Prescrire Int. 2009 Dec;18(104):263-6.
(1) New marketing authorizations continue to be granted for treatments of multiple myeloma, and new trials and meta-analyses continue to be published. This review re-examines our previous conclusions based on data published between 2003 and 2008. We again used the standard Prescrire methodology to review the latest data; (2) In patients who are symptomatic but who do not qualify for haematopoietic stem cell transplantation (especially people aged over 65), the results of five comparative trials suggest that adding thalidomide to the melphalan-prednisone combination delays myeloma progression by an additional 5 to 10 months. There is possibly also an increase in overall survival time. This triple combination is therefore a first-line treatment option. There is no firm evidence that replacing thalidomide with bortezomib in this combination provides an advantage; (3) In symptomatic patients aged under 65, two meta-analyses have compared high-dose chemotherapy followed by autologous stem cell transplantation with conventional chemotherapy. Unlike early trials, these meta-analyses showed no overall survival benefit but only a delay in myeloma progression. Initial treatment with two successive transplantation procedures has a negative risk-benefit balance. (4) The optimal chemotherapy regimen prior to autologous stem cell transplantation is controversial. It is unclear which combination (vincristine + doxorubicin + dexamethasone, cyclophosphamide + dexamethasone, cyclophosphamide + dexamethasone, or bortezomib + dexamethasone, etc.) has a better risk-benefit balance in terms of survival and quality of life; (5) According to a meta-analysis of three clinical trials, thalidomide maintenance therapy appears to improve overall survival after Autologous stem cell transplantation; (6) Despite their inadequate evaluation, lenalidomide and pegylated liposomal doxorubicin are licensed for use in patients who relapse or who are refractory to initial treatment. In view of their major adverse effects, we consider that these drugs should only be used in clinical trials.
(1) 多发性骨髓瘤治疗的新上市许可持续获批,新的试验和荟萃分析也不断发表。本综述基于2003年至2008年期间发表的数据重新审视了我们之前的结论。我们再次采用标准的Prescrire方法来评估最新数据;(2) 在有症状但不符合造血干细胞移植条件的患者(尤其是65岁以上人群)中,五项对照试验的结果表明,在美法仑 - 泼尼松组合中添加沙利度胺可使骨髓瘤进展再延迟5至10个月。总体生存时间可能也会增加。因此,这种三联组合是一线治疗选择。没有确凿证据表明在此组合中用硼替佐米替代沙利度胺会带来优势;(3) 在65岁以下的有症状患者中,两项荟萃分析比较了大剂量化疗后自体干细胞移植与传统化疗。与早期试验不同,这些荟萃分析显示总体生存无获益,仅骨髓瘤进展有所延迟。连续两次移植程序作为初始治疗的风险效益比为负;(4) 自体干细胞移植前的最佳化疗方案存在争议。目前尚不清楚哪种组合(长春新碱 + 阿霉素 + 地塞米松、环磷酰胺 + 地塞米松、硼替佐米 + 地塞米松等)在生存和生活质量方面具有更好的风险效益比;(5) 根据三项临床试验的荟萃分析,沙利度胺维持治疗似乎可改善自体干细胞移植后的总体生存;(6) 尽管评估不足,来那度胺和聚乙二醇脂质体阿霉素已获批用于复发或对初始治疗难治的患者。鉴于其主要不良反应,我们认为这些药物仅应在临床试验中使用。