including a total of 1,200 patients. Using the random-effects model to pool the five RCT with a statistically significant heterogeneity (P = 0.03; X² = 10.69; df = 4; I² = 63%), the weighted risk ratios of a complete response (CR) for (bortezomib plus lenalidomide/thalidomide)-containing regimens was 1.81 (P = 0.005; 95% CI: 1.20-2.73). When we excluded the study by Cavo et al. (Lancet 376:2075-2085, 2010), the pooled risk ratio for CR was 1.59 (P < 0.0001, 95% CI: 1.29-1.96) with no statistically significant heterogeneity (P = 0.54; X² = 2.14; df = 3; I² = 0%) among four RCT under the fixed effects mode. The pooled odds ratio for the main grade III/IV adverse events (the peripheral neuropathy, thrombotic events, and infections) were 1.76 (P = 0.32; 95% CI: 0.58-5.31), 0.92 (P = 0.76, 95% CI: 0.52-1.61), and 1.05 (P = 0.82, 95% CI: 0.70-1.57), respectively. Our analysis showed (bortezomib plus lenalidomide/thalidomide)-containing regimens as induction treatment in newly diagnosed multiple myeloma improved CR but did not increase the risk of major adverse events (the peripheral neuropathy, thrombotic events, and infections).
本研究的目的是对新诊断多发性骨髓瘤患者中硼替佐米联合来那度胺/沙利度胺与硼替佐米或来那度胺/沙利度胺方案作为诱导治疗的疗效和安全性进行荟萃分析。我们检索了电子和印刷来源的相关文章。纳入标准如下：新诊断多发性骨髓瘤患者中硼替佐米联合来那度胺/沙利度胺与硼替佐米或来那度胺/沙利度胺方案作为诱导治疗的随机对照试验（RCT）。两名审查员独立评估了潜在合格的研究并提取了相关数据。我们检索了 5 项 RCT 研究，共纳入 1200 例患者。使用随机效应模型对具有统计学显著异质性的 5 项 RCT（P = 0.03；X² = 10.69；df = 4；I² = 63%）进行合并，硼替佐米联合来那度胺/沙利度胺方案完全缓解（CR）的加权风险比为 1.81（P = 0.005；95%CI：1.20-2.73）。当我们排除 Cavo 等人的研究（Lancet 376:2075-2085, 2010）时，CR 的合并风险比为 1.59（P < 0.0001，95%CI：1.29-1.96），固定效应模型下四项 RCT 之间无统计学显著异质性（P = 0.54；X² = 2.14；df = 3；I² = 0%）。主要 3/4 级不良事件（周围神经病变、血栓事件和感染）的合并优势比为 1.76（P = 0.32；95%CI：0.58-5.31）、0.92（P = 0.76，95%CI：0.52-1.61）和 1.05（P = 0.82，95%CI：0.70-1.57）。我们的分析表明，硼替佐米联合来那度胺/沙利度胺作为新诊断多发性骨髓瘤的诱导治疗可提高 CR，但不会增加主要不良事件（周围神经病变、血栓事件和感染）的风险。
