Pharmacy Department, Hospital Doctor Jose Molina Orosa, Arrecife, Spain.
Pharmacology Department, Facultad de Farmacia, Universidad de Sevilla, Sevilla, Spain.
Eur J Haematol. 2020 Jul;105(1):56-65. doi: 10.1111/ejh.13407. Epub 2020 Mar 15.
Multiple myeloma (MM) is a complex disease. Lack of direct comparisons among treatments and incorporation of new alternatives make it necessary to perform studies that allow for clinical decision-making. A network meta-analysis (NMA) was developed to evaluate the comparative efficacy among different therapeutic alternatives in newly diagnosed transplant-ineligible MM patients.
MEDLINE and EMBASE were systematically searched up for these drugs: lenalidomide, thalidomide, bortezomib, and daratumumab. Comparative phase II-III randomized clinical trials (RCTs) were included. Progression-free survival (PFS) was selected as efficacy outcome. The NMA was developed using Bayesian methods. Fixed- and random-effects models were assessed using deviance information criteria.
The systematic search yielded 593 results. Ten RCTs were included. No differences were observed between fixed- and random-effects models. The combination of daratumumab, bortezomib, melphalan, and prednisone showed the best HR in PFS (reference treatment). Along with this scheme, the best PFS results were obtained by combination of daratumumab, lenalidomide, and dexamethasone (HR 1.2, 95% CrI 0.64-2.4) and bortezomib with lenalidomide and dexamethasone (HR 1.6, 95% CrI 0.81-3.0).
Schemes with the best PFS results were daratumumab treatments and combination of bortezomib, lenalidomide, and dexamethasone, although the latter scheme has been analyzed in heterogeneous populations.
多发性骨髓瘤（MM）是一种复杂的疾病。由于缺乏对各种治疗方法的直接比较，且新的治疗选择不断涌现，因此有必要开展研究以辅助临床决策。本研究采用网状荟萃分析（NMA）来评估不适合移植的新诊断 MM 患者的不同治疗选择之间的比较疗效。
系统检索了 MEDLINE 和 EMBASE 中这些药物的相关文献：来那度胺、沙利度胺、硼替佐米和达雷妥尤单抗。纳入了比较 II-III 期随机对照临床试验（RCT）。无进展生存期（PFS）被选为疗效结局。采用贝叶斯方法进行 NMA。采用偏差信息准则评估固定效应和随机效应模型。
系统检索共得到 593 项结果，其中纳入了 10 项 RCT。固定效应和随机效应模型之间没有差异。达雷妥尤单抗、硼替佐米、美法仑和泼尼松联合方案的 PFS 风险比（HR）最高（参照治疗）。在这个方案基础上，达雷妥尤单抗、来那度胺和地塞米松联合方案（HR 1.2，95%可信区间 0.64-2.4）和硼替佐米、来那度胺和地塞米松联合方案（HR 1.6，95%可信区间 0.81-3.0）的 PFS 结果最好。
达雷妥尤单抗治疗方案和硼替佐米、来那度胺和地塞米松联合方案的 PFS 结果最好，尽管后者的方案在异质人群中进行了分析。
